Federal Register, Volume 78 Issue 11 (Wednesday, January 16, 2013)

[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Proposed Rules]
[Pages 3504-3646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00123]

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Vol. 78

Wednesday,

No. 11

January 16, 2013

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 1, 16, 106, Et al.

Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption; Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for Human Food; Draft
Qualitative Risk Assessment of Risk of Activity/Food Combinations for
Activities (Outside the Farm Definition) Conducted in a Facility Co-
Located on a Farm; Availability; Proposed Rules

Federal Register / Vol. 78 , No. 11 / Wednesday, January 16, 2013 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 112

[Docket No. FDA-2011-N-0921]
RIN 0910-AG35

Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: To minimize the risk of serious adverse health consequences or
death from consumption of contaminated produce, the Food and Drug
Administration (FDA) is proposing to establish science-based minimum
standards for the safe growing, harvesting, packing, and holding of
produce, meaning fruits and vegetables grown for human consumption. FDA
is proposing these standards as part of our implementation of the FDA
Food Safety Modernization Act (FSMA). These standards would not apply
to produce that is rarely consumed raw, produce for personal or on-farm
consumption, or produce that is not a raw agricultural commodity. In
addition, produce that receives commercial processing that adequately
reduces the presence of microorganisms of public health significance
would be eligible for exemption from the requirements of this rule. The
proposed rule would set forth procedures, processes, and practices that
minimize the risk of serious adverse health consequences or death,
including those reasonably necessary to prevent the introduction of
known or reasonably foreseeable biological hazards into or onto produce
and to provide reasonable assurances that the produce is not
adulterated on account of such hazards. We expect that the proposed
rule, if finalized as proposed, would reduce foodborne illness
associated with the consumption of contaminated produce.

DATES: Submit either electronic or written comments on the proposed
rule by May 16, 2013. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by February 15, 2013 (see the
``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0921 and/or Regulatory Information Number RIN 0910-AG35, by any of
the following methods, except that comments on information collection
issues under the Paperwork Reduction Act of 1995 must be submitted to
the Office of Regulatory Affairs, Office of Management and Budget (OMB)
(see the ``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-N-0921 and Regulatory Information Number RIN
0910-AG35 for this rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-1636.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
Proposed Rule
I. Introduction
A. Contamination With Microbiological Hazards
B. Contamination With Chemical, Physical or Radiological Hazards
II. Efforts To Address Produce Safety
A. Inspections and Investigations
B. Guidance Documents and Letters to Industry
C. Produce Safety Action Plan
D. Public Hearings
E. Partnerships and Collaborations
F. Current Industry Practices
G. 2010 Federal Register Notice and Preliminary Stakeholder
Comments
H. White House Food Safety Working Group
I. Other Related Issues
III. Legal Authority
A. Section 105 of FSMA and Section 419 of the FD&C Act
B. Other Provisions of the FD&C Act
C. The Public Health Service Act
D. Legal Authority for Records Requirements
E. Intrastate Activities
F. Relevance of Section 415 of the FD&C Act to ``Farm''
Definition and Related Definitions
IV. Regulatory Approach
A. Qualitative Assessment of Risk
B. Focus on Biological Hazards
C. Consideration of Differing Risk of Different Commodities and
Practices
D. Framework of the Rule
E. Records
F. Farm-specific Food Safety Plans
G. Foreign Farms
H. Consistency With Codex Guidelines
I. Product Testing as a Strategy to Control Pathogens
J. Effective Dates
K. Compliance Dates
V. The Proposal
A. Subpart A--General Provisions
B. Subpart B--General Requirements
C. Subpart C--Standards Directed to Personnel Qualifications and
Training
D. Subpart D--Standards Directed to Health and Hygiene
E. Subpart E--Standards Directed to Agricultural Water
F. Subpart F--Standards Directed to Biological Soil Amendments
of Animal Origin and Human Waste
G. Reserved
H. Reserved
I. Subpart I--Standards Directed to Domesticated and Wild
Animals
J. Reserved
K. Subpart K--Standards Directed to Growing, Harvesting, Packing
and Holding Activities
L. Subpart L--Standards Directed to Equipment, Tools, Buildings,
and Sanitation
M. Subpart M--Standards Directed to Sprouts
N. Subpart N--Analytical Methods
O. Subpart O--Requirements Applying to Records That You Must
Establish and Keep
P. Subpart P--Variances
Q. Subpart Q--Compliance and Enforcement
R. Subpart R--Withdrawal of Qualified Exemption
VI. Preliminary Regulatory Impact Analysis
VII. Analysis Of Environmental Impact
VIII. Federalism
IX. Comments
X. References

Executive Summary

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
requires FDA to publish a notice of proposed rulemaking to establish
science-based

[[Page 3505]]

minimum standards for the safe production and harvesting of those types
of fruits and vegetables that are raw agricultural commodities for
which we have determined such standards minimize the risk of serious
adverse health consequences or death. Further, new section 419 also
requires FDA to adopt a final regulation based on known safety risks,
setting forth procedures, processes, and practices that we determine to
minimize the risk of serious adverse health consequences or death,
including those that are reasonably necessary to prevent the
introduction of known or reasonably foreseeable hazards into produce
and to provide reasonable assurances that produce is not adulterated
under section 402 of the FD&C Act.
This proposed rule focuses on microbiological hazards related to
produce growing, harvesting, packing, and holding. We conducted a
``Draft Qualitative Assessment of Risk to Public Health from On-Farm
Contamination of Produce'' and considered the findings of this
assessment in developing this proposed rule. While we acknowledge the
potential for chemical, physical or radiological contamination of
produce, for reasons discussed in this proposed rule, we are not
proposing specific standards for these hazards in this rulemaking.

Scope of Coverage of the Proposed Rule

The proposed rule would apply to both domestic and imported
produce. However, as explained in the remainder of this document, the
proposed rule contains several exemptions:
The proposed rule would not apply to certain specified
produce commodities that are rarely consumed raw.
The proposed rule also would not apply to produce that is
used for personal or on-farm consumption, or that is not a raw
agricultural commodity.
The proposed rule would provide an exemption for produce
that receives commercial processing that adequately reduces the
presence of microorganisms (e.g. a ``kill step'') as long as certain
documentation is kept.
The proposed rule would not cover farms that have an
average annual value of food sold during the previous three-year period
of $25,000 or less.
The proposed rule would provide a qualified exemption and
modified requirements for farms that meet two requirements: (1) The
farm must have food sales averaging less than $500,000 per year during
the last three years; and (2) the farm's sales to qualified end-users
must exceed sales to others. A qualified end-user is either (a) the
consumer of the food or (b) a restaurant or retail food establishment
that is located in the same State as the farm or not more than 275
miles away. Instead, these farms would be required to include their
name and complete business address either on the label of the produce
that would otherwise be covered (if a label is required under the FD&C
Act and its implementing regulations) or at the point-of-purchase. This
exemption may be withdrawn in the event of an active investigation of
an outbreak that is directly linked to the farm, or if it is necessary
to protect the public health and prevent or mitigate an outbreak based
on conduct or conditions on the farm that are material to the safety of
the produce. As explained in the Preamble, these entities are either
exempt from all the requirements of the rule or are subject to a
narrower set of requirements.

Summary of the Major Provisions of the Regulatory Action

The proposed rule would establish science-based minimum standards
for the safe growing, harvesting, packing, and holding of produce on
farms. We propose new standards in the following major areas:
Worker Training and Heath and Hygiene
[cir] Establish qualification and training requirements for all
personnel who handle (contact) covered produce or food-contact surfaces
and their supervisors (proposed Sec. Sec. 112.21, 112.22, and 112.23);
[cir] Require documentation of required training (proposed Sec.
112.30); and
[cir] Establish hygienic practices and other measures needed to
prevent persons, including visitors, from contaminating produce with
microorganisms of public health significance (proposed Sec. Sec.
112.31, 112.32, and 112.33).
Agricultural Water
[cir] Require that all agricultural water must be of safe and
sanitary quality for its intended use (proposed Sec. 112.41).
Agricultural water is defined in part as water that is intended to, or
likely to, contact the harvestable portion of covered produce or food-
contact surfaces (proposed Sec. 112.3(c));
[cir] Establish requirements for inspection, maintenance, and
follow-up actions related to the use of agricultural water, water
sources, and water distribution systems associated with growing,
harvesting, packing, and holding of covered produce (proposed
Sec. Sec. 112.42 and 112.46);
[cir] Require treatment of agricultural water if you know or have
reason to believe that the water is not safe and of adequate sanitary
quality for its intended use, including requirements for treating such
water and monitoring its treatment (proposed Sec. 112.43);
[cir] Establish specific requirements for the quality of
agricultural water that is used for certain specified purposes,
including provisions requiring periodic analytical testing of such
water (with exemptions provided for use of public water supplies under
certain specified conditions or treated water), and requiring certain
actions to be taken when such water does not meet the quality standards
(proposed Sec. Sec. 112.44 and 112.45); and provide for alternative
requirements for certain provisions under certain conditions (proposed
Sec. 112.12); and
[cir] Require certain records, including documentation of
inspection findings, scientific data or information relied on to
support the adequacy of water treatment methods, treatment monitoring
results, water testing results, and scientific data or information
relied on to support any permitted alternatives to requirements
(proposed Sec. 112.50).
Biological Soil Amendments
[cir] Establish requirements for determining the status of a
biological soil amendment of animal origin as treated or untreated, and
for their handling, conveying, and storing (proposed Sec. Sec. 112.51,
112.52)
[cir] Prohibit the use of human waste for growing covered produce
except in compliance with EPA regulations for such uses or equivalent
regulatory requirements (proposed Sec. 112.53);
[cir] Establish requirements for treatment of biological soil
amendments of animal origin with scientifically valid, controlled,
physical and/or chemical processes or composting processes that satisfy
certain specific microbial standards (proposed Sec. Sec. 112.54 and
112.55); and provide for alternative requirements for certain
provisions under certain conditions (proposed Sec. 112.12);
[cir] Establish application requirements and minimum application
intervals for untreated and treated biological soil amendments of
animal origin (proposed Sec. 112.56); and provide for alternative
requirements for certain provisions under certain conditions (proposed
Sec. 112.12); and
[cir] Require certain records, including documentation of
application and harvest dates relevant to application intervals;
documentation from suppliers of treated biological soil amendments of
animal origin, periodic test results, and scientific data or
information relied on to support any permitted alternatives to
requirements (proposed Sec. 112.60).

[[Page 3506]]

Domesticated and Wild Animals
[cir] If animals are allowed to graze or are used as working
animals in fields where covered produce is grown and under the
circumstances there is a reasonable probability that grazing or working
animals will contaminate covered produce, require, at a minimum, an
adequate waiting period between grazing and harvesting for covered
produce in any growing area that was grazed, and measures to prevent
the introduction of known or reasonably foreseeable hazards into or
onto covered produce (proposed Sec. 112.82); and
[cir] If under the circumstances there is a reasonable probability
that animal intrusion will contaminate covered produce, require
monitoring of those areas that are used for a covered activity for
evidence of animal intrusion immediately prior to harvest and, as
needed, during the growing season (proposed Sec. 112.83).
Equipment, Tools, and Buildings
[cir] Establish requirements related to equipment and tools that
contact covered produce and instruments and controls (including
equipment used in transport), buildings, domesticated animals in and
around fully-enclosed buildings, pest control, hand-washing and toilet
facilities, sewage, trash, plumbing, and animal excreta (proposed
Sec. Sec. 112.121-134); and
[cir] Require certain records related to the date and method of
cleaning and sanitizing equipment used in growing operations for
sprouts, and in covered harvesting, packing, or holding activities
(proposed Sec. 112.140).
Sprouts
[cir] Establish measures that must be taken related to seeds or
beans for sprouting (proposed Sec. 112.141);
[cir] Establish measures that must be taken for the growing,
harvesting, packing, and holding of sprouts (proposed Sec. 112.142);
[cir] Require that you test the growing environment for Listeria
spp. or L. monocytogenes and that you test each production batch of
spent irrigation water or sprouts for E. coli O157:H7 and Salmonella
species and take appropriate follow-up actions (proposed Sec. Sec.
112.143, 112.144, 112.145, 112.146); and
[cir] Require certain records, including documentation of your
treatment of seeds or beans for sprouting, a written environmental
monitoring plan and sampling plan, test results, and certain methods
used (proposed Sec. 112.150).
As proposed, the effective date is 60 days after a final rule is
published, however, we are providing for a longer timeline for farms to
come into compliance. Small businesses (i.e., those subject to proposed
part 112 and, on a rolling basis, the average annual monetary value of
food sold during the previous three-year period is no more than
$500,000) would have three years after the effective date to comply;
for some of the water requirements, they would have five years. In
addition, very small businesses (i.e., those subject to proposed part
112 and, on a rolling basis, the average annual monetary value of food
sold during the previous three-year period is no more than $250,000)
would have four years after the effective date to comply; for some of
the water requirements, they would have six years. All other farms
would have two years after the effective date to comply; for some of
the water requirements, they would have four years to comply.

Costs and Benefits

The baseline estimate for preventing all illnesses associated with
microbial contamination of produce covered by this proposed regulation
is $1.6 billion; however, we do not expect that we will eliminate all
illnesses associated with covered produce. Instead, we expect that the
proposed produce safety regulation will prevent some portion of this
illness burden from recurring. We estimate the number of foodborne
illness prevented by this regulation to be 1.75 million, with an
associated benefit of $1.04 billion, annually. As described in the
Preliminary Regulatory Impact Analysis (PRIA), making a precise
estimate of the rule's likely effectiveness is extremely difficult,
because FDA has only limited data that would establish a clear baseline
estimate of how contamination occurs and the likely impact of the
proposed provisions on that baseline, with respect to causing human
illness. We estimate the costs of the proposed rule to be $459.56
million annually for domestic farms, $170.62 million annually for
foreign farms covered by the rule (for a grand total of $630.18 million
annually), resulting in $406.22 million annually in estimated potential
net benefits.

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Total domestic Total foreign Total costs
Summary of Costs and Benefits of the Prevented foodborne Total benefits costs (in costs (in (domestic + Net benefits
Proposed Rule \1\ Illnesses (in millions) (in millions) millions) millions) foreign) (in millions)
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Total.................................. 1.75...................... $1,036.40 $459.56 $170.62 $630.18 $406.22
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Very small Small Large
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Average Annual Cost per Farm................................. $4,697 $12,972 $30,566
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\1\ As described in detail in the PRIA, data to estimate the costs and benefits of this rule are limited. Best
estimates were made for both the costs and the benefits of the rule, given the data available. We request
comment on these estimations, and request, in particular, data related to the amount of contamination
attributable to each potential pathway of contamination, the relative effectiveness of each provision at
reducing contamination, and data related to current industry food safety practices.

Proposed Rule

I. Introduction

Each year, about 48 million Americans (1 in 6) get sick, 128,000
are hospitalized, and 3,000 die from foodborne diseases, according to
estimates from the Centers for Disease Control and Prevention. The FDA
Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law
by President Obama on January 4, 2011, enables FDA to better protect
public health by helping to ensure the safety and security of the food
supply. FSMA enables us to focus more on preventing food safety
problems rather than primarily reacting to problems after they occur.
The law also provides us with new enforcement authorities to help us
achieve higher rates of compliance with prevention- and risk-based
safety standards and to better respond to and contain problems when
they do occur. In addition, the law gives us important new tools to
better ensure the safety of imported foods and directs us to build an
integrated national food safety system in partnership with State and
local authorities.
Section 105 of FSMA adds section 419 to the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 350h) requiring FDA to publish a
notice of proposed rulemaking to establish science-based minimum
standards for

[[Page 3507]]

the safe production and harvesting of those types of fruits and
vegetables that are raw agricultural commodities for which we have
determined such standards are necessary to minimize the risk of serious
adverse health consequences or death. Further, new section 419 also
requires FDA to adopt a final regulation based on known safety risks,
setting forth procedures, processes, and practices that we determine to
minimize the risk of serious adverse health consequences or death,
including those that are reasonably necessary to prevent the
introduction of known or reasonably foreseeable hazards into produce
and to provide reasonable assurances that produce is not adulterated
under section 402 of the FD&C Act. This proposed rule sets forth such
standards, as well as certain exemptions from the standards, consistent
with section 419 of the FD&C Act.
Two additional proposed rules, with the produce safety proposed
rule, will be the foundation of, and central framework for, a new food
safety system in the United States. In an accompanying notice in this
issue of the Federal Register, FDA is publishing the preventive
controls proposed rule that would apply to human food and require
domestic and foreign facilities that are required to register under the
FD&C Act to have written plans that identify hazards, specify the steps
that will be put in place to minimize or prevent those hazards, monitor
results, and act to correct problems that arise.
FDA also intends to publish the foreign supplier verification
program (FSVP) proposed rule, which would help ensure the safety of
foods imported into the U.S. by making importers accountable for
verifying that the food they import is produced using processes and
procedures that achieve the same level of public health protection for
imported food as required of domestic growers and processors under
FSMA's new standards for produce safety and preventive controls.
Eating fruits and vegetables is an important part of a healthy diet
(Ref. 1). FDA is responsible for ensuring the safety of all domestic
and imported fruits and vegetables consumed in the United States. We
place a high priority on identifying and implementing measures that can
reduce the incidence of foodborne illness associated with produce and
maintain a high level of consumer confidence in this important food
category. Produce is vulnerable to contamination with microorganisms of
public health significance (e.g., bacteria and viruses that can cause
disease), as well as chemical, physical, and radiological contaminants.
Contamination of produce can occur on-farm during growing (either in an
open environment or in a fully- or partially-enclosed building),
harvesting, packing, or holding; or elsewhere along the farm-to-table
continuum.

A. Contamination With Microbiological Hazards

American consumers enjoy one of the safest supplies of produce in
the world. Over the last few decades, however, problems linked to
produce, including the associated public health implications, have been
reported in a number of countries worldwide. Many factors affect the
occurrence of microbial contamination of fresh produce, including
worker health and hygiene, the quality of agricultural water, the use
of animal manure and other materials of animal origin as fertilizer,
the presence of wild or domestic animals in or near fields or packing
areas, growing and harvesting operations, and equipment and building
sanitation. As discussed in more detail below, FDA has taken several
steps to help reduce the likelihood of microbial contamination;
significant advances have been made. However, in spite of these
efforts, produce-associated foodborne illnesses continue.
FDA has looked specifically at outbreaks where the point of
contamination is likely to have happened early in the production chain,
during growing, harvesting, manufacturing, processing, packing,
holding, or transportation (Ref. 2). Of the total reported outbreaks
and outbreak-related illnesses linked to FDA-regulated foods between
1996 and 2010, in the FDA database, produce accounted for 23.3% and
42.3%, respectively. Both domestic produce and imported produce were
identified as vehicles in these outbreaks. From 1996 to 2010,
approximately 131 produce-related reported outbreaks occurred,
resulting in 14,132 outbreak-related illnesses, 1,360 hospitalizations
and 27 deaths. These outbreaks were associated with approximately 20
different fresh produce commodities (Ref. 3). Commodities associated
with outbreaks during this time period included sprouts; leafy greens
such as lettuce and spinach; tomatoes; melons such as cantaloupe and
honeydew; berries such as raspberries, blueberries, blackberries, and
strawberries; fresh herbs such as basil and parsley; and green onions
as well as fresh-cut fruits and vegetables. FDA also has evidence that
contamination occurs on some produce crops at least intermittently
based on sampling performed as part of investigation, inspections, and
FDA Domestic and Import Field Assignments and data from United States
Department of Agriculture (USDA)'s Agricultural Marketing Service (AMS)
Microbiological Database program (MDP) (Ref. 4 Ref. 5). For instance,
in 2009, AMS tested eight types of produce for E. coli O157:H7, non-
O157 E. coli carrying shiga toxin and enterotoxin genes, and
Salmonella. MDP identified 51 samples with E. coli carrying shiga toxin
genes; however only 24 of these were determined to be pathogenic. MDP
identified 32 samples with Salmonella confirmed by culture. The USDA
AMS MDP was discontinued in 2012 and FDA is evaluating options for any
future collection of similar microbiological data.
The following commodities accounted for 88.5% of the total produce-
associated outbreaks:
34 outbreaks associated with sprouts,
30 outbreaks associated with leafy greens such as lettuce
and spinach
17 outbreaks associated with tomatoes
14 outbreaks associated with melons such as cantaloupe and
honeydew
10 outbreaks associated with berries, such as raspberries,
blueberries, blackberries and strawberries
6 outbreaks associated with fresh herbs such as basil and
parsley
3 outbreaks associated with green onions.
(Ref. 2)
In the FDA database, fresh-cut fruits and vegetables accounted for
16.8% of the total produce-related outbreaks. Generally, the most
likely point of original contamination for the fresh-cut-related
outbreaks, as determined by FDA and its federal and state partners
during the outbreak investigations, appears to be during growing,
harvest, packing or holding, while the commodity is still in its raw
agricultural commodity (RAC) form, rather than during manufacturing/
processing of the fresh-cut product (Ref. 2). In a few instances, such
as unwashed, field packed tomatoes being removed from a warm ripening
room and placed in cold water to firm for slicing (which may have
promoted infiltration of pathogens) (Ref. 6), it is possible that
practices or conditions at the fresh-cut facility contributed to the
contamination event. It is possible that the way product is handled
during processing, including mixing large batches of fresh-cut product,
may spread contamination across a larger volume of product, impacting
the size and scope of an outbreak associated with fresh-cut

[[Page 3508]]

produce. However, there have also been a number of very large outbreaks
associated with RACs.
Pathogens associated with the produce outbreaks include bacteria,
viruses and parasites. Between 1996 and 2010, the majority of fresh
produce-related outbreaks and illnesses in the FDA database were
associated with bacterial agents (86.5%), followed by parasites (11.6%)
and viruses (1.9%). These outbreaks involved a number of pathogens,
including E. coli O157:H7, E. coli O157, Salmonella species (Salmonella
spp.), Listeria monocytogenes (L. monocytogenes), Cyclospora, Shigella
sonnei, and Hepatitis A.
In an accompanying document titled ``Draft Qualitative Assessment
of Risk to Public Health from On-Farm Contamination of Produce,'' FDA
has conducted a qualitative assessment of risk associated with growing,
harvesting, packing, and holding of produce (hereafter referred to as
the Qualitative Assessment of Risk (QAR)). In particular, the QAR is
intended to address various risk management questions related to
biological hazards of concern in fresh produce that can lead to serious
adverse health consequences or death; potential routes of
contamination; and the likelihood of contamination and likelihood of
illness attributable to consumption among various types of produce
commodities. The findings of this qualitative assessment of risk
informed our regulatory approach and several proposed provisions. We
provide a summary of the findings in section IV; additionally, we refer
to the QAR throughout this proposed rule, including the discussion of
proposed provisions in section V of this document.

B. Contamination With Chemical, Physical or Radiological Hazards

Chemical contaminants of produce can originate from a variety of
sources. Most common among these include soil (through previous
chemical exposure), equipment (e.g., lubricants, fuels, and
refrigerants), pesticides, insecticides and related agents, and
cleaning compounds (e.g., sanitizers) normally used in the course of
maintaining buildings and equipment. FDA monitors chemical and
pesticide residues in foods through its regulatory monitoring programs
with emphasis on raw agricultural commodities (RACs) and foods consumed
by infants and children. Illnesses attributable to chemical hazards are
rare (Ref. 7). In fact, between 1997 and 2011, there have been no Class
I recalls of produce associated with a chemical hazard for which there
is a reasonable probability of causing serious health problems or death
(Ref. 8). Current monitoring, regulations, and industry practice have
been sufficient to keep these hazards under control.
Similarly, the potential public health consequences of physical
hazard contamination (e.g. glass or metal fragments) in produce appear
to be relatively (Ref. 7). Rarely do the physical hazards associated
with produce suggest a risk of serious adverse health consequences or
death for individuals that would consume the product. In fact, between
1997 and 2011, there have been no Class I recalls of produce associated
with a physical hazard for which there is a reasonable probability of
causing serious health problems or death (Ref. 8).
The presence of radiological hazards in foods is a rare event and
consumer exposure to harmful levels of radionuclide hazards, outside of
catastrophic events, is very low (Ref. 7. Ref. 9).
While we acknowledge the potential for chemical, physical or
radiological contamination of produce, based on our analysis (Ref. 7),
and for the reasons discussed in section IV.B of this document, we are
not proposing specific standards for these hazards in this rulemaking.

II. Efforts to Address Produce Safety

FDA and others have taken a number of actions to address produce
safety in the last two decades. This section describes several of these
activities up to and including FSMA.

A. Inspections and Investigations

We have conducted a number of inspections and investigations that
have provided useful information about the routes of contamination.
Investigations involved visiting multiple field locations and packing
operations. Observations during the investigations revealed several
areas of farm practices that seem most likely to have been possible
routes of contamination for produce involved in the outbreaks. Our
inspections, investigations, and surveillance sampling activities are
described in more detail in accompanying documents.

B. Guidance Documents and Letters to Industry

1. GAPs Guide
On October 2, 1997, President Clinton announced the ``Initiative to
Ensure the Safety of Imported and Domestic Fruits and Vegetables''
(Produce and Imported Food Safety Initiative or PIFSI). As part of this
initiative, the President directed the Secretary of the Department of
Health and Human Services (HHS) and the Secretary of the U.S.
Department of Agriculture (USDA), in cooperation with the agricultural
community, to issue guidance on good agricultural practices (GAPs) for
fresh fruits and vegetables. In October, 1998, we issued final guidance
to industry entitled ``Guide to Minimize Microbial Food Safety Hazards
for Fresh Fruits and Vegetables'' (GAPs Guide) (Ref. 10). This guide
contains voluntary recommendations for good agricultural practices
(GAPs) that growers and packers can undertake to address common factors
contributing to contamination in their operations. The GAPs Guide is a
broad scope guidance that takes into account the diversity of
conditions and practices associated with the growing, harvesting,
packing and holding of fresh produce. We noted that firms should use
the general recommendations in the GAPs Guide to tailor practices to
their individual operations. As the GAPs Guide notes, current
technologies cannot eliminate all potential food safety hazards
associated with fresh produce that will be eaten raw. Therefore, the
focus of the GAPs Guide is on implementing measures to minimize the
potential for introduction of such hazards.
On September 2, 2008, we issued a notice in the Federal Register
(73 FR 51306) requesting comments and scientific data and information
to assist us in improving the GAPs Guide. We specifically asked for
information about (1) current agricultural practices and conditions
used to produce, harvest, pack, cool, and transport fresh produce; (2)
risk factors for contamination of fresh produce associated with these
practices; and (3) possible recommendations or additional measures that
would enhance the safety of fresh produce. We also requested
information about the estimated costs and benefits of current practices
and/or the cost and benefits of any recommendations. We received
approximately two dozen submissions from organizations and individuals,
including: Industry, government, universities, environmental groups,
consumers, and consumer groups. A number of comments discussed the
value of performing operational assessments, developing food safety
plans and record keeping but suggested that any updated guidance
acknowledge that these activities should be commensurate with the
complexity of an operation and associated risks. Other

[[Page 3509]]

comments requested additional information on microbial testing to
ensure that when testing is done it is meaningful and cost effective.
2. Letters to Lettuce, Tomato, and Cilantro Industries
On February 5, 2004, we issued a letter to firms that grow,
harvest, pack or hold fresh lettuce and fresh tomatoes, expressing
concern regarding outbreaks of foodborne illness associated with the
consumption of these products, and recommending actions to enhance the
safety of these products (Ref. 11). On November 4, 2005, we issued a
second letter to firms that grow, harvest, pack, hold or manufacture/
process fresh and fresh-cut lettuce, reiterating concerns about
continuing outbreaks (Ref. 12). In the November 2005 letter, we
strongly encouraged applicable firms to review their current operations
in light of the GAPs Guide, as well as other available information
regarding the reduction or elimination of pathogens on fresh produce.
We encouraged firms to consider modifying their operations to ensure
that they were taking the appropriate measures to provide a safe
product to the consumer. We recommended that firms from the farm level
through the distribution level undertake these steps.
In March, 2011, we issued a letter to firms that grow, harvest,
pack or hold fresh cilantro, expressing concern about positive sample
findings and recommending actions to enhance the safety of these
products (Ref. 13). Between 2004 and March, 2011, there had been 28
confirmed Salmonella positive sample results in fresh cilantro in, or
entering into, commerce. Samples were of both U.S. and imported origin.
As with earlier letters to the industry, we strongly encouraged
applicable firms to review their current operations in light of the
GAPs Guide, as well as other available information regarding the
reduction or elimination of pathogens on fresh produce. We encouraged
firms to consider modifying their operations to ensure that they were
taking the appropriate measures to provide a safe product to the
consumer. In addition, we encouraged these firms to assess hazards
unique to the production of cilantro and to develop commodity-specific
preventive control strategies. We recommended that firms from the farm
level through the distribution level undertake these steps.
3. Guidances and Letters Regarding Sprouts
On October 27, 1999, we published a notice of availability (64 FR
57893) for two guidance documents to inform all parties involved in the
production of sprouts (i.e., producers, conditioners, and distributors
of seeds and beans used for sprouting, sprout producers) that sprouts
have been recognized as an important cause of foodborne illness and to
provide recommendations for preventive controls that we believed should
be taken immediately to reduce the likelihood of sprouts serving as a
vehicle for foodborne illness (Ref. 14).(Ref. 15) The first guidance
document, ``Reducing Microbial Food Safety Hazards for Sprouted Seeds''
(the Sprout Guide), provides recommendations based on the
recommendations of the National Advisory Committee on Microbiological
Criteria for Foods (NACMCF) (Ref. 16). We also released a second
guidance, ``Sampling and Microbial Testing of Spent Irrigation Water
During Sprout Production'' (the Sprout Testing Guide), to assist
sprouters in implementing one of the principal recommendations in the
broader Sprout Guide, i.e., that producers test spent irrigation water
for two pathogens (Salmonella spp. and E coli O157:H7) before product
enters commerce. We refer to these guidances collectively as the Sprout
Guides.
On April 22, 2005, we announced in the Federal Register (70 FR
20852) a public meeting to elicit information on current science
related to foodborne illness associated with the consumption of
sprouts. The meeting notice contained a series of questions to help
focus comments, including questions regarding: (1) Practices that may
contribute to contamination of seeds used for sprouting and
intervention strategies that could help prevent, reduce, or control
contamination of seeds used for sprouting; (2) Whether the preventive
controls recommended in our Sprout Guides could be improved and, if so,
how this might be done; (3) What can or should be done to increase the
involvement of producers of seeds for sprouting and seed distributors
to ensure the safety of sprouts; (4) How, if at all, should the actions
to improve the safety of seeds for sprouting be structured to take into
account variation within the seed and sprout industry, including
variations in size of establishments, the types of seeds and sprouts
produced and the practices used in production; and (5) Existing food
safety systems or standards (such as international standards) that we
should consider as part of our efforts to minimize foodborne illness
associated with the consumption of sprouts.
In general, comments expressed a need to include the seed industry,
as well as the sprout industry, in efforts to improve the safety of
sprouts. Several comments stated that any recommendations should be
scientifically sound, based on appropriate (and feasible) expectations
for risk reduction, and be easy to understand and implement. Comments
expressed concern about the effect on worker health of treating seed
with 20,000 ppm calcium hypochlorite. Comments were generally
supportive of recommendations in the Sprout Guides to test spent
irrigation water; several comments supported expanded testing,
including seed testing by seed producers and distributors. All but one
comment maintained that seeds were the primary source of contamination
in sprout-associated outbreaks. Several comments discussed practices
and conditions, such as animal grazing, which could contaminate seed in
the field. One comment suggested the industry develop a GAPs guidance
specific to the production of seed for use in sprouts. Several comments
supported applying Current Good Manufacturing Practices (CGMPs) (21 CFR
Part 110) to sprout facilities. A number of comments cited the
diversity of sprout types currently being produced and noted this
diversity of products is likely to continue to grow. These comments
maintained it was therefore appropriate to provide flexibility for
individual operations to select mitigations appropriate for the
products they produce. Comments to the 2005 Sprout Public Meeting were
considered in this rulemaking and will be further described when we
discuss proposed provisions specific to sprouts in section V.M. of this
document.
On May 1, 2009, we issued a letter to suppliers and distributors of
seeds and beans used for sprouting, and sprouters, to make firms aware
of our serious concerns with continuing outbreaks associated with the
consumption of raw and lightly cooked sprouts and to urge firms to
review their operations in light of our Sprout Guides and other
available information (Ref. 17), and to modify their operations
accordingly to ensure they are taking appropriate measures to provide a
safe product to consumers. We also shared a May 1, 2008, letter from
the California Department of Public Health (CDPH) to the California
sprout industry outlining several critical areas of concern identified
in recent investigations and CDPH recommendations for controlling
hazards associated with those observations (Ref. 18).
4. Draft Commodity Specific Guidances
On August 3, 2009, we published a notice in the Federal Register
announcing the availability for public

[[Page 3510]]

comment of draft commodity specific guidances (CSGs) for melons (74 FR
38437), tomatoes (74 FR 38438) and leafy greens (74 FR 38439). The
draft CSGs are intended for growers, packers, processors, transporters,
retailers, and others throughout the supply chain. The draft CSGs, if
finalized, would provide a framework for identifying and implementing
appropriate measures to minimize the likelihood of microbial
contamination of tomatoes, leafy greens, and melons. The draft CSGs
reflect both commodity specific information, such as recommendations
for tomato repacking, and advances in collective thinking in broader
areas, such as assessing potential hazards in and near the field before
beginning production and immediately before harvest, and protecting and
maintaining water quality at its source and during distribution and
use. The draft CSGs are designed to complement our GAPs Guide and
Fresh-cut Guide. On November 4, 2009, we published a notice in the
Federal Register, extending to January 4, 2010, the comment period on
the draft CSGs. We have not yet issued these guidances in final form.
In developing the draft CSGs, we relied heavily on existing
industry commodity specific guidelines, our produce safety initiatives
and programs, lessons learned from outbreak investigations, and other
public and private programs. We have since received several dozen
written comments, from industry, States, and individuals. Comments were
generally supportive of the scope and objectives of the draft CSGs.
Comments provided their views on both commodity specific issues (e.g.,
recommendations for field packing tomatoes, water quality for
rehydrating leafy greens after harvest) and cross-cutting issues (e.g.,
management of wild animal intrusion, quality of water used in
postharvest operations). A number of comments requested that we
recognize different risks may be associated with different commodities
within the commodity groups covered by the CSGs, noting, for example,
that cantaloupe (not watermelon) have been identified as the vehicle in
the majority of foodborne illness outbreaks associated with melons. A
number of comments expressed concern about potential bias of the CSG
approach (i.e., separate recommendations for different commodities)
against small farms growing a diversity of crops, especially the
concern that the CSG approach could require such farms to have multiple
food safety plans to cover each of the commodities they grow.
Additional comments will be discussed when we describe proposed
provisions relevant to those comments.
5. Guidances Regarding Nuts
On March 11, 2009, we published a notice in the Federal Register
(74 FR 10598) announcing the availability for public comment of draft
guidance for industry: Measures to Address the Risk for Contamination
by Salmonella Species in Food Containing a Peanut-Derived Product as an
Ingredient. Additionally, on June 29, 2009, we published a notice in
the Federal Register (74 FR 310308) announcing the availability for
public comment of draft guidance for industry: Measures to Address the
Risk for Contamination by Salmonella Species in Food Containing a
Pistachio-Derived Product As An Ingredient. These draft guidance
documents were intended for manufacturers who use a peanut-derived
product or pistachio-derived product as an ingredient in a food
product. These draft guidances provide recommendations for evaluating
the effectiveness of certain Salmonella control measures. We have not
yet issued these guidances in final form.
6. Fresh-cut Guide
On March 6, 2006, we published a notice in the Federal Register (71
FR 11209) announcing the availability on our Web site of a draft
Guidance for Industry entitled ``Guide to Minimize Microbial Food
Safety Hazards of Fresh-cut Fruits and Vegetables'' (the Fresh-cut
Guide). We received a number of comments from trade associations,
consumer groups, and industry. Comments were generally supportive of
the draft Guide. A few comments included questions about our draft
definition of fresh-cut produce and whether the recommendations in the
draft guidance were mandatory or voluntary, in light of the mandatory
requirements in existing CGMPs.
On February 25, 2008, we published a notice (73 FR 10037)
announcing our finalization and the availability of our ``Guide to
Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and
Vegetables'' (the Fresh-cut Guide). The Fresh-cut Guidance complements
the CGMPs in 21 CFR, Part 110 and provides recommendations for a
framework for identifying and implementing appropriate measures to
minimize the likelihood of microbial contamination during the
processing of fresh-cut produce. Examples of recommendations for fresh-
cut processors in the Fresh-cut Guidance include: (1) Know your
suppliers and have a mechanism to verify that your suppliers use good
agricultural practices, good manufacturing practices, and other
appropriate food safety practices; and (2) ensure equipment is designed
to prevent water collection. While fresh-cut produce is not covered
under the scope of this proposed rule, we include a reference to our
guidance on fresh-cut produce as some of the measures recommended in
that document are relevant to the requirements proposed for covered
produce in this rule.

B. Produce Safety Action Plan

On June 15, 2004, we published a Federal Register notice (69 FR
33393) announcing a public meeting to elicit information from
stakeholders concerning key elements of a draft produce safety action
plan entitled ``Produce Safety From Production to Consumption: An
Action Plan to Minimize Foodborne Illness Associated With Fresh
Produce'' (the Produce Safety Action Plan or PSAP). We posted the draft
PSAP on June 18, 2004 (Ref. 19). The draft PSAP continued the 1997
Produce and Imported Food Safety Initiative, building on experience
from earlier efforts such as the development and implementation of the
GAPs Guide, inspections of farms and produce packing facilities,
surveillance sampling assignments, and investigations of foodborne
illness outbreaks. The draft PSAP addressed all principal points
between the farm and table where contamination of produce could occur.
It covered fresh fruit and vegetables in their native (RAC) form and
raw, minimally processed products (i.e., fresh-cut produce) that have
received some processing to alter their form but have not been subject
to a thermal process that would eliminate microbial hazards. The draft
PSAP was not intended to cover processed products such as juice, or
agricultural products other than fruits and vegetables.
After considering comments received from various stakeholders, in
October 2004, we issued the final PSAP. In recognition that
contamination of produce can happen at any point in the supply chain,
the PSAP expands on the areas covered by the GAPs Guide (i.e., farms
and packing houses) to extend to all parts of the food supply chain
from farm through retail or consumer preparation and consumption. The
PSAP does not cover frozen fruits and vegetables, fruit and vegetable
juices, or nuts. The PSAP has four main objectives: (1) Prevent
contamination of fresh produce with pathogens; (2) minimize the public
health impact when contamination of fresh produce

[[Page 3511]]

occurs; (3) improve communication with producers, packers, processors,
transporters, distributors, preparers, consumers, and other government
entities about the safety of fresh produce; and (4) facilitate and
support research relevant to the contamination of fresh produce. For
each objective, the PSAP identifies steps or actions that could
contribute to the achievement of that objective. The PSAP has
measurable goals and outcomes, and several steps outlined in the PSAP
are already in progress or have been completed. For example, we issued
the Fresh-cut Guide and provided technical assistance to industry
efforts to develop commodity specific supply chain guidance as part of
the PSAP objective regarding prevention of contamination.

C. Public Hearings

On February, 27, 2007, we published a notice (72 FR 8750) of two
public hearings, and request for comment, on the safety of fresh
produce. In that notice, we stated that we believe that the measures
outlined in the PSAP, the GAPs Guide, and other public and private
sector actions, when implemented, can be effective in reducing the
likelihood of microbial contamination of fresh produce. However, the
fact that outbreaks of foodborne illness associated with fresh produce
continue to occur supports the need for a close examination of: The
extent to which these measures have been implemented; whether they have
been effective when implemented properly; and, what additional or
different interventions might be appropriate to reduce the likelihood
of future outbreaks.
We held the public hearings to share information about recent
outbreaks of foodborne illness associated with microbial contamination
of fresh produce, and to invite comments, data, and other scientific
information about: Current practices used to grow, harvest, pack, hold,
manufacture/process, and transport fresh produce; risk factors for
contamination of fresh produce associated with these practices; and
measures FDA could take to enhance the safety of fresh produce. The
notice of hearings included a list of issues and questions to help
focus comments and asked for scientific information and data. We
received approximately 48 submissions from industry, government,
universities, environmental groups, consumers, and consumer groups.
Recurring comments included: The importance of activities to promote or
enhance rapid, accurate traceback; strengthened coordination and
communication between all sectors (i.e., researchers, regulators, and
industry) on available science and current unpublished data; and an
integrated, multidisciplinary approach to identify best practices not
currently incorporated by industry. A number of comments expressed
concerns about the cost of third party audits and lack of
standardization of such audits. Comments also indicated a desire for
training. Comments were divided on whether we should continue to
promote adoption of voluntary GAPs guidance or pursue rulemaking to
establish mandatory requirements. Comments supporting mandatory
requirements differed on what these requirements should look like;
suggestions ranged from mandatory GAPs to a Hazard Analysis and
Critical Control Point (HACCP)-like approach, or a combination of the
two. Comments were in general agreement that, whatever regulatory
approach was chosen, it should be consistent across the United States,
based on sound science, and cover a broad range of commodities while
being flexible enough to accommodate the needs of specific commodities,
regions, operations, practices, and different sizes of operations.

D. Partnerships and Collaborations

1. Public and Private Standards
Because the GAPs Guide is voluntary, FDA and food safety partners
in the public and private sectors have emphasized education and
outreach to industry to promote adoption of the guidance. Buyer
requirements that producers and other suppliers provide self- or third
party audit verification that they are following the GAPs Guide have
further promoted adoption of the guidance. We have worked with the
fresh produce industry since the release of the GAPs Guide to promote
its recommendations and to advance the scientific knowledge applicable
to enhancing the safety of fresh produce. For example, in conjunction
with the PSAP, we have provided technical assistance to industry in
developing several industry commodity specific guidelines that cover
the entire supply chain, including commodity-specific guidelines for
melons, leafy greens, tomatoes, and green onions; these commodities
together accounted for 70 percent of the foodborne outbreaks associated
with produce between 1998 and 2009 (Ref. 3). These industry guidelines
were in turn helpful to us in developing FDA's draft commodity specific
guidances for the same commodities (see section II.B.4 of this
document). Additional industry guidelines have been developed or are in
progress for a broad range of commodities, including: strawberries,
mushrooms, watermelon, potatoes, storage onions, and citrus.
We provided technical assistance to the Association of Food and
Drug Officials (AFDO) to formulate a Model Code of Practice for the
Production of Fresh Fruits and Vegetables (the Model Code) (Ref. 20).
This work grew out of a request from the tomato industry in late 2006
to address outbreaks of foodborne illness attributed to fresh tomatoes.
However, the AFDO Board believed that it was also important to address
GAPs in the production of a broader range of fresh fruits and
vegetables. Thus, AFDO convened a working group to develop a Model Code
for produce safety during growing, harvesting, packing and holding that
could be considered as a model for guidance and/or regulation by
Federal and State regulatory bodies, and for collaboration among such
parties and the industry. The Model Code does not address the
additional processing steps that may occur at a fresh-cut or other
processing facility, which is covered by the CGMPs in 21 CFR part 110.
The Model Code focuses on minimizing the potential for contamination of
fresh produce with pathogens.
Through cooperative agreement with Cornell University, FDA has,
together with USDA AMS, established a jointly funded Produce Safety
Alliance (PSA), based on the successful Seafood HACCP Alliance for
Training and Education. The PSA is a public-private partnership that
will develop and disseminate science- and risk-based training and
education programs to provide produce farms with fundamental food
safety knowledge, starting in advance of this proposed rule and
continuing after the final rule is promulgated. The PSA includes active
participation from the produce industry and academic institutions
nationwide. The curriculum development process has already started,
through establishment of topic-specific working committees charged with
identifying challenges to understanding and implementing GAPs on farms.
This first phase of work, in advance of a final rule, is intended to
assist farms, especially small farms, in establishing appropriate food
safety measures, consistent with the GAPs Guide and other existing
guidances, so that they will be better positioned when we issue a final
rule establishing produce safety standards under section 419 of the
FD&C Act. As this rulemaking progresses, the PSA materials will be
modified, as needed, to be consistent with the requirements in the
rule.

[[Page 3512]]

2. Foodborne Illness Investigations--Environmental Assessment Model
An ``environmental assessment,'' in the foodborne illness outbreak
or food contamination setting, means an investigation that is triggered
by an outbreak of foodborne illness or food contamination incident with
the purpose of determining how the environment may have contributed to
the introduction or transmission of pathogens or other hazards that
caused illness or contamination. In addition to our more traditional
investigational team approach, during this process we work
collaboratively with a number of experts from CDC, State and local
agencies, and industry.
In 2010, we conducted an environmental assessment in response to a
foodborne illness outbreak involving 33 cases of STEC O145 infection in
5 States. While we have not made a definitive determination regarding
how or at what point in the supply chain E. coli O145 contamination
occurred, this assessment was important in a number of respects. As
mentioned above, we worked collaboratively with a number of experts
from CDC, State and local agencies, and industry. Working with this
team, we assessed potential sources of E. coli O145 not just in the
field of interest, but in the larger growing area surrounding the field
of interest, along with the potential for E. coli O145 to be
transported from a source in the surrounding area to the field where
implicated lettuce was grown. This highly collaborative, systems-based
approach allowed for the discovery of important environmental risk
factors that would not typically be explored by conventional
investigation methods (Ref. 21). On December 29, 2010, we posted a
report, entitled ``Environmental Assessment: Non-O157 Shiga Toxin-
Producing E. coli (STEC): Findings and Potential Preventive Control
Strategies'' (Ref. 21), outlining the environmental assessment approach
used in this investigation, our observations and tentative conclusions.
In 2011, we conducted an environmental assessment in response to a
foodborne illness outbreak involving a total of 139 persons infected
with any of four outbreak-associated strains of L. monocytogenes,
including 29 deaths, in 28 States (as of November 1, 2011). On October
19, 2011, we posted a report, entitled ``Environmental Assessment:
Factors Potentially Contributing to the Contamination of Fresh Whole
Cantaloupe Implicated in a Multi-State Outbreak of Listeriosis,''
providing an overview of the assessment process, potential contributing
factors in this outbreak, and recommended measures firms should employ
to prevent similar contamination (http://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htm). As discussed further in sections III.F
and V.A.2.b.i of this document, this proposed rule would not apply to
off-farm packing facilities such as the packing facility associated
with this cantaloupe outbreak--such facilities would instead be subject
to existing part 110 and section 418 of the FD&C Act. However, we
include the findings of this environmental assessment here because the
contributing factors are relevant to both on-farm and off-farm produce
packing practices.
3. Produce Safety Initiative Assessments
In August 2006 we launched the Leafy Greens Safety Initiative
(LGSI), a multi-year initiative which involved assessments of practices
and conditions at select leafy greens farms and facilities in
California (Ref. 22). In the summer of 2007, we began a multi-year
Tomato Safety Initiative (TSI) to assess practices and conditions
associated with growing and packing tomatoes on the Eastern Shore of
Virginia, followed by assessments in three tomato growing areas in
Florida (Ref. 23).
The initiatives were conducted as part of a strategy to reduce
foodborne illness by focusing food safety efforts on specific products,
practices, and growing areas that have been identified in past outbreak
investigations. The initiatives were a collaborative effort between FDA
and the State health and agriculture departments in California,
Virginia, and Florida, in cooperation with several universities and
members of the produce industry. Both initiatives contained several
important components, the most visible of which was a series of
assignments to the field to assess conditions and practices at farms
and packing houses that could lead to contamination and to observe
actions taken by growers and packers in response to these conditions.
Other important components of the initiatives included continuing
communication and outreach with the industry at all points along the
supply chain, facilitating and promoting research to enhance leafy
green and tomato safety, and strengthening collaboration between
Federal, State, and local public health officials in disease detection
and response.
Assessments of tomato packing facilities covered dump tank water
quality parameters, employee hygiene, and facility cleaning and
sanitation practices. Assessments of the farms addressed irrigation
water sources (such as ponds and wells), source water and procedures
for mixing crop chemicals, the potential impacts of weather events,
such as drought and flooding, and animal proximity to growing fields.
Assessments were scheduled to coincide with tomato production and
harvest seasons on the Eastern Shore of Virginia and in three tomato
producing regions in Florida.
Where the teams observed conditions or practices at one or more
locations that might be improved, they shared those observations
directly with the individual firm and also shared observations in
general terms at a post-assessment meeting so that all interested
parties could apply the findings to their operations. For example, we
identified issues related to proximity of portable toilets to
irrigating ponds and harvesting of drops at one or more locations. The
teams recommended that portable toilets should be distanced from the
irrigation pond and policies that forbid the harvesting of drops should
be strictly enforced. We also shared preliminary observations through
other venues, including a tomato research priorities meeting in College
Park (hosted by Joint Institute for Food Safety and Applied Nutrition
(JIFSAN) and the University of Florida's Institute of Food and
Agricultural Sciences) (JIFSAN 2010 (update)), a Leafy Greens Research
Needs workshop hosted by United Fresh in Herndon, VA (United Fresh
2008), and as technical assistance to public and private efforts to
develop new or enhanced guidances.
4. Research
FDA researchers have focused on refining or developing methods to
detect, isolate and subtype pathogens of concern in produce, to enhance
our ability to analyze samples in support of our compliance activities.
As resources permit, FDA scientists also directly investigate questions
about factors contributing to produce contamination. We also supported
extramural research and collaborations with other Federal agencies,
academic institutions, and industry-supported entities to leverage
research efforts, expertise, and resources (such as experimental
stations for field research). This includes successful collaborations
with USDA on research of mutual interest. To fill knowledge gaps, thus
facilitating implementation of any new policies, we have initiated new
agreements with USDA to conduct research in key areas such as
agricultural water and soil amendments (Ref. 24). Specifically, FDA has
provided approximately one million dollars to sponsor research at USDA

[[Page 3513]]

ARS and to develop a produce safety rule research network at the
Western Center for Food Safety at University of California Davis. We
intend these collaborative efforts to result in the collection of data
that may help resolve questions about the necessary time between
application of raw manure or contaminated water and safe harvest of
produce in key agro-ecological growing conditions and for key crops.
Our goal is for this research to result in suggested protocols that
farms could follow in compliance with a final produce rule, and for
this process to be duplicated for other crops and regions as further
funding is secured. This FDA sponsored research was initiated to
demonstrate the commitment of federal agencies to address the needs of
farmers, to provide initial data to finalize study protocols for
further research, and to attract matching funds from industry.
In partnership with academic institutions across the country, FDA
has also created four Centers of Excellence (CoE), each housed at a
university and charged with specific food-safety tasks (Ref. 25). In
2008, a 5-year cooperative agreement was awarded to the University of
California, Davis (UC Davis) to establish the most recent of these
CoEs, the Western Center for Food Safety (WCFS). Through this
agreement, FDA has been able to leverage the resources and expertise of
UC Davis to study the impact of the unique geography and ecology of the
growing regions of the Western United States.
5. Engagement With Other Federal Agencies
FDA regularly consults and coordinates with other Federal agencies
in the area of produce safety. Examples of these efforts can be found
throughout this document and include collecting samples, sharing data,
providing training and technical assistance to industry, and research.
Our partnerships with USDA and CDC have been particularly valuable to
our efforts.
6. Engagement with Industry and Academia
We regularly engage with experts in the produce industry and in
academia. These engagements serve to both educate the industry about
our thinking, activities, and expectations, and to educate us about
current industry practices and academic efforts to enhance the safety
of produce.
In addition to the collaborations mentioned above, we initiated
multiple produce industry listening sessions across the country prior
to the passage of FSMA. At these sessions, we provided local industry
and academia an opportunity to ask questions and voice concerns about
the potential for legislation impacting the produce industry. We
visited a total of 13 States with significant produce production in
2010. FDA and USDA technical experts, scientists and managers
participated in these meetings, and we were able to tour large and
smaller scale farms, and talk to people with practical experience in
production and implementing food safety programs on farms.
We also were involved with the Produce Safety Project (PSP), a
research and advocacy organization based at Georgetown University and
funded by the Pew Charitable Trust. The PSP provided four issue briefs
(Ref. 26.Ref. 27.Ref. 28.Ref. 29) each focused on specific aspects of
produce production, the risks they may represent, prevention and
mitigation strategies to address these risks, and further research
needs in the area. Further, PSP held 6 regional stakeholder discussion
sessions to elicit comment and reaction from the produce industry, and
to offer an avenue to speak directly to the documents' authors. A
common message from the industry during these discussions was concern
about food safety and a desire to know how to reduce risks. Small
growers and packers in particular conveyed a need for information and
technical support that would assist them in implementing food safety
practices.

E. Current Industry Practices

In response to foodborne illnesses associated with produce in the
mid 1990s, the produce industry developed produce safety guidance,
engaged in outreach regarding produce safety best practices, developed
compliance auditing programs, and funded produce safety research.
1. Industry Produce Safety Best Practices Guidance
In 1997, the International Fresh-cut Produce Association and the
Western Growers Association published Voluntary Food Safety Guidelines
for Fresh Produce, which provided generalized voluntary industry
guidelines to minimize the potential for contamination for fresh
produce in growing, packing, shipping and processing operations. After
FDA issued our GAPs Guide, industry developed commodity specific
guidances for various produce industry segments including: Commodity
Specific Food Safety Guidelines for the Melon Supply Chain (2005),
Commodity Specific Food Safety Guidelines for the Lettuce and Leafy
Greens Supply Chain (2006), Commodity Specific Food Safety Guidelines
for the Fresh Tomato Supply Chain (2006 1st Edition, 2008 2nd edition)
and Commodity Specific Food Safety Guidelines for the Production,
Harvest, Post-Harvest, and Valued-Added Unit Operations of Green Onions
(2010). In addition, other industry segments including, but not limited
to mushrooms, strawberries, watermelons, citrus, avocados, almonds, and
dry bulb onions developed commodity specific guidances. The fresh-cut
produce industry, via the International Fresh Produce Association,
published in 1992 Food Safety Guidelines for the Fresh-cut Produce
Industry and updated this publication periodically, with the 4th
edition being published most recently in 2001.
2. Produce Industry Food Safety Compliance Auditing
Shortly after the FDA GAPs Guide was finalized, a number of retail
produce buyers informed suppliers that as a condition of sale, their
produce suppliers must follow, and be third party audited for
conformance with, the FDA GAPs guide (Ref. 30). In 1999 USDA AMS began
developing a GAPs and Good Handling Practices (GAP & GHP) Audit
Verification Program, in response to requests from growers and the
Association of Fruit and Vegetable Inspection and Standardization
Agencies. The program, based on the GAPs Guide, was piloted in 2000 and
fully available later that same year. In September 2001 the United
Fresh Fruit and Vegetable Association published guidance entitled Food
Safety Auditing Guidelines: Core Elements of Good Agricultural
Practices for Fresh Fruits and Vegetables to provide the basis for GAPs
audits in the produce industry. In 2011 the United Fresh Produce
Association published a Harmonized GAPs Standard for use by producers
and third party auditors in the fresh produce industry.
In 2007 leafy greens growers in California, with the assistance of
the USDA AMS and CDFA, developed and implemented the California Leafy
Greens Marketing Agreement (CA LGMA) (Ref. 31). The objective of the CA
LGMA is to protect public health via compliance with the food safety
practices accepted by the LGMA board, verified through mandatory
government audits of members and signatories to the agreement by CDFA
auditors trained and licensed by USDA AMS (Ref. 31). In 2007 leafy
greens growers in Arizona also adopted a similar marketing agreement
and audit structure for their growers (Ref. 32). At the request of
industry, the USDA AMS in 2009 held seven hearings throughout the
United

[[Page 3514]]

States to solicit input from the leafy greens industries across the
U.S. regarding their desire to develop a proposed national marketing
agreement for leafy greens (74 FR 45565). A decision regarding the
proposed USDA AMS national marketing agreement for leafy greens is
currently pending.
In 2007, the Florida Legislature passed a law that provided the
Department of Agriculture and Consumer Services with the authority to
address safety concerns related to fresh tomatoes. Implementing
regulations which became effective on July 1, 2008 (Florida Tomato
Inspection Regulation 5G-6, 2007) adopted and incorporated by reference
almost all of the recommendations in the Commodity Specific Food Safety
Guidelines for the Fresh Tomato Supply Chain, 2nd Edition (July 2008).
GAPs implementation and GAPs audits have now become common
components of purchase specifications for produce in some market
segments, and have been a significant force in increasing awareness of
GAPs and promoting their implementation (Ref. 33). However, growers and
packers who sell product through direct marketing channels, or to
buyers who do not include GAPs as a condition of sale, may be less
familiar with GAPs.
3. Produce Industry Produce Safety Education Outreach
In addition to participation in the PSA housed at Cornell
University (discussed above in section II.D. of this document), the
produce industry promoted adoption and implementation of the
recommendations in the FDA GAPs Guide through education and outreach
efforts in cooperation with the land grant universities. The National
GAPs Program at Cornell University, with collaborators at other land
grant universities, developed a series of publications to train
domestic growers and packers on the key principles of produce safety,
including: Food Safety Begins on the Farm: A Grower's Guide (2000);
Food Safety Begins on the Farm: A Grower Self Assessment of Food Safety
Risks (2003); and, Fruits, Vegetables, and Food Safety: Health and
Hygiene on the Farm (2004). These publications and others developed by
land grant universities throughout the United States have been used to
train the produce industry on produce safety best practices.

F. 2010 Federal Register Notice and Preliminary Stakeholder Comments

On February 23, 2010, we published in the Federal Register (75 FR
8086; 2010 FR notice) a notice opening a docket to obtain information
about current practices and conditions for the production and packing
of fresh produce. On May 20, 2010, we extended the original 90-day
comment period for the docket until July 23, 2010 (75 FR 28263). We
established this docket to provide an opportunity for interested
parties to provide information and share views that would inform the
development of (1) safety standards for fresh produce at the farm and
packing house and (2) strategies and cooperative efforts to ensure
compliance.
In particular, we welcomed input on these general categories: (1)
Role of the good agricultural practice recommendations in the GAPs
Guide; (2) Standards for domestic and foreign growers and packers; (3)
Identification and prioritization of risk factors; (4) Environmental
assessment of hazards and possible pathways of contamination; (5) The
impact of scale/size of growing operations on the nature and degree of
possible food safety hazards; (6) Methods to tailor preventive controls
to particular hazards and conditions affecting an operation; (7)
Possible approaches to tailoring preventive controls to the scale of an
operation so that the controls achieve an appropriate level of food
safety protection and are feasible for a wide range of large and small
operations; (8) Coordination of produce food safety practices and
sustainable and/or organic production methods; (9) Coordination of
produce food safety practices and environmental and/or conservation
goals or practices; (10) Coordination of produce food safety practices
and Federal, state, local and tribal government statutes and
regulations; (11) Microbial testing; (12) Postharvest operations and
the role of the CGMPs in 21 CFR part 110; (13) Records and other
documentation that would be useful to industry and regulators in
ensuring the safety of fresh produce; and (14) Strategies to enhance
compliance.
We further advised that information previously submitted to the
dockets requesting comments on the draft commodity-specific guidances
(CSGs), or to the docket requesting comments and scientific data and
information to update the GAPs Guide, would be considered in this
rulemaking and need not be resubmitted. Comments submitted to these
dockets, i.e., dockets on the GAPs Guide update and draft CSGs, as well
as comments at the Sprouts Public Meeting and Produce Safety Hearings,
are discussed in sections II.B. and II.D. of this document.
In response to the 2010 FR notice, we received about 880 comments
from consumers, farmers and producers, industry groups and trade
associations, consumer groups, environmental groups, academia, retail
establishments, packers and handlers, food markets and coops,
laboratories and public health facilities, and federal, state, local
and foreign governments. The USDA Agricultural Marketing Service (AMS)
submitted a record of their public hearings related to their proposed
voluntary national marketing agreement for leafy green vegetables
(NLGMA) (74 FR 45565, September 3, 2009 and 74 FR 48423, September 23,
2009), and requested that we consider the contents of that record
(which included testimony, exhibits, and written arguments or briefs
based on evidence received at the public hearing) in our deliberations
to develop safety standards for fresh produce. A summary of general
comments received is presented in this section while specific comments
relevant to the issues addressed in this proposed rule are discussed in
sections V.C through V.R of this document.
1. Comments on Impact, Flexibility and Transparency
Overall, a majority of stakeholders, including farmers, producers,
consumers and industry, expressed concern about the scope and impact of
regulation on the livelihoods of those who produce food and on their
ability to produce food in an economically-feasible manner. Most
comments supported a food safety system, grounded in science, for the
production of produce in a fair and equitable manner for both domestic
and imports. Comments noted that regulations developed should be
science-based and provide for producers to manage risks in a manner
appropriate to their operations. Several comments maintained that risk
assessments, hazard assessments, operational assessments and
development of food safety plans are vital tools for farmers to be able
to demonstrate that the food safety practices they employ are
effective. Conversely, others questioned the need for some industry
segments, such as small farms or growers of ``low risk'' commodities to
establish food safety plans. A majority of comments also stated that
research is needed on various issues relevant to produce safety,
including water quality, soil amendments, animals (both wildlife and
domesticated), and worker health and hygiene. Comments urged the agency
to tailor regulations to reflect variables such as farm size, markets
served, growing conditions, and risk. In addition, comments highlighted
the importance of transparency in the

[[Page 3515]]

development and implementation of food safety standards, and expressed
that transparency provides regulators, buyers, and the public with the
confidence they need to ensure that all reasonable and required
practices have been put in place and that any specific producer or
packer of produce is in compliance with required food safety practices.
FSMA directs us to establish science-based minimum standards for
produce safety. These standards are to include procedures, processes,
and practices that we determine to be reasonably necessary to prevent
the introduction of known or reasonably foreseeable biological,
chemical, and physical hazards into covered produce and to provide
reasonable assurances that produce is not adulterated under section 402
of the FD&C Act. As discussed in section IV below, FDA intends to adopt
a regulatory approach that considers the risk posed by both the
commodity and relevant agronomic practices, and provides the most
appropriate balance between public health protection and flexibility.
We recognize the need to incorporate appropriate flexibility within
regulations to reflect the diversity of commodities and associated
processes, practices, and conditions covered within the scope of this
rule. For example, exemptions based on monetary value of food sold by
the farm and direct farm marketing, commercial processing of
commodities, and other criteria are reflected in proposed subpart A.
Under certain specified conditions, qualified exemptions and associated
modified requirements in a calendar year are also provided under
proposed subpart A. In addition, proposed Sec. 112.12 would establish
a framework for alternatives to certain requirements of the rule. We
realize that numerous differences exist among practices based on risk
or agro-ecological conditions and therefore alternatives to certain
requirements would be permitted when adequate and documented scientific
data or information support such alternatives. Similarly, proposed
subpart P sets procedures for a State or foreign country to request a
variance from one or more requirements of this part when certain
conditions are met, as required by Section 419(c)(2) of the FD&C Act.
For example, a State or foreign country may consider that the
historical performance of an industry within their jurisdiction (e.g.,
as indicated by the epidemiological record) and the combination of
measures taken by that industry merits requesting a variance from some
or all provisions of this proposed rule. In requesting a variance,
among other things, the State or foreign country would submit
information that, while the procedures, processes and practices to be
followed under the variance would be different from those prescribed in
this proposed rule, the requested variance is reasonably likely to
ensure that the produce is not adulterated under section 402 of the
FD&C Act and provide the same level of public health protection as the
requirements of the final regulations (see proposed 112.173). FDA would
encourage consideration of these kinds of submissions.
Furthermore, in addition to soliciting comments on the proposed
regulation through this notice, we will be holding public meetings in
diverse geographic areas of the United States to provide persons in
different regions an opportunity to comment, as required under Section
419(a)(2) of the FD&C Act.
2. Comments on Environmental Considerations
Several comments pointed out that there are a number of state and
federal laws and programs that relate to environmental stewardship, and
noted that environmental conservation and food safety are not
necessarily cross-competing goals. Comments favored a uniform
regulatory approach among Federal, State, local and tribal governments'
statutes and regulations, and recommended that we consider the work of
other Federal agencies, including the Environmental Protection Agency,
the Department of Agriculture, and the Department of the Interior in
developing proposed requirements for produce to ensure such
requirements do not unnecessarily inhibit co-management of food safety
and environmental concerns. In this regard, a few comments stated that
while co-management of food safety and sustainability may be
considered, ultimately, food safety has to be top priority and it is
unacceptable to sell unsafe food to customers.
Section 419(a)(3)(D) of the FD&C Act directs that this proposed
rule take into consideration, consistent with ensuring enforceable
public health protection, conservation and environmental practice
standards and policies established by Federal natural resource
conservation, wildlife conservation, and environmental agencies. As
discussed further in Sections III.A.8 and V.I, we consulted with
several Federal agencies in order to take into consideration
conservation and environmental practice standards and policies
established by those agencies. FDA also plans to work closely with
Federal, State, and local agencies in implementing the final rule.
3. Comments on Guidance and Education
A majority of comments also expressed the need for guidance to
assist stakeholders in implementing the requirements established in
final regulations. Moreover, several comments stressed the importance
of educational programs and incentives in any effective food safety
system.
Section 419(e) of the FD&C Act requires FDA to publish updated good
agricultural practices and guidance for the safe production and
harvesting of specific types of fresh produce, in consultation with the
Secretary of Agriculture, representatives of State departments of
agriculture, farmer representatives, and various types of entities
engaged in the production and harvesting or importing of fruits and
vegetables that are raw agricultural commodities, including small
businesses. In addition, section 419(e) of the FD&C Act requires FDA to
conduct education and outreach regarding this guidance through public
meetings in diverse geographical regions. FDA intends to provide ample
opportunity for public consultation and input and will strive to
develop stronger partnerships with the private sector to ensure optimal
use of resources.
4. Comments Related to Foreign Producers
A number of foreign governments expressed concerns with the foreign
producers' ability to comply with and FDA's enforcement of the
regulation, stressing the need for transparency. Some comments
requested we consider convergence with existing private schemes, such
as the Global Food Safety Initiative and Global G.A.P to avoid
duplication of efforts while others urged us to consider recognition of
foreign governments' produce safety initiatives.
In implementing a final rule based on this proposed rule, we intend
to provide equal treatment in the application, compliance, and
enforcement of the proposed standards for foreign and domestic
facilities. Recognizing that foreign farms in some countries may have
difficulty in understanding the rule's applicability to them, we will
partner with stakeholders to identify areas for outreach and technical
cooperation to achieve greater understanding of the proposed
provisions.
Furthermore, consistent with section 419(c)(2) of the FD&C Act, in
proposed subpart P, we establish a procedure

[[Page 3516]]

whereby a State or foreign country could request a variance from one or
more requirements proposed in the rule, where the State or foreign
country determines that (1) the variance is necessary in light of local
growing conditions; and (2) the procedures, processes, and practices to
be followed under the variance are reasonably likely to ensure that the
produce is not adulterated under section 402 of the FD&C Act, and to
provide the same level of public health protection as the requirements
of this rule (see section V.P. of this document).

G. White House Food Safety Working Group

In 2009, President Obama established a White House Food Safety
Working Group to identify measures needed to upgrade our food safety
laws for the 21st Century, coordinate Federal efforts, and develop
short- and long-term agendas to make food safer. Specific objectives of
this workgroup included: Fostering coordination of food safety efforts
throughout the government and ensuring laws are being adequately
enforced to keep the American people safe from foodborne illness. The
workgroup was co-chaired by the Secretaries of the HHS and USDA.
Participating agencies included FDA, USDA's Food Safety and Inspection
Service (FSIS), CDC, the Department of Homeland Security, the
Department of Commerce, the Department of State, EPA, and several
offices of the White House.
On July 7, 2009, the workgroup released its report ``Implementing a
National Public Health Approach to Food Safety: Report to the
President.'' This report included recommendations for a new public
health-focused approach to the safety of all food based on three core
principles: (1) Prioritizing prevention, (2) strengthening surveillance
and enforcement, and (3) improving response and recovery. Workgroup
recommendations and White House directives specific to produce included
(1) issuing commodity-specific guidances to reduce the likelihood of
microbial contamination in the production and distribution of tomatoes,
melons, and leafy greens; and (2) taking steps (including seeking
public comment) to establish required practices through regulation. The
numerous steps we have taken in response to these directives are
described throughout this section.

H. Other Related Issues

1. Tracking and Tracing of Produce
Our regulations in 21 CFR part 1, subpart J require that persons
who manufacture, process, pack, transport, distribute, receive, hold,
or import food in the United States establish and maintain records
identifying the immediate previous sources and immediate subsequent
recipients of food. During an outbreak of foodborne illness, these
records can help determine the source of the food implicated in the
outbreak. Farms are excluded from the requirements of part 1, subpart
J. We recently held public meetings to stimulate and focus a discussion
about mechanisms to enhance product tracing systems for food in general
(74 FR 56843; November 3, 2009) and for produce in particular (73 FR
55115; September 24, 2008). Section 204 of FSMA now directs us to take
a variety of different actions that will enhance our ability to track
and trace foods, including to establish pilot projects to explore and
evaluate methods to rapidly and effectively identify recipients of food
to prevent or control a foodborne illness outbreak. Further efforts to
enhance the tracking and tracing of food are outside of the scope of
this proposed rule.
2. Transportation of Food
On April 30, 2010 (75 FR 22713), we published in the Federal
Register an Advance Notice of Proposed Rulemaking (ANPRM) as a first
step in implementing the Sanitary Food Transportation Act of 2005
(SFTA). SFTA requires the Secretary of HHS to issue regulations setting
forth sanitary transportation practices to be followed by shippers,
carriers by motor vehicle or rail vehicle, receivers, and others
engaged in food transport. Section 111 of FSMA directs us to promulgate
regulations to implement SFTA. We intend to focus our efforts directed
to sanitary transportation practices as a separate rulemaking, already
underway under the ANPRM. However, such efforts are outside of the
scope of this proposed rule.

III. Legal Authority

FDA is proposing this regulation under the FD&C Act as amended by
FSMA, and the Public Health Service Act (PHS Act).

A. Section 105 of FSMA and Section 419 of the FD&C Act

On January 4, 2011, the FDA Food Safety Modernization Act (FSMA)
(Pub. L. 111-353) was signed into law. Section 105 of FSMA, Standards
for Produce Safety, among other things, amends the FD&C Act to create a
new section 419 with the same name.
Section 419(a)(1)(A) of the FD&C Act directs the Secretary of HHS,
``in coordination with the Secretary of Agriculture and representatives
of State departments of agriculture (including with regard to the
national organic program established under the Organic Foods Production
Act of 1990), and in consultation with the Secretary of Homeland
Security,'' to ``publish a notice of proposed rulemaking to establish
science-based minimum standards for the safe production and harvesting
of those types of fruits and vegetables, including specific mixes or
categories of fruits and vegetables, that are raw agricultural
commodities for which the Secretary has determined that such standards
minimize the risk of serious adverse health consequences or death.'' In
addition to this broad direction in section 419(a)(1)(A), section
419(a)(3) establishes more specific requirements for the content of the
proposed rule, including that the proposed rule:
``[P]rovide sufficient flexibility to be applicable to
various types of entities engaged in the production and harvesting of
fruits and vegetables that are raw agricultural commodities, including
small businesses and entities that sell directly to consumers, and be
appropriate to the scale and diversity of the production and harvesting
of such commodities'' (section 419(a)(3)(A));
``[I]nclude, with respect to growing, harvesting, sorting,
packing, and storage operations, science-based minimum standards
related to soil amendments, hygiene, packaging, temperature controls,
animals in the growing area, and water'' (section 419(a)(3)(B));
``[C]onsider hazards that occur naturally, may be
unintentionally introduced, or may be intentionally introduced,
including by acts of terrorism'' (section 419(a)(3)(C));
``[T]ake into consideration, consistent with ensuring
enforceable public health protection, conservation and environmental
practice standards and policies established by Federal natural resource
conservation, wildlife conservation, and environmental agencies''
(section 419(a)(3)(D));
``[I]n the case of production that is certified organic,
not include any requirements that conflict with or duplicate the
requirements of the national organic program established under the
Organic Foods Production Act of 1990, while providing the same level of
public health protection as the requirements under guidance documents,
including guidance

[[Page 3517]]

documents regarding action levels, and regulations under the FDA Food
Safety Modernization Act'' (section 419(a)(3)(E)); and
``[D]efine, for purposes of [section 419], the terms
`small business' and `very small business''' (section 419(a)(3)(F)).

Furthermore, section 419(b) of the FD&C Act establishes additional
requirements that the final regulation:
``[P]rovide for minimum science-based standards for those
types of fruits and vegetables, including specific mixes or categories
of fruits and vegetables, that are raw agricultural commodities, based
on known safety risks, which may include a history of foodborne illness
outbreaks'' (section 419(b)(1));
``[P]rovide for coordination of education and enforcement
activities by State and local officials, as designated by the Governors
of the respective States or the appropriate elected State official as
recognized by State statute'' (section 419(b)(2)(A)); and
``[I]nclude a description of the variance process under
[section 419(c)] and the types of permissible variances the Secretary
may grant'' (section 419(b)(2)(B)).

In section 419(c), the FD&C Act establishes criteria for the final
regulation, including that the final regulation:
``[S]et forth those procedures, processes, and practices
that the Secretary determines to minimize the risk of serious adverse
health consequences or death, including procedures, processes, and
practices that the Secretary determines to be reasonably necessary to
prevent the introduction of known or reasonably foreseeable biological,
chemical, and physical hazards, including hazards that occur naturally,
may be unintentionally introduced, or may be intentionally introduced,
including by acts of terrorism, into fruits and vegetables, including
specific mixes or categories of fruits and vegetables, that are raw
agricultural commodities and to provide reasonable assurances that the
produce is not adulterated under section 402'' (section 419(c)(1)(A));
``[P]rovide sufficient flexibility to be practicable for
all sizes and types of businesses, including small businesses such as a
small food processing facility co-located on a farm'' (section
419(c)(1)(B));
``[C]omply with chapter 35 of title 44, United States Code
(commonly known as the `Paperwork Reduction Act'), with special
attention to minimizing the burden (as defined in section 3502(2) of
such Act) on the business, and collection of information (as defined in
section 3502(3) of such Act), associated with such regulations''
(section 419(c)(1)(C));
``[A]cknowledge differences in risk and minimize, as
appropriate, the number of separate standards that apply to separate
foods'' (section 419(c)(1)(D));
``[N]ot require a business to hire a consultant or other
third party to identify, implement, certify, compliance with these
procedures, processes, and practices, except in the case of negotiated
enforcement resolutions that may require such a consultant or third
party'' (section 419(c)(1)(E);
``[P]ermit States and foreign countries from which food is
imported into the United States to request from the Secretary variances
from the requirements of the regulations, subject to [section 419(c)(2)
of the FD&C Act], where the State or foreign country determines that
the variance is necessary in light of local growing conditions and that
the procedures, processes, and practices to be followed under the
variance are reasonably likely to ensure that the produce is not
adulterated under section 402 [of the FD&C Act] and to provide the same
level of public health protection as the requirements of the
regulations adopted under [section 419(b) of the FD&C Act]'' (section
419(c)(1)(F)); and
Establish requirements relating to variances, including
that:
[cir] ``A State or foreign country from which food is imported into
the United States may in writing request a variance from the Secretary.
Such request shall describe the variance requested and present
information demonstrating that the variance does not increase the
likelihood that the food for which the variance is requested will be
adulterated under section 402, and that the variance provides the same
level of public health protection as the requirements of the
regulations adopted under [section 419(b) of the FD&C Act]. The
Secretary shall review such requests in a reasonable timeframe''
(section 419(c)(2)(A)).
[cir] ``The Secretary may approve a variance in whole or in part,
as appropriate, and may specify the scope of applicability of a
variance to other similarly situated persons'' (section 419(c)(2)(B)).
[cir] ``The Secretary may deny a variance request if the Secretary
determines that such variance is not reasonably likely to ensure that
the food is not adulterated under section 402 and is not reasonably
likely to provide the same level of public health protection as the
requirements of the regulation adopted under [section 419(b) of the
FD&C Act]. The Secretary shall notify the person requesting such
variance of the reasons for the denial'' (section 419(c)(2)(C)).
[cir] ``The Secretary, after notice and an opportunity for a
hearing, may modify or revoke a variance if the Secretary determines
that such variance is not reasonably likely to ensure that the food is
not adulterated under section 402 and is not reasonably likely to
provide the same level of public health protection as the requirements
of the regulations adopted under [section 419(b) of the FD&C Act]''
(section 419(c)(2)(D)).
In addition, section 105(c) of FSMA creates a new section 301(vv)
in the FD&C Act (21 U.S.C. 331(vv)) to prohibit ``[t]he failure to
comply with the requirements under section 419 [of the FD&C Act].''
1. Coordination and Consultation Requirements
Consistent with section 419(a)(1)(A) of the FD&C Act, FDA has
coordinated with the Secretary of Agriculture and representatives of
State departments of agriculture (Ref. 34. Ref. 35) and consulted with
the Secretary of Homeland Security regarding this proposed rule.
2. Definitions of Small and Very Small Businesses
Section 419(a)(3)(F) of the FD&C Act requires that the regulations
define the terms ``small business'' and ``very small business.'' These
terms are significant because section 419 of FSMA contains provisions
specific to such entities.

``With respect to small and very small businesses* * *
that produce and harvest those types of fruits and vegetables that
are raw agricultural commodities that the Secretary has determined
are low risk and do not present a risk of serious adverse health
consequences or death, the Secretary may determine not to include
production and harvesting of such fruits and vegetables in such
rulemaking, or may modify the applicable requirements of regulations
promulgated pursuant to [section 419]'' (section 419(a)(1)(B) of the
FD&C Act).
``[T]he regulations promulgated under [section 419 of
the FD&C Act] shall apply to a small business* * * after the date
that is 1 year after the effective date of the final regulation* * *
[and] to a very small business* * * after the date that is 2 years
after the effective date of the final regulation'' (section
419(b)(3) of the FD&C Act).

In section V.A. of this document, we discuss our proposed
definitions of small and very small business. In section IV.K. of this
document, we discuss our proposal to establish compliance dates for
small and very small businesses that are three and four years,
respectively, after the effective

[[Page 3518]]

date of the final regulation, with additional, more extended compliance
dates for certain proposed provisions related to water. FDA has
tentatively decided not to exempt or modify the requirements of the
proposed rule with respect to small and very small businesses that
produce and harvest certain types of produce based on a determination
that such types of produce are low risk and do not present a risk of
serious adverse health consequences or death using the discretionary
authority provided by section 419(a)(1)(B). It is not necessary to use
this discretionary authority in part because, as discussed in section
V.A. of this document, FDA proposes in Sec. 112.2 to exclude certain
types of low risk produce from the coverage of this rule without regard
to the business size of the farm producing and harvesting such produce.
As discussed in section IV.C.2. of this document, these exclusions are
based on our tentative conclusion that science-based minimum standards
to minimize the risk of serious adverse health consequences or death
from biological hazards in these commodities are not warranted. Another
reason it is not necessary to use the discretionary authority in
section 419(a)(1)(B) is because, as discussed in section V.A. of this
document, FDA proposes in Sec. 112.4 to apply this regulation only to
businesses with an average annual monetary value of food sold during
the previous three-year period of more than $25,000 on a rolling basis,
based on a tentative conclusion that businesses with $25,000 or less in
sales do not contribute significantly to the produce market (1.5% of
covered produce acres) and, therefore, to the volume of production that
could become contaminated. Accordingly, we tentatively conclude that
imposing the proposed requirements on these businesses is not warranted
because it would have little measurable public health impact. We note
that such farms would continue to be subject to the applicable
requirements of the FD&C Act.
3. Exemptions and Exceptions
Section 419(f)(1) of the FD&C Act establishes an exemption from the
requirements under section 419 based on average annual monetary value
of the food sold directly to ``qualified end-users'' (as defined in
section 419(f)(4)) as compared to all other buyers and average annual
monetary value of all food sold. Section 419(f)(2) establishes
requirements for consumer notifications with respect to food from
exempt farms, and section 419(f)(3) provides that the Secretary may
withdraw the exemption in specified circumstances. In sections V.A and
V.R of this document, we discuss proposed Sec. Sec. 112.5 and 112.6,
and subpart R, respectively, which would implement these provisions of
the FD&C Act.
Section 419(g) of the FD&C Act states ``[t]his section shall not
apply to produce that is produced by an individual for personal
consumption.'' In section V.A. of this document, we discuss proposed
Sec. 112.2(a)(2), which would implement this provision.
Section 419(h) of the FD&C Act states ``[t]his section shall not
apply to activities of a facility that are subject to section 418.'' In
sections III.F and V.A.2.b.i of this document we discuss proposed Sec.
112.4(a), which would implement this provision.
4. Intentional Adulteration
FDA proposes to implement section 105 of FSMA in two regulations,
rather than a single regulation that covers all hazards relevant to
produce. This rulemaking is not intended to address hazards ``that may
be intentionally introduced, including by acts of terrorism.'' (Sec.
419(a)(3)(C) and (c)(1)(A) of the FD&C Act). FDA plans to implement
section 105 of FSMA regarding such hazards in a separate rulemaking in
the future, and intends to consult with the Secretary of Homeland
Security in that rulemaking, as required by Sec. 419(a)(1)(A) of the
FD&C Act. FDA tentatively concludes that intentional hazards likely
will require different kinds of controls and would be best addressed in
a separate rulemaking.
5. Science-Based Minimum Standards Related to Specific Topics
Consistent with the provisions in Section 419(a)(3)(B) of the FD&C
Act that requires us to establish ``science-based minimum standards
related to soil amendments, hygiene, packaging, temperature controls,
animals in the growing area, and water,'' this proposed rule addresses
specific topics relevant to production and harvesting of produce on
farms. We address standards related to soil amendments in subpart F;
standards for hygiene in subpart D, standards for animals in the
growing area in subpart I; and standards for water in subpart E. We
address packaging as part of our proposed standards for harvest,
packing, and holding activities in subpart K; and temperature controls
as part of our proposed standards for agricultural water in subpart E.
6. Providing Sufficient Flexibility To Be Practicable
As required by section 419(a)(3)(A) and (c)(1)(B), this proposed
rule would provide sufficient flexibility to be practicable for all
sizes and types of entities engaged in the production and harvesting of
fruits and vegetables that are raw agricultural commodities, including
small businesses and entities that sell directly to consumers, and is
appropriate to the scale and diversity of the production and harvesting
of such commodities.
As discussed in section IV of this document, we have chosen a
regulatory approach that provides significant flexibility. We propose a
variety of different types of measures (including GMP-type measures,
numerical standards, requirements to monitor and take action under
certain circumstances, and written plans) to tailor the requirements of
the proposed rule appropriately and to be practical for the diversity
of farms and commodities that would be covered by the proposed rule.
Wherever possible, we have also attempted to fashion this
regulation to be as flexible as possible to accommodate future changes
in science and technology and the particularities of local growing
conditions and commodities. As discussed in section V.B of this
document, in proposed Sec. 112.12, we list the specific requirements
established in this rule for which we would allow alternatives to be
established and used in appropriate circumstances. This provision would
provide significant flexibility by allowing individual farms to develop
alternative standards suitable to their operations with appropriate
scientific support. In addition, consistent with sections 419(c)(1)(F)
and (c)(2) of the FD&C Act, in proposed subpart P, we provide for a
mechanism by which a State or a foreign country from which food is
imported into the United States may request a variance from one or more
requirements proposed in this part, where the State or foreign country
determines that: (a) The variance is necessary in light of local
growing conditions; and (b) the procedures, processes, and practices to
be followed under the variance are reasonably likely to ensure that the
produce is not adulterated under Section 402 of the Act and to provide
the same level of public health protection as the requirements of this
part. Proposed subpart P would provide additional flexibility for
alternative practices to be used where appropriate to specific local
growing conditions and commodities.

[[Page 3519]]

7. Use of Third Parties
In accordance with section 419(c)(1)(E) of the FD&C Act, we are not
proposing to require a farm to hire a consultant or third party to
identify, implement, certify, or comply with these produce safety
standards. These standards are intended to be capable of implementation
by those who engage in routine activities on the farm. As discussed in
section II.D.1 and V.Q., FDA has, together with USDA AMS, established a
jointly funded Produce Safety Alliance (PSA), a public-private
partnership that will develop and disseminate science- and risk-based
training and education programs to provide produce farms with
fundamental food safety knowledge. Education and outreach through
mechanisms like PSA and other sources of information that are familiar
to the produce farming community (such as Cooperative Extension, land
grant universities and trade associations) is the foundation of our
intended compliance strategy. Through these mechanisms, FDA aims to
assist farmers in gaining the food safety knowledge they will need to
comply with the provisions of a final produce safety rule.
8. Consideration of Environmental Standards
As required by section 419(a)(3)(D), in developing these produce
safety standards and consistent with ensuring enforceable public health
protection, we took into consideration conservation and environmental
practice standards and policies established by Federal natural resource
conservation, wildlife conservation, and environmental agencies. In
developing this rule, we consulted with USDA's National Organic Program
and Natural Resources Conservation Service, U.S. Fish and Wildlife
Service, and the EPA to take into consideration conservation and
environmental practice standards and policies established by those
agencies (Ref. 34). Our proposed requirements encourage the application
of practices that can enhance food safety, including sustainable
conservation practices. Additionally, as discussed in section V.E of
this document, this proposed rule is designed to be compatible with
existing conservation practices in the management of agricultural water
systems. Moreover, as discussed in section V.I of this document, this
proposed rule would not require the destruction of habitat or the
clearing of farm borders around outdoor growing areas or drainages.
9. Consistency With National Organic Program
In accordance with section 419(a)(3)(E), this proposed rule does
not include any requirements that conflict with or duplicate the
requirements of the National Organic Program. In developing this
proposed rule, we consulted with technical experts and representatives
from the National Organic Program (Ref. 34). Compliance with the
provisions of this proposed rule would not preclude compliance with the
requirements for organic certification in 7 CFR part 205. Moreover,
where this proposed rule and the National Organic Program would include
similar or related requirements, we propose that our requirements may
be satisfied concurrently with those of the National Organic Program
(i.e., to the extent the requirements are the same, compliance with
this proposed rule could be achieved without duplication). For example,
proposed Sec. 112.54(c) would establish multiple options for
composting processes used to treat biological soil amendments of animal
origin used to grow covered produce, including two options (Sec.
112.54(c)(1) and (2)) that are consistent with the options available to
USDA-certified organic farms under the National Organic Program
regulations in 7 CFR 205.203(c)(2).
As another example, the National Organic Program application
intervals for the use of raw manure as a soil amendment in 7 CFR
205.203(c)(1) are 90 days and 120 days before harvest, depending on
whether the edible portion of the crop contacts the soil. Proposed
Sec. 112.56(a)(1)(i) would require a 9 month application interval for
use of raw manure in the growing of covered produce when application is
performed in a manner that does not contact covered produce during
application and minimizes the potential for contact with covered
produce after application. Proposed Sec. 112.56(a)(1)(ii) would not
require an application interval for use of raw manure in the growing of
covered produce when application is performed in a manner that does not
contact covered produce during or after application. For certified
organic farms growing produce that would be subject to this rule, the
National Organic Program application intervals would run concurrently
with the proposed application interval in this proposed rule, rather
than consecutively. Organic farms (like other farms) using raw manure
would either need to wait 9 months between application and harvest and
use application methods meeting the proposed requirements for avoiding
and minimizing contact between covered produce and raw manure, or apply
the raw manure in a manner that does not contact covered produce during
or after application. Doing so would not jeopardize their compliance
with the requirements of the National Organic Program.
In addition, this proposed rule would establish in proposed Sec.
112.163 that records kept for other purposes could be used to satisfy
the recordkeeping requirements in this proposed rule. Accordingly,
records kept under 7 CFR 205.103 for the purposes of the National
Organic Program that contain information that would be required in
records under this proposed rule would not need to be duplicated.
Further, while not critical to our conclusion regarding compliance
with section 419(a)(3)(E) of the FD&C Act, we note that the provisions
of the proposed rule are not in conflict with or duplicative of the
non-binding recommendations of the National Organic Standards Board's
Compost Tea Task Force (Ref. 36). Certified organic farms would be able
to comply with the provisions of this proposed rule with respect to
their use of agricultural teas while simultaneously meeting or
exceeding the non-binding recommendations in the NOSB Compost Tea Task
Force Report.
We seek comment on our approach to ensuring that this proposed rule
does not conflict with or duplicate the requirements of the National
Organic Program while providing the same level of public health
protection as required under FSMA.
10. Minimizing PRA burden
In implementing section 419 of the FD&C Act through this proposed
rule, FDA has complied with chapter 35 of title 44, United States code
(commonly known as the ``Paperwork Reduction Act'' (PRA)), with special
attention to minimizing the burden (as defined in section 3502(2) of
such Act (44 U.S.C. 3502(2)) on the facility, and collection of
information (as defined in section 3502(3) of such Act (44 U.S.C.
3502(3)), associated with the proposed rule. Under section 3502(2) of
the PRA, ``burden'' means the ``time, effort, or financial resources
expended by persons to generate, maintain, or provide information to or
for a Federal agency.'' Under section 3502(3) of the PRA, ``collection
of information'' means, in relevant part, ``the obtaining, causing to
be obtained, soliciting, or requiring the disclosure to third parties
or the public, of facts or opinions by or for an agency, regardless of
form or format, calling for * * * answers to identical questions

[[Page 3520]]

posed to, or identical reporting or recordkeeping requirements imposed
on, ten or more persons.* * *'' In section X of this document, we
discuss how this proposed rule complies with the requirements of the
PRA. In addition, in implementing section 419 of the FD&C Act, we have
paid special attention to minimizing burden and collection of
information associated with this proposed rule.
As discussed above, we are proposing requirements that provide
significant flexibility for different sizes and types of farms. By
making these requirements flexible enough to be practicable for
different sizes and types of farms, the proposed rule also avoids
creating unnecessary information collection burden for entities,
because farms should be able to tailor their recordkeeping to their
specific circumstances while still complying with the requirements of
the proposed rule.
In addition, as discussed in section IV.E. of this document, the
only requirements we are proposing that constitute collections of
information are those that are necessary to implement section 419 of
the FD&C Act and for the efficient enforcement of the FD&C Act. We
propose to require records under this rule only in instances where
maintenance of detailed information is needed to keep track of measures
directed at minimizing the risk of a known or reasonably foreseeable
hazards, where identification of a pattern of problems is important to
minimizing the risk of such hazards, or where they are important to
facilitate verification and compliance with standards and this cannot
be effectively done by means other than a review of records. These
instances are discussed in more detail in section IV.E. of this
document and throughout section V of this document. In addition,
although we recognize their value and encourage their use, we are not
proposing to require farms to conduct operational assessments or to
develop written food safety plans akin to similar requirements for
facilities subject to section 418 of the FD&C Act or our juice HACCP or
seafood HACCP regulations.

B. Other Provisions of the Federal Food, Drug, and Cosmetic Act

FDA's authority for this proposed rule also derives from sections
402(a)(3), 402(a)(4), and 701(a) of the FD&C Act. Section 402(a)(3) of
the FD&C Act provides that a food is adulterated if it consists in
whole or in part of any filthy, putrid, or decomposed substance, or if
it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act
provides that a food is adulterated if it has been prepared, packed, or
held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious
to health. Under section 701(a) of the FD&C Act, FDA is authorized to
issue regulations for the efficient enforcement of the FD&C Act. The
proposed rule includes many requirements that are necessary to prevent
food from being adulterated (either because it consists in whole or in
part of a filthy, putrid, or decomposed substance, because it is
otherwise unfit for food, or because it has been held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health). A regulation
that requires measures to prevent food from being held under insanitary
conditions whereby either of the proscribed results may occur allows
for the efficient enforcement of the FD&C Act. See, e.g., regulations
to require HACCP systems for fish and fishery products (21 CFR Part
123) and juice (part 120), regulations to require a safe handling
statement on cartons of shell eggs that have not been treated to
destroy Salmonella organisms and to require refrigeration of shell eggs
held for retail distribution (parts 101 and 115), and regulations for
the production, storage, and transportation of shell eggs (part 118).

C. The Public Health Service Act

In addition to the FD&C Act, FDA's legal authority for the proposed
rule derives from the PHS Act. Authority under the PHS Act for the
proposed regulations is derived from the provisions of sections 311,
361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable
disease. The PHS Act authorizes the Secretary to make and enforce such
regulations as ``are necessary to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries
into the States * * * or from one State * * * into any other State''
(section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966
at 42 U.S.C. 202 for transfer of authority from the Surgeon General to
the Secretary; see 21 CFR 5.10(a)(4) for delegation from the Secretary
to FDA.) The provisions in the proposed rule are necessary to prevent
food from being contaminated with human pathogens such as Salmonella,
L. monocytogenes, and E. coli O157, and therefore to prevent the
introduction, transmission, or spread of communicable disease from
foreign countries into the United States, or from one state in the
United States to another. As discussed in section II of this document,
without appropriate prevention steps, certain practices on farms can
lead to the contamination of food with pathogens, increasing the
likelihood of foodborne illness. We tentatively conclude that the
proposed provisions in this document are necessary to prevent the
spread of communicable disease and to prevent food from containing
filthy, putrid, or decomposed substances; being otherwise unfit for
food, or being prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or whereby it may
have been rendered injurious to health.

D. Legal Authority for Records Requirements

We are proposing to use our authority under the FD&C Act and the
PHS Act to institute certain records requirements as follows:
For covered produce that is exempted from the requirements
of the proposed rule because it receives commercial processing that
adequately reduces the presence of microorganisms of public health
significance, the identity of the recipient that receives this produce
(Sec. 112.2);
For alternatives that farms may establish and use for
certain requirements of the proposed rule, the scientific data and
information used to support such alternatives (Sec. 112.12);
Documentation of compliance with certain requirements
related to training of personnel (Sec. 112.30); water monitoring and
testing (Sec. 112.50); biological soil amendments of animal origin
(Sec. 112.60); sanitizing of equipment used in growing operations for
sprouts, or for covered harvest, packing, or holding activities (Sec.
112.140), and sprouts (Sec. 112.150); and
General requirements in subpart O that apply to records
required to be established and maintained.
As discussed further in sections V.A., V.B., V.C., V.E., V.F.,
V.L., V.M., and V.O. of this document, the proposed recordkeeping
requirements are necessary for covered farms to ensure their own
compliance with these aspects of the proposed rule and for FDA to
ensure that covered farms are complying with the same aspects of the
proposed rule. Therefore, these proposed requirements are necessary for
the efficient enforcement of the FD&C Act because they will aid both
farms and FDA in ensuring that food is not adulterated, and are
necessary to prevent the spread of communicable disease because they
will aid both farms and FDA in ensuring that food does not

[[Page 3521]]

become contaminated with human pathogens.
In addition to having the authority under the FD&C Act and the PHS
Act to require this recordkeeping, we also have the authority to
require access to the records. Because the underlying requirements are
necessary to minimize the likelihood of adulteration and the spread of
communicable disease, access to records that demonstrate that a farm
has followed those requirements is essential to confirm compliance and
achieve the full benefits of the rule. We also have the authority to
copy the records when necessary. We may consider it necessary to copy
records when, for example, our investigator may need assistance in
reviewing a certain record from relevant experts in headquarters. If we
are unable to copy the records, we would have to rely solely on our
investigators' notes and reports when drawing conclusions. In addition,
copying records will facilitate follow up regulatory actions.
Therefore, we have tentatively concluded that the ability to access and
copy records is necessary to enforce the rule and prevent adulteration
and the spread of communicable disease. In other relevant sections of
this document, we explain in more detail the recordkeeping provisions
that we believe are necessary and, because they are limited to what is
necessary, that we believe do not create an unreasonable recordkeeping
burden.

F. Intrastate Activities

FDA tentatively concludes that the provisions in the proposed rule
should be applicable to activities that are intrastate in character.
The plain language of section 419 of the FD&C Act directs FDA to
establish science-based minimum standards for the safe production and
harvesting of fruit and vegetable RACs to minimize the risk of serious
adverse health consequences or death. Section 419 does not include a
limitation to interstate commerce. In addition, the exemption provided
in section 419(f) of the FD&C Act, based in part on the proportion of a
farm's sales made to restaurants or retail food establishments
intrastate or within 275 miles, suggests that Congress intended the
rule issued under section 419 to apply to intrastate commerce because
otherwise there would be no need to provide an exemption for farms
whose sales are intrastate in character. In addition, section 301(vv)
of the FD&C Act provides that ``[t]he failure to comply with the
requirements under section 419'', or the causing thereof, is a
prohibited act. Section 301(vv) does not require an interstate commerce
nexus. Notably, other subsections in section 301 of the FD&C Act, and
section 304 of the FD&C Act (21 U.S.C. 334) demonstrate that Congress
has included a specific interstate commerce nexus in the provisions of
the FD&C Act when that is its intent. Accordingly, it is reasonable to
interpret sections 419 and 301(vv) of the FD&C Act as not limiting the
application of the proposed rule only to those farms with a direct
connection to interstate commerce.
FDA is mindful that its interpretation of FSMA and the FD&C Act
should not cast doubt on the constitutionality of those statutes. (See
Solid Waste Agency of Northern Cook County v. U.S., 531 U.S. 159
(2001)). FDA has considered the relevant provisions of FSMA and the
FD&C Act, FDA's responsibilities in implementing those statutes, and
the law interpreting the commerce clause of the Constitution (Article
I, section 8). Congress's power to legislate under the commerce clause
is very broad. However, such power is not without limits, see United
States v. Lopez, 514 U.S. 549, 567 (1995); U.S. v. Morrison, 529 U.S.
598, 618 (2000), and these limits have been construed in light of
relevant and enduring precedents. In particular, in Lopez, supra, the
Supreme Court acknowledged the continuing vitality of Wickard v.
Filburn, 317 U.S. 111 (1942), noting that ``although Filburn's own
contribution to the demand for wheat may have been trivial by itself,
that was not `enough to remove him from the scope of Federal regulation
where, as here, his contribution, taken together with that of many
others similarly situated, is far from trivial.''' (514 U.S. at 556.)
See also Gonzales v. Raich, 545 U.S. 1, 17-25 (2005). This principle
applies to the application of sections 419 and 301(vv) of the FD&C Act,
as added by section 105 of FSMA. Accordingly, given the collective
impact on commerce of farms that grow, harvest, pack, or hold food that
is sold in ``intrastate'' commerce, FDA tentatively concludes that such
farms should be subject to the proposed rule unless an exemption from
the rule applies (for example, if the farm is eligible for the
qualified exemption in proposed Sec. 112.5, or if the farm only grows
produce exempt from the regulation under one of the exemptions in
proposed Sec. 112.2). This outcome is consistent with section 709 of
the FD&C Act (21 U.S.C. 379a), which states that in any action to
enforce the act's requirements respecting foods, drugs, devices, and
cosmetics, any necessary connection with interstate commerce is
presumed. Likewise, this outcome is consistent with FSMA's risk-based,
preventive approach to food safety because the risk presented by unsafe
food can be great, whether or not the food moves from one state to
another. FDA seeks comment on the number of so-called ``intrastate''
farms that would not be exempt from the proposed rule either under the
proposed exemption in Sec. 112.5 or as a result of growing only
produce that would be exempt under proposed Sec. 112.2.

E. Relevance of Section 415 of the FD&C Act to ``Farm'' Definition and
Related Definitions

Section 419 directs FDA to issue a proposed rule ``for the safe
production and harvesting'' of certain produce. Section 419 does not
affirmatively identify the businesses to which the proposed rule must
apply, but requires FDA to address ``with respect to growing,
harvesting, sorting, packing, and storage operations * * * soil
amendments, hygiene, packaging, temperature controls, animals in the
growing area, and water'' (419(a)(3)(B)); frequently uses the term
``farm'' (e.g., section 419(f)); and clarifies that section 419 does
not apply to produce produced by an individual for personal consumption
(section 419(g)) or activities of facilities subject to section 418
(section 419(h)). FDA intends to issue a notice of proposed rulemaking
implementing section 418 of the FD&C Act (section 103 of FSMA) in the
near future. FDA tentatively concludes that ``activities of facilities
subject to section 418'' are those activities triggering the
requirement to register with FDA under section 415 of the FD&C Act (21
U.S.C. 350d), ``Registration of Food Facilities.'' FDA therefore
tentatively concludes that it is reasonable to apply this proposed rule
to farms and activities of farm mixed-type facilities that are within a
definition of ``farm'' consistent with that utilized in FDA's
implementation of section 415 of the FD&C Act, except to the extent
that such entities are producing fruits and vegetables for their own
consumption. In the near future, we plan to address how we will
coordinate the definitions in the section 415 registration regulations
with the definitions we are proposing for the purpose of the produce
safety proposed rule. Ultimately, FDA intends that the activities to be
regulated under this proposed rule will not trigger the requirement to
register under section 415 of the FD&C Act and as a result will not be
``activities of a facility subject to section 418,'' consistent with
the requirement in section 419(h). Moreover, the activities within the
definition of ``farm'' we propose as part of this rulemaking closely
track those identified in section 419(a)(3)(B), and

[[Page 3522]]

this interpretation is consistent with section 419(f)'s use of the term
``farm.''
Because section 418(o)(2) of the FD&C Act defines the term
``facility'' for the purposes of section 418 to mean only those
facilities required to register under section 415 of the FD&C Act, FDA
tentatively concludes that Congress intended the exemptions from the
registration requirement set forth in section 415 and FDA's
implementing regulations in part 1, subpart H (including the farm
exemption in Sec. 1.226(b)) to be meaningful for the purposes of
defining section 418's applicability (and in turn, section 419's
applicability). Thus, we tentatively conclude that activities within a
definition of ``farm'' consistent with the definition utilized to
implement the section 415 registration requirement are not subject to
section 418 of the FD&C Act, but activities outside such a definition
of ``farm'' are subject to section 418 when they cause a facility to be
required to register with FDA under section 415. We discuss the
proposed definition of ``farm'' and related definitions in section
V.A.2.b.i of this document. We seek comment on these interpretations.

IV. Regulatory Approach

A. Qualitative Assessment of Risk

As discussed below, we are proposing to adopt an approach that
focuses on the likelihood of contamination of produce posed by the
agricultural practices applied to the crop, while exempting only the
lowest-risk produce. We conducted a qualitative assessment of risk
(QAR) of hazards related to produce production and harvesting. The QAR
indicated that produce commodities are potentially subject to similar
microbiological hazard pathways: Commodities can potentially become
contaminated from, for example, direct exposure to contaminated water
or soil amendment. Therefore, we propose to adopt a regulatory approach
for minimizing the risks associated with those hazards and, as
appropriate, provide flexibility for the use of alternative measures
that would provide the same level of public health protection as the
proposed standard.
The QAR addressed various questions related to produce safety,
including: (1) What are the biological hazards of concern in produce
that can lead to serious adverse health consequences or death? (2) How
does produce become contaminated (i.e., routes of contamination) during
on-farm growth, harvesting, and postharvest operations? (3) Does the
likelihood of contamination vary among produce commodity types? (4)
Does the likelihood of illness attributable to produce consumption vary
among produce commodity types? (5) What is the impact of postharvest
practices on the level of contamination at consumption? (6) What on-
farm interventions are available to reduce the likelihood of
contamination? (Ref. 2). The qualitative assessment of risk document is
currently being peer reviewed and changes can be reasonably anticipated
based on the peer review. The peer review plan is available online at
http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. We will
consider peer reviewers' and public comments in finalizing the
qualitative assessment and this proposed rule.
While data and information available to us at this time permitted
us to conduct only a qualitative (not quantitative) assessment, some
important conclusions can be drawn, which provide a basis for our
proposed science-based minimum standards for the safe production and
harvesting of produce commodities. We provide below a brief summary of
conclusions of the QAR.
Key conclusions from this assessment are:
Produce can be contaminated with biological hazards, and
the vast majority of produce-related illnesses are associated with
biological hazards.
The most likely routes of contamination from growing,
harvesting, and on-farm postharvest activities are associated with seed
(for sprouts), water, soil amendments, animals, worker health and
hygiene, and buildings/equipment.
Although some types of produce have been repeatedly
associated with outbreaks, all types of produce commodities have the
potential to become contaminated through one or more of these potential
routes of contamination.
The specific growing, harvesting, and on-farm postharvest
conditions and practices associated with a produce commodity influence
the potential routes of contamination and the likelihood that the given
route could lead to contamination and illness. Use of poor agricultural
practices could lead to contamination and illness, even where the
potential for contamination is relatively low.
Postharvest practices such as cooking (and, possibly
certain peeling) before consumption may have an impact on the
likelihood of contamination of the edible portion and the likelihood of
illness.
Hazards of concern in produce--The scientific evidence from
outbreaks, surveys and published literature establish that human
pathogens (e.g., Salmonella, pathogenic E.coli, Shigella, Cyclospora)
constitute a biological hazard with the potential to cause serious
adverse health consequences or death and result in the vast majority of
foodborne illness known to be associated with produce consumption.
Potential routes of contamination--Based on our observations during
inspections, investigations, and surveillance activities and other
available information, we have grouped the possible routes of
contamination into five major pathways: Water, Soil amendments,
Animals, Worker health and hygiene, and Equipment and buildings. Seed
is an additional route of contamination for sprouts.
Likelihood of contamination--All produce commodities can be
contaminated before, during, and/or after harvest through one or more
of the potential routes of contamination. Although the likelihood of
contamination varies by commodity, it appears to be dependent on the
practices employed and, to a lesser extent, on the characteristics of
the commodity. There appears to be greater variability in the
likelihood of contamination among commodities during growing than
during harvest or after harvest.
Likelihood of exposure--Subsequent to any contamination on-farm,
consumer and retail handling practices and produce consumption rates
affect the likelihood that consumers will be exposed to contamination.
Postharvest practices such as cooking (and possibly certain peeling)
before consumption may have an impact on the likelihood of exposure if
indeed the produce is contaminated.
Risk of illness--Contaminated produce has the potential to cause
illness. However, there are differences among commodities in the risk
of illness primarily based on the routes of contamination associated
with the commodity.
Produce commodities that are ranked as ``higher'' risk of illness
and those ranked as ``lower'' risk of illness share some of the same
characteristics. Both categories include:
Crops where the harvestable portion grows in the ground;
Row crops where the harvestable portion grows on or near
the ground;
Crops where the harvestable portion grows above the
ground;
Crops where the harvestable portion grows on trees, high
above the ground; and

[[Page 3523]]

Crops that are generally grown without soil.
Such diversity suggests that sorting commodities for risk based
only on the manner in which commodities grow would be inappropriate.
This diversity also characterizes commodities associated with
outbreaks. Even within a commodity group, physical characteristics
(such as texture of the fruit) of the commodity that could alter the
potential for contamination and, therefore, association with an
outbreak, do not always appear to do so.
In summary, some produce types are repeatedly associated with
reported foodborne illness whereas other produce types are only
intermittently associated with foodborne illness. Still other produce
commodities have not been associated with reported foodborne illness.
Likely factors contributing to the likelihood of contamination,
exposure, and illness include: Agricultural practices used during
growing, harvesting, and postharvest; physical characteristics of the
crop; consumer and retail handling practices (such as cooking and
peeling); and rates of consumption. However, use of poor agricultural
practices could lead to contamination and illness, even where the
potential for contamination is relatively low.
With regard to water as a route of contamination:--
Agricultural water can be a source of contamination of
produce.
Public Drinking Water Systems (domestically regulated by
the EPA) have the lowest relative likelihood of contamination due to
existing standards and routine analytical testing.
Groundwater has the potential to pose a public health
risk, despite the regulation of many U.S. public wells being subject to
regulation under the Ground Water Regulation.
There is a significant likelihood that U.S. surface waters
will contain human pathogens, and surface waters pose the highest
potential for contamination and the greatest variability in quality of
the agricultural water sources.
Susceptibility to runoff significantly increases the
variability of surface water quality.
Water that is applied directly to the harvestable portion
of the plant is more likely to contaminate produce than water applied
by indirect methods that are not intended to, or not likely to, contact
produce.
Proximity of the harvestable portion of produce to water
is a factor in the likelihood of contamination during indirect
application.
Timing of water application in produce production before
consumption is an important factor in determining likelihood of
contamination.
Commodity type (growth characteristics, e.g. near to
ground) and surface properties (e.g., porosity) affect the probability
and degree of contamination.
Microbial quality of source waters, method of application,
and timing of application are key determinants in assessing relative
likelihood of contamination attributable to agricultural water use
practices.
With regard to soil amendments as a route of contamination--
Soil amendments can be a source of contamination to
produce
Biological soil amendments of animal origin have a greater
likelihood of containing human pathogens than do chemical or physical
soil amendments or those that do not contain animal waste (e.g., plant-
based soil amendments).
Human waste is the most likely waste to contain human
pathogens.
Animal waste subject to treatments, such as chemical and
physical treatments and composting, has relatively lower levels of
human pathogens than untreated animal waste.
Composting is less likely than controlled chemical or
physical treatments to fully eliminate human pathogens from animal
waste.
Incompletely treated, or re-contaminated, biological soil
amendments of animal origin may also contain human pathogens.
Human pathogens in untreated or composted biological soil
amendments, once introduced to the growing environment, will eventually
die off, but the rate of die-off is dependent upon a number of
environmental, regional, and other agro-ecological factors.
Treatments, such as chemical and physical treatments and
composting, can effectively reduce the levels of human pathogens in
animal waste.
Among application methods, application of soil amendments
in a manner in which they contact the harvestable portion of the crop
presents the greatest likelihood of contamination, especially when
applied close to harvest.
With regard to animals as a route of contamination--
Animals can be a source of contamination to produce.
Animal excreta poses a high likelihood of contamination of
produce.
Excreta from domesticated animals poses a greater
likelihood of contamination of produce than does excreta of wild
animals. However, domesticated animals can be expected to be more
readily controlled (i.e., kept apart from produce growing, harvesting,
and postharvest areas).
Excreta from wild animals that rarely associate with human
activities poses the least likelihood of contamination of produce.
Human pathogens from animal excreta, once introduced to
the growing environment, can be expected to eventually die off; but the
rate of die-off is dependent upon a number of environmental, regional,
and other agro-ecological factors.
With regard to worker health and hygiene as a route of
contamination--
Humans (i.e., workers and visitors) are potential carriers
of foodborne pathogens and can be a source of contamination of produce.
Individuals with communicable diseases that can be spread
via food who are engaged in activities in which they contact produce or
food contact surfaces can result in contamination of the produce or
food-contact surfaces with human pathogens.
Hand-washing reduces the potential for contamination of
produce. Its efficacy varies depending upon the use of soap, the
quality of the water, and whether or not hands are dried after washing.
Dirty and damaged gloves may contaminate produce.
Workers or visitors that touch animals can contaminate
produce or food contact surfaces.
Poor hygienic practices, e.g. lack of hand washing, can
lead to contamination of produce.
The presence of adequate toilet facilities in reasonable
proximity to growing areas can reduce produce contamination.
With regard to equipment and buildings as a route of
contamination--
Food contact surfaces are potential routes of
contamination of produce.
Food contact surfaces such as equipment that are designed
and constructed to be cleanable minimize the potential for
contamination of produce.
Pests in buildings used to grow or pack produce can be a
source of contamination of produce.
Waste material can be a source of contamination, or may
become an attractant for pests and thereby act as a source of
contamination to produce, if not properly contained, stored, and
conveyed.
The provisions proposed in section V of this document reflect the
above conclusions drawn from our qualitative assessment of risk. We
seek public comment on the QAR, conclusions drawn from that assessment,
and our consideration of those conclusions in

[[Page 3524]]

developing the proposed requirements. We also request you to submit any
data or factual information that may help the agency to conduct, as
warranted, a thorough and robust quantitative assessment of risk
associated with produce production and harvesting practices.

B. Focus on Biological Hazards

Section 419 of the FD&C Act directs us to establish science-based
minimum standards for the safe production and harvesting of those types
of fruit and vegetable raw agricultural commodities (RACs) for which we
determine that such standards minimize the risk of serious adverse
health consequences or death (section 419(a)(1)(A) of the FD&C Act).
These standards are to be based on known safety risks and to include
procedures, processes, and practices that we determine to be reasonably
necessary to prevent the introduction of known or reasonably
foreseeable biological, chemical, and physical hazards into fruit and
vegetable RACs and to provide reasonable assurances that produce will
not be adulterated under section 402 of the FD&C Act (sections
419(b)(1) and 419(c)(1)(A) of the FD&C Act).
As discussed in the QAR, available data and information clearly
establish that human pathogens constitute a biological hazard with the
potential to cause serious adverse health consequences or death and
result in the vast majority of foodborne illness known to be associated
with produce consumption. By contrast, chemical, physical, and
radiological hazards associated with produce rarely pose a risk of
serious adverse health consequences or death for individuals that would
consume the product (Ref. 7). Section 419(c)(1)(A) of the FD&C Act
requires FDA to ``set forth those procedures, processes, and practices
that the Secretary determines to minimize the risk of serious adverse
health consequences or death, including procedures, processes, and
practices that the Secretary determines to be reasonably necessary to
prevent the introduction of known or reasonably foreseeable biological,
chemical, and physical hazards * * * and to provide reasonable
assurances that the produce is not adulterated under section 402 [of
the FD&C Act].'' The frequency and nature of chemical, physical, and
radiological hazards in produce are such that promulgation of a new
regulatory regime for their control does not, at this time, appear to
be reasonably necessary to prevent their introduction into produce or
to provide reasonable assurances that produce will not be adulterated
under section 402 of the Act. FDA tentatively concludes that existing
programs, such as EPA registration of pesticides, and State and
industry efforts to control the presence of pesticides and mycotoxins
in produce, are sufficient to keep these hazards under control. In
addition, under its broader food safety regulatory framework, FDA
monitors natural toxins (e.g., mycotoxins), pesticides, industrial
chemicals (such as dioxins; cooking or heating related chemicals, such
as acrylamide), and other chemical contaminants, and radionuclides in
foods.
For these reasons, we tentatively conclude that the proposed rule
should be limited in scope to biological hazards and science-based
standards necessary to minimize the risk of serious adverse health
consequences or death associated with biological hazards. Because of
the proposed rule's focus on biological hazards, and because of the
effectiveness of cooking and similar processes on the reduction of the
likelihood of contamination of such hazards, as described in the
Qualitative Assessment of Risk, we also propose to exempt produce that
is rarely consumed raw or that receives commercial processing that
adequately reduces the presence of microorganisms of public health
significance (see section V.A. of this document).
We request comment on this approach, and specifically on whether
there are practices that are reasonably necessary to prevent the
introduction of known or reasonably foreseeable chemical, physical or
radiological hazards into produce or otherwise to provide reasonable
assurances that produce is not adulterated under section 402 of the
FD&C Act because of chemical, physical, or radiological hazards. For
example, proposed Sec. 112.11 would require covered farms to take
appropriate measures to minimize risks of serious adverse health
consequences or death from the use of, or exposure to, covered produce
attributable to biological hazards that may arise unexpectedly and
therefore not be reflected in a specific standard set forth in proposed
subparts C to O of this rule, or when there are biological hazards
specific to a covered farm's location or circumstances for which such
measures would be appropriate. Should Sec. 112.11 also apply, for
example, in the event of an accident or other unexpected event, such as
a likelihood of radiological contamination relevant to a covered farm's
location, to require that the covered farm take appropriate measures to
prevent the introduction of radiological hazards into or onto the
produce or by taking measures to provide reasonable assurances that the
produce is not adulterated under section 402 of the FD&C Act? Such
measures might include, for example, preventing covered produce from
entering commerce if it may have been contaminated with radiological
hazards that may render it injurious to health. As another example, if
a covered farm's land was previously used for another activity that may
have contaminated the soil with chemical hazards such that using the
land to grow covered produce may cause introduction of those hazards
into or onto the covered produce, should proposed Sec. 112.11 require
the covered farm to take appropriate measures to prevent the
introduction of the chemical hazards into or onto the produce or by
taking measures to provide reasonable assurances that the produce is
not adulterated under section 402 of the FD&C Act? Such measures might
include, for example, collecting and analyzing soil samples for
residues of pesticides that are typically used in the production of
cotton, if you intend to use a former cotton field for produce
production. We seek comment on whether, and to what extent, chemical,
physical, or radiological hazards should be covered within the scope of
this rule.

C. Consideration of Differing Risk of Different Commodities and
Practices

Section 419 of the FD&C Act also directs us to establish
requirements that would provide sufficient flexibility to be applicable
to various types of entities engaged in the production and harvesting
of fruit and vegetable RACs, including small businesses and entities
that sell directly to consumers, and to be appropriate to the scale and
diversity of the production and harvesting of such commodities (section
419(a)(3)(A) of the FD&C Act). Section 419 further directs us to
acknowledge differences in risk while minimizing, as appropriate, the
number of separate standards we apply to separate foods (section
419(c)(1)(D) of the FD&C Act). We considered different approaches to
determine how we might most appropriately respond to these directives,
informed by the information contained in the Qualitative Assessment of
Risk. These primarily included:
Commodity-specific approach--covering only those produce
commodities or commodity groups that might be described as posing a
relatively higher risk of foodborne illness or applying different
requirements to commodity categories based on relative risk of
foodborne illness represented by the commodity category (such as
higher, moderate and lower risk). A benefit of opting to pursue a
commodity specific

[[Page 3525]]

approach would be a reduction in the costs of the proposed rule. Some
commodities have little or no history of links to foodborne illness
and, thus, exempting them from coverage could reduce costs to farmers
with little or no reduction in calculated benefits from the rule.
However, because foodborne illness outbreaks have regularly been
associated with commodities that have previously not been linked to
outbreaks, this approach carries the risk of failing to prevent future
outbreaks.
Integrated approach--covering all produce commodities
except those that pose little or no risk of foodborne illness and then
applying the most stringent requirements to agricultural practices that
pose the greatest likelihood of contamination of the produce,
regardless of the covered produce commodity. A benefit of selecting
this option is that we would cover all commodities except those that
pose little or no risk of foodborne illness, an approach that takes
into account the sporadic and unpredictable nature of illness
outbreaks, while still being sensitive to risk.
As discussed below, we explored both approaches thoroughly using
information available to us at this time, and propose to use an
integrated approach. Based on available data, we have not been able to
fully develop a commodity-specific approach that we believe would
adequately minimize risk of serious adverse health consequences or
death from biological hazards in produce. However, as discussed in
section IV.C.1.b., we have tentatively identified an approach based on
outbreak data, and we further explore that option in that section. We
welcome comment on this approach and ask that you provide data and
factual information that would help us to further consider developing
this or another appropriate commodity-specific approach.
1. Commodity-Specific Approaches
As noted above, there are multiple possible approaches that we
could take with respect to produce. One of them is what we refer to as
a ``commodity-specific approach'' in which this rule would apply only
to those produce commodities or commodity groups that pose a relatively
higher risk of foodborne illness. (We could also simply apply different
or less stringent requirements to the relatively lower-risk
commodities.) In theory, commodities might also be grouped into higher,
moderate, or lower levels of risk with different levels of stringency
applied to each. As discussed in section IV.A. above, we attempted to
categorize commodities and commodity groups by risk in our Qualitative
Assessment of Risk.
a. Relative Risk Considerations
To fully explore the viability of a commodity-specific approach, we
reviewed the relative risk of different commodities using four such
data sources: Outbreak data; Pathogen surveillance data; Commodity
characteristics; and Market channels. Our analysis shows that each data
source presents certain gaps that make it challenging to develop a
commodity-specific approach that would adequately minimize risk of
serious adverse health consequences or death. We explain our analysis
below and request data and factual information on how we might address
these gaps and further develop and consider a commodity-specific
approach.
i. Outbreak Data and Commodity Risk: We reviewed FDA's data on
produce-related outbreaks and considered categorizing commodities or
commodity groups by risk based on documented association of specific
produce commodities with specific outbreaks of human illness (Ref. 2).
Using this approach, we could exempt certain commodities or commodity
groups that had never been linked to human illnesses or were only
rarely linked to human illness; this would allow us to reduce the costs
of the rule with little or no reduction in calculated benefits.
However, our QAR also leads us to tentatively conclude that past
patterns of outbreaks by commodity have limitations which make it
challenging to use as a key determining factor in establishing the
scope of this proposed rule or how its provisions apply. We briefly
discuss the reasons here (please refer to the QAR for more
information).
Our QAR concluded that some produce types are repeatedly associated
with reported foodborne illness, whereas other produce types are
intermittently associated with reported foodborne illness. Still other
produce commodities have not been associated with reported foodborne
illness. As such, five commodity groups (leafy greens, tomatoes, herbs,
melons, and sprouts) together account for 77 percent of all produce-
related outbreaks from 1996-2010 (Ref. 3). These commodity groups also
account for 54 percent of produce-related illnesses and 56 percent of
produce-related hospitalizations. Sprouts account for a quarter of the
produce related outbreaks (26%), 15 percent of the illnesses, 9 percent
of the hospitalizations, and one death.
As discussed in the QAR, because only a small percentage of
outbreaks are both reported and assigned to a food vehicle, outbreak
data may not provide a complete picture of the commodities upon which
we need to focus to minimize current and future risk of illness. The
food vehicle responsible for an outbreak is not identified in about
half of all outbreaks. Identifying the vehicle of an outbreak in which
the vehicle is contained in a multi-ingredient food (e.g., salsa,
salads) is particularly challenging. As our abilities to detect
outbreaks and to identify food vehicles responsible for an outbreak
improve, including refining our approach to outbreaks associated with
multi-ingredient foods, it is likely that previously unrecognized
outbreak vehicles will be identified. A further complication to use of
outbreak data as an indication of commodity risk is that, until a food
is identified as a vehicle in an outbreak, public health officials may
not be likely to include questions about that commodity when
investigating an outbreak, making the attribution of outbreaks to
commodities with no outbreak history more difficult.
In addition, as discussed in the QAR, our data show that the
patterns of outbreaks associated with produce commodities change over
time. Some commodities have a continuing and repeated pattern of
association with outbreaks, over multiple years, such as tomatoes and
leafy greens (Ref. 2). On the other hand, occasionally a produce
commodity is associated with an outbreak that had not been previously
linked to foodborne illness. For example, prior to the 2008 Salmonella
Saintpaul outbreak (Ref. 37), jalapeno and serrano peppers had not been
identified as vehicles in a foodborne illness outbreak. Papayas had
also not been associated with outbreaks, prior to an outbreak that
occurred in 2011. Therefore, a regulatory approach that relied on a
static list of commodities prepared solely from a history of outbreaks
would not be able to prevent future outbreaks in commodities not
previously associated with an outbreak.
If we adopted an approach that exempted commodities without a
history of outbreaks, we would likely need to add commodities as future
outbreaks occur. For example, we could adopt a ``moving window''
approach that would consider only outbreaks over a given time period.
For example, we could consider only the outbreaks over the most recent
five years at any given time. Using such an approach, produce
commodities or commodity groups might move onto and off of the higher
risk list over time based on changes in outbreak data. The advantage of
such an approach could potentially be to

[[Page 3526]]

recognize and reward efforts by industry segments that implement
changes in practices contributing to reduced outbreaks associated with
their commodities, and provide an incentive for other industry segments
to enhance the safety of their practices. However, the adoption of such
practices by an industry segment does not change the risk posed by the
commodity in the absence of such practices, such as when practices are
not universally adopted or they are discontinued. In the absence of
those practices, illness outbreaks may resume. For example, sprout
associated outbreaks appeared to decline after release of our Sprout
Guides in 1999 and, for three years (2005-2007), there were no reported
outbreaks associated with sprouts, presumably because of improved
practices during the production of sprouts (Ref. 3). However, outbreaks
have recurred since that time period, possibly because practices have
regressed to some extent or possibly because of the entry of new sprout
growers who were not familiar with the voluntary recommendations in the
Sprout Guides and had not adopted them. In late 2008, there was one
sprout-associated Salmonella outbreak; in 2009, a Salmonella outbreak
associated with sprouts resulted in more than 200 illnesses; and in
2010, there were 3 outbreaks associated with sprouts (Ref. 3). Further,
as discussed in the QAR, some commodities (e.g., leafy greens) are
consistently associated with outbreaks while others (e.g., grapes,
jalapeno peppers) are only rarely associated with outbreaks. With a
moving window approach those commodities that only intermittently are
associated with outbreaks may cycle on and off the higher risk list,
even though their risk may not have actually changed. For these
reasons, we have tentatively concluded that a ``moving window''
approach for determining risk based on outbreak history is not viable.
Grouping commodities based on outbreak history also has challenges.
Within a commodity group, contamination may have been associated with
relatively few types of produce, such as cantaloupe and honeydew melons
within the melon group, which includes multiple species, or more
broadly, such as roma, red round, plum, and grape tomatoes within the
tomato group, which consists of multiple varieties within a single
species (Ref. 3).
Having considered that making exemptions solely based on outbreak
data could significantly reduce the costs of the proposed rule with
little or no reduction in calculated benefits, we have not selected
this alternative, because we do not believe that the past history of
outbreaks can be fully predictive of future outbreaks. Historically,
outbreaks are sometimes linked to commodities that had no previous
associated illnesses. If we were to develop a commodity-specific list
of covered produce, we could add commodities to the list as more data
became available. We request comment on whether this option would
adequately minimize the risk of serious adverse health consequences or
death and whether it would sufficiently move toward a prevention-based
food safety system. We request comment on this determination and on the
specific approaches we have outlined here. We are particularly
interested in the marginal effects of adopting this approach: If we
exempted commodities based on a history of outbreaks, what would the
likely reductions in the costs of the rule be, and what would the
likely increase in human illnesses be from this approach.
ii. Pathogen Surveillance Data and Commodity Risk: As an
alternative to categorizing and regulating commodities based on
outbreak history, we considered using data on levels and frequency of
pathogen detection, such as by surveillance sampling assignments in
specific produce commodities. As demonstrated in the QAR, this approach
would also present a number of challenges. Of most importance, our
contamination data are limited in that most sampling programs have
focused on produce commodities that have an existing history of known
outbreaks, providing little additional information about the risk
presented by commodities that do not have such a history. Given the
potential for system failure and sporadic contamination, it is probable
that testing of other produce commodities may eventually lead to
positive identification of contamination. For example, when we added
cucumbers to our surveillance sampling program in 2009, we found a
significant number of positive samples for Salmonella spp. although, in
previous years, cucumbers had not been identified as the vehicle of a
foodborne outbreak in FDA's database. We also found pathogens in and on
produce commodities such as broccoli, culantro, rapini, and radicchio
that have not been currently identified in outbreaks (Ref. 3). For this
reason, we do not believe that pathogen surveillance data alone can
provide sufficient information for a risk-based exemption from the
proposed rule's provisions. We request comment on this determination.
iii. Commodity Characteristics and Commodity Risk: As an
alternative to categorizing and regulating commodities based on
outbreak history or surveillance data, we also considered using
characteristics of produce commodities themselves, such as growth
habit. In other words, if, for example, the risk of illnesses
associated with tree fruit, were consistently lower than the risk of
illness from commodities grown in the soil, such a distinction might
provide the basis of an exemption. However, as demonstrated in the QAR,
we found that it would be extremely difficult to make conclusions
across commodity groups that are consistent with outbreak and
surveillance data, in light of the diversity of commodities, practices,
and conditions across operations.
Attempts to categorize produce by commodity characteristics is
confounded by the outbreak data, which show no consistent pattern that
can be matched to commodity characteristics such as growth habit. As
discussed in the QAR, the characteristics of approximately 20 produce
commodities associated with outbreaks are diverse and include:
Crops generally grown without soil, such as sprouts;
Crops where the harvestable portion grows in the ground,
such as green onions;
Row crops where the harvestable portion grows on or near
the ground, such as lettuce, spinach, basil, parsley and cantaloupe;
Crops where the harvestable portion grows above the
ground, such as tomatoes and chili peppers, raspberries and
blueberries; and
Crops where the harvestable portion grows on trees, high
above the ground, such as mangoes and almonds.
Moreover, as discussed in the QAR, even within what may be a
reasonable set of commodities to group together, physical
characteristics of the produce that could alter the potential for
contamination do not always appear to do so. For example, within the
melon group, cantaloupe has a netted rind, whereas honeydew has a
smooth rind, seemingly making it less likely to harbor pathogens.
However, both have been associated with outbreaks (Ref. 3).
In addition, multiple characteristics would have to be considered
to create commodity groupings, making such an approach very
complicated. For example, while growth characteristics, such as
distance between the edible portion of the plant and the ground, may
make a commodity less likely to become contaminated through certain
routes, (e.g., tree fruit may be less vulnerable to contamination from
grazing animals), distance from the

[[Page 3527]]

ground does not necessarily provide an increased level of protection
against other sources of contamination (e.g., direct contact with a
crop protection spray if the spray mix were made using contaminated
water). Furthermore, once the produce commodity is removed from the
growing area, it may lose any safety advantage it had in the field
based on growth characteristics if it is exposed to routes of
contamination such as poor worker hygiene practices, contaminated
water, or insanitary food contact surfaces. As another example, mangoes
are an example of a produce commodity that may be thought to present
relatively low risk of foodborne illness, but for which poor water
quality management during insect disinfestation hot water treatment and
cooling as part of harvest, packing, and holding resulted in an
outbreak (Ref. 38). Some physical characteristics of produce
commodities (e.g., netted rind of cantaloupe or large, rough surface
area of some leafy greens) may increase the likelihood of contaminants
being trapped and surviving long enough to cause illness, but as noted
earlier, these characteristics do not necessarily determine whether
contamination occurs or persists.
For the reasons described here, we have tentatively determined that
such an approach cannot serve as the sole basis for a risk-based
exemption from the proposed rule. We request comment on this
determination and on whether there are known produce characteristics
that could serve as a reliable and practicable indicator of
contamination and illness risk. We seek comment on this issue and data
to inform commodity categorization.
iv. Market Channel and Risk: We also considered whether different
market channels might have an impact on the likelihood of contamination
of produce and therefore whether use of certain market channels should
be a factor in covering or regulating produce in this proposed rule. In
particular, we considered whether there is a difference in the
likelihood of contamination of produce that is sold directly to the
consumer or end user (``direct market channels'') as compared to that
of produce that is sold into other commercial channels. We are not
aware of any data that would enable us to compare the likelihood of
contamination in these two situations. We tentatively conclude that
produce in both direct market channels and other commercial channels
are subject to the same routes of contamination, although the number of
opportunities for contamination during packing and holding may be
greater for produce in other commercial channels as compared to produce
in direct market channels if there are greater numbers of touch points
and handlers in these channels than there are in direct market
channels. We seek comment on this tentative conclusion.
Section 419(f) of the FD&C Act provides a qualified exemption from
this proposed rule for many farms selling directly to consumers or
other ``qualified end users,'' and as a result, many farms that
primarily use direct market channels will not be subject to the
requirements of this proposed rule (with qualifications provided by the
statute). Because the statutory qualified exemption addresses market
channels as a possible risk factor, and because we identified no data
that would allow us to otherwise use market channels as a factor in
covering and regulating produce under this proposed rule, we
tentatively conclude that we should not otherwise use market channels
as a basis of risk categorization in this proposed rule. We seek
comment on this tentative conclusion.
b. Considering an Appropriate Commodity-Specific Approach
In the previous section, IV.C.1.a, we discuss four different
relative risk considerations that might be used to develop an
appropriate commodity-specific approach. Each has a set of challenges,
as discussed above. Of the four, outbreak data provide the most direct
representation of public health burden, even considering the confines
associated with these data. In this section we further explore how
outbreak data might be used to identify commodity groups or specific
commodities to cover in this proposed rule.
One possible commodity-specific approach would be to cover those
commodity groups that have been associated with outbreaks. Commodity
groups ``associated with outbreaks'' could be identified as, for
example, commodity groups associated with one or more outbreaks during
a set period of time. The remaining commodity groups could then either
not be subject to the proposed rule, or be subject to the proposed rule
but with less stringent requirements. A commodity-specific approach
that covers the commodity groups associated with outbreaks would target
the commodity groups that present the greatest public health burden.
However, as discussed above in section IV.C.1.a., there are various
drawbacks with using outbreak data in this way. For example, because
only a small percentage of outbreaks are both reported and assigned to
a food vehicle, outbreak data may not provide a complete picture of the
commodities upon which we need to focus to minimize current and future
risk of illness.
Another possible commodity-specific approach that attempts to
account for the drawbacks of the above approach would be to cover all
of the commodities that have been identified as associated with an
outbreak at any time. Produce commodities that have not been identified
as associated with an outbreak could then either not be subject to the
proposed rule, or be subject to the proposed rule but with less
stringent requirements. This option would address more than the percent
of known outbreaks addressed by the above approach in that it would
address all known outbreaks. This approach would also significantly
reduce the costs of the proposed rule by exempting produce categories
that have never been associated with human illness. As discussed above,
however, outbreaks have been associated with commodities without an
illness history. Although we would expect to use additional data to
update any list we might develop of commodities subject to the
provisions of the rule, we would expect that this approach would not
minimize the risk of occurrence of some number of additional outbreaks
and illnesses.
We have discussed limitations with each of the above methods of
creating a risk-based exemption from the rule. We could also combine
two or more of the approaches used above to create a more holistic
picture of risk. For example, we might combine a history of outbreak
data with the growing characteristics of a commodity or class of
commodity. Such an approach could potentially exempt additional
commodities that pose minimal or no risk (in addition to those we
already considered in the proposed approach: Those specified as rarely
consumed raw, and those that are receive commercial processing that
adequately reduces the presence of microorganisms of public health
significance). If there were individual commodities or classes of
commodities that have not been linked to human illness and we had
reason to believe that they were unlikely to be linked to human illness
in the future, we would consider exempting these commodities or classes
of commodities from some or all provisions of the rule. This would
reduce the cost of the rule without significantly reducing the
calculated benefits of the rule. However, we have not been able to
fully develop an approach that might combine a history of outbreak data
with the growing characteristics of a commodity or class

[[Page 3528]]

of commodities to create risk-based exemptions from the rule and, thus,
minimize the risk of serious adverse health consequences or death. We
seek comment on this issue. Is there information in the QAR that could
be used to develop such a system of risk-based exemptions? Are there
commodity characteristics or growth conditions that could be used as a
basis to develop such a system? Do the proposed provisions for
variances (see section V.P. below) adequately address this issue?
We ask for comment on all of the above approaches, and we
especially ask for comment on the likely marginal effects of the
different risk-based exemptions. If we adopted one of the approaches
above, what would the likely reductions in the costs of the proposed
rule be, and what would the likely increases in human illnesses be
(using our proposed rule as a baseline). We also ask for comment on
whether any of the above approaches would be sufficiently protective of
the public health.
c. Need for additional data and information
We seek comment on our analysis and considerations related to
considering an appropriate commodity-specific approach that would
adequately minimize risk of serious adverse health consequences or
death from biological hazards associated with produce. We also request
comment on whether and how different relative risk considerations,
including outbreak data, pathogen surveillance data, commodity
characteristics and/or market channels, could be used to develop a
commodity-specific approach, and data and factual information that
would address the drawbacks that are discussed in this section IV.C.
that may be accounted for in such an approach. Specifically,
[ssquf] Are there specific commodities or categories of commodities
that should be excluded from the scope of the rule, based on data
related to their relative risk considerations? (Note that under our
proposed integrated approach, we propose to exempt certain commodities,
including a specified list of produce that is rarely consumed raw, and
produce that receives commercial processing that adequately reduces the
presence of microorganisms of public health significance; see section
V.A.2.a. of this rule.)
[cir] For example, the QAR ranked certain produce commodities, such
as bananas and coconuts, as lower risk for illness, in part because
such commodities are peeled or shelled before consumption in a manner
that can be expected not to transfer contamination onto the interior,
edible portion of the commodity. Should such commodities be covered by
the rule? Is coverage of these commodities unnecessary? Should they be
covered but subject to a less stringent set of requirements?
[cir] Certain commodities are ranked in the QAR as presenting a
relatively lower likelihood of exposure, in part because such
commodities have fewer potential routes of contamination and/or lower
potential for contamination. In addition, some commodities are not
known to have been associated with outbreaks. Some commodities (for
example, pears, grapefruit, oranges, and lemons) meet both of these
criteria, considering the rankings and outbreak data used in the QAR.
Should commodities that meet both of these criteria be covered by the
rule? Is coverage of these commodities unnecessary? Should they be
covered but subject to a less stringent set of requirements? How should
the rule address the changing nature of outbreak data over time?
[cir] How should the agency account for uncovered commodities in
considering a commodity-specific approach that relies on outbreak data?
[ssquf] Are there pathogen surveillance data from sampling programs
focusing on produce commodities that have no history of known outbreaks
that would be useful in considering a commodity-specific approach?
[ssquf] Can commodity characteristics be used as a basis to
consider a commodity-specific approach? While the outbreak data show no
consistent pattern that can be matched to commodity characteristics
such as growth habit, our QAR shows that produce commodities that are
ranked as higher risk of illness and those ranked as lower risk of
illness do share some of the same characteristics. A further refinement
of our assessment might be helpful in developing a commodity-specific
approach based on commodity characteristics. Considering the
qualitative nature of our assessment, are there quantitative data sets
available that would enable a further refinement of our assessment?
[ssquf] Are produce in both direct market channels and other
commercial channels subject to the same routes of contamination? Is the
number of opportunities for contamination during packing and holding
greater for produce in other commercial channels as compared to produce
in direct market channels? If yes, is this due to greater numbers of
touch points and handlers in these channels than there are in direct
market channels, or to other factors?
[ssquf] Should market channels be used as a basis for risk
categorization? If so, how? Is there a need to consider market channels
in risk categorization, considering that the statutory qualified
exemption already addresses market channels as a possible risk factor?
[ssquf] Are other data or information available that would
otherwise be useful in considering a commodity-specific approach?
2. Integrated Approach, as Proposed
As discussed in section IV.A. above, our QAR indicates that some
produce types are repeatedly associated with reported foodborne illness
whereas other produce types are intermittently associated with
foodborne illness. Still other produce commodities have not been
associated with reported foodborne illness. Likely factors contributing
to the likelihood of contamination, exposure, and illness include:
Agricultural practices used during growing, harvesting, and
postharvest; physical characteristics of the crop; consumer and retail
handling practices (such as cooking and peeling); and rates of
consumption. However, use of poor agricultural practices could lead to
contamination and illness, even where the potential for contamination
is relatively low.
Therefore, we tentatively conclude that an integrated approach that
focuses on the likelihood of contamination of produce posed by the
agricultural practices applied to the crop, while exempting the lowest-
risk produce, would provide the most appropriate balance between public
health protection, flexibility, and appropriate management of different
levels of risk. We tentatively conclude that controls should be
tailored, taking into account the analysis done by the farm in certain
areas, to the potential routes of contamination that each commodity
presents based on the agricultural practices employed, and the
characteristics of the commodity and the environmental conditions under
which it is grown.
Based on our QAR, we are able to identify certain conditions under
which produce commodities constitute very low to no risk with respect
to biological hazards. We tentatively conclude that, under these
conditions, science-based minimum standards to minimize the risk of
serious adverse health consequences or death from biological hazards in
produce are not warranted. As described in the QAR, such conditions
include produce that receives commercial processing that

[[Page 3529]]

adequately reduces the presence of microorganisms of public health
significance (proposed Sec. 112.2(b)); and produce commodities that
are rarely consumed raw (proposed Sec. 112.2(a)(1)). In each of these
cases the produce can be expected to receive commercial processing or
other treatments that significantly minimize the risk of serious
adverse health consequences or death from biological hazards associated
with such produce.
In addition, as discussed in section V.A. of this document, FDA
proposes in Sec. 112.4 to apply this regulation only to businesses
with an average annual monetary value of food sold during the previous
three-year period of more than $25,000 on a rolling basis, based on a
tentative conclusion that businesses with $25,000 or less in sales do
not contribute significantly to the produce market and, therefore, to
the volume of production that could become contaminated. Accordingly,
imposing the proposed requirements on these businesses would have
little measurable public health impact. In addition to these exclusions
proposed by FDA, section 419(f) of the FD&C Act provides a qualified
exemption for certain farms, which FDA proposes to implement in
proposed Sec. Sec. 112.5 and 112.6, and subpart R, as discussed in
sections V.A. and V.R. of this document.
For produce commodities that would be covered within the scope of
this rule (i.e., ``covered produce'' as defined in proposed Sec.
112.3), we are proposing to establish science-based minimum standards
to minimize the risk of serious adverse health consequences or death.
Given our current understanding of existing microbiological hazards and
current data limitations, as described in our QAR, we have determined
that a regulatory approach that addresses the potential likelihood of
contamination posed by procedures, processes, and practices employed in
the growing, harvesting, packing, and holding of produce commodities
will be more effective and appropriate than an approach based on the
individual commodities' physical characteristics, known record of
contamination, or known outbreak history. The only commodity-specific
requirements proposed in this rule are those designated for sprouts,
which have unique growing procedures (i.e., warm, moist nutrient-rich
environment for an extended period of time that supports pathogen
growth in addition to sprouting) and, therefore, present a unique risk
profile (Ref. 16.Ref. 2). For this reason, and as discussed in section
V.M. of this document, we tentatively conclude that a specific set of
safety standards (proposed subpart M) for this produce commodity is
warranted.
The requirements of the proposed regulation would be based on
identified routes of contamination and the associated practices that
affect the likelihood that produce becomes contaminated: Agricultural
practices that are more likely to contaminate produce would require
more stringent measures to ensure that the likelihood of contamination
is sufficiently minimized. For example, as discussed in section V.E. of
this document, we are proposing the most stringent standards for water
that is used in direct contact with the harvestable portion of covered
produce during or after harvest activities (when there is little
further opportunity for pathogen die off) and in certain other uses
that present significant safety risk for the safety of the produce
(such as irrigation of sprouts); less stringent standards for water
that directly contacts the harvestable portion of covered produce
(other than sprouts) during growing activities (when the opportunity
for pathogen die off is greater); and no requirements when water is
used during growing, but does not contact the harvestable portion of
covered produce (other than sprouts). Similarly, we are proposing to
prohibit the use on covered produce of biological soil amendments that
present the greatest likelihood of pathogen contamination, i.e.,
untreated human waste (Ref. 39). Untreated manure or other untreated
biological soil amendments of animal origin, which are less likely to
be contaminated with human pathogens than human waste, but are
relatively likely to be contaminated (Ref. 35. Ref. 36. Ref. 37), would
be allowed, subject to stringent requirements; manure or other
biological soil amendments of animal origin that have been properly
composted to reduce the level of pathogens contained therein would be
subject to less stringent requirements; and certain chemically or
physically treated biological soil amendments of animal origin that
receive more robust treatments to eliminate pathogens would be subject
to the least stringent requirements.
In addition, we are proposing to include other measures that would
be broadly applicable (e.g., personnel qualifications and training
requirements in proposed subpart C, health and hygiene requirements in
proposed subpart D; requirements for equipment, tools, buildings, and
sanitation in proposed subpart L) and the proposed standards for these
are consistent for all covered growing, harvesting, packing, and
holding operations.
We tentatively conclude that the appropriate way to minimize the
risk of serious adverse health consequences or death is to require all
covered farms to comply with the standards in this proposed rule with
regard to all but the lowest risk produce. Identifying the higher-risk
agricultural practices and setting standards in which the stringency of
the requirement tracks the risk of the chosen practices is appropriate
from a public health risk mitigation standpoint and would also provide
an incentive for farmers to move to lower-risk practices where such
options are available. We also expect that our proposed approach is
more workable for row crop farmers who may grow multiple produce
commodities than it would be if we were to assign different
requirements to specific commodities based on the risk of foodborne
illness associated with those commodities. In these types of
operations, many agricultural practices and agricultural inputs (such
as water sources and distribution systems, soil amendments and their
application methods) tend to be farm-specific and, thus, relatively
consistent across produce commodities on a given farm. Requiring
different measures from row to row based on the produce commodity in
that row would likely pose a considerable burden on such farms. Setting
standards that enable such farms to apply consistent measures to
multiple crops is consistent with the statutory provision in section
418(c)(1)(D) of the FD&C Act that directs the agency to ``acknowledge
differences in risk and minimize, as appropriate, the number of
separate standards that apply to separate foods.''

D. Framework of the Rule

In developing a framework for this proposed rule we considered
various models used in proposed and final FDA regulations, including
those applied in: (1) The existing Current Good Manufacturing Practice
in Manufacturing, Packing or Holding Human Food regulation (current 21
CFR part 110; ``Food CGMP regulation''); (2) the Production, Storage,
and Transportation of Shell Eggs regulation (21 CFR part 118; ``Shell
Egg Regulation''); (3) the Hazard Analysis and Critical Control Point
(HACCP) Systems (``juice HACCP'') regulation (21 CFR part 120); and (4)
the Fish and Fishery Products (``seafood HACCP'') regulation (21 CFR
part 123). None of these regulations applies to fruits and vegetables
at the point at which we propose to regulate such food by this
regulation (during growing, harvesting,

[[Page 3530]]

packing, and holding on farms), but as models they are instructive.
Generally, the Food CGMP Regulation sets out mandatory, broad,
generally-applicable practices and conditions that are required to be
met, and the criteria and definitions in that part are applicable in
determining whether the food is adulterated (1) within the meaning of
section 402(a)(3) of the act, in that the food has been manufactured
under such conditions that it is unfit for food, or (2) within the
meaning of section 402(a)(4) of the act, in that the food has been
prepared, packed, or held under insanitary conditions whereby it may
have become contaminated with filth, or whereby it may have been
rendered injurious to health. The criteria and definitions in that part
are also applicable in determining whether a food violates section 361
of the Public Health Service Act. In some instances where the
appropriate measures are universal and well recognized, the cGMP
requirements are prescriptive (e.g., the requirement to remove
unsecured jewelry at Sec. 110.10(a)(4), the requirement that each
freezer and cold storage compartment be fitted with a temperature
indicating thermometer, temperature measuring device or temperature
recording device at Sec. 110.40(e)). However, more commonly, because
of the diversity of operations subject to the regulation and the desire
to provide flexibility for operators to put in place measures that are
best suited to the specifics of their operation, the cGMP rule sets out
more general requirements (e.g., the requirement that persons working
in direct contact with food conform to hygienic practices to the extent
necessary to protect against contamination of the food at Sec.
110.10(b), the requirement that food that can support the rapid growth
of undesirable microorganisms be held in a manner that prevents the
food from becoming adulterated at Sec. 110.80(b)(3)). Many provisions
of the Shell Egg Regulation also take a similar approach to the Food
CGMP Regulation.
The Juice HACCP and Seafood HACCP Regulations set out mandatory
frameworks through which entities subject to those regulations assess
the hazards that are reasonably likely to occur in their products and
processes and design tailored controls to prevent or eliminate them or
reduce them to an acceptable level. These regulations require the
development of a plan, based on the assessment of hazards, which
includes monitoring procedures, corrective action procedures,
verification procedures, and recordkeeping procedures. The plan also
includes the identification of the critical control points (CCPs) where
the controls must be applied and critical limits, which are the set
points for the process that must be met to ensure product safety.
The Food CGMP Regulation and the Shell Egg Regulation do not use
the structure applied in the other regulations identified here to
ensure that the conditions and practices are keeping hazards in check
as anticipated (through hazard analysis, establishment of critical
control points, monitoring, corrective actions, verification, and
recordkeeping in all applicable contexts). The Food CGMP Regulation
preceded the HACCP regulations and is generally thought of as a pre-
requisite or foundation to those regulations. That is, it is generally
recognized that HACCP-type regulations must build on the foundation of
a good manufacturing practice (GMP)-type regulation in order to further
reduce the risk of illness or injury to consumers associated with
contaminated produce (Ref. 40 Ref. 41).
In developing the framework for this proposed rule, we considered
the following: (1) The produce farming community is very diverse,
including very small and large farms, some with significant expertise
in the area of food safety and others with minimal knowledge in the
area, some located in the U.S. and some abroad; (2) there is a broad
range of crops and agricultural practices employed by the produce
farming community, such that a measure for addressing an on-farm route
of contamination for one produce commodity in one region may not be
practical or effective for another on-farm route of contamination,
produce commodity or region; (3) this proposed rule is the first effort
by FDA to regulate the produce farming community--the produce farming
community does not have the history of regulatory interaction with FDA
and the same experience with food safety regulations as does the food
manufacturing industry; (4) the adequacy of some measures to control
specific known or reasonably foreseeable hazards affecting produce is
well established, while others are poorly studied, suggesting that
future research may identify alternative measures that may be more
effective and/or efficient; and (5) some on-farm routes of
contamination occur in a relatively controlled environment (e.g., a
fully or partially enclosed building), while others occur in an outdoor
environment that may be beyond the control of the farm (e.g., an open
field), affecting the ability of the farm to take measures that
minimize the likelihood of contamination.
Given these considerations, and the need to tailor the proposed
requirements to specific on-farm routes of contamination (as discussed
in section IV.C of this document), we propose an integrated approach
that draws on our past experiences in the regulations discussed above.
In some cases, we propose standards that are very similar to those
contained in the Food CGMP Regulation, especially where the routes of
contamination are well-understood and appropriate measures are well-
established and generally applicable across covered produce commodities
(e.g., personnel qualifications, training, health, and hygiene;
harvesting, packing, and holding activities; equipment, tools,
buildings, and sanitation). We rely on this approach where possible, in
part, because we tentatively conclude that compliance would be more
suitable with this regulatory framework (given the diversity of the
industry with respect to size, agricultural practices, and knowledge of
food safety) than would be the case with a more complex framework such
as one that also required an individual written plan.
In other cases, we have proposed specific numerical standards
against which the effectiveness of a farm's measures would be compared
and actions taken to bring the operation into conformance with the
standards, as necessary (e.g., proposed standards for agricultural
water in subpart E; biological soil amendments of animal origin in
subpart F; sprout environmental testing and spent sprout irrigation
water testing in subpart M). We rely on such a numerical standards
approach where the effectiveness of individual measures (e.g.,
protection of agricultural water sources from contamination,
establishment of application intervals for certain soil amendments, and
chemical disinfection treatment of seeds before sprouting) is not
complete or fully known and/or because much of what affects the on-farm
route of contamination is outside the control of the farm (e.g., the
quality of a particular surface water source). In some of these cases
(e.g., composting of biological soil amendments of animal origin in
proposed Sec. 112.54) we have provided measures that are well
established to meet the numerical standard under a wide range of
conditions, while also recognizing that other measures, if properly
validated, may also be suitable (see proposed Sec. 112.12, discussed
in section V.B. of this document). Our proposed use of numerical
standards is similar to the

[[Page 3531]]

requirement for egg testing in the Shell Egg Regulation.
In still other cases, we have proposed a standard that requires the
farm to inspect or monitor an on-farm route of contamination and take
appropriate measures if conditions warrant. We rely on such a
monitoring approach where the diversity of conditions that can be
expected relative to an on-farm route of contamination is very high and
it would be impractical and unduly restrictive to set out a standard
that specifies the appropriate measures for each possible circumstance
(e.g., requirements for monitoring for animal intrusion in proposed
Sec. 112.83, requirement for inspection of agricultural water system
in proposed Sec. 112.42). In addition, we propose this approach in
instances where further research is needed to fully understand the
effectiveness of measures to mitigate the risk of serious adverse
health consequences or death. Our proposed use of inspection and
monitoring followed by appropriate corrective action is similar to the
requirement to monitor for rodent activity and take corrective action
on egg farms in the Shell Egg Regulation (Sec. 118.4).
Finally, in still other cases, we propose a standard that requires
the farm to develop a written plan, committing itself to specific
measures (e.g., sprout environmental testing and spent sprout
irrigation water testing). We propose the use of written plans where
the details of the measures to be taken are more than can be reasonably
expected to be retained in memory, especially where the details may
change over time and a historical record of the evolution of the
measures is important for the operator to assess whether further
changes to the measures are needed (e.g., changes or rotation in the
sampling sites for sprout environmental testing). Such plans are also
important for the efficient enforcement of the standard as they serve
as a clear commitment on the part of the operator of the farm to a
particular course of action, against which their actual performance can
be judged by the regulator. Our proposed use of written plans in these
specific instances is similar to the requirement for a written
Salmonella Enteritidis prevention plan on egg farms in the Shell Egg
Regulation (Sec. 118.4).
We performed a quantitative risk assessment to estimate the
predicted effectiveness of some of the provisions of the proposed
regulation with respect to one example commodity and one example
pathogen (Ref. 42). This quantitative risk assessment evaluated the
combination of fresh-cut lettuce, enterohemorrhagic E. coli (EHEC), and
irrigation water (with and without proposed measures in place), and
concluded that a number of variables may influence the predicted EHEC
illnesses associated with fresh-cut lettuce, as defined by the model
scenarios that included contamination from irrigation water and other
environmental sources on the farm, and changes in the contamination
during the product life cycle from farm to consumption. The
quantitative risk assessment document is currently being peer reviewed
and changes can be reasonably anticipated based on the peer review. The
peer review plan is available online at http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. We will
consider peer reviewers' and public comments in finalizing the
quantitative risk assessment and this proposed rule.
This rulemaking is not intended to address ``hazards that may be
intentionally introduced, including by acts of terrorism.'' (Sec.
418(b)(2) of the FD&C Act). FDA plans to implement section 103 of FSMA
regarding such hazards in a separate rulemaking in the future. FDA
tentatively concludes that intentional hazards likely will require
different kinds of controls and would be best addressed in a separate
rulemaking. However, we request comment on whether we should include
standards related to preventing economically motivated intentional
adulteration of produce in this rule. Is economically motivated
adulteration of produce reasonably likely to occur and, if so, by what
mechanisms may potential hazards be intentionally introduced in produce
for economic reasons? If such adulteration is reasonably likely to
occur, what standards should FDA consider for preventing such
adulteration?

E. Records

We are proposing to require that farms keep records as a component
of the above described standards, under certain, limited circumstances.
In determining those circumstances in which records are necessary, we
considered the statutory direction in section 419(c)(1)(C) of the FD&C
Act to comply with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.)
``with special attention to minimizing'' the recordkeeping burden on
the business and collection of information as defined in that act.
Records are useful for keeping track of detailed information over a
period of time. Records can identify patterns of problems and, thus,
enable a farm to find and correct the source of problems. Records are
also useful for investigators during inspections to determine
compliance with requirements (e.g., by FDA investigators to determine
compliance with requirements that would be established by this rule, or
by a third party auditor that a farm or retailer may voluntarily engage
under a business arrangement between the farm and the retailer). We
propose to require records in instances where they are important to
facilitate verification and compliance with standards and this cannot
be effectively done by means other than a review of records; where
identification of a pattern of problems is important to minimizing the
likelihood of contamination; and where maintenance of detailed
information is needed by the operator in order to minimize the risk of
contamination and demonstrate their compliance.

F. Farm-Specific Food Safety Plans

Each farm has a unique combination of size, climate, crops grown,
current and previous use of its own land and nearby land, sources of
agricultural water, growing, harvesting, packing, and holding
practices, animal grazing, potential for domestic and wild animals to
enter growing or packing areas, and sewage or septic system. Relevant
documents on produce safety, such as our GAPs Guide (Ref. 10), industry
CSGs for melons, tomatoes, leafy greens, and green onions (Ref. 43.
Ref. 44. Ref. 45. Ref. 46), the CA and AZ LGMA (Ref. 31. Ref. 32), the
AFDO Model Code of Produce Safety (Ref. 20), the Codex Guide (Ref. 47),
and Industry Harmonized GAPs (Ref. 48. Ref. 49) recommend that a farm
tailor its food safety practices to the practices and conditions at its
individual operation. In addition, many of these documents explicitly
recommend that a farm conduct an assessment of its growing environment
and may specify when assessments should be done (e.g., before planting,
during production, and immediately prior to harvest) to identify
potential food safety hazards in light of its particular commodities,
practices and conditions (Ref. 43. Ref. 44. Ref. 45. Ref. 46. Ref. 40.
Ref. 47).
Several of these documents further recommend that a farm use the
findings of its assessment to help establish a plan to control
potential hazards (Ref. 43. Ref. 46. Ref. 48. Ref. 45. Ref. 49. Ref.
28. Ref. 18)(Ref. 50. Ref. 51). For example, the introduction to the
AFDO Model Code notes that a food safety plan should be commensurate
with the size and complexity of an operation and the inherent risks of
the commodities

[[Page 3532]]

grown, along with site specific practices and conditions. The purpose
of a food safety plan is to establish measures designed to prevent the
introduction of known or reasonably foreseeable food safety hazards
into or onto produce in light of the crops, practices, and conditions
at the physical location of the farm and would include, for example,
measures applicable to an individual farm for agricultural water,
animal grazing, and any specific hazards identified in the recommended
operational assessment. The FDA draft CSGs recommend developing and
maintaining written food safety plans and SOPs for areas such as
handling and storage practices, field, facility, and vehicle cleaning
and sanitation, and employee training programs. A number of comments to
the 2010 FR notice maintained that the most effective approach to
produce safety would be one that incorporates food safety plans
developed at the operational level. Conversely, another group of
comments questioned the need for some industry segments, such as small
farms or growers of ``low risk'' commodities to develop or implement
food safety plans. The above-mentioned documents provide guidance or
recommendations for operators to consider and, as such, do not
represent requirements that must be met. We recognize that requiring
covered farms to conduct a hazard analysis and develop a food safety
plan at the level required in our juice and seafood HACCP regulations,
or prescribed by section 418 of FSMA for food manufacturing/processing
facilities, may not be feasible. We also recognize that, at this time,
only limited tools are available to help with the development of on-
farm food safety plans.
Also as noted above, this proposed rule is the first effort by FDA
to regulate the produce farming community. We have tentatively
concluded, in part based on the statutory direction in section 419 to
establish ``minimum science-based standards,'' and in recognition of
the direction to pay special attention to minimizing recordkeeping
burden and collection of information, that the most appropriate
approach for this proposed rule is to establish standards of the type
described in section D above. We are not proposing to require farms to
conduct operational assessments or to develop food safety plans akin to
similar requirements for facilities subject to section 418 of FSMA or
our juice HACCP or seafood HACCP regulations. We acknowledge that
operational assessments and food safety plans have a prominent place in
many public and private produce guidance documents, as discussed above.
The importance of tailoring what you do at an individual operation
to your commodities, practices and conditions is commonly accepted, and
an operational assessment and food safety plan could be valuable tools
for farms to select and implement those recommendations which are
appropriate for their circumstances. While we are not proposing to
require farms to conduct an operational assessment or develop a food
safety plan, we do recommend that farms do so, because this could help
farms be more effective in protecting the safety of their produce.
Further, we request comment on whether we should require that some
or all covered farms perform operational assessments and/or develop a
food safety plan, and if only some, what criteria should be used to
separate those to whom the requirement would apply from those to whom
it would not.

G. Foreign Farms

The proposed rule would apply to foreign farms that meet the
criteria to be covered farms and that grow, harvest, pack, or hold
covered produce for import into the United States. This is protective
of public health, as foreign farms have been implicated in foodborne
illness outbreaks associated with contaminated produce consumed in the
United States (Ref. 3). This is also consistent with the requirements
of section 419 of the FD&C Act, which clearly contemplates that the
rule issued under that authority will apply to foreign farms. This is
apparent in sections 419(c)(1)(F) and (c)(2), which provide for a
variance process in which states or foreign countries from which food
is imported into the US may request variances from FDA. Foreign
countries would not be eligible to request variances from this rule if
Congress did not intend the rule to apply to farms in foreign
countries.

H. Consistency With Codex Guidelines

In developing our proposed approach, we considered the
recommendations of relevant Codex guidelines, specifically, the Codex
Code of Hygienic Practice for Fresh Fruits and Vegetables (CAC/RCP 53-
2003) (the Codex Code). Many of the provisions proposed in this rule
are parallel to or consistent with the recommendations in the Codex
Code. For example, like our proposed approach of focusing on biological
hazards, the Codex Code (while intended to help control microbial,
chemical and physical hazards associated with production of fresh
fruits and vegetables) pays particular attention to minimizing
microbial hazards. It concentrates on microbial hazards and addresses
physical and chemical hazards only in so far as they relate to good
agricultural and manufacturing practices. The Codex Code recommends
measures applicable to all stages of the production of fresh fruits and
vegetables, from primary production to packing, with a particular
emphasis on those intended to be consumed raw (Section 2.1 of the Codex
Code). In proposed Sec. 112.2(a)(1), we propose to exempt a specified
list of produce that is rarely consumed raw from the scope of this
rule. Similarly, for those commodities not cooked before consumption,
the Codex Code recommends a set of broadly applicable minimum
standards, with risk-based adjustments.
With respect to agricultural water, the Codex Code recommends the
assessment of agricultural water for suitability for use; special
attention to irrigation water that is directly applied to edible
portion, especially close to harvest; and use of clean water for
initial stages followed by potable water for later stages during and
after harvest, including cooling (Section 3.2.1.1 of the Codex Code).
Many of the proposed provisions described in section V.E. of this
document are consistent with these recommendations.
As another example, the Codex Code recommends that personnel follow
health and hygiene requirements and that toilet and hand washing and
drying facilities be provided during and after harvest, which are
reflected in the proposed provisions described in section V.D. of this
document. In addition, the proposed provisions described in section
V.L. of this document and the Codex Code both recognize the importance
of proper design, construction, maintenance and cleaning of buildings
and equipment in ensuring produce safety.
Moreover, the Codex Code recommends that ``manure, biosolids and
other natural fertilizers which are untreated or partially treated may
be used only if appropriate corrective actions are being adopted to
reduce microbial contaminants, such as maximizing the time between
application and harvest of fresh fruits and vegetables'' (Section
3.2.1.2 of the Codex Code). The recommendation to consider maximizing
time between application of untreated amendments and harvest is
reflected in proposed provisions described in section V.F. of this
document, in particular proposed Sec. 112.56, which stipulates
application

[[Page 3533]]

intervals for different biological soil amendments of animal origin.
The Codex Code also recommends that ``existing practices should be
reviewed to assess the prevalence and likelihood of uncontrolled
deposits of animal faeces coming into contact with crops. Considering
this potential source of contamination, efforts should be made to
protect fresh produce growing areas from animals. As far as possible,
domestic and wild animal should be excluded from the area'' (Section
3.1 of the Codex Code). We believe that the proposed provisions in
Sec. 112.82, which requires an adequate waiting period between grazing
by working animals and harvesting when under the circumstances there is
a reasonable probability that grazing or working animals will
contaminate covered produce, and Sec. 112.83, which requires
monitoring for wild animal intrusion and assessment of safety of
harvest where significant intrusion is evident if under the
circumstances there is a reasonable probability that animal intrusion
will contaminate covered produce, are consistent with (though not
identical to) these Codex recommendations.
Furthermore, the proposed requirements related to the maintenance
of records (described in section V.O. of this document) are in concert
with the Codex documentation and records recommendations for growers
and packers, which states: ``Growers should keep current all relevant
information on agricultural activities such as the site of production,
suppliers' information on agricultural inputs, lot numbers of
agricultural inputs, irrigation practices, use of agricultural
chemicals, water quality data, pest control and cleaning schedules for
indoor establishments, premises, facilities, equipment and containers.
Packers should keep current all information concerning each lot such as
information on incoming materials (e.g. information from growers, lot
numbers), data on the quality of processing water, pest control
programmes, cooling and storage temperatures, chemicals used in
postharvest treatments, and cleaning schedules for premises,
facilities, equipment and containers, etc.'' (Section 5.7 of the Codex
Code). In the discussion throughout section V of this document, we
point out where the proposed provisions are consistent with these and
other recommendations of the Codex Code.

I. Product Testing as a Strategy To Control Pathogens

We considered requiring microbiological product testing either
routinely or under specific conditions as a strategy to minimize known
or reasonably foreseeable hazards. While not widely adopted, product
testing is being used by some in the produce industry. Some produce
buyers for retail distributors require routine microbial testing of
product as a condition of sale in their purchasing specifications (Ref.
52). Individual fresh-cut produce companies began product testing in
response to the 2006 E. coli O157:H7 outbreak associated with bagged
fresh spinach (Ref. 53). At least one company is reported to use
product testing to verify the efficacy of good agricultural practices
programs and to prevent contaminated product lots from entering
commerce (Ref. 52). The California Leafy Greens Marketing Agreement
requires crop testing for E. coli O157:H7 and Salmonella spp. whenever
a crop has been directly contacted with water that exceeds the
agreements' acceptance criteria for generic E. coli (Ref. 31).
Product testing, especially microbiological testing, for process
control purposes presents several challenges. Pathogen prevalence in
produce as a result of contamination events that occur during growing,
harvesting, packing, or holding on farms are generally temporally
intermittent, non-homogeneous in a lot or a field, and at low
concentrations (Ref. 54). Therefore, unlike some processed foods that
may consist of batches of homogeneous material (e.g., bulk flour, milk,
juice), produce are best thought of as individual units, and while a
positive test result for one unit does raise concern about the rest of
the lot or the field subject to the same conditions, procedures,
processes, and practices, any contamination present in one unit may not
have necessarily spread to other units. In addition, it is generally
recognized that negative product test results do not necessarily
indicate the absence of a hazard, particularly when the hazard is
present at very low levels and is not uniformly distributed (Ref. 55.
Ref. 56). Sampling plans intended to ensure detection of contamination
with a reasonable assurance of success in produce lots or fields can be
cost-prohibitive, and may not be effective for use in produce. For
example, for any given contamination rate, the probability of detecting
Salmonella increases with the number of samples tested and it is not
feasible to identify low levels of contamination in an individual lot.
For example, when 30 samples in a lot are tested, the probability of
detecting Salmonella is 1 percent when the contamination rate is 1 in
3000, 26 percent when the contamination rate is 1 in 100, and 96
percent when the contamination rate is 1 in 10 (Ref. 57). Both industry
and FDA survey data indicate that contamination rates in produce
(melons, greens, tomatoes), while variable, are typically very low
(Ref. 58. Ref. 59). In addition, microbial testing can only detect the
pathogens that the analytical procedures are designed to detect.
Testing instead for indicator organisms may be a viable option, but is
not without challenges, as discussed in section V.E.2. of this
document.
Another factor affecting the utility of product testing for
pathogens as a control measure is that FDA recommends, and it is
generally industry practice, to hold any batch of product from which
samples are taken for testing to prevent the need for a recall should
the test results demonstrate the presence of a pathogen. With a highly
perishable product as is the case for most produce, storing product
during such analyses would significantly reduce the shelf-life of the
product. For these reasons, we tentatively conclude that product
testing would be impracticable as a component of science-based minimum
standards proposed in this rule except as set forth in proposed subpart
M under certain circumstances for sprouts.

J. Effective Dates

We are proposing that the effective date of this rule would be 60
days after the date of publication of the final rule in the Federal
Register with staggered compliance dates. The effective date is the
date that provisions in the rule affect the current CFR.
An effective date of 60 days after date of publication of the final
rule in the Federal Register would be consistent with the effective
dates in recent FDA rules directed to food safety. See, e.g., Federal
Register of July 9, 2009 (74 FR 33029 at 33030), establishing an
effective date of September 8, 2009, for a final rule for the
prevention of Salmonella Enteritidis in shell eggs during production,
storage, and transportation; and Federal Register of June 25, 2007 (72
FR 34751 at 34752), establishing an effective date of August 24, 2007,
for a final rule for current good manufacturing practice in
manufacturing, packaging, labeling, or holding operations for dietary
supplements.

K. Compliance Dates

We are proposing that the compliance dates for entities subject to
the rule would be based on the size of a farm and the effective date of
the requirement, with additional flexibility

[[Page 3534]]

for compliance with proposed provisions for water quality in Sec.
112.44 and related provisions in Sec. Sec. 112.45 and 112.50
(specifically, 112.50(b)(5), 112.50(b)(6), and 112.50(b)(7)).
The compliance date for very small businesses (those subject to
proposed part 112 and, on a rolling basis, the average annual monetary
value of food sold during the previous three-year period is no more
than $250,000, as defined in proposed Sec. 112.3(b)(1)) would be four
years from the effective date (with the exception of compliance with
Sec. Sec. 112.44, 112.45, 112.50(b)(5), 112.50(b)(6), and
112.50(b)(7), as discussed below). The compliance date for very small
businesses would not be in conflict with the requirement in section
419(b)(3)(B) of the FD&C Act for the regulations promulgated under
section 419 to apply to very small businesses ``after the date that is
2 years after the effective date of the final regulation. * * *''
because this requirement specifies that the regulations shall apply
after, not on, the date that is 2 years after the effective date. To
provide additional flexibility to small businesses, we would provide
two more years for very small businesses to comply with the rule than
is required under section 419(b)(3)(B). Providing an extended
compliance period to very small businesses as a means of providing
additional flexibility is consistent with our approach to compliance
dates in recent rules directed to food safety. (See, e.g., 74 FR 33029
at 33034 and 72 FR 34751 at 34752.)
The compliance date for small businesses (those subject to proposed
part 112 and, on a rolling basis, the average annual monetary value of
food sold during the previous three-year period is no more than
$500,000, as defined in proposed Sec. 112.3(b)(2)) would be three
years from the effective date (with the exception of compliance with
Sec. Sec. 112.44, 112.45, 112.50(b)(5), 112.50(b)(6), and
112.50(b)(7), as discussed below). The compliance date for small
businesses would not be in conflict with the requirement in section
419(b)(3)(A) of the FD&C Act for the regulations promulgated under
section 419 to apply to small businesses ``after the date that is 1
year after the effective date of the final regulation. * * *'' because
this requirement specifies that the regulations shall apply after, not
on, the date that is 1 year after the effective date. To provide
additional flexibility to small businesses, we would provide two more
years than is required under section 419(b)(3)(A). Providing an
extended compliance period to small businesses as a means of providing
additional flexibility is consistent with our approach to compliance
dates in recent rules directed to food safety. (See, e.g., 74 FR 33029
at 33034 and 72 FR 34751 at 34752.)
The compliance date for all other farms subject to the rule would
be two years from the effective date (with the exception of compliance
with Sec. Sec. 112.44, 112.45, 112.50(b)(5), 112.50(b)(6), and
112.50(b)(7), as discussed below).
The compliance dates for water quality requirements in proposed
Sec. 112.44 and related provisions in Sec. Sec. 112.45, 112.50(b)(5),
112.50(b)(6), and 112.50(b)(7) would be two years beyond the compliance
date for the rest of the final rule applicable to the farm based on its
size. We recognize that farms may need additional time to cope with
implementation of the water quality testing, monitoring, and related
record-keeping provisions. This additional compliance period would also
be expected to permit farms to consider identifying alternatives to the
standard in proposed Sec. 112.44(b) and developing adequate scientific
data or information necessary to support a conclusion that the
alternative would provide the same level of public health protection as
the standard that would be established in this part, and would not
increase the likelihood that the covered produce will be adulterated
under section 402 of the FD&C Act, in light of the farm's covered
produce, practices, and conditions. The extended compliance dates for
the water quality testing, monitoring, and related record keeping
requirements in proposed Sec. Sec. 112.44, 112.45, 112.50(b)(5),
112.50(b)(6), and 112.50(b)(7) would then be six years from the
effective date for very small businesses, five years from the effective
date for small businesses, and four years from the effective date for
all other farms subject to the rule.
The compliance dates would apply to all farms subject to the rule,
including those farms that satisfy the requirements in proposed Sec.
112.5 for an exemption from most requirements of the rule, because such
farms have modified requirements (proposed Sec. 112.6) to which they
would be subject on the relevant compliance date.
We seek comment on these proposed implementation periods. In
addition, given that activities related to produce production,
harvesting, packing, and holding may be affected by the produce growing
season, we seek comment on whether these compliance dates sufficiently
address any issues related to the seasonal nature of produce-related
activities.

V. The Proposal

A. Subpart A--General Provisions

As proposed, subpart A contains provisions that establish the scope
of, and definitions applicable to, this regulation, and identifies who
is subject to the requirements of this part. This subpart also
describes the proposed modified requirements and procedures governing
qualified exemptions from this rule.
1. Comments Related to Proposed Provisions
We received several comments in response to the 2010 FR notice that
addressed issues relevant to the general scope of this proposed rule.
Some comments requested that tree crops be exempt from this regulation.
For example, an apple grower asserted that apples are not as
susceptible to E. coli and other pathogens as are lettuce and tomatoes,
and therefore they should not be subject to the same controls and
restrictions. Additionally, one grower stated that citrus fruits should
be exempt because citrus fruits have not been identified to be the
source of an incident of food-borne illness, a majority of such produce
does not touch the ground, citrus fruit are washed during the packing
process, and the peel is rarely consumed raw. Several comments from
produce associations requested removal of watermelons from the
``melon'' category, stating that they should have their own category
since they have a different risk profile from other melons. In
addition, comments from several tree nut growers stated that some tree
nut commodities should have less rigorous requirements or be exempt.
As we explained in Section IV.C, we tentatively concluded that an
approach that considers both the risk associated with the commodity and
that associated with the agricultural practices applied to the crop
under the conditions in which it is grown, would provide the most
appropriate balance between public health protection, flexibility, and
appropriate management of different levels of risk. Under this
approach, we considered available information on outbreaks and
contamination as well as existing evidence on characteristics of the
commodity (such as whether the commodity grows on trees or has a smooth
rind). This evidence informed the proposed requirements, but we have
tentatively concluded that limiting the scope of this rule based on
outbreak data or on the levels of frequency of pathogen detection alone
would not adequately address the risk of serious adverse health
consequences or death. Therefore, as discussed in section

[[Page 3535]]

V.A.2.a. of this document, we are proposing to cover apples, citrus
fruits, watermelons, and tree nuts in this proposed rule. Because the
scope and stringency of the regulatory requirements depends in several
cases on the types of practices employed within operations, producers
of different commodities who use different practices will not be
subject to all of the same controls and restrictions. We seek comment
on our proposed approach. Because our regulatory approach does not
depend on categorizing commodities based on risk profiles, we do not
see the need to distinguish among fruits, including watermelons, on
this basis. We do note, however, that in proposed Sec. 112.1(b)(1) we
have listed watermelons separately from other melons. While we propose
to cover tree nuts that do not meet the criteria we propose for
``rarely consumed raw'' (see section V.A.2.a) in this proposed rule,
such as walnuts and almonds, we recognize that many of these tree nuts
receive commercial processing to adequately reduce pathogens and, thus,
may be eligible for an exemption under proposed Sec. 112.2(b)
(discussed in section V.A.2.a. of this document). Our main food safety
concerns relevant to on-farm growing, harvesting, packing, and holding
of tree nuts pertain to those tree nuts that would be sold raw and
untreated. We request comments on our treatment of tree nuts in this
proposal.
We also received comments regarding various activities performed on
produce in relation to the scope of this proposed rule. One comment
stated that ``processing'' should not refer to rinsing heads of lettuce
or bunches of greens before they are packed for market, but rather
should be defined specifically to include other processes that appear
to involve additional risk to the consumer. Some comments suggested
that no grower should be exempt from these food safety regulations,
whereas another stakeholder stated that the produce safety standards
must be very clear as to what constitutes produce processing versus
produce preparation for market acceptance and that Part 110 should be
reserved for situations where extensive commingling, cutting, washing
and bagging of produce are practiced. Finally, a comment suggested that
growers who deliver produce to the consumer within 24-30 hours should
be exempt from this regulation. As discussed in section III.F. of this
document and further in section V.A.2.b.i below, this proposed rule
would apply to activities of farms and farm mixed-type facilities that
are within the definition of ``farm'' proposed here. A farm or farm
mixed-type facility that washes its own covered produce would be
harvesting within the farm definition and therefore that activity would
be covered by this proposed rule unless another exemption applied.
However, a farm mixed-type facility that washes covered produce not
grown on that farm or another farm under the same ownership for
distribution into commerce would be engaging in an activity outside the
farm definition (i.e., a manufacturing/processing activity). Such
activities would not be subject to this rule but instead would be
subject to section 418 of the FD&C Act.
As discussed in section I of this document and the QAR, produce is
vulnerable to contamination by pathogens, which can occur at various
points during growing, harvesting, packing, and holding. Although
contamination usually occurs in low doses, even low doses of some of
these harmful pathogens can result in human illness or death (Ref. 60).
Thus, if produce is contaminated with a pathogen, there is a reasonable
possibility that the amount of the pathogen present will be enough to
cause serious adverse health consequences or death to a consumer even
without an extended time period before consumption for the pathogen to
grow and multiply. In addition, even in cases where the delivery time
may not exceed 24-30 hours, consumers and other recipients may store
produce (in a refrigerator or otherwise) thereafter and not consume it
immediately, allowing additional time for pathogen growth. Therefore,
FDA tentatively concludes it would not be appropriate to exempt any
farms from this proposed rule based on the speed of their deliveries to
the consumer.
2. Proposed Requirements
a. Food Covered by This Rule
This proposal is applicable to certain farm activities performed on
certain produce for use as human food. Section 105 of FSMA does not
specify whether the rulemaking conducted under that section should
apply to human food, animal food, or both. The general rulemaking
requirements in 419(a)(1)(A), (b)(1), and (c)(1)(A) authorize FDA to
establish standards for the safe production and harvesting of fruits
and vegetables that are raw agricultural commodities for which the
Secretary has determined that such standards minimize the risk of
serious adverse health consequences or death. FDA tentatively concludes
that the risk posed to animals, and to humans from contact with animals
or consumption of animals as food, by farm practices in producing and
harvesting fruits and vegetables does not merit imposition of new
regulatory requirements at this time. Therefore, this proposal is
limited to produce for use as human food. Produce that is intended for
use as animal food would not be subject to the requirements of this
rule. This is reflected in the title of the proposed rule (``Standards
for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption'') and its proposed location in Chapter I, Subchapter B of
Title 21, Code of Federal Regulations (``Food for Human Consumption'').
As proposed, Sec. 112.1 establishes the scope of food that is
subject to this rule. Under proposed Sec. 112.1(a), food that meets
the definition of produce in Sec. 112.3(c) and that is a raw
agricultural commodity (RAC) as defined in section 201(r) of the FD&C
act, would be covered by part 112, unless it is excluded by Sec.
112.2. Section 201(r) defines ``raw agricultural commodity'' as any
food in its raw or natural state, including all fruits that are washed,
colored, or otherwise treated in their unpeeled natural form prior to
marketing.'' This includes produce RACs grown domestically and produce
RACs that will be imported or offered for import in any State or
territory of the United States, the District of Columbia, or the
Commonwealth of Puerto Rico. As discussed in section III and IV of this
document, FDA tentatively concludes that proposed Sec. 112.1(a) is
consistent with section 419(a)(1)(A) of the FD&C Act, which directs us
to establish science-based minimum standards for the safe production
and harvesting of those types of fruits and vegetables that are raw
agricultural commodities for which the Secretary has determined that
such standards minimize the risk of serious adverse health consequences
or death.
We propose to establish a definition of ``produce'' in proposed
Sec. 112.3(c) (see section V.A.2.b.iii. of this document) that would
be relevant to the use of that term in proposed Sec. 112.1.
``Produce'' would mean any fruit or vegetable (including specific mixes
or categories of fruits and vegetables) grown for human consumption,
and would include mushrooms, sprouts (irrespective of seed source),
peanuts, tree nuts and herbs. Within the definition of ``produce,'' we
would further define ``fruit'' and ``vegetable'' to reflect the common
meanings of those terms.
We would define a fruit as the edible reproductive body of a seed
plant or tree

[[Page 3536]]

nut (such as apple, orange and almond), such that fruit would mean the
harvestable or harvested part of a plant developed from a flower. This
is consistent with the common meaning of the term ``fruit,'' as
demonstrated by the Merriam-Webster Dictionary definition of ``fruit''
to mean, in relevant part ``the usually edible reproductive body of a
seed plant; especially: One having a sweet pulp associated with the
seed * * * a succulent plant part (as the petioles of a rhubarb plant)
used chiefly in a dessert or sweet course * * * a product of
fertilization in a plant with its modified envelopes or appendages;
specifically: The ripened ovary of a seed plant and its contents * *
*'' (Ref. 61).
We would define a vegetable as the edible part of an herbaceous
plant (such as cabbage and potato) or fleshy fruiting body of a fungus
(such as white button and shiitake) grown for an edible part, such that
vegetable would mean the harvestable or harvested part of any plant or
fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers,
bulbs, stems, leaves, or flower parts are used as food and includes
mushrooms, sprouts, and herbs (such as basil and cilantro).
This is consistent with the common meaning of the term
``vegetable,'' as demonstrated by the Merriam-Webster Dictionary
definition of ``vegetable'' to mean, in relevant part, ``a usually
herbaceous plant (as the cabbage, bean, or potato) grown for an edible
part that is usually eaten as part of a meal; also: Such an edible part
* * *'' (Ref. 61).
We are proposing to specify in the definition of produce that it
includes mushrooms, sprouts, peanuts, tree nuts and herbs, to leave no
doubt about the status of these foods. Taxonomically, a mushroom is a
fungus (Ref. 62). For regulatory purposes in the United States,
however, mushrooms have generally been treated as vegetables. Mushrooms
are classified as vegetables by USDA AMS under the Perishable
Agricultural Commodities Act (7 U.S.C. 499a-499t) (PACA) (Ref. 63),
using a definition stating in relevant part that ``fresh fruits and
fresh vegetables'' means ``all produce in fresh form generally
considered as perishable fruits and vegetables * * *'' (21 CFR
46.2(u)). The USDA 2010 Dietary Guidelines for Americans also include
mushrooms in the ``vegetable'' food group (Ref. 64). In addition, the
produce industry appears to recognize mushrooms as vegetables, as
demonstrated by various industry documents (Ref. 65. Ref. 66).
Moreover, the hazards and controls relevant to minimizing serious
adverse health consequences or death during the growing, harvesting,
packing, and holding of mushrooms are generally similar to those for
other produce (Ref. 67). Accordingly, we tentatively conclude that it
is reasonable to include mushrooms in the proposed definition of
``vegetable.''
Sprouts meet the definition of ``vegetable'' above from the
Merriam-Webster Dictionary (Ref. 61). In addition, sprouts are
classified as vegetables by USDA AMS under PACA (Ref. 63). The USDA
2010 Dietary Guidelines for Americans also include ``bean sprouts'' in
the ``vegetable'' food group (Ref. 64). In addition, the produce
industry appears to recognize sprouts as vegetables, as demonstrated by
various industry documents (Ref. 68). Moreover, the hazards and
controls relevant to minimizing serious adverse health consequences or
death during the growing, harvesting, packing, and holding of sprouts
are generally similar to those for other produce, but with additional
controls necessary due to the unique risks presented by sprouts (Ref.
160. Ref. 161) (see section V.M of this document). Accordingly, we
tentatively conclude that it is reasonable to include sprouts in the
proposed definition of ``vegetable.'' Herbs meet the definition of
``vegetable'' above from the Merriam-Webster Dictionary (Ref. 61).
Herbs are generally consumed in combination with other foods (for
example, in salads or as garnishes) rather than consumed as distinct
servings, but they nonetheless satisfy the dictionary definition of
``vegetable.'' In addition, USDA considers herbs to be covered
commodities under PACA, such that they are classified as ``herbs'' but
fall within the broader category of ``fresh fruits and fresh
vegetables'' (Ref. 63). In addition, the produce industry appears to
recognize herbs as vegetables, as demonstrated by various industry
documents (Ref. 66). Moreover, the hazards and controls relevant to
minimizing serious adverse health consequences or death during the
growing, harvesting, packing, and holding of herbs are generally
similar to those for other produce(Ref. 13. Ref. 50). Accordingly, we
tentatively conclude that it is reasonable to include herbs in the
proposed definition of ``vegetable.''
Peanuts and tree nuts both meet the definition of ``fruit'' above
from the Merriam-Webster Dictionary (Ref. 61). The Merriam-Webster
Dictionary defines ``peanut,'' in relevant part, as ``a low-branching
widely cultivated annual herb * * * of the legume family with showy
yellow flowers having a peduncle which elongates and bends into the
soil where the ovary ripens into a pod containing one to three oily
edible seeds * * *,'' and ``nut,'' in relevant part, as ``a hard-
shelled dry fruit or seed with a separable rind or shell and interior
kernel * * *'' (Ref. 61). In addition, the produce industry appears to
recognize peanuts and tree nuts as produce, as demonstrated by various
industry documents (Ref. 65. Ref. 66). Moreover, the hazards and
controls relevant to minimizing serious adverse health consequences or
death during the growing, harvesting, packing, and holding of peanuts
and tree nuts are generally similar to those for other produce (Ref.
69. Ref. 70). Specifically, peanuts and tree nuts share the significant
hazard of pathogens with other covered produce. To a significant
extent, this hazard is eliminated during manufacturing/processing
operations, such as roasting, by facilities subject to section 418 of
the FD&C Act, rather than through measures taken by farms subject to
this regulation. However, as discussed in section V.A.2.a below,
peanuts meet our proposed criteria for ``rarely consumed raw'' and
therefore would be exempt from this proposed rule. Tree nuts that do
not meet the criteria for ``rarely consumed raw'' would also be exempt
from this proposed regulation if you establish and keep documentation
that demonstrates that the recipient of the produce performs commercial
processing in accordance with proposed Sec. 112.2(b)(1). For tree nuts
that remain subject to the proposed rule, the kinds of measures
necessary to minimize the risk of known or reasonably foreseeable
biological hazards are the same as those in subparts A through O of
this proposed rule (e.g., control of soil amendments, agricultural
water, worker hygiene). Accordingly, we conclude it is reasonable to
include peanuts and tree nuts in the proposed definition of produce as
a ``fruit.'' We recognize that peanuts and tree nuts are not covered
commodities under PACA ((Ref. 63. Ref. 71) and that the USDA 2010
Dietary Guidelines for Americans consider nuts a ``protein food''
rather than as part of the ``fruits and vegetables'' group for the
purpose of providing dietary advice (Ref. 72); however, in light of the
treatment of peanuts and tree nuts as produce in common usage and in
the produce industry, and the commonality of on-farm hazards and
controls for peanuts, tree nuts, and other produce (Ref. 70. Ref. 69),
we tentatively conclude that it is reasonable to include peanuts and
tree nuts in the proposed definition of produce as ``fruits.''
We propose to specify in the definition of ``produce'' that the
term would not include food grains, meaning the small, hard fruits or
seeds of arable

[[Page 3537]]

crops, or the crops bearing these fruits or seeds, that are grown and
processed for use as meal, flour, baked goods, cereals and oils rather
than for fresh consumption (including cereal grains, pseudo cereals,
oilseeds and other plants used in the same fashion). Examples of food
grains would include barley, dent- or flint-corn, sorghum, oats, rice,
rye, wheat, amaranth, quinoa, buckwheat, cotton seed, and soybean. Our
proposed definition of ``food grains'' is consistent with the common
meaning of the term ``grain'' when used in the context of food, as
demonstrated by the Merriam-Webster Dictionary definition of ``grain''
to mean, in relevant part, ``a seed or fruit of a cereal grass * * *
the seeds or fruits of various food plants including the cereal grasses
and in commercial and statutory usage other plants (as the soybean) * *
* plants producing grain * * *'' (Ref. 61). In addition, the industry
appears to recognize grains as a separate commodity group from produce,
as demonstrated by various industry documents regarding ``produce'' and
``fruits and vegetables'' that do not include grains (Ref. 65. Ref.
66). Grains are not covered commodities under PACA (Ref. 63). The USDA
2010 Dietary Guidelines for Americans treat grains as a separate food
group from the ``fruits and vegetables'' food group (Ref. 73). In
addition, the hazards and controls relevant to minimizing serious
adverse health consequences or death during the growing, harvesting,
packing, and holding of grains are significantly different from those
relevant to fruits and vegetables (Ref. 74). Specifically, the hazards
of concern in grains are primarily chemical hazards such as mycotoxins
and pesticides, rather than biological hazards (which, as discussed in
section IV.B. of this document, are the only hazards we currently
propose to address in this rule, as they are the most significant
hazards affecting covered produce), because grains are milled and/or
cooked such that pathogens that may be present are reduced to a level
where they are unlikely to present a risk to public health for most
products. Accordingly, we tentatively conclude that it is reasonable to
exclude grains from the definition of ``produce.''
Proposed Sec. 112.1(b)(1) lists specific examples of produce
covered by this rule. Such covered produce would include almonds,
apples, apricots, aprium, asian pear, avocados, babaco, bamboo shoots,
bananas, Belgian endive, blackberries, blueberries, broccoli, cabbage,
cantaloupe, carambola, carrots, cauliflower, celery, cherries, citrus
(such as clementine, grapefruit, lemons, limes, mandarin, oranges,
tangerines, tangors, and uniq fruit), cucumbers, curly endive, garlic,
grapes, green beans, guava, herbs (such as basil, chives, cilantro,
mint, oregano, and parsley), honeydew, kiwifruit, lettuce, mangos,
other melons (such as canary, crenshaw and persian), mushrooms,
nectarine, onions, papaya, passion fruit, peaches, pears, peas, peppers
(such as bell and hot), pineapple, plums, plumcot, radish, raspberries,
red currant, scallions, snow peas, spinach, sprouts (such as alfalfa
and mung bean), strawberries, summer squash (such as patty pan, yellow
and zucchini), tomatoes, walnuts, watercress and watermelon.
The list of fruits and vegetables provided in proposed Sec.
112.1(b)(1) is not an exhaustive list of produce covered by this rule.
This section is intended simply to provide examples of produce commonly
consumed in the United States that would be included within the scope
of this regulation. The absence of a specific fruit or vegetable from
this list does not indicate that it is not covered, except where the
specific fruit or vegetable is exempted from the regulation by Sec.
112.2(a)(1). We request comment on the examples of fruits and
vegetables listed in 112.1(b)(1).
Proposed Sec. 112.1(b)(2) would clarify that mixes of intact
fruits and vegetables (such as fruit baskets) are also covered by this
rule. Proposed Sec. 112.1(b)(2) is consistent with section
419(a)(1)(A) of the FD&C Act, which includes mixes or categories of
fruits and vegetable RACs as part of the rulemaking requirement we are
implementing through this proposed rule.
As proposed, Sec. 112.2(a) identifies three types of produce not
covered by this rule. First, proposed Sec. 112.2(a)(1) provides an
exclusion for produce that is rarely consumed raw. FDA proposes to
establish the following exhaustive list of specific fruits and
vegetables that would be exempt under this provision: arrowhead,
arrowroot, artichokes, asparagus, beets, black-eyed peas, bok choy,
brussels sprouts, chick-peas, collard greens, crabapples, cranberries,
eggplant, figs, ginger root, kale, kidney beans, lentils, lima beans,
okra, parsnips, peanuts, pinto beans, plantains, potatoes, pumpkin,
rhubarb, rutabaga, sugarbeet, sweet corn, sweet potatoes, taro,
turnips, water chestnuts, winter squash (acorn and butternut squash),
and yams. Because these listed fruits and vegetables are almost always
consumed only after being cooked, which is a kill-step that adequately
reduces the presence of microorganisms of public health significance,
we propose that these listed produce be excluded from the requirements
of this rule. Studies have shown that the numbers of microorganisms of
public health significance (such as Listeria monocytogenes, Salmonella,
shiga toxin-producing E. coli) are significantly reduced in produce by
a variety of relatively moderate heat treatments (Ref. 75. Ref. 76.
Ref. 77. Ref. 78). Therefore, we tentatively conclude that the cooking
that the produce listed in Sec. 112.2(a)(1) receive before they are
consumed, whether commercially or by the consumer, would be sufficient
to minimize the risk of serious adverse health consequences or death.
We note that all produce commodities are and will continue to be
covered under the adulteration provisions and other applicable
provisions of the Federal Food, Drug, and Cosmetic Act and applicable
implementing regulations, irrespective of whether they are included
within the scope of this proposed rule.
We developed this list in proposed Sec. 112.2(a)(1) of produce
that rarely is consumed raw by analyzing consumption data on selected
produce commodities using data available from the National Health and
Nutrition Examination Survey (NHANES) and other resources (Ref. 79). We
looked at the percentage of the population consuming the produce
commodity in fresh form as well as the percentage of eating occasions
on which the produce commodity is eaten uncooked (Ref. 79. Ref. 80). As
explained further in a memo to the record, we found that artichokes,
asparagus, beets, bok choy, brussels sprouts, cranberries, eggplant,
figs, ginger root, lima beans, okra, plantains, potatoes, rhubarb,
sweet corn, sweet potatoes, turnips, and yams are eaten uncooked by
less than 0.1% of the U.S. population and are consumed uncooked on less
than 0.1% of eating occasions (Ref. 79). Other commodities, including
black-eyed peas, chick-peas, collard greens, crabapples, kale, kidney
beans, lentils, parsnips, peanuts, pinto beans, pumpkin, rutabaga,
sugarbeet, taro, water chestnut, and winter squash (which includes both
acorn and butternut squash) are included in the NHANES data set but
their categories of reported consumption do not include ``uncooked,''
indicating that they are not consumed uncooked in any measurable
quantity (Ref. 79). Still other commodities on the list, namely,
arrowhead and arrowroot, are not identified in the NHANES data set as
being eaten in the United States in any form, uncooked or otherwise
(Ref. 79). Other references indicated that those commodities are
typically consumed

[[Page 3538]]

cooked (Ref. 63. Ref. 82). We request comment on the proposed criteria
used for identifying the commodities that are rarely consumed raw.
Further, we request comment on additional commodities that should be
considered for inclusion in the list in 112.2(a)(1). As noted above, we
analyzed consumption data on selected produce commodities to generate
this list. We acknowledge that there may be additional commodities that
would meet these criteria that we did not analyze. Also, we anticipate
that, in the case of some commodities, the consumption rates in the
United States may be too low for the NHANES data and other data sources
used in our analysis to support a conclusion that the commodity is
rarely consumed raw using our proposed criteria. We request comment on
additional sources of information and/or criteria that should be
applied in such cases.
We also request comment on the inclusion of commodities that our
analysis indicates are rarely consumed raw, but may not be prepared in
a manner that would kill microbial contaminants, should they be present
on the food. For example, we have included asparagus, bok choy, and
cranberries in the list of commodities that will be exempt from the
requirements of this rule in proposed Sec. 112.2(a)(1) because the
NHANES data indicated that these commodities are consumed uncooked by
less than 0.1% of the U.S. population and are consumed uncooked on less
than 0.1% of eating occasions (Ref. 79). However, we are concerned that
the method of food preparation that these commodities may be subjected
(for example, stir frying bok choy) to prior to consumption may not
constitute a kill-step that adequately reduces the presence of
microorganisms of public health significance. We request comment on our
tentative conclusions about these commodities and others proposed for
exclusion in Sec. 112.2(a)(1).
Second, Sec. 112.2(a)(2) proposes to exempt produce that is
produced by an individual for personal consumption or produced for
consumption on the farm or another farm under the same ownership. With
respect to the exemption for personal consumption, section 419(g) of
the FD&C Act specifically exempts food produced by an individual for
personal consumption from this rulemaking, and proposed Sec.
112.2(a)(2) implements this exclusion. With respect to the exclusion
for produce for consumption on the farm or another farm under the same
ownership, such activities are within the definition of farm that we
propose here, and would therefore be subject to this rule without an
exemption. To the extent that there is any difference between produce
``for personal consumption'' and produce ``consumed on the farm or
another farm under the same ownership,'' FDA proposes to exclude
produce for either type of consumption from this proposed rule.
Third, Sec. 112.2(a)(3) proposes to exclude produce that is not a
raw agricultural commodity from this proposed rule. For example, this
would exclude ``fresh-cut'' produce, which is subject to current part
110 and to section 418 of the FD&C Act as applicable (Ref. 83). This is
consistent with section 419(a)(1)(A) of the FD&C Act, which directs FDA
to ``establish science-based minimum standards for the safe production
and harvesting of those types of fruits and vegetables * * * that are
raw agricultural commodities * * *.'' This is also consistent with the
application of this rule to activities within the farm definition. In
section V.A.2.b.i of this document, we discuss how we considered how
the activities of farms relate to the concept of a RAC and tentatively
concluded that the farm definition and related definitions in this
proposed rule should be revised based on the concept that RACs are the
essential products of farms. Accordingly, the definitions proposed here
(for the terms farm, mixed-type facility, harvesting, manufacturing/
processing, packing, and holding) reflect the tentative conclusion that
activities involving RACs that farms traditionally do for the purposes
of growing their own RACs, removing them from the growing areas and
preparing them for use as a food RAC, and for packing, holding and
transporting them, should all be within the definition of ``farm.''
This is the case even if the same activities off-farm would be
considered to be ``manufacturing/processing'' because those activities
involve ``making food from one or more ingredients, or synthesizing,
preparing, treating, modifying or manipulating food.'' This special
classification of on-farm activities, however, should only apply to
RACs because only RACs, not processed foods, are the essential products
of farms. For all of these reasons, RACs are a logical and appropriate
focus for these produce safety standards.
In addition to these three exemptions mentioned above, under the
conditions specified in Sec. 112.2(b), we propose to allow covered
produce which receives commercial processing that adequately reduces
the presence of microorganisms of public health significance to be
eligible for an exemption from the requirements of this part (except
for subparts A, Q, and O). Examples of commercial processing that
adequately reduces the presence of microorganisms of public health
significance are processing in accordance with the requirements of part
113, part 114, or part 120; treating with a validated process to
eliminate spore-forming microorganisms (such as processing to produce
tomato paste or shelf-stable tomatoes); and processing such as refining
or distilling produce into products such as sugar, oil, spirits, or
similar products. As discussed in section IV.C. of this document, FDA
tentatively concludes that such commercial processing significantly
minimizes the risk of serious adverse health consequences or death
associated with biological hazards for such produce, such that the
produce can be considered to be low risk and the imposition of the
requirements in this proposed rule is not warranted. We note that such
produce is and will continue to be covered under the adulteration
provisions and other applicable provisions of the Federal Food, Drug,
and Cosmetic Act and applicable implementing regulations, irrespective
of whether it is included within the scope of this proposed rule.
As proposed, to qualify for the Sec. 112.2(b) exemption, proposed
Sec. 112.2(b)(2) would require you to establish and keep documentation
of the identity of the recipient of the covered produce that performs
the commercial processing in accordance with the requirements of
proposed subpart O. FDA tentatively concludes that such records are
necessary for the efficient enforcement of the FD&C Act. Without such
records, FDA would have no way to assess whether farms are complying
with the terms of this exemption. In addition, proposed Sec.
112.2(b)(3) would clarify that the requirements of subparts A and Q
apply to such produce because subpart A includes relevant provisions
such as the scope of this rule and definitions, and Q contains
provisions relating to compliance and enforcement.
It is important to note that any of the exemptions in proposed
Sec. 112.2 are only applicable to the produce specified in the
exemption. In other words, a covered farm may not rely on these
exemptions for all of its covered produce simply because a subset of
that produce is rarely consumed raw; is for personal or on-farm
consumption; is not a RAC; or will receive the requisite commercial
processing; in those instances, only the subset that meets the relevant
exemption criteria would be exempt from this proposed rule. For

[[Page 3539]]

example, if you own or operate a farm that produces both tomatoes that
will be processed into tomato paste, and tomatoes that will not receive
any commercial processing to adequately reduce pathogens, and you do
not qualify for any other exemption, you would be subject to the rule
when you grow, harvest, pack or hold those tomatoes that will not be
processed to adequately reduce pathogens. Likewise, if you produce both
artichokes and lettuce, you would be subject to the rule when you grow,
harvest, pack or hold lettuce, but you would not be subject to the rule
when you grow, harvest, pack, or hold artichokes.
We request comment on proposed Sec. Sec. 112.1 and 112.2,
including the specific examples of produce that would be covered by the
rule; the list of produce that would not be covered by the rule because
it is rarely consumed raw; and the proposed exemption for produce that
receives commercial processing, including the types of processing that
should qualify for this exemption.
b. Definitions
Proposed Sec. 112.3 would establish the definitions of terms for
purposes of part 112. To the extent possible, the new definitions
proposed in Sec. 112.3 are consistent with the common meanings of
these terms as well as the definitions of the terms in other food
safety regulations (see, e.g., current Sec. 110.3 and Sec. 111.3) and
other applicable sources. As proposed in Sec. 112.3(a), to provide
clarity and consistency, the definitions and interpretations of terms
in section 201 of the FD&C Act will apply to such terms when used in
part 112.
i. Definitions of ``Farm,'' ``Mixed-Type Facility,'' and Related
Activities
We are proposing to establish an inter-related series of
definitions in this proposed rule that, collectively, would address
several issues related to the scope of establishments (namely,
``farms'') that would be subject to the rule. These inter-related
definitions include two definitions for types of establishments (i.e.,
``farm'' and ``mixed-type facility'') and five definitions for types of
activities (i.e., ``harvesting,'' ``holding,'' ``manufacturing/
processing,'' ``packaging,'' and ``packing'') conducted on farms and
mixed-type facilities.
These proposed definitions are based on definitions already
established in our regulations (e.g., in Sec. 1.227 in the regulations
for Registration of Food Facilities, established under section 415 of
the FD&C Act; hereinafter the section 415 registration regulations).
However, the definitions that we are proposing for the purpose of the
produce safety rule have some differences relative to the current
definitions established in the section 415 registration regulations. In
the near future, we plan to address how we will coordinate the
definitions in the section 415 registration regulations with the
definitions we are proposing for the purpose of the produce safety
proposed rule.
In developing these proposed definitions, we considered how the
activities of farms relate to the statutory concepts of ``raw
agricultural commodity'' and ``processed food.'' The FD&C Act defines
``raw agricultural commodity'' and ``processed food'' in relation to
each other, and identifies certain activities that transform a raw
agricultural commodity (RAC) into a processed food and others that do
not. Section 201(r) of the FD&C Act (21 U.S.C. 321(r)) defines ``raw
agricultural commodity'' to mean ``any food in its raw or natural
state, including all fruits that are washed, colored, or otherwise
treated in their unpeeled natural form prior to marketing.'' Section
201(gg) of the FD&C Act (21 U.S.C. 321(gg)) defines ``processed food''
to mean ``any food other than a raw agricultural commodity and includes
any raw agricultural commodity that has been subject to processing,
such as canning, cooking, freezing, dehydration, or milling.'' In
addition, section 201(q)(1)(B)(i)(II) of the FD&C Act (which defines
pesticide chemicals) contains the following language regarding
activities that do not transform a RAC into a processed food: ``the
treatment [with pesticide chemicals] is in a manner that does not
change the status of the food as a raw agricultural commodity
(including treatment through washing, waxing, fumigating, and packing
such commodities in such manner).''
The status of a food as a RAC or processed food is relevant for
many different purposes under the FD&C Act, including section
419(a)(1)(A) of the FD&C Act, which authorizes FDA to establish minimum
science-based standards applicable to certain fruits and vegetables
that are RACs. For example, under 403(w) of the FD&C Act (21 U.S.C.
343(w)), labeling requirements related to major food allergens apply to
processed foods but do not apply to RACs. Under sections 201(q),
403(k), 403(l), and 408 of the FD&C Act (21 U.S.C. 321(q), 343(k),
343(l), and 346a), the status of a food as a RAC has an impact on the
manner in which pesticide chemicals and their residues are regulated.
FSMA created more provisions in the FD&C Act and elsewhere that take
status as a RAC or processed food into account, including section
417(f) of the FD&C Act (21 U.S.C. 350f(f)), establishing notification
requirements for reportable foods that do not apply to fruits and
vegetables that are RACs; section 418(m) of the FD&C Act, which
authorizes FDA to exempt or modify the requirements for compliance
under section 418 with respect to facilities that are solely engaged in
the storage of RACs other than fruits and vegetables intended for
further distribution or processing; and section 204(d)(6)(D) of FSMA
(21 U.S.C. 2223(d)(6)(D)), which contains special provisions for
commingled RACs applicable to FDA's authority under section 204 of FSMA
to establish additional recordkeeping requirements for high risk foods.
The term ``raw agricultural commodity'' and similar terms also
appear in other Federal statutes. While these statutes are not
implemented or enforced by FDA and do not directly impact the
interpretation of the definitions in sections 201(r) and 201(gg) of the
FD&C Act, they do provide some suggestions about what ``raw
agricultural commodity'' and related concepts can mean in various
circumstances. For example, the Secretary of Transportation may
prescribe commercial motor vehicle safety standards under 49 U.S.C.
31136, but the Motor Carrier Safety Improvement Act of 1999 (Pub. L.
106-159, title II, Sec. 229, Dec. 9, 1999), as added and amended by the
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users (Pub. L. 109-59, title IV, Sec. 4115, 4130, Aug. 10,
2005), provided an exemption from maximum driving or on-duty times for
drivers transporting ``agricultural commodities'' or farm supplies
within specific areas during planting and harvest periods. In that
circumstance, ``agricultural commodity'' is defined as ``any
agricultural commodity, non-processed food, feed, fiber, or livestock *
* * and insects'' (49 U.S.C. 31136 note). Another example is 19 U.S.C.
1677(4)(E), which provides for certain circumstances in which producers
or growers of raw agricultural products may be considered part of the
industry producing processed foods made from the raw agricultural
product for the purposes of customs duties and tariffs related to such
processed foods. In that circumstance, ``raw agricultural product'' is
defined as ``any farm or fishery product'' (19 U.S.C. 1677(4)(E)).
These statutes are informative in that they suggest that the ``raw
agricultural commodity'' concept describes and

[[Page 3540]]

signifies the products of farms in their natural states, or, in other
words, that which a farm exists to produce on a basic level.
Because the status of a food as a RAC or processed food is of great
importance in defining the jurisdiction of FDA and the U.S.
Environmental Protection Agency (EPA) over antimicrobial substances,
FDA and EPA have developed guidance regarding whether or not various
activities transform RACs into processed foods. FDA and EPA jointly
issued a legal and policy interpretation of the agencies' jurisdiction
under the FD&C Act over antimicrobial substances used in or on food
(hereinafter the ``1998 Joint EPA/FDA Policy Interpretation'') (63 FR
54532, October 9, 1998). In 1999, FDA issued guidance addressing
several of the issues discussed in the 1998 Joint EPA/FDA Policy
Interpretation. (See Guidance for Industry: Antimicrobial Food
Additives, July 1999 (hereinafter ``Antimicrobial Guidance'') (Ref.
84)). Table 1 summarizes activities that cause food RACs to become
processed foods and activities that do not change the status of a food
RAC, as set out in the 1998 Joint EPA/FDA Policy Interpretation and the
Antimicrobial Guidance.

Table 1--The Effect of Activities on RACs That Are Foods
------------------------------------------------------------------------
Activities that change a RAC into a Activities that do not change
processed food the status of a RAC
------------------------------------------------------------------------
Canning................................ Application of pesticides
(including by washing, waxing,
fumigation, or packing).
Chopping............................... Coloring.
Cooking................................ Drying for the purpose of
storage or transportation.
Cutting................................ Hydro-cooling.
Drying that creates a distinct Otherwise treating fruits in
commodity. their unpeeled natural form.
Freezing............................... Packing.
Grinding............................... Refrigeration.
Homogenization......................... Removal of leaves, stems, and
husks.
Irradiation............................ Shelling of nuts.
Milling................................ Washing.
Pasteurization......................... Waxing.
Peeling................................ Activities designed only to
isolate or separate the
commodity from foreign objects
or other parts of the plant.
Slaughtering animals for food and
activities done to carcasses post-
slaughter, including skinning,
eviscerating, and quartering.
Slicing.
Activities that alter the general state
of the commodity.
------------------------------------------------------------------------

In developing the proposed definitions, we also considered the
definition of ``manufacturing/processing'' that FDA established in
Sec. 1.227. Under Sec. 1.227(b)(6), ``manufacturing/processing''
means making food from one or more ingredients, or synthesizing,
preparing, treating, modifying or manipulating food, including food
crops or ingredients. Examples of manufacturing/processing activities
are cutting, peeling, trimming, washing, waxing, eviscerating,
rendering, cooking, baking, freezing, cooling, pasteurizing,
homogenizing, mixing, formulating, bottling, milling, grinding,
extracting juice, distilling, labeling, or packaging. The summary in
Table 1 demonstrates that the activities that transform a RAC into a
processed food (and are sometimes therefore referred to as
``processing'' in the context of a food's status as a RAC or processed
food) are not coextensive with the definition of ``manufacturing/
processing'' that FDA established in Sec. 1.227(b)(6) for the purposes
of the section 415 registration regulations. The definition of
``Manufacturing/processing'' in that regulation includes most food-
handling activities because it is satisfied by any degree of ``making
food from one or more ingredients, or synthesizing, preparing,
treating, modifying or manipulating food.'' In contrast, transforming a
RAC into a processed food seems to require meeting a threshold of
altering the general state of the commodity (Ref. 3, section 7 and 63
FR 54532 at 54541), sometimes referred to as transformation of the RAC
into a new or distinct commodity (61 FR 2386 at 2388). Because the
activities that transform a RAC into a processed food are not
coextensive with the definition of ``manufacturing/processing'' in
Sec. 1.227(b)(6), a given activity may be manufacturing/processing
under the current definition in Sec. 1.227(b)(6) without transforming
a RAC into a processed food. Examples of such activities include
coloring, washing, and waxing.
The current section 415 registration regulations demonstrate that
some activities may be classified differently on farms and off farms.
For example, ``washing'' is an example of manufacturing/processing
under the definition of that term in Sec. 1.227(b)(6). However,
``washing'' produce is identified as part of harvesting under the farm
definition in Sec. 1.227(b)(3), so washing on farms is harvesting
rather than manufacturing/processing under the Section 415 registration
regulations. To date, we have not articulated organizing principles
explaining these differences.
In this document, we are tentatively articulating five organizing
principles (summarized in Table 2 below) to explain the basis for the
proposed definitions that would classify activities on-farm and off-
farm for the purpose of this proposed rule. In the near future, we plan
to address how we will coordinate the definitions in the section 415
registration regulations with the definitions we are proposing for the
purpose of this proposed rule.
First Organizing Principle. The statutes we describe above, and
previous interpretations of the concepts of RACs and processed food as
set forth in the 1998 Joint EPA/FDA Policy Interpretation and the
Antimicrobial Guidance, lead FDA to tentatively conclude that the basic
purpose of farms is to produce RACs and that RACs are the essential
products of farms.
Second Organizing Principle. Our second organizing principle is
that activities that involve RACs and that farms traditionally do for
the purposes of growing their own RACs, removing them from the growing
areas, and preparing them for use as a food RAC, and for packing,
holding and transporting them, should all be within the definition of
``farm.'' This is because

[[Page 3541]]

the basic purpose of farms is to produce RACs (principle 1). This is
the case even if the same activities off-farm would be considered to be
manufacturing/processing, because those activities involve ``making
food from one or more ingredients, or synthesizing, preparing,
treating, modifying or manipulating food.''
Third Organizing Principle. Activities should be classified based
in part on whether the food operated on is a RAC or a processed food,
and on whether the activity transforms a RAC into a processed food.
This is because principle 2 (i.e., the special classification of on-
farm activities) should only apply to RACs. A farm that chooses to
transform its RACs into processed foods should be considered to have
chosen to expand its business beyond the traditional business of a
farm.
Fourth Organizing Principle. Principle 2 (i.e., the special
classification of on-farm activities) should only apply to RACs grown
or raised on the farm itself or on other farms under the same ownership
because the essential purpose of a farm is to produce its own RACs, not
to handle RACs grown on unrelated farms for distribution into commerce.
(For the purposes of this discussion, we refer to RACs grown or raised
on a farm or another farm under the same ownership as a farm's ``own
RACs,'' in contrast to RACs grown on a farm under different ownership,
which we refer to as ``others' RACs.'') Activities that farms may
perform on others' RACs should appropriately be classified as
manufacturing/processing, packing, or holding in the same manner as
these activities are classified off-farm when the RACs are to be
distributed into commerce. In general, when a farm opts to perform
activities outside the farm definition, the establishment's activities
that are within the farm definition should be classified as
manufacturing/processing, packing, or holding in the same manner as for
a farm that does not perform activities outside the farm definition,
but the activities that are outside the farm definition should be
classified in the same manner as for an off-farm food establishment.
Fifth Organizing Principle. Manufacturing/processing, packing, or
holding food-- whether RACs or processed foods, from any source--for
consumption on the farm should remain within the farm definition
because otherwise farms could not feed people and animals on the farm
without being considered to have engaged in activities outside the farm
definition.

Table 2--Summary of Organizing Principles Regarding Classification of
Activities On-Farm and Off-Farm
------------------------------------------------------------------------
Number Organizing principle
------------------------------------------------------------------------
1............................ The basic purpose of farms is to produce
RACs and RACs are the essential products
of farms.
2............................ Activities that involve RACs and that
farms traditionally do for the purposes
of growing their own RACs, removing them
from the growing areas, and preparing
them for use as a food RAC, and for
packing, holding and transporting them,
should all be within the definition of
``farm.''
3............................ Activities should be classified based in
part on whether the food operated on is
a RAC or a processed food, and on
whether the activity transforms a RAC
into a processed food.
4............................ Activities farms may perform on others'
RACs should appropriately be classified
as manufacturing/processing, packing, or
holding in the same manner as these
activities are classified off-farm when
the RACs are to be distributed into
commerce.
5............................ Manufacturing/processing, packing, or
holding food--whether RACs or processed
foods, from any source--for consumption
on the farm should remain within the
farm definition.
------------------------------------------------------------------------

We are proposing to include definitions for two types of
establishments (i.e., ``farm'' and ``mixed-type facility'') and five
types of activities (i.e., ``harvesting,'' ``holding,''
``manufacturing/processing,'' ``packaging,'' and ``packing''), to
reflect the organizing principles articulated immediately above and to
clarify how those definitions apply to specific activities depending on
where the activities take place, the food used in the activities, where
the food comes from, and where the food is consumed. We discuss these
proposed definitions in this section because they are inter-related;
however, we propose that they appear in Sec. 112.3(c) in alphabetical
order with the other definitions discussed in section V.A.2.b.iii of
this document below.
We are proposing to define ``farm'' to mean a facility in one
general physical location devoted to the growing and harvesting of
crops, the raising of animals (including seafood), or both. The term
``farm'' includes: (i) Facilities that pack or hold food, provided that
all food used in such activities is grown, raised, or consumed on that
farm or another farm under the same ownership; and (ii) Facilities that
manufacture/process food, provided that all food used in such
activities is consumed on that farm or another farm under the same
ownership. The proposed definition of ``farm'' is based on the
definition already established in Sec. 1.227(b) in the section 415
registration regulations, except that it does not include the statement
``Washing, trimming of outer leaves of, and cooling produce are
considered part of harvesting.'' The description of harvesting
activities is included in a separate proposed definition of
``harvesting'' and thus would be redundant in the proposed definition
of ``farm.''
We are proposing to define ``Mixed-type facility'' to mean an
establishment that engages in both activities that are exempt from
registration under section 415 of the FD&C Act and activities that
require the establishment to be registered. This term and its
definition were initially developed in the preamble to the proposed
rule on food facility registration (68 FR 5378 at 5381) and in the
interim final rule on food facility registration (68 FR 58894 at 58906-
7, 58914, 58934-8). The proposed definition would also provide, as an
example of such a facility, a definition of a ``farm mixed-type
facility.'' A ``farm mixed-type facility'' would be defined as an
establishment that grows and harvests crops or raises animals and may
conduct other activities within the farm definition, but also conducts
activities that require the establishment to be registered. This
definition is important to include in this rule because the activities
of farm mixed-type facilities that are within the definition of
``farm'' are potentially subject to this rule, as provided in proposed
Sec. 112.4. FDA would apply this proposed rule only to the ``farm''
portion of these establishments' activities, and not to the ``non-
farm'' portion of their activities (which would be subject to section
418 of the FD&C Act and therefore not subject to this proposed rule,
consistent with section 419(h) of the FD&C Act). Put another way, farms
and the ``farm'' portion of

[[Page 3542]]

the activities of farm mixed-type facilities would be subject to this
proposed rule as applicable. For simplicity, FDA proposes to reference
these activities collectively in proposed Sec. 112.4(a) as one aspect
of what makes an entity a ``covered farm'' and then to refer only to
``covered farms'' throughout the proposed rule. Thus, references to
``farms'' and ``covered farms'' throughout this proposed rule should be
understood to include the portion of a farm mixed-type facility's
activities that are within the farm definition.
We are proposing to define the term ``Harvesting'' to apply to
farms and farm mixed-type facilities and be defined as activities that
are traditionally performed by farms for the purpose of removing raw
agricultural commodities from the place they were grown or raised and
preparing them for use as food. Harvesting would be limited to
activities performed on raw agricultural commodities on the farm on
which they were grown or raised, or another farm under the same
ownership. Harvesting would not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the FD&C Act,
into a processed food as defined in section 201(gg) of the FD&C Act.
Gathering, washing, trimming of outer leaves of, removing stems and
husks from, sifting, filtering, threshing, shelling, and cooling raw
agricultural commodities grown on a farm or another farm under the same
ownership would be listed as examples of harvesting. This proposed
definition would include the same examples of ``harvesting'' that are
currently part of the farm definition in Sec. 1.227(b)(3) (washing,
trimming of outer leaves, and cooling) and would add other examples to
help clarify the scope of the definition of harvesting. ``Harvesting''
is a category of activities that is only applicable to farms and farm
mixed-type facilities. Activities that would be ``harvesting'' when
performed on a farm on the farm's own RACs would be classified
differently under other circumstances, such as at a processing facility
that is not on a farm, or when performed by a farm on others' RACs. For
example, at an off-farm facility that packs tomatoes, washing the
tomatoes after they are received would not be ``harvesting'' because it
is not being performed on the farm that produced the tomatoes (or
another farm under the same ownership). Instead, washing tomatoes at
the off-farm packing facility would be ``manufacturing,'' because it
involves preparing, treating, modifying, or manipulating food.
We are proposing to define ``Holding'' to mean the storage of food.
The proposed definition would state that, for farms and farm mixed-type
facilities, holding would also include activities traditionally
performed by farms for the safe or effective storage of RACs grown or
raised on the same farm or another farm under the same ownership, but
would not include activities that transform a RAC, as defined in
section 201(r) of the FD&C Act, into a processed food as defined in
section 201(gg) of the FD&C Act. This would mean that more activities
than just storage of food would be classified as ``holding'' when a
farm or farm mixed-type facility performs those activities on its own
RACs. For example, fumigating or otherwise treating a farm's own RACs
against pests for the purpose of safe and effective storage would be
``holding'' under this proposed definition. However, fumigating or
otherwise treating food against pests under other circumstances (such
as off-farm or by a farm handling others' RACs) would not be
``holding'' food because it is not storage of food, which would remain
the definition of holding applicable to most circumstances.
We are proposing to define ``Manufacturing/processing'' to mean
making food from one or more ingredients, or synthesizing, preparing,
treating, modifying or manipulating food, including food crops or
ingredients. The proposed definition would also state that, for farms
and farm mixed-type facilities, manufacturing/processing would not
include activities that are part of harvesting, packing, or holding.
Under this proposed definition, the expanded definitions of ``packing''
and ``holding,'' and the extra category ``harvesting,'' would apply to
activities performed by farms and farm mixed-type facilities on their
own RACs. These expanded and extra categories would not apply off-farm
or to foods other than a farm's own RACs or a farm mixed-type
facility's own RACs. Thus, some activities that would otherwise be
manufacturing/processing would instead be defined as packing, holding,
or harvesting by virtue of being performed by a farm or farm mixed-type
facility on its own RACs. Accordingly, these activities would not be
manufacturing/processing because they would already be classified into
the expanded definitions of packing or holding, or into the extra
category of harvesting.
We are proposing to define ``Packaging'' to mean (when used as a
verb) placing food into a container that directly contacts the food and
that the consumer receives. We are proposing to use the same definition
of ``packaging'' as is currently established in Sec. 1.227.
We are proposing to define ``Packing'' to mean placing food into a
container other than packaging the food. The proposed definition would
also state that, for farms and farm mixed-type facilities, packing
would also include activities (which may include packaging)
traditionally performed by farms to prepare RACs grown or raised on the
same farm or another farm under the same ownership for storage and
transport, but would not include activities that transform a RAC, as
defined in section 201(r) of the FD&C Act, into a processed food as
defined in section 201(gg) of the FD&C Act. This would mean that more
activities than just placing food into a container other than packaging
would be classified as ``packing'' when a farm or farm mixed-type
facility performs those activities on its own RACs. For example,
packaging (placing food into a container that directly contacts the
food and that the consumer receives) a farm's own RACs would be
``packing'' under this definition because farms traditionally do this
to provide greater protection for fragile RACs than would be possible
if the RACs were placed in containers other than the consumer
container, and because this activity does not transform a RAC into a
processed food. However, packaging food under other circumstances would
not be ``packing'' food because packaging is explicitly excluded from
the definition of packing applicable to most circumstances (placing
food into a container other than packaging). Other examples of
activities that could be packing when performed by a farm or a farm
mixed-type facility on its own RACs include packaging or packing a mix
of RACs together (e.g., in a bag containing three different colored
bell peppers, or a box of mixed produce for a community sponsored
agriculture program farm share); coating RACs with wax, oil, or resin
coatings used for the purposes of storage or transport; placing
stickers on RACs; labeling packages containing RACs; sorting, grading,
or culling RACs; and drying RACs for the purpose of storage or
transport.
Table 3 provides examples of how we would classify activities
conducted off-farm and on-farm (including farm mixed-type facilities)
using these proposed definitions.

[[Page 3543]]

Table 3--Classification of Activities Conducted Off-Farm and On-Farm
[including farm mixed-type facilities]
----------------------------------------------------------------------------------------------------------------
On farm (including farm mixed-
Classification Off farm type facilities)
----------------------------------------------------------------------------------------------------------------
Harvesting................................... Notes: Not applicable. Notes: Activities traditionally
Harvesting is a classification performed by farms for the
that only applies on farms and purpose of removing RACs from
farm mixed-type facilities. growing areas and preparing
them for use as food.
Harvesting is limited to
activities performed on RACs
on the farm on which they were
grown or raised, or another
farm under the same ownership.
Harvesting does not include
activities that change a RAC
into processed food.
Activities that are harvesting
are within the farm
definition.
Examples: Not applicable........ Examples: activities that fit
this definition when performed
on a farm's ``own RACs'' (a
term we use to include RACs
grown or raised on that farm
or another farm under the same
ownership) include gathering,
washing, trimming of outer
leaves, removing stems and
husks, sifting, filtering,
threshing, shelling, and
cooling. These activities,
performed on a farm's own
RACs, are inside the farm
definition.
Packing...................................... Notes: Placing food in a Notes: Placing food in a
container other than packaging container other than packaging
the food (where packaging means the food (using the same
placing food into a container definition of packaging), or
that directly contacts the food activities (which may include
and that the consumer receives). packaging) traditionally
performed by farms to prepare
RACs grown or raised on that
farm or another farm under the
same ownership for storage or
transport. Packing does not
include activities that change
RAC into a processed food.
Activities that are packing
are within the farm definition
when they are performed on
food grown, raised, or
consumed on that farm or
another farm under the same
ownership; under any other
circumstances they are outside
the farm definition.
................................
Examples: putting individual Examples: activities that fit
unit cartons into a larger box the definition of packing when
used for shipping, and putting performed on a farm's own RACs
articles of produce in non- include packaging, mixing,
consumer containers (such as coating with wax/oil/resin for
shipping crates). the purpose of storage or
transport, stickering/
labeling, drying for the
purpose of storage or
transport, and sorting/grading/
culling. These activities,
performed on a farm's own
RACs, are inside the farm
definition.
Activities that fit the
definition of packing when
performed on a farm on any
other foods, including RACs
grown or raised on a farm not
under the same ownership,
include putting individual
unit cartons into a larger box
used for shipping, and putting
articles of produce in non-
consumer containers (such as
shipping crates)--the same
activities that fit the
definition of packing off
farm. These activities,
performed on food other than a
farm's own RACs, are outside
the farm definition unless
done on food for consumption
on the farm.
Holding...................................... Notes: Storage of food.......... Notes: Storage of food, or
activities traditionally
performed by farms for the
safe or effective storage of
RACs grown or raised on that
farm or another farm under the
same ownership. Holding does
not include activities that
change a RAC into a processed
food. Activities that are
holding are within the farm
definition when they are
performed on food grown,
raised, or consumed on that
farm or another farm under the
same ownership; under any
other circumstances they are
outside the farm definition.
Example: storing food, such as Examples: activities that fit
in a warehouse. the definition of holding when
performed on a farm's own RACs
include fumigating during
storage, and storing food,
such as in a warehouse. These
activities, performed on a
farm's own RACs, are inside
the farm definition.

[[Page 3544]]

An activity that fit the
definition of holding when
performed on a farm on any
other foods, including RACs
grown or raised on a farm not
under the same ownership, is
storing food, such as in a
warehouse--the same activity
that fits the definition of
holding off farm. This
activity, performed on food
other than a farm's own RACs,
is outside the farm definition
unless done on food for
consumption on the farm.
Manufacturing/Processing..................... Notes: Making food from 1 or Notes: Making food from 1 or
more ingredients, or more ingredients, or
synthesizing, preparing, synthesizing, preparing,
treating, modifying, or treating, modifying, or
manipulating food. Includes manipulating food; except for
packaging (putting food in a things that fall into the
container that directly categories of harvesting,
contacts food and that consumer packing, or holding (see rows
receives). above). Activities that are
manufacturing/processing are
outside the farm definition
unless done on food for
consumption on the farm.
Examples: activities that fit Examples: activities that fit
this definition include the definition of
washing, trimming of outer manufacturing/processing when
leaves, removing stems and performed on a farm's own RACs
husks, sifting, filtering, include slaughtering animals
threshing, shelling, cooling, or post-slaughter operations,
packaging, mixing, coating, irradiation, cutting/coring/
stickering/labeling, drying, chopping/slicing, canning,
sorting/grading/culling not coating with things other than
incidental to packing or wax/oil/resin, drying that
holding, fumigating, creates a distinct commodity,
slaughtering animals or post- artificial ripening, cooking,
slaughter operations, pasteurizing/homogenizing,
irradiation, cutting/coring/ infusing, distilling, salting,
chopping/slicing, canning, smoking, grinding/milling, and
artificial ripening, cooking, freezing. These activities,
pasteurizing/homogenizing, performed on a farm's own
infusing, distilling, salting, RACs, are outside the farm
smoking, grinding/milling, and definition unless done on food
freezing. for consumption on the farm.
Activities that fit the
definition of manufacturing/
processing when performed on a
farm on any other foods,
including RACs grown or raised
on a farm not under the same
ownership include washing,
trimming of outer leaves,
removing stems and husks,
sifting, filtering, threshing,
shelling, cooling, packaging,
mixing, coating, stickering/
labeling, drying, sorting/
grading/culling not incidental
to packing or holding,
fumigating, slaughtering
animals or post-slaughter
operations, irradiation,
cutting/coring/chopping/
slicing, canning, artificial
ripening, cooking,
pasteurizing/homogenizing,
infusing, distilling, salting,
smoking, grinding/milling, and
freezing--the same activities
that fit the definition of
manufacturing/processing off
farm. These activities,
performed on food other than a
farm's own RACs, are outside
the farm definition unless
done on food for consumption
on the farm.
----------------------------------------------------------------------------------------------------------------

ii. Proposed Definitions of ``Very Small Business'' and ``Small
Business''

Summary of Proposed Qualifications
[on a rolling basis, average annual monetary value of food sold during
the previous three-year period]
------------------------------------------------------------------------

------------------------------------------------------------------------
Above $250,000 and no more than Small Business.
$500,000.
Above $25,000 and no more than Very Small Business.
$250,000.
$25,000 or less.................. Excluded from coverage.
------------------------------------------------------------------------

As required by section 419(a)(3)(F) of the FD&C Act, proposed Sec.
112.3(b) defines the terms ``very small business'' and ``small
business'' for purposes of this proposed rule only. FDA uses a measure
of the average annual monetary value of food sold to determine farm
size. This measure should serve as a valid proxy for both the volume
and value of production within size category and commodities. The USDA
National Commission on Small Farms recommended a definition for a small
farm as a family farm with less than $250,000 annual monetary value of
all commodities sold (Ref. 85). The Commission's recommendation was
based on the reasoning that these farms are the likeliest to exit the
industry, and have the greatest need to improve net farm incomes Ref.
85). The Commission states that although 94% of all U.S. farms generate
less than $250,000 annual monetary value of all commodities sold, their
revenue constitutes only 41% of total gross revenue from all farms
(Ref. 85). We propose to use the $250,000 annual monetary value of food
sold threshold for our cutoff of a very small farm since the revenue of
covered produce farms below this threshold constitutes only 12% of
total gross revenue from food

[[Page 3545]]

sales by produce farms and make up 83% of all produce farms. We propose
to use the statutory cutoff of $500,000 annual monetary value of food
sold as one part of the criteria for the qualified exemption in section
419(f) of the FD&C Act (implemented in proposed Sec. 112.5) as the
threshold for a small farm. Farms below the $500,000 annual value of
food sold cutoff make up 89% of covered farms, and their revenue
constitutes 18% of total gross revenue from food sales by produce
farms. We developed this proposed definition using sales class breaks
found in generally available information from USDA (Ref. 86).
Proposed Sec. 112.3(b)(1) would define your farm to be a very
small business if it is subject to proposed part 112 and, on a rolling
basis, the average annual monetary value of food you sold during the
previous three-year period is no more than $250,000.
Proposed Sec. 112.3(b)(2) would define your farm to be a small
business if it is subject to proposed part 112 and, on a rolling basis,
the average annual monetary value of food you sold during the previous
three-year period is no more than $500,000; and your farm is not a very
small business as provided in proposed Sec. 112.3(b)(1).
For clarity, in both proposed Sec. 112.3(b)(1) and (2), the
limitation ``if it is subject to this part'' is intended to exclude
farms not subject to the proposed rule per proposed Sec. 112.4(a),
that is, farms with $25,000 or less of annual value of food sold. As
discussed in section V.A.2.c of this document, we propose to exclude
such farms from the coverage of this proposed rule such that there
would be no reason for them to be classified as small or very small
businesses.
iii. Additional Proposed Definitions
Proposed Sec. 112.3(c) would establish the following additional
definitions that would apply for the purposes of part 112.
We propose to define ``adequate'' to mean that which is needed to
accomplish the intended purpose in keeping with good public health
practice. This proposed definition is the same as the definition we
have established in Sec. 110.3 with respect to current good
manufacturing practice in manufacturing, packing, or holding human
food. We have been applying this definition for the purpose of
enforcing the regulations in part 110 for more than 40 years and
tentatively conclude that it would be an appropriate definition to
apply to part 112 as well. Throughout this document, we provide
examples of what we mean by ``adequate'' for purposes of complying with
specific proposed provisions.
We propose to define ``adequately reduce microorganisms of public
health significance'' to mean reduce the presence of such
microorganisms to an extent sufficient to prevent illness. This
proposed definition would establish in part 112 a definition that we
have used in guidance associated with the risk of foodborne illness
from pathogens (Ref. 87. Ref. 88). As discussed in those documents, the
extent of reduction sufficient to prevent illness is usually determined
by the estimated extent to which a pathogen may be present in the food
combined with a safety factor to account for uncertainty in that
estimate. For example, if it is estimated that there would be no more
than 1,000 (i.e., 3 logs) Salmonella organisms per gram of food, and a
safety factor of 100 (i.e., 2 logs) is employed, a process that
adequately reduces Salmonella spp. would be a process capable of
reducing Salmonella spp. by 5 logs per gram of food.
We propose to define ``agricultural tea'' to mean a water extract
of biological materials (such as humus, manure, non-fecal animal
byproducts, peat moss, pre-consumer vegetative waste, table waste, or
yard trimmings), excluding any form of human waste, produced to
transfer microbial biomass, fine particulate organic matter, and
soluble chemical components into an aqueous phase. Agricultural teas
are held for longer than one hour before application. We developed this
term to cover a wide range of ``teas'' used in production of fresh
produce, but not to include ``tea'' served as a beverage. The term
``agricultural tea'' was based in part on the definition of ``compost
tea'' developed by the National Organic Standards Board (Ref. 89).
Human waste would be excluded for consistency with proposed Sec.
112.53 regarding the use of human waste as a soil amendment. The one
hour limitation is intended to distinguish between agricultural teas
and other liquids such as leachate and runoff and is consistent with
the recommendations of the recommendations of the National Organic
Standards Board (Ref. 36).
We propose to define ``agricultural tea additive'' to mean a
nutrient source (such as molasses, yeast extract, or algal powder)
added to agricultural tea to increase microbial biomass. The term
``agricultural tea additive'' was based in part on the definition of
``compost tea additive'' developed by the National Organic Standards
Board (Ref. 89).
We propose to define ``agricultural water'' to mean water used in
covered activities on covered produce where water is intended to, or is
likely to, contact covered produce or food-contact surfaces, including
water used in growing activities (including irrigation water applied
using direct water application methods, water used for preparing crop
sprays, and water used for growing sprouts) and in harvesting, packing,
and holding activities (including water used for washing or cooling
harvested produce and water used for preventing dehydration of covered
produce). This proposed definition is different from our definition of
agricultural water in our Good Agricultural Practices guide (Ref. 10)
both because it is not limited to water in the growing environment, and
because we have excluded water that does not contact covered produce
from this definition based on the information in our QAR.
We propose to define ``animal excreta'' to mean solid or liquid
animal waste. By contrast, we are proposing to define ``manure'' to
mean animal excreta, alone or in combination with litter (such as straw
and feathers used for animal bedding) for use as a soil amendment. We
are proposing definitions to distinguish ``animal excreta'' from
``manure'' based on whether the animal excreta is used as a soil
amendment because some proposed requirements make such a distinction.
For example, the proposed requirements in Sec. Sec. 112.54 and 112.56
are directed to the treatment and safe application of biological soil
amendments of animal origin, including manure intentionally used as a
soil amendment, and the proposed requirements in Sec. Sec. 112.82 and
112.83 would be directed to preventing contamination of covered produce
with animal excreta deposited by wild or domestic animals that intrude
in an area where a covered activity is conducted on covered produce.
The proposed definition of ``manure'' also accounts for the potential
inclusion of animal litter that is collected with animal excreta, e.g.,
from barns.
We propose to define ``application interval'' to mean the time
interval between application of an agricultural input (such as a
biological soil amendment of animal origin) to a growing area and
harvest of covered produce from the growing area where the agricultural
input was applied. The proposed definition would provide a simple term
to use when describing such a time interval. The proposed application
intervals for biological soil amendments in proposed Sec. 112.56 would
establish requirements regarding such time intervals.
We propose to define ``biological soil amendment'' to mean any soil

[[Page 3546]]

amendment containing biological materials such as humus, manure, non-
fecal animal byproducts, peat moss, pre-consumer vegetative waste,
sewage sludge biosolids, table waste, agricultural tea, or yard
trimmings, alone or in combination. We are proposing this definition as
a means to distinguish soil amendments that contain biological
components from those that do not (like chemical fertilizers). In
addition, we propose to define ``biological soil amendment of animal
origin'' to mean a biological soil amendment which consists, in whole
or in part, of materials of animal origin, such as manure or non-fecal
animal byproducts, or table waste, alone or in combination. The term
``biological soil amendment of animal origin'' does not include any
form of human waste. We are proposing this definition as a means to
distinguish these biological soil amendments from soil amendments that
are wholly plant-based (such as yard trimmings).
We propose to define ``composting'' to mean a process to produce
humus in which organic material is decomposed by the actions of
microorganisms under thermophilic conditions for a designated period of
time (for example, 3 days) at a designated temperature (for example,
131[emsp14][deg]F (55 [deg]C)), followed by a curing stage under cooler
conditions. The proposed definition is consistent with definitions or
explanations of ``compost'' and ``composting'' in documents such as a
State regulation (Ref. 90), Appendix B to 40 CFR part 503 (Ref. 91),
documents prepared by the U.S. EPA (Ref. 92), and the Produce Safety
Project Issue Brief on Composting of Animal Manures (Ref. 27).
We propose to define ``covered activity'' to mean growing,
harvesting, packing, or holding covered produce, provided that all
covered produce used in covered packing or holding activities is grown,
raised, or consumed on that farm or another farm under the same
ownership. Covered activities would not include manufacturing/
processing within the definition elsewhere in proposed Sec. 112.3(c).
As discussed in sections III.F and V.A.2.b.i of this document,
manufacturing/processing on a farm is potentially subject to the
coverage of Section 418 of the FD&C Act, unless all of the food used in
such activities is consumed on that farm or another farm under the same
ownership. Where all of the manufactured/processed food is consumed on
that farm or another farm under the same ownership, the activity would
be potentially within the scope of Section 419 of the FD&C Act and this
proposed rule, except that Section 419(g) of the FD&C Act specifies
that ``[t]his section shall not apply to produce that is produced by an
individual for personal consumption,'' and section 419(c)(1)(B) of the
FD&C Act also requires that FDA ensure that the final rule is
practicable for ``a small food processing facility co-located on a
farm.''
FDA tentatively concludes that on-farm manufacturing/processing
activities for on-farm consumption (like produce for individual
consumption) should not be subject to this rule, either because it is
automatically excluded by Section 419(g) or because, to the extent
there may be any difference between produce ``for personal
consumption'' and produce ``consumed on the farm or another farm under
the same ownership,'' it is appropriate to exclude on-farm
manufacturing/processing for on-farm consumption from the rule. The
definition of covered activity would also specify, for clarity, that
this part does not apply to activities of a facility that are subject
to part 110 of this chapter .
We propose to define ``covered produce'' to mean produce that is
subject to the requirements of this part in accordance with Sec. Sec.
112.1 and 112.2. The term ``covered produce'' refers to the harvestable
or harvested part of the crop. We are proposing to define ``covered
produce'' to provide a simple term to use when describing food that
would be within the scope of the rule under proposed Sec. 112.1 and
not exempt from the rule under proposed Sec. 112.2.
We propose to define ``curing'' to mean the maturation stage of
composting, which is conducted after much of the readily metabolized
biological material has been decomposed, at cooler temperatures than
those in the thermophilic phase of composting, to further reduce
pathogens, promote further decomposition of cellulose and lignin, and
stabilize composition. This proposed definition is consistent with
definitions of ``curing'' in a State regulation (Ref. 93), documents
prepared by the U.S. EPA (Ref. 92), and a glossary of composting terms
prepared by the Cornell Waste Management Institute (Ref. 94).
We propose to define ``direct water application method'' to mean
using agricultural water in a manner whereby the water is intended to,
or is likely to, contact covered produce or food-contact surfaces
during use of the water. This proposed definition would provide a
simple term to use when describing such water within regulations such
as proposed Sec. 112.44(c). By cross-reference to the definitions of
``covered produce'' and ``produce'', this term only applies to methods
in which the water is intended to, or is likely to, contact the
harvestable part of the covered produce.
We propose to define ``food'' to mean food as defined in section
201(f) of the FD&C Act and to include seeds and beans used to grow
sprouts. We have long considered seeds and beans used to grow sprouts
to be ``food'' within the meaning of section 201(f) of the FD&C Act
(Ref. 95). Seeds and beans used to grow sprouts are both articles used
for food and articles used for components of articles used for food. We
are proposing to include them specifically in the definition of food
for purposes of this rule for clarity because sprouts are covered by
this rule.
We propose to define ``food-contact surfaces'' to mean those
surfaces that contact human food and those surfaces from which drainage
or other transfer onto the food or onto surfaces that contact the food
ordinarily occurs during the normal course of operations. ``Food-
contact surfaces'' includes food-contact surfaces of equipment and
tools used during harvest, packing, and holding. This proposed
definition of ``food-contact surfaces'' is consistent with the
definition of this term in Sec. 110.3 except that we propose to add
the phrase ``or other transfer'' after ``drainage'' definition of
``food-contact surfaces'' to clarify that surfaces from which any
transfer involving liquids or non-liquids onto the food or onto
surfaces that contact the food are food-contact surfaces.
We propose to define ``hazard'' to mean any biological agent that
is reasonably likely to cause illness or injury in the absence of its
control. The proposed definition is consistent with the NACMCF HACCP
guidelines, the Codex HACCP Annex, Federal HACCP regulations for
seafood, juice, and meat and poultry, except that for the purposes of
this rule the term would be limited to biological hazards because, as
discussed in section IV.A. of this document, this proposed rule is only
addressing biological hazards. The NACMCF HACCP guidelines (Ref. 41)
and our HACCP regulation for juice (Sec. 120.3(g)) define ``hazard''
and ``food hazard,'' respectively as a biological, chemical, or
physical agent that is reasonably likely to cause illness or injury in
the absence of its control. The Codex HACCP Annex defines ``hazard'' as
a biological, chemical or physical agent in, or condition of, food with
the potential to cause an adverse health effect (Ref. 96). Our HACCP
regulation for seafood (Sec. 123.3(f)) and the FSIS HACCP regulation
for meat and poultry (9 CFR 417.1) define ``food safety hazard'' as any
biological, chemical, or physical property that may cause a food

[[Page 3547]]

to be unsafe for human consumption. We recognize that there are other
hazards relevant to produce safety on farm that would not be addressed
in this proposed rule such as chemical, physical, and radiological
hazards (see section IV.B. of this document) and do not intend to
suggest by this definition that such hazards are not hazards. We
request comment on whether we should instead use the term ``biological
hazards'' in this rule.
We propose to define ``humus'' to mean a stabilized (i.e.,
finished) biological soil amendment produced through a controlled
composting process. We are proposing to use ``humus'' as the term to
identify the final, mature product of composting for the purpose of
this rule. Our proposed definition derives from our proposed
definitions for ``composting'' and ``curing'' and the Cornell Waste
Management Institute's glossary of composting terms (Ref. 94), which
defines humus as a complex aggregate made during the decomposition of
plant and animal residues; mainly derivatives of lignin, proteins, and
cellulose combined with inorganic soil parts. However, other relevant
documents (Ref. 27. Ref. 92. Ref. 97) refer to the production of
``humus-like material'' through composting, and humus can be produced
by mechanisms other than the action of microorganisms (Ref. 98). We
request comment on whether our proposed definition and use of the term
``humus'' for the final product of composting is appropriate for the
purpose of this rule, or whether we should use a term other than
``humus,'' such as ``mature compost.''
We propose to define ``manure'' to mean animal excreta, alone or in
combination with litter (such as straw and feathers used for animal
bedding) for use as a soil amendment. As discussed above in the
definition of animal excreta, this definition is intended to make a
distinction between the terms ``manure'' and ``animal excreta.''
We propose to define ``microorganisms'' to mean yeasts, molds,
bacteria, viruses, protozoa, and microscopic parasites and to include
species having public health significance. As proposed, the term
``undesirable microorganisms'' includes those microorganisms that are
of public health significance, that subject food to decomposition, that
indicate that food is contaminated with filth, or that otherwise may
cause food to be adulterated. The substantive difference between this
proposed definition and that in current Sec. 110.3 is the addition of
protozoa (e.g., Giardia lamblia) and microscopic parasites (e.g.,
Cyclospora cayetanensis). Because such microorganisms are relevant to
produce safety, we tentatively conclude that it is reasonable to
include them.
We propose to define ``monitor'' to mean to conduct a planned
sequence of observations or measurements to assess whether a process,
point, or procedure is under control, and, when applicable, to produce
an accurate record of the observation or measurement.
We propose to define ``non-fecal animal byproduct'' to mean solid
waste (other than manure) that is animal in origin (such as meat, fat,
dairy products, eggs, carcasses, blood meal, bone meal, fish meal,
shellfish waste (such as crab, shrimp, and lobster waste), fish
emulsions, and offal) and is generated by commercial, institutional, or
agricultural operations. This proposed definition reflects the use of a
similar term in sources such as the State of Florida's regulations
(Ref. 90). However, we are proposing to include more examples of these
byproducts than are included in Florida's regulations to clearly
communicate what we mean by the term. We propose to define ``pest'' to
mean any objectionable animals or insects including birds, rodents,
flies, and larvae. This proposed definition is consistent with the
definition of ``pest'' in current Sec. 110.3.
We propose to define ``pre-consumer vegetative waste'' to mean
solid waste that is purely vegetative in origin, not considered yard
trash, and derived from commercial, institutional, or agricultural
operations without coming in contact with animal products, byproducts
or manure or with an end user (consumer). As proposed, pre-consumer
vegetative waste includes material generated by farms, packing houses,
canning operations, wholesale distribution centers and grocery stores;
products that have been removed from their packaging (such as out-of-
date juice, vegetables, condiments, and bread); and associated
packaging that is vegetative in origin (such as paper or corn-starch
based products). As proposed, pre-consumer vegetative waste does not
include table waste, packaging that has come in contact with materials
(such as meat) that are not vegetative in origin, or any waste
generated by restaurants. This proposed definition is consistent with a
State regulation (Ref. 90).
For the purpose of this rule, we propose to define the term
``produce'' to mean any fruit or vegetable (including mixes of intact
fruits and vegetables) and includes mushrooms, sprouts (irrespective of
seed source), peanuts, tree nuts and herbs. For the purposes of this
rule, we propose to define ``fruit'' as the edible reproductive body of
a seed plant or tree nut (such as apple, orange and almond) such that
fruit means the harvestable or harvested part of a plant developed from
a flower; and ``vegetable'' as the edible part of an herbaceous plant
(such as cabbage or potato) or fleshy fruiting body of a fungus (such
as white button or shiitake) grown for an edible part such that
vegetable means the harvestable or harvested part of any plant or
fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers,
bulbs, stems, leaves, or flower parts are used as food and includes
mushrooms, sprouts, and herbs (such as basil or cilantro).
For the purposes of this rule, produce does not include ``food
grains'' meaning the small, hard fruits or seeds of arable crops, or
the crops bearing these fruits or seeds, that are grown and processed
for use as meal, flour, baked goods, cereals and oils rather than for
fresh consumption (including cereal grains, pseudo cereals, oilseeds
and other plants used in the same fashion). Examples of food grains
include barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat,
amaranth, quinoa, buckwheat, cotton seed, and soybeans. With this
definition, we are proposing to specifically include mushrooms, sprouts
(irrespective of seed source), peanuts, tree nuts and herbs, and
specifically exclude food grains. We explain our proposed definition of
``produce'' in detail above, in section V.A.2.a of this document. We
request comments on our proposed definition of ``produce.''
We propose to define ``production batch of sprouts'' to mean all
sprouts that are started at the same time in a single growing unit
(e.g., a single drum or bin, or a single rack of trays that are
connected to each other), whether or not the sprouts are grown from a
single lot of seed (including, for example, when multiple types of
seeds are grown within a single growing unit). Through this definition,
we intend to treat as a production batch product that would be exposed
to the same conditions during sprouting, such as multiple seed types
grown in a common drum or multiple trays in a single rack that may be
exposed to water that has contacted other product in the same growing
unit. This term is used in proposed subpart M. Limiting the definition
of ``production lot'' to a single growing unit would prevent sprout
growers from ``pooling'' samples from multiple growing units within an
operation whereby contamination in spent water in one unit could be
diluted by non-contaminated water from other units to

[[Page 3548]]

the point where pathogens might not be detected. This proposed
definition is consistent with our 1999 guidance for industry on
sampling and microbial testing of spent irrigation water during sprout
production (Ref. 15). We recognize that there are a diversity of
growing practices and a variety of growing units that may represent
different product volumes, so we request comment on this proposed
definition.
We propose to define ``qualified end-user,'' with respect to a
food, to mean the consumer of the food; or a restaurant or retail food
establishment (as those terms are defined in Sec. 1.227) that is
located (i) in the same State as the farm that produced the food; or
(ii) not more than 275 miles from such farm. The definition would also
state that the term ``consumer'' does not include a business. This
definition implements section 419(f)(4) of the FD&C Act. We note that
section 419(f)(4)(A) of the FD&C Act does not provide for a different
analysis for when an international border falls within the 275 miles;
thus, we tentatively conclude that international borders should not
affect the distance calculation. Thus, for example, a farm in Mexico
selling food to a restaurant or retail food establishment in the U.S.
that is within 275 miles of the farm could count that sale as a sale to
a qualified end user. As another example, the same would also be true
for a U.S. farm selling food to a restaurant or retail food
establishment in Mexico that is within 275 miles of the farm. Finally,
we also note that the requirements related to distance (in the same
state or within 275 miles of the farm) only apply to restaurants and
retail food establishment customers, and not to consumers. Thus, a farm
may count any sale directly to a consumer as a sale to a qualified end-
user.
We propose to define ``raw agricultural commodity (RAC)'' to mean
``raw agricultural commodity'' as defined in section 201(r) of the FD&C
Act. We propose to include this reference to the FD&C Act definition to
provide additional clarity regarding the meaning of this term.
We propose to define ``reasonably foreseeable hazard'' to mean a
potential hazard that may be associated with the farm or the food. We
provide a proposed definition for this term as it is used in section
419(c)(1)(A) of the FD&C Act and reflected in several requirements
proposed in this rule. As noted in the discussion of the proposed
definition of ``hazard'' in this section, this definition would be
limited to biological hazards because those are the only hazards we are
currently proposing to address in this rule. We recognize that there
are other reasonably foreseeable hazards relevant to produce safety on
farm that would not be addressed in this proposed rule such as
chemical, physical, and radiological hazards (see section IV.B of this
document) and do not intend to suggest by this definition that such
hazards are not reasonably foreseeable. We request comment on whether
we should instead use the term ``reasonably foreseeable biological
hazards'' in this rule.
We propose to define ``sanitize'' to mean to adequately treat
cleaned food-contact surfaces by a process that is effective in
destroying vegetative cells of microorganisms of public health
significance, and in substantially reducing numbers of other
undesirable microorganisms, but without adversely affecting the product
or its safety for the consumer. This proposed definition is consistent
with the existing Sec. 110.3 definition for ``sanitize'' except that
we propose to include the term ``cleaned'' before ``food-contact
surfaces.'' It is well established that sanitizers can be inactivated
by organic material and, thus, are not effective unless used on clean
surfaces (Ref. 99). This proposed definition is consistent with the
definition of ``sanitize'' in Sec. 111.3.
We propose to define ``sewage sludge biosolids'' to mean the solid
or semi-solid residue generated during the treatment of domestic sewage
in a treatment works within the meaning of the definition of `sewage
sludge' in 40 CFR 503.9(w). This proposed definition is consistent with
that of the U.S. Environmental Protection Agency (EPA), which has
regulatory jurisdiction over treated domestic sewage and has
established terms to describe specific types of treated waste.
We propose to define ``soil amendment'' to mean any chemical,
biological, or physical material (such as elemental fertilizers, humus,
manure, non-fecal animal byproducts, peat moss, perlite, pre-consumer
vegetative waste, sewage sludge biosolids, table waste, agricultural
tea and yard trimmings) intentionally added to the soil to improve the
chemical or physical condition of soil in relation to plant growth or
to improve the capacity of the soil to hold water. This proposed
definition is consistent with commonly used definitions in industry
guidelines and marketing agreements (Ref. 46. Ref. 31). We also propose
to include within the meaning of ``soil amendment'' growth media that
serve as the entire substrate during the growth of covered produce
(such as mushrooms and some sprouts). While this inclusion is not
consistent with the common usage of the term, it provides convenience
since it is addressing the identical standards that we are proposing
for identical hazards that exist for such growth media and soil
amendments.
We propose to define ``spent sprout irrigation water'' to mean
water that has been used in the growing of sprouts. This definition is
intended to minimize the potential for confusion between spent sprout
irrigation water and water used for irrigation of other types of
covered produce.We are proposing to define ``static composting'' to
mean a process to produce humus in which air is introduced into
biological material (in a pile (or row) covered with at least 6 inches
of insulating material, or in an enclosed vessel) by a mechanism that
does not include turning. As proposed, examples of structural features
for introducing air would include embedded perforated pipes and a
constructed permanent base that includes aeration slots. As proposed,
examples of mechanisms for introducing air include passive diffusion
and mechanical means (such as blowers that suction air from the
composting material or blow air into the composting material using
positive pressure). The proposed definition derives from definitions
and explanations of ``static composting'' in documents such as prepared
by the U.S. EPA (Ref. 92), the Produce Safety Project Issue Brief on
Composting of Animal Manures (Ref. 27), and a report from the Food and
Agriculture Organization of the United Nations (Ref. 100).
We propose to define ``surface water'' to mean all water which is
open to the atmosphere and subject to surface runoff, including water
obtained from an underground aquifer that is held or conveyed in a
manner that is open to the atmosphere, such as in canals, ponds, other
surface containment or open conveyances. This proposed definition is
consistent with EPA's definition and with common usage of the term
``surface water'' (Ref. 101). We propose to define this term to
distinguish ``surface water'' from other water, such as water from an
underground aquifer that has not been held or conveyed in a manner open
to the environment (``ground water'') because there is a greater
likelihood that surface water could become contaminated, for example,
by surface runoff.
We propose to define ``table waste'' to mean any post-consumer food
waste, irrespective of whether the source material is animal or
vegetative in origin, derived from individuals, institutions,
restaurants, retail

[[Page 3549]]

operations, or other sources where the food has been served to a
consumer. This definition is intended to distinguish post-consumer food
waste from pre-consumer vegetative waste.
We propose to define ``turned composting'' to mean a process to
produce humus in which air is introduced into biological material (in a
pile, row, or enclosed vessel) by turning on a regular basis. Turning
is the process of mechanically mixing biological material that is
undergoing a composting process with the specific intention of moving
the outer, cooler sections of the material being composted to the
inner, hotter sections. The proposed definition is consistent with
definitions or explanations of ``windrow composting'' in documents
prepared by the U.S. EPA (Ref. 92. Ref. 91), the Produce Safety Project
Issue Brief on Composting of Animal Manures (Ref. 27), and a report
from the Food and Agriculture Organization of the United Nations (Ref.
100). We are proposing to use the term ``turned composting'' rather
than ``windrow composting'' so that the term describing this method
would not be limited to use in ``rows.''
We propose to define ``water distribution system'' to mean a system
to carry water from its primary source to its point of use, including
pipes, sprinklers, irrigation canals, pumps, valves, storage tanks,
reservoirs, meters, and fittings. The proposed definition would provide
a simple term to use when describing such systems.
We propose to define ``we'' to mean the U.S. Food and Drug
Administration.
We propose to define ``yard trimmings'' to mean purely vegetative
matter resulting from landscaping maintenance or land clearing
operations, including materials such as tree and shrub trimmings, grass
clippings, palm fronds, trees, tree stumps, untreated lumber, untreated
wooden pallets, and associated rocks and soils. This proposed
definition is consistent with a definition in State composting
regulations (Ref. 90), except that we are proposing to use the term
``yard trimmings'' rather than ``yard trash.'' We are proposing to use
the term ``yard trimmings'' to avoid potentially negative connotations
associated with the word ``trash,'' even though some components of our
proposed definition (e.g., untreated wooden pallets) arguably are not
``trimmings.'' We request comment on whether our proposed use of the
term ``yard trimmings'' is appropriate for the purpose of this rule, or
whether we should propose to use a term other than ``yard trimmings,''
such as ``yard trash'' or ``yard waste.''
We propose to define ``you'' to mean a person who is subject to
some or all of the requirements in this part.
c. Persons Subject to This Rule
Proposed Sec. 112.4(a) states that, except as provided in
paragraph (b) of that section, if you are a farm or farm mixed-type
facility with an average annual monetary value of food (as ``food'' is
defined in Sec. 112.3(c)) sold during the previous three-year period
of more than $25,000 (on a rolling basis), you are a ``covered farm''
subject to this part; however, specific exemptions and partial
exemptions apply. If you are a covered farm subject to this part, you
must comply with all applicable requirements of this part when you
conduct a covered activity on covered produce. We are proposing to
apply this proposed rule only to farms and farm mixed-type facilities
with an average annual monetary value of food (as ``food'' is defined
in Sec. 112.3(c)) sold during the previous three-year period of more
than $25,000 (on a rolling basis) because we have tentatively concluded
that farms with $25,000 or less in sales do not contribute
significantly to the produce market. Farms below the $25,000 limit
collectively account for only 1.5% of covered produce acres, suggesting
that they contribute little exposure to the overall produce
consumption. We note that such farms are and will continue to be
covered under the adulteration provisions and other applicable
provisions of the Federal Food, Drug, and Cosmetic Act and applicable
implementing regulations, irrespective of whether they are included
within the scope of this proposed rule.
As proposed, Sec. 112.4(a) would make clear that the rule applies
to both farms and farm mixed-type facilities, and that such entities
would be subject to the rule when they conduct a covered activity on
covered produce, as those terms are defined in proposed Sec. 112.3(c).
This would mean that, for example, a farm mixed-type facility that is a
covered farm and that grows, harvests, packs, and holds its own lettuce
would be subject to the proposed rule when conducting those activities
(unless an exemption applies, such as that in proposed Sec. 112.4(b)).
However, the covered farm would not be subject to the rule when
conducting other activities that are not covered activities, or when
conducting operations on food other than covered produce. For example,
if the farm mixed-type facility applied a manufacturing/processing step
(such as chopping) to its lettuce for distribution into commerce (i.e.,
not for consumption on the farm or another farm under the same
ownership, or for personal consumption), this would not be a ``covered
activity'' as that term is defined in proposed Sec. 112.3(c) and would
therefore not be subject to this rule. In proposed Sec. 112.4(b), we
propose to state that you are not a covered farm if you satisfy the
requirements in Sec. 112.5 and we have not withdrawn your exemption in
accordance with the requirements of subpart R of this part. This
implements section 419(f) of the FD&C Act and is discussed further
immediately below.
d. Qualified Exemptions
i. Criteria for Eligibility for a Qualified Exemption
Proposed Sec. 112.5(a) establishes the criteria for eligibility
for a qualified exemption and associated special requirements based on
average monetary value of all food sold and direct farm marketing. This
exemption is mandated by Section 419(f) of the FD&C Act. Except as
provided in Sec. 112.6, you would be exempt from all of the
requirements of this part, except proposed subparts except A, Q, and R,
in a calendar year if:
During the previous 3-year period preceding the applicable
calendar year, the average annual monetary value of the food you sold
directly to qualified end-users during such period exceeded the average
annual monetary value of the food you sold to all other buyers during
that period (Sec. 112.5(a)(1)); and
The average annual monetary value of all food you sold
during the 3-year period preceding the applicable calendar year was
less than $500,000, adjusted for inflation (Sec. 112.5(a)(2)).
Proposed Sec. 112.5(b) provides that, for the purpose of
determining whether the average annual monetary value of all food sold
during the 3-year period preceding the applicable calendar year was
less than $500,000, adjusted for inflation, the baseline year for
calculating the adjustment for inflation is 2011. The conditions
related to average annual monetary value established in section
419(f)(1)(B) of the FD&C Act allow adjustment for inflation. To
establish a level playing field for all farms that may satisfy the
criteria for the qualified exemption, we are proposing to establish the
baseline year for the calculation in proposed Sec. 112.5(a)(2). We are
proposing to establish 2011 as the baseline year for inflation because
2011 is the year that FSMA was enacted into law.
Section 419(f) of the FD&C Act does not specifically target
arrangements such as community-sponsored agriculture (CSA), you-pick
operations,

[[Page 3550]]

or farmers markets. It does seem likely that many such operations will
meet the criteria for qualified exemption. Each such operation would
need to analyze its sales under the terms of Sec. 112.5 to determine
its eligibility for the qualified exemption. For example, if a you-pick
operation has an average annual monetary value of food sold during the
relevant 3-year period of less than $500,000, and all of its sales were
to individuals who come to the farm to pick their own produce, all of
its sales would be sales to consumers (who are qualified end-users,
regardless of location) for the purpose of determining the proportion
of the sales that are to qualified end-users. In this example, the you-
pick farm would be eligible for the qualified exemption. As another
example, if a CSA farm has an average annual monetary value of food
sold during the relevant 3-year period of less than $500,000; and 25%
of the monetary value of its sales comes from sales to individual
consumers enrolled in the CSA, 50% of the monetary value of its sales
comes from sales to restaurants in the same state as the farm, and 25%
of the monetary value of its sales comes from sales to other buyers who
are not qualified end-users; the CSA farm would be eligible for the
qualified exemption. In this example, the CSA farm's sales to qualified
end-users (consumers and in-state restaurants) make up 75% of the
average annual monetary value of food sold, so the value of the farm's
sales to qualified end-users exceed the value of its sales to all other
buyers during the relevant time period.
ii. Applicable Requirements for Qualified Exemptions
Proposed Sec. 112.6 establishes the requirements that apply to you
if you are eligible for a qualified exemption in accordance with Sec.
112.5. Proposed Sec. 112.6(a) explains that subparts A, Q, and R
remain applicable to those who qualify for a qualified exemption under
Sec. 112.5. This is because subpart A contains this provision and
other general provisions such as definitions, Subpart Q contains
provisions related to compliance and enforcement, and subpart R
contains provisions necessary to implement section 419(f)(3) of the
FD&C Act, as discussed further in section V.R. of this document.
Consistent with section 419(f)(2) of the FD&C Act, proposed Sec.
112.6(b) establishes the modified requirements (label or point of
purchase display) applicable to those who meet the requirements under
Sec. 112.5 for a qualified exemption.
Specifically, proposed Sec. 112.6(b)(1) would require that, when a
food packaging label is required on food that would otherwise be
covered produce under the FD&C Act or its implementing regulations, you
include prominently and conspicuously on the food packaging label the
name and complete business address of the farm where the produce was
grown. Proposed Sec. 112.6(b)(2) requires that, when a food packaging
label is not required on food that would otherwise be covered produce
under the FD&C Act, you prominently and conspicuously display, at the
point of purchase, the name and complete business address of the farm
where the produce was grown. As proposed, the name and address of the
farm must be displayed on a label, poster, sign, placard, or documents
delivered contemporaneously with the produce in the normal course of
business, or, in the case of Internet sales, in an electronic notice.
That is, if a label is otherwise required on the produce that would
otherwise be covered (for example, tomatoes in a ``clam shell''
package) then the label must include the name and business address of
the farm where the produce was grown. If a label is not required (for
example, unpackaged tomatoes) then the name and business address of the
farm where the produce was grown must be displayed at the point of
purchase (such as on a poster, for example). These proposed provisions
reflect our interpretation of section 419(f)(2)(A)(i) and (ii) as
applying only to food that would otherwise be covered produce but for
the qualified exemption. We tentatively conclude that this
interpretation is reasonable because applying these consumer
notification requirements to food that would not otherwise be covered
produce would mean applying requirements to food that bears no
relationship to the subject of this rulemaking (e.g., to milk from a
farm that also grows and harvests produce and that meets the criteria
for the qualified exemption from this proposed rule).
Proposed 112.6(b)(3) states that the complete business address that
you must include in accordance with the requirements of paragraph
(b)(1) or (2) of this section must include the street address or post
office box, city, state, and zip code for domestic farms, and
comparable full address information for foreign farms. Proposed Sec.
112.6(b)(3) would enable consumers to contact the farm where the food
that would otherwise be covered produce was grown (e.g., if the
consumer identifies or suspects a food safety problem with a the
produce) irrespective of whether the produce bears a label. The use of
the term ``business address'' in section 419(f)(2)(A) of the FD&C Act
contrasts with Congress' use of a different term, ``place of
business,'' in section 403(e) of the FD&C Act (21 U.S.C. 343(e)).
Section 403(e) provides that foods in package form are misbranded
unless the product label bears the name and place of business of the
manufacturer, packer, or distributor of the food. Our regulations
interpret ``place of business'' as requiring only the firm's city,
state, and zip code to appear on the product label, as long as the
firm's street address is listed in a current telephone directory or
other city directory (21 CFR 101.5(d)). We tentatively conclude that
the use of the term ``business address'' in section 419(f)(2)(A)
demonstrates Congress' intent to require the farm's full address,
including the street address or P.O. box, to appear on labels or other
required notifications when the farm qualifies for the exemption in
section 419(f) of the FD&C Act. If Congress had considered the less
complete address already required under section 403(e)(1) of the FD&C
Act and the ``place of business'' labeling regulation (Sec. 101.5(d))
to be adequate for notification to consumers for foods required to bear
labels, there would have been no need to impose a new, more specific
requirement in section 419(f)(2)(A)(1) for the farm's ``business
address'' to appear on the food label. Requiring the complete business
address for this purpose is consistent with our guidance to industry on
the labeling of dietary supplements as required by the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (Ref. 103).
When proposed Sec. 112.5(b) would apply to a food for which a food
packaging label is required under any other provision of the FD&C Act,
the complete business address would substitute for the ``place of
business'' required under section 403(e)(1) of the FD&C Act and 21 CFR
101.5(d) and would not impose any requirement for a label that would be
in addition to any label required under any other provision of the FD&C
Act. We seek comment on the feasibility of the labeling provisions in
proposed 112.6(b), particularly in the case of consolidating produce
from several farm locations.
Section 419 of the FD&C Act does not explicitly require farms that
meet the criteria for the qualified exemption to establish and maintain
documentation of the basis for their exemption. FDA considers that it
may be necessary for farms to maintain such records, and to allow FDA
access to such records upon

[[Page 3551]]

request, in order to efficiently enforce section 419 of the FD&C Act.
Otherwise we would have no way to determine whether a farm claiming the
qualified exemption actually met the criteria for that exemption. This
could be important, for example, if a farm claiming the qualified
exemption is directly linked to a foodborne illness outbreak during an
active investigation or if FDA determines, based on conduct or
conditions associated with the farm that are material to the safety of
the food produced or harvested at such farm, that it is necessary to
protect the public health and prevent or mitigate a foodborne illness
outbreak to withdraw the farm's qualified exemption (see section V.R.
of this document discussing proposed subpart R). Because the withdrawal
procedure in proposed subpart R would only apply to farms that are
eligible for the qualified exemption, we would need to know whether the
farm is indeed eligible for the exemption in order to select the
appropriate and efficient enforcement strategy. We request comment on
whether we should require farms to be able to provide adequate
documentation, as needed, to demonstrate the basis for the qualified
exemption. Specifically, we request comment on whether we should do
this by requiring records to be established and maintained in
accordance with the requirements of proposed subpart O, or if there is
an alternative strategy by which we could require retention of and
access to such records (such as by requiring farms only to retain
records kept in the normal course of their business bearing on the
criteria for the qualified exemption that they use to determine their
eligibility and requiring FDA access to such records upon request).

B. Subpart B--General Requirements

As proposed, subpart B discusses the general requirements
applicable to persons who are subject to this part and alternatives
from the requirements established in this part that would be permitted,
under specified conditions.
1. Comments Relevant to Proposed Provisions
We received several comments in response to the 2010 FR notice that
addressed issues relevant to the general requirements established in
this subpart of the rule. A consumer organization urged FDA to take
additional steps to ensure the safety of bagged salads and all leafy
greens. Some comments recommended that FDA include in this rule an
amendment mechanism that can expeditiously accommodate new scientific
knowledge.
Section 402 of the FD&C Act specifies conditions under which a food
is deemed adulterated, including if the food bears or contains any
added poisonous or deleterious substance which may render it injurious
to health (402(a)(1)); if it is unfit for food (402(a)(3)); or if it
has been prepared, packed, or held under insanitary conditions whereby
it may have become contaminated with filth, or whereby it may have been
rendered injurious to health (402(a)(4)). In proposed Sec. 112.11, we
would specifically require that covered farms take appropriate measures
to minimize the risk of serious adverse health consequences or death
from the use of, or exposure to, covered produce, including those
measures reasonably necessary to prevent the introduction of known or
reasonably foreseeable hazards into covered produce as well as to
provide reasonable assurances that the produce is not adulterated under
section 402 of the FD&C Act on account of such hazards. Such hazards
would include all pathogens to the extent that they pose a risk of
serious adverse health consequences or death, including Salmonella and
E. coli O157:H7, in all covered produce raw agricultural commodities,
including leafy greens. With respect to bagged salads, we note that
such salads are manufactured in facilities that are required to
register with us and, therefore, would be covered under section 418 of
the FD&C Act and any regulations promulgated pursuant to that
authority, rather than by this proposed rulemaking.
We recognize the value in making this regulation flexible, where
appropriate, to accommodate future changes in science and technology.
In proposed Sec. 112.12, we list the specific requirements established
in this rule for which we believe alternatives may be appropriate and
the circumstances under which such alternatives could be used. In
addition, consistent with section 419(c)(2) of the FD&C Act, in
proposed subpart P, we provide for a mechanism by which a State or a
foreign country from which food is imported into the United States may
request a variance from one or more requirements proposed in this part,
where the State or foreign country determines that: (a) The variance is
necessary in light of local growing conditions; and (b) the procedures,
processes, and practices to be followed under the variance are
reasonably likely to ensure that the produce is not adulterated under
Section 402 of the Act and to provide the same level of public health
protection as the requirements of this part (see section V.P. of this
document). We also intend to publish guidance, as appropriate, to
provide updates on current thinking with respect to best practices in
produce safety.
2. Proposed Requirements
a. General Requirements Applicable to Persons Subject to This Part
As proposed, Sec. 112.11 establishes the general requirements
applicable to persons who are subject to this rule. Proposed Sec.
112.11 requires that you take appropriate measures to minimize the risk
of serious adverse health consequences or death from the use of, or
exposure to, covered produce, including those measures reasonably
necessary to prevent the introduction of known or reasonably
foreseeable hazards into covered produce, and to provide reasonable
assurances that the produce is not adulterated under section 402 of the
FD&C Act on account of such hazards.
This provision is consistent with the requirements of section
419(c)(1)(a) of the FD&C Act, which mandates, in relevant part, that we
publish regulations that ``set forth those procedures, processes, and
practices that the Secretary determines to minimize the risk of serious
adverse health consequences or death, including procedures, processes,
and practices that the Secretary determines to be reasonably necessary
to prevent the introduction of known or reasonably foreseeable
biological, chemical, and physical hazards, including hazards that
occur naturally, may be unintentionally introduced, * * * into fruits
and vegetables, * * * and to provide reasonable assurances that the
produce is not adulterated under section 402.'' As discussed in section
IV.B. of this document, we have tentatively concluded that this rule
should focus solely on biological hazards.
In subparts C to O, we propose science-based minimum standards
related to the growing, harvesting, packing, and holding of covered
produce that we believe are necessary to minimize the risk of serious
adverse health consequences or death by preventing the introduction of
hazards and providing reasonable assurances that the covered produce is
not adulterated.
Proposed Sec. 112.11 would require, for example, that whenever a
standard specified in this part is not met, you would take those steps
reasonably necessary to identify and evaluate the cause of the problem
and ensure that it is rectified. Accurate identification of

[[Page 3552]]

the cause of the failure is critical to the success of any potential
corrective actions. For example, if your employees are having
difficulty identifying covered produce that should not be harvested due
to potential contamination, you might initially think the answer is to
provide more frequent training; however upon investigation, you may
discover that the actual cause of the problem is that your employee
training program is providing inaccurate information. In this case, to
correct the problem, you would need to fix your training program.
Promptly taking such follow-up actions once the cause of the problem
has been identified is necessary to minimize the risk of serious
adverse health consequences or death from the use of, or exposure to,
your covered produce and to provide reasonable assurances that the
product is not adulterated under section 402 of the FD&C Act.
In addition, proposed Sec. 112.11 would require you to take
appropriate measures to minimize risks of serious adverse health
consequences or death from the use of, or exposure to, covered produce
that may arise unexpectedly and therefore not be reflected in a
specific standard set forth in proposed subparts C to O of this rule.
For example, in the event of an unexpected event, such as receipt of
information suggesting that your covered produce from a particular
field is adulterated because it bears or contains a pathogen that may
render the produce injurious to health, proposed Sec. 112.11 would
require you to take appropriate measures to minimize the risk of
serious adverse health consequences or death from the use of, or
exposure to, your covered produce by preventing the introduction of
biological hazards into or onto your produce or by taking measures to
provide reasonable assurances that the produce is not adulterated under
section 402 of the FD&C Act. Such measures might include, for example,
conducting a root cause investigation to try to determine the source of
the contamination, making appropriate changes to your conditions and
practices suggested by the root cause investigation, including to
produce in other fields, as appropriate, determining the extent of the
impact of the root cause (i.e., within the suspect field and in other
fields), and excluding adulterated produce from commerce. We note,
however, that we do not intend for proposed Sec. 112.11 to suggest
that you would need to take measures to exclude animals from outdoor
growing areas, to destroy animal habitats near your outdoor growing
areas, to clear farm borders around outdoor growing areas or drainages,
or to take any action that would violate applicable environmental laws
or regulations.
We propose to include proposed Sec. 112.11 in order to account for
the variety of possible circumstances that might arise in which an
unexpected circumstance or unique farm characteristics would justify
preventive measures to prevent introduction of hazards or provide
assurances against adulteration in order to minimize the risk of
serious adverse health consequences or death. We request comment on
this approach, and on whether we should instead establish specific
standards for any types of hazards that would be covered in proposed
Sec. 112.11 but for which we have not proposed specific standards in
proposed subparts C through O.
b. Alternatives to Certain Requirements
As proposed, Sec. 112.12 allows for the use of alternatives to
certain requirements of this part. Subparagraph (a) lists the specific
requirements for which alternatives may be considered provided you are
in compliance with subparagraphs (b) and (c), which describe the
conditions for use of an alternative. Proposed Sec. 112.12(b) states
that you may establish and use an alternative to any of the
requirements listed in paragraph (a), provided you have adequate
scientific data or information to support a conclusion that the
alternative would provide the same level of public health protection as
the applicable requirement established in this part (including meeting
the same microbiological standards, where applicable) and would not
increase the likelihood that your covered produce will be adulterated
under section 402 of the FD&C Act, in light of your covered produce,
practices, and conditions, including agro-ecological conditions and
application interval. We do not propose to require you to submit such
scientific data or information to us for review or approval prior to
marketing. However, we would require that you maintain a record of any
such scientific data or information, including any analytical
information, and make such data and information available to us to
evaluate upon request.
Proposed Sec. 112.12(c) clarifies that the scientific data and
information used to support an alternative to a requirement may be
developed by you, available in the scientific literature, or available
to you through a third party, and further provides that documentation
of such data and information must be established and maintained in
accordance with the requirements of subpart O of this part. As
discussed in section II.E.4. of this document, FDA is collaborating
with partners on research that may provide scientific support for
specific alternatives to certain of these requirements. FDA intends to
issue guidance on specific alternatives that it may identify as meeting
the requirements of the rule in order to assist farms in complying with
the final rule. For example, a farm that applies crop protection sprays
to the harvestable portion of crops (i.e., application of water
containing crop protection substances using a direct water application
method) several days before the crop is harvested using a water source
that does not meet the requirements of Sec. 112.44(c) (i.e, EPA
generic E. coli ``recreational water'' standard), may use an
alternative measure provided by their Cooperative Extension agent, for
example, as long as the measure is based on scientifically sound data
and meets the conditions described above (i.e., provides the same level
of public health protection as the applicable requirement and does not
increase the likelihood that covered produce will be adulterated). For
example, the study might demonstrate that the quality of water used for
direct application method irrigation is not important as long as there
are at least two days between application and harvest, or that water of
some lesser standard than that in Sec. 112.44(c) could safely be
applied immediately before harvest. The farm operator would maintain a
copy of the information provided by the agent as documentation that the
alternative measure was based on sound science. When FDA becomes aware
of such information, it is our intention to include it in guidance, so
that farm operators can also rely on FDA guidance for such alternative
measures.
As proposed in Sec. 112.12(a), you may establish alternatives to
the following requirements:
(1) The requirements in Sec. 112.44(c), for testing water, and
taking action based on test results, when agricultural water is used
during growing operations for covered produce (other than sprouts)
using a direct water application method;
(2) The composting treatment processes required in Sec.
112.54(c)(1) and (2);
(3) The minimum application interval established in Sec.
112.56(a)(1)(i) for an untreated biological soil amendment of animal
origin; and
(4) The minimum application interval established in Sec.
112.56(a)(4)(i) for a biological soil amendment of animal origin
treated by a composting process.

[[Page 3553]]

Under proposed Sec. 112.12(a)(1), you may establish an alternative
to the requirements, established in proposed Sec. 112.44(c) for
testing water, and taking action based on test results when
agricultural water is used during growing operations for covered
produce (other than sprouts) using a direct water application method.
Under proposed Sec. 112.44(c), you must test the quality of water you
use during growing activities for covered produce (other than sprouts)
in accordance with one of the appropriate analytical methods in
proposed subpart N. If you find that there is more than 235 CFU (or
MPN, as appropriate) generic E. coli per 100 ml for any single sample
or a rolling geometric mean (n=5) of more than 126 CFU (or MPN, as
appropriate) per 100 ml of water, you must immediately discontinue use
of that source of agricultural water and/or its distribution system for
the uses described in that paragraph and before you may use the water
source and/or its distribution system again for those uses, you must
either: (1) Re-inspect the entire agricultural water system under your
control, identify any conditions that are reasonably likely to
introduce known or reasonably foreseeable hazards into or onto covered
produce or food-contact surfaces, make necessary changes, and retest
the water to determine if your changes were effective, or (2) treat the
water in accordance with the requirements of Sec. 112.43. As discussed
in section V.E. of this document, we considered several factors and
ultimately determined that the microbial standard in proposed Sec.
112.44(c), which is based on certain aspects of U.S. EPA's recreational
water standards is appropriate for the uses of agricultural water
covered by proposed Sec. 112.44(c). We seek comment on this approach.
However, we acknowledge that in specific circumstances an
alternative standard (e.g., a standard that applies an application
interval (time between application and harvest) in place of the
112.44(c) water standard, but is limited to a specific commodity or
commodity group and region) may be appropriate if the alternative
standard is shown to provide the same level of public health protection
as the standard in proposed Sec. 112.44(c) and not to increase the
likelihood that the covered produce will be adulterated. For example,
we are working with USDA and other stakeholders to facilitate research
into application intervals that would be commodity- and region-
specific, such that water not meeting the proposed Sec. 112.44(c)
standard could be used in a direct water application method for growing
covered produce other than sprouts as long as it was applied before the
start of the scientifically established application interval (i.e., at
a certain number of days before harvest or earlier). Therefore, we
tentatively conclude that it would be appropriate to allow for
alternatives to the requirements in proposed Sec. 112.44(c).
Under proposed Sec. 112.12(a)(2), you may establish an alternative
to the treatment processes, established in proposed Sec. 112.54(c)(1)
and (2), for composting, provided you comply with Sec. 112.54(c)(3).
The processes established in Sec. 112.54(c)(1) and (2) as
scientifically valid controlled composting processes demonstrated to
satisfy the microbial standard in Sec. 112.55(b) for Salmonella and
for fecal coliforms are: (1) Static composting that maintains aerobic
(i.e., oxygenated) conditions at a minimum of 131 [deg]F (55 [deg]C)
for 3 days and is followed by adequate curing, which includes proper
insulation; and (2) Turned composting that maintains aerobic conditions
at a minimum of 131 [deg]F (55 [deg]C) for 15 days, with a minimum of
five turnings, and is followed by adequate curing, which includes
proper insulation. We tentatively conclude that it would be appropriate
to allow for the use of other static or turned composting protocols
that maintain conditions for a combination of temperatures and time
other than the temperature and times specified in proposed Sec. Sec.
112.54(c)(1) and (2), and is followed by adequate curing, which
includes proper insulation, if they achieve the same level of pathogen
reduction (i.e., meet the microbial standard in Sec. 112.55(b)). In
this sense, the microbial standards would provide a performance
standard; practices that meet this objective measure would be
acceptable. It would be your responsibility to consider the moisture
content, pH, carbon to nitrogen ratio (C:N), feedstock, and any other
appropriate consideration needed during composting to adequately
achieve the microbial standards of proposed Sec. 112.55(b).
Under proposed Sec. 112.12(a)(3), you may establish an alternative
to the minimum application interval of nine (9) months, established in
proposed Sec. 112.56(a)(1)(i), for an untreated biological soil
amendment of animal origin that is reasonably likely to contact covered
produce after application or for a compost agricultural tea that
contains compost agricultural tea additives. As discussed in section
V.F of this document, we have tentatively concluded that, under certain
circumstances, the application interval in Sec. 112.56(a)(1)(i) may be
more than what is necessary for minimizing the likelihood that covered
produce that is grown in soils amended with an untreated biological
soil amendment, and is reasonably likely to contact the soil after
application, pose to the public health. These circumstances could
include differences in likelihood of contamination posed by the
specific feedstock, application method or treatment method, especially
given the potential for new innovations in such methods.
Under proposed Sec. 112.12(a)(4), you may establish an alternative
to the minimum application interval of 45 days, established in proposed
Sec. 112.56(a)(4)(i), for a biological soil amendment of animal origin
treated by a composting process in accordance with the requirements of
proposed Sec. 112.54(c) that satisfies the microbial standard in
proposed Sec. 112.55(b), and that is reasonably likely to contact
covered produce after application. As discussed in section V.F. of this
document, we are proposing a multiple-hurdle approach to minimizing the
likelihood of contamination by addition of an application interval of
45 days to any biological soil amendment of animal origin treated by
composting that is reasonably likely to contact covered produce after
application. This time period has been shown to be effective when the
population of the pathogen is minimal (Ref. 104) as can be expected of
a fully composted biological soil amendment of animal origin. This
multiple hurdle approach and time interval has also been utilized in
current industry standards for leafy greens (Ref. 31). We seek comments
on this proposal. We have also tentatively concluded that, under
certain circumstances, the application interval in Sec.
112.56(a)(4)(i) may be more than what is necessary for minimizing the
likelihood of contamination of covered produce that is grown in soils
amended with a treated biological soil amendment, and that is
reasonably likely to contact the soil after application. These
circumstances could include differences in likelihood of contamination
posed by the specific feedstock, application method or treatment
method, especially given the potential for new innovations in such
methods.
As noted above, in any use of alternatives permitted in Sec.
112.12(a)(1) through Sec. 112.12(a)(4), in accordance with proposed
Sec. 112.12(b), you would be required to have adequate scientific data
or information to support a conclusion that the alternative would
provide the same level of public health protection as the requirement
specified

[[Page 3554]]

in the proposed rule and would not increase the likelihood that your
covered produce will be adulterated under section 402 of the FD&C Act.
Further, in accordance with proposed Sec. 112.12(c), you must
establish and maintain documentation of such scientific data or
information, which may be developed by you, available in the scientific
literature, or available to you through a third party. We are working
with USDA and other stakeholders to conduct research on relevant
alternative practices and intend to make the results of that research
available in the future. We seek comment on whether we should require
you to notify FDA of your conclusion to establish or use an alternative
that is permitted under Sec. Sec. 112.12(a)(1) through (a)(4), and
whether we should require you to submit relevant scientific data or
information to FDA as part of such a notification.

C. Subpart C--Standards Directed to Personnel Qualifications and
Training

As proposed, subpart C discusses minimum standards directed to
personnel qualifications and training that are reasonably necessary to
minimize the risk of serious adverse health consequences or death from
the use of, or exposure to, covered produce, including those reasonably
necessary to prevent the introduction of known or reasonably
foreseeable hazards into covered produce, and to provide reasonable
assurances that the covered produce is not adulterated under section
402 of the FD&C Act.
1. Comments Related to Proposed Provisions
We received several comments in response to the 2010 FR notice that
addressed issues relevant to personnel qualifications and training.
Several comments expressed concern over language and educational
barriers greatly impeding the farm's ability to effectively fulfill the
training requirements for their field workers. They also stressed the
need for far reaching, accurate, consistent, and well-rounded training
programs with skilled trainers providing the same information to
growers, processors and distributors. Comments further suggested that
training materials should have addendums to reflect the differences
among the varied growing regions, commodities, and production practices
and processes, as well as train-the-trainer programs for individuals
responsible for training farm workers. Many firms also urged
organizations, universities, and extension agencies to share
experiences and to provide resources for worker training. Several
comments pointed out difficulties in training due to the transient or
short term nature of farm workers and due to the seasonal relocation of
their operations. In addition, comments expressed concern over the cost
of implementation, including regular refresher courses and training
materials, and the reliability of third-party training materials. One
comment requested that individuals responsible for the training program
and materials should ensure that curricula are updated to reflect any
new scientific information.
We believe that adequate and appropriate training of personnel who
handle covered produce or food-contact surfaces, or who are engaged in
the supervision thereof, is an essential component of standards for
produce safety. Regardless of the nature of the farm workers, we
propose that they must receive training upon hiring, at the beginning
of each growing season, and with periodic updates as necessary in order
to prevent contamination of covered produce. Farm workers need to know
how to recognize potential contamination problems (e.g., a leafy green
vegetable contaminated with manure) and to be trained to know what to
do when those situations present themselves. The farm worker is a key
component in the food chain for ensuring the safety of covered produce.
No matter the transient nature, any worker can be a potential pathway
for contamination of produce during growing, harvesting, packing, and
holding (e.g., because of hygiene issues or illness) or fail to
identify a situation that may result in contamination of the covered
produce being grown, harvested, packed, or held if they are not
cognizant of proper food safety procedures and standards. It is not
uncommon for workers to change based on season and location and,
therefore, proposed Sec. 112.21(a) would require personnel to receive
training upon hiring and at the beginning of each growing season (if
applicable). Proposed Sec. 112.21(a) would also require that personnel
receive periodic updates as a way of reminding them of the proper
procedures including any changes in those procedures. Such updates may
not require full training sessions, but only short descriptive sessions
to ensure that all personnel remain aware of all procedures necessary
to maintain the safety of produce.
Together with the USDA, Cornell University's National GAPs program,
the Association of Food and Drug Officials (AFDO), and the National
Association of State Departments of Agriculture (NASDA), we have formed
the Produce Safety Alliance (PSA), which is a public-private
partnership established to provide educational outreach assistance to
fresh produce growers and packers. This program is in the process of
creating training materials that will be both region- and commodity-
specific. We expect these materials to be standardized, multi-
formatted, and multi-lingual, and available in pictorial format to help
overcome literacy issues. Specific focus areas for the PSA include GAPs
and co-management education and outreach efforts for produce farmers
and packers, with special emphasis on small-scale operations. This
alliance will also include a train-the-trainer lesson plan and an
education outreach program delivery for farmers, trainers, and
regulators. We intend to explore the need for additional such
partnerships, as appropriate, to address any commodity-specific needs
for outreach and assistance. We welcome comments and suggestions for
training development strategies.
2. Proposed Requirements
Proposed Sec. 112.21 would establish requirements for the
qualifications and training for personnel who handle (contact) covered
produce or food-contact surfaces, or who are engaged in the supervision
thereof. Having personnel follow proper food hygiene practices,
including personal health and hygiene, can reduce the potential for on-
farm contamination of covered produce. Educating personnel who conduct
covered activities in which they contact covered produce and
supervisors about food hygiene, food safety, and the risks to produce
safety associated with illnesses and inadequate personal hygiene is a
simple step that can be taken to reduce the likelihood of pathogens
being spread from or by personnel to covered produce.
Most current FDA, private and international guidelines for the
produce industry include provisions related to training food handlers
in the importance of personal health and hygiene to food safety (Ref.
10. Ref. 20. Ref. 50. Ref. 48. Ref. 96. Ref. 26). As described in the
QAR, FDA's follow-up farm investigations in response to outbreaks and
contamination events identified poor worker health and hygiene, unsafe
produce handling and storage practices, and specifically poor training
in these areas, as likely contributing factors to these events. This
information reinforces the importance of training farm personnel,
including supervisors, in food hygiene, food safety, employee health
and personal hygiene.

[[Page 3555]]

Proposed Sec. 112.21(a) would require that all personnel
(including temporary, part time, seasonal and contracted personnel) who
handle (contact) covered produce or food-contact surfaces and their
supervisors receive training that is appropriate to the person's
duties, upon hiring, at the beginning of each growing season (if
applicable), and periodically thereafter. Because ensuring that covered
produce is not contaminated is dependent on personnel following proper
food safety and hygiene practices, all personnel who contact covered
produce and food-contact surfaces must receive training when hired,
before they participate in the growing, harvest, packing or holding of
covered produce in which they contact covered produce, and must be
periodically reminded about the need to follow these practices through
refresher training. When a farm hires workers after the beginning of a
growing season, these workers would need to be trained upon hiring.
Because the farm does not employ these workers at the beginning of the
first growing season, the requirement for training at the beginning of
each growing season would not be applicable to those workers until the
beginning of the next growing season, if they are still employed by the
farm at that time. Managers and supervisors must have the necessary
knowledge of food safety and hygiene principles and practices to be
able to assess whether their staff are following appropriate practices,
and take the necessary action to remedy any deficiencies, which could
include on-the-spot training for their staff.
Periodic refresher training for all relevant personnel, including
managers and supervisors, is necessary to ensure continual awareness of
important food safety and hygiene principles. It is also important when
new information is available about practices that may contribute to
foodborne illness or when, for that reason or other reasons, changes in
the farm's procedures are put in place. For example, during the past
decade several segments of the produce industry reviewed and revised
their industry guidelines or developed new guidelines to address
current food safety concerns relative their specific commodity (i.e.,
lettuce, tomatoes, sprouts, and cilantro).
Proposed Sec. 112.21(b) would require that all personnel
(including temporary, part time, seasonal and contracted personnel) who
handle (contact) covered produce or food-contact surfaces and their
supervisors have the training, in combination with education or
experience, to perform the person's assigned duties in a manner that
ensures compliance with this part. Proposed Sec. 112.21(b) would
provide flexibility for how personnel become qualified to perform their
assigned duties by recognizing multiple pathways to obtain the
necessary qualifications: Training (such as training provided on-the-
job), in combination with education, or experience (e.g., work
experience related to an employee's current assigned duties). The
standards in subparts C through O often involve action by farm
personnel (e.g., monitoring of animal intrusion, inspecting
agricultural water system) that require specific knowledge, skills and
abilities, without which the standard could not be properly achieved.
Proposed Sec. 112.21(b) requires that those farm personnel have the
training so that they will have the necessary knowledge, skills, and
abilities to perform their duties.
Proposed Sec. 112.21(c) would establish requirements for training
to be conducted in a manner that is easily understood by personnel
being trained. The goals of training cannot be achieved if the person
receiving the training cannot understand it. Training could be
understood by personnel being trained if, for example, it was conducted
in the language that employees customarily speak and at the appropriate
level of education. In some cases in may be necessary to use easily
understood pictorials or graphics of important concepts (Ref. 105).
Proposed Sec. 112.21(d) would establish requirements for training
to be repeated as necessary and appropriate in light of observations or
information indicating that personnel are not adequately meeting
standards established by FDA in subparts C through O of the rule. The
goals of training are not achieved if the persons receiving the
training do not correctly implement those standards taught. Moreover,
repeated training as proposed in Sec. 112.21(d) is necessary when an
employee that does not follow the correct food safety protocol, because
such behavior may increase the likelihood of introducing a food safety
hazard to covered produce. When an employee requires additional
training, it may consist of informal on-the-spot instruction to focus
on those measures not being adequately implemented as opposed to more
comprehensive training. For example, if you observe an employee commit
a minor error, such as an inappropriate method for recording monitoring
information in a log, an appropriate action could be to show the
employee the correct method of recording the information and contrast
this with the inappropriate method the employee had been using.
However, if an employee displays repeated mistakes or a fundamental
misunderstanding of the correct procedures for handling covered
produce, an appropriate action may be to have the employee repeat
relevant training, or to attend a comprehensive training course. If you
conclude that the employee may not have the skills to conduct certain
covered activities, an appropriate action may be to train the employee
for new responsibilities that are more suitable to his or her skills.
Proposed Sec. 112.22(a) would require that, at a minimum, all
personnel who handle (contact) covered produce during covered
activities must receive training that would include: (1) Principles of
food hygiene and food safety (proposed Sec. 112.22(a)(1)); (2) the
importance of health and personal hygiene for all personnel and
visitors, including recognizing symptoms of a health condition that is
reasonably likely to result in contamination of covered produce or
food-contact surfaces with microorganisms of public health significance
(proposed Sec. 112.22(a)(2)); and (3) the standards as applicable to
the employee's job responsibilities, including those established by FDA
in subparts C through O of this part (proposed Sec. 112.22(a)(3)).
We tentatively conclude that the broad topic areas addressed in
proposed Sec. 112.22(a) are those minimum topic areas necessary to be
covered during training for all employees who handle (contact) covered
produce. Training in the principles of food hygiene and food safety are
necessary to provide an overall framework for job performance. Training
in health, hygiene, and disease control can teach workers how to
minimize the likelihood of transferring pathogens to covered produce.
These topics are covered in several currently used guidance documents
(Ref. 10. Ref. 20. Ref. 50. Ref. 48. Ref. 96). In addition, training in
the specific standards established in subparts C through O of this part
which are necessary for the employee to use during the course of their
duties will increase the likelihood that those standards will be
implemented correctly and effectively. We seek comments on the scope,
frequency, and methods outlined in the proposed training sections of
the proposed rule.
Proposed Sec. 112.22(b) would require that persons who conduct
covered harvest activities for covered produce also receive training
that includes all of the following: (1) Recognizing covered produce
that should not be harvested, including covered produce that may be
contaminated with known or reasonably

[[Page 3556]]

foreseeable food safety hazards (proposed Sec. 112.22(b)(1)); (2)
inspecting harvest containers and equipment to ensure that they are
functioning properly, clean, and maintained so as not to become a
source of contamination of covered produce with known or reasonably
foreseeable food safety hazards (proposed Sec. 112.22(b)(2)); and (3)
correcting problems with harvest containers or equipment, or reporting
such problems to the supervisor (or other responsible party), as
appropriate to the person's job responsibilities (proposed Sec.
112.23(b)(3)).
We tentatively conclude that the topic areas addressed in proposed
Sec. 112.22(b), in addition to Sec. 112.22(a), are those minimum
topic areas necessary to be covered during training for persons who
conduct harvest activities. Harvest workers need to learn how to
recognize produce that should not be harvested (such as rotten or
decayed fruit, ``drops,'' or harvestable items that have been
contaminated with feces), because not harvesting such covered produce
would be the first opportunity to prevent that produce from entering
commerce, and as a practical matter may be the only such opportunity
(for example, during a field-pack operation with no subsequent culling
stage). Proposed Sec. 112.112 would require that farms take all
measures reasonably necessary to identify and not harvest covered
produce that is visibly contaminated with animal excreta.
Harvest workers must be trained to both recognize this condition
and to avoid harvesting covered produce that exhibits the condition.
Harvest workers also need to know how to inspect harvest containers and
equipment to ensure that they are functioning properly, clean, and
maintained so that they will not act as a source of contamination or
lead to damage of covered produce (damaged produce is more likely to
harbor pathogens, and at a greater population, than is sound produce
(Ref. 59. Ref. 106)). Harvest workers also need to know how to correct
problems with harvest equipment or containers when they encounter them,
or need to know that they should report such problems to someone who
would be responsible for ensuring that the problem is corrected. These
topics are covered in several currently used relevant documents (Ref.
8. Ref. 33. Ref. 18. Ref. 89. Ref. 84). We acknowledge the challenge
these training requirements may pose to farms that employ contracted
harvest crews. In such cases, we expect that the harvest crew company
could provide the required training to workers, who move from farm to
farm under the employment of the harvest crew company. Farms on which
such harvest crews work could request certification from the harvest
crew company that their workers have received the required training. We
seek comment on the feasibility of the proposed training requirements,
particularly with respect to harvest activities.
Proposed Sec. 112.22(c) would require that at least one supervisor
or responsible party for your farm successfully complete food safety
training at least equivalent to that received under standardized
curriculum recognized as adequate by the Food and Drug Administration.
Experience at farming does not necessarily convey knowledge of food
safety, particularly that of microbial food safety hazards, and
therefore specialized training is needed to address the specific
concerns of on-farm food safety. The purpose of training a supervisor
or other responsible party is so that person can help train other
employees, recognize conditions that could lead to contamination of
covered produce, and take action to correct those conditions. As
discussed in section II.D. of this document, FDA has, together with
USDA AMS, established the jointly funded PSA, a public-private
partnership that will develop and disseminate science- and risk-based
training and education programs to provide produce growers and packers
with fundamental, on-farm food safety knowledge, starting in advance of
this proposed rule and continuing after the final regulation is
promulgated. A first phase of PSA's work is intended to assist growers,
especially small growers, in establishing food safety programs
consistent with the GAPs Guide and other existing guidances and
requirements so that they will be better positioned to comply with a
final produce rule. As this rulemaking progresses, FDA will work to
ensure that the PSA materials are modified, as needed, to be consistent
with the requirements of this rule. Included in that material will be
the standardized curriculum against which FDA intends to compare other
training programs. After reviewing the final draft of the PSA training
materials, FDA intends to publish a notice of availability of the
documents in the Federal Register. We would encourage trainers outside
the PSA to evaluate their courses, past, present, and future, against
the PSA materials when they become available and to modify or adapt
curricula, where necessary, to ensure that they are consistent with,
and provide at least an equivalent level of instruction to, the
Alliance course. We have no plans to publish a list of ``approved''
courses other than the Alliance course materials. Proposed Sec. 112.23
would require that you assign or identify personnel to supervise (or
otherwise be responsible for) your operations to ensure compliance with
the requirements of the rule. Oversight by a qualified individual is
essential to the effective implementation of the rule. Under proposed
Sec. 112.23, the personnel that you assign or identify to supervise
(or otherwise be responsible for) your operations may be a single
person (including yourself), or may be a team of individuals, each with
specific areas of responsibility (e.g., you may assign or identify
separate persons to be responsible for your water distribution system,
your harvest activities, your sanitary accommodations, and your packing
activities).
Proposed Sec. 112.30(a) would require that you establish and keep
records required under subpart C in accordance with the requirements of
subpart O of the rule. Proposed Sec. 112.30(b) would require that you
establish and keep records that document required training of
personnel, including the date of the training, the topics covered, and
the person(s) trained. An example of records that would comply with
proposed Sec. 112.30(b) is an attendance sheet with the date, list of
those in attendance, and the particular topics covered (such as proper
hand washing or how to collect samples for water testing). The records
required by proposed Sec. 112.30(b) would enable you to track the
training personnel receive, thereby enabling you to identify personnel
and training topics for periodic updates and personnel that have the
prerequisite training for assignment to certain responsibilities. Such
records would enable you to document that a person has, as would be
required under proposed Sec. Sec. 112.21(a) and (b), successfully
completed training as appropriate to the person's duties, upon hiring
and periodically thereafter, including the principles of food hygiene
and food safety and also the training that would be specific to a
person's tasks and responsibilities.

D. Subpart D--Standards Directed to Health and Hygiene

As proposed, subpart D discusses science-based minimum standards
directed to health and hygiene that are reasonably necessary to
minimize the risk of serious adverse health consequences or death from
the use of, or exposure to, covered produce, including those reasonably
necessary to prevent the introduction of known or

[[Page 3557]]

reasonably foreseeable hazards into covered produce, and to provide
reasonable assurances that the produce is not adulterated under section
402 of the FD&C Act.
1. Comments Relevant to Proposed Provisions
We received some comments in response to the 2010 FR notice that
addressed issues relevant to health and hygiene. Several comments noted
the challenges of enforcing use of gloves and clean clothes. Others
expressed concerns related to identifying sick employees who could
contaminate covered produce or food-contact surfaces, while another
comment asked about potential requirements on hygienic practices and
questioned whether hand jewelry could contaminate produce such as leafy
greens.
We recognize the importance of taking appropriate measures to
prevent sick or infected persons from contaminating covered produce or
food-contact surfaces. In proposed Sec. 112.22(a)(2), we propose to
require training of personnel to recognize symptoms of a health
condition that is reasonably likely to result in contamination of
covered produce or food-contact surfaces with microorganisms of public
health significance. The proposed requirements for standards directed
to health and hygiene focus on maintaining adequate personal
cleanliness. Gloves can provide a barrier to reduce the potential for
contamination; however, gloves themselves can transfer pathogens to
covered produce if they become contaminated. Therefore, while we are
not proposing to require the use of gloves, we are proposing to require
the proper use of gloves when workers wear them (proposed Sec.
112.32(b)(4)). Clothes should be adequately clean if by virtue of type
of operation the workers are performing, the clothes could potentially
contaminate covered produce with pathogens.
2. Proposed Requirements
Proposed subpart D would require that you take those measures that
we tentatively conclude are reasonably necessary to prevent personnel
and visitors from introducing known or reasonably foreseeable hazards
into or onto covered produce or food-contact surfaces. As discussed
above (see sections I.A. of this document, and QAR), people can carry a
wide variety of pathogens (including hepatitis A virus, Salmonella, E.
coli O157:H7, Shigella, Cyclospora, and Cryptosporidium (Ref. 93) (Ref.
107). Bacteria, viruses, and parasites are frequently transmitted from
person to person and from person to food, particularly through the
fecal-oral route (Ref. 95. Ref. 96. Ref. 97. Ref. 98. Ref. 93). Several
of the provisions of proposed subpart D are similar to requirements in
our Current Good Manufacturing Practice regulations for food and for
dietary supplements (Sec. 110.10 and 111.10, respectively), and to
provisions in our GAPs Guide (Ref. 10), the AFDO Model Code (Ref. 20),
various produce industry guidelines (Ref. 46. Ref. 44), a marketing
agreement (Ref. 31), and international guidelines (Ref. 96).
Proposed Sec. 112.31 would require that you take measures
necessary to prevent ill or infected persons from contaminating covered
produce with microorganisms of public health significance. Proposed
Sec. 112.31(a) would require that you take measures to prevent
contamination of covered produce and food-contact surfaces with
microorganisms of public health significance from any person with an
applicable health condition (such as communicable illnesses that
present a public health risk in the context of normal work duties,
infection, open lesion, vomiting, or diarrhea).
Proposed Sec. 112.31(b)(1) would require that you exclude any
person from working in any operations that may result in contamination
of covered produce or food-contact surfaces with microorganisms of
public health significance when the person (by medical examination, the
person's acknowledgement, or observation (for example, by a supervisor
or responsible party)) is shown to have, or appears to have, an
applicable health condition, until the person's health condition no
longer presents a risk to public health. Applicable health conditions
would not include non-communicable diseases such as cancer, diabetes,
or high blood pressure, or non-communicable conditions such as
pregnancy, which would not present a likelihood of contamination to
covered produce or food contact surfaces. For example, if an employee
tells you that his or her physician has diagnosed that the employee has
a fever, and the employee normally handles your covered produce, you
must take steps to ensure that the employee does not come into contact
with your covered produce because the fever may suggest that the
employee has an infection and there is a reasonable possibility of
contamination. Likewise, if you see that an employee has an open wound
or sore, and the employee normally handles covered produce, you must
take steps to ensure that he or she is excluded from handling covered
produce if the wound could be a source of microbial contamination.
Proposed Sec. 112.31(b)(1) is similar to requirements in current
Sec. Sec. 110.10(a) and 111.10(a) and to provisions in our GAPs Guide
(Ref. 10), the AFDO Model Code, various produce industry guidelines
(Ref. 89. Ref. 84. Ref. 99), and a marketing agreement (Ref. 31), and
the Codex Code (Ref. 96).
Proposed Sec. 112.31(b)(2) would require that you instruct your
personnel to notify their supervisor(s) (or a responsible party) if
they have, or if there is a reasonable possibility that they have, an
applicable health condition. Consistent with the training requirement
proposed in Sec. 112.22(a)(2), we are proposing this requirement as a
measure specifically directed at preventing sick or infected persons
from contaminating covered produce or food-contact surfaces and to
emphasize that individual workers have a responsibility--every day--to
take action to prevent contamination due to their own illness or
infection. In a small or very small business, such as a farm largely
operated by a husband and wife, the impact of proposed Sec.
112.31(b)(2) would, in essence, be for a sick worker to take
appropriate steps to exclude himself or herself from working in any
operations that may result in contamination of covered produce or food-
contact surfaces with pathogens. Proposed Sec. 112.31(b)(2) is similar
to requirements in current Sec. Sec. 110.10(a) and 111.10(a) and to
provisions in the AFDO Model Code (Ref. 20), and a produce industry
guideline ( (Ref. 46). We seek comments on the notification and other
proposed requirements related to workers health.
Proposed Sec. 112.32 would require that personnel use certain
hygienic practices. Proposed Sec. 112.32(a) would require that
personnel who work in an operation in which covered produce or food-
contact surfaces are at likelihood of contamination with known or
reasonably foreseeable hazards use hygienic practices while on duty to
the extent necessary to protect against such contamination. Hygienic
practices can prevent introduction of microbial (such as bacteria and
viruses that could be present in saliva or on skin) contamination of
covered produce (Ref. 108). Inadequate hygienic practices among workers
have been associated with outbreaks transmitted by various produce
commodities, including strawberries, green onions, mamey, leaf lettuce,
and basil (Ref. 107). Proposed Sec. 112.32(a) is similar to
requirements in current Sec. Sec. 110.10(b) and 111.10(b) and to
provisions in our GAPs Guide (Ref.

[[Page 3558]]

44), the AFDO Model Code (Ref. 20), various produce industry guidelines
(Ref. 46. Ref. 44), a marketing agreement (Ref. 31), and the Codex Code
(Ref. 96).
Proposed Sec. 112.32(b) would require that personnel who handle
(contact) covered produce use specific hygienic practices to satisfy
the requirements of proposed Sec. 112.32(a). Proposed Sec.
112.32(b)(1) would require the specific practice of maintaining
adequate personal cleanliness to protect against contamination of
covered produce and food-contact surfaces. Requiring that workers
maintain adequate personal cleanliness is similar to requirements in
current Sec. Sec. 110.10(b) and 111.10(b) and to provisions in the
Codex Code (Ref. 96). We would expect that maintaining adequate
personal cleanliness would include wearing adequate outer garments as
necessary and appropriate to protect against contamination of covered
produce and food-contact surfaces. Outer garments (e.g., smocks,
aprons, or coveralls worn over a worker's personal clothing) may be
necessary and appropriate when a worker conducts an activity that has
increased potential to contaminate the worker's personal garments with
hazards that could be transferred to covered produce or food-contact
surfaces during subsequent activities in which the worker may contact
covered produce. For example, a worker's personal clothing could become
contaminated with pathogens while a worker shovels manure, and such
contamination could be transferred from the clothing to covered produce
if the worker subsequently harvests covered produce wearing the same
clothes. An apron, smock, or coverall worn over the worker's personal
clothing while shoveling the manure could simply be removed before the
worker moves on to a harvest activity, which would reduce the
likelihood of contaminating covered produce during the subsequent
harvest activity. We intend to provide further information about
adequate worker personal cleanliness in guidance.
Proposed Sec. 112.32(b)(2) would require that personnel avoid
contact with animals other than working animals, and that personnel in
direct contact with working animals take appropriate steps to minimize
the likelihood of contamination of covered produce. Pathogens can be
directly transmitted from animals to people when persons touch, pet,
feed, or are licked by animals because animal hair, fur, saliva and
skin can harbor pathogens (Ref. 98. Ref. 99. Ref. 100). For example,
transmission of the pathogen Giardia lamblia from animals to humans was
linked to an outbreak of foodborne illness associated with consumption
of contaminated produce (Ref. 109).
Proposed Sec. 112.32(b)(3) would require that personnel wash hands
thoroughly, including scrubbing with soap and running water that
satisfies the requirements of Sec. 112.44(a) (as applicable) for water
used to wash hands, and that personnel dry hands thoroughly using
single-service towels, clean cloth towels, sanitary towel service or
other adequate hand drying devices on specified occasions. Those
specified occasions include before starting work; before putting on
gloves; after using the toilet; upon return to the work station after
any break or other absence from the work station; as soon as practical
after touching animals (including livestock and working animals) or any
waste of animal origin; and at any other time when the hands may have
become contaminated in a manner that is reasonably likely to lead to
contamination of covered produce with known or reasonably foreseeable
hazards. Under proposed Sec. 112.32(b)(3), we would not expect workers
to immediately stop work and wash their hands each time hands become
soiled during the usual course of farm work with dirt or plant litter.
However, we would expect workers to have sufficient training to
recognize potential sources of hazards and to wash their hands when
appropriate. We tentatively conclude that proposed Sec. 112.32(b)(3)
provides sufficient flexibility for operations to provide running water
in a manner best suited to the conditions of use. For example, water
can be supplied by a Public Water System, private well, or other source
satisfying the requirements of Sec. 112.44(a) through plumbed
connections to building faucets (e.g., inside a packing house) to
supply running water throughout the facility. Alternatively, water
supplied from sources above and used to fill clean, portable water
containers suited to field use (such as a carboy, tank, water buffalo,
or similar container) fitted with a valve, spout, or spigot such that
water released passes over the hands also can provide adequate running
water for washing hands. Under proposed Sec. 112.44(a), with certain
exceptions set forth in proposed Sec. 112.45, you must test the
quality of water used for hand washing during and after harvest to
ensure that there is no detectable generic E. coli (see section V.E. of
this document).
Workers often touch produce with their bare hands, and the produce
covered by this rule would not necessarily have a ``kill step'' to
adequately reduce pathogens that could be transmitted through bare-hand
contact. Hand-washing, when done effectively, can eliminate both
resident bacterial contamination (such as on the hands of a worker who
may not realize he is ill or infected) and transient microbial
contamination (such as bacteria, viruses, and parasites that gets onto
hands through contact with the environment) (Ref. 110). As a result,
hand-washing is a key control measure in preventing contamination of
covered produce and food-contact surfaces (Ref. 26). The effectiveness
of hand-washing is determined by multiple factors, including whether or
not soap is used, the quality of water used, the duration of scrubbing
and rinsing, and whether hands are dried. Soap serves as an emulsifier
that enables dirt and oil to be suspended and washed off (Ref. 110).
Rinsing hands without using soap, and not drying hands after washing,
can promote the spread of microorganisms. For example, rinsing hands
without using soap can loosen microorganisms without removing them,
leaving the microorganisms more readily transferable to the next
surface touched (Ref. 110). An investigation in follow-up to an
outbreak of foodborne illness caused by E. coli O157:H7 in Florida
found an association between illness and visits to fairs where visitors
came in contact with animals, and found that persons who washed their
hands with soap and water had a decreased likelihood of illness (Ref.
111). Drying hands is important because wet skin is more likely to
transmit microorganisms than dry skin (Ref. 110). In addition, hand-
drying has been demonstrated to remove bacteria from the hands and
decrease ``touch-contact-associated bacterial transfer'' after hand-
washing (Ref. 112). Proposed Sec. 112.32(b)(3) does not prohibit use
of hand sanitizers as a part of the hand washing process. However, our
review of hand washing indicates that soap and water are far more
effective than sanitizers in removing pathogens. The effectiveness of
hand sanitizers has been shown to be highly dependent upon the removal
of organic material from the hands prior to their use, as the presence
of dirt, grease, or soil significantly reduces their effectiveness in
eliminating bacteria on hands (Ref. 107).
Proposed Sec. 112.32(b)(3) is similar to provisions in our GAPs
Guide (Ref. 10), the AFDO Model Code (Ref. 20), various produce
industry guidelines (Ref. 89. Ref. 84. Ref. 99), a marketing agreement
(Ref. 31), and the Codex Code (Ref. 96). Several differences exist
between proposed Sec. 112.32(b)(3) and analogous provisions in current
Sec. Sec. 110.10(b) and 111.10(b). For example, proposed

[[Page 3559]]

Sec. 112.32(b) would not specify, in addition to the requirements for
hand washing, that hands also be sanitized if necessary to protect
against microbial contamination, while both Sec. Sec. 111.10(b) and
111.10(b) have such a requirement. We tentatively conclude that the
circumstances where use of a hand sanitizer as an additional measure to
reduce likelihood of contamination with pathogens would be limited on a
farm. Hand sanitizers are less likely to be effective on a farm than in
a processing plant, since growers' hands are more likely to get dirty
during production on a farm and the resulting presence of organic
material on the hands would impede the effectiveness of hand sanitizers
(Ref. 113).
In addition, proposed Sec. 112.32(b)(3)(v) would specifically
require washing hands after touching animals, a requirement that is not
included in current Sec. 110. We are proposing this requirement here
because contact with animals is more likely to happen on a farm. In
addition, the National Association of State Public Health Veterinarians
has recommend washing hands after touching animals as a protection
against outbreaks of E. coli O157:H7, Salmonella Enteritidis,
Cryptosporidium parvum, non-O157 STEC, Salmonella typhimurium, and
Campylobacter jejuni (Ref. 111).
Proposed Sec. 112.32(b)(3) also would repeat some of the
characteristics of an adequate hand-washing facility specified in
proposed Sec. 112.130 (i.e., soap, running water of specified
microbial quality, and adequate drying devices). Currently, in our CGMP
regulation for food facilities, Sec. 110.37(e) identifies examples of
how to achieve compliance with the requirements for an adequate hand-
washing facility, but it does not repeat them in the requirement in
Sec. 110.10(b) regarding workers washing their hands. In proposed
Sec. 112.32(b)(3) (and in proposed Sec. 112.130), we are proposing to
identify specific characteristics of an adequate hand-washing facility
because many of these facilities are likely to be in outdoor growing
areas and be portable. Standard features that we have come to expect as
a matter of course in a hand-washing facility in a building used for
manufacturing/processing food may not be standard in a portable hand-
washing facility. Moreover, the outdoor nature of many areas where
covered activities take place naturally presents workers with
situations where they will get dirt on their hands, and workers may be
routinely handling food, with their bare hands, that will not be cooked
to adequately reduce pathogens. Therefore, we believe it is appropriate
to repeat these requirements in the proposed provisions for workers to
wash their hands as well as in the proposed provisions directed to
hand-washing facilities. We seek comment on the hand-washing proposals
described above.
Proposed Sec. 112.32(b)(4) would require that, if you choose to
use gloves in handling covered produce or food-contact surfaces, you
maintain gloves in an intact and sanitary condition, and that you
replace such gloves when you are no longer able to do so. We are not
proposing to require the use of gloves, but gloves are used in many
operations to protect workers' hands. While gloves also provide a
barrier that can reduce the potential for pathogens on workers' hands
to contaminate covered produce, gloves themselves, whether re-usable or
disposable, can transfer pathogens to covered produce if the gloves
become contaminated (Ref. 26). If gloves are used in handling covered
produce or food contact surfaces, requiring that such gloves be either
in an intact and sanitary condition, or else be replaced, reduces the
potential for the gloves to be a source of contamination for covered
produce. Proposed Sec. 112.32(b)(4) is similar to requirements in
current Sec. Sec. 110.10(b) and 111.10(b). Our GAPs Guide (Ref. 10),
various produce industry guidelines (Ref. 89. Ref. 84. Ref. 99) and the
Codex Code (Ref. 96) include specific provisions directed to the use of
gloves. The AFDO Model Code (Ref. 20) and a marketing agreement (Ref.
31) direct farms to establish policies to ensure proper use of gloves.
It has been reported that glove use can foster a ``false sense of
security'' that can lead to less sanitary practices such as wearing the
same pair of gloves for extended periods of time without cleaning them,
or washing hands infrequently (Ref. 114). If your workers wear gloves,
you should ensure that they know that wearing gloves in no way
diminishes the importance of washing hands, and that gloves must be
maintained and replaced, when necessary and appropriate.
Proposed Sec. 112.33 would require that you take measures to
prevent visitors from contaminating covered produce and food-contact
surfaces with microorganisms of public health significance. Proposed
Sec. 112.33(a) would define a visitor as any person (other than
personnel) who enters your covered farm with your permission. Proposed
Sec. 112.33(b) would require that you make visitors aware of policies
and procedures to protect covered produce and food-contact surfaces
from contamination by people, and that you take all steps reasonably
necessary to ensure that visitors comply with such policies and
procedures. Proposed Sec. 112.33(c) would require that you make toilet
and hand-washing facilities accessible to visitors. In contrast to food
processing facilities, on-farm visitors often enter areas where covered
produce is grown and harvested, particularly on farms that offer
consumers an opportunity to pick their own fruits and vegetables. As
with workers, visitors can transmit pathogens to covered produce and
food-contact surfaces. Thus, we are proposing to require that farms
address the potential for visitors to contaminate covered produce, even
though we have no similar requirements in regulations such as parts 110
and 111. Proposed Sec. 112.33 is similar to provisions in our GAPS
Guide (Ref. 10), the AFDO Model Code (Ref. 20), various produce
industry guidelines (Ref. 89. Ref. 84. Ref. 99), a marketing agreement
(Ref. 31), and the Codex Code (Ref. 96). A farm could comply with these
proposed requirements by, for example, indicating the location of
restrooms and hand-washing facilities accessible to visitors and
clearly posting rules applicable to visitors where they are likely to
be seen and read at the beginning of a visitor's visit, such as near
the entrance or cash register at a ``pick-your-own'' farm operation.

E. Subpart E--Standards Directed to Agricultural Water

As proposed, subpart E discusses science-based minimum standards
directed to agricultural water that are reasonably necessary to
minimize the risk of serious adverse health consequences or death from
the use of, or exposure to, covered produce, including those reasonably
necessary to prevent the introduction of known or reasonably
foreseeable hazards into covered produce, and to provide reasonable
assurances that the produce is not adulterated under section 402 of the
FD&C Act.
1. Comments Relevant to Proposed Provisions
We received some comments in response to the 2010 FR notice that
addressed issues relevant to agricultural water. Several comments
expressed concern that our proposed regulations could have an adverse
effect upon or be in conflict with on-farm conservation or land
management practices efforts; or that they could set standards for
limiting all animal access to surface waters (e.g., by fencing or other
barrier) or prohibit vegetation (normally used to stabilize soil or for
use as a natural water filter) surrounding surface water sources.

[[Page 3560]]

In developing the provisions in proposed part 112, we consulted
with USDA's National Organic Program and Natural Resources Conservation
Service, U.S. Fish and Wildlife Service, and the EPA (Ref. 115) to take
into consideration conservation and environmental practice standards
and policies established by those agencies. We recognize the importance
of ensuring, to the extent possible, that our proposed provisions are
compatible with existing conservation practices in the management of
agricultural water systems. In proposed Sec. 112.42(a)(1)-(5), we
would require that you inspect your entire agricultural water system at
the beginning of every growing season, focused on identifying
conditions that are reasonably likely to introduce known or reasonably
foreseeable hazards into or onto covered produce or food-contact
surfaces. A similar (re)inspection would be required in proposed
Sec. Sec. 112.44(b) and (c) if the water you use for certain purposes
does not meet the microbiological criteria described in those
provisions. In each of these provisions, however, we do not describe
specific inspection findings likely to adversely affect microbial water
quality and relate them to specific required actions. For example, we
do not propose that vegetation surrounding an on-farm pond be cut back
and/or removed or that fencing must be used to prevent access to a pond
by wildlife and domestic animals. We recognize that each farm, State,
region, or produce commodity group may approach water management
differently with respect to the likelihood of contamination of
agricultural water and the use of specific conservation practices that
may be appropriate or consistent with measures used to mitigate the
likelihood of contamination. Practices used for one region or commodity
may not be appropriate for others based upon historical experience.
Under this proposed subpart, we would require that you address such
issues only if they are reasonably likely to contribute to
contamination of covered produce, and we would provide flexibility in
the way in which you address any identified hazards, such that measures
you implement to mitigate such hazards can be consistent with your
current conservation practices. This approach allows you to put in
place measures you deem most effective in addressing the potential for
water contamination and to assess the effectiveness of those measures
as they may be reflected in your microbial water quality data.
We also received a number of comments expressing concern about
costs and associated burden related to testing of agricultural water,
including pathogen testing, indicators, and frequency of testing. As
described in section in the QAR, pathogen presence and distributions in
the environment and water systems can be expected to be sporadic, with
survival dependent on a multitude of factors. Thus, broad
generalizations concerning their presence or persistence in water or on
produce are problematic, and their detection difficult. Therefore,
rather than testing for the presence or levels of various pathogenic
microorganisms, we propose to use a microbial indicator as a monitoring
measure to assess the potential for contamination. After considering
various microbial indicators of water quality (see section V.E.2. of
this document), we tentatively conclude that generic Escherichia coli
(E. coli) is best suited for this purpose. It can be found in at least
90 percent of all human and animal feces (Ref. 116) and is most closely
associated with incidents of fecal contamination (Ref. 107. Ref. 108.
Ref. 109. Ref. 110. Ref. 108. Ref. 111. Ref. 112). There are multiple
test methods, commercial kits, and formats available at relatively low
cost, and the accuracy, precision, and sensitivity of these analytical
testing options would meet the requirements in this proposed rule.
Although the correlation between generic E. coli and fecal
contamination is strong, as discussed in section V.E.2. of this
document, generic E. coli does not always reliably predict the presence
of pathogens despite fecal pollution being a known source of pathogenic
microorganisms. This is explainable, however, considering the current
understanding of pathogen occurrence and distribution described in the
QAR and the taxonomic diversity of waterborne pathogens (e.g.,
bacteria, viruses, and protists). Thus, generic E. coli monitoring
serves as a measure to assess the potential for fecal contamination,
not to directly predict the presence of pathogens.
Comments also emphasized that microbial testing should be performed
at a frequency dependent upon the results of an assessment of the risks
posed by your agricultural water system. We agree that the frequency
should reflect the risk. In proposed Sec. 112.45(a), with certain
exceptions, we propose to require you to test water used for certain
purposes at the beginning of each growing season, and every three
months thereafter during the growing season. We tentatively conclude
that this frequency would provide sufficient information regarding the
microbial quality of your agricultural water. We are proposing in
addition in Sec. 112.45(b) that untreated surface waters must be
tested more frequently than ground water sources because surface
watersheds are subject to a greater number of external forces that
shape their overall composition, chemistry, and microbial water quality
(e.g., erosion, run-off, dust, suspended sediments). We seek comment on
our proposed approach.
A number of comments related to quantifying risks associated with
the use of agricultural water as a function of water source, time of
application, irrigation method, and commodity type. Our research shows
that this is an extremely difficult task. In the QAR, we considered
various factors relevant to produce production and harvesting,
including water sources and use (See the QAR document). Some
conclusions related to likelihood of produce contamination associated
with water use can be drawn, although the relevance of these findings
and whether they can be generalized across commodities, regions, and
climates is not known. For example, Stine et al (2005) (Ref. 109) and
Song et al. (2006) (Ref. 117) provide strong evidence that subsurface
drip irrigation lowers the likelihood of waterborne contamination
compared to furrow or overhead irrigation. These authors also suggest
that proximity of the edible portion relative to water applied and
surface texture of the edible portion play key roles in likelihood of
contamination.
In addition, according to a WHO risk assessment (Ref. 118) of
wastewater use in agriculture, pathogen (bacteria, protists, and
viruses) die-off during the interval between last irrigation and
consumption is approximately 1 log per day, although the rate varies
with climatic conditions. Other measures that can be protective include
cessation of watering, choice of irrigation method (localized
irrigation--bubbler, drip, trickle is more protective than flood,
furrow, or spray/sprinkler), and food preparation measures (washing)
(Ref. 118). It is difficult to determine to what extent this assessment
can be applied to water systems that are not based on wastewater use
where high pathogen loads can be expected. Produce grown with water of
significantly higher water quality continues to be implicated in
disease outbreaks (Ref. 119). These outbreaks not only illustrate the
challenge in assigning absolute risk reduction values to measures used
in the mitigation of risk, but also the sporadic nature of pathogen
occurrence and localized conditions leading to the persistence of
pathogens in the environment.

[[Page 3561]]

A few comments recommended that equipment used to hold or convey
water should be inspected to ensure that it is clean.
We agree that equipment used to hold or convey water should be
maintained in a manner necessary to protect against contamination. In
proposed 112.42(c), we propose to require that all agricultural water
distribution systems must be adequately maintained as necessary and
appropriate to prevent the water distribution system from being a
source of contamination to covered produce, food-contact surfaces,
areas used for a covered activity, or water sources, including by
regularly inspecting and adequately storing all equipment used in the
system. In addition, in proposed 112.42(b), we propose to require that
all agricultural water sources that are under the control of a covered
farm (such as wells) must be adequately maintained by regularly
inspecting each source and keeping the source free of debris, trash,
domesticated animals, and other possible sources of contamination of
covered produce to the extent practicable and appropriate under the
circumstances.
We seek comment on our proposals and approach related to
agricultural water.
2. Water Quality Testing, Indicators, and Standards
In this subsection, we present a technical discussion of issues
related to water quality such as testing samples, microbial quality
indicators, and microbial quality standards. We discuss these issues in
greater detail in this subsection to further support the provisions
proposed below related to water quality testing and microbial
indicators.
A fundamental component in assessing the adequacy of water for its
intended use is a routine sampling and microbial testing program (Ref.
120. Ref. 29). Water sampling and testing allows for informed decisions
regarding the management of water use, such as choosing a water source
and combining that selection with, for example, the irrigation method
for a specific commodity or time period prior to harvest. Testing for
microbial quality of water can identify possible fecal contamination at
the water source or in a section of its distribution system (e.g., line
break). Additionally, regular testing data may be used to identify
seasonal (or other) trends and highlight areas of the system that may
require attention. For example, regular testing results may show that
periodic increases in indicator organisms are correlated with
precipitation levels or suspended sediments in surface waters,
providing useful information about when and how that water source can
be safely used.
Microbial water quality testing can be performed using a variety of
methods that have been validated for water testing. A key element of
any testing program is determining the indicator organism or specific
pathogen(s) and the frequency of testing. The sensitivity of the method
is also important, although most test methods available today have
sensitivities that match or exceed requirements for EPA drinking water
and FDA bottled water standards.
Surface water quality and pathogen monitoring studies reported in
the literature often quantify indicator organisms or pathogens on a
monthly basis. However, most studies do not specifically address the
impact of water quality on produce safety (Ref. 115. Ref. 116. Ref.
117. Ref. 118). A lack of consensus among the different recommendations
and approaches underscores the complexity and uncertainty in water
quality sampling and testing strategies. Nevertheless, a vast majority
of studies that address frequency of testing recommend that surface
water sources should be sampled more frequently than ground water
sources (Ref. 121).
Two key determinants of an appropriate testing frequency emerge
from this information: (1) Variability of the water source and (2) the
extent to which it can be protected. The discussion above suggests that
water obtained from a public water source is least likely to be a
vehicle for pathogen contamination of produce, followed by water
obtained from deep underground aquifers, shallow wells, and surface
waters, in that order. This is consistent with findings reported in the
literature (Ref. 122. Ref. 29). For purposes of defining likelihood of
contamination, we further divide surface water into two types, based on
the potential for contamination (through runoff), and the degree to
which potential contamination can be recognized and controlled (i.e.,
(1) surface waters where runoff is difficult to recognize and control
because of the size of the watershed (e.g., river or lake) and (2)
surface waters where runoff can be easily detected and which can be
managed so as to protect them from runoff (e.g., on-farm reservoir or
pond)). Runoff is used here in differentiating the likelihood of
contamination of surface water because it has the potential to carry
pathogens and is known to mobilize pathogens from sediment reservoirs
to the water column (Ref. 117. Ref. 120. Ref. 121. Ref. 122. Ref. 123)
as well as carry pathogens to the surface water system from sources
such as failing septic systems and deposited animal feces (Ref. 123.
Ref. 124).
a. Microbiological Indicators of Water Quality
A primary consideration in establishing a microbiological water
quality testing program is the choice of target organism(s). Two
general approaches are commonly used: Test for the presence of an
indicator organism(s) that may signal the presence of pathogens or test
for pathogens themselves. In the United States, bacterial indicators
have a long history of being used to demonstrate the safety of drinking
water and adequacy of its treatment at the source. They have also been
used to monitor the status of drinking water in distribution systems
and determine if surface waters are microbiologically safe for
recreational use (e.g., swimming) and shellfish harvest (Ref. 123).
Bacterial fecal indicators are non-pathogenic microorganisms that
are commonly found in the intestines of warm-blooded animals that are
easily isolated and quantified as a measure of fecal contamination and
potential for enteric pathogens. Desired characteristics for effective
indicator organisms include: Ease of detection; being present only when
fecal contamination or pathogens are present; and, being in numbers
that correlate with the amount of contamination, numbers of pathogens
and risk of illness. Survival times of indicator organisms in sediments
and in water should be equal (or greater) to those for pathogens and
their detection should be accomplished by simple, rapid methods at low
cost. Indicator microorganisms are widely used in water quality testing
because of their broad utility across many types of water but no single
indicator that is universally accepted (Ref. 123).
Pathogen detection has the obvious advantage of directly targeting
microorganisms in water that are a risk to public health. However,
sampling water for pathogens may present additional challenges,
including larger sample sizes to facilitate detection, inherently
higher costs, and the wide array of potential target pathogens (i.e.,
the presence or absence of one pathogen may not predict for the
presence or absence of other pathogens).
A number of indicator microorganisms have been used to predict the
presence of pathogens in water, with varying degrees of success. These
include total coliforms, fecal coliforms, enterococci, generic E. coli,

[[Page 3562]]

and coliphages. However, their presence does not always signal the
presence of pathogens and the absence in their detection is not
assurance that pathogens are absent (Ref. 126. Ref. 127. Ref. 128. Ref.
129. Ref. 130).
Consequently, Gerba (2009) (Ref. 120) suggested indicators be
defined by a purpose for which they are better suited instead as an
indicator for pathogens. For example, efficacy of treatment (e.g.,
public water systems) or integrity in manufacturing processes (e.g.,
bottled water) can be effectively monitored by total coliforms because
these environmental bacteria are not expected to survive the treatment
conditions or be introduced during the manufacturing process. Their
presence in treated municipal water or in bottled water may signal an
inadequate treatment or deficient manufacturing step meriting
investigation and subsequent corrective action to resolve the problems
identified. Another example is using fecal indicator bacteria (e.g.,
enterococci or generic E. coli) to assess the risk of gastrointestinal
illness (or other adverse health conditions) in marine and freshwater
swimmers, because their presence is statistically correlated to adverse
health outcomes in these groups (Ref. 119. Ref. 120). Generic E. coli
alone, as an easily distinguishable member of the fecal coliform group,
is more likely than the fecal coliform group as a whole to indicate
fecal pollution (Ref. 120). Used in this way, indicator organisms are
not used specifically to predict the presence of pathogens, but are
useful predictors of undesirable conditions (e.g., ineffective
treatment, defective manufacturing process, presence of fecal
material).
Total coliforms have frequently been used to assess water quality
of several different types of natural waters (e.g., freshwater and
marine) but their use for this purpose has decreased recently as they
have been found to be present in natural water both because of fecal
contamination and as natural environmental inhabitants. They are
regularly isolated from soil, plants, vegetables, and effluents from
agricultural and food industries but their presence does not reliably
signal a fecal contamination event (Ref. 131. Ref. 112). Fecal
coliforms share a similar problem. Fecal coliforms are coliforms that
are capable of growth at higher temperatures, conditions similar to
those which can be found in the mammalian gut. However, some of its
members (e.g., Klebsiella, Citrobacter, Enterobacter spp.) can normally
be found outside the intestine including soil, water, vegetation, fresh
vegetables, silage, insects, and many others (Ref. 124) and there is
ample evidence that they can grow and multiply there (Ref. 132. Ref.
133. Ref. 114. Ref. 123). This makes using fecal coliforms as
indicators for fecal contamination problematic, as it would be
difficult to separate increases in their numbers due to natural forces
(e.g., precipitation, erosion, wind, temperature) from increases due to
fecal contamination events.
Generic E. coli is a member of both the coliform and fecal coliform
groups but has been shown to more consistently be associated with fecal
contamination than other indicators (Ref. 134. Ref. 135. Ref. 133. Ref.
136. Ref. 137. Ref. 138. Ref. 112). It can be found in at least 90
percent of all human and animal feces (Ref. 108) (Ref. 116) where it
persists, more than other transient fecal coliforms (Ref. 125. Ref.
124). While its association with fecal contamination is very strong, it
has also been isolated from environments with no apparent fecal
contamination, including tropical watersheds (Ref. 126) and paper mill
effluents (Ref. 127). Outside of these findings, reports of generic E.
coli growth and proliferation outside the gut (e.g., in water) are
generally rare. Generic E. coli demonstrates variable survival times in
water but may only persist from 4 to 12 weeks at 15-18 degrees Celsius
(Ref. 116).
Generic E. coli has an extensive history of use as an indicator of
fecal contamination and is considered the best indicator for monitoring
water quality (Ref. 119). Its detection and enumeration can be
performed using a variety of commercial products at relatively low
cost. However, its ability to signal fecal contamination events is
dependent upon sampling frequency and location relative to the source
of contamination. Thus, instances of non-detection are not considered
confirmation of the absence of fecal contamination because sampling
frequency may not be adequate to detect events occurring over short
periods of time. Sampling results can only be considered snapshots of
water quality over time. Moreover, the fate and transport of generic E.
coli in watersheds may be different than other fecal constituents in
response to localized conditions (e.g., sunlight, temperature) (Ref.
128. Ref. 129. Ref. 130).
One challenge in using indicator organisms to predict water quality
is correlating information concerning their numbers to the presence or
absence of pathogens (as compared to the presence or absence of fecal
material). Although generic E. coli is recognized as a good indicator
of fecal contamination, pathogens are not always present in that fecal
material because their distribution and persistence is sporadic. As a
consequence, the record of generic E. coli as a predictor of pathogens
is mixed. The Canadian Federal-Provincial-Territorial Committee on
Drinking Water states generic E. coli is unsatisfactory in predicting
the presence of Giardia, Cryptosporidium, and enteric viruses (Ref.
119. Ref. 124) and Horman et al. 2004 (Ref. 131) found poor correlation
between generic E. coli and the presence of pathogens (Campylobacter
spp., Giardia spp., Cryptosporidium spp., and noroviruses) in Finnish
surface waters. However, they did conclude that the absence of generic
E. coli was a very strong predictor for the absence of pathogens. Duris
et al (2009) (Ref. 132) found generic E. coli inconsistently correlated
to genetic markers for generic E. coli O157 in Michigan and Indiana
river water but suggested the relationship could be strengthened by
increased sample size. Alternately, Wilkes et al., 2009 (Ref. 133)
reported generic E. coli concentrations were the best indicator of
pathogens (E. coli O157:H7, Salmonella spp., Campylobacter spp, Giardia
and Cryptosporidium) presence/absence in Canadian watersheds. Others
have noted that generic E. coli has a better record as an indicator for
Salmonella than for E. coli O157:H7 (Ref. 134). Review of these studies
illustrates the complexity of possible interactions between indicators
and pathogens in water, and their potential for separate fates within
those systems.
Studies relating indicators, pathogens, and the risks associated
with produce consumption are few and are complicated by the
relationships described above. Different survival profiles between
indicators and pathogens on produce may also affect risk. The World
Heath Organization (Ref. 118) proposed a set of pathogen reduction
measures that can be used alone or in combination to achieve a 6-7 log
pathogen reduction they determined necessary to meet health-based
targets. To verify the effectiveness of the measures, they recommend
monitoring generic E. coli levels in treatment effluents and in crops
at harvest. They noted that field pathogen die-off is variable (0.5-2
log per day), dependent on temperature, sunlight, crop type, time, and
other factors.
Produce contamination events that occur during growing, harvesting,
packing, or holding on farm are generally thought to occur
intermittently and at low doses. As a result, the detection of human

[[Page 3563]]

pathogens in contaminated produce using available testing methodologies
remains an arduous process. It is impractical to test 100% of the
product; therefore sampling plans to collect a statistically
significant subset must be devised. Unfortunately, although such
testing has in the past prevented some contaminated product from
entering the market when pathogens are found, it is also very possible
that testing can entirely miss a point contamination, thus it cannot
provide a litmus test for food safety because the sample size needed to
detect low dose, low frequency, and non-uniformly distributed
contamination is impractically large (Ref. 135). In addition, microbial
testing can only detect the pathogens the analytical procedures are
designed to detect, and we tend to only test for pathogens known to be
of concern. Considering the range of potential pathogens, these are
significant limitations.
b. Microbial Water Quality Standards
The lack of sufficient information to support a pathogen-based
microbiological standard for water used in the production of produce
has led to the adoption of the generic E. coli component of the U.S.
EPA recreational water standards (for frequently used beaches) by some
industry groups (Ref. 44. Ref. 31). The EPA recreational water
standards were developed from epidemiological studies that correlated
the risk of gastrointestinal illness to exposure to marine and
freshwater by swimmers (Ref. 136). Generic E. coli was found to be a
good predictor of swimming associated illness in freshwater and the EPA
recommended criteria include a geometric mean of 126 CFU per 100 ml and
a single sample maximum for designated beach areas of 235 CFU per 100
ml (Ref. 136). British Columbia, Canada has announced their intention
to use a similar approach in setting generic E. coli criteria for
irrigation water used on produce consumed raw. Their irrigation
criteria (less than or equal to 77 CFU per 100 ml geometric mean) are
the same as and were derived from those used for primary-contact
recreation (Ref. 137). See section V.E. of this document for additional
discussion of this issue.
The U.S. EPA criteria were developed from epidemiological studies
of beach areas subject to point source fecal contamination rather than
non-point source contamination (e.g., birds, agricultural and livestock
runoff). Non-point sources may also influence the quality of
agricultural water. Further, adverse health outcomes as a consequence
of immersion while swimming in contaminated water may be different from
those as a result of eating produce irrigated with contaminated water.
The routes of infection and pathogen mortality rates are different in
each environment.
Based upon a WHO analysis of tolerable risk for irrigation water,
the minimum microbial quality for water used on root crops that are
eaten raw is 1,000 CFU generic E. coli per 100 ml (10,000 CFU generic
E. coli per 100 ml in leaf crops) (Ref. 120. Ref. 118). According to
the WHO analysis, using water of this microbial quality is dependent
upon a 2 log reduction due to die-off between last irrigation and
consumption (includes die-off in the field and during distribution) and
a 1 log reduction attributed to washing prior to consumption. This
analysis recognizes the variable nature of die-off values, ranging from
0.5-2.0 log per day (Ref. 118). The WHO analysis considers the need for
a four log reduction through dilution, die-off, or treatment between
the levels of generic E.coli in raw sewage (well represented in sewage
by fecal coliform levels) and the levels in irrigation water used on
root crops that are eaten raw (3 log for leaf crops), in addition to
the 3 log reduction discussed above.
3. Proposed Requirements
a. General Requirement
Proposed Sec. 112.41 would establish the requirement that all
agricultural water must be safe and of adequate sanitary quality for
its intended use. The principle of ``safe and of adequate sanitary
quality for its intended use'' contains elements related both to the
quality of the source water used and the activity, practice, or use of
the water. Uses vary significantly, including: Crop irrigation (using
various direct water application methods); crop protection sprays;
produce cooling water; dump tank water; water used to clean packing
materials, equipment, tools and buildings; and hand washing water. The
way in which water is used for different commodities and agricultural
practices can determine how effectively pathogens that may be present
are transmitted to produce.
Comparing the probability of contamination of covered produce
associated with key practices at different stages of production and
across a range of commodities, the interrelatedness of these factors
becomes apparent. The QAR shows that the likelihood of contamination
associated with indirect water use for irrigation is relatively low
compared to irrigation water that directly contacts produce (Ref. 2).
Therefore, in Section V.A.2.b (Definitions), we propose to define
``agricultural water'' to mean water used in covered activities on
covered produce, where water is intended to, or is likely to, contact
covered produce or food-contact surfaces, including water used in
growing activities (including irrigation water applied using direct
water application methods, water used for preparing crop sprays, and
water used for growing sprouts) and in harvesting, packing, and holding
activities (including water used for washing or cooling harvested
produce and water used for preventing dehydration of covered produce).
As we propose in Sec. 112.3(c), ``covered produce'' refers to the
harvestable or harvested portion of the crop. As proposed,
``agricultural water'' does not include indirect water application
methods used during growing. For example, generally, the water used for
drip or furrow irrigation in apple orchards would not be considered
agricultural water because the water is unlikely to contact the
harvestable portion of the crop. As another example, generally, the
water used for overhead spray irrigation of romaine lettuce would be
considered agricultural water because the water is likely to contact
the harvestable portion of the crop. We are proposing to distinguish
between water that is intended to, or is likely to, contact covered
produce or food-contact surfaces (e.g., direct water application method
irrigation water) and water that is not intended to, or is not likely
to, contact covered produce or food-contact surfaces based on the
relative likelihood of contamination from water that contacts covered
produce and the need for measures to minimize such likelihood.
If finalized as proposed, indirect water application methods would
not be subject to the requirements of this rule. While indirectly
applied water is unlikely to contact produce or food-contact surfaces,
we recognize that it presents the possibility of produce contamination.
For example, use of contaminated water in drip or furrow irrigation may
still serve as a vehicle for bringing contaminants into the growing
environment which may potentially be transferred to produce by rain
splash, workers, or equipment; use of contaminated water for dust
abatement on farm roads may also be transferred to produce by run-off,
rain splash, workers, or equipment.
Indirect water application methods would remain subject to Section
402(a)(4) of the FD&C Act. That is, indirect water application may

[[Page 3564]]

adulterate produce if, considering the water quality and the manner of
its application, the use of the water causes produce to be prepared,
packed, or held under insanitary conditions whereby it may have been
contaminated with filth or rendered injurious to health. Moreover, if a
pathogen is detected in or on produce, such produce would be considered
adulterated under Sections 402(a)(1) of the FD&C Act, in that it
contains a poisonous or deleterious substance which may render it
injurious to health. Therefore, we tentatively conclude that indirect
water application methods do not need to be covered within the scope of
``agricultural water'' for the purposes of this rule.
We ask for comment on the limited scope of ``agricultural water''
to only water that is intended to, or likely to contact covered produce
or food-contact surfaces. We also seek comment on its resulting effect
on the applicability of the general requirement in proposed Sec.
112.41 that agricultural water must be safe and of adequate sanitary
quality for its intended use, to only water that is intended to, or
likely to, contact covered produce or food-contact surfaces. Water that
is not safe or of adequate sanitary quality for its intended use may
lead to contamination of covered produce, even where the water use is
indirect. We have previously recommended measures such as indirect
water use when water quality is poor or unknown as a measure to
minimize risk (Ref GAPs Guide). Considering the FD&C Act would still
apply to such uses, and that there is a lower likelihood of
contamination of produce by indirect water use, is there a need to
subject indirect water use, including water used for dust abatement, to
the general requirement in proposed Sec. 112.41? We welcome comment on
this approach, as well as other actions that have been found to be
effective through practice and experience.
We also considered proposing some requirements for water that is
used during growing, but which does not contact the harvestable portion
of covered produce. For example, water that did not contact produce
would not have been subject to any testing requirement, although we
considered requiring this water and all agricultural water to be of
safe and adequate sanitary quality for its intended use (proposed Sec.
112.41). We also considered requiring indirect water to comply with
proposed Sec. 112.42(a) (sanitary survey) and Sec. 112.42(b) through
(d) (adequately maintaining water sources under your control). If we
did include both direct and indirect water use in the definition of
``agricultural water'' in the final rule, which of the proposed
requirements for agricultural water described in section V.E. of this
document would (or would not) be appropriate for indirect water use?
Are there other factors that we should consider? In every application
of water, careful consideration should be given to what you know about
the water's quality at its source, the impact your distribution system
may have on the water quality, and when or how that water is to be
used. For example, water that contains Salmonella would not be safe or
of adequate sanitary quality for its intended use when used in a
postharvest dump tank for tomatoes. Salmonella is a food safety hazard
that is well-documented to present a risk of severe adverse health
consequences or death, and tomatoes can become contaminated by water
containing Salmonella (Ref. 138. Ref. 139. Ref. 140). As another
example, when the surface water (e.g., river) that you use for crop
irrigation using a direct application method has a noticeable decrease
in quality due to an upstream event like the failure of a waste water
treatment plant, resulting in the accidental discharge of untreated
municipal sewage into the river, your water source would not be safe or
of adequate sanitary quality for its intended use until the discharge
is over and the water has been tested because the incompletely treated
sewage in the discharge is likely to contain pathogenic microorganisms
that could compromise the safety of irrigated covered produce.
The most frequently used irrigation methods include overhead,
surface and subsurface drip, furrow, flood, and seep irrigation (Ref.
29). These practices may be commodity-specific and choices may be
limited by the availability of different water sources, crop needs,
climate, precipitation levels, or regional practices. Each irrigation
method presents a different likelihood of contamination, independent of
the water source and its application to a particular commodity. For
example, the likelihood of produce contamination may be reduced if
irrigation water is delivered by subsurface drip irrigation compared to
using the same water to irrigate by overhead spray (Ref. 141. Ref.
122). Researchers also concluded that both the physical properties of
the edible portion of the crop, such as surface texture, and the
location of the edible portion of the plant in relation to irrigation
water played significant roles in contamination (Ref. 130). As
discussed in the QAR, the timing of irrigation water application also
plays a role in minimizing the persistence of contamination. For
example, water containing elevated generic E. coli used in overhead
irrigation shortly before harvest may increase the likelihood of
covered produce being contaminated with the pathogen at harvest, but
the same water could safely be used to establish a crop and throughout
the majority of the growing season because, as discussed in the QAR,
pathogens die-off over time on the surface of produce. Water used for
washing hands during and after harvest, sprout irrigation, directly
contacting produce during or after harvest (such as in washing and
cooling, or to make ice that directly contacts produce), making treated
agricultural tea, and water or ice that will contact food contact
surfaces that contact covered produce presents an even greater
likelihood of microbial contamination of covered produce (Ref. 131.
Ref. 132). Waterborne pathogens can be transferred to covered produce
with little opportunity for die-off if contaminated water is used for
hand washing during or after harvest, or in harvest, packing or holding
activities where it directly contacts produce or surfaces that contact
produce and, therefore, it is important to ensure that the water is
safe and of adequate sanitary quality for such uses. Moreover, the high
nutrient, high moisture conditions inherent to sprout production and
agricultural teas not only support pathogen survival but are also
conducive to their amplification if present (Ref. 142. Ref. 16). Again,
the selection of a water source for these uses must ensure that the
water is safe and of adequate sanitary quality for that use.
b. Measures Regarding Agricultural Water Sources and Distribution
Systems
Proposed Sec. 112.42 would establish the measures that you must
take with respect to agricultural water sources, water distribution
systems, and pooling of water.
Proposed Sec. 112.42(a) would establish that at the beginning of a
growing season, you must inspect the entire agricultural water system
under your control (including water source, water distribution system,
facilities, and equipment), to identify conditions that are reasonably
likely to introduce known or reasonably foreseeable hazards into or
onto covered produce or food-contact surfaces in light of your covered
produce, practices, and conditions, including consideration of the
following:
(1) The nature of each agricultural water source (for example,
ground water or surface water);
(2) The extent of your control over each agricultural water source;

[[Page 3565]]

(3) The degree of protection of each agricultural water source;
(4) Use of adjacent or nearby land; and
(5) The likelihood of introduction of known or reasonably
foreseeable hazards to agricultural water by another user of
agricultural water before the water reaches your covered farm.
Human pathogens can enter an agricultural water system anywhere
from its source to point of use. Central to the prevention of pathogen
contamination of agricultural water is an inspection of water source
and the components of the distribution system to identify potential
routes of contamination. Inspections of water sources and components of
its distribution system are recommended by government and industry
references (Ref. 10. Ref. 20. Ref. 45. Ref. 44).
Generally, inspection of the agricultural water system under your
control beginning at the water system source is the first opportunity
for ensuring that it will deliver water that is safe and of adequate
sanitary quality for its intended use. Inspection of your water source
provides an opportunity to identify and characterize activities and
situations that may lead to contamination of your agricultural water.
Further, inspection results provide you with historical knowledge of
your water sources, their quality, and factors that may affect their
quality (Ref. 31). Inspection of the water source and any equipment
used to obtain the water from the source (e.g., well head, pumps,
pipes) can ensure that the water that enters the distribution system is
suitable for its intended use.
Proposed Sec. 112.42(a)(1) requires you to consider the nature of
your agricultural water sources to identify conditions that are
reasonably likely to introduce known or reasonably foreseeable hazards
into or onto covered produce or food-contact surfaces. As discussed in
the QAR, ground water which is often believed to be pathogen free can
be contaminated. Ground water can also be compromised and its water
quality degraded if wells are improperly constructed, poorly
maintained, or improperly located (e.g., near areas of extensive
livestock production or fields where manure is applied (Ref. 143. Ref.
144. Ref. 122). U.S. water systems using ground water as source waters
for drinking must operate in compliance with the U.S. EPA Ground water
Rule (GWR) (40 CFR parts 141 and 142) to protect against illness from
waterborne pathogens in ground water. However, the GWR does not address
private wells because they are not under the jurisdiction of the Safe
Drinking Water Act and are therefore not subject to EPA regulation.
Thus, water quality and survey data on ground water used for
agriculture are not publicly available. By their nature, surface waters
are open systems, subject to the influence of various environmental
factors that can impact the safety of the water. For example, increased
precipitation levels, storm events, or wind may result in a spike in
water turbidity, due to redistribution of sediments. We tentatively
conclude that there exists significant potential for contamination of
ground and surface waters and, therefore, we propose to require you to
include both ground and surface water sources in your inspection of
your agricultural water systems. We seek comment on this tentative
conclusion and associated proposals.
Proposed Sec. 112.42(a)(2) requires you to consider the extent to
which you have control over your agricultural water source to identify
conditions that are reasonably likely to introduce known or reasonably
foreseeable hazards into or onto covered produce or food-contact
surfaces. You may have more control over your ground water source
(well) if it draws water from an aquifer beneath your property and
which you protect from the influence of surface activities. You would
likely have less control if your well is located near a concentrated
animal feeding operation or is influenced by surface water (e.g., a
shallow well). You may have greater access to and control of on-farm
surface water sources such as impoundments, catches, and ponds, than
you would for flowing surface waters that only course through but do
not originate on your land.
Proposed Sec. 112.42(a)(3) requires you to consider the degree of
protection of each agricultural water source. Examples of protection
for water sources include covers, containments, or fencing that exclude
domesticated animals or other possible sources of contamination from
the water source or earthen berms or other barriers that help minimize
the influence of runoff on the water source.
Proposed Sec. 112.42(a)(4) requires you to consider the use of
adjacent or nearby land. Agricultural water may be affected by upstream
agricultural practices and runoff from those operations into surface
water sources that you use. For example, an upstream alfalfa grower may
apply raw manure as a soil amendment, and irrigation water runoff from
that field may flow into your agricultural surface water source. While
you may have little or no control of other agricultural water user
practices, this proposed requirement to consider those nearby uses of
which you are aware will help you determine appropriate and safe use of
that water source.
Proposed Sec. 112.42(a)(5) requires you to consider the likelihood
of introduction of known or reasonably foreseeable hazards to
agricultural water by another user of agricultural water before the
water reaches your covered farm. For example, if you use water from a
river and are downstream from a waste water treatment plant that
discharges into that river, this provision would require you to
consider the likelihood that the wastewater treatment plant introduces
hazards into the water before it reaches your farm. For example, you
would consider the likelihood of accidental discharge of untreated
municipal sewage into the river.
Proposed Sec. 112.42(b) would require that you adequately maintain
all agricultural water sources that are under your control (such as
wells) by regularly inspecting each source and keeping the source free
debris, trash, domesticated animals, and other possible sources of
contamination of covered produce to the extent practicable and
appropriate under the circumstances. Regular maintenance of your water
sources is imperative to ensure the continued safety of your water.
Maintenance of on-farm water sources may include upkeep and repair of
berms, pipes, liners, or any structural elements, that are used to
protect the source. Properly maintaining a well includes conducting
wellhead inspections, during which time you check the condition of the
well covering, casing, and cap to make sure all are in good repair,
leaving no cracks or other entry points for potential contaminants.
Properly maintaining a storage tank includes cleaning the interior
surfaces of all rust scale, paint scale, dirt, and bio-film forming
growths and inspecting exterior surfaces for corrosion which may become
a route of contamination (Ref. 31). Properly maintaining a farm pond
that is used for irrigation using a direct application method, with
respect to keeping it free from domesticated animals, could mean
fencing the pond if you keep domesticated animals in the area such that
they would otherwise have access to the pond. On the other hand, if you
treat the water before use in this way, you may not need to take steps
to prevent access of the domesticated animals to the pond. This
proposed provision should not be construed to require the ``taking'' of
an endangered species, as the term is defined in the Endangered Species
Act (16 U.S.C. 1532(19)) (i.e., to harass, harm, pursue,

[[Page 3566]]

hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to
engage in any such conduct).
Proposed Sec. 112.42(c) would require that you adequately maintain
all agricultural water distribution systems as necessary and
appropriate to prevent the water distribution system from being a
source of contamination to covered produce, food-contact surfaces,
areas used for a covered activity, or water sources, including by
regularly inspecting and adequately storing all equipment used in the
system. Regular maintenance of your agricultural water distribution
system can be performed in conjunction with inspections and cleaning,
as applicable. If not regularly maintained, portions of a water
distribution system may fail, corrode, collect debris, or otherwise
become a source of contamination. For agricultural water distribution
system components that are underground, it would be important to look
for signs of erosion or wet soil areas, as they may indicate a damaged
underground component requiring further inspection and maintenance
(Ref. 145).
Proposed Sec. 112.42(d) would establish that you must immediately
discontinue use of a source of agricultural water and/or its
distribution system, and not use the water source and/or its
distribution system when you have determined or have reason to believe
that your agricultural water is not safe and of adequate sanitary
quality for its intended use, until you either: (1) Re-inspect the
entire agricultural water system under your control, identify any
conditions that are reasonably likely to introduce known or reasonably
foreseeable hazards into or onto covered produce or food-contact
surfaces, make necessary changes, and test the water to determine if
your changes were effective and to ensure that your agricultural water
is safe and of adequate sanitary quality for its intended use; or (2)
treat the water in accordance with the requirements of Sec. 112.43.
Using agricultural water that is not safe or of adequate sanitary
quality for its intended use may lead to contamination of covered
produce. Lapses in sanitary quality of water can occur in any segment
of a water system, from source to point of use. For example, if you
find that water contains Salmonella at the point where it would be used
in a dump tank for tomatoes, it would not be safe or of adequate
sanitary quality for that intended use. As another example, your water
would not be considered safe or of adequate sanitary quality for its
intended use if you found detectable generic E. coli in a 100 ml water
sample you obtained at the point where the agricultural water is used
for washing produce as described in proposed Sec. 112.44(a).
Similarly, your water would not be considered safe or of adequate
sanitary quality if you found that test results exceeded 235 CFU per
100 ml generic E. coli in a water sample you obtained from water used
to overhead irrigate lettuce (a direct application method) as provided
in proposed Sec. 112.44(c). We seek comment on these proposed
thresholds.
Under this proposed provision in Sec. 112.42(d)(1), for example,
you would review your previous inspection results for the affected
portion of your agricultural water system and compare those results to
conditions you currently observe. You would identify changes likely to
have an impact on the quality of water (e.g., evidence of runoff,
animal intrusion, suspended sedimentation, changes in adjacent land
use) or any lapses in your procedures (e.g., outdated well inspection,
break in the water treatment schedule). You would test the water after
you make changes you find necessary during your inspection. Under the
proposed provision in Sec. 112.42(d)(2), you could instead choose to
treat your water in accordance with the requirements of Sec. 112.43 to
ensure its safety. We tentatively conclude that the measures proposed
in Sec. 112.42(d) are necessary and adequate to address deficiencies
that may exist in your water management system and practices so that
your agricultural water does not serve as a source of contamination to
covered produce. We welcome comment on this approach, as well as other
actions that have been found to be effective through practice and
experience.
Proposed Sec. 112.42(e) would establish that, as necessary and
appropriate, you must implement measures reasonably necessary to reduce
the potential for contamination of covered produce with known or
reasonably foreseeable hazards as a result of pooling of water. For
example, such measures may include using protective barriers or staking
to keep covered produce from touching the ground, or using an
alternative irrigation method. Pooling may occur if excessive water is
applied to a crop, especially in areas of poor drainage. Pooled water
that remains for extended periods of time has been shown to increase
likelihood of contamination (Ref. 10. Ref. 45). Further, if pooled
water is in close proximity to the crop, it may serve as an attractant
for pests. Mounding soil, staking, subsoil drip irrigation, drip tape
or plasticulture (use of agricultural plastics) are methods that are
used to reduce the potential for pooling or to separate the pooled
water from the covered produce. We acknowledge the potential for small
pools of water to temporarily form in field areas or at the base of
plants after irrigation. Small amounts of water of this nature, which
are temporary and occur in the normal course of irrigation practices,
are not reasonably likely to contribute to the contamination of covered
produce. We are not suggesting that it will always be possible to
eliminate pooling. Avoiding pooling by careful control of irrigation is
ideal; however, events such as rainfall or irrigation malfunction may
sometimes make pooling inevitable. In those cases, the proposed
requirement would require farms to take steps to protect covered
produce from contamination that may build in the pooled water.
c. Requirements for Treating Agricultural Water
Water treatment is an effective means of decreasing the number of
waterborne outbreaks in sources of drinking water (Ref. 146). However,
treatments that are inadequate or improperly applied, interrupted, or
intermittent have been associated with waterborne disease outbreaks
(Ref. 146). Failures in treatment systems are largely attributed to
suboptimal particle removal and treatment malfunction (Ref. 147). For
this reason, when treating water, it is important to monitor the
treatment parameters to ensure the treatment is delivered in an
efficacious manner. Monitoring treatment can be performed in lieu of
microbial water quality monitoring, if under the intended conditions of
the treatment, the water is rendered safe and of adequate sanitary
quality for its intended use. Many operations choose to perform
microbial water quality testing in addition to monitoring the water
treatment as a further assurance of treatment effectiveness (Ref. 148).
Proposed Sec. 112.43 would establish requirements related to
treatment of agricultural water. Specifically, proposed Sec. 112.43(a)
would require that you must treat any agricultural water that you use
(such as with an EPA-registered antimicrobial pesticide product) if you
know or have reason to believe that the water is not safe and of
adequate sanitary quality for its intended use, whereas proposed Sec.
112.43(b) would require that any method you use to treat agricultural
water to satisfy this requirement in paragraph Sec. 112.43(a) must be
effective to make the water safe and of adequate sanitary quality for
its intended use. In addition, proposed Sec. 112.43(c) would require
you to: (1) Deliver any treatment

[[Page 3567]]

of agricultural water required by Sec. 112.43(a) in a manner to ensure
that the treated water is consistently safe and of adequate sanitary
quality for its intended use; and (2) monitor any treatment of
agricultural water at a frequency adequate to ensure that the treated
water is consistently safe and of adequate sanitary quality for its
intended use.
If you choose to use water that is not safe or of adequate sanitary
quality for its intended use, the water must be treated before it is
put to such use to minimize the likelihood for contamination. For
example, treating agricultural water with antimicrobial compounds can
be an effective means to eliminate pathogens if done properly,
including under conditions that ensure the effectiveness of the active
ingredient (Ref. 149. Ref. 150). Any chemicals used in the treatment of
water would require EPA registration under the Federal Insecticide,
Fungicide and Rodenticide Act before they can be lawfully used. We
note, however, that at the present time, no such registration for
chemical treatment of irrigation water exists. We anticipate that the
proposed delayed implementation period for water quality testing (see
section IV.K. of the document) would provide industry adequate time to
address such issues. We seek comment on this issue.
To ensure water treatment is delivered in an effective manner,
monitoring the conditions of treatment is also essential. An effective
monitoring program would measure the level of active compound as well
as those factors that may affect its activity, such as pH, temperature,
and contact time. For example, monitoring water treated with
hypochlorite in an orange postharvest wash would include, at a minimum,
monitoring the level of active antimicrobial (free available chlorine)
and pH, since it is known that hypochlorite activity is reduced both by
organic material (e.g., soil, plant debris) and pH values outside its
effective range (pH 6.0-7.5) (Ref. 149. Ref. 150). The concentration of
active disinfectant and pH must be adjusted, as necessary, taking into
account variations in water quality in order to maintain the
effectiveness of the treatment. In addition, the frequency in which you
monitor agricultural water treatment must be adequate to ensure that
the conditions for proper treatment are consistently met and adjusted,
as necessary, to result in water that is safe and adequate for its
intended use. Research has shown that in other settings, monitoring of
physical parameters, such as temperature, pH and disinfectant
concentration, can be done in real-time and in an inexpensive,
automated manner, facilitating good control of the process (Ref. 149).
As a verification that the treatment process, monitored in accordance
with the proposed requirements of Sec. 112.43(c)(2), is effective in
achieving a certain microbial standard (e.g., no detectable generic E.
coli in 100 ml of water), you may chose to perform periodic
microbiological analysis of the treated agricultural water. We are not
proposing at this time that treated water must be tested in this manner
because we believe that the effectiveness of various treatment
processes is well understood. However, we encourage farms to perform
such testing to provide further assurance of the effectiveness of their
treatment under the specific conditions that exist on their farm. We
seek comment on this issue.
d. Testing and Frequency of Testing of Agricultural Water
Proposed Sec. 112.44 would establish requirements related to
testing of agricultural water and subsequent actions based on the test
results. Specifically, proposed Sec. 112.44(a) would require that you
test the quality of agricultural water according to the requirements in
Sec. 112.45 using a quantitative, or presence-absence method of
analysis provided in subpart N to ensure there is no detectable generic
E. coli in 100 ml agricultural water when it is:
(1) Used as sprout irrigation water;
(2) Applied in any manner that directly contacts covered produce
during or after harvest activities (for example, water that is applied
to covered produce for washing or cooling activities, and water that is
applied to harvested crops to prevent dehydration before cooling),
including when used to make ice that directly contacts covered produce
during or after harvest activities;
(3) Used to make a treated agricultural tea;
(4) Used to contact food-contact surfaces, or to make ice that will
contact food-contact surfaces; or
(5) Used for washing hands during and after harvest activities.
We seek comment on the appropriateness of these proposed categories
in which testing would be required.
Proposed Sec. 112.44(b) would require that if you find that there
is any detectable generic E. coli in 100 ml of water, you must
immediately discontinue use of that source of agricultural water and/or
its distribution system for the uses described in Sec. 112.44(a).
Before you may use the water source and/or distribution system again
for the uses described in Sec. 112.44(a), you must either re-inspect
the entire agricultural water system under your control, identify any
conditions that are reasonably likely to introduce known or reasonably
foreseeable hazards into or onto covered produce or food-contact
surfaces, make necessary changes, and retest the water to determine if
your changes were effective and to ensure that the water meets the
requirements of Sec. 112.44(a); or treat the water in accordance with
the requirements of Sec. 112.43.
We reviewed the most widely used indicator(s) or indicator groups
for their potential in assessing the microbial quality of water used
for purposes described in proposed Sec. 112.44(a) and all other uses
of agricultural water as described in section V.E.2 of this document.
We considered total coliforms and fecal coliforms as indicators of
fecal contamination but determined that neither of them can serve as
reliable indicators of a fecal contamination event (Ref. 124. Ref. 119.
Ref. 151. Ref. 152). Generic E. coli is a member of both the coliform
and fecal coliform groups but, unlike some members of those groups, it
has been shown using various detection methods to be the only coliform
consistently associated with fecal contamination (Ref. 132. Ref. 133.
Ref. 134. Ref. 135. Ref. 136. Ref. 137. Ref. 108). Generic E. coli has
an extensive history and support for use as an indicator of fecal
contamination. Recently, it has emerged as the preferred indicator for
monitoring water quality, not only because of the problems with other
groups noted above, but also due to the development of superior methods
of detection with greater accuracy, sensitivity, and simplicity over
those previously used (Ref. 119). Despite widespread use and support
for generic E. coli as an indicator of fecal contamination, its ability
to signal contamination events is not without challenges. Sampling
frequency and location relative to the source of contamination are
reported to affect the performance of generic E. coli as an indicator
of fecal contamination (Ref. 133. Ref. 143. Ref. 153. Ref. 131). Thus,
non-detection cannot be considered absolute confirmation that fecal
contamination has not occurred. Further, the fate and transport of
generic E. coli takes different paths in different watersheds, and
reservoirs have been identified, particularly sediments, where they may
escape detection in the water column (Ref. 128. Ref. 129. Ref. 130.
Ref. 154). Nevertheless, based on our review of the literature, we

[[Page 3568]]

tentatively conclude that generic E. coli serves as the most
appropriate microbial indicator of fecal contamination of water at this
time and, therefore, we propose to use a microbial standard of no
detectable generic E. coli in 100 ml agricultural water when it is for
the intended uses listed in Sec. 112.44(a). We seek comment on our
selection of this indicator.
As discussed in the QAR, water used for the purposes listed in
proposed Sec. 112.44(a) has the potential to serve as a vehicle of
pathogen contamination by direct contact with covered produce. Water
used in sprout production must be free of fecal contamination because
the conditions under which sprouted seeds are produced (warm, moist,
nutrient-rich environment for extended period of time) are conducive to
pathogen multiplication (Ref. 14). As discussed in section I.A. of this
document, outbreaks associated with sprouted seeds are well documented;
Salmonella and E. coli O157:H7 have been the major causes of sprout-
associated outbreaks (Ref. 14). Similarly, the conditions under which
agricultural tea is produced (moist and nutrient-rich) are similar in
that they support the multiplication of pathogens, if present (Ref.
142). Even a low number of pathogens introduced into or onto covered
produce through contaminated water could rapidly increase to levels
that could present risk of serious adverse health consequences or death
to those who consume the covered produce for which the tea was used.
Further, water that is used in direct contact with produce or food
contact surfaces, or in making ice that directly contacts produce or
food contact surfaces, must also be free of fecal contamination and
pathogens. These water applications normally occur during or shortly
after harvest, leaving only a relatively short period of time before
consumption for the environmental factors that drive pathogen die-off
to exercise a significant effect (see the QAR). In addition, we propose
to apply the microbial standard in proposed Sec. 112.44(a) to
agricultural water that is intended for use in washing hands during
harvesting, packing, and holding activities, where there is little
opportunity for microbial die-off prior to consumption. Hands that
contact produce during and after harvest must be free of microbial
contaminants (Ref. 133). In the United States, the Occupational Safety
and Health Administration (OSHA) of the U.S. Department of Labor has
established requirements for water used for washing workers' hands.
Under 29 CFR 1928.110(b), a hand-washing facility means ``a facility
providing either a basin, container, or outlet with an adequate supply
of potable water, soap and single-use towels;'' and potable water means
``water that meets the standards for drinking purposes of the State or
local authority having jurisdiction, or water that meets the quality
standards prescribed by the U.S. EPA's National Primary Drinking Water
Regulations [NPDWR] (40 CFR part 141).'' The OSHA requirements in 29
CFR 1928.110 require that farms employing eleven or more employees
engaged in hand-labor operations in the field for a period of more than
three hours in a day provide water that satisfies the microbial maximum
contaminant level (MCL) in the NPDWR, which states that any generic E.
coli-positive repeat sample or generic E. coli-positive routine sample
(which would include a finding of any detectable generic E. coli in 100
ml of water using the methods of analysis in proposed subpart N)
constitutes a violation of the MCL for total coliforms. Therefore, the
microbial standard for hand washing water during harvesting, packing,
and holding activities that is specified in proposed Sec. 112.44(a)
would be consistent with the OSHA requirements.
We acknowledge the difficulty of associating specific indicator
concentrations with specific produce related health risks. Even so, we
have tentatively concluded that such difficulty does not negate the
value of applying generic E. coli test results to the requirement to
discontinue use of a water source until compliance with applicable
generic E. coli standard is again achieved, because elevated indicator
organism concentrations indicate increased levels of fecal
contamination and elevated potential for the presence of human
pathogens of fecal origin (Ref. 154). The uses listed in proposed Sec.
112.44(a) are similar in that, if pathogens or fecal contamination are
present, it is reasonably likely they could be transferred directly to
covered produce through direct or indirect (via food-contact surfaces)
contact with the water. Therefore, testing the agricultural water used
for these purposes to ensure that it is absent of generic E. coli would
provide reasonable assurances that the water does not contain
pathogens, and therefore that the water is not likely to introduce
pathogens into or onto covered produce and to provide reasonable
assurances that the produce will not be adulterated under section 402
of the FD&C Act. Moreover, a requirement that there be no detectable
generic E. coli per 100 mL of agricultural water used in these
activities and practices would be consistent with EPA's MCLs for
microbiological contaminants in public drinking water systems (40 CFR
141.63(b)) and with our standard of quality for bottled water (21 CFR
165.110(b)(2)(B)). We request comment on the need for, and
appropriateness of, this proposed requirement and any other criteria
that would ensure the safety of water for these intended uses.
We tentatively conclude that we should require that if the water
you use for the purposes listed in Sec. 112.44(a) does not meet the
microbial standard of no detectible generic E. coli per 100 ml, you
must immediately discontinue use of the water and/or distribution
system for those purposes. Before you use the water source and/or
distribution system again for those uses, you would need to either (1)
re-inspect the entire agricultural water system under your control,
identify any conditions that are reasonably likely to introduce known
or reasonably foreseeable hazards into or onto covered produce or food-
contact surfaces, make necessary changes, and retest the water to
determine if your changes were effective and to ensure that the water
meets the required microbial standard; or (2) treat the water in
accordance with the requirements of Sec. 112.43 (proposed Sec.
112.44(b)). This proposed requirement is parallel to the requirement in
proposed Sec. 112.42(d), which is discussed above.
Proposed Sec. 112.44(c) would require that when agricultural water
is used during growing activities for covered produce (other than
sprouts) using a direct water application method, you must test the
quality of water in accordance with one of the appropriate analytical
methods in subpart N. If you find that there is more than 235 colony
forming units (CFU) (or most probable number (MPN), as appropriate)
generic E. coli per 100 ml for any single sample or a rolling geometric
mean (n=5) of more than 126 CFU (or MPN, as appropriate) per 100 ml of
water, you must immediately discontinue use of that source of
agricultural water and/or its distribution system for the uses
described in Sec. 112.44(c). Before you may use the water source and/
or distribution system again for the uses described in Sec. 112.44(c),
you must either re-inspect the entire agricultural water system under
your control, identify any conditions that are reasonably likely to
introduce known or reasonably foreseeable hazards into or onto covered
produce or food-contact surfaces, make necessary changes, and retest
the water to determine if your changes were

[[Page 3569]]

effective; or treat the water in accordance with the requirements of
Sec. 112.43. We seek comment on this approach.
As discussed in section V.E.2 of this document, the WHO recommends
monitoring generic E. coli numbers in treatment effluents as
verification of wastewater treatment, and laboratory analysis of crop
contamination levels with generic E. coli at harvest and in retail to
verify pathogen mortality (die-off) (Ref. 118). However, they also
noted the variability in pathogen die-off (0.5-2 log/day), dependent on
temperature, sunlight intensity, crop type, time of water application,
and other factors.
Some industry groups have adopted the generic E. coli component of
the U.S. EPA recreational water standards (for beaches used frequently)
for certain uses of agricultural water (Ref. 31. Ref. 44). In this
regard, EPA recommends that criteria include a maximum steady state
geometric mean of 126 CFU of generic E. coli per 100 ml and a single
sample maximum allowable density of 235 CFU of generic E. coli per 100
ml (Ref. 136). British Columbia, Canada has announced their intention
to use generic E. coli criteria for irrigation water used on produce
consumed raw. Their irrigation criteria (less than or equal to 77 CFU
per 100 ml geometric mean) are the same as and were derived from those
used for primary-contact recreation (Ref. 137). Similarly, the generic
E. coli component of EPA's recreational water standard (for beaches
used frequently) serves as the basis for our proposed standard for
microbial water quality for water used in direct application methods
during growing (proposed Sec. 112.44(c)).
It should be noted that EPA's recreational water standards for
beaches used frequently also includes a recommendation for a maximum
steady state geometric mean of 33 CFU of enterococci per 100 ml and a
single sample maximum allowable density of 61 CFU of enterococci per
100 ml (Ref. 136). Similarly, the current British Columbia criteria for
irrigation water used on produce consumed raw is a geometric mean of
less than or equal to 200 CFU fecal coliform per 100 ml and they have
announced their intention to use a geometric mean of less than or equal
to 20 CFU enterococci per 100 ml (along with generic E. coli, as
discussed above). We have tentatively concluded to not include
enterococci or fecal coliform in our proposed standard at Sec.
112.44(c) because we believe generic E. coli to be the superior
indicator of fresh water quality and do not believe that the added cost
of testing for both generic E. coli and enterococci is warranted. Wade
et al (2003) (Ref. 155) performed a systematic review of 27 studies of
water quality indicators used for the regulation of recreational
waters. They compared the ability of enterococci, fecal coliform,
generic E. coli and total coliform levels to predict for the occurrence
of gastrointestinal illness. They concluded that for freshwater,
generic E. coli was the more consistent predictor. Working under the
framework of a WHO project for setting guidelines for quality of
recreational waters and bathing beaches, Pruss (1998) (Ref. 156)
reviewed 22 studies on uncontrolled waters (seas, lakes, and rivers)
for dose-related relationships between GI illness and bacterial
indicator (most commonly generic E. coli, enterococci, and fecal
coliforms) counts. The author found the two indicator organisms which
correlate best with health outcomes were enterococci for both marine
and freshwater and generic E. coli for freshwater.
We considered proposing a drinking water standard for water used on
covered produce other than sprouts during growing in a direct water
application method, but tentatively conclude that such criteria would
be unnecessarily restrictive as it would not sufficiently account for
forces driving pathogen die-off (e.g., sunlight, competing
microorganisms) (see section V.E.2 of this document). We also
considered proposing a second lower microbial quality criteria for
water used in growing, but where the water used for irrigation is not
reasonably likely to contact the edible portion of the covered produce
(e.g., surface irrigation of tree crops). However, we are not aware of
another standard for which there is sufficient scientific support.
We acknowledge that the EPA recreational water standards were
developed from epidemiological studies that correlated the risk of
gastrointestinal illness to exposure to marine and freshwater by
swimmers (Ref. 136), rather than to consumption of produce. These
epidemiological studies were performed in beach areas subject to point
source fecal contamination rather than non-point sources (e.g., birds,
agricultural and livestock runoff), which may impact agricultural
water. Further, risks of adverse health outcomes resulting from full
body contact in contaminated water may be different than risks
associated with consuming produce irrigated with contaminated water,
given the differences in the expected routes of infection and pathogen
mortality rates in the different environments (bodies of water for the
EPA recreational water standards; soil, plants, and produce for this
proposed rule).
We also acknowledge that the proposed standard is more stringent
than the WHO standard. Based upon an analysis of tolerable risk for
irrigation water, WHO recommends that the minimum microbial quality for
water used on root crops that are eaten raw is 1000 CFU generic E. coli
per 100 ml (10,000 CFU generic E. coli per 100 ml in leaf crops) (Ref.
118. Ref. 120). According to the WHO analysis, using water of this
microbial quality is dependent upon a 2 log reduction due to die-off
between last irrigation and consumption (includes die-off in the field
and during distribution) and a 1 log reduction attributed to washing
prior to consumption. This analysis recognizes the variable nature of
die-off values, ranging from 0.5-2.0 log per day (Ref. 118). The WHO
analysis considers the need for a four log reduction through dilution,
die-off, or treatment between the levels of generic E.coli in raw
sewage (well represented in sewage by fecal coliform levels) and the
levels in irrigation water used on root crops that are eaten raw (3 log
for leaf crops), in addition to the 3 log reduction discussed above.
We tentatively conclude that the recreational water generic E. coli
criteria would serve to minimize risk of known or reasonably
foreseeable hazards when used as a standard for agricultural water used
on produce other than sprouts during growing in a direct water
application method. We recognize that is somewhat more protective than
the WHO standard, which we believe is appropriate given the uncertainty
in die-off values. We request comment on the need for, and
appropriateness of, this requirement or other criteria that would
ensure the quality of agricultural water used for this purpose.
We tentatively conclude that if agricultural water you use on
produce other than sprouts during growing in a direct application
method does not meet the microbial water quality described in Sec.
112.44(c), you must immediately discontinue use of that source of
agricultural water and/or its distribution system and either (1) re-
inspect the agricultural water system components under your control,
identify conditions that are reasonably likely to introduce hazards to
the system, make necessary changes based upon your observations, and
retest the water to determine if your changes were effective; or (2)
treat the water in accordance with the requirements of Sec. 112.43.
This proposed requirement is parallel to the requirement proposed Sec.
112.42(d), which is discussed above.

[[Page 3570]]

We tentatively conclude that violation of microbial water quality
standards proposed in Sec. Sec. 112.44(a) and (c) in and of itself
would not necessarily establish evidence of adulteration of covered
produce subjected to use of the water, nor would it necessarily mean
that the food was contaminated. However, use of water that is shown to
violate these standards would violate the requirement at proposed Sec.
112.41 that all agricultural water must be safe and of adequate
sanitary quality for its intended use. As described immediately above,
these proposed standards are based on likelihood of fecal contamination
(as indicated by the presence of generic E. coli), that we have
tentatively concluded minimize the risk of serious adverse health
consequences or death by preventing the introduction of hazards and
providing reasonable assurances that produce is not adulterated under
section 402 of the FD&C Act. Agricultural water in violation of these
standards indicates increased likelihood of fecal contamination of the
water and, consequently, increased likelihood of produce contamination
with human pathogens, beyond that which is appropriate for the intended
use. Therefore, we propose to require you to immediately discontinue
use of that source of agricultural water and/or its distribution system
until you have either followed certain prescribed steps to mitigate the
problem or treated the water.
Under the provisions of proposed Sec. 112.44, if covered farms
choose to treat irrigation water in accordance with the requirements of
proposed Sec. 112.43, any chemicals used in such treatment would
require registration under the Federal Insecticide, Fungicide and
Rodenticide Act before they can be lawfully used. At the present time,
no such registration for chemical treatment of irrigation water exists.
As discussed in section IV.K. of this document, FDA is proposing to
delay implementation of certain provisions, including the water quality
testing requirements in proposed Sec. 112.44, beyond the effective
dates for other provisions of the rule. The proposed extended
compliance dates for the water quality testing, monitoring, and related
record keeping requirements in proposed Sec. Sec. 112.44, 112.45,
112.50(b)(5), 112.50(b)(6), and 112.50(b)(7) are six years from the
effective date for very small businesses, five years from the effective
date for small businesses, and four years from the effective date for
all other farms subject to the rule. We expect these extended
compliance dates to provide adequate time for industry to address
issues related to water quality testing. We seek comment on the
adequacy of this timeline.
Proposed Sec. 112.44(d) would also allow you to establish and use
alternatives to the requirements established in proposed Sec.
112.44(c) provided you satisfy the requirements of proposed Sec.
112.12. As discussed in section V.B. of this document, under proposed
Sec. 112.12(a)(1), you may establish an alternative to the
requirements, established in proposed Sec. 112.44(c) for testing
water, and taking action based on test results when agricultural water
is used during growing operations for covered produce (other than
sprouts) using a direct water application method. We acknowledge that
in specific circumstances an alternative standard (e.g., a standard
that applies an application interval (time between application and
harvest) in place of the Sec. 112.44(c) standard, but is specific to a
specific commodity or commodity group and region) may be appropriate if
the alternative standard is shown to provide the same level of public
health protection as the standard in proposed Sec. 112.44(c) and not
to increase the likelihood that the covered produce will be
adulterated. Therefore, we tentatively conclude that it would be
appropriate to allow for alternatives to the requirements in proposed
Sec. 112.44(c).
We are working with USDA and other stakeholders to facilitate
research into application intervals that would be commodity- and
region-specific, such that water not meeting the proposed Sec.
112.44(c) standard could be used in a direct water application method
for growing covered produce other than sprouts as long as it was
applied before the start of the scientifically established application
interval (i.e., at a certain number of days before harvest or earlier).
Proposed Sec. 112.45 would establish requirements related to
frequency of testing agricultural water that is subject to the
requirements of Sec. 112.44. Specifically, proposed Sec. 112.45(a)
would require that you test any agricultural water that is subject to
the requirements of Sec. 112.44 at the beginning of each growing
season, and every three months thereafter during the growing season,
except that there would be no requirement to test water when:
(1) You receive water from a Public Water System, as defined under
the Safe Drinking Water Act (SDWA) regulations, 40 CFR Part 141, that
furnishes water that meets the microbial requirements under those
regulations or under the regulations of a State approved to administer
the SDWA public water supply program, and you have Public Water System
results or certificates of compliance that demonstrate that the water
meets that requirement;
(2) You receive water from a public water supply that furnishes
water that meets the microbial requirement described in 112.44(a), and
you have public water system results or certificates of compliance that
demonstrate that the water meets that requirement; or
(3) You treat water in accordance with the requirements of Sec.
112.43.
Water testing frequencies recommended by various industry documents
vary widely, in part because there is a lack of publicly available
information pertaining to the quality of irrigation waters.
Recommendations range from monthly testing to once each year, for
sources with a history of compliance with commodity specific
recommendations (Ref. 31. Ref. 44). Even for sources considered
reliable (e.g., well water), a one year period between testing does not
minimize the risk of known or reasonably foreseeable hazards because
microbiological water quality, even when sourced from ground water
sources, is too variable for this frequency of testing to be protective
(e.g., effects of flooding, runoff) (Ref. 29). Alternatively, we
tentatively conclude testing more frequently (less than every 3 months)
would not significantly improve the accuracy of your assessment of
ground water quality and would therefore be unnecessary. We also
considered proposing testing frequencies established as a function of
commodity, irrigation method (e.g., furrow, seep, subsurface
dripfoliar), and timing of application (days prior to harvest), and
concluded that the most effective approach is to test on a frequency
related to the reliability of the agricultural water sources. We
tentatively conclude that requiring testing as a function of time
before harvest would be impractical for many farms as we have observed
single sources (e.g., a well) providing water for multiple crops in
different phases of production. We request comment on whether we should
allow for adjustment of ground water testing frequencies dependent upon
historical test results. For example, we are considering requiring
testing ground water sources every three months for one year and yearly
after that if the ground water consistently met the standard. We also
request public comments on our proposed approach to frequency of
testing, each of the options described here, and any other alternative
testing frequencies that can be supported by water quality data.

[[Page 3571]]

Proposed Sec. 112.45(a)(1) provides an exception to testing
required in Sec. 112.45(a) when the water is sourced from a Public
Water System or State authority approved to administer the SDWA public
water supply program, and you have results of the water testing or
certificates of compliance that demonstrate that the water meets the
requirements of that program. These systems operate so that the water
they deliver meets the microbial requirement in 112.44(a). In the U.S.,
Public Water Systems are required under U.S. EPA National Primary
Drinking Water Regulations (NPDWR) in 40 CFR 141 to provide safe, clean
water suitable for drinking and thus are at the lowest likelihood for
pathogen contamination. Under the sampling, testing and reporting
requirements of 40 CFR 141, we tentatively conclude that additional
actions by the grower to assure its safety are unwarranted. Similarly,
proposed Sec. 112.45(a)(2) provides for an exception to testing when
the water is furnished from a public water supply that furnishes water
that meets the standards of Sec. 112.44(a), and you have results of
the water testing or certificates of compliance that demonstrate that
the water meets that standard. The standard in Sec. 112.44(a) is
derived from the EPA drinking water standard, and this provision is
included to accommodate foreign public water supplies that are not
governed by the requirements of the EPA drinking water program, but
provide water of a quality that meets the microbial requirement of
proposed Sec. 112.44(a). Where public water that meets or is
comparable to (in other countries) EPA's drinking water standards is
used in produce operations, we are not aware of anything suggesting a
need for additional testing at its delivery point to the farm. We seek
comments on this issue, including any practice(s) that could materially
change the quality of public or municipal water between treatment and
delivery to the farm, including changes in water quality during water
distribution and holding. Finally, Sec. 112.45(a)(3) exempts from
testing water that you treat in accordance with proposed Sec. 112.43,
which is discussed above.
Proposed Sec. 112.45(b)(1) would establish that if you use
untreated surface water for purposes that are subject to the
requirements of proposed Sec. 112.44, and if the untreated surface
water is from any source where a significant quantity of runoff is
likely to drain into the source (for example, a river or natural lake),
then you must test the water at least every 7 days during the growing
season. Proposed Sec. 112.45(b)(2) would establish that if you use
untreated surface water for purposes that are subject to the
requirements of proposed Sec. 112.44, and if the untreated surface
water is from any source where underground aquifer water is transferred
to a surface water containment constructed and maintained in a manner
that minimizes runoff drainage into the containment (for example, an
on-farm man-made water reservoir), then you must test the water at
least once each month during the growing season.
Surface water is subject to a great number of environmental factors
that may alter its microbial water quality as discussed in the QAR and,
when untreated, presents a significant source of pathogen contamination
of produce. We tentatively conclude that the most important among these
is runoff, because it has the potential to increase the number of
pathogens in the water column if its origins include human, livestock
or wildlife feces and because it has the potential to increase the
amount of suspended sediments, which are likely to harbor pathogens
(Ref. 157. Ref. 154). In proposing these testing frequencies, we
tentatively divided untreated surface water into two categories based
upon their potential to be impacted by runoff and the degree to which
you reasonably could be expected to exercise protection and control
over them. Flowing surface waters (e.g., river, stream, or creek) or
sources that are not protected against runoff (e.g., natural ponds,
lakes) must be tested at a relatively higher frequently than surface
waters for which you have direct control and which you can manage in a
way so to minimize the effect of runoff and other sources of
contamination (e.g., on-farm reservoir or pond). Contamination events
that can lead to surface water contamination can have profound effects
on the quality of the water, but those effects can be fleeting,
especially those involving runoff from rainfall (several days to
several weeks). After the contamination event passes, water quality
generally returns to background levels (Ref. 158). If sampling is less
frequent than weekly from surface water sources subject to these kinds
of contamination events, there is a good chance that some contamination
events will go undetected. On the other hand, for surface water sources
that are not subject to significant runoff, the water quality tends to
remain stable, and the purpose of sampling is primarily to accurately
characterize the background level. Monthly sampling provides 12 samples
per year that give a good representation of the quality of water
through the seasons. The sampling and testing frequencies proposed in
Sec. 112.45(b) are the minimum that we tentatively conclude provide
sufficient information concerning your source surface water quality for
you to use in determining method of application and its timing for
which the water is safe and of adequate sanitary quality. We encourage
additional sampling if you have reason to believe that its quality may
have changed from the previous test. We welcome comments on the need
for, and appropriateness of, our proposed testing frequencies,
including any alternative approaches and examples where testing should
be more or less frequent based upon your experience or observation.
The monitoring frequencies proposed in this rule are practical
intervals that we tentatively conclude are reflective of the varying
potential for changes in water quality between ground aquifers and
surface watersheds. In proposing the monitoring frequencies for
untreated surface waters, we considered factors that are most likely to
impact water quality. Precipitation and its effects (e.g., discharge
and flow rate) along with temperature are common factors reported to
affect the microbial quality of watersheds with agricultural land
inputs (Ref. 159. Ref. 158). Precipitation levels have also been
successfully used to manage openings and closings of molluscan
shellfish harvest areas. These harvest areas are well characterized in
terms of changes in the microbial water quality due to non-point source
runoff as a consequence of rainfall. However, we have not proposed
surface water testing frequency based upon precipitation because such
an approach would require full characterization of its effects (Ref.
143) on the quality of surface water sources that are not likely to be
generally useful across farms, States, or regions. Our approach to
testing untreated surface water is to propose practical intervals of
testing both because they are likely to capture transient events that
may degrade quality and because they are useful regardless of
geographic location. We welcome comments on this approach, including
any alternate approaches, specifically if you believe that surface
waters can be thoroughly characterized such that they require less
frequent testing than proposed in Sec. 112.45.
e. Requirements for Water Used in Harvesting, Packing, and Holding
Activities
Proposed Sec. 112.46 would establish the measures you must take
for water that you use during harvest, packing, and

[[Page 3572]]

holding activities for covered produce. Specifically, proposed Sec.
112.46(a) would require that you manage the water as necessary,
including by establishing and following water-change schedules for re-
circulated water, to maintain adequate sanitary quality and minimize
the potential for contamination of covered produce and food-contact
surfaces with known or reasonably foreseeable hazards (for example,
hazards that may be introduced into the water from soil adhering to the
covered produce). The proposed language allows sufficient flexibility
for you to establish measures that are best suited to your needs based
on practice and experience. For example, you may establish a water-
change schedule for water used in an apple flume based upon the rate of
product flow, organic load, or other variables you determine best
correlate with safety and sanitary quality of the flume water. Many
commonly used wash water antimicrobials have decreased efficacy when
organic matter is present in the water. For example, organic matter
builds up in agricultural water flume systems from dirt and debris on
the surface of fresh produce that are placed into the flume systems.
Once the soluble and/or insoluble organic load builds up to
sufficiently high levels, the addition of wash water antimicrobials
becomes ineffective and inefficient. Changing the flume water on a
regular basis, based on that system's unique operating conditions, can
assure that wash water disinfection treatments are consistently
effective (Ref. 149. Ref. 150). We point out that while water
disinfection is one means to manage water quality, we are not
specifically proposing to require disinfection treatment of re-
circulated or single use water that is used in harvesting, packing, or
holding activities. We are proposing that re-circulated or single pass
water must be safe and of adequate sanitary quality for its intended
use (Sec. 112.41) and that it contain no detectable E. coli (Sec.
112.44(a)). Further, if you have reason to believe that the water is
not safe and of adequate sanitary quality for its intended use,
proposed provisions in Sec. 112.43 for water treatment can be applied.
However, we are not proposing treatment of water as the only option.
Other options for farms include making changes to the system and
retesting the water successfully (Sec. 112.42(d)) and using the same
water source for other uses for which it does qualify. For example,
using water that does not meet the zero E. coli standard but does meet
the 235 CFU per 100 ml standard for direct application method
irrigation of produce other than sprouts; or for water that does not
meet the 235 CFU per 100 ml standard, applying the water for irrigation
in a different manner that is not a direct application method (Sec.
112.44). These provisions offer flexibility for farms to choose among
different options to ensure that the water is safe and adequate for the
purpose for which it is intended. Should farms choose to disinfect
water as a measure to control waterborne hazards during handling during
and after harvest, we tentatively conclude that an effective
disinfection program would render such water safe and of adequate
sanitary quality. However, we request public comment on the
appropriateness of this tentative conclusion and on whether a provision
specifically directed to disinfection of water used during and after
harvest is needed. We also seek public input regarding practices or
conditions when disinfection of re-circulated or single use water would
be unnecessary, inappropriate, or impractical.
Proposed Sec. 112.46(b) would require that you visually monitor
the quality of water that you use during harvest, packing, and holding
activities for covered produce (for example, water used for washing
covered produce in dump tanks, flumes, or wash tanks, and water used
for cooling covered produce in hydrocoolers) for build-up of organic
material (such as soil and plant debris). Organic matter such as soil
and plant debris has to the potential to adversely affect the quality
of water; it may be a source of bacteria (including pathogens), support
the growth of bacteria, and reduce the effectiveness of antimicrobial
compounds (e.g., chlorine compounds) (Ref. 150). Such monitoring allows
you to recognize conditions that require action, such as a water change
in a dump tank.
Proposed Sec. 112.46(c) would require that you maintain and
monitor the temperature of water at a temperature that is appropriate
for the commodity and operation (considering the time and depth of
submersion) and is adequate to minimize the potential for infiltration
of microorganisms of public health significance into covered produce.
Water temperature can influence processes leading to infiltration of
microorganisms into many types of produce. As discussed in the QAR,
infiltration of water containing pathogens into produce has been
demonstrated in apples (Ref. 160), oranges (Ref. 161), tomatoes (Ref.
138. Ref. 139), and mangoes (Ref. 38) and was suggested to play a role
in a 1999 Salmonella outbreak associated with mangos (Ref. 162). A
recent study demonstrated that additional factors, such as tomato
variety and the time delay between tomato stem removal and water
immersion have a significant impact on the frequency and population of
internalized Salmonella in tomatoes. (Ref 140). However, this study
also demonstrated that Salmonella internalization of tomatoes via their
stem scar can occur even under a zero temperature differential, and
temperature differentials up to 10 [deg]F have no effect on the
internalization frequency and have limited impact on Salmonella cell
populations internalized in tomatoes.
We considered proposing a single standard on temperature
differential between water and product core temperature (e.g., water
must be at least 10 degrees F warmer than core) but tentatively
conclude that there is insufficient scientific evidence supporting such
a standard across all covered produce. However, we recognize the North
American Tomato Trade Work Group and California Tomato Commission have
recommended such a standard (Ref. 44). We seek public comment on the
need for, and appropriateness of, the proposed provisions, including
any alternative approaches that you found to be effective through
experience or observation.
f. Records Requirements
Proposed Sec. 112.50 would establish requirements about the
records that you would need to establish and keep under this proposed
subpart E. Specifically, proposed Sec. 112.50(a) would require that
you establish and keep records required under this proposed subpart E
in accordance with the requirements of proposed subpart O. Proposed
Sec. 112.50(b) would require that you establish and keep the following
records:
(1) The findings of the inspection of your agricultural water
system in accordance with the requirements of proposed Sec. 112.42(a);
(2) Documentation of the results of any analytical tests conducted
to determine whether agricultural water is safe and of adequate
sanitary quality for its intended use;
(3) Scientific data or information you rely on to support the
adequacy of a method used to satisfy the requirements of Sec.
112.43(b) and (c)(1);
(4) Documentation of the results of water treatment monitoring
under Sec. 112.43(c)(2);
(5) Documentation of the results of water testing you perform to
satisfy the requirements of Sec. 112.44;

[[Page 3573]]

(6) Scientific data or information you rely on to support any
alternative to the requirements established in Sec. 112.44(c) for
agricultural water used during growing activities using a direct water
application method in accordance with the requirements of Sec.
112.44(d); and
(7) Annual documentation of the results or certificates of
compliance from a public water system under 112.45(a)(1) or (2), if
applicable.
Proposed Sec. 112.50(b)(1) would require that you establish and
keep records of agricultural water system inspection findings in order
for FDA to verify compliance with the proposed requirement to inspect
the agricultural water system. The records would also allow you to more
effectively manage your agricultural water, to identify trends and
changes in your agricultural water system over time, and to help
identify potential sources of contamination of the water system and
covered produce. In addition, these records may aid you in determining
the most appropriate frequencies for maintenance of well and surface
water sources, distribution and holding systems.
Proposed Sec. 112.50(b)(2) would require that you establish and
keep records of any analytical test results from any tests you may have
conducted to determine if water meets the quality requirements proposed
in Sec. 112.41. We have tentatively concluded that these records are
necessary because otherwise FDA would have no way to determine whether
you were making appropriate decisions about whether your water is safe
and of adequate sanitary quality for its intended use. When such tests
are conducted, results of those tests are also fundamental in making
informed decisions concerning your use of water.
We are proposing under Sec. 112.50(b)(3) and (4) that you must
establish and keep scientific information or data documenting the
effectiveness of the treatment method that you use and records
demonstrating that you deliver the treatment consistently to ensure the
water is safe and of adequate sanitary quality. These records may
include information provided by the antimicrobial product supplier,
product labels with instructions for use, product material safety data
sheets (MSDS), batch test results demonstrating correct active
ingredient concentration, mixing proportions, and schedules or
application rates you have developed to ensure water is treated
effectively. They may also include results of testing you perform to
confirm your treatment methods are being followed, such as records of
active ingredient concentration, pH, temperature, flow rate, immersion
time, or water changes, if they significantly impact the effectiveness
of the treatment. Monitoring frequency may be affected by product flow,
organic load on incoming product, temperature, UV exposure, and
consumption rates or breakdown rate (expected and observed) for the
active antimicrobial compound, among other factors. These records are
necessary so that FDA can verify your compliance with those
requirements. They will also allow you to ensure your own compliance
with the requirements for water treatment in proposed Sec. 112.43.
We are proposing in Sec. 112.50(b)(5) that you must establish and
keep records of the results of water testing you perform to satisfy the
requirements of Sec. 112.44. For example, records for water tests you
perform to ensure input water used in sprout production meets the
requirements in Sec. 112.44(a) would include, at a minimum, the test
date, specific water source (e.g., municipal water or well number 3),
method name (e.g., multiple tube fermentation, membrane filter method,
presence-absence test, and commercial product name, if applicable) and
the test result (e.g., not detected, generic E. coli MPN or CFU, as
applicable). Records you maintain to demonstrate the microbial water
quality meets the requirements of Sec. 112.44(c) for foliar
application of spinach would include, at a minimum, the test date,
specific water source (e.g., ranch X, well 3 or canal collection point
2), method name (e.g., multiple tube fermentation, membrane filter
method, and commercial product name, if applicable) and the test result
(e.g., E. coli MPN or CFU, as applicable). We tentatively conclude that
documentation of the results of water testing are necessary to
demonstrate that the water you use meets the requirements of Sec.
112.44 and to provide a history of the microbial quality of your water
system, which will be useful in spotting problems before they occur,
minimizing the potential for water to be a source of contamination to
covered produce. These records are necessary so that FDA can verify
your compliance with those requirements and so that you can ensure your
own compliance with the requirements for water testing and responding
to test results in proposed Sec. 112.44. In proposed Sec.
112.50(b)(6), we would require you to establish and keep that
scientific data or information you rely on to support any alternative
to the requirements established in Sec. 112.44(c) for agricultural
water used during growing activities using a direct water application
method in accordance with the requirements of Sec. 112.44(d). Such
documentation will enable us to verify, and you to ensure, that the
alternative standard you use provides the same level of public health
protection as the standard in proposed Sec. 112.44(c) and does not
increase the likelihood that the covered produce will be adulterated,
in accordance with proposed Sec. 112.12.
We are proposing in Sec. 112.50(b)(7) that if you use water from a
public water system, you must establish and keep annual documentation
(e.g., certificate of compliance, water quality testing results)
demonstrating that system supplies water meeting the microbial
requirements of Sec. 112.45(a)(1) or (2), if applicable. We
tentatively conclude that maintaining such annual documentation is
necessary for FDA to verify that the water you use is not subject to
the requirements for testing under proposed Sec. 112.45 and to ensure
that it meets the microbial requirements of proposed 112.44, and for
you to demonstrate that those requirements have been met. We seek
comment on the appropriateness of the proposed record-keeping
requirements.

F. Subpart F--Standards Directed to Biological Soil Amendments of
Animal Origin and Human Waste

Proposed subpart F establishes standards directed to treated and
untreated biological soil amendments of animal origin and human waste.
These standards include requirements applicable for determining the
status of a biological soil amendment of animal origin; procedures for
handling, conveying, and storing biological soil amendments of animal
origin; provisions regarding the use of human waste in growing covered
produce; acceptable treatment processes for biological soil amendments
of animal origin applied in the growing of covered produce; microbial
standards applicable to treatment processes; application requirements
and minimum application intervals; requirements specific to
agricultural teas; and records requirements. The proposed requirements
in subpart F derive from current recommendations in our GAPs guidance
(Ref. 10), commodity-specific guidances (Ref. 31) (Refs. LGMA), State
regulations (Ref. 90. Ref. 163. Ref. 164), other Federal Regulations
(40 CFR 503, 7 CFR 205), and international guidelines (Ref. 100. Ref.
51).
1. Comments Relevant to Proposed Requirements
We received several comments in response to the 2010 FR notice that
addressed issues relevant to biological

[[Page 3574]]

soil amendments of animal origin and human waste.
a. Definitions
One comment stated that manure and compost are two different
things, and the two words should not be used interchangeably as it
causes confusion. We agree. As discussed in the QAR, and noted in the
Produce Safety Project Issue Brief on Composting of Animal Manures
there are documented differences in the populations and level of human
pathogens in raw manure and animal feces and in properly composted
manure (Ref. 27). We are proposing definitions that make the
distinction clear. We are proposing to use the phrase ``untreated
biological soil amendments of animal origin'' as a category that
includes raw manure (see proposed Sec. 112.3(c) and section
V.A.2.b.iii of this document regarding ``biological soil amendment of
animal origin,'' and proposed Sec. 112.51(a) and section V.F.2.a of
this document regarding ``untreated'' biological soil amendments of
animal origin). We use the term ``treated biological soil amendments of
animal origin'' to include treatments that meet the requirements of the
standards presented in this subpart (see proposed Sec. 112.51(a) and
section V.F.2.a of this document). To further alleviate confusion, we
use the term ``compost'' as a verb, to mean the act of composting, and
do not use it as a noun to describe a soil amendment that was treated
by a composting method. Instead, we use the term ``humus'' in its
common agricultural meaning (see proposed Sec. 112.3(c) and section
V.A.2.b.iii of this document).
b. Consideration of Other Regulations and Guidances
Comments from growers whose operations are certified for organic
produce requested us to ensure that our regulations do not interfere
with existing organic certification systems or organic production
practices. Another comment stated that the California code of
regulations for composting yards (Cal. Code Regs. title. 14, ch. 3.1)
would be an acceptable starting point in developing our regulations.
We consider that organic production practices and food safety are
not cross-competing goals. In developing the provisions proposed in
this rule, we consulted with technical experts and representatives from
other Federal Agencies, including the Environmental Protection Agency,
the Department of Agriculture (including both the National Organic
Program and the Natural Resources Conservation Service), and the
Department of the Interior (Fish & Wildlife Service) (Ref. 115). As
discussed in section III.A.8. of this document, we tentatively conclude
that compliance with the provisions of this proposed rule would not
preclude compliance with the requirements for organic certification in
7 CFR part 205, and we seek comment on this tentative conclusion. Use
of organic practices alone is not sufficient to ensure food safety. The
use of raw manure at a time close to harvest, during organic or
conventional production, presents a significant likelihood of
contamination of covered produce if produce is reasonably likely to
contact the soil. On this particular issue, and as discussed in
sections II.E.4 and V.B of this document, we are working with USDA and
other stakeholders to conduct research on application intervals
necessary to ensure the safety of covered produce when raw manure is
applied to a growing area and covered produce is reasonably likely to
contact the soil. We also note that we considered several regulations,
recommendations, and guidelines that address soil amendments, including
those from State, federal, and international agencies, industry, and
trade associations (including the California code of regulations for
composting yards). In addition, we consulted with experts from multiple
organizations and academia for scientific and technical input on the
issues addressed in these provisions. The provisions proposed take into
account information and input gathered through these consultations.
c. Treatments, Processes, and Practices
One comment suggested that many growers are accepting food waste
compost, which has no manure in it but can often have a readily
detectable level of Salmonella, and stated that ``green waste'' (or
similar) does not necessarily equate to zero risk. Comments stated that
if raw manure is used, there should be a science- and risk-based
standard for determining the application-to-harvest waiting interval
and that maximizing the time interval between soil amendment
application and harvest is only logical if using fresh manure.
Similarly, one comment stated that raw manure can be applied to soil if
it is plowed and then given sufficient time before planting.
Our review of various composting methods suggests that, regardless
of the source, if the process is properly conducted (including proper
turning of feedstock) the expected pathogen load and subsequent
likelihood of produce contamination can be minimized. We agree that
certain sources, including plant material (Ref. 165) and animal sources
(Ref. 166), have differing likelihood of containing human pathogens or
higher population levels of human pathogens. To address this concern,
we propose separate, but related, provisions. First, we do not propose
treatment or timing restrictions for biological soil amendments that do
not contain any animal waste product or human waste (such as would be
the case with yard waste, purely vegetative matter, or shrub trimmings,
or agricultural teas made from such materials). Such biological soil
amendments would not be subject to the requirements in proposed subpart
F because they would not fit the definition of ``biological soil
amendments of animal origin'' and they do not contain human waste.
Further, in Sec. 112.51(b)(4) we propose that a biological soil
amendment of animal origin contains a component that is untreated waste
that you know or have reason to believe is contaminated with a hazard
or has been associated with foodborne illness, you must regard it as if
it were an untreated biological soil amendment of animal origin for
application and treatment purposes if you still wish to utilize it. In
addition, we treat ``table waste'' as ``animal waste'' for the purposes
of the definition of biological soil amendments of animal origin. As
discussed in the QAR, post-consumer waste, or table waste (such as
plate scrapings), has a greater likelihood of being contaminated, or
contaminated at higher populations, with human pathogens due to its
unknown content (e.g., animal products, vegetable products, etc.) and
its greater likelihood of containing human fluids or waste (e.g.,
spittle, vomitus, etc) (Ref. 167).
Proposed Sec. 112.56(a)(1)(i) would require that if you apply a
biological soil amendment of animal origin that is untreated (such as
raw manure), where covered produce is reasonably likely to contact the
soil after application, the material must be applied in a manner that
does not contact covered produce during application and minimizes the
potential for contact with covered produce after application and the
minimum application interval is nine (9) months. In section V.F.2.f. of
this document we discuss the reasons for this proposed requirement in
detail. Proposed Sec. 112.56(b) would allow you to establish and use
an alternative application interval under certain conditions (discussed
further in section V.B. of this document). In situations where the
covered produce will not contact the soil after application, proposed
Sec. 112.56(a)(1)(ii) would require that the biological soil

[[Page 3575]]

amendment of animal origin be applied in a manner that does not contact
the produce at or after application, but would not require an
application interval. Also, as discussed in section II.E.4. of this
document, FDA is collaborating with partners on research that may
provide scientific support for specific alternatives to this proposed
application interval.
One comment stated that compost made with animal manure must meet
temperature, mixing, and time requirements to ensure its safety,
whereas another comment stated that biologically active soil suppresses
pathogens and that E. coli pathogens decline more rapidly in soils with
a large diversity of microorganisms rather than in sterile soils. One
comment recommended that we require compost operations to have standard
operating procedures, a quality assurance plan, compost testing within
specified timeframes of sale, and a Hazard Analysis Critical Control
Point (HACCP) program. According to this commenter, several growers are
requesting testing prior to purchase, and are refusing compost that has
not been recently tested.
Based on our review of the literature and as discussed in our QAR,
we determined that improper composting will not have the desired
pathogen reduction effect, and may enhance the survival of pathogenic
organisms (Ref. 168). Therefore, we propose specific time and
temperature controls for composting procedures in proposed Sec.
112.54(c), and further recognize the need for composters to consider
other factors that will impact the successful treatment of their
particular composting situation (e.g., feedstock, C:N ratios, pH). We
consider that the potential effects of soil ecological diversity on
pathogen populations are regionally specific, and may be highly
effective under some circumstances, while potentially inert under other
circumstances. We recognize the need for consistent treatment by
suppliers of treated biological soil amendments of animal origin, and
for assurance by those that use such amendments that the material has
been produced under adequate conditions, to avoid it being a source of
contamination. We have tentatively concluded that the most reliable and
least burdensome proposal regarding the use of purchased treated
biological soil amendments of animal origin is to require growers to
obtain certain documentation (such as a Certificate of Conformance)
from the treating operation that validated treatment methods were
utilized, the treatment process is periodically verified through
testing, and good handling practices were followed. This is proposed in
subpart 112.60(b)(2) and we request comment on this proposed
requirement, including periodic verification through testing.
d. Testing for Pathogens
Several comments suggested that variable minimum application-to-
harvest waiting intervals should be applied using science-based
knowledge about pathogen levels in and transfer from compost, and that
if a compost tests pathogen-free, there should be no time limit between
application, planting, and harvest. Another comment stated that
pathogen testing has significant limitations, and that it would be more
important to evaluate a treatment process to ensure that it is
effective in inactivating pathogens.
We considered testing of individual lots of biological soil
amendments of animal origin as a means to determine if they were
suitable for application to a fresh produce growing area and
tentatively conclude that such testing is not a reliable means of
determining the safety or expected likelihood of contaminating produce
by use of biological soil amendments of animal origin. We have multiple
concerns that led us to this conclusion. First, we were unable to
determine standardized testing methods, such as sample collection
methods, sample collection times, or location of sample collection,
which would yield repeatable and reliable results under different
circumstances. Second, we were unable to determine the frequency and
sample size that would reliably indicate the microbiological safety of
a given manure lot. Third, we recognize that there are numerous
pathogens which may be present in biological soil amendments of animal
origin and that pathogen testing would be necessary for all such
potential contaminants, which would be a significant economic burden.
Therefore, we tentatively conclude that an approach that is the most
reasonable and the most protective of public health would involve the
use of treatments that have been validated to meet certain specified
microbial standards as proposed in this subpart.
e. Research Needs
Some comments suggested that there is a need for research to
identify means other than through heat to inactivate pathogens, and
that such alternative approaches may be more practical for farmers.
Comments opined on the use of chemical inactivation, and noted that the
effectiveness of use of volatile acids or ammonia in the inactivation
of pathogens is not fully established but that further research may
help refine time and temperature parameters for chemical inactivation.
We agree that further research and innovation may lead to
alternatives to heat treatments. Proposed Sec. 112.54 addresses the
use of physical processes, chemical processes, or combinations of
physical and chemical processes, in addition to composting, that may be
used as treatments for biological soil amendments of animal origin,
provided that they meet the applicable requirements of Sec. 112.55 and
the treated biological soil amendment of animal origin is applied in
accordance with the applicable requirements in Sec. 112.56. We
consider heat treatments to be physical processes within the meaning of
that term in Sec. 112.54, and we have purposefully chosen the broader
term ``physical processes'' to allow for possibilities other than heat
treatment. Thus, these proposed requirements would allow for the use of
alternatives to heat treatment, and are intended to be flexible to
foster innovation and development of new means of treating biological
soil amendments of animal origin to ensure produce safety.
2. Proposed Requirements
As proposed in Sec. 112.3, ``soil amendment'' would be defined to
mean any chemical, biological, or physical material (such as elemental
fertilizers, humus, manure, non-fecal animal byproducts, peat moss,
perlite, pre-consumer vegetative waste, sewage sludge biosolids, table
waste, agricultural tea and yard trimmings) intentionally added to the
soil to improve the chemical or physical condition of soil in relation
to plant growth or to improve the capacity of the soil to hold water.
Additionally, ``biological soil amendment'' would be defined in Sec.
112.3 to mean any soil amendment containing biological materials such
as humus, manure, non-fecal animal byproducts, peat moss, pre-consumer
vegetative waste, sewage sludge biosolids, table waste, agricultural
tea, or yard trimmings, alone or in combination. Finally, proposed
Sec. 112.3 would define ``biological soil amendment of animal origin''
to mean a biological soil amendment which consists, in whole or in
part, of materials of animal origin, such as manure or non-fecal animal
byproducts, or table waste, alone or in combination, and would specify
that the term does not include any form of human waste. See section
V.A.2.b.iii. of this document. Proposed subpart F is focused on
biological soil amendments of animal origin, which include animal

[[Page 3576]]

manures and other materials of animal origin that you intentionally add
to a growing area, and on human waste. Standards directed to animal
feces deposited by domestic or wild animals that are not a part of your
planned growing activities (e.g., by working animals, by animals that
graze or encroach into your growing areas) are proposed to be included
in subpart I, as discussed in section V.I. of this document.
As discussed in the QAR, animal waste is likely to contain
bacterial pathogens (e.g., Campylobacter, Salmonella spp.,
enterohemorrhagic E. coli) and various other pathogens such as
parasites (e.g., Cryptosporidium parvum, helminthes), which may infect
humans. The type of pathogen that may be present, and the extent to
which it may be present, is dependent on the source of the manure
(e.g., E. coli is more common from ruminants such as cattle, whereas
Salmonella is more common from fowl such as chickens) and the rearing
practices of the source animals (e.g., animals from densely populated
farms or farms with a high population of immature animals have an
increased likelihood of harboring various pathogens) (Ref. 169).
Enteric (or gastroinstestinal) pathogens are not generally considered
to be environmental, and are more commonly expected to be derived (and
in higher populations) from a human or animal source (e.g., through
feces, mortalities, blood, spittle, etc.) (Ref. 170). Material that
does not contain any animal waste is far less likely to harbor these
food safety hazards at microbial populations that can reasonably be
expected to lead to severe adverse health consequences or death (Ref.
94). We have tentatively concluded that the likelihood of contaminating
produce by use of biological soil amendments that do not contain animal
waste or human waste (e.g., yard trimmings, pre-consumer vegetative
waste) carrying human pathogens is low. Similarly, we are unaware of a
situation in which chemical and physical soil amendments, such as
elemental fertilizers (e.g., potash, aqueous nitrates), soil
stabilizers (e.g., sand or crushed rock) or others typically made of
mined or synthetic materials, have served as sources of microbial
contamination and, therefore, neither chemical nor physical soil
amendments are a focus of provisions of this rule. Therefore, in this
proposed subpart F, we are proposing to focus on biological soil
amendments of animal origin and human waste, which present a reasonable
likelihood of harboring human enteric pathogens. Unless otherwise
specifically noted, chemical soil amendments, physical soil amendments,
and biological soil amendments that are not of animal origin (other
than those that contain human waste, which are covered by proposed
Sec. 112.53) are not covered by this rule. We encourage comment on our
tentative decision not to provide requirements for the use of these
kinds of soil amendments in this proposed rule.
a. Requirements for Determining Status
Proposed Sec. 112.51 would establish requirements for determining
the status of a biological soil amendment of animal origin for use in
covered activities. Proposed Sec. 112.51(a) would categorize a
biological soil amendment of animal origin as treated if it has been
processed to completion to adequately reduce microorganisms of public
health significance in accordance with the requirements of Sec.
112.54, or in the case of an agricultural tea, the biological materials
used to make the tea have been so processed and the water used to make
the tea satisfies the requirements of 112.44(a). Section 112.51(b)
would categorize a biological soil amendment of animal origin as
untreated if: (1) It has not been processed to completion in accordance
with the requirements of Sec. 112.54, or in the case of an
agricultural tea, the biological materials used to make the tea have
not been so processed or the water used to make the tea does not
satisfy the requirements of 112.44(a); (2) it has become contaminated
after treatment; (3) it has been recombined with an untreated
biological soil amendment of animal origin; (4) it is or contains a
component that is untreated waste that you know or have reason to
believe is contaminated with a hazard or has been associated with
foodborne illness; or (5) it is an agricultural tea that contains an
agricultural tea additive.
Proposed Sec. 112.51(a) would provide a simple method of referring
to biological soil amendments of animal origin as treated if they have
received one of the treatment processes described in proposed Sec.
112.54. We discuss those treatment process options in detail in section
V.F.2.d of this document. Agricultural teas are mentioned separately
for two reasons. First, treatments are typically applied to the
biological materials used to make agricultural teas rather than to the
teas themselves and our explicit mention of this fact is intended to
aid in clarity. Second, we specify that the water used to make a
treated agricultural tea must meet the standard in proposed Sec.
112.44(a) to prevent the introduction of pathogens into treated
agricultural teas, which can be applied with fewer application
restrictions than untreated agricultural teas in accordance with
proposed Sec. 112.56. As discussed in section V.E.2.d of this
document, the conditions under which agricultural tea is produced
(moist and nutrient-rich) support the multiplication of pathogens, if
present (Ref. 142). Even a low number of pathogens introduced into or
onto covered produce through contaminated water could rapidly increase
to levels that could present risk of serious adverse health
consequences or death to those who consume the covered produce for
which the tea was used (Ref. 142).
Proposed Sec. 112.51(b) addresses the situations in which a
biological soil amendment of animal origin should be regarded as
untreated because they present a greater likelihood of contamination to
covered produce than a treated biological soil amendment of animal
origin. A treated biological soil amendment of animal origin can be
expected to have a high content of available nutrients and minerals
which can support rapid and prolific microbial population growth if
sufficient moisture is available, possibly with limited competitive
native microflora (Ref. 171) (depending on the specific treatment,
treatment parameters, and handling used, (e.g., heat treated poultry
manure pellets would be expected to have limited microorganism content
including competitive native microflora, and composted manure would be
expected to have substantial competitive native microflora)) (Ref. 171.
Ref. 172). Accordingly, pathogens could grow prolifically in a treated
biological soil amendment of animal origin if it were to become
contaminated through contact or partial mixing with an untreated
biological soil amendment of animal origin, or other potential
contaminant source, and if sufficient moisture were available (Ref.
171). Prolific microbial growth could also occur through premature
termination of treatment, which could leave surviving microorganisms
and a higher moisture content than after composting is completed. In
addition, if a biological soil amendment of animal origin contains a
component that is untreated waste that you know or have reason to
believe is contaminated with a hazard or has been associated with
foodborne illness, we tentatively conclude that the increased
likelihood of pathogen presence in such materials results in a need to
apply the most stringent controls to their use in the growing of

[[Page 3577]]

covered produce. Prolific growth of a human pathogen in a nutrient-
rich, possibly competition poor, biological soil amendment of animal
origin could lead to the amendment acting as an inoculum that spreads
microorganisms on any field or covered produce growing area to which
the amendment may be applied, leading to a potential significant
likelihood of produce contamination. To avoid such inoculation, we
propose to require you to regard any biological soil amendment of
animal origin that is partially or incompletely treated as an untreated
biological soil amendment of animal origin. Finally, we tentatively
conclude that agricultural teas that contain agricultural tea additives
should be regarded as untreated biological soil amendments in light of
their content and the likelihood that they contain human pathogens.
As discussed in section V.F.2.f. of this document, we tentatively
conclude that the treatment process (including composting processes)
can reduce the populations of pathogens significantly. However, it has
been recently reported that while pathogens that are present in
agricultural teas made from properly composted humus are reduced to
undetectable levels within 8.5 days, such agricultural teas with added
nutrient supplements (i.e., agricultural tea additives) allow low
populations of remaining E. coli O157:H7, Salmonella, and fecal
coliforms to grow and multiply (Ref. 142). For this reason, we propose
to impose the same application restrictions on agricultural teas that
have been prepared with nutrient additives as those that we propose for
the use of untreated biological soil amendments of animal origin, such
as raw manure (proposed Sec. 112.56(a)(1)(i)), and seek comment on
this proposal. See section V.F.2.f. of this document for further
discussion of the reasons for these restrictions.
b. Requirements for Handling, Conveying, and Storing
Proposed Sec. 112.52 would establish requirements for handling,
conveying and storing soil amendments of animal origin. Specifically,
we propose in Sec. 112.52(a) that you handle, convey, and store any
biological soil amendment of animal origin in a manner and location
such that it does not become a potential source of contamination to
covered produce, food-contact surfaces, areas used for a covered
activity, water sources, and water distribution systems. As discussed
immediately above, prolific growth of a human pathogen in a potentially
competition-poor, nutrient-rich, biological soil amendment of animal
origin could lead to the amendment acting as an inoculum that spreads
microorganisms on any field or covered produce growing area to which
the amendment may be applied, as well as to food-contact surfaces,
areas used for covered activities, water sources, and water
distribution systems. To fulfill the proposed requirement in Sec.
112.52(a), we would expect you to take specific measures to ensure that
untreated biological soil amendments of animal origin do not
contaminate covered produce directly or indirectly through contact with
food contact surfaces, areas in which covered activities are conducted,
water sources, or distribution systems. Such measures may include, for
example, separation of treated and untreated manure (or other
biological soil amendments of animal origin) and preventing any
leachate originating from untreated biological soil amendments of
animal origin from becoming a source of contamination for source water
or water distribution systems (Ref. 173).
As discussed in the QAR, any untreated biological soil amendment of
animal origin that contaminates a food contact surface could be a
source of further cross-contamination to covered produce. Moreover, a
biological soil amendment of animal origin that has been treated by a
composting process may still have a residual population of pathogens,
since composting is not a complete kill step (Ref. 174); therefore,
such biological soil amendments require a multiple hurdle approach to
minimize the likelihood of introducing pathogens to a field on which
they are applied. If composted material contaminates a food contact
surface, the combined presence of available nutrients plus any
pathogens that may have survived the composting process present a
potential source of contamination for any covered produce that comes in
contact with the contaminated food contact surface. Further, a fully
heat-treated biological soil amendment of animal origin, while
reasonably likely to be free of pathogens, may act as a source of
nutrients for pathogens that might contaminate the food contact
surface, thereby allowing them to multiply and pose a likelihood of
contaminating any produce coming in contact with the food contact
surface.
As proposed, Sec. 112.52(b) requires that you handle, convey and
store any treated biological soil amendment of animal origin in a
manner and location that minimizes the likelihood of it becoming
contaminated by an untreated or in-process biological soil amendment of
animal origin. This proposed requirement is necessary because a
biological soil amendment of animal origin previously treated to reduce
pathogens can become re-contaminated by pathogens if not properly
handled and stored (Ref. 175). For example, if you fully compost manure
produced by your cows with the intent of using it to amend a field you
use to grow covered produce, proposed Sec. 112.52(b) would require
that you handle, convey, and store the fully composted manure in a
manner and location to prevent its contamination by raw manure, or by
manure in the composting process. This requirement is critical because
bacterial pathogens, such as E. coli O157:H7 or Salmonella spp., if
allowed to re-contaminate finished compost, may grow and spread to
populations that present a significant likelihood of contaminating any
environment in which the soil amendment is used (Ref. 171). An example
of cross-contamination may include turning a pile of manure that is in
the process of composting with a front-end loader, and then proceeding
to handle fully composted humus from a mature pile with the same
equipment. To avoid such cross-contamination, you could clean the
front-end loader between manipulating an incomplete pile and
manipulating a mature pile; move ``downstream,'' beginning with
sanitary equipment and manipulating the most mature piles first, then
proceeding to less mature piles; or designate certain equipment to only
be used on piles of a certain maturity; or adopt other strategies that
meet the same goals.
Proposed Sec. 112.52(c) would require you to handle, convey, and
store any biological soil amendment of animal origin that has become
contaminated (for example, by an untreated or in-process biological
soil amendment of animal origin) as if it was untreated. In other
words, a treated biological soil amendment of animal origin that has
become contaminated would need to be applied in accordance with the
application and interval restrictions of proposed Sec. 112.56(a)(1)
for untreated biological soil amendments of animal origin, or it would
need to be treated in compliance with one of the options in proposed
Sec. 112.54 and then applied in accordance with the applicable
requirements in Sec. 112.56 for the treatment used. For example, if a
treated or in-process biological soil amendment of animal origin
becomes unintentionally contaminated (e.g., from runoff from an
untreated biological soil amendment of animal origin), you would either
need to treat that material in accordance with an option in proposed
Sec. 112.54 and then apply it in

[[Page 3578]]

accordance with the applicable requirements in Sec. 112.56 for the
treatment used, or you would have to follow the application
requirements for untreated biological soil amendments of animal origin
in proposed Sec. 112.56(a)(1) for the contaminated material.
c. Prohibition Regarding Use of Human Waste
Proposed Sec. 112.53 would prohibit the use of human waste for
growing covered produce, except sewage sludge biosolids used in
accordance with the requirements of 40 CFR Part 503, subpart D, or
equivalent regulatory requirements. Human waste has a high probability
of containing multiple diverse human pathogens, including bacteria,
parasites and viruses, at potentially very large populations, thus
presenting a significant likelihood of harboring and spreading these
various microbiological hazards (Ref. 92). We recognize that an
application of untreated human waste could occur outside of your
control (for example, as a run-off event from adjacent land not under
your control), or may have occurred as a previous use of land before
you took possession. If you know or have reason to believe such an
event has occurred, we would expect you to take measures reasonably
necessary to minimize the risk of serious adverse health consequences
or death based on your specific circumstances. Such measures may
include crop diversion, reconditioning or destruction, and/or land
remediation, or other comparable methods.
Under 40 CFR part 503 subpart D (Sec. 503.30, 31, 32 and 33), the
U.S. EPA requires that the application of sewage sludge biosolids to
fields in which food or feed crops are grown adhere to certain pathogen
reduction requirements, and use certain vector attraction reduction
options. Depending on which options are implemented, there are
different ranges of wait periods between application of the soil
amendment, and the harvest of the crop grown. For example, if an
untreated human waste (i.e., equivalent to domestic septage: ``Liquid
or solid material removed from a septic tank, cesspool, portable
toilet'') (40 CFR 503.9(f)), is applied to a field used to produce a
food crop, then ``Food crops with harvested parts that touch the sewage
sludge/soil mixture and are totally above the land surface shall not be
harvested for 14 months after application of sewage sludge'' (40 CFR
503.32(c)(1), cross-referencing Sec. (b)(5) of the same section). We
agree these standards are appropriate for protecting public health and,
therefore, we are not proposing to implement further restrictions. Our
proposed definition of agricultural teas, discussed in section
V.A.2.b.iii. of this document, would provide that agricultural teas are
not made from any form of human waste because doing so would not be
permissible under 40 CFR part 503 subpart B.
d. Acceptable Treatment Processes
Although there is great variability in available data on pathogen
survival in animal manure depending on the type and source of manure in
question, the location and environment under which the manure is
stored, and numerous other factors (Ref. 176. Ref. 177. Ref. 178) there
are data to suggest it is reasonable to expect that, given the proper
conditions, pathogens in certain animal manures may survive for months
(Ref. 179), years (Ref. 180), or even indefinitely (Ref. 174). Because
the use of soil amendments that contain materials of animal origin
poses a significant likelihood of contaminating the growing environment
and covered produce with human pathogens, we have tentatively concluded
that such materials used as a soil amendment require some level of
treatment, or other risk-reducing steps (such as application
restrictions), for use in the growing of covered produce. Proposed
Sec. 112.54(a)-(c) would establish acceptable treatment processes for
a biological soil amendment of animal origin when applied in the
growing of covered produce, along with associated microbial standards
against which they must be validated in proposed Sec. 112.55. A
validated process, when properly implemented and monitored, would be
expected to meet the listed microbial standards and thereby reduce the
likelihood of hazards associated with biological soil amendments of
animal origin from contaminating covered produce. The microbial
standards in proposed Sec. 112.55 are not meant as lot-by-lot
microbial testing requirements. Instead, the person applying the
treatment process would need to monitor the physical parameters of the
process (e.g., temperature of a compost pile) to ensure that they meet
the conditions under which the process was validated. In addition,
proposed Sec. 112.54 would provide that the resulting biological soil
amendments must be applied in accordance with the applicable
application requirements in Sec. 112.56. We seek comments on this
approach.
The underlying framework for the provisions of Sec. Sec.
112.54(a)-(c), 112.55, and 112.56 is that as the likelihood that a
method of application of a biological soil amendment of animal origin
will result in it contacting covered produce increases, the extent of
measures taken to reduce the likelihood of known or reasonably
foreseeable microbial hazards being present in the applied soil
amendment must also increase. That is, for an application practice that
is more likely to result in the amendment contacting covered produce
(e.g., broadcast application of a soil amendment vs. subsurface soil
amendment injection for the same crop, or in-row application of a soil
amendment for a row crop vs. in-row application for a tree crop), it is
more important to have stricter controls for known or reasonably
foreseeable microbial hazards in the applied soil amendment than for
another amendment whose application practice is less likely to result
in the amendment coming into contact with covered produce. Therefore,
proposed Sec. 112.54 consists of multiple acceptable options for the
treatment of soil amendments and corresponding standards against which
they are to be validated (as further described in Sec. 112.55). These
proposed treatment options were designed to be flexible to allow you to
determine what your operation's needs are, and select the option that
best fits those needs. In developing these proposed requirements, we
have taken into account the wide variation presented by different
feedstocks used in preparing biological soil amendments of animal
origin, the diversity of commodities, and various growing regions. In
addition, we considered the likelihood of contamination posed by
biological soil amendments of animal origin subjected to each of these
multiple treatment options when determining the appropriate application
requirements, as proposed in Sec. 112.56. We have tentatively
concluded that the use of the physical, chemical, and composting
treatments listed in proposed Sec. 112.54(a)-(c), when applied in
accordance with proposed Sec. 112.56, are capable of adequately
reducing pathogen levels in biological soil amendments of animal
origin. We request comment on the appropriateness of each of the
options considered, and discussion of any other options not listed in
proposed Sec. 112.54.
Physical treatments usually involve some form of high-heat
treatment (cooking) of the biological soil amendment of animal origin
to kill undesirable microorganisms. By contrast, chemical treatments
usually involve greatly altering the pH of a biological soil amendment
of animal origin, to the point that undesirable

[[Page 3579]]

microorganisms do not survive. In a study treating chicken manure with
ammonia to reach high (alkaline) pH levels, a 3 to 4 log decrease of
generic E. coli was observed over 6 days at 20[deg]C, and drying manure
to 10% moisture content and exposing it to ammonia gas (1% of manure
wet weight) reduced pathogen load by 8 log (99.999999% reduction) (Ref.
181). To perform either physical or chemical treatments, the feedstock
is generally placed in a large treatment container, and large amounts
of energy are required in order to initiate the treatment. These
factors alone make these forms of treatment impracticable for many
farms. While such treatments can be expected to have a strong lethal
impact on microorganisms present in the feedstock, they do not always
result in complete elimination of pathogens. For example, chicken
manure may be heat-treated to create a dried, pelleted material that is
functionally sterile due to the high heat used during production;
however, it has been observed that if the heat treatment is not
uniform, the end product may still harbor human pathogens and pose a
likelihood of the material being re-colonized by the microbial
pathogen, leading to the possible contamination of any covered produce
to which it is applied (Ref. 115).
Biological soil amendments of animal origin may also be prepared by
combining multiple treatments, either alone or in combination. For
example, a single feedstock may be heat-treated (physical) while also
drenched in strong ammonia (chemical) to acidify the material (Ref.
182). Alternatively, feedstock may first be composted and then treated
by heat to further reduce pathogens, effectively pasteurizing the
material, as is common practice in the production of mushroom growth
media (Ref. 183). These systems have been shown to be highly effective
when proper controls are in place and monitored, but they also require
significant inputs and capital investments.
Proposed Sec. 112.54(a) would establish that a scientifically
valid controlled physical process (e.g., thermal), chemical process
(e.g., high alkaline pH), or combination of scientifically valid
controlled physical and chemical processes that have been demonstrated
to satisfy the microbial standard in Sec. 112.55(a) for Listeria
monocytogenes, Salmonella spp., and E. coli O157:H7 is a treatment
option for biological soil amendments of animal origin. This standard
is currently used by the mushroom industry, which utilizes a two-phase
process consisting of a composting treatment that meets the composting
standard proposed in Sec. 112.54(c) followed by a subsequent heating
process that meets the microbial standard of proposed Sec. 112.55(a).
Together, the treatment reduces over 7 log cfu/g of Listeria,
Salmonella, and E. coli O157:H7 to undetectable levels (Ref. 183). It
also eliminates much of the native microflora (Ref. 183). We have
tentatively concluded that a treatment meeting this standard would
significantly reduce or eliminate known or reasonably foreseeable
microbial hazards in biological soil amendments of animal origin, and
would constitute the lowest expected likelihood of any of the proposed
treatment options. We have also tentatively concluded that a biological
soil amendment of animal origin that has been treated to this standard
would be appropriate for use when the likelihood for contamination of
covered produce is the highest, such as the substrate (growth media)
used for growing mushrooms and some sprouts. Therefore, as provided in
proposed Sec. 112.56(a)(2) and discussed further in section V.F.2 f of
this document, any biological soil amendment of animal origin treated
to this standard would have the fewest limitations on its application.
Proposed Sec. 112.54(b) would establish that a scientifically
valid controlled physical process, chemical process, or combination of
scientifically valid controlled physical and chemical processes, that
has been demonstrated to satisfy the microbial standard in Sec.
112.55(b) for Salmonella and fecal coliforms is a treatment option for
biological soil amendments of animal origin. We have tentatively
concluded that a treatment meeting this standard would significantly
reduce known or reasonably foreseeable microbial hazards in biological
soil amendments of animal origin leading to minimal likelihood of
contamination. A biological soil amendment of animal origin that has
been treated to this standard would be appropriate for use when there
is a high likelihood that the soil amendment will come into contact
with covered produce. Moreover, as provided in proposed Sec. 112.56
and discussed further in section V.F.2.f of this document, any
biological soil amendment of animal origin treated to this standard
would have minimal limitations on its application.
Proposed Sec. 112.54(c) would establish that a scientifically
valid controlled composting process that has been demonstrated to
satisfy the microbial standard in Sec. 112.55(b) for Salmonella and
fecal coliforms is a treatment option for biological soil amendments of
animal origin. Two specific scientifically valid controlled composting
processes that could be used to meet the requirements of proposed Sec.
112.54(c) are provided: (1) Static composting that maintains aerobic
(i.e., oxygenated) conditions at a minimum of 131[emsp14][deg]F (55
[deg]C) for 3 days and is followed by adequate curing, which includes
proper insulation; and (2) turned composting to maintain aerobic
conditions at a minimum of 131[emsp14][deg]F (55 [deg]C) for 15 days,
with a minimum of five turnings, and is followed by adequate curing,
which includes proper insulation. These two composting processes are
currently considered by the U.S. Environmental Protection Agency as
Processes to Further Reduce Pathogens (Appendix B to 40 CFR part 503,
part B.1). Both are recommended for use by the U.S. Department of
Agriculture's Agricultural Research Service (Ref. 184), Natural
Resources Conservation Service (Ref. 97), and National Organic Program
(7 CFR part 205), and both are commonly accepted practices within the
industry (Ref. 185). While there is robust discussion in the literature
on times, temperatures, and other conditions (pH, moisture, oxygen
levels, etc.) needed for significant reductions (albeit not
elimination) of human pathogens in cattle, sheep and chicken manures,
it is clear that composting cannot be considered as a pathogen-
elimination step because of the many variables that can affect the
efficacy of the composting process (e.g., feedstock mixtures, climatic
conditions, and various other physio-chemical parameters) (Ref. 174).
These limits are currently used as composting endpoints by other
federal agencies (40 CFR 503) States (Ref. 90. Ref. 164. Ref. 163), and
industry (Ref. 31).
Composting is generally the least expensive method with the lowest
capital investment requirement, and if properly managed, can be
expected to significantly reduce pathogen populations in feedstock
materials (Ref. 186). As noted in the Produce Safety Project Issue
Brief on Composting of Animal Manures, composting has been shown to
reduce the overall concentration of nitrogen in the soil amendment,
which poses a concern for some farmers, but it also has been
demonstrated that the remaining nitrogen is both in a more bio-
available state (i.e., more easily utilized by plants) and will persist
in the environment for a longer time (therefore providing nutrients to
plants for a longer time) (Ref. 27). Composting leaves much of the
native microflora intact (Ref. 187).

[[Page 3580]]

Proper composting is not difficult for most operations, but it does
require a labor commitment to ensure conditions are met and maintained
to achieve the desired effect. Some of the most critical elements of
composting include proper stacking of a pile, proper aeration and
turning, and ensuring the pile attains the proper temperature and is
allowed to cool (cure) for an adequate time (Ref. 27). There are
currently no federally mandated composting standards for food safety.
The USDA/NOP offers standards that are meant to maximize soil fertility
in 7 CFR 205.203 (these are required to achieve ``USDA Certified
Organic'' status, but otherwise are recommendations only), and EPA
standards in 40 CFR part 503 are specific to sewage sludge, not animal
manures. While these standards were not developed for food safety,
several studies suggest that they would be appropriate for use as food
safety measures (Ref. 27). Proper handling and storage during and after
composting to avoid cross-contamination of cured product and in-process
or raw product is critical, as discussed in section V.F.2.b of this
document above regarding proposed Sec. 112.52 of this rule. Other
important factors in proper composting (such as the carbon to nitrogen
ratio of the feedstock (C:N), the moisture content of the pile, the
reaction to high cellulose-content material (i.e., plant material such
as straw or vegetative waste), and the specifics of the beneficial
microbial content will vary depending on the feedstock (Ref. 187). The
person who manages the composting process would also need to consider
such factors as the moisture content, pH, carbon to nitrogen ratio
(C:N), and feedstock to achieve the microbial standards set forth in
proposed Sec. 112.55. Many resources are available that discuss these
details, such as the USDA NRCS handbook (Ref. 97). When composting
processes are carried out in an incorrect manner, the organic matter in
the finished product remains poorly stabilized and recontamination is
more likely to occur, which can potentially result in the compost
becoming a source of pathogens that could contaminate the field to
which it is applied and any crops that are grown in the amended soil
(Ref. 165).
As noted in the Produce Safety Project Issue Brief on Composting of
Animal Manures, adequate curing, including proper insulation (usually
consisting of around one foot thick of insulating material, e.g., hay,
straw, finished compost) is included as part of this proposed
requirement, because curing is an important step in the composting
process to further reduce the levels of pathogens, complete the
chemical reactions of composting, and mitigate the impact that
incomplete turning (creating temperature stratification within an
active pile) would have on composting efficacy (Ref. 27). Proper
insulation serves as a layer of protection from external influences
(e.g., temperature changes, wild animal encroachment).
The treatment processes proposed in Sec. 112.54(c), paragraphs (1)
and (2), may not be the only means of achieving adequate composting to
meet the microbial standards in proposed Sec. 112.55(b). Therefore, we
have tentatively concluded that it would be appropriate to allow for
the use of static or turned composting protocols other than those
specified in Sec. 112.54(c)(1) and (2), if they meet the microbial
standards for validation for composting in proposed Sec. 112.55(b).
Proposed Sec. 112.54(c)(3) allows for the use of other scientifically
valid, controlled composting processes, provided you satisfy the
requirements of Sec. 112.12, including that the alternative has been
demonstrated to satisfy the microbial standard in Sec. 112.55(b). No
such alternatives are provided for the treatment requirements of Sec.
112.54(a) and 112.54(b), because those parts do not explicitly define
the processes to be conducted to meet the microbial standards
presented; therefore, any scientifically valid controlled physical,
chemical, or combination of physical and chemical processes that has
been demonstrated to satisfy the relevant microbial standard in either
Sec. 112.55(a), or Sec. 112.55(b) will meet the requirements of those
subparts.
e. Microbial Standards Applicable to Treatment Processes
Proposed Sec. 112.55 establishes microbial standards applicable to
the treatment processes in Sec. 112.54. Proposed Sec. 112.55(a) would
provide microbial standards for the treatment process in proposed Sec.
112.54(a). It would require: (1) L. monocytogenes to be not detectable
using a method that can detect one colony forming unit (CFU) per five
gram analytical portion; (2) Salmonella spp. to be less than 3 most
probable number (MPN) per four grams of total solids (dry weight
basis); and (3) E. coli O157:H7 to be less than 0.3 MPN per 1 gram
analytical portion. As discussed immediately above regarding proposed
Sec. 112.54(a), these standards are the most stringent and meant for
applications in which a biological soil amendment of animal origin
would otherwise pose the greatest likelihood of transferring a known or
reasonably foreseeable hazard to a covered produce commodity. These
standards would also be useful if you wanted to use a biological soil
amendment of animal origin with the least amount of application
restrictions available under proposed Sec. 112.56. As previously
noted, these microbial standards are currently used by the mushroom
industry for growth media and reduce over 7 log CFU/g of Listeria,
Salmonella, and E. coli O157:H7 to undetectable levels (Ref. 183).
Proposed Sec. 112.55(b) would provide two microbial standards,
both of which must be satisfied for the treatment processes in proposed
Sec. 112.54(b) and (c). This section would require less than 3 MPN
Salmonella spp. per 4 grams of total solids (dry weight basis), and
less than 1,000 MPN fecal coliforms per gram of total solids (dry
weight basis). These limits are currently used as composting validation
endpoints by EPA (40 CFR 503), some States (Ref. 90. Ref. 164. Ref.
163), and industry (Ref. 31). Ohio and California (Ref. 163. Ref. 164),
industry (Ref. 31) and other nations such as Canada and the United
Kingdom (Ref. 27) use both of these criteria, while EPA and Florida
(Ref. 92. Ref. 90) allow for either criteria to be used. As noted in
the Produce Safety Project Issue Brief on Composting of Animal Manures,
the EPA requirement of validation with either Salmonella spp. or fecal
coliforms is based on the observation that reduction in fecal coliforms
is well correlated to reduction in Salmonella spp. when biosolids are
composted (Ref. 27). However, we tentatively conclude that satisfying
both of these criteria is necessary to significantly minimize known or
reasonably foreseeable hazards when combined with the applicable
application requirements in proposed Sec. 112.56. Monitoring the
relative levels of indicator microbes such as fecal coliforms, which
are predominantly E. coli in manures and freshly mixed compost, is
advantageous in that they are abundant in manure. In the absence of a
reliably present pathogen, fecal coliforms are useful to validate the
efficiency of the thermophilic composting process (Ref. 27).
Additionally, E. coli, the primary fecal coliform in manure, has been
documented to be a good indicator of the inactivation of E. coli
O157:H7 (Ref. 168). Validating solely with Salmonella spp. is not
sufficiently protective or useful for validating the efficiency of a
thermophilic composting process, since Salmonella spp. cannot be
assumed to be present in all composting feedstock materials. On the
other hand,

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Salmonella spp. is the most common microbiological hazard associated
with fresh produce (Ref. 3). As such, validating with fecal coliforms
and Salmonella spp. not only assures the efficacy of the thermophilic
composting process but also assures significant reduction of the
pathogen Salmonella spp. when commonly used compost feedstocks are used
that are likely sources of Salmonella spp. (e.g., cattle and poultry
manure) (Ref. 188). We seek comment on these proposed microbial
standards and potential alternatives.
We do not intend this proposed provision to require that farms test
their treated biological soil amendments for compliance with the
microbial standards. Rather, we intend this provision to provide the
standard against which treatment processes must be validated. Farms
would be able to use treatment processes that are validated to meet the
relevant microbial standard in this section without needing to test the
end products of their treatments to confirm that the microbial standard
was achieved.
f. Application Requirements and Minimum Application Intervals
Proposed Sec. 112.56 establishes the application requirements and
minimum application intervals applicable to biological soil amendments
of animal origin. Proposed Sec. 112.56(a) would establish a
requirement that, except as provided in subparagraph (b), any
biological soil amendment of animal origin that you use must be applied
with the application method requirements and minimum application
intervals specified in the table presenting proposed Sec.
112.56(a)(1)-(4). The different application method requirements and
intervals for biological soil amendments of animal origin are presented
so that you may determine the amendment, application, and interval that
is most appropriate for your situation, based on the expected
likelihood of contaminating produce by use of the biological soil
amendment of animal origin you plan to use.
In developing the application methods requirements of proposed
Sec. 112.56(a)(1)-(4), we first considered specifications of each type
of biological soil amendment of animal origin, and then considered the
likelihood that the soil amendment will come into contact with covered
produce. For example, those biological soil amendments of animal origin
treated with a process or processes capable of consistently and
reliably reducing or eliminating pathogens as per Sec. 112.54(a) do
not have any application restrictions, and may come into contact with
covered produce during harvest and growing (proposed Sec.
112.56(a)(2)), such as in the growing of mushrooms and some sprouts.
Conversely, those treatments that are expected to have some likelihood
of harboring significant numbers of human pathogens, i.e., those
treated in accordance with the requirements of Sec. 112.54(b) or (c),
have proposed limitations on the method of application that minimize
the potential for the treated biological soil amendment of animal
origin to contact covered produce during and after application
(proposed Sec. 112.56(a)(3), (a)(4)(ii)) and also allow for pathogen
die-off when it is reasonably likely that covered produce will contact
soil after application of the soil amendment (proposed Sec.
112.56(a)(4)(i)). Requirements would include the application of
untreated biological soil amendments of animal origin in situations
where it is reasonably likely that covered produce will contact the
soil after application of the soil amendment (Sec. 112.56(a)(1)(i)),
where the amendment would be permitted to be applied in a manner that
minimizes the potential for contact with covered produce after
application, but with an additional food safety measure that it can be
applied only in a manner that does not contact covered produce during
application and using a minimum application interval of 9 months. By
contrast, in situations where covered produce will not contact the
soil, (Sec. 112.56(a)(1)(ii)), the amendment would be permitted to be
applied without an application interval. We explain each of these
proposals in detail below.
Proposed Sec. 112.56(a)(1)(i) requires that if you apply a
biological soil amendment of animal origin that is untreated, then the
material must be applied in a manner that does not contact covered
produce during application and minimizes the potential for contact with
covered produce after application and the minimum application interval
is nine (9) months. This provision would apply to any situation in
which the covered produce is reasonably likely to contact the soil
after application of the soil amendment. Proposed Sec.
112.56(a)(1)(ii) requires that if you apply a biological soil amendment
of animal origin that is untreated, and the material is applied in a
manner that does not contact covered produce during or after
application, there is no minimum application interval. This provision
would apply to any situation in which the covered produce will not
contact the soil after application of the soil amendment. The specific
microbial populations of raw manure are generally unknown, but can be
expected to be very high, and are likely to include zoonotic
microorganisms that pose a food safety hazard (such as Salmonella spp.
up to 10[supcaret]7 (Ref. 176) and E. coli O157:H7 up to 10[supcaret]6
(Ref. 189)). Based on our QAR, we have determined that raw animal waste
(manure, litter, mortalities, etc.) is likely to contain human
pathogens and has the highest likelihood of contaminating covered
produce. Therefore, we tentatively conclude that such material should
only be used where, and in a manner, that such likelihood is minimized.
As discussed above, the likelihood of produce contamination by an
agricultural tea that contains agricultural tea additives is also high
(Ref. 142). Given the desire to both allow for the continued use of raw
manure, agricultural teas containing agricultural tea additives, and
other untreated biological soil amendments of animal origin; and to
minimize the risk of known and reasonably foreseeable hazards, we have
tentatively concluded that we should require that untreated biological
soil amendment of animal origin (including raw manure) applied in the
growing of covered produce should either first be treated to reduce
microbial food safety hazards; or if the covered produce is reasonably
likely to contact the soil after application of the soil amendment, the
untreated soil amendment should be applied in a manner that keeps it
from coming into contact with covered produce during application,
minimizes the potential for contact after application, and allows for
the die-off of pathogens; and if the covered produce will not contact
the soil after application of the soil amendment, the untreated soil
amendment should be applied in a manner that keeps it from coming into
contact with covered produce during and after application. In the case
of agricultural teas containing agricultural tea additives, we
tentatively conclude that because additional treatment is not an option
they should be applied in the same manner as untreated biological soil
amendments of animal origin. Proposed Sec. 112.56(a)(1)(i) would
therefore establish such restrictions on the manner of application for
these materials when they are reasonably likely to come in contact with
covered produce after application, as well as a minimum application
interval (waiting period) of nine (9) months from the application of
untreated biological soil amendments of animal origin to the harvest of
covered produce. On the

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other hand, under proposed Sec. 112.56(a)(1)(ii), untreated biological
soil amendments of animal origin would be permitted for use with no
minimum waiting period when the soil amendment is applied in a manner
that does not contact covered produce during or after application. We
investigated the potential for survival of many enteric pathogens of
public health concern (Ref. 190. Ref. 92) and determined that across
various pathogens and their potential environments, pathogen survival
and die-off time in soils amended with raw manures are extremely
varied. One consistency across many trials was an observed rapid early
die off of many pathogens, followed by a prolonged survival of the
remaining low populations (Ref. 191. Ref. 104. Ref. 192). It is unclear
in the existing literature at what point the population is low enough
to minimize the potential for contamination of covered produce; it is
reasonable to suggest that once pathogen populations fall below
detection limits, their risks are minimized.
Some of the longest survival times involved organisms initially
present at very high initial populations (e.g., E. coli O157:H7 in
sheep manure (Ref. 177) surviving for 21 months) or involved certain
pathogens such as encysting parasites (Cryptosporidium parvum cysts
surviving for over a year (Ref. 193) or the eggs of parasitic flatworms
(Ascaris ova surviving for over 15 years (Ref. 174)). Some enteric
pathogens are reported to be more resilient to deleterious effects of
the environment than others (most notably, Salmonella seems better
attuned for survival outside of a host than does E. coli O157:H7 (Ref.
194)) and those microorganisms that produce spores are especially
hardy. Basing all manure application standards on these extreme cases
would be unnecessary. The majority of survival studies showed that most
enteric pathogens of public health importance, under the most common
conditions, would not survive in the soil past 1 year (Ref. 190). This
includes organisms less commonly associated with fresh produce, such
Cryptosporidium, Giardia, and Ascaris (parasitic flat worms). Organisms
most commonly associated with fresh produce outbreaks (such as E. coli,
Salmonella and Listeria) are unlikely to survive at detectable
population levels in soil past 270 days (Ref. 181. Ref. 182. Ref. 183).
Therefore, we tentatively conclude that utilizing a 9-month waiting
period between the application of untreated biological soil amendment
of animal origin and the harvest of covered produce would be protective
for the preponderance of environments in situations where covered
produce is reasonably likely to contact the soil after application of
untreated biological soil amendments of animal origin. This is not
inconsistent with the 12-month restriction used by some segments of the
produce industry (Ref. 31). Where the soil amendment does not contact
covered produce either during or after application, we do not believe
that a minimum application interval is reasonably necessary to prevent
the introduction of known or reasonably foreseeable hazards into
covered produce. Therefore, proposed Sec. 112.56(a)(1)(ii) provides
for the option to use untreated biological soil amendments of animal
origin with no minimum waiting period, provided the soil amendment is
applied in a manner that does not contact covered produce during or
after application. We seek comment on the proposed waiting period.
One study, which specifically addressed considerations of microbial
survival in soil and resulting transfer on to produce grown in the
soil, suggested that, under ideal conditions for survival, organisms
could survive for greater than 226 days (Ref. 191). The study was
performed in the Southeastern U.S. (Georgia) and, therefore, is
unlikely to reflect climatic conditions prevalent in other areas of the
country, including the potential for the ground to freeze during
winter. While microbes present on frozen ground can be expected to be
reduced in population more rapidly (Ref. 195), those surviving are
likely to persist for a longer time period in a state of dormancy (Ref.
196). The dormancy of microorganisms also means that they will pose a
likelihood of contamination for greater periods of time, creating a
wider window of opportunity for covered produce to become contaminated.
We request comment on whether and how, as an additional requirement for
the application of untreated biological soil amendments of animal
origin, the time period when the soil is frozen should count toward the
proposed application interval. Further, it has been noted that rapid
freeze-thaw cycles of weather may cause more rapid die-off rates of
pathogens present in soils (Ref. 197). We request comment on the impact
that freeze-thaw cycles may have on use of biological soil amendments
of animal origin.
Proposed Sec. 112.56(a)(2) would establish that the use of a
biological soil amendment of animal origin treated by a scientifically
valid controlled physical or chemical process, or combination of
scientifically valid controlled physical and chemical processes, in
accordance with the requirements of Sec. 112.54(a) to meet the
microbial standard in Sec. 112.55(a), would have no application method
restrictions and no minimum application interval. At this level of
microbial reduction, a treated biological soil amendment of animal
origin can be expected to present negligible likelihood of
contamination. Therefore, we have tentatively concluded that no further
action is necessary for the safe use of such a product in conjunction
with covered produce.
For example, unlike other biological soil amendments of animal
origin, the nature of a growth medium that is a biological soil
amendment of animal origin and is used for growing mushrooms, some
sprouts and similarly grown produce, makes contact between the covered
produce and the growth medium inevitable. This precludes the ability to
utilize application restrictions as a meaningful measure to minimize
the likelihood of pathogen contamination of covered produce through a
multiple-hurdle approach, that would allow for the use of less robust
treatment processes in combination with application manner
restrictions. Therefore, we tentatively conclude that, such growth
media must be treated by a scientifically valid controlled physical or
chemical process, or combination of scientifically valid controlled
physical and chemical processes, in accordance with the requirements of
Sec. 112.54(a) to meet the microbial standard in Sec. 112.55(a).
As proposed, Sec. 112.56(a)(3) would require that a biological
soil amendment of animal origin treated by a scientifically valid
controlled physical or chemical process, or a combination of
scientifically valid controlled physical and chemical processes, in
accordance with the requirements of Sec. 112.54(b) to meet the
microbial standard in Sec. 112.55(b) be used in a manner that
minimizes the potential for contact with covered produce during and
after application, with no minimum application interval. We have
tentatively concluded that treating a biological soil amendment of
animal origin to meet the standards of Sec. 112.54(b) would
significantly decrease the population of any microorganisms of public
health significance that may have previously been present. Further, the
proposed application restriction of minimizing direct contact of the
amendment with the edible portion of covered produce would further
reduce the likelihood of any remaining microorganisms in a treated soil
amendment contaminating covered produce, as well as reduce the

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likelihood that the soil amendment would provide a nutrient source for
any microorganisms of public health significance already present on
covered produce. We have tentatively concluded that the treatment of
the biological soil amendment of animal origin, combined with
minimizing its contact with covered produce would adequately reduce the
likelihood of contamination and subsequent severe adverse health
consequences or death. We have also tentatively concluded that, with
the likelihood already minimized, it is unnecessary to implement a
further burden by proposing a minimum application interval for soil
amendments treated by physical or chemical processes, or combinations
of such processes, to the standards of Sec. 112.54(b). For example,
chicken manure pellets that have been treated by a controlled high-
temperature process according to a protocol that has been validated to
meet the standards in proposed Sec. 112.54(b) could be used as an in-
furrow side-dress for leafy greens immediately before harvest. However,
in this same example, the application could not be conducted by
overhead broadcast spreading, since this method would not minimize
contact of the biological soil amendment with the covered produce.
Proposed Sec. 112.56(a)(4)(i) would establish requirements for use
of a biological soil amendment of animal origin treated by a composting
process in accordance with the requirements of Sec. 112.54(c) to meet
the microbial standard in Sec. 112.55(b) in a manner that minimizes
the potential for contact with covered produce during and after
application and with a minimum application interval of 45 days. This
provision would apply to situations in which the covered produce is
reasonably likely to contact the soil after application of the soil
amendment.
Proposed Sec. 112.56(a)(4)(ii) requires that if you apply a
biological soil amendment of animal origin treated by a composting
process in accordance with the requirements of Sec. 112.54(c) to meet
the microbial standard in Sec. 112.55(b), and the material is applied
in a manner that does not contact covered produce during or after
application, there is no minimum application interval. This provision
would apply to any situation in which the covered produce will not
contact the soil after application of the soil amendment. Although the
microbial standards and application restrictions for biological soil
amendments of animal origin treated to meet the requirements of
proposed Sec. 112.56(a)(4) are the same as those described under
proposed Sec. 112.56(a)(3), there is an additional 45 day application
interval for Sec. 112.56(a)(4)(i) that would not be required in Sec.
112.56(a)(3). We have tentatively concluded that process controls
during chemical or physical treatments can be expected to be less prone
to failure than process controls for composting. For example, heat
treatments are often conducted in enclosed heat-treatment chambers
(i.e., ovens), often with various means of agitation (such as stirring
rods, etc.), that can be accurately monitored and controlled to reach
the required treatment conditions throughout the material being
treated. Conversely, composting usually occurs outdoors, is exposed to
fluctuating environmental pressures and wildlife activity, is not
homogeneous in nature and prone to having ``cold-spots'' that are not
completely treated (even with proper turning) (Ref. 174). In general,
in composting, there is a higher likelihood of having a systems
failure, which is also more likely to go undetected, should it occur.
Composting may result in a treated biological soil amendment of animal
origin that may continue to harbor human pathogens of food safety
concern (Ref. 174), although any such hazards that may be present can
be expected to be present at low populations and unlikely to survive
for extended periods under normal environmental conditions after
application. Examples of a system failure that may occur during
composting, but would not be expected during a thermal or physical
treatment, could include animal intrusion, incomplete turning, or
reduced efficiency of composting due to environmental or climatic
conditions (e.g., heavy rainfall or excessive cloud cover reducing the
temperature of the pile or portions of the pile). Therefore, we propose
to impose an additional mitigation measure in situations where covered
produce is reasonably likely to contact the soil after application of
biological soil amendments of animal origin treated by composting by
requiring a minimum application interval of 45 days. This time period
has been shown to be effective when the population of the pathogen is
minimal (Ref. 92. Ref. 91) (Ref. 198), as can be expected of a fully
composted biological soil amendment of animal origin. This multiple
hurdle approach and time interval has also been utilized in a current
industry standard (Ref. 31). Where a biological soil amendment of
animal origin does not contact covered produce either during or after
application, we do not believe that a minimum application interval is
reasonably necessary to prevent the introduction of known or reasonably
foreseeable hazards into covered produce. Therefore, proposed Sec.
112.56(a)(4)(ii) provides for the option to use a biological soil
amendment of animal origin treated by composting with no minimum
waiting period, provided the soil amendment is applied in a manner that
does not contact covered produce during or after application. We seek
comment on the appropriateness of the proposed application period
intervals.
We have not proposed any provisions specific to the status of spent
mushroom mulch (growth media already used in the production of
mushrooms for subsequent use as a biological soil amendment of animal
origin in the growing of other covered produce) and specifically
request comment on how to classify its status. The practice of storing
spent mushroom mulch for subsequent use in the growing of covered
produce is not known to be a likely source of introduced contamination
because the growth media would have been previously treated to
eliminate pathogens (Ref. 62). Therefore, we tentatively conclude that
spent mushroom mulch previously treated (in accordance with proposed
Sec. 112.54(a), to meet the microbial standards of Sec. 112.55(a))
before use in the growing of mushrooms would still be considered as
``treated'' to meet the standards of Sec. 112.54(c) after use for
growing mushrooms, and for any possible subsequent use in the growing
of fresh produce without any intervening treatment, unless you know or
have reason to believe it has been otherwise contaminated with a hazard
or has been associated with foodborne illness. We tentatively conclude
that spent mushroom mulch should be considered, for the purpose of the
application requirements in proposed Sec. 112.56, as though it has
been treated by composting, instead of considering it as though it has
been treated in accordance with the most robust chemical/physical
treatment process (Sec. 112.54(a)), though it would have received such
a treatment in accordance with proposed Sec. 112.54(a) before its use
to grow mushrooms. This would have the effect of subjecting spent
mushroom mulch used subsequently to grow other covered produce to the
requirement to minimize the potential for contact with covered produce
during and after application, and a minimum application interval of 45
days. We consider the weathering process (the common practice of spent
mushroom mulch being placed in a field

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in windrow for further composting over the course of several weeks to
years) to be similar to composting in terms of likelihood of
introduction of contaminants. We request comment on this tentative
conclusion.
Under this proposal, you would, in most cases, maintain the
flexibility to choose among a variety of treated and untreated soil
amendments of animal origin based on the commodity being grown, growing
conditions, and other factors relevant to your operation, but you would
have to consider both the method of application (e.g., whether it would
result in contact between the amendment and the produce) and, for
certain amendments, the interval before harvest. We would expect you to
determine which application method is most appropriate for your
situation by selecting the application method and interval restrictions
that would coincide best with your operation, and then purchase or
treat a biological soil amendment of animal origin that meets the
corresponding specifications (i.e., the first column in the table in
Sec. 112.56(a)). For example, if you intend to apply a side-dress of a
biological soil amendment of animal origin close to harvest, you would
find Sec. 112.56(a)(1)(ii), (2), (3), and (4)(ii) have no minimum
application interval. You would accordingly either use a controlled
physical or chemical process that meets the requirements of Sec.
112.54(a) and have no further restrictions, use a controlled physical
or chemical process that meets the less stringent microbial standards
of Sec. 112.54(b) if you can apply the treated biological soil
amendment of animal origin in a manner that minimizes potential for
contact with the covered produce during and after application, or use
composted or untreated biological soil amendments of animal origin if
you can apply them in a manner that ensures they do not contact covered
produce during or after application (for example, if you are growing
tree crops such as oranges, you apply the untreated soil amendment
without causing it to contact the oranges, and you do not harvest
oranges that have been allowed to come into contact with the soil after
application of the soil amendment). Conversely, you may determine which
application method and interval is most appropriate by evaluating which
specification your biological soil amendment of animal origin meets,
and then apply it according to the coinciding application method and
interval restrictions. If, for example, you wish to apply raw manure to
your field, you would find the requirements that apply to raw manure in
Sec. 112.56(a)(1) and note that, if it is reasonably likely that your
covered produce will come in contact with the soil (for example, where
almonds are harvested by intentionally dropping to the ground) after
application of the raw manure, the use of raw manure is restricted to
application in a manner that does not contact covered produce during
application and minimizes the potential for contact with covered
produce after application, and may be applied no less than 9 months
before harvest. On the other hand, if you can apply the raw manure in a
manner that ensures it does not contact covered produce during or after
application, you may use it without a minimum application interval. Any
minimum application interval that you use can be concurrent with any
application intervals that you are already required to, or voluntarily,
apply. For example, if you are a USDA-certified organic grower, and
utilize a 120-day application interval for the use of raw manure as
part of participation in the National Organic Program, the proposed 9-
month application interval requirement in Sec. 112.56(a)(1)(i) would
be concurrent, not consecutive, with the 120 days. Thus, your use of a
9-month application interval for raw manure would satisfy both this
proposed rule and the requirements of the National Organic Program. As
another example, if you plan to apply a biological soil amendment of
animal origin to a field of spinach that is nearing harvest for fresh
market consumption, assuming the spinach is reasonably likely to
contact the soil after application of the soil amendment, you could
select a biological soil amendment of animal origin that is heat-
treated to meet the standards presented in Sec. 112.54(b) (e.g.,
chicken manure pellets), provided that you can apply it in a manner
that minimizes the potential for contact with covered produce during
and after application (e.g., used as a side-dressing), because there
would not be an application restriction interval with that type of
biological soil amendment of animal origin. If you plan to use manure
as a biological soil amendment of animal origin for the same crop and
plan to apply the amendment before planting, and do not wish to utilize
a treatment such as described by Sec. 112.54(a) or (b), you would
choose to compost the soil amendment to meet the requirements of Sec.
112.54(c). Use of such a biological soil amendment of animal origin
would only be restricted to application in a manner that minimizes the
potential for contact with covered produce during and after
application, and application at least 45 days prior to harvest.
Proposed Sec. 112.56(b) would establish requirements for the use
of alternatives to the minimum application intervals established in
paragraphs (a)(1)(a) and (4)(a) of proposed Sec. 112.56, provided you
satisfy the requirements of Sec. 112.12. We have tentatively concluded
that, under certain circumstances, an alternative standard may be
appropriate if it is shown to provide the same level of public health
protection as the standard in proposed Sec. 112.56(a)(1)(i) and (4)(a)
and not to increase the likelihood that the covered produce will be
adulterated. For example, alternatives to the proposed minimum
application intervals could take into account specific characteristics
of the locality, crop and the agro-ecological environment. Such
alternatives could consider differences in feedstock; application
methods; and treatment methods, especially given the potential for new
innovations in such methods. In any such case, as discussed below, we
propose in Sec. 112.60(b)(5) that you establish and keep documentation
of the scientific data and information you are relying on to support
the use of an alternative minimum application interval. We do not
propose that you would be required to submit such data and information
to us for prior approval; we do, however, propose the requirement that
you maintain a record of any such data and information for us to
evaluate upon request.
h. Records Requirements
Proposed Sec. 112.60(a) requires that you establish and keep
records for subpart F in accordance with the requirements of subpart O
of this part. Proposed Sec. 112.60(b) would establish requirements for
records you must establish and keep regarding biological soil
amendments of animal origin that you use. Proposed Sec. 112.60(b)(1)
would require documentation of the date of application of any untreated
biological soil amendment of animal origin (including raw manure) or
any biological soil amendment of animal origin treated by composting to
a growing area and the date of harvest of covered produce from that
growing area, except when covered produce does not contact the soil
after application of the soil amendment. These records would be
required because the application of both raw manure and compost include
minimum application intervals (Sec. 112.56(a)(1)(i) and (4)(i),
respectively), so it would enable FDA to verify compliance with the
application intervals associated with raw manure

[[Page 3585]]

and compost. These records would also allow you to keep track of the
dates on which those biological soil amendments of animal origin were
applied in order to determine when covered produce from those growing
areas could be harvested in compliance with the rule. USDA-certified
organic growers who already maintain records of when biological soil
amendments of animal origin are applied in compliance with 7 CFR
205.103 would not need to duplicate those records to meet the
requirements of Sec. 112.60(b)(1).
Proposed Sec. 112.60(b)(2) would require documentation (such as a
Certificate of Conformance) for a treated biological soil amendment of
animal origin that you receive from a third party. We have tentatively
concluded that the information you will need both to verify that any
biological soil amendment of animal origin you purchase for use in
performing a covered activity is in compliance with this subpart F, and
to inform your decisions on further handling, conveying, and storing of
the purchased biological soil amendment of animal origin, includes the
following: (i) The process used to treat the biological soil amendment
of animal origin is a scientifically valid process that has been
carried out with appropriate process monitoring; (ii) the applicable
treatment process is periodically verified through testing using a
scientifically valid analytical method on an adequately representative
sample to demonstrate that the process satisfies the applicable
microbial standard in Sec. 112.55, including the results of such
periodic testing; and (iii) the biological soil amendment of animal
origin has been handled, conveyed and stored in a manner and location
to minimize the likelihood of contamination by an untreated or in-
process biological soil amendment of animal origin. Aspects (i) and
(iii) of this proposed requirement reflect information that you would
have if you treated the biological soil amendment of animal origin on
your own farm in accordance with this proposed rule. Aspect (ii) of
this requirement would provide you with reasonable assurances that your
supplier is carrying out the applicable treatment process in an
effective manner such that the biological soil amendment of animal
origin that you purchase meets the applicable standards in proposed
Sec. Sec. 112.54 and 112.55. We tentatively conclude that it is
appropriate to require this additional level of assurance from your
suppliers in order to allow FDA to verify your compliance with these
requirements. These requirements will also provide you with a
comparable level of control over your supplier's process of treating a
biological soil amendment of animal origin as you would have if you
were to apply the treatment process on-farm, where you would be able to
monitor the process controls yourself. You would not be required to
perform any treatment processes on a biological soil amendment of
animal origin that you purchase and for which you have the appropriate
documentation showing it has already been treated by a validated
process in accordance with Sec. 112.55. These records would also allow
you to ensure that a treated biological soil amendment that you
purchase from a third party meets the requirements of this proposed
rule and to determine the relevant application restrictions you must
apply to such a soil amendment.
Proposed Sec. 112.60(b)(3) would require documentation that
process controls (for example, time, temperature and turnings) were
achieved for any treated biological soil amendment of animal origin you
produce for your own covered farms. This documentation is required to
verify that the treatment or treatments you performed were properly
carried out. For example, such records would inform you of any
breakdown in the process or treatments, how they occurred or can be
corrected, and create a history to help you predict and prevent any
future breakdowns. Without such records, you would not be able to
ensure, and we would not be able to verify, that the process or
treatment you performed achieved the required parameters that are
validated to meet the microbial standards of Sec. 112.55 or that the
alternatives that you are using (if applicable) satisfy the
requirements of proposed Sec. 112.12.
Proposed Sec. 112.60(b)(4) would require documentation of
scientific data or information you rely on to support any alternative
composting process used to treat a biological soil amendment of animal
origin in accordance with the requirements of Sec. 112.54(c)(3).
Similarly, proposed Sec. 112.60(b)(5) would require documentation of
scientific data or information you rely on to support any alternative
minimum application interval in accordance with the requirements of
Sec. 112.56(b). The records described in Sec. 112.60(b)(4) and (5)
would be required only if you choose to use alternatives to those
processes presented in Sec. 112.54(c)(1) and (c)(2) or application
intervals in Sec. 112.56(a)(1)(i) and (a)(4)(i), respectively. This
documentation would be required so that, as necessary, we are able to
verify that use of your alternative process achieves the required
parameters of proposed subpart F and satisfies the requirements of
proposed Sec. 112.12.
Finally, we seek comment on an issue that is not explicitly
addressed in our proposed provisions. Biological soil amendments
(including agricultural teas derived from biological materials) are
nutrient rich and may support rapid and prolific growth of human
pathogens, if pathogens are present. Seeds used for sprouting have
repeatedly been demonstrated to have the potential to be contaminated
with human pathogens and cause human illnesses. We note that the
National Organic Standards Board Compost Tea Task Force recommended not
allowing for the use of ``compost tea'' for the production of edible
seed sprouts (Ref. 36). We are concerned that using a biological soil
amendment (including agricultural teas derived from biological
materials) could increase the likelihood of rapid and prolific growth
of human pathogens, if present, during sprout growing. We request
comment on whether sprouters currently use biological soil amendments
(including agricultural teas made from biological materials, such as
``compost teas'') in the growing of sprouts. In addition, we request
comment on the likelihood of contamination presented by such a practice
and whether the practice should be prohibited.

G. Subpart G--We Have Tentatively Reserved Subpart G of This Proposed
Rule

H. Subpart H--We Have Tentatively Reserved Subpart H of This Proposed
Rule

I. Subpart I--Standards Directed to Domesticated and Wild Animals

As proposed, subpart I provides science-based minimum standards
that are directed to domesticated and wild animals and are reasonably
necessary to minimize the risk of serious adverse health consequences
or death from the use of, or exposure to, covered produce, including
those reasonably necessary to prevent the introduction of known or
reasonably foreseeable hazards into covered produce, and to provide
reasonable assurances that the produce is not adulterated under section
402 of the FD&C Act.
1. Comments Related to Proposed Provisions
We received several comments in response to the 2010 FR notice that
addressed issues relevant to standards directed to domesticated and
wild animals. Some comments expressed concern about requiring measures
that prohibit the use of domesticated work animals on farms. Some
comments

[[Page 3586]]

asserted that monitoring wildlife in a farm environment is untenable,
whereas other comments recommended that we prepare a list of ``animals
of concern'' to enable farmers to know where to target preventive
controls for domesticated and wild animals. Some comments recommended
that sustainable conservation practices should be adopted and
recognized as enhancing food safety. Several comments noted that
farmers are subject to State and Federal laws regarding wildlife (e.g.,
Endangered Species Act and Clean Water Act) and that there are programs
that emphasize environmental stewardship (e.g., National Organic
Program and programs of the Natural Resources Conservation Service).
Others expressed concern about any requirements that would lead to
destruction of habitat or clearing of farm borders.
This proposed rule would not prohibit the use of on-farm
domesticated working animals. Rather, this proposed rule would require
you to take measures to prevent the introduction of known or reasonably
foreseeable hazards into or onto covered produce, if you use working
animals in a growing area where a crop has been planted and when, under
the circumstances, there is a reasonable probability that animals will
contaminate covered produce. We disagree with comments that asserted
that monitoring for animal intrusion is untenable. Periodic monitoring
for animal intrusion and deposition of their excreta is a necessary
measure to prevent contamination of covered produce with biological
food safety hazards when there is a reasonable probability that animals
will contaminate covered produce. We consider that monitoring during
the growing season and immediately prior to harvest is a practical and
minimum necessary standard to sufficiently ensure that any potential
hazards related to animal intrusion are identified for appropriate
follow-up actions in these situations. Proposed Sec. 112.83 is
intended to provide you with information about animal movements on your
farm, allow you to recognize significant intrusion, and facilitate your
taking appropriate measures following significant animal intrusion.
While we recognize the value of establishing a list of ``animals of
concern,'' we tentatively conclude that current scientific evidence on
the extent to which specific animals present the greatest risk for
pathogens is inadequate to develop such a list. Moreover, data on
regional and seasonal variations in the prevalence of pathogens in
different kinds of animals are scarce. We encourage the application of
practices that can enhance food safety, including sustainable
conservation practices. A set of examples of biodiversity and
conservation practices that may enhance food safety is available from
the Resource Conservation District of Monterey County, CA (Ref. 199).
This proposed rule would not require the destruction of habitat or the
clearing of farm borders. Instead, we propose to require you to monitor
those areas that are used for a covered activity for evidence of animal
intrusion when, under the circumstances, there is a reasonable
probability that animals will contaminate covered produce.
2. Proposed Requirements
Proposed subpart I includes standards that would be directed to the
potential for biological hazards from animal excreta to be deposited by
your own domesticated animals (such as livestock, working animals, and
pets), by domesticated animals from a nearby area (such as livestock
from a nearby farm), or by wild animals (such as deer and wild swine)
on covered produce or in an area where you conduct a covered activity
on covered produce. Proposed subpart I would not be directed to the
potential for biological hazards from manure that may be used as a soil
amendment; such requirements directed to biological soil amendments of
animal origin are discussed in section V.F of this document.
Consistent with sections 419(a)(1)(A), 419(a)(3)(E), and
419(a)(3)(D) of the Act, we consulted with USDA's National Organic
Program and Natural Resources Conservation Service, U.S. Fish and
Wildlife Service, and the EPA (Ref. 115) to ensure that environmental
and conservation standards and policies established by those agencies
are appropriately considered in developing the requirements proposed in
this subpart. Based on these consultations, we tentatively conclude
that the provisions of proposed subpart I do not conflict with or
duplicate the requirements of the National Organic Program. In
addition, also based on these consultations, we tentatively conclude
that the provisions of proposed subpart I are consistent with existing
conservation and environmental practice standards and policies while
providing for enforceable public health protection measures.
Furthermore, the provisions in proposed subpart I are consistent with
current recommendations in our GAPs Guide (Ref. 10), the AFDO Model
Code (Ref. 20), Commodity-specific industry guidances (Ref. 44. Ref.
46), and the LGMA (Ref. 31). We seek comment on the interactions of the
proposed rule with the National Organic Program and opportunities to
streamline compliance with both programs.
We acknowledge the longstanding co-location of animals and plant
food production in agriculture. However, as discussed in the QAR, both
wild and domestic animals may be a source of human pathogens. In fact,
domesticated animals, due to their close proximity and interaction with
humans, are generally more likely to harbor zoonotic pathogens than are
wild animals (Ref. 200). Therefore we tentatively conclude that
measures should be taken to minimize the likelihood of covered produce
being contaminated by excreta from grazing and working animals. The
likelihood of contaminating fresh produce with human pathogens from
excreta from grazing and working animals is determined by numerous
factors, including but not limited to the species of the animal, the
number of animals per unit area of land, agro-ecological conditions,
and the time period between animal grazing or working in fields and the
harvest of fresh produce (Ref. 176. Ref. 169. Ref. 201. Ref. 202).
Proposed Sec. 112.81(a) would establish that the requirements of
proposed subpart I apply when a covered activity takes place in an
outdoor area or a partially-enclosed building and when, under the
circumstances, there is a reasonable probability that animals will
contaminate covered produce. We have tentatively concluded that
measures directed to domesticated and wild animals (such as cows,
swine, and deer) are necessary when a covered activity takes place in
an outdoor area or a partially-enclosed building if, under the
circumstances, there is a reasonable probability that animals will
contaminate covered produce, because it is reasonably likely that such
animals will encroach on such areas and deposit excreta on covered
produce or food contact surfaces. Some human pathogens of public health
concern (e.g., E. coli O157:H7) that have been associated with produce
foodborne outbreaks are zoonotic, meaning that they may originate from
animals as well as humans. Therefore, animals, both wild and domestic,
may be a source of human pathogens during the growing, harvesting,
packing and holding of covered produce. We expect this provision to
provide flexibility for farmers to consider the nature of covered
produce and covered activities (including characteristics of covered
produce) in light of the potential for contamination, and determine
whether

[[Page 3587]]

the proposed requirements of subpart I would be applicable under the
circumstances. For example, in the case of covered produce that grows
completely underground, we expect that there would not be a reasonable
probability of contamination of covered produce by domesticated or wild
animals that may graze on or encroach into fields. The proposed
requirements in Sec. Sec. 112.82 and 112.83, therefore, would not
apply to covered activities taking place in an outdoor area or a
partially-enclosed building when such activities relate to covered
produce that grows completely underground. We note, however, that we do
not intend the phrase ``under the circumstances'' in these proposed
requirements to suggest that farms alter their surrounding environment
in order to reduce the chances of animal intrusion, such as by clearing
farm borders around outdoor growing areas or drainages. This proposed
rule is not intended to require such actions. We intend the phrase
``under the circumstances'' to refer to the nature of the covered
produce (such as its growth habit) and the nature of covered activities
(such as the manner in which working animals are used in growing
areas). We request comment on this issue.
Proposed Sec. 112.81(b) would provide that the provisions of
proposed subpart I would not apply to fully enclosed buildings. We
tentatively conclude that the measures proposed in this section
directed to domesticated and wild animals (such as cows, dogs, swine,
and deer) are not necessary when a covered activity takes place in a
fully-enclosed building. Rather, we propose measures directed at
domesticated and wild animals (such as horses, dogs, and rodents) in a
fully-enclosed building in proposed Sec. 112.127 (see section V.L. of
this document).
Proposed Sec. 112.82 would establish requirements for measures
that you must take, at a minimum, if you allow animals to graze or use
them as working animals in fields where you grow covered produce and
under the circumstances there is a reasonable probability that grazing
or working animals will contaminate covered produce. Proposed Sec.
112.82(a) would require you to implement an adequate waiting period
between grazing and time of harvest for covered produce in any growing
area that was grazed, to ensure the safety of the harvested crop. The
potential likelihood of animals to act as vectors of human pathogens is
determined by several factors, including but not limited to the type of
commodity (as discussed above), and the species of the animal and its
association with human or domesticated animal activity or waste (Ref.
199). A suitable time period based on these and other relevant factors
must be established for the purpose of reducing, via die-off, pathogen
levels in the excreta that may be transferred to covered produce. We
would not expect it to be necessary for such time periods to exceed 9
months, which is the application interval we propose for use of raw
manure as a soil amendment in proposed Sec. 112.56(a)(1)(i).
Proposed Sec. 112.82(b) would require that, if you use working
animals in a growing area where a crop has been planted, you must take
measures to prevent the introduction of known or reasonably foreseeable
hazards into or onto covered produce. For example, if you use draft
horses as working animals in your covered produce fields, you could
establish and use horse paths which are segregated from covered produce
plantings, and minimize entry of the horses into covered produce
plantings, thus minimizing the opportunity for horse excreta to contact
covered produce or food contact surfaces.
Proposed Sec. 112.83 would establish requirements for measures
related to animal intrusion in those areas that are used for covered
activities for covered produce when under the circumstances there is a
reasonable probability that animal intrusion will contaminate covered
produce. We are proposing to require that you monitor these areas as
needed throughout the growing season, based on the covered produce
being grown and your observations and experiences (proposed Sec.
112.83(a)(1)(i) and (ii)), and immediately prior to harvest (proposed
Sec. 112.83(a)(2)). In proposed Sec. 112.83(b) we would also require
that, if animal intrusion occurs, as evidenced by observation of
significant quantities of animals, animal excreta or crop destruction
via grazing, you must evaluate whether the covered produce can be
harvested in accordance with the requirements of proposed Sec.
112.112.
We acknowledge that when covered produce is grown in an outdoor
environment, wild animals are likely to have access to production
fields. The presence of animals in a production field of covered
produce, in and of itself, is not a significant food safety risk.
However, wild animals are known zoonotic disease reservoirs for human
pathogens, and therefore their excreta may contaminate growing covered
produce crops (Ref. 169. Ref. 203). Monitoring immediately prior to
harvest will enable you to identify instances when covered produce
cannot be safely harvested, such as when it is not possible to
effectively avoid the harvest of covered produce that was directly
exposed to animal excreta or that may be cross-contaminated during
harvest (e.g., contamination of covered produce by contact with a food-
contact surface that contacted animal excreta), as provided for in
proposed Sec. 112.112.
Monitoring throughout the growing season may assist you in
developing an understanding of when and the degree to which animal
intrusion occurs throughout the production season from planting to
harvest. This proposed provision should not be construed to require the
``taking'' of an endangered species, as the term is defined in the
Endangered Species Act (16 U.S.C. 1532(19)) (i.e., to harass, harm,
pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to
attempt to engage in any such conduct), or to require farms to take
measures to exclude animals from outdoor growing areas or destroy
animal habitat or otherwise clear farm borders around outdoor growing
areas or drainages.

J. Subpart J--We Have Tentatively Reserved Subpart J of This Proposed
Rule

K. Subpart K--Standards Directed to Growing, Harvesting, Packing, and
Holding Activities

As proposed, subpart K discusses science-based minimum standards
directed to growing, harvesting, packing, and holding activities that
are reasonably necessary to minimize the risk of serious adverse health
consequences or death from the use of, or exposure to, covered produce,
including those reasonably necessary to prevent the introduction of
known or reasonably foreseeable hazards into covered produce, and to
provide reasonable assurances that the produce is not adulterated under
section 402 of the FD&C Act.
1. Comments Relevant to the Proposed Provisions
We received some comments in response to the 2010 FR notice that
addressed the adequacy and cleanliness of food-packing material and
requested that reusable containers be allowed in packing produce
commodities.
It is important to ensure that food-packing material that is used
in covered activities is adequate for its intended use, including that
it is clean. In proposed Sec. 112.116 below, we address the adequacy
and cleanliness of food-packing material. Specifically, proposed Sec.
112.116(b) would require that if you reuse food-packing material, you
take

[[Page 3588]]

measures to ensure that food-contact surfaces are clean, such as by
cleaning and sanitizing, when necessary, food-packing containers or
using a clean liner.
2. Proposed Requirements
Proposed Sec. 112.111 would establish that if you grow, harvest,
pack or hold produce that is not covered in this part (i.e., excluded
produce in accordance with Sec. 112.2) and also conduct such
activities on covered produce, and the excluded produce is not grown,
harvested, packed or held in accordance with this part, you must take
measures during these covered activities, as applicable, to: (a) Keep
covered produce separate from excluded produce (proposed Sec.
112.111(a)); and (b) Adequately clean and sanitize, as necessary, any
food-contact surfaces that contact excluded produce before using such
food-contact surfaces for covered activities on covered produce
(proposed Sec. 112.111(b)). As discussed in the QAR, raw produce may
have a variety of microorganisms in and on it, including, occasionally,
human pathogens. The types of microorganisms, including human
pathogens, detected on raw produce are diverse and may often be found
in high numbers (Ref. 204. Ref. 205. Ref. 206). In addition, some human
pathogens that are commonly isolated from the growing environment
(e.g., L. monocytogenes) are reported to adapt and survive in the food
production environment (e.g., food contact surfaces, floors, walls,
drains, sinks, standing water, and seals) and, thus, pose a potential
source of contamination (Ref. 207). The proposed standards included in
this part are designed to reduce the likelihood that human pathogens
are present in or on covered produce. For this reason, excluded produce
that is not grown, harvested, packed and stored in accordance with the
standards proposed in this part is likely to present a greater
likelihood of contamination with human pathogens than would covered
produce that is grown, harvested, packed, and held in accordance with
this part. We tentatively conclude that for operations handling both
covered and excluded produce, cross-contamination is reasonably likely
in the absence of measures directed toward its prevention. Such
measures include separation of the two types of produce to avoid
physical contact and any transfer of pathogens from one to the other;
and cleaning and sanitizing, as necessary, food contact surfaces used
on such excluded produce before those surfaces come in contact with
covered produce so that any pathogens picked up by the food-contact
surface from excluded produce are not transferred to covered produce.
Proposed Sec. 112.112 would require you to take all measures
reasonably necessary to identify, and not harvest, covered produce that
is reasonably likely to be contaminated with a known or reasonably
foreseeable hazard, including steps to identify and not harvest covered
produce that is visibly contaminated with animal excreta. For example,
you would comply with this provision by not harvesting a head of
lettuce if you see evidence of bird excreta on the head of lettuce. As
discussed in the QAR, it is well established that animal excreta is a
source of pathogens. Transmission of pathogens from animal excreta to
covered produce and, subsequently, to humans through consumption is
reasonably likely in cases where the presence of animal excreta can be
visually confirmed. Therefore, if the presence of animal excreta in a
field of covered produce precludes your ability to safely harvest the
covered produce, either because a significant portion of the covered
produce has animal excreta on it or because the animal excreta that is
present would be likely to contaminate food contact surfaces of harvest
equipment, you must not harvest the relevant portions of that field.
Proposed Sec. 112.113 would require that you handle harvested
covered produce during covered activities in a manner that protects
against contamination with known or reasonably foreseeable hazards, for
example, by avoiding contact of cut surfaces of harvested produce with
soil. As discussed in the QAR, research demonstrates that soil
microorganisms, including human pathogens, may effectively colonize
produce when the produce has lost its protective covering (e.g.
cuticle) in the course of harvest activities (e.g., cutting or
trimming) or when damaged during such operations (Ref. 208. Ref. 209).
Once established, the high moisture content of produce provides a
suitable environment for survival and growth of such pathogens.
Pathogens, if present, may be transferred to cut surfaces of harvested
produce from soil and, therefore, preventing unnecessary contact
between such cut surfaces and soil will reduce the likelihood of such
transfer. For example, you could take steps to temporarily place cut
lettuce heads on clean cardboard or other clean surface during field
packing, rather than placing them directly on the soil.
We considered washing as a requirement to reduce the likelihood of
contamination. Washing is an attractive option because it effectively
removes excess dirt, debris, and other organic matter and its use
incurs a relatively low cost allowing it to be employed across a
variety of equipment (water flumes, hydrocoolers, dips, scrubbers,
sorters, etc.) or steps in combination, or in sequence before
packaging. Despite these advantages, a number of studies have concluded
that wash water, with or without an active antimicrobial agent, does
not completely disinfect produce that may contain microorganisms of
public health significance (Ref. 206. Ref. 210. Ref. 209). Wash water
containing an antimicrobial such as chlorine is reported to reduce
microbial populations by two or three log units (100 to 1000 fold), but
does not eliminate microbes (Ref. 211. Ref. 210). Bacteria may find
harborage and protection on plants through hydrophobic areas, stomata,
lenticels, punctures, and bruises and where it is not readily washed
off (Ref. 212. Ref. 213). Of special significance to bacterial survival
on plants are circumstances that lead to bacterial cells being drawn in
or internalized inside the edible portion of the plant where they may
escape the action of water altogether. This phenomenon, termed
internalization, may occur as a consequence of temperature
differentials created when warm produce (from field heat or daytime
high temperatures) is submerged in cooler water. Under these
conditions, infiltration of water occurs because intercellular air
spaces within fruits and vegetables contract, thereby creating a
partial pressure differential that draws the water into the internal
compartments of the plant. If the cooling water contains human
pathogens the fresh produce item will now be internally contaminated.
This phenomenon has been seen with Salmonella and E. coli O157:H7 in
tomatoes, oranges, or mangoes (Ref. 138. Ref. 139. Ref. 214). As part
of a post-outbreak study, Penteado et al. 2004 reported evidence that
Salmonella spp. may have internalized in fresh mangoes during a
postharvest cooling step involving a water bath (Ref. 38). We seek
comment on whether we should consider washing, alone or in combination
with other measures, as a requirement to reduce the likelihood of
contamination.
Proposed Sec. 112.114 would prohibit you from distributing covered
produce that drops to the ground before harvest (dropped covered
produce) unless it is exempt under Sec. 112.2(b) (i.e. if it receives
commercial processing to

[[Page 3589]]

adequately reduce the presence of microorganisms of public health
significance). Dropped covered produce does not include root crops
(such as carrots) that grow underground or crops (such as cantaloupe)
that grow on the ground. However, produce that grows off the ground,
such as tomatoes and apples, and that drop to the ground before harvest
would be considered dropped covered produce. Evidence from studies of
tree fruit (e.g., apples and pears) indicates that dropped and damaged
fruit contain coliform bacteria in significantly higher numbers than
intact tree fruit (Ref. 215). Risk assessment models for apple
contamination (Ref. 216) show that dropped apples are more likely to be
contaminated with bacteria than tree-picked apples, and dropped fruit
used in the production of apple products (e.g., apple cider) are likely
to increase rates of product contamination (Ref. 216). While data
available to us is primarily derived from studies investigating apples,
we tentatively conclude that all dropped covered produce is likely to
present a potential likelihood for contamination, although to varying
degrees. Studies have indicated that when produce drops to the ground,
the produce can become structurally damaged, which is considered to be
a factor for proliferation of human pathogens on such produce (Ref.
217. Ref. 218. Ref. 219). Excluding dropped fruit from harvest is also
recommended in some existing guidance documents (Ref. 220. Ref. 221.
Ref. 44). However, some produce is dropped to the ground as a part of
the harvesting practice (e.g., some tree nuts). We expect that such
harvesting practices were developed because the fall does not damage
the edible crop, because the crop is protected with a durable shell.
Accordingly, we have defined ``dropped covered produce'' to exclude
produce that is intentionally dropped as part of harvesting. Further,
we do not propose to prohibit the use of dropped covered produce in a
commercial process (e.g., canning) that is designed to adequately
reduce the presence of microorganisms of public health significance.
Therefore, dropped covered produce that is exempt under proposed Sec.
112.2(b) may be distributed for such commercial processing as described
in proposed Sec. 112.2 (see section V.A. of this document).
We seek comment on this provision and whether specific commodities
should be exempted from this provision based on the harvesting
practices associated with the commodity and/or the nature of the
commodity itself. If specific commodities should be exempted from this
provision, please explain the practices, processes, and conditions
associated with that commodity that would justify such exemption. We
expect that this proposed provision would prevent the marketing for
fresh use of produce that may have been bruised as a result of the
fall. As noted above, damaged or bruised fruit provide an opportunity
for pathogen intrusion into the edible portion and may liberate
nutrients for pathogen growth. We note that produce that is
intentionally dropped to the ground as part of the harvesting method
would not be considered ``dropped covered produce'' as defined in
proposed Sec. 112.114 (i.e., produce that drops to the ground before
harvest). We seek comment on whether proposed Sec. 112.114 adequately
takes into account produce that is intentionally dropped during
harvesting and whether such harvesting practices do not cause damage to
the produce. Proposed Sec. 112.115 would establish measures that you
must take when packaging covered produce. Specifically, proposed Sec.
112.115 would require that you package covered produce in a manner that
prevents the formation of Clostridium botulinum toxin, if such toxin is
a known or reasonably foreseeable hazard (such as for mushrooms). The
potential for toxin production by C. botulinum in mushrooms packaged
under reduced oxygen conditions is well-known (Ref. 222). Mushrooms
grow close to the ground, which is a source of C. botulinum spores.
Mushrooms remain metabolically active after harvest, which may quickly
reduce the amount of oxygen, particularly when mushrooms are packaged
under conditions that limit the transfer of oxygen across the layer of
packaging (Ref. 223). In such reduced oxygen or anoxic conditions, C.
botulinum spores can germinate resulting in the formation of botulinum
toxin, which can occur before any overt signs of mushroom spoilage
(Ref. 222). Modified or reduced-oxygen packaging of other produce may
present a similar risk for botulinum toxin formation (Ref. 224).
Perforated packaging film allows free air access to mushrooms and is
recommended as a means to reduce the potential for toxin formation in
mushrooms (Ref. 225). Other means of preventing toxin formation in
modified or reduced oxygen packaging may include use of time-
temperature integrators on individual packages of produce to signal
when a cumulative time-temperature combination has been reached that
presents a risk for C. botulinum toxin formation or use of
antimicrobial compounds (Ref. 224). We request comment on the need for
this proposed provision and on the types or conditions of modified or
reduced oxygen packaging methods that may or may not increase the risk
of formation of botulinum toxin.
Proposed Sec. 112.116 would establish measures that you must take
when using food-packing (including food packaging) material.
Specifically, proposed Sec. 112.116(a) would require that food-packing
material must be adequate for its intended use. For example, food-
packing material that would be adequate for its intended use include
plastic bins for holding fresh-picked fruit, wax-impregnated corrugated
cardboard for broccoli to be hydrocooled or top-iced after packing,
plastic clamshells used for packaging strawberries for retail sale, and
single-use cardboard containers for packing tomatoes. Wooden bins or
boxes, and canvas bags that may be used during harvest also would need
to meet this requirement, and could be used if they are adequately
clean and sanitary for their intended use. To implement this provision,
you would have to use food-packing materials that are: (1) Cleanable or
designed for single use and (2) unlikely to support growth or transfer
of bacteria. In addition, proposed Sec. 112.116(b) would require that
if you reuse food-packing material, you take measures to ensure that
food-contact surfaces are clean, such as by cleaning and sanitizing,
when necessary, food-packing containers or using a clean liner.
Evidence from scientific literature indicates that the number of
microorganisms detected on the surface of fruits is directly correlated
to the amount of contact time between the fruit commodity and its
packing material (Ref. 226. Ref. 227). Although some food-packing
material is sufficiently sturdy to be used multiple times, it may serve
as a source of contamination in the absence of regular cleaning and
sanitizing between each such use. Further, certain food-packing
material may have a serviceable shelf life beyond which it may not
possible to effectively clean and sanitize the material. It is
reasonably likely that such packing material, if it continues to be
used, may serve as harborage sites for pathogens, if they become
established on its surface.

L. Subpart L--Standards Directed to Equipment, Tools, Buildings, and
Sanitation

Proposed subpart L establishes science-based minimum standards that
are reasonably necessary to prevent

[[Page 3590]]

equipment, tools, buildings, and inadequate sanitation from introducing
known or reasonably foreseeable hazards into or onto covered produce or
food-contact surfaces, and to provide reasonable assurances that the
covered produce is not adulterated under section 402 of the FD&C Act.
A few comments recommended that equipment used to hold or convey
water should be inspected to ensure that it is clean.
We agree that equipment used to hold or convey water should be
maintained in a manner necessary to protect against contamination. In
112.42 (b), we would require that you must adequately maintain all
agricultural water sources that are under your control (such as wells)
by regularly inspecting each source and keeping the source free of
debris, trash, domesticated animals, and other possible sources of
contamination of covered produce to the extent practicable and
appropriate under the circumstances. In 112.42 (c), we would require
that you must adequately maintain all agricultural water distribution
systems as necessary and appropriate to prevent the water distribution
system from being a source of contamination to covered produce, food-
contact surfaces, areas used for a covered activity, or water sources,
including by regularly inspecting and adequately storing all equipment
used in the system.
1. Comments Relevant to Proposed Provisions
We received some comments in response to the 2010 FR notice that
expressed that the use of animals on a farm or their presence near
farming operations should not be prohibited.
We address issues related to animals in and around farming
operations in subpart I (see section V.I. of this document) of this
rule. However, in this subpart, we address the presence of animals in
fully-enclosed buildings. Specifically, proposed Sec. 112.127 would
require that you take reasonable precautions to prevent domesticated
animals, including guard and guide dogs, in and around a fully-enclosed
building from contaminating covered produce, food-contact surfaces, and
food packing materials with known or reasonably foreseeable hazards.
2. Proposed Requirements
a. Equipment, Tools, and Buildings That Are Subject to the Requirements
of This Subpart
Any equipment and tools used during covered activities that are
intended to, or likely to, contact covered produce would be subject to
proposed subpart L. In addition, instruments or controls used to
measure, regulate, or record conditions to control or prevent the
growth of undesirable microorganisms or other contamination would be
subject to proposed subpart L. In proposed Sec. 112.121, we provide
examples of such equipment and tools, i.e., knives, implements,
mechanical harvesters, waxing machinery, cooling equipment (including
hydrocoolers), grading belts, sizing equipment, palletizing equipment,
and equipment used to store or convey harvested covered produce (such
as containers, bins, food-packing material, dump tanks, flumes, and
vehicles or other equipment used for transport).
Proposed Sec. 112.122 would identify the types of buildings that
are subject to the requirements of proposed subpart L. Such buildings
would include any fully- or partially-enclosed buildings used for
covered activities, including minimal structures that have a roof but
do not have any walls (proposed Sec. 112.122(a)). Fully-enclosed
buildings are typically used to grow covered produce such as sprouts
and mushrooms and may be used to grow a variety of covered produce
indoors to create or extend the growing season in a particular
geographic area. Partially-enclosed buildings can be used to grow
covered produce such as tomatoes, and are often used to pack covered
produce. Buildings that are subject to the requirements of the rule
would also include storage sheds, buildings, or other structures used
to store food-contact surfaces (such as harvest containers and food-
packing materials) (proposed Sec. 112.122(b)). We are proposing this
requirement because contaminated food-contact surfaces can contaminate
covered produce (Ref. 182) (Ref. 228) and, thus, present a potential
hazard.
b. General Requirements Applicable to Equipment and Tools
As proposed, Sec. 112.123 establishes general requirements
applicable to equipment and tools subject to subpart L. Proposed Sec.
112.123(a) would require you to use equipment and tools that are of
adequate design, construction, and workmanship to enable them to be
adequately cleaned and properly maintained. For example, some lettuce
coring knives currently used in the industry are designed in a way that
gives them the propensity to transfer microbial contaminants from soil
to the lettuce (Ref. 229). Using a tool that is designed to minimize
the potential for pathogen transfer from soil to the produce and/or
that allows for mechanical polishing to facilitate cleaning and
sanitizing the tool would enhance food safety (Ref. 230).
Proposed Sec. 112.123(b)(1) would establish that equipment and
tools you use must be installed and maintained in a manner that
facilitates cleaning of the equipment and of all adjacent spaces. For
example, equipment that is permanently installed in an on-farm packing
operation would need to be installed in such a manner that both
maintenance and cleaning crews are able to easily access any food
contact surfaces, protective covering or barriers, and any movable
parts or other potential sources of contamination. A conveyor belt
system that is part of a grading line would be considered properly
installed if there is easy access to the belt (a food-contact surface)
for cleaning. The proposed provisions in Sec. 112.123(b)(1) are
consistent with the requirements in current Sec. 110.40(a) and Sec.
111.27(a).
Proposed Sec. 112.123(b)(2) would establish that equipment and
tools you use must be stored and maintained to protect covered produce
from being contaminated with known or reasonably foreseeable hazards
and to prevent the equipment and tools from attracting or harboring
pests. As discussed in the QAR, if farm equipment or tools are stored
outside or in a partially-enclosed building, they may attract or harbor
pests, which can carry human pathogens (Ref. 231). Appropriate
practices for storing and maintaining equipment and tools can reduce
the potential for these problems. For example, you would comply with
this provision by storing equipment and tools indoors when practical,
and when not practical, minimizing surrounding debris and checking
periodically for pests.
Proposed Sec. 112.123(c) would establish that seams on food-
contact surfaces of equipment and tools that you use must be either
smoothly bonded, or maintained to minimize accumulation of dirt, filth,
food particles, and organic material and thus minimize the opportunity
for harborage or growth of microorganisms. This provision is consistent
with current Sec. 110.40(a) and (b) and Sec. 111.27(a).
Proposed Sec. 112.123(d)(1) would require you to inspect,
maintain, and clean and sanitize (when necessary and appropriate) all
food-contact surfaces of equipment and tools used in covered activities
as frequently as reasonably necessary to protect against contamination
of covered produce. This provision is intended to prevent transfer of
contaminants on food-contact surfaces of equipment or tools (e.g.,
harvest knives, grading belts, or harvest

[[Page 3591]]

bins) to covered produce. As discussed in the QAR, for example, it has
been documented that E. coli O157:H7 can be transferred to Iceberg
lettuce from contaminated coring devices used in a simulated field
coring (Ref. 229). Even food contact surfaces made of stainless steel
can transfer pathogens to covered produce, if not properly cleaned and
sanitized. For example, transfer of pathogens from stainless steel
tools to lettuce has been demonstrated to occur to various extents,
depending on the amount of water on the leaf surface (Ref. 232).
Proposed Sec. 112.123(d)(2) would require you to maintain and
clean all non-food-contact surfaces of equipment and tools subject to
subpart L used in covered activities during harvesting, packing, and
holding as frequently as reasonably necessary to protect against
contamination of covered produce. The potential for an equipment or
tool to come into contact with covered produce varies with the type and
intended use of the equipment or tool. Non-food-contact surfaces of
tools and equipment used in contact with covered produce can be sources
of contamination. Therefore, it is important to maintain such surfaces
of covered equipment and tools in a clean and sanitary condition.
However, such surfaces may not require cleaning as frequently as those
that come into direct contact with produce, and may not require
sanitizing. An example of such a surface is the handle of a tool used
when working directly with covered produce, although depending on the
use, such equipment or tool may be or consist of a food-contact
surface. For example, a truck used to harvest produce may not need to
be thoroughly cleaned or sanitized; however, the flatbed of the same
truck if used to haul un-packed/loose produce would be considered a
food-contact surface.
Proposed Sec. 112.123(e) would establish that, if you use
equipment such as pallets, forklifts, tractors, and vehicles such that
they are intended to, or likely to, contact covered produce, you do so
in a manner that minimizes the potential for contamination of covered
produce or food-contact surfaces with known or reasonably foreseeable
hazards. For example, you may consider the appropriate route for any
equipment to move in, through, and out of production fields, and when
there may be a need to visually inspect and clean such equipment to
prevent contamination or cross-contamination of covered produce. The
potential for transfer of contaminants from tractors to covered
produce, for example, if the tractors drive through or otherwise come
in contact with manure is also highlighted in our GAPs Guide (Ref. 10).
We seek comment on the appropriateness of the proposed cleaning
provisions related to equipment and tools.
c. General Requirements Applicable to Instruments and Controls
Proposed Sec. 112.124 would establish that instruments or controls
you use to measure, regulate, or record temperatures, hydrogen-ion
concentration (pH), sanitizer efficacy or other conditions, in order to
control or prevent the growth of pathogens or other contamination, must
be: (a) Accurate and precise as necessary and appropriate in keeping
with their purpose; (b) adequately maintained; and (c) adequate in
number for their designated uses. Proposed Sec. 112.124 is consistent
with current Sec. 111.27(a)(6), and similar to requirements in current
Sec. 110.40(f). Accuracy addresses whether the recorded measurements
are equal to the true value of that which is being measured, while
precision addresses whether individual measurements are close to each
other when made under the same conditions. Both accuracy and precision
are necessary to ensure the validity and reliability of measurements.
The appropriate degree of accuracy and precision, however, would need
to be determined based on the nature of the instrument and its specific
use for the covered activity. Instruments must also be adequately
maintained to ensure that they are functioning properly for their
intended use. For example, an in-line water oxidation-reduction
potential meter that is used to determine the approximate sanitizer
concentration in a water flume system must be appropriately maintained
to ensure that there is no debris build-up that would interfere with
its proper operation. In addition, you must have an adequate number of
instruments as needed for the designated use. For example, if you are
composting a small pile of manure and monitoring the temperature, one
thermometer may be sufficient. However, if you are composting large
windrows in excess of several hundred yards in length, and using an
automated system to monitor the internal temperature of the pile, you
would need multiple thermocouples placed throughout the pile to get a
good reading of the overall temperature.
d. Transport of Covered Produce
Proposed Sec. 112.125 would establish that equipment subject to
subpart L that you use to transport covered produce during covered
activities must be: (a) Adequately clean before use in transporting
covered produce; and (b) adequate for use in transporting covered
produce. Transport equipment that is intended to, or likely to, contact
covered produce that is not clean, or that is not adequate for the
covered produce it is being used to transport, can be a source of
cross-contamination of covered produce. Equipment used to transport
covered produce would not be adequately clean if, for example, there is
dirt, filth, organic material, particles of food, remains of previous
shipping loads, or any other extraneous materials or contaminants on
surfaces that are likely to come into contact with the produce.
Equipment used to transport covered produce would not be adequate if,
for example, the same equipment is used to haul live animals or garbage
that is not completely contained, and the equipment is either not
designed in a manner that allows cleaning and sanitizing or it is not
cleaned or sanitized, before it is used to transport covered produce.
Proposed Sec. 112.125 is consistent with recommendations in FDA's GAPs
Guide (Ref. 10), the AFDO Model Code (Ref. 20), commodity-specific
guidances (Ref. 85. Ref. 94. Ref. 27), and international guidelines
(Ref. 96. Ref. 96).
e. Design and Construction Requirements Applicable to Buildings
Proposed Sec. 112.126 would establish requirements applicable to
the design and construction of buildings. As proposed, Sec. 112.126(a)
requires that your buildings must be suitable in size, construction,
and design to facilitate maintenance and sanitary operations for
covered activities to reduce the potential for contamination of covered
produce or food-contact surfaces with known or foreseeable hazards. For
buildings to be suitable in size, it should have enough room for
covered activities to be conducted without cross-contact between
covered produce or food-contact surfaces and building materials, non-
food-contact surfaces, or clothing. Proposed Sec. 112.126(a)(1) would
establish requirements that your building provide sufficient space for
placement of equipment and storage of materials. This is necessary for
the maintenance of sanitary operations and the conduct of covered
activities. The proposed provisions in Sec. 112.126(a)(1) are
consistent with requirements in current Sec. 110.20(b)(1) and Sec.
111.20. Proposed Sec. 112.126(a)(2) would establish requirements that
your buildings must permit proper precautions to be taken to reduce the
potential for contamination of covered produce, food contact surfaces,
or packing material with known or reasonably foreseeable hazards. The

[[Page 3592]]

potential for contamination must be reduced by effective design,
including the separation of operations in which contamination is likely
to occur, by one or more of the following means: Location, time,
partition, enclosed systems, or other effective means. This provision
provides flexibility in the precautions you take for your buildings and
proposes separation of operations, such as by having sufficient space
so that incompatible operations can be kept at a reasonable distance
from each other, for example, so that spray coming off equipment being
washed does not contact covered produce being packed. The proposed
provisions in Sec. 112.126(a) are similar to requirements in current
Sec. 110.20(b)(2) and Sec. 111.20.
Proposed Sec. 112.126(a)(3) would require buildings to be
constructed in a manner such that floors, walls, ceilings, fixtures,
ducts, and pipes can be adequately cleaned and kept in good repair, and
that drip or condensate does not contaminate covered produce, food-
contact surfaces, or packing materials. Buildings where covered
activities occur must be suitably constructed to allow adequate
cleaning and sanitizing in order to minimize the presence or
persistence of hazards and the potential for damage or contamination of
covered produce. Buildings should be kept in good repair so as to
prevent drip or condensate from pipes or ceilings to drop onto covered
produce or food-contact surfaces, and holes in walls of enclosed
buildings from permitting pests access to covered produce or areas of
covered activities. The proposed provisions in Sec. 112.126(a)(3) are
consistent with requirements in current Sec. 110.20(b)(4) and Sec.
111.20.
Finally, proposed Sec. 112.126(b) would establish requirements
that you provide adequate drainage in all areas where normal operations
release or discharge water or other liquid waste on the ground or floor
of the building. Standing water can attract pests and support the
growth of pathogens, such as L. monocytogenes, presenting potential for
contamination of covered produce. The proposed provision in Sec.
112.126(b) is similar to requirements in current Sec. 110.37(b)(4) and
Sec. 111.15(f)(4).
f. Domesticated Animals in and Around Fully-Enclosed Buildings
Proposed Sec. 112.127(a) would require you to take reasonable
precautions to prevent contamination of covered produce, food-contact
surfaces, and food-packing materials in fully-enclosed buildings with
known or reasonably foreseeable hazards from domesticated animals by:
(1) Excluding domesticated animals from fully-enclosed buildings where
covered produce, food-contact surfaces, or food-packing material is
exposed; or (2) separating domesticated animals in a fully-enclosed
building from an area where a covered activity is conducted on covered
produce by location, time, or partition. As discussed in the QAR,
domesticated animals can carry pathogens, potentially resulting in
contamination of covered produce or food contact surfaces. However,
consistent with current Sec. 110.35(c), we propose to permit guard or
guide dogs in some areas of a fully-enclosed building if the presence
of the dogs is unlikely to result in contamination of produce, food-
contact surfaces, or food-packing materials (proposed Sec.
112.127(b)). You would need to take reasonable precautions to prevent
contamination of covered produce, food-contact surfaces, and food-
packing material with hazards from such dogs. We believe that animals
such as guard or guide dogs, when kept under control and where the
activities of the animal can be contained, are unlikely to result in
contamination of produce, food-contact surfaces, or food-packing
materials. We seek comment on the appropriateness of this provision and
whether proposed provision Sec. 112.127(b) should be extended to all
working animals.
g. Pest Control
As discussed in the QAR, pests such as rodents, snakes, lizards,
turtles, iguanas, and birds are known to carry human pathogens, such as
Salmonella spp. and, if not controlled, can cause the contamination of
covered produce, food contact surfaces or food-packing materials.
Therefore, in proposed Sec. 112.128(a), we propose to require you to
take measures reasonably necessary to protect covered produce, food-
contact surfaces, and food-packing materials from contamination by
pests in buildings, including routine monitoring for pests as necessary
and appropriate. Furthermore, we propose to require you to take
measures to exclude pests from fully-enclosed buildings (proposed Sec.
112.128(b)) and to prevent pests from becoming established in
partially-enclosed buildings (such as by use of screens or by
monitoring for the presence of pests and removing them, when present)
(proposed Sec. 112.128(c)). We recognize that it might be impossible
to exclude pests, such as birds, from entering buildings that are not
fully-enclosed. To comply with proposed Sec. 112.128(c), you would
need to take those steps reasonably necessary to prevent birds or other
animals from building nests in partially-enclosed buildings and, if
possible, to find and remove any nests that become established. Any
measures or steps taken under these provisions would need to comply
with applicable wildlife conservation regulations.
h. Toilet and Hand-Washing Facilities
Human feces may contain pathogens in relatively high concentrations
(Ref. 233). The most basic measure to prevent the potential transfer of
pathogens from human feces into or onto covered produce and food-
contact surfaces is to provide toilet facilities that collect and
contain human feces. Proposed Sec. 112.129 would establish
requirements related to toilet facilities, including that you must
provide personnel with adequate, readily accessible toilet facilities,
including facilities readily accessible to growing areas during
harvesting activities (proposed Sec. 112.129(a)). In proposed Sec.
112.129(b), we propose to establish that toilet facilities must be
designed, located, and maintained to: (1) Prevent contamination of
covered produce, food-contact surfaces, areas used for a covered
activity, water sources, and water distribution systems with human
waste (proposed Sec. 112.129(b)(1)); (2) be directly accessible for
servicing, be serviced and kept clean on a schedule sufficient to
ensure suitability of use, and be kept supplied with toilet paper
(proposed Sec. 112.129(b)(2)); and (3) provide for the sanitary
disposal of waste and toilet paper (proposed Sec. 112.129(b)(3)).
These provisions are intended to contribute to an overall sanitary
measure to help protect covered produce and areas where covered
activities are conducted from contamination with pathogens. A portable
toilet facility that leaks or a fixed toilet facility that lacks proper
drainage or backflow devices would not be considered properly designed
or maintained. As discussed in the QAR, runoff from such a toilet
facility has the potential to directly contaminate covered produce,
while contamination of soil and irrigation water from such runoff can
have longer-lasting impact. To minimize the potential for contamination
during events such as flooding or high winds, toilet facilities should
be located away from water sources and water distribution systems, and
at a reasonable distance from growing and packing areas. Sewage
transport or other servicing trucks should have clear access to toilet
facilities to ensure proper collection and disposal of wastes. In
addition, workers are more likely to use toilet facilities that are
clean, well-stocked, and in good condition (Ref. 234). We recognize
that the growing area of a farm may spread

[[Page 3593]]

across several acres of land, and workers or visitors may be in growing
areas for an extended period of time primarily during harvest
activities. At times other than during harvest, we would consider
toilet facilities to be readily accessible if, for example, the
facility is available to workers at a farm building before and after
they work in a growing area, or at a nearby public facility that is
readily accessible to your workers. However, during harvest activities
we consider it likely that workers and visitors will spend a
significant amount of time in growing areas. We point out that the
field sanitation requirements prescribed by the Occupational Safety and
Health Administration (OSHA) under the Occupational Safety and Health
Act, specifically 29 CFR 1928.110, describes the appropriate number of
toilets to the number of workers, proper handwashing facilities,
maximum worker-to-restroom distance, and frequency of cleaning
facilities. Agricultural establishments subject to the requirements of
29 CFR 1928.110(c)(2), must provide one toilet facility for each 20
employees or fraction thereof (except that toilet facilities are not
required for employees who perform field work for a period of three
hours or less (including transportation time to and from the field)
during the day).
As discussed in the QAR, the fecal-oral route for contamination of
food with pathogens is well-established and proper washing and drying
of hands are fundamental practices demonstrated to be effective in
breaking the fecal-oral route of contamination. Therefore, in proposed
112.129(c), we would establish requirements that you provide a hand-
washing station during growing activities that take place in a fully-
enclosed building, and during covered harvesting, packing, or holding
activities, that is in sufficiently close proximity to toilet
facilities to make it practical for persons who use the toilet facility
to wash their hands. We discuss the importance of hand-washing in
presenting the proposed requirements for hygienic practices in section
V.D. of this document.
The provisions in proposed Sec. 112.129 are consistent with
recommendations in our GAPs Guide (Ref. 10), the AFDO Model Code (Ref.
20), commodity-specific guidances (Ref. 85. Ref. 94. Ref. 194), and
international guidelines (Ref. 96. Ref. 96). These provisions are also
similar to requirements in current Sec. 110.37(d) and Sec. 111.15.
With respect to hand-washing facilities, we propose to require you
to provide personnel with adequate, readily accessible hand-washing
facilities during growing activities that take place in a fully-
enclosed building, and during covered harvest, packing, or holding
activities (proposed Sec. 112.130(a)). In addition, in proposed Sec.
112.130(b), we would establish requirements that your hand-washing
facilities must be furnished with: Soap (or other effective surfactant)
(proposed Sec. 112.130(b)(1)); running water that satisfies the
requirements of Sec. 112.44(a) for water used to wash hands (proposed
Sec. 112.130(b)(2)); and adequate drying devices (such as single
service towels, clean cloth towels or sanitary towel service) (proposed
Sec. 112.130(b)(3)). As discussed in the QAR, hand-washing is a key
control measure in preventing the spread of pathogens from ill or
infected workers to covered produce and food-contact surfaces. Workers
often touch produce with their bare hands. Hand-washing, when done
effectively, can significantly reduce the number of resident bacteria
on the hands of a worker who may not be aware of being ill or infected,
as well as transient microbial pathogens that get onto hands through
contact with the environment or other ill workers. The effectiveness of
hand-washing is determined by multiple factors, including whether or
not soap is used, the quality of water used, the duration of scrubbing
and rinsing, and whether and how hands are dried. The frequency of
hand-washing, as well as the efficacy of a single hand-washing event,
may also be important factors in the spread of microbial pathogens by
ill or contaminated workers (Ref. 107).
Proposed subpart 112.130(c) would establish requirements that you
provide for appropriate disposal of waste (for example, waste water and
used single-service towels) associated with a hand-washing facility and
take appropriate measures to prevent waste water from a hand-washing
facility from contaminating covered produce, food-contact surfaces,
areas used for a covered activity, agricultural water sources, and
agricultural water distribution systems with known or reasonably
foreseeable hazards. A hand-washing facility produces waste that can
lead to contamination, and such waste needs to be controlled. For
example, if the sink of a portable hand-washing station in field
actively being harvested does not have a catch-basin or tank, but
instead is open the ground, the waste-water from the sink can
contaminate the soil. Finally, in proposed Sec. 112.130(d), we would
establish that you may not use hand antiseptic/sanitizer as a
substitute for soap and water. As discussed in the QAR, hand sanitizers
have not been found to be effective substitutes for washing hands with
soap and water, because the presence of dirt, grease, or soil reduces
their effectiveness in eliminating bacteria. However, we are not
proposing to prohibit the use of sanitizers as they may be effective as
an additional measure in reducing the number of bacteria on hands after
proper washing with soap and water followed by drying
The hand-washing provisions in proposed Sec. 112.130 are
consistent with recommendations in our GAPs Guide (Ref. 10), the AFDO
Model Code (Ref. 20), commodity-specific guidances (Ref. 85. Ref. 94.
Ref. 194), and international guidelines (Ref. 96). They are also
similar to the requirements in current Sec. 110.37(e) and Sec.
111.15(i).
i. Disposal of Sewage, Trash, Litter, and Other Waste
As discussed in the QAR, human feces may contain pathogens in
relatively high concentrations and, therefore, sewage must be properly
disposed and sewage and septic systems must be maintained to minimize
the potential for failure, leakage, or spills (and any leakage or spill
appropriately managed) to prevent contamination of covered produce.
Events such as flooding or earthquakes also have the potential to
damage sewage and septic systems and impair their function and,
therefore, it would be appropriate to assess your sewage systems for
damage or other failures, following such events. Proposed Sec. 112.131
would establish requirements that apply to the control and disposal of
sewage, including that you must dispose of sewage into an adequate
sewage or septic system or through other adequate means (proposed Sec.
112.131(a)), which is consistent with current Sec. 110.37(c) and Sec.
111.15(g); you must maintain sewage and septic systems in a manner that
prevents contamination of covered produce, food-contact surfaces, areas
used for a covered activity, agricultural water sources, and
agricultural water distribution systems with known or reasonably
foreseeable hazards (proposed Sec. 112.131(b)); you must manage and
dispose of leakages or spills of human waste in a manner that prevents
contamination of covered produce, and prevents or minimizes
contamination of food-contact surfaces, areas used for a covered
activity, agricultural water sources, or agricultural water
distribution systems (proposed Sec. 112.131(c)); and that after a
significant event (such as flooding or an earthquake) that could
negatively impact a sewage or septic system, you must take appropriate
steps to ensure

[[Page 3594]]

that sewage and septic systems continue to operate in a manner that
does not contaminate covered produce, food-contact surfaces, areas used
for a covered activity, agricultural water sources, or agricultural
water distribution systems (proposed Sec. 112.131(d)). These
provisions are consistent with recommendations in our GAPs Guide (Ref.
10), commodity-specific guidances (Ref. 44. Ref. 46), and the AFDO
Model Code (Ref. 20).
Proposed subpart 112.132 would establish requirements that apply to
the control and disposal of trash, litter, and other waste in areas
used for covered activities. Proposed Sec. 112.132(a) would establish
requirements that you convey, store, and dispose of trash, litter and
waste to: (1) Minimize the potential for trash, litter, or waste to
attract or harbor pests (proposed Sec. 112.132(a)(1)); and (2) Protect
against contamination of covered produce, food-contact surfaces, areas
used for a covered activity, agricultural water sources, and
agricultural water distribution systems with known or reasonably
foreseeable hazards (proposed Sec. 112.132(a)(2)). In addition, we
propose to require that you adequately operate systems for waste
treatment and disposal so that they do not constitute a potential
source of contamination in areas used for a covered activity (proposed
Sec. 112.132(b)). The provisions proposed in Sec. 112.132 are
consistent with requirements in current Sec. Sec. 111.15(a) and (g)
and similar to requirements in current Sec. 110.37(f). These
provisions are also consistent with recommendations for packing areas
in our GAPs Guide (Ref. 10), and commodity-specific guidance (Ref. 46).
j. Plumbing
Proposed Sec. 112.133 would establish that plumbing must be of an
adequate size and design and be adequately installed and maintained to
(1) distribute water under pressure as needed, in sufficient
quantities, in all areas where used for covered activities, for
sanitary operations, or for hand-washing and toilet facilities
(proposed Sec. 112.133(a)); (2) properly convey sewage and liquid
disposable waste (proposed Sec. 112.133(b)); (3) avoid being a source
of contamination to covered produce, food-contact surfaces, areas used
for a covered activity, or agricultural water sources (proposed Sec.
112.133(c)); and (4) not allow backflow from, or cross connection
between, piping systems that discharge waste water or sewage and piping
systems that carry water used for a covered activity, for sanitary
operations, or for use in hand-washing facilities (proposed Sec.
112.133(d)). An example of a problem that may result from inadequate
plumbing is improper drainage of refrigeration drip pans. If drip pans
do not drain properly, they may drip onto covered produce or allow
moisture to accumulate providing an environment that can support the
establishment of and growth of L. monocytogenes. Proposed Sec. 112.133
is intended to ensure that your plumbing and water distribution systems
do not adversely affect the water you use in covered activities on
covered produce. If the plumbing and water distribution systems are not
adequately installed and maintained, they may contaminate your water
supply and, in turn, contaminate your covered produce through direct
contact (such as when you use water in irrigation or harvest
activities), or through indirect contact (such as when the contaminated
water is used to wash a food-contact surface). Such cross-contamination
of clean water and waste water has been implicated in outbreak
investigations (Ref. 235). It would also be important to prevent
contamination of water that must meet the requirements under subpart E
by water that does not meet the relevant requirements. For example,
water used for irrigation of covered produce other than sprouts using a
direct water application method would need to meet the requirements of
Sec. Sec. 112.41 and 112.44(c) or (d), but would not necessarily meet
the requirements of Sec. 112.44(a) (see section V.E. of this
document). These provisions are consistent with the requirements in
current Sec. Sec. 110.37(b) and 111.15(f), and with the
recommendations in our GAPs Guide (Ref. 10), the AFDO Model Code (Ref.
20), and commodity-specific guidances (Ref. 46. Ref. 44).
k. Control of Animal Excreta and Litter From Domesticated Animals
In proposed Sec. 112.134(a), we would require that, if you have
domesticated animals, to prevent contamination of covered produce,
food-contact surfaces, areas used for a covered activity, agricultural
water sources, or agricultural water distribution systems with animal
waste, you must: (1) Adequately control their excreta and litter, and
(2) maintain a system for control of animal excreta and litter. For
example, you would comply with this provision by not locating manure
piles adjacent to packing sheds in which covered produce is exposed. As
discussed in the QAR, pathogens inhabit the gut of a variety of warm-
blooded animal species and are often shed in feces in high numbers. If
not effectively controlled, such pathogens may persist in the
environment for long periods of time (see the QAR) and may pose a
threat to water quality from runoff and leaching (Ref. 236. Ref. 169),
creating multiple opportunities for these pathogens to contaminate
produce or food contact surfaces.
l. Record Keeping
Proposed Sec. 112.140(a) would make clear that records required
under this subpart L must be established and kept in accordance with
the requirements of subpart O of this part. Records required to be
established and kept under this subpart L include documentation of the
date and method of cleaning and sanitizing of the equipment you use in
growing operations for sprouts (proposed Sec. 112.140(b)(1)) and in
covered harvesting, packing, or holding activities (proposed Sec.
112.140(b)(2)). These documentation requirements are intended to enable
us to verify and you to ensure that requirements of this subpart are
met.

M. Subpart M--Standards Directed to Sprouts

Proposed subpart M would establish science-based minimal standards
for the growing, harvesting, packing and holding of sprouts that are
reasonably necessary to minimize the risk of known or reasonably
foreseeable hazards that are associated with serious adverse health
consequences or death. As noted in section I of this document, sprouts
have been frequently associated with foodborne illness outbreaks (Ref.
3). As a result, we issued our first commodity-specific guidance for
sprouts. Likewise, the Codex Alimentarius Commission supplemented its
Codex Fresh Fruits and Vegetables Code with a Sprout Annex (Ref. 50).
Sprouts present a special concern with respect to human pathogens
than other covered produce because of the warm, moist, and nutrient-
rich conditions required to produce sprouts, the same conditions that
are also ideal for the proliferation of pathogens if present (Ref. 208.
Ref. 16). Therefore, we believe it is necessary to incorporate this
additional subpart establishing standards specific to sprouts. The
provisions of proposed subpart M are consistent with recommendations in
FDA's Sprout Guides (Ref. 14. Ref. 15), industry guidance (Ref. 237),
and international regulations and guidelines (Ref. 38. Ref. 191. Ref.
192. Ref. 193).
We are also seeking comment on whether, or to what extent, the
measures in this subpart should be applied to soil-grown sprouts. The
NACMCF Sprout White paper and our Sprout Guides do not distinguish
soil-grown sprouts and hydroponic sprouts (Ref. 14. Ref. 15.

[[Page 3595]]

Ref. 16). However, we are not aware of any outbreaks associated with
sprouts grown in soil or media, which could be because of the lower
percentage of sprouts grown in that manner, the nature of the species
of sprouts grown in that manner, or a difference in likelihood of
contamination posed by that method and hydroponics. This could be the
case because of the relative ease of transfer of pathogens between
sprouts in a water environment and, possibly, a greater amplification
of pathogens during hydroponic sprout production compared to the more
stressful environment for pathogen growth posed by exposure to air and
sunlight when seeds are grown under conditions more typical of a
natural setting (soil and media methods). On the other hand, we expect
that seeds or beans would be a potential vehicle of contamination,
regardless of sprouting method employed. Seeds or beans (in the form of
seed leaves or cotyledons) could be part of the food consumed,
regardless of the method used for sprouting. In addition, flats of soil
or media grown sprouts may be placed on a growing rack, similar to
hydroponic sprouts grown in clamshells (as opposed to large bins for
bean sprouts or rotating drums used to start green sprouts), with
overhead sprout irrigation water, providing an opportunity for
pathogens, if present, to be spread within a flat of sprouts and to
other flats on racks below. Alternatively, flats may be placed side-by-
side in a growing area such as a greenhouse, where the likelihood of
pathogen spread would presumably be lower than when a growing rack is
used.
Finally, as discussed in section IV of this document, while we
recommend that farms conduct an operational assessment and develop a
food safety plan, at this time, we are not proposing to require them to
do so. We request comment on whether, in a final rule, a food safety
plan and/or an operational assessment should be required for farms
conducting covered activities related to sprouts, either in addition to
or in place of the standards proposed in this subpart. We also request
comment on whether a written plan similar to the type required under
section 418 of the FD&C Act would be more appropriate for farms
conducting covered activities related to sprouts.
1. Comments Relevant to the Proposed Provisions
We received very few comments related specifically to sprouts.
Those that were submitted were generally supportive of our efforts to
create policies to prevent illness and produce safer sprouts, citing
the need for addressing residual agricultural chemicals and microbial
contamination of seed, seed disinfection treatments, worker health and
hygiene, and sanitation. One comment hoped that we understood the
realities currently facing the sprout industry worldwide, and would
take actions to ensure truly practical measures that would be accepted
by the sprout industry, questioning, for example, the need for
extensive record keeping or monitoring sprout facilities for Listeria.
This comment maintained that we should consider current production
methods and consumption practices in establishing standards for
sprouts.
As discussed further in section V.M.3. of this document, our
proposed rule carefully considers the various conditions under which
sprouts are grown and consumed. The proposal provides flexibility to
achieve the goal of minimizing the risk of known or reasonably
foreseeable hazards that are associated with serious adverse health
consequences or death. We consider that the proposed requirements for
the growing, harvesting, packing and holding of sprouts, as well as for
record keeping, are all practical and necessary to protect public
health. With respect to consideration of the method of growth, as
discussed above, we are seeking comment on whether soil-grown sprouts
are subject to the same risk factors as hydroponic sprouts and to
whether, or to what extent, the measures in this subpart should be
applied to them.
One comment recommended that bean sprouts be subjected to less
stringent requirements compared to others, e.g., green sprouts, because
bean sprouts are rarely consumed raw (less than 1% according to their
estimates). This comment suggested that seed disinfection treatments
might not be necessary (or argued for more disinfection method choices)
for bean sprouts. Our 1999 Sprout Guides apply to all sprouted seeds
and beans (Ref. 14. Ref. 15) and we are proposing in subpart M to cover
all sprouts, including bean sprouts. Our earliest efforts to promote
sprout safety, including consumer advisories, focused primarily on
green sprouts, such as alfalfa and clover sprouts, where we were seeing
sprout outbreaks and because we assumed bean sprouts were most often
cooked before consumption (Ref. 238). However, in 2002, we updated our
consumer advisories to include advice on the risks associated with
eating all types of sprouts, including raw and lightly cooked bean
sprouts based on four foodborne illness outbreaks associated with mung
bean sprouts between 2000 and 2002 (Ref. 239). As noted in section
V.A.2.a. of this document, we analyzed consumption of selected produce
commodities to determine those that are rarely consumed raw. We
included sprouts (alfalfa and mung bean) in our analysis, and based on
data available from the NHANES, alfalfa and mung bean sprouts do not
meet our criteria for rarely consumed raw commodities (Ref. 79).
2. Proposed Requirements
Proposed Sec. 112.141 would establish measures directed to seeds
or beans used to grow sprouts. Seeds and beans used for sprouting are
believed to be the vehicle for contamination in most E. coli O157:H7
and Salmonella foodborne illness outbreaks associated with sprouts
(Ref. 3. Ref. 16). Proposed Sec. 112.141 is consistent with our Sprout
Guide and other public and private programs (Ref. 50. Ref. 240).
Proposed Sec. 112.141(a) would require that, if you grow seeds or
beans for use to grow sprouts, you must take measures reasonably
necessary to prevent the introduction of known or reasonably
foreseeable hazards into or onto seeds or beans that you will use for
sprouting. These measures would need to be taken during growing,
harvesting, packing, and holding of seeds and beans, which include such
activities as cleaning, conditioning, and blending.
Various crops may be grown to produce seeds and beans for sprouting
with different production practices, growing seasons, conditions, and
crop needs. Some of these plants set seeds or beans without
intervention from growers, while others (such as alfalfa) may require
steps, such as being cut-back, to encourage seed set. Harvesting,
packing, and holding may also vary by seed type and by the conditions
needed to maintain seed quality, such as germination. Because of the
diversity of practices, processes, and procedures, the controls
reasonably necessary to prevent the introduction of known or reasonably
foreseeable hazards into or onto seeds or beans that you use for
sprouting may vary. Therefore, we are not proposing to prescribe
specific measures that are reasonably necessary to prevent the
introduction of known or reasonably foreseeable hazards into or onto
seeds or beans. However, you may refer to our recommendations in
relevant guidances (Ref. 14. Ref. 10).
It is well-established that sprouts can become contaminated through
the use of contaminated seeds for sprouting. Therefore, we considered
proposing a supplier approval and verification program for seeds and
beans received by sprouters for sprouting purposes. Such

[[Page 3596]]

a program would provide assurance that seeds or beans received from a
third party for use to grow sprouts are grown, harvested, stored, and
handled using measures reasonably necessary to prevent the introduction
of known or reasonably foreseeable hazards into or onto seeds or beans
used for sprouting.
However, a supplier approval and verification program may not be
practical or effective for seeds and beans received by sprouters for
sprouting purposes. For example, for most crops, only a small
percentage of the harvested seeds or beans goes to sprout production
(Ref. 16. Ref. 241). Several distributors sell seeds and beans
primarily for agricultural use with little or no sales for sprouting
(Ref. 16). Seeds and beans have a relatively long shelf-life, sometimes
being stored for a year or longer, and they often pass through a number
of business entities before their final sale. Therefore, the ultimate
end use of seeds and beans will likely not be known by many growers,
handlers, or distributors (Ref. 16. Ref. 196. Ref. 192. Ref. 197). We
are also not aware of any regulatory standards that include a supplier
approval and verification program for seeds and beans received by
sprouters for sprouting purposes. For example, Food Standards Australia
New Zealand (FSANZ) considered but did not require such a program (Ref.
242). We ask for comment on this approach and whether there are
additional practical steps or practices that can be taken to ensure the
safety of seeds and beans used for sprout production. Specifically, we
request comments on whether a supplier approval and verification
program for seeds and beans intended for sprout production is practical
and effective.
We also considered whether to propose a requirement that you test
incoming seeds and beans, and rejected this approach. Although
epidemiological investigations often identify seeds and beans as the
most likely source of contamination, contamination may be at very low
levels (4 CFU/kg seed) (Ref. 16) and laboratory analyses have
frequently been unable to isolate pathogens from implicated seeds or
beans (Ref. 243). In a recent EFSA publication, the authors concluded
that a 2-class sampling plan ``absence in 25g'', n=5; c=0, as specified
in EC Regulation 2073/2005 for sprouted seeds, will not give sufficient
confidence to demonstrate the absence of a target pathogen at these low
levels in seeds. To increase the probability of rejection of a positive
lot, the authors estimated that it would be necessary to analyze
kilogram quantities of the sample (Ref. 244). Guidances from Canadian
and Irish authorities include recommendations that seeds and beans be
tested by the distributor, and that the sprouter obtain a Certificate
of Analysis (CoA) for the seeds and beans (Ref. 240. Ref. 245), but
recognize the limitations of testing seeds.
While a negative test result is not a guarantee of the absence of
pathogens, a positive test result would facilitate detection of
contaminated seeds and beans for destroying or diverting to non-food
use. Thus, we would encourage seed suppliers and sprouters to test seed
using statistically valid sampling and testing protocols. However, we
tentatively conclude that testing seeds and beans is not sufficiently
reliable to include as a measure necessary to prevent the introduction
of known or reasonably foreseeable hazards. Instead, we propose to
focus on seed treatment (proposed Sec. 112.142) and testing spent
irrigation water from each production batch of sprouts (or testing each
production batch of sprouts at the in-process stage when testing spent
irrigation water is not practicable) (proposed Sec. 112.143).
When seeds or beans are used to produce sprouts, they are ``food,''
as defined in section 201(f) of the FD&C Act (Ref. 95). The definition
of ``food'' in proposed Sec. 112.3 is consistent with this
interpretation. When you grow, harvest, pack, and store seeds and beans
for sprouting at your operation, you know the end use of the seeds and
beans, and proposed Sec. 112.141(a) would require that you exercise
control over that input into your sprout production. On the other hand,
growers of seeds and beans may be unaware as to whether their crop will
be used for sprout production. We seek comment on any provisions that
would be effective in reducing the risk posed by contaminated seeds or
beans in such cases, without also imposing an undue burden on the
agricultural sector that produces seed used primarily for purposes of
growing food or feed crops and not intended for use as food for human
consumption as sprouts.
Proposed Sec. 112.141(b) through (c) would establish additional
requirements to ensure that seeds and beans do not serve as a vehicle
for introducing contamination in sprouts. Proposed Sec. 112.141(b)
would require that if you know or have reason to believe that a lot of
seeds or beans has been associated with foodborne illness, you must not
use that lot of seeds or beans to produce sprouts. Contamination of
seeds and beans is generally at a low level and not distributed
homogeneously throughout a seed lot. Thus, a seed lot may be in
distribution for some time and in use by multiple sprout farms before
it is known or suspected to be contaminated. As discussed in the QAR,
we are aware of outbreaks associated with multiple sprout farms using
the same lot of seed. In addition, pathogens, such as Salmonella and E.
coli O157:H7, can survive for an extended period of time on seeds and
beans, as evidenced by outbreaks linked to seed that is a year or two
old, so setting aside a potentially contaminated seed lot for later use
does not reduce the likelihood of producing contaminated sprouts from
that lot of seeds or beans (Ref. 16. Ref. 243). For these reasons, we
have tentatively concluded that, once you know or have reason to
believe that a lot of seeds or beans is contaminated, through microbial
testing or implication as the vehicle in an outbreak, there is reason
to believe that other parts of that lot may also be contaminated, you
must not use that lot of seeds or beans to produce sprouts. This is
consistent with existing guidances and standards (Ref. 16. Ref. 18.
Ref. 192. Ref. 193).
Proposed Sec. 112.141(c) would require that you visually examine
seeds and beans, and packaging used to ship seeds or beans, for signs
of potential contamination with known or reasonably foreseeable
hazards. Visual examination of seeds and beans for sprouting, and the
packaging used to ship them, provides an opportunity to see signs of
potential contamination, such as rodent or bird feces or urine, which
may introduce pathogens into or onto sprouts (Ref. 241. Ref. 246).
Feces from rodents and birds are known to carry pathogens (Ref. 247).
This proposed provision is consistent with recent FDA and international
guidance (Ref. 38. Ref. 18. Ref. 192. Ref. 193).
Proposed Sec. 112.142 would establish measures you must take for
growing, harvesting, packing, and holding sprouts. Specifically,
proposed Sec. 112.142(a) would require that you grow, harvest, pack,
and hold sprouts in a fully-enclosed building. Proposed Sec.
112.142(b) would require that any food-contact surfaces you use to
grow, harvest, pack, or hold sprouts must be sanitized after cleaning
and before contact with sprouts or seeds or beans used to grow sprouts.
As discussed in the QAR, although the source of contamination in
outbreaks associated with sprouts has most often been incoming seeds or
beans, pathogens can also be introduced during sprout growing,
harvesting, packing, and holding.
Therefore, we are proposing these additional requirements for
sprout farms (i.e., conducting operations in a fully enclosed building,
sanitizing food-

[[Page 3597]]

contact surfaces after cleaning) because we have tentatively concluded
that the sprouting process represents a unique bacterial amplification
step that requires a higher level of care compared to the growing,
harvesting, packing, and holding of other covered produce. This
proposed approach, a higher level of care compared to produce growing,
harvesting, packing and holding generally, is consistent with Codex
guidelines (Ref. 50).
Proposed Sec. 112.142(c) would require you to treat seeds or beans
that will be used to grow sprouts using a scientifically valid method
immediately before sprouting to reduce microorganisms of public health
significance. Consistent with our previous discussion of the term
``scientifically valid'' with respect to testing in the proposed rule
to establish Current Good Manufacturing Practice requirements for
dietary ingredients and dietary supplements (68 FR 12157 at 12198), we
use the term ``scientifically valid'' to mean using an approach that is
based on scientific information, data, or results published in, for
example, scientific journals, references, text books, or proprietary
research. Methods used for reducing microorganisms of public health
significance in seeds or beans for sprouting must be scientifically
valid if they are to provide assurance that they are effective.
Prior treatment conducted by a grower, handler, or distributor of
seeds or beans, does not eliminate your responsibility to treat seeds
or beans immediately before sprouting, at your covered farm. This
proposed requirement is consistent with NACMCF recommendations and our
Sprout Guide (Ref. 16. Ref. 14) and international guidance (Ref. 193.
Ref. 191. Ref. 38). Specifically, NACMCF recommends that seed
treatments that deliver less than a 5-log pathogen reduction be coupled
with a microbial testing program. We did not cite any specific log
reduction in our Sprout Guide as ``adequate to reduce pathogens.'' At
that time, few if any seed treatments were thought to be capable of
consistently delivering a 5-log pathogen reduction.
A number of treatments have been shown to reduce levels of, but not
eliminate, pathogenic bacteria present on seeds. Such treatments are
likely to reduce the level of contamination if present and, in turn,
decrease the risk for foodborne disease with sprouted seeds (Ref. 16).
We cited in the Sprout Guide a 20,000 ppm calcium hypochlorite
treatment as an example of a treatment that has been shown to be
effective for the reduction of pathogens on seed. Scientific literature
indicates that the 20,000 ppm Ca(OCl)2 treatment, widely
adopted by sprouters who treat seed prior to sprouting, produces a 2.5
log reduction, with a range of 1.0-6.5 log reduction (Ref. 192. Ref.
201). Other chemical and physical seed disinfection treatments, alone
and in combination, have been evaluated for efficacy but there is a
high degree of variability in research results based on a number of
factors (e.g., seed type, whether seed was naturally or artificially
contaminated, level of initial contamination). In their evaluation of
the current state of microbiological safety of seeds and sprouts, Fett
et al. (Ref. 243) present a comparison of the efficacy of select
aqueous chemical disinfection treatments with Ca(OCl)2 for
sanitizing alfalfa seed from the literature. Canada recommends a lower
level of calcium hypochlorite, 2,000 ppm (Ref. 245).
We acknowledge that several outbreaks have brought into question
the effectiveness of seed disinfection treatments. For example, an
outbreak of Salmonella kottbus in alfalfa sprouts was linked to seed
that underwent a chlorine sanitization step, although records indicate
the concentration of chlorine was probably lower than the recommended
20,000 ppm (Ref. 248). Conversely, in 1999, an outbreak of Salmonella
enterica serotype Mbandaka occurred in Oregon, Washington, Idaho, and
California. Based on epidemiologic and pulsed-field gel electrophoresis
evidence from 87 confirmed cases, the outbreak was linked to
contaminated alfalfa seeds grown in California's Imperial Valley.
Trace-back and trace-forward investigations identified a single lot of
seeds used by five sprout growers during the outbreak period. Cases of
salmonellosis were linked with two sprout growers who had not employed
chemical disinfection; no cases were linked to the three sprout growers
who used seed disinfection (Ref. 249). In another outbreak of
Salmonella typhimurium in clover sprouts linked to seed sold to
multiple sprout operations, sprouters who had treated the seeds in
20,000 ppm chlorine had fewer cases attributed to their sprouts
compared to those that did not (Ref. 250). This is consistent with
modeling work by Montville and Schaffner, indicating that, while
disinfection of seeds prior to sprouting did not guarantee pathogen
free sprouts, disinfection reduced the percentage of contaminated
batches. Seed disinfection was most effective when contamination was
sporadic and at low levels; at a low prevalence (1 out of 10,000 25-g
samples are positive), as would normally be expected, the percentage of
contaminated batches was reduced from 13.7 to 0.1%. Where the initial
contamination was high and uniform, the proportion of contaminated
batches was reduced only from 100 to 87.7% (Ref. 251).
For these reasons we continue to believe that seed disinfection
treatments are valuable as one of several measures necessary to ensure
the safety of sprouts. We ask for comment on this approach.
Proposed Sec. 112.143 would establish requirements for testing
procedures you apply to the growing, harvesting, packing, and holding
of sprouts. Specifically, proposed Sec. 112.143(a) would require that
you test the growing, harvesting, packing, and holding environment for
Listeria spp. or L. monocytogenes (Lm) in accordance with the
requirements of Sec. 112.144. The proposed testing requirement in
Sec. 112.143(a) is in response to emerging concerns about positive
sample findings and multiple recalls associated with L. monocytogenes
in sprouts (Ref. 17. Ref. 252). Between 2002 and 2010, there have been
10 recalls involving multiple sprout types due to potential or
confirmed contamination with L. monocytogenes (Ref. 253). In one of
these recalls, the strain found in sprouts matched the strain isolated
from 20 confirmed cases of listeriosis in 6 States and positive sample
findings from an environmental investigation at the sprouting operation
(Ref. 252).
Contamination from L. monocytogenes from the environment is common
(Ref. 207) and, thus, targeted preventive controls to minimize L.
monocytogenes in RTE foods are warranted. While appropriate sanitation
measures can minimize the presence of environmental pathogens in a
sprouting operation, we tentatively conclude that environmental
monitoring is still necessary for sprouting operations as an added
safety measure. Such monitoring can be conducted by testing for the
specific pathogenic microorganism or by testing for an ``indicator
organism,'' which can indicate conditions in which the environmental
pathogen may be present. Typically, a firm that finds an indicator
organism during environmental monitoring conducts microbial testing of
surrounding surfaces and areas to determine the potential source of the
contamination, cleans and sanitizes the contaminated surfaces and
areas, and conducts additional microbial testing to determine whether
the contamination has been eliminated. Further steps may be necessary
if the indicator organism is

[[Page 3598]]

found on retest. Tests for the indicator organism Listeria spp. detect
multiple species of Listeria, including the pathogen L. monocytogenes.
For example, USDA's FSIS regulations and guidelines use Listeria spp.
as an appropriate indicator organism for L. monocytogenes in for RTE
meat or poultry products exposed to the processing environment after
cooking to prevent product adulteration by L. monocytogenes (Ref. 254).
FDA's current thinking is that Listeria spp. is an appropriate
indicator organism for L. monocytogenes, because tests for Listeria
spp. will detect multiple species of Listeria, including L.
monocytogenes, and because the available information supports a
conclusion that modern sanitation programs, which incorporate
environmental monitoring for Listeria spp., have public health
benefits. The taking of actions based on the presence of an appropriate
indicator organism is protective of public health, since there will be
times when steps are taken in the absence of the pathogen. Therefore,
we tentatively conclude that testing the growing, harvesting, packing
and holding environment for Listeria spp. or L. monocytogenes is a
necessary measure to ensure the safety of sprouts.
Proposed Sec. 112.143(b) would require that you either: (1) Test
spent sprout irrigation water from each production batch of sprouts for
E. coli O157:H7 and Salmonella spp. in accordance with the requirements
of Sec. 112.146; or (2) if testing spent sprout irrigation water is
not practicable (for example, for soil-grown sprouts), that you test
each production batch of sprouts at the in-process stage (i.e., while
sprouts are still growing) for E. coli O157:H7 and Salmonella spp. in
accordance with the requirements of Sec. 112.146. A production batch
for which either of these pathogens is detected in the spent irrigation
water for the sprouts would be considered adulterated under Section
402(a)(4) of the FD&C Act, in that it has been prepared, packed, or
held under insanitary conditions whereby it may have been rendered
injurious to health. A production batch for which either of these
pathogens is detected in the sprouts would be considered adulterated
under Sections 402(a)(1) of the FD&C Act, in that the sprouts contain a
poisonous or deleterious substance which may render it injurious to
health. Therefore, we tentatively conclude that microbiological testing
of spent irrigation water from each production lot (or of each
production batch of sprouts) is necessary to provide reasonable
assurances that sprouts are not adulterated under Section 402 of the
FD&C Act. The proposed testing requirement in Sec. 112.143(b) to test
spent sprout irrigation water (or sprouts) for Salmonella and E. coli
O157:H7 would codify current recommendations in our Sprout Guides and
is consistent with existing international guidelines and regulations
(Ref. 38. Ref. 191. Ref. 193).
We are proposing these testing requirements in Sec. 112.143(b) in
addition to the proposed treatment requirements in Sec. 112.142(c)
because pathogens that are merely injured, but not killed, by seed
treatment could potentially grow out again when subjected to enrichment
conditions, as experienced during sprouting (Ref. 16. Ref. 74). Because
seed disinfection treatments can reduce, but may not eliminate,
pathogens on seed, we are proposing to require microbiological testing.
Spent irrigation water that has flowed over and through sprouts is a
good indicator of the types and quantities of microorganisms in the
sprouts themselves (differing by only 1 log or less from the level in
the sprouts) and the microflora in spent irrigation water is fairly
homogeneous (Ref. 15. Ref. 198. Ref. 209). The optimal time for testing
is when pathogen levels are highest (approximately 24-48 hours after
the start of sprouting), but also when it is early enough in the
sprouting process to obtain results before product is shipped.
We have emphasized testing irrigation water in proposed Sec.
112.143(b) because testing sprouts has several significant
disadvantages compared to testing spent irrigation water. First,
contamination of sprouts is not likely to be as homogeneous as is the
spent irrigation water (Ref. 243. Ref. 255). Second, multiple sprout
samples must be taken from different locations in the drum or trays to
ensure that the sample collected is representative of the batch.
Furthermore, additional preparation (e.g., selecting representative
subsamples for analyses, blending or stomaching) is required when
testing sprouts. Each additional step introduces a possibility for
error. Consequently, testing of spent sprout irrigation water is
generally preferred over testing sprouts unless production methods make
it impractical to test spent sprout irrigation water. For example,
spent irrigation water may not be available when sprouts are grown in
soil.
We chose pathogen testing for Salmonella spp. and E. coli O157:H7
because these pathogens are the two most common agents in sprout-
associated outbreaks in the U.S. (Ref. 3). Recently, EFSA concluded
that there are currently no indicator organisms that can effectively
substitute for the testing of pathogens in seeds, sprouted seeds or
irrigation water (Ref. 244). We tentatively concur with this
conclusion.
In developing our Sprout Guides in 1999 and in deliberations for
this proposed rule, we also considered whether to include testing spent
sprout irrigation water for L. monocytogenes, in addition to testing it
for Salmonella spp. and E. coli O157:H7. However, we tentatively
concluded that testing spent sprout irrigation water for Listeria has a
number of potential challenges. The warm, moist, nutrient-rich
conditions during sprouting encourage the proliferation of Salmonella
and E. coli O157:H7 and this proliferation increases the probability of
their detection, if present. In contrast, Listeria may be a poor
competitor at the warmer temperatures and against the high level of
native microflora present during the sprouting process. In addition,
Listeria is ubiquitous. We would expect frequent positives using rapid
tests for Listeria spp., which would not necessarily mean pathogens
were present. Such testing would need to be followed by confirmatory
testing to determine whether or not L. monocytogenes was present in
order to determine appropriate actions with respect to the product.
While rapid test kits are now available to screen for L. monocytogenes,
their use on spent sprout irrigation water or sprouts would need to be
validated (Ref. 14). We tentatively conclude that environmental
monitoring for Listeria spp. or L. monocytogenes is the most practical
approach for control of this pathogen. We request comments on this
tentative conclusion.
We also considered the appropriateness of proposing provisions for
testing spent sprout irrigation water for non E. coli O157:H7 shiga
toxin-producing E. coli (STEC) which were involved in the recent large
sprout associated E. coli O104 foodborne illness outbreak in Europe
(Ref EU OB). The O104:H4 strain that caused the outbreak in Europe was
an unusual strain that none of the tests that were being used to test
for enterohaemorrhagic E. coli (EHEC) at that time would have picked it
up. The challenge is that there are estimated to be 400 serotypes of E.
coli that produces any one of the 3 Stx1 and/or 8 Stx2 subtypes and
many of these are isolated from environmental and animal sources but
have not been implicated in human illness. Many of the STEC strains
entailed tedious plating and retesting to isolate and even longer to
serotype (Ref. 256). For these reasons, we tentatively conclude that
proposing to require testing spent sprout irrigation water for

[[Page 3599]]

non E. coli O157:H7 STECs would not be a practical approach at this
time.
We request comments on this tentative conclusion, and on whether
pathogens in addition to E. coli O157:H7 and Salmonella spp. should be
included in testing of spent sprout irrigation water or in-process
sprouts, either by specifically listing the additional pathogens or by
set criteria (e.g., association with one or more outbreaks linked to
sprouts) for inclusion.
Proposed Sec. 112.144 would establish requirements for how you
test the growing, harvesting, packing, and holding environment for
Listeria spp. or L. monocytogenes. Specifically, proposed Sec.
112.144(a) would require that you establish and implement a written
environmental monitoring plan that is designed to find L. monocytogenes
if it is present in the growing, harvesting, packing or holding
environment. Proposed Sec. 112.144(b) would require that your written
environmental monitoring plan be directed to sampling and testing for
Listeria spp. or L. monocytogenes. Proposed Sec. 112.144(c)(1) through
(3) would require that your written environmental monitoring plan
include a sampling plan that specifies: What you will test collected
samples for (i.e., Listeria spp. or L. monocytogenes) (proposed Sec.
112.144(c)(1)); How often you will collect environmental samples, which
must be no less than monthly (proposed Sec. 112.144(c)(2)); and Sample
collection sites. The number and location of sampling sites must be
sufficient to determine whether measures are effective and must include
appropriate food-contact surfaces and non-food-contact surfaces of
equipment, and other surfaces within the growing, harvesting, packing,
and holding environment (proposed Sec. 112.144(c)(3)). Proposed Sec.
112.144(d) would require you to collect environmental samples and test
them for Listeria spp. or L. monocytogenes according to the method in
Sec. 112.152.
Proposed Sec. 112.144(c)(1) would require that you specify whether
you will be testing for the pathogen L. monocytogenes or the indicator
organism, Listeria spp. As discussed above, FDA's current thinking is
that Listeria spp. may be an appropriate indicator organism for L.
monocytogenes, because tests for Listeria spp. will detect multiple
species of Listeria, including L. monocytogenes. FDA expects
environmental monitoring to be conducted with sufficient frequency to
detect the environmental pathogen or appropriate indicator organism if
present. We tentatively conclude that monthly sampling and testing is a
minimum requirement (proposed Sec. 112.144(c)(2)). More frequent
testing may be needed. For example, the frequency of monitoring for
environmental pathogens should increase as a result of finding the
environmental pathogen or an indicator of the environmental pathogen or
as a result of situations that pose an increased likelihood of
contamination, e.g., construction (Ref. 211. Ref. 212). The frequency
of taking environmental samples will vary depending on existing data on
the presence of the environmental pathogen of concern in the
environment where foods are exposed to the environment. In the absence
of information, data should be generated to assist in determining the
frequency of monitoring (Ref. 257). We request comment on whether the
minimum frequency of at least monthly for environmental monitoring is
adequate to assess whether the measures taken to minimize the risk
associated with L. monocytogenes in sprouts are effective. We
tentatively conclude that specifying the frequency of testing in the
written environmental monitoring plan is necessary to enable assurance
by the operator and verification by FDA that testing efforts are
consistent with a carefully thought through effort to find the
environmental pathogen if it is present in the environment.
The purpose of environmental monitoring is to verify the
implementation and effectiveness of sanitation measures for controlling
the presence of L. monocytogenes in the sprout production environment.
The monitoring must be designed to find environmental pathogens that
remain in the sprouting operation after routine cleaning and sanitizing
procedures in order to prevent contamination of product that could lead
to illness. To accomplish this purpose, there must be a scientific
basis for the locations selected for sampling, the number of samples
taken, the frequency of sampling, the sampling procedures used and the
test methodology. The sampling must be biased--i.e., the locations to
be tested must be those in which the environmental pathogens can enter
the environment where the food is exposed and those areas where
harborage of the pathogen is likely (Ref. 258).
One approach to defining sampling locations is to divide the
sprouting operation into zones based on the likelihood of contamination
of the product. A common industry practice is to use four zones (Ref.
213. Ref. 212): Zone 1 consists of food-contact surfaces; Zone 2
consists of non-food-contact surfaces in close proximity to food and
food-contact surfaces; Zone 3 consists of more remote non-food-contact
surfaces that are in the area used for growing, harvesting, packing,
and holding and could lead to contamination of zones 1 and 2; and Zone
4 consists of non-food-contact surfaces, outside of the area used for
growing, harvesting, packing, and holding from which environmental
pathogens can be introduced into the growing, harvesting, packing, and
holding environment. Generally the number of samples and frequency of
testing is higher in zones 1 and 2 because of the greater likelihood of
food contamination if the environmental pathogen is present in these
zones. Information on appropriate locations for sampling within these
zones can be found in the literature (Ref. 175. Ref. 212). Operators
should become familiar with locations in which environmental pathogens
have been found in other sprout firms and use this information in
selecting sites to sample.
L. monocytogenes frequently establishes itself in a harborage site
on equipment and grows (increases in number) there, where both food and
moisture are available. L. monocytogenes organisms work their way out
of the harborage site during production and contaminate food. Testing
food-contact surfaces for Listeria spp. is a commonly recommended
verification measure for firms producing refrigerated RTE foods (Ref.
175. Ref. 211).
Examples of appropriate non-food-contact surfaces that could be
monitored include exteriors of equipment, equipment supports, control
panels, door handles, floors, drains, refrigeration units, ducts,
overhead structures, cleaning tools, and motor housings. Standing water
in growing, harvesting, and packing areas and areas that have become
wet and then have dried are also appropriate places to monitor. Testing
non-food-contact surfaces for L. monocytogenes or Listeria spp. is a
commonly recommended verification measure for firms producing
refrigerated or frozen RTE foods (Ref. 258. Ref. 259) and can detect L.
monocytogenes that is brought into the plant by people or objects.
Actions you then take can prevent transferring the organisms to a food-
contact surface (where they can contaminate food) or from establishing
a harborage that can serve as a source of contamination.
Proposed Sec. 112.145 would establish requirements for actions you
must take if you detect Listeria spp. or L. monocytogenes in the
growing, harvesting, packing, or holding environment, i.e., Conduct
additional microbial testing of surfaces and areas surrounding the area
where Listeria spp.

[[Page 3600]]

or L. monocytogenes was detected to evaluate the extent of the problem,
including the potential for Listeria spp. or L. monocytogenes to have
become established in a niche (proposed Sec. 112.145(a); Clean and
sanitize the affected surfaces and surrounding areas (proposed Sec.
112.145(b)); Conduct additional microbial sampling and testing to
determine whether the Listeria spp. or L. monocytogenes has been
eliminated (proposed Sec. 112.145(c)); Conduct finished product
testing when appropriate (proposed Sec. 112.145(d)); and Perform any
other actions necessary to prevent reoccurrence of the problem
(proposed Sec. 112.145(e)). Testing the environment of a sprouting
operation for L. monocytogenes (or for Listeria spp. as an indicator of
potential contamination with L. monocytogenes), and taking actions to
eliminate L. monocytogenes or Listeria spp. when found in the
environment of a sprouting operation, is an important component of
controlling microorganisms of public health significance (Ref. 175.
Ref. 211). The actions we are proposing to require, including
additional testing to determine the extent of contamination, ensuring
contamination is eliminated and taking steps to prevent its recurrence,
are consistent with recommendations in our Listeria Guide (Ref. 260).
If an environmental pathogen or an appropriate indicator organism
(the test organism) is detected in the environment, steps must be taken
to eliminate the organism, including finding a harborage site if one
exists (Ref. 175. Ref. 211) (Ref. 257). Otherwise, the presence of the
environmental pathogen could result in contamination of food-contact
surfaces or food. The presence of the indicator organism suggests that
conditions exist in which the environmental pathogen may be present and
could result in contamination of food-contact surfaces or food. Actions
must be taken for every finding of an environmental pathogen or
indicator organism in the environment to prevent contamination of food-
contact surfaces or food.
Sampling and microbial testing from surfaces surrounding the area
where the test organism was found (proposed Sec. 112.145(a)) are
necessary to determine whether the test organism is more widely
distributed than on the original surface where it was found and to help
find the source of contamination if other sites are involved. Cleaning
and sanitizing the contaminated surfaces and surrounding areas
(proposed Sec. 112.145(b)) are necessary to eliminate the test
organism that was found there. Additional sampling and microbial
testing (proposed Sec. 112.145(c)) are necessary to determine the
efficacy of cleaning and sanitizing. For example, detection of the test
organism after cleaning and sanitizing indicates that the initial
cleaning was not effective, and additional, more intensified cleaning
and sanitizing, or other actions may be needed, including dismantling
equipment, scrubbing surfaces, and heat-treating equipment parts (Ref.
207). The finding of a test organism on a food-contact surface usually
represents transient contamination rather than a harborage site (Ref.
259). However, finding the test organism on multiple surfaces in the
same area, or continuing to find the test organism after cleaning and
sanitizing the surfaces where it was found, suggests a harborage site
for the test organism. Mapping the location of contamination sites,
whether the harborage site is on equipment or in the environment, can
help locate the source of the harborage site or identify additional
locations to sample (Ref. 257).
Proposed Sec. 112.145 would not specify how certain actions must
be performed, such as the number of sites to test when the test
organism is found in a sprouting operation, or how to clean and
sanitize the surfaces on which the test organism was detected. The
number of sites appropriate for testing and the applicable cleaning and
sanitizing procedures will depend on the sprouting operation and the
equipment. We tentatively conclude that, when microbial testing is
conducted as part of steps in light of the results of environmental
monitoring, specifying such procedural requirements would not provide
facilities with sufficient flexibility to develop and implement
aggressive and appropriate actions to find and eliminate the source of
the contamination in the environment. Such actions may involve
investigative procedures when the initial measures have not been
successful in eliminating the environmental pathogen or indicator
organism. One example of an investigative procedure is taking samples
from food-contact surfaces and/or produce at multiple times during the
day while the equipment is operating and producing product (Ref. 207).
Proposed Sec. 112.145(d) would require that if environmental
monitoring identifies the presence of an environmental pathogen or
indicator organism, the operator conduct finished product testing, when
appropriate. As discussed in section IV.I. of this document, there are
shortcomings for microbiological testing of food for process control
purposes. Testing cannot ensure the absence of a hazard, particularly
when the hazard is present at very low levels and is not uniformly
distributed. If an environmental pathogen is detected on a food-contact
surface, finished product testing would be appropriate only to confirm
actual contamination or assess the extent of contamination, because
negative findings from product testing could not adequately assure that
the environmental pathogen is not present in food exposed to the food-
contact surface. If you detect an environmental pathogen on a food-
contact surface, the sprouting operation should presume that the
produce is adulterated under Section 402(a)(4) of the FD&C Act.
Finished product testing could be appropriate if an environmental
pathogen is detected on a non-food-contact surface, such as on the
exterior of equipment, on a floor or in a drain. The potential for food
to be contaminated directly from contamination in or on a non-food-
contact surface is generally low, but transfer from non-food-contact
surfaces to food contact surfaces can occur. Finished product testing
can provide useful information on the overall risk of a food when
pathogens have been detected in the environment.
Proposed Sec. 112.145(e) would require that if environmental
monitoring identifies the presence of an environmental pathogen or
appropriate indicator organism, the operator perform any other steps
necessary to prevent recurrence of the contamination. Actions taken as
a result of monitoring for an environmental pathogen or an indicator
organism for such pathogen must ensure these requirements are met. The
measures for environmental monitoring specified in proposed Sec.
112.145(a) through (d) are not all inclusive. Examples of measures that
may be necessary include reinforcing employee hygiene practices and
traffic patterns; repairing damaged floors; eliminating damp
insulation, water leaks, and sources of standing water; replacing
equipment parts that can become harborage sites (e.g., hollow conveyor
rollers and equipment framework), and repairing roof leaks (Ref. 180.
Ref. 219). Additional information on measures for environmental
monitoring can be found in the literature (Ref. 180. Ref. 221. Ref.
219). Proposed Sec. 112.145 is consistent with the FSIS Listeria
Guidelines (Ref. 254).
Proposed Sec. 112.146 would establish requirements for how you
collect and test samples of spent sprout irrigation water or sprouts.
Specifically, proposed Sec. 112.146(a) would require that you
establish and implement a written

[[Page 3601]]

sampling plan that identifies the number and location of samples (of
spent sprout irrigation water or sprouts) to be collected for each
production batch of sprouts to ensure that the collected samples are
representative of the production batch when testing for contamination.
Additionally, proposed Sec. 112.146(b) would require that, in
accordance with the written sampling plan required under paragraph (a)
of this section, you aseptically collect samples of spent sprout
irrigation water or sprouts, and test the collected samples for E. coli
O157:H7 and Salmonella spp. using a method that has been validated for
its intended use (testing spent sprout irrigation water or sprouts) to
ensure that the testing is accurate, precise, and sensitive in
detecting these pathogens. This proposed provision is consistent with
recommendations in our Sprout Testing Guide, the Canada and Irish Codes
and the FSANZ standard (Ref. 15. Ref. 206. Ref. 201. Ref. 203).
One means to test for E. coli O157:H7 and Salmonella spp. as
required under proposed Sec. 112.146(b) is to follow our guidance on
sampling and testing spent irrigation water or sprouts (Ref. 15). The
methods described in our guidance have been validated to be effective
on spent sprout irrigation water and sprouts (Ref. 15. Ref. 223. Ref.
224). The effectiveness of detection methods can vary depending on
multiple factors, including but not limited to whether the sample
tested is representative of the food, type of food, level of microflora
present, the enrichment procedure and type of test used. Spent sprout
irrigation water and sprouts have a high level of natural microflora
that can interfere with detection (Ref. 15. Ref. 243). Therefore, other
methods that have been validated to be effective for other foods may
not work for spent sprout irrigation water and sprouts. Because the
microflora in spent sprout irrigation water is more homogeneous
compared to seeds or sprouts, sampling procedures described in our
guidance for sprout irrigation water are relatively simple. In
addition, spent sprout irrigation water can be used directly in the
test procedures described in our guidance, thus reducing the
possibility of error (Ref. 15. Ref. 243). Sampling spent sprout
irrigation water or sprouts is an important testing procedure to ensure
contaminated product does not enter commerce. The testing procedures
described in our guidance give accurate results as quickly and simply
as possible on the presence or absence of E. coli O157:H7 and
Salmonella spp.
Proposed Sec. 112.150 would establish requirements for records
that you must establish and keep regarding sprouts. Under proposed
Sec. 112.150(a), you must establish and keep the required records in
accordance with the requirements of proposed subpart O. As discussed in
section V.O. of this document, proposed subpart O would establish
general requirements applicable to all records.
Proposed Sec. 112.150(b) would require you to establish and keep
the following records: Documentation of your treatment of seeds or
beans to reduce microorganisms of public health significance in the
seeds or beans, at your farm (proposed Sec. 112.150(b)(1)); your
written environmental monitoring plan in accordance with the
requirements of Sec. 112.144 (proposed Sec. 112.150(b)(2)); your
written sampling and testing plan for each production batch of sprouts
in accordance with the requirements of Sec. 112.146(a) (proposed Sec.
112.150(b)(3)); the results of any testing conducted in accordance with
the requirements of Sec. Sec. 112.143 and 112.144 (proposed Sec.
112.150(b)(4)); any analytical methods you use in lieu of the methods
that are incorporated by reference in Sec. 112.152 (proposed Sec.
112.150(b)(5)); and the testing method you use in accordance with the
requirements of Sec. 112.146(b) (proposed Sec. 112.150(b)(6)). We are
proposing to require you to keep the above records specific to sprout
operations in order to help document your compliance with the
provisions of this rule. We tentatively conclude that such records are
needed for us to verify and you to ensure that appropriate measures are
being followed consistently and correctly (e.g., your sampling plan for
spent sprout irrigation water from each production lot). The records
would also allow FDA or you to identify trends that might signal a need
to adjust the measures in your environmental monitoring plan to improve
its effectiveness and reliability (e.g., test results from your
environmental monitoring program may signal the need to enhance
sprouting operation cleaning and sanitation).

N. Subpart N--Analytical Methods

Proposed subpart N would specify methods of analysis for testing
the quality of water and the growing environment for sprouts, as
required under proposed subparts E and M (see sections V.E. and V.M.,
respectively, of this document).
Proposed Sec. 112.151 would establish that you must test the
quality of water to satisfy the requirements of Sec. 112.45 by one of
three methods: (1) Official methods of analysis published by the AOAC
International; (2) standards methods for the examination of water and
wastewater as published by the American Public Health Association; or
(3) methods prescribed in the FDA Bacteriological Analytical Manual, or
by another method that is at least equivalent to the above-mentioned
three methods in accuracy, precision and sensitivity in detecting E.
coli.
Proposed Sec. 112.151(a)(1) provides for the use of official
methods of analysis published by AOAC International in the latest
edition of their publication ``Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 18th edition, revision 4
(published in 2011). The Official Methods of Analysis of AOAC
International (18th Ed., revision 4, 2011) would be incorporated by
reference with the approval of the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR Part 5.
Proposed Sec. 112.151(a)(2) would establish that methods of
analysis published in the Standard Methods for the Examination of Water
and Wastewater (21st Edition, 2005), American Public Health Association
would be acceptable for testing the quality of water. In addition, the
Standards Methods for the Examination of Water and Wastewater, (21st
Ed., 2005), would be incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 5.
Proposed Sec. 112.151(a)(3) would establish that methods of
analysis published in Chapter 4 of the FDA Bacteriological Analytical
Manual (Edition 8, Revision A, 1998) (BAM), as updated in June 2011,
would be acceptable for testing the quality of water. In addition,
Chapter 4 of the BAM (Edition 8, Revision A, 1998), as updated in June
2011, would be incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 5. With advances in science and as appropriate,
FDA periodically updates the BAM to add newer methods or revise
existing ones. For the purposes of this proposed rule, we refer to
Chapter 4 of the BAM (edition 8, revision A, published in 1988) as
updated in June 2011. However, should FDA update or revise the methods
and procedures currently listed in Chapter 4 of the June 2011 version,
for the purpose of testing the quality of water, we encourage industry
to use such relevant, updated methods and procedures.
Proposed Sec. 112.151(a)(4) would provide for the use of a method
that is at least equivalent in accuracy, precision, and sensitivity to
the methods in Sec. 112.151(a)(1), (a)(2) or (a)(3). Test kit methods
are generally not published in the literature due to their proprietary
nature. FDA is aware of

[[Page 3602]]

programs, such as the AOAC Research Institute's Performance Tested
Methods Program that provides an independent third-party review of
proprietary test method performance. Test methods demonstrated to meet
acceptable performance criteria are granted Performance Test Methods
(PTM) status. The PTM certification assures users that an independent
assessment has found that the test method performance meets an
appropriate standard for the claimed use. FDA would consider methods,
particularly test kit methods, approved by the PTM program or other
similar programs acceptable for testing the quality of water. FDA is
also aware that there are numerous scientific testing and diagnostic
development companies that have invented rapid tests and systems for
pathogens and water quality. Many of these products undergo rigorous
internal quality control and performance testing, as well as receive
additional third-party and/or regulatory approvals. FDA is also aware
that the Environmental Protection Agency (EPA) approves analytical
methods that industrial and municipal facilities use to determine
pollutants of wastewater (published in 40 CFR Part 136) and to meet
federal requirements or to demonstrate compliance with drinking water
and ground water regulations (40 CFR 141.402 and 40 CFR 141.403). For
example, the EPA, has approved the use of E*Colite[supreg] Test, m-
ColiBlue 24[supreg] Test, and Colitag[supreg] Test for compliance
monitoring related to EPA's Ground Water Rule. FDA would consider these
tests acceptable for testing the quality of water to satisfy the
requirements of Sec. 112.45.
Proposed Sec. 112.152 establishes the methods you must use to test
the growing environment for Listeria spp. or L. monocytogenes to
satisfy the requirements of Sec. Sec. 112.143(a) and 112.144. As
proposed, you must test environmental samples using the methods and
procedures described in Chapter 10 of the BAM, ``Listeria
monocytogenes, Detection and Enumeration of Listeria monocytogenes in
Foods.'' Chapter 10 of the BAM (Edition 8, Revision A, 1998), as
updated in April 2011, would be incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 5. With advances in science and as
appropriate, FDA periodically updates the BAM to add newer methods or
revise existing ones. For the purposes of this proposed rule, we refer
to Chapter 10 of the BAM (Edition 8, revision A, published in 1998) as
updated in April 2011. However, should FDA update or revise the methods
and procedures currently listed in Chapter 10 of the April 2011
version, for the purpose of testing the growing environment for
Listeria spp. or L. monocytogenes, we encourage industry to use such
relevant, updated methods and procedures.
Proposed Sec. 112.152 would also provide for the use of a method
at least equivalent in accuracy, precision, and sensitivity in
detecting Listeria spp. or L. monocytogenes as is the method described
in Chapter 10 of the BAM. For example, prescribed rapid detection kits
with their respective enrichment media may be conditionally used to
screen for presence of Listeria contaminants. Isolates may be rapidly
positively or negatively confirmed as L. monocytogenes by using
specific test kits. FDA is aware that there are numerous scientific
testing and diagnostic development companies that have invented rapid
tests and systems for Listeria spp. or L. monocytogenes. Many of these
products undergo rigorous internal quality control and performance
testing, as well as receive additional third-party and/or regulatory
approvals. As discussed above in proposed Sec. 112.151(a)(4), FDA
would consider methods, particularly test kit methods, approved for
example by the AOAC Research Institute's Performance Tested Methods
Program PTM program or other similar, acceptable for testing Listeria
spp. or L. monocytogenes.

O. Subpart O--Requirements Applying to Records That You Must Establish
and Keep

As proposed, subpart O discusses the general requirements
applicable to documentation and records that you must establish and
maintain under proposed part 112.
1. Comments Relevant to the Proposed Requirements
We received several comments in response to the 2010 FR notice that
addressed issues relevant to establishing and maintaining documents and
records. Comments expressed concern over the costs of complying with
record keeping requirements. Several comments also stated that there
should not be a requirement for electronic record keeping for farmers,
especially if they are small-scale. One comment requested that, to
protect the confidentiality of individual farm businesses, any
recordkeeping requirements be accompanied by assurance that information
accessed by federal government authorities with respect to food safety
protocols will remain confidential. Another comment requested that we
consider pre-existing records kept by the produce industry for other
purposes, so as to avoid duplication, while another farmer commented
that records or documents would not ensure safety and, therefore, asked
that records should be required for only annual activities, such as
employee training and surveys of surrounding land activities. Finally,
several comments indicated that the current legal liability system in
the United States serves to discourage any grower or packing house from
keeping additional detailed records related to food safety and that
such records are subject to intrusive judicial subpoena power.
We believe that documentation of some practices is critical to
ensure that science-based minimum produce safety standards proposed in
this rule are adequately implemented on the farm. Records are useful
for keeping track of detailed information over a period of time.
Records can identify patterns of problems and, thus, enable a farm to
find and correct the source of problems. Records are also useful for
investigators during inspections to determine compliance with
requirements (e.g., by FDA investigators to determine compliance with
requirements that would be established by this rule, or by a third
party auditor that a farm or retailer may voluntarily engage under a
business arrangement between the farm and the retailer). Therefore, we
tentatively conclude that records of only annual activities are
insufficient to ensure produce safety. However, in determining those
circumstances in which records are necessary as part of science-based
minimum standards that minimize the risk of serious adverse health
consequences or death and provide reasonable assurances that produce is
not adulterated under section 402 of the FD&C Act, we considered the
statutory direction in section 419(c)(1)(C) of the FD&C Act to comply
with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) ``with
special attention to minimizing'' the recordkeeping burden on the
business and collection of information as defined in that act. We
propose to require records in instances where maintenance of detailed
information is needed to keep track of measures directed at minimizing
the risk of known or reasonably foreseeable hazards, where
identification of a pattern of problems is important to minimizing the
risk of such hazards, or where they are important to facilitate
verification and compliance with standards and this cannot be
effectively done by means other than a review of records. See section
IV.E of this document for further discussion.

[[Page 3603]]

We appreciate the concerns expressed by some commenters with respect to
cost and burden to farms. To the extent possible, we attempted to
propose documentation requirements that are risk-based and capable of
being tailored to your individual farm, taking into account the unique
characteristics of the operation, the commodities handled, and the
operation's growing, harvesting, packing, and holding procedures. A
large majority of growers, farmers, and producers indicated during
listening sessions and other stakeholder discussions that they already
practice good agricultural practices and keep adequate records. They
agreed that such recordkeeping is necessary. Moreover, they indicated
that the cost of a large scale recall event would have the potential to
far exceed the cost of routine record keeping.
As proposed, the recordkeeping requirements allow the use of
existing records and do not require duplication, provided such records
satisfy all of the applicable requirements of this part (see proposed
Sec. 112.163). In addition, per proposed Sec. 112.165, electronic
records would be acceptable but would not be required by this subpart.
Records would be acceptable under this subpart if kept in forms as
diverse as hard copies of handwritten logs, invoices, and documents
reporting laboratory results, provided that they are indelible and
legible.
We understand the concerns regarding confidentiality. Our
disclosure of information is subject to the Freedom of Information Act
(FOIA) (5 U.S.C. 552), the Trade Secrets Act (18 U.S.C. 1905), the FD&C
Act, and our implementing regulations under part 20, which include
protection for confidential commercial information and trade secrets.
We note that many segments of the food industry already are subject to
food safety-related recordkeeping requirements similar to those
proposed in this subpart. Other existing food safety regulations, such
as the infant formula quality control procedures regulation (Sec.
106.100), the dietary supplement regulation (Sec. 111.605 and Sec.
111.610), the acidified foods regulation (Sec. 114.100), the
regulation on production, storage, and transportation of shell eggs
(Sec. 118.10), the juice HACCP regulation (Sec. 120.12), and the
seafood HACCP regulation (Sec. 123.9) require similar record keeping.
In addition, many farmers that are part of the various programs such as
National Organic Program and LGMA already have similar recordkeeping
requirements (Ref. 45. Ref. 261). Recordkeeping has proven useful for
the above-mentioned food industries and, thus far, we are not aware
that any of these industries has been adversely affected by excessive
judicial subpoenas resulting from their recordkeeping.
2. Proposed Requirements
Proposed subpart O would establish requirements that would be
applicable to all records required by part 112. FDA tentatively
concludes that the requirements in subpart O describing how records
must be established and maintained, including the general requirements,
record retention requirements, and requirements for official review and
public disclosure, are applicable to all records that would be required
under all subparts, because records that would be required under each
of the subparts would aid farms in complying with the requirements of
part 112; and allow farms to show, and FDA to determine, compliance
with the requirements of part 112.
a. General Requirements
As proposed, Sec. 112.161(a)(1) requires that your records
include: (i) The name and location of your farm; (ii) actual values and
observations obtained during monitoring; (iii) an adequate description
(such as the commodity name, or the specific variety or brand name of a
commodity, and, when available, any lot number or other identifier) of
covered produce applicable to the record; (iv) the location of a
growing area (for example, a specific field) or other area (for
example, a specific packing shed) applicable to the record; and (v) the
date and time of the activity documented.
The name and location of your farm and the date and time would
allow the owner, operator, or agent in charge of a farm (and, during
inspection, an FDA investigator) to assess whether the record is
current and establish the relevance of the record to your farm, which
is necessary for review by regulators. An adequate description of
covered produce would allow the farm to more readily track measures,
identify a pattern of problems, and verify compliance. Such a
description will also allow the farm to identify specific produce for
which the standards of this part have not been met, and to take
appropriate measures as provided for under Sec. 112.11.
Recording actual values and observations during monitoring are
necessary to produce an accurate record. Notations that monitoring
measurements are ``satisfactory'' or ``unsatisfactory,'' without
recording the actual times and observations (e.g., temperatures and
turnings in treating biological soil amendments of animal origin) are
vague and subject to varying interpretations and, thus, will not ensure
that required measures have been taken or standards have been met. In
addition, it is not possible to discern a trend without actual
measurement values.
Proposed Sec. 112.161(a)(1) is consistent with our HACCP
regulations for seafood and juice. Our HACCP regulations for seafood
and juice require that all records include the name and location of the
processor; the date and time of the activity that the record reflects;
the signature or initials of the person performing the operation; and
where appropriate, the identity of the product and the production code,
if any (Sec. Sec. 123.9(a) and 120.12(b), respectively). Our HACCP
regulations for seafood and juice also require that records contain the
actual values (such as temperature) and observations obtained during
monitoring (Sec. Sec. 123.6(c)(7) and 120.12(b)(4), respectively).
Additional requirements in proposed Sec. 112.161(a) include that
records must be created at the time an activity is performed or
observed (proposed Sec. 112.161(a)(2)); be accurate, legible, and
indelible (proposed Sec. 112.161(a)(3)); and be dated, and signed or
initialed by the person who performed the activity documented (proposed
Sec. 112.161(a)(4)).
These requirements would ensure that the records are useful to the
owner, operator, or agent in charge of a farm in complying with the
requirements of part 112, for example, in documenting compliance with
monitoring requirements. These proposed requirements would also ensure
that the records would be useful to FDA in determining compliance with
the requirements of part 112. For example, the signature of the
individual who made the observation would ensure responsibility and
accountability. In addition, if there is a question about the record, a
signature would ensure that the source of the record will be known.
These proposed requirements are consistent with our HACCP regulations
for seafood and juice. Our HACCP regulations for seafood and juice
require that processing and other information be entered on records at
the time that it is observed (Sec. Sec. 123.9(a)(4) and 120.12(b)(4),
respectively).
As proposed, under Sec. 112.161(b), when records are required to
be established and kept in subparts C, E, F, L, and M of this part
(Sec. Sec. 112.30, 112.50, 112.60, 112.140, and 112.150), you must
establish and keep documentation of actions you take when a standard in
those subparts is not met. This documentation is necessary to show that
you have taken the steps reasonably

[[Page 3604]]

necessary to minimize the risk of serious adverse health consequences
or death from the use of, or exposure to, covered produce, including
those measures reasonably necessary to prevent the introduction of
known or reasonably foreseeable hazards into covered produce, and to
provide reasonable assurances that the produce is not adulterated under
section 402 of the FD&C Act. For example, if under Sec. 112.44(b) you
are required to discontinue the use of agricultural water and take
corrective steps, this provision would require you to establish and
keep a record of the corrective steps that you took.
As proposed, Sec. 112.161(c) would require a supervisor or
responsible party to review, date, and sign those records that are
required under 112.50(b)(4), 112.50(b)(5), 112.60(b)(1), 112.60(b)(3),
112.140, 112.150(b)(1), 112.150(b)(4), and 112.161(b). These records
relate to certain of your testing, monitoring, sanitizing, and
corrective action activities. As described above, one of the primary
purposes for establishing and maintaining records is so that you can
review the records to see if the requirements of this part have been
met. Requiring a signature from a supervisor or responsible party for
these records emphasizes the importance of such a review.
b. Storage of Records
Proposed Sec. 112.162 would establish the requirements regarding
where your records must be stored. Proposed Sec. 112.162(a)
establishes that offsite storage of records is permitted after 6 months
following the date the record was made if such record can be retrieved
and provided onsite within 24 hours of request for official review. FDA
realizes that the proposed requirements for recordkeeping could require
some farms to store a significant quantity of records, and that there
may not be adequate storage space in the farm for these records.
Providing for offsite storage of most records after 6 months would
enable a farm to comply with the proposed requirements for record
retention while reducing the amount of space needed for onsite storage
of the records without interfering with the purpose of record
retention, because the records will be readily available. Proposed
Sec. 112.162(b) would clarify that electronic records are considered
to be onsite at your farm if they are accessible from an onsite
location at your farm. For example, we would consider electronic
records to be onsite if they were available from your computer,
including records transmitted to your computer via a network connection
or accessed from either the Internet or electronic or digital storage
applications.
Proposed Sec. 112.162 is consistent with our HACCP regulations for
seafood and juice. Our HACCP regulation for seafood provides for
transfer of records if record storage capacity is limited on a
processing vessel or at a remote processing site, if the records could
be immediately returned for official review upon request (Sec.
123.9(b)(3)). Our HACCP regulation for juice permits offsite storage of
processing records after 6 months following the date that the
monitoring occurred, if such records can be retrieved and provided
onsite within 24 hours of request for official review and considers
electronic records to be onsite if they are accessible from an onsite
location (Sec. 120.12(d)(2)). We seek comment on the appropriateness
of the proposed recordkeeping requirements.
c. Use of Existing Records
As proposed, Sec. 112.163 would clarify that the regulations in
this part do not require duplication of existing records if those
records contain all of the information required by this part. In this
provision, we seek to minimize the burden of keeping records to that
which is necessary to accomplish the intended purposes of this part.
For example, as proposed, you are not required to duplicate
existing records, such as records kept to satisfy the requirements of
the National Organic Program, if those records contain all of the
information required by this part. Additionally, you are not required
to keep all of the information required by this part in one set of
records. Similarly, if you have records containing some but not all of
the required information, this proposed regulation provides you the
flexibility to keep any additional information required by this part
either separately or combined with your existing records. While we
propose this provision to give you the greatest degree of flexibility,
we remind you that keeping records together in one place likely will
expedite review of records in the event of a public health emergency or
during an FDA inspection or investigation.
d. Length of Time for Records Storage
Proposed Sec. 112.164(a) would require that you keep records
required by this part for two years after the date the record was
created. Retaining records for at least this length of time is
necessary to ensure that the records are available for reference during
verification activities as well as during FDA inspections. It is also
critical for documentation and observation of trends of the food safety
risks that may affect your operation over time. Multi-year retention of
records allows an owner, operator, or agency to better understand and
proactively respond to the risk factors affecting his or her farm.
Since many weather events, such as drought or floods, which have an
influence on the safety of fresh produce are relatively rare;
maintaining historical records to inform the development of preventive
controls specific to a given operation is invaluable. Similarly,
proposed Sec. 112.164(b) would establish that records that relate to
the general adequacy of the equipment or processes being used by a
farm, including the results of scientific studies and evaluations, must
be retained at the farm for at least two years after the use of such
equipment or processes is discontinued.
Certain growers and packers of covered produce currently retain
records for at least two years. For example, produce operations
certified by the National Organic Program must maintain their records
relating to the production, harvesting, and handling of ``organic''
agricultural products for at least five years beyond the creation of
the records (7 CFR 205.103). USDA's Agricultural Marketing Service
requires that restricted use pesticide records be maintained for two
years from the date of pesticide application (7 CFR 110.3). Under
USDA's regulations implementing the Perishable Agricultural Commodities
Act, 1930 (PACA), packers who pack and sell another firm's produce and
growers and packers who voluntarily obtain a PACA license are required
to preserve records for two years (7 CFR 46.14). Under the Florida
Tomato Rule (``Tomato Good Agricultural Practices [T-GAP] & Tomato Best
Management Practices'') (Ref. 262), firms must keep records documenting
adherence to T-GAPs, ``including those addressing environmental review,
water usage, record of completed education and training, pest control
and crop production practices for the operation,'' for at least three
calendar years (Ref. 44). Participants in the California Leafy Green
Marketing Agreement (LGMA) must maintain their records kept under the
LGMA agreement for two years (Ref. 45).
e. Acceptable Formats for Records
As proposed, Sec. 112.165 would require that you keep records as
either: (a) Original records; (b) true copies (such as photocopies,
pictures, scanned copies, microfilm, microfiche, or other accurate
reproductions of the original records); or (c) electronic records in
compliance

[[Page 3605]]

with part 11. True copies of records should be of sufficient quality to
detect whether the original record was changed or corrected in a manner
that obscured the original entry (e.g., through the use of white-out).
Proposed Sec. 112.165 would provide flexibility for mechanisms for
keeping records while maintaining the integrity of the recordkeeping
system. The proposed requirement allowing true copies is consistent
with other regulations such as our Good Manufacturing Practices (GMPs)
regulation for dietary supplements (Sec. 111.605(b)) and provides
options that may be compatible with the way records are currently being
kept in plants and facilities.
Proposed Sec. 112.165 also would require that electronic records
be kept in accordance with part 11 (21 CFR part 11). Part 11 provides
criteria for acceptance by FDA, under certain circumstances, of
electronic records, electronic signatures, and handwritten signatures
executed to electronic records as equivalent to paper records and
handwritten signatures executed on paper. The proposed requirement
clarifies and acknowledges that records required by part 112 may be
retained electronically, provided that they comply with part 11.
FDA tentatively concludes that it is appropriate to apply the
requirements of part 11 to the records that would be required to be
kept under part 112. However, we request comment on whether there are
any circumstances that would warrant not applying part 11 to records
that would be kept under part 112. For example, would a requirement
that electronic records be kept according to part 11 mean that current
electronic records and recordkeeping systems would have to be recreated
and redesigned, which we determined to be the case in the regulation
Establishment and Maintenance of Records Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (69 FR
71562; December 9, 2004 (the BT records regulation))? For the purposes
of the records requirements in the BT records regulation, we concluded
that it was not necessary for new recordkeeping systems to be
established as long as current practices would satisfy the requirements
of the Act and, therefore, we exempted the records from the
requirements of part 11 (21 CFR 1.329(b)). We also exempted records
related to certain cattle materials prohibited from use in human food
and cosmetics from part 11 (21 CFR 189.5(c)(7) and 700.27(c)(7),
respectively). We also seek comment on whether we should allow
additional time for electronic records to be kept in accordance with
part 11. Comments should provide the basis for any view that the
requirements of part 11 are not warranted.
f. Making Records Available for Official Review
Proposed Sec. 112.166(a) would require that you have all records
required under this part readily available and accessible during the
retention period for inspection and copying by FDA upon oral or written
request, except that you have 24 hours to obtain records you keep
offsite and make them available and accessible to FDA for inspection
and copying. Our access to records required under this part would
expedite efforts to document and ensure that covered produce is not
adulterated, as well as to quickly and accurately identify any
adulterated covered produce and prevent it from reaching consumers. For
example, during a foodborne illness outbreak or contamination
investigation, records access would help enable you and us to pinpoint
the source and cause of contamination in a timely manner. This
provision is consistent with our HACCP regulations for juice (Sec.
120.12(e)) and seafood (Sec. 123.9(c)), and dietary supplement GMPs
(Sec. 111.610(b)), which require that all records required under those
rulemakings be available for review and copying at reasonable times.
This provision also is similar to requirements in the infant formula
quality control procedures regulation (Sec. 106.100(l)) stating that
manufacturers make readily available for authorized inspection all
records required under those regulations. In addition, this proposed
provision is similar to provisions in the juice HACCP regulation (Sec.
123.9(f)) and in the regulation on production, storage, and
transportation of shell eggs (Sec. 118.10(d)) that require that firms
be able to retrieve and provide any records stored offsite within 24
hours of request for official review.
Proposed Sec. 112.166(b) would require that if you use electronic
techniques to keep records, or to keep true copies of records, or if
you use reduction techniques such as microfilm to keep true copies of
records, that you provide the records to us in a format in which they
are accessible and legible. For example, you might provide us with an
unencrypted copy of an electronic record or provide us with suitable
equipment for viewing, printing, and copying a record. This provision
would enable us to comprehend your records in a timely manner.
Consistent with proposed Sec. 112.166(a), proposed Sec.
112.166(c) would require that if your farm is closed for a prolonged
period, the records may be transferred to some other reasonably
accessible location but must be returned to your farm within 24 hours
for official review upon request. Allowing for transfer of records will
give practical storage relief to seasonal operations or those closed
for other reasons for prolonged periods. Proposed Sec. 112.166(c) is
consistent with our HACCP regulations for seafood and juice, which
provide for transfer of records for facilities closed for prolonged
periods (between seasonal packs, in the case of juice) if the records
could be immediately returned for official review upon request
(Sec. Sec. 123.9(b)(3) and 120.12(d)(3) for seafood and juice,
respectively).
g. Disclosure Requirements
Proposed Sec. 112.167 would specify that records required by this
part are subject to the disclosure requirements under part 20 of this
chapter. FDA's regulations in 21 CFR part 20, FOIA, the Trade Secrets
Act [18 U.S.C. 1905], and the FD&C Act govern FDA's disclosures of
information, including treatment of confidential commercial information
and trade secret information. Our general policies, procedures, and
practices relating to the protection of confidential information
received from third parties would apply to information received under
this rule. Proposed Sec. 112.167 is consistent with, but framed
differently than, the disclosure provisions of the HACCP regulations
for seafood and juice (Sec. Sec. 123.9(d) and 120.12(f),
respectively). Proposed Sec. 112.167 is framed similarly to the
disclosure provisions for records that must be kept under part 118
(Prevention of Salmonella Enteritidis in Shell Eggs During Production);
under Sec. 118.10(f), records required by part 118 are subject to the
disclosure requirements under part 20.

P. Subpart P--Variances

1. Relevant Provisions of Section 419 of the FD&C Act
In section 419(c), the FD&C Act establishes criteria for the final
regulation, including that the final regulation ``permit States and
foreign countries from which food is imported into the United States to
request from the Secretary variances from the requirements of the
regulations, subject to [section 419(c)(2) of the FD&C Act], where the
State or foreign country determines that the variance is necessary in
light of local growing conditions and that the procedures, processes,
and practices to be followed

[[Page 3606]]

under the variance are reasonably likely to ensure that the produce is
not adulterated under section 402 [of the FD&C Act] and to provide the
same level of public health protection as the requirements of the
regulations adopted under [section 419(b) of the FD&C Act]'' (section
419(c)(1)(F)). Section 419(c)(2) specifies the following:
``REQUESTS FOR VARIANCES.--A State or foreign country from which
food is imported into the United States may in writing request a
variance from the Secretary. Such request shall describe the variance
requested and present information demonstrating that the variance does
not increase the likelihood that the food for which the variance is
requested will be adulterated under section 402, and that the variance
provides the same level of public health protection as the requirements
of the regulations adopted under [section 419(b) of the FD&C Act]. The
Secretary shall review such requests in a reasonable timeframe''
(section 419(c)(2)(A)).
``APPROVAL OF VARIANCES.--The Secretary may approve a variance in
whole or in part, as appropriate, and may specify the scope of
applicability of a variance to other similarly situated persons''
(section 419(c)(2)(B)).
``DENIAL OF VARIANCES.--The Secretary may deny a variance request
if the Secretary determines that such variance is not reasonably likely
to ensure that the food is not adulterated under section 402 and is not
reasonably likely to provide the same level of public health protection
as the requirements of the regulation adopted under [section 419(b) of
the FD&C Act]. The Secretary shall notify the person requesting such
variance of the reasons for the denial'' (section 419(c)(2)(C)).
``MODIFICATION OR REVOCATION OF A VARIANCE.--The Secretary, after
notice and an opportunity for a hearing, may modify or revoke a
variance if the Secretary determines that such variance is not
reasonably likely to ensure that the food is not adulterated under
section 402 and is not reasonably likely to provide the same level of
public health protection as the requirements of the regulations adopted
under [section 419(b) of the FD&C Act]'' (section 419(c)(2)(D)).
2. Proposed Requirements
Consistent with the statutory provisions mentioned above, in this
subpart, we propose a process by which variances from one or more
requirements of part 112 may be requested by a State or foreign
government, information that must accompany such requests, and the
procedures and circumstances under which FDA may grant or deny such
requests, and modify or revoke such variances. Variances approved by
FDA would be limited to the requirements of part 112 specified by FDA,
and have no effect on the application of other provisions of the FD&C
Act.
Consistent with section 419(c)(2)(A) of the Act, proposed Sec.
112.171 would establish that a State or foreign country from which food
is imported into the U.S. may request a variance from one or more of
the requirements proposed in part 112, where the State or foreign
country determines that the variance is necessary in light of local
growing conditions (proposed Sec. 112.171(a)); and the procedures,
processes, and practices to be followed under the variance are
reasonably likely to ensure that the produce is not adulterated under
Section 402 of the Act and to provide the same level of public health
protection as the requirements of proposed part 112 (proposed Sec.
112.171(b)). Such a determination would likely be based on the
particular crop, climate, soil, geographic, and environmental
conditions of a particular region, as well as processes, procedures, or
practices followed in that region. Given the diversity of covered
produce commodities and covered activities subject to the requirements
of part 112, we tentatively conclude that this provision provides
sufficient flexibility while ensuring the same level of public health
protection for covered produce. For example, a State or foreign country
may consider that the historical performance of an industry within
their jurisdiction (e.g., as indicated by the epidemiological record)
and the combination of measures taken by that industry merits
requesting a variance from some or all provisions of this proposed
rule. In requesting a variance, among other things, the State or
foreign country would submit information that, while the procedures,
processes and practices to be followed under the variance would be
different from those prescribed in this proposed rule, the requested
variance is reasonably likely to ensure that the produce is not
adulterated under section 402 of the FD&C Act and provide the same
level of public health protection as the requirements of the final
regulations (see proposed 112.173). FDA would encourage consideration
of these kinds of submissions, and welcomes requests for pre-petition
consultations, including meetings, with interested States or foreign
governments to facilitate the development of variance petitions,
including data and information that would be needed to demonstrate that
the variance is necessary in light of local growing conditions and that
the procedures, processes, and practices to be followed under the
variance are reasonably likely to ensure that the produce is not
adulterated under Section 402 of the Act and provide the same level of
public health protection as the requirements in this rule, when
finalized. As discussed in section IV.K, FDA is proposing extended
compliance dates for this proposed rule. We expect that these
compliance periods would allow sufficient time for variance petitions
to be developed, submitted, and reviewed by FDA. We request comment on
the compliance periods.
In proposed Sec. 112.172, we propose to establish that a request
for a variance, as described in proposed Sec. 112.171, must be
submitted by the competent authority (e.g., the regulatory authority
for food safety) for the state or foreign government to FDA in the form
of a citizen petition in accordance with 21 CFR 10.30.
In proposed Sec. 112.173, we propose that, in addition to the
requirements set forth in Sec. 10.30, the Statement of Grounds (which
is specified under Sec. 10.30(b)) such petition requesting a variance
must include a statement that the applicable State or foreign country
has determined that the variance is necessary in light of local growing
conditions and that the procedures, processes, and practices to be
followed under the variance are reasonably likely to ensure that the
produce is not adulterated under Section 402 of the Act and to provide
the same level of public health protection as the requirements of this
part (proposed Sec. 112.173(a)). In addition, the Statement of Grounds
would be required to describe with particularity the variance
requested, including the persons to whom the variance would apply and
the provision(s) of part 112 to which the variance would apply
(proposed Sec. 112.173(b)); and present information demonstrating that
the procedures, processes, and practices to be followed under the
variance requested are reasonably likely to ensure that the produce is
not adulterated under Section 402 of the Act and to provide the same
level of public health protection as the requirements of proposed part
112 (proposed Sec. 112.173(c)). Under these provisions, a State or
foreign country would be required to submit relevant and
scientifically-valid information or materials specific to the covered
produce or covered activity to support the petitioner's determination
that the variance requested is reasonably likely

[[Page 3607]]

to ensure that the produce is not adulterated under Section 402 of the
Act and to provide the same level of public health protection as the
requirements of this part. This would include information about the
crop, climate, soil, and geographical or environmental conditions of a
particular region, as well as the processes, procedures, or practices
followed in that region.
Proposed Sec. 112.174 establishes our presumption that information
submitted in a petition requesting a variance and comments submitted on
such a petition, including a request that a variance be applied to its
similarly situated persons, does not contain information exempt from
public disclosure under part 20 of this chapter and would be made
public as part of the docket associated with this request. We do not
believe that information exempt from disclosure under part 20 of this
chapter is the type of information that FDA is requiring to be
submitted in such a petition or that would be relevant in any comments
submitted on such a petition. We also believe that providing full
public access to this information is important to ensuring transparency
and for the opportunity for states and foreign governments to request
similar variances for similarly situated persons. Therefore, we expect
to make these submissions publicly available.
Proposed Sec. 112.175 would establish the Director or Deputy
Directors of the Center for Food Safety and Applied Nutrition (CFSAN),
or the Director of the Office of Compliance, CFSAN as the responsible
official for responding to a request for a variance from one or more
requirements in proposed part 112.
Proposed Sec. 112.176 would establish the general procedures
applying to a petition requesting a variance from one or more
requirements in proposed part 112. Proposed Sec. 112.176(a) would
provide that the procedures sets forth in Sec. 10.30 govern the
process by which FDA responds to a petition requesting a variance.
Section 10.30 of this chapter specifies the requirements for any
citizen petition submitted by a person (including a petitioner who is
not a citizen of the United States) to FDA. Proposed Sec. 112.176(b)
would establish that, under Sec. 10.30(h)(3) of this chapter, we will
publish a notice in the Federal Register, requesting information and
views on the filed petition, including information and views from
persons who could be affected by the variance if the petition were to
be granted (either because their farm is covered by the petition or as
a person similarly situated to persons covered by the petition). For
example, similarly situated persons may include those whose farm
operates under similar circumstances with similar procedures,
processes, and practices as those covered by the petition. Proposed
Sec. 112.176(c) would establish that, under Sec. 10.30(e)(3), FDA
will respond to the petitioner in writing and will publish a notice on
our Web site announcing our decision to either grant or deny the
petition. Proposed Sec. 112.176(c)(1) would establish that, if we
grant the petition, either in whole or in part, we will specify the
persons to whom the variance would apply and the provision(s) of this
part to which the variance would apply. Proposed Sec. 112.176(c)(2)
would establish that, if FDA denies the petition (including partial
denials), FDA will explain the reason(s) for the denial in its written
response to the petitioner and in the notice on our Web site announcing
the decision to deny. Under proposed Sec. 112.176(d), we propose to
make readily accessible to the public, and periodically update, a list
of filed petitions requesting variances, including the status of each
petition (for example, pending, granted, or denied). The provisions in
proposed Sec. 112.176 would ensure transparency in FDA's activities
and decision-making, which allows the public to better understand the
agency's decisions, increasing credibility and promoting
accountability.
Proposed Sec. 112.177 would establish circumstances under which an
approved variance could apply to any person other than those identified
in the petition requesting the variance. Under proposed Sec.
112.177(a), a State or a foreign country that believes that a variance
requested by a petition submitted by another State or foreign country
should also apply to similarly situated persons in its jurisdiction may
request that the variance be applied to its similarly situated persons
by submitting comments in accordance with Sec. 10.30. These comments
must include the information required in Sec. 112.173. If FDA
determines that these comments should instead be treated as a separate
request for a variance, FDA will notify the State or foreign country
that submitted these comments that a separate request must be submitted
in accordance with Sec. Sec. 112.172 and 112.173. Moreover, under
proposed Sec. 112.177(b), we propose that if we grant a petition
requesting a variance, in whole or in part, we may specify that the
variance also applies to persons in a specific location who are
similarly situated to those identified in the petition. Consequently,
under proposed Sec. 112.177(c), if we specify that the variance also
applies to persons in a specific location who are similarly situated to
those identified in the petition, we will inform the applicable State
or foreign country where the similarly situated persons are located of
our decision in writing and will publish a notice on our Web site
announcing our decision to apply the variance to similarly situated
persons in that particular location. We tentatively conclude that the
provisions in proposed Sec. 112.177 ensure consideration of the
application of variances to similarly situated persons to and provide
for transparency and accountability in FDA's review of requests and
decision-making.
Proposed Sec. 112.178 would provide that we may deny a variance
request if it does not provide the information required under proposed
Sec. 112.173 (including the requirements of Sec. 10.30), or if we
determine that the variance is not reasonably likely to ensure that the
produce is not adulterated under Section 402 of the Act and to provide
the same level of public health protection as the requirements of this
part. For example, we would expect to deny a petition if the State or
foreign government failed to submit scientifically-valid data,
information, or materials to demonstrate that the procedures,
processes, or practices to be followed under the requested variance are
reasonably likely to ensure that the produce is not adulterated under
Section 402 of the Act and to provide the same level of public health
protection as the requirements of proposed part 112.
Proposed Sec. 112.179 would specify that a variance approved by
FDA becomes effective on the date of our written decision on the
petition.
Under proposed Sec. 112.180, we would be able to modify or revoke
an approved variance if we determine that such variance is not
reasonably likely to ensure that the produce is not adulterated under
Section 402 of the Act and to provide the same level of public health
protection as the requirements of proposed part 112. For example, we
may deem it necessary to modify terms and conditions of the variance
based on a review of updated scientific data or factual information
that is applicable to the covered produce and procedures, processes, or
practices followed under the variance.
Proposed Sec. 112.181 would establish the procedures that apply if
FDA determines that an approved variance should be modified or revoked.
Under Sec. 112.181(a), we would provide notice of such a determination
as follows: (1) We will notify a State or a foreign country directly,
in writing at the

[[Page 3608]]

address identified in its petition, if we determine that a variance
granted in response to its petition should be modified or revoked. Our
direct, written notification will provide the State or foreign country
with an opportunity to request an informal hearing under part 16 of
this chapter; (2) We will publish in the Federal Register a notice of
our determination that a variance should be modified or revoked. This
notice will establish a public docket so that interested parties may
submit written submissions on our determination; and (3) When
applicable, we will: (i) Notify in writing any States or foreign
countries where a variance applies to similarly situated persons of our
determination that the variance should be modified or revoked; (ii)
Provide those States or foreign countries with an opportunity to
request an informal hearing under part 16 of this chapter; and (iii)
Include in the Federal Register notice described in paragraph (a)(2) of
this section public notification of our decision to modify or revoke
the variance granted to States or foreign countries in which similarly
situated persons are located.
Under Sec. 112.181(b), we would consider submissions from affected
States or foreign countries and from other interested parties as
follows: (1) We will consider requests for hearings by affected States
or foreign countries under part 16 of this chapter. If FDA grants a
hearing, we will provide the State or foreign country with an
opportunity to make an oral submission. We will provide notice on our
Web site of the hearing, including the time, date, and place of
hearing. If more than one State or foreign country requests an informal
hearing under part 16 of this chapter about our determination that a
particular variance should be modified or revoked, we may consolidate
such requests (for example, into a single hearing); and (2) We will
consider written submissions submitted to the public docket from
interested parties.
Under Sec. 112.181(c), we would provide notice of our final
decision as follows: (1) On the basis of the administrative record, FDA
will issue a written decision, as provided for under part 16 of this
chapter; and (2) We will publish a notice of our decision in the
Federal Register. The effective date of the decision will be the date
of publication of the notice.
We tentatively conclude that these provisions are necessary not
only to ensure transparency and accountability in FDA's activities and
decision-making, but also to provide relevant parties with an
opportunity for due process.
Finally, in proposed Sec. 112.182, we would provide examples of
permissible types of variances. These examples of variances from
certain requirements in proposed part 112 are consistent with our
proposed provisions in subpart B for alternatives from requirements in
proposed part 112. A State or foreign government may request a variance
from other requirements in proposed part 112, provided the conditions
described in proposed Sec. 112.171 are met.
3. Conforming Amendment to 21 CFR Part 16
We propose to amend Sec. 16.1(b)(1) to include Section
419(c)(2)(D) of the FD&C Act relating to the modification or revocation
of a variance from the requirements of Section 419 of the FD&C Act, to
the list of statutory and regulatory provisions under which regulatory
hearings are available.

Q. Subpart Q--Compliance and Enforcement

1. Overall Strategy for Implementation and Compliance
FDA expects this proposed rule to improve produce safety to the
extent the proposed requirements related to practices are actually
implemented by farms. Many farms already follow some or all of the
proposed practices, but we recognize that, when finalized, the proposed
rule will be the first national standard for on-farm practices related
to produce safety and that it will take time and a concerted,
community-wide effort for the wide range of farms to come into full
compliance. FDA is committed to working with the produce community and
with partners in the U.S. Department of Agriculture, State agencies,
and foreign governments to facilitate compliance through education,
technical assistance and regulatory guidance.
We anticipate that compliance will be achieved primarily through
the conscientious efforts of farmers, complemented by the efforts of
State and local governments, extension services, private audits and
certifications, and other private sector supply chain management
efforts. We also recognize that the time needed to comply will vary, so
we are proposing to phase in compliance dates based on farm size (see
section IV.K of this document).
Under the FD&C Act, FDA has authority to inspect produce farms and
can take enforcement action when needed to prevent significant hazards
from entering the food supply or in response to produce safety
problems, although FDA faces severe constraints in inspection and
enforcement when it comes to foreign farms. FDA's inspection resources
are very limited, however, in relation to the number of produce farms
and the many other food production, processing and storage settings for
which FDA has regulatory responsibility. Thus, as outlined below, FDA
inspection will play an important but necessarily limited role in the
overall compliance effort. FDA invites comment on all aspects of its
compliance strategy.
2. Education, Technical Assistance and Regulatory Guidance
Education and technical assistance is the foundation of our
intended compliance strategy. As discussed in section II.D. above, FDA
has, together with USDA AMS, established a jointly-funded Produce
Safety Alliance (PSA), a public-private partnership that will develop
and disseminate science- and risk-based training and education programs
to provide produce growers and packers with fundamental food safety
knowledge. A first phase of PSA's work is intended to assist farms,
especially small and very small farms, in establishing food safety
programs consistent with the GAPs Guide and other existing guidances so
that they will be better positioned to comply when we issue a final
produce safety rule under section 419 of the FD&C Act. As this
rulemaking progresses, FDA will work to ensure that the PSA materials
are modified, as needed, to be consistent with the requirements of the
produce safety rule. FDA intends to work with federal, State, and local
officials, industry, and academia through the PSA to assist farmers to
implement measures necessary to minimize the risk of serious adverse
health consequences or death from consumption of covered produce.
We also will work to provide education and technical assistance
through other sources of information that are familiar to the produce
farming community (such as Cooperative Extension, land grant
universities, trade associations, and foreign partners and JIFSAN to
reach farmers exporting covered produce into the U.S. in their local
languages). We plan to work with these and other stakeholders to
develop a network of institutions that can provide technical assistance
to the farming community, especially small and very small farms, as
they endeavor to comply with the provisions of the final rule.
FDA intends to further facilitate compliance with a final produce
safety rule through the development and dissemination of guidance, in
multiple

[[Page 3609]]

languages, on procedures, conditions, and practices that farms can
implement to reduce the risk of known or reasonably foreseeable
hazards. Section 419(e) of the FD&C Act requires FDA to develop
guidance ``for the safe production and harvesting of specific types of
fresh produce under [section 419]'' and to hold at least three public
meetings in diverse geographical areas of the U.S. as part of an effort
to conduct education and outreach regarding the guidance. Consistent
with this statutory provision, FDA plans to develop guidance materials,
including additional guidances specific to commodities, practices, and
conditions, as needed and informed, in part, by stakeholder input,
including that received during public meetings.
Section 419(a)(4) of FSMA states that ``the Secretary shall
prioritize the implementation of the regulations under this section for
specific fruits and vegetables that are raw agricultural commodities
based on known risks which may include a history and severity of
foodborne illness outbreaks.'' As discussed immediately above, we
intend to fulfill this mandate by (1) conducting extensive outreach and
educational efforts focused on the known risks of specific types of
produce and specific types of agricultural practices applied to such
produce; (2) focusing our inspection and enforcement efforts on farms
that present the greatest risk based, in part, on past association with
outbreaks, contamination, or the known risks of their agricultural
practices and conditions and/or their specific types of produce; and
(3) developing guidance materials related to the rule (including
commodity-specific guidances) focused on known risks. We request
comment on this approach and on specific strategies we should employ in
order to best prioritize our implementation of the rule in this manner.
3. Supply Chain Management
FDA anticipates that significant incentives and accountability for
compliance with a final produce safety rule will come through non-
regulatory audits and supply chain management initiated by private
entities.
As discussed in section II.F.2. of this document, a number of
retail produce buyers currently require, as a condition of sale, that
their produce suppliers comply with and be audited by third parties for
conformance with the FDA GAPs guide. USDA AMS also offers a GAPs and
Good Handling Practices (GAP&GHP) Audit Verification Program. USDA AMS
and the California Department of Food and Agriculture (CDFA) have
developed and are implementing the California Leafy Greens Marketing
Agreement (CA LGMA) to protect public health via compliance with the
food safety practices that are accepted by the LGMA board (Ref. 45).
Compliance with such practices is further verified for members and
signatories to the agreement through mandatory government audits by
CDFA auditors who are trained and licensed by USDA AMS (Ref. 263).
Leafy greens growers in Arizona have adopted a similar marketing
agreement and audit structure for their growers (Ref. 32).
At the request of industry, the USDA AMS in 2009 held seven
hearings throughout the United States to solicit input from the leafy
greens industries across the U.S. regarding their desire to develop a
proposed national marketing agreement for leafy greens. A decision
regarding the proposed USDA AMS national marketing agreement for leafy
greens is currently pending, but FDA and USDA are committed to working
together to harmonize the provisions of any national or regional
marketing agreements for produce with the provisions of any final rule
FDA issues under section 419 of the FD&C Act. Rigorous audits conducted
under national or regional marketing agreements can be an important
tool for fostering compliance with the produce safety rule.
FDA also intends to issue notices of proposed rulemaking
implementing sections 418 and 805 of the FD&C Act (sections 103 and 301
of FSMA). FDA is aware of the diversity in quality of audits and the
need to strengthen that system, but we anticipate that audits will be
an important source of accountability for compliance with a final
produce safety rule.
4. Inspections
With a community as large and diverse as the produce farming
industry, it is not reasonable to expect that industry-wide compliance
can be gained primarily through inspection and enforcement, though, of
course, inspection and enforcement must be a component of our efforts.
Inspections will, of necessity, be targeted to those farms that present
the greatest risk based, in part, on their association with past
outbreaks or contamination events and the risk associated with the
agricultural practices they apply in the growing, harvesting, packing,
and holding of covered produce.
FDA intends to work collaboratively with our federal and State
regulatory partners to use available inspection resources to conduct
risk-based inspections of farms for compliance with a final produce
safety regulation. Section 702(a)(1)(A) of the FD&C Act [21 U.S.C.
372(a)(1)(A)] expressly authorizes FDA to conduct examinations and
investigations for the purposes of the FD&C Act through any health,
food, or drug officer or employee of any State, Territory, or political
subdivision thereof (such as a locality), duly commissioned to act on
behalf of FDA. Qualified State, Territorial, or local regulatory
officials may be commissioned or serve under contract with FDA to
conduct examinations, inspections, and investigations for purposes of
the FD&C Act. In addition, section 702(a)(2) [21 U.S.C. 372(a)(2)]
expressly authorizes FDA to conduct examinations and investigations for
the purposes of the FD&C Act through officers and employees of another
Federal department or agency, subject to certain conditions set forth
in that section. We expect to continue to cooperatively leverage the
resources of federal, State, and local government agencies in this way
as we strive to obtain industry-wide compliance with a final produce
safety rule.
Section 419(b)(2)(A) of the FD&C Act specifically instructs FDA to
``provide for coordination of education and enforcement activities by
State and local officials, as designated by the Governors of the
respective States or the appropriate elected State official as
recognized by State statute.'' Consistent with this provision and with
the direction to improve the training of State, local, territorial, and
tribal food safety officials under Section 1011 of the FD&C Act (21
U.S.C. 399c, added to the FD&C Act by section 209 of FSMA), FDA intends
to work closely with extension and education organizations and State,
local, territorial, and tribal partners to develop the tools and
training programs needed to facilitate consistent inspection and
regulatory activities associated with the requirements of a final
produce safety rule. We expect to build on our collaboration with
State, local, territorial, and tribal officials in the development of
tools and training for use by inspectors in farm investigations on
issues specific to food safety during growing, harvest, packing and
holding produce.
FDA anticipates that some States may choose to adopt requirements
modeled after the provisions of a final federal produce safety rule and
may choose to perform inspections under their own authorities to
enforce those provisions of their state laws. Such actions would
further drive compliance with a final federal produce safety rule.

[[Page 3610]]

5. Comments Related to the Proposed Provisions
We received many comments on strategies for compliance, including
comments from farmers, consumers, retail, State, federal and foreign
governments, academia, trade associations and industry groups, and a
non-profit research and advocacy organization. These comments broadly
expressed strategies for compliance that included specific suggestions
on how to ensure that all covered produce is in compliance with a final
rule. Several comments recognized the importance of partnerships with
respect to bringing about compliance with, and ultimately enforcing, a
final rule. Comments urged the agency to work in cooperation with other
federal, State, Territorial, tribal and local agencies with
jurisdiction and expertise to ensure a coordinated and uniform approach
to enforcement and compliance that will improve efficiency and
effectiveness. Several comments noted that governmental testing
laboratories should be recognized and funding should be provided to
States to hire and train auditors.
We agree that partnerships will play a crucial role in bringing the
produce industry into compliance with a final rule. As discussed in our
overall strategy above and reflected in proposed 112.193, FDA intends
to work with State, Territorial, tribal, and local partners to develop
the education and enforcement tools and training programs needed to
facilitate consistent inspection and regulatory activities associated
with the requirements of a final produce safety rule. Education and
outreach through mechanisms like PSA and other sources of information
that are familiar to the produce farming community (such as Cooperative
Extension, land grant universities, and trade associations) are the
foundation of our intended compliance strategy. We also plan to work
with these and other stakeholders to develop a network of institutions
that can provide technical assistance to the farming community,
especially small and very small farms, as they endeavor to comply with
the provisions of a final rule. Of course, although much of our initial
effort will be focused on education and outreach, we will also inspect
farms on a targeted basis for compliance with a final produce safety
rule. Partnerships will play an important role with regard to
inspections as well. FDA intends to work collaboratively with our
federal, State, Territorial, tribal, and local regulatory partners to
use available inspection resources to conduct risk-based inspections of
farms for compliance with the final regulation. FDA intends to further
facilitate compliance with our final regulation through the development
and dissemination of guidance on procedures, conditions, and practices
that farms can implement to reduce the risk of known or reasonably
foreseeable hazards.
Several comments noted that foreign governments could also play an
important role in verifying compliance. Some noted that global
recognition of food safety and food defense efforts should be
developed. One country specifically requested that we recognize foreign
fresh produce initiatives as equivalent oversight of the industry.
We agree that foreign governments will play an important part in
bringing about compliance with a final produce rule with respect to
foreign products. We have already begun to reach out to foreign
governments regarding the requirements of FSMA and will continue to
provide technical assistance as we move closer to finalizing rules
issued under FSMA authorities. There are several provisions of FSMA
that directly relate to these partnerships. Section 305 of FSMA
specifically directs us to develop a plan to build the capacity of
foreign governments with respect to food safety that will include,
among other things, training of foreign governments on our
requirements, provisions for mutual recognition of inspection reports,
and provisions for multilateral acceptance of laboratory methods and
testing and detection techniques. Under section 307 of FSMA, which
added section 808 to the FD&C Act [21 U.S.C. 384d], we are directed to
establish a system for the recognition of accreditation bodies that
accredit third-party auditors to certify that eligible entities meet
certain requirements. Under that section, foreign governments or
agencies of foreign governments, may be accredited as third party
auditors who could help to ensure compliance with a final produce
safety rule. Section 303 of FSMA amended section 801 of the FD&C Act
to, among other things, allow us to designate an agency or
representative of the foreign government of the country from which a
food originated to provide certification or other assurances that
certain foods are in compliance with the FD&C Act, if FDA chooses to
require such certifications or assurances for certain foods. We are
working to implement these provisions of FSMA. In addition, as set
forth in subpart P of this proposed rule, foreign countries may request
variances from requirements proposed in this rule, provided they meet
certain conditions. See section V.P. of this document for further
discussion of the process, conditions, and procedures related to a
request for variance(s).
In addition to partnering with other U.S. agencies and foreign
governments, several comments discussed the strength of industry
programs imposed throughout the supply chain and urged us to leverage
these private sector efforts. Some commented on the importance of
verification of compliance by qualified and independent third parties
and recognition of third party certification. These third parties could
be those hired by industry, including retailers, to ensure the safety
of produce from their suppliers. However, some comments identified
duplicative audits and excessive documentation as problematic,
particularly for small growers. Other comments recognized that
importers can play an important role in verifying compliance with a
final produce safety rule and safety of imported produce.
We agree that we should leverage the efforts of private supply
chain management to further compliance with a final rule in this area.
See discussion of our overall enforcement and compliance strategy
immediately above. We also agree that importers will play an important
role in ensuring the safety of produce grown in other countries and
shipped to the United States. Under section 301 of FSMA, importers will
have to verify that imported covered produce is produced in compliance
with processes and procedures that provide the same level of public
health protection as those required under section 419 of the FD&C Act.
Other comments noted that compliance with produce safety
requirements should be tiered to reflect farm size, market requirements
and risk. One comment noted that there should be dedicated inspectors
for identified groups that may need additional assistance.
We agree that we should prioritize our compliance and enforcement
efforts. As discussed above, we will be targeting our education efforts
to the smaller businesses that may not be as familiar with our
requirements as some of the larger farms. We also propose to give small
and very small businesses extra time to comply with the final rule, as
discussed in section IV.K of this document. With respect to
inspections, they will, of necessity, be targeted to those farms that
present the greatest risk based, in part, on their association with
past outbreaks or contamination events and the risk associated with the
agricultural practices they apply in the

[[Page 3611]]

growing, harvesting, packing, and holding of covered produce.
A few comments mentioned that research can play an important part
in bringing about industry compliance. Some noted that foodborne
illness outbreak investigations needed to be improved and used as
educational opportunities to support food safety research. They noted
that better investigative methods should be developed to help reveal
possible sources of contamination. FDA agrees, as reflected in the
recent establishment of the Coordinated Outbreak Response and
Evaluation (CORE) Network, which is a permanent cadre of FDA experts
whose full time responsibility is to enhance outbreak detection,
response, and follow up investigations to inform future prevention
efforts. CORE will work with CDC, state and local partners, and the
food industry to investigate root causes of major outbreaks and share
findings with the food safety community.
Comments also noted that a permanent institutional part of
government should be developed to coordinate research, information,
responses to, and control measures for, human pathogens and their
evolution in the environment, including the farm environment, animal
production, the industrial and commercial environment and the medical
(healthcare) system. As discussed previously, we are pursuing
regulatory science and research activities in collaboration with
various partners. See section II.E. of this document for further
information.
6. Proposed Requirements
Proposed Sec. 112.191 states that the criteria and definitions in
this part apply in determining whether a food is adulterated (1) within
the meaning of section 402(a)(3) of the Federal Food, Drug, and
Cosmetic Act in that the food has been grown, harvested, packed, or
held under such conditions that it is unfit for food; or (2) within the
meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic
Act in that the food has been prepared, packed, or held under
insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health. The
criteria and definitions in this part also apply in determining whether
a food is in violation of section 361 of the Public Health Service Act
(42 U.S.C. 264).
As discussed in section III of this document, FDA proposes these
regulations under the FD&C Act as amended by FSMA, and the Public
Health Service Act (PHS Act). We note that section 419(c)(1)(A) of the
FD&C Act provides that FDA shall establish in this rulemaking
``procedures, processes, and practices that the Secretary determines to
be reasonably necessary * * * to provide reasonable assurances that the
produce is not adulterated under section 402 [of the FD&C Act]'' and
that similar references to preventing adulteration under section 402 of
the FD&C Act also appear in section 419(c)(1)(F), (c)(2)(A), (c)(2)(C),
and (c)(2)(D). In sections V.A. through V.O. of this document, we
explain how the proposed provisions are necessary to protect against
contamination with hazards that may adulterate food. We tentatively
conclude that the link between the proposed provisions and the
potential for adulteration provides a basis for applying the criteria
and definitions in proposed part 112 in determining whether, under
particular circumstances, a food is adulterated under section 402(a)(3)
or (a)(4) or in violation of section 361 of the PHS Act. We also note
402(a)(4) of the FD&C Act provides that food is adulterated if it has
been ``prepared, packed, or held under insanitary conditions'' whereby
either of the proscribed results may occur. ``Prepared, packed, or
held'' includes growing, harvesting, packing, and holding. The common
meaning of ``prepare,'' as represented by the dictionary definition is,
in relevant part, ``to make ready beforehand for some purpose, use, or
activity * * * to put together'' (Ref. 264). Growing and harvesting are
operations that make food ready for use as food. In addition, growing
and harvesting at times involve holding of food.
Section 105(c) of FSMA amends section 301 of the FD&C Act (21
U.S.C. 331) by adding a new section--(vv)--to the list of acts and the
causing thereof that are prohibited. Under section 301(vv), the
following act, and the causing thereof, is prohibited: ``[t]he failure
to comply with the requirements under section 419 [of the FD&C Act].''
To clearly communicate that failure to comply with regulations
established under section 419 is a prohibited act, proposed Sec.
112.192 would establish that the failure to comply with the
requirements of part 112, issued under section 419 of the Federal Food,
Drug, and Cosmetic Act, is a prohibited act under section 301(vv) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(vv)).
Proposed Sec. 112.193 provides that under Section 419(b)(2)(A) of
the FD&C Act, FDA coordinates education and enforcement activities by
State, Territorial, tribal, and local officials. As described above, we
plan to work closely with State, Territorial, tribal, and local
partners to develop the education and enforcement tools and training
programs needed to facilitate consistent inspection and regulatory
activities associated with the requirements proposed in subparts A
through O.

R. Subpart R--Withdrawal of Qualified Exemption

As proposed, subpart R establishes the procedures that would govern
the circumstances and process whereby we may issue an order withdrawing
a qualified exemption applicable to a farm in accordance with the
requirements of Sec. 112.5. Specifically, proposed Sec. 112.201 lists
the circumstances under which FDA can withdraw a qualified exemption
applicable to a farm, while Sec. Sec. 112.202 and 112.203 specify the
procedure and information that FDA would include in an order to
withdraw such qualified exemption. In addition, proposed Sec. Sec.
112.204 through 112.207 provide for a process whereby you may submit a
written appeal (which may include a request for a hearing) of an order
to withdraw a qualified exemption applicable to your farm, and proposed
Sec. Sec. 112.208 through 112.211 provide a procedure for appeals,
hearings, and decisions on appeals and hearings.
1. Requirements of Section 419 of the FD&C Act
Section 419(f)(3)(A) of the FD&C Act specifies that, ``[i]n the
event of an active investigation of a foodborne illness outbreak that
is directly linked to a farm subject to an exemption under [section
419(f) of the FD&C Act], or if the Secretary determines that it is
necessary to protect the public health and prevent or mitigate a
foodborne illness outbreak based on conduct or conditions associated
with a farm that are material to the safety of the food produced or
harvested at such farm, the Secretary may withdraw the exemption
provided to such farm under [section 419(f) of the FD&C Act].'' Section
419 does not expressly prescribe the procedures for withdrawing a
qualified exemption provided to a farm under section 419(f). We
tentatively conclude that it is appropriate to be transparent about the
process we would use to withdraw a qualified exemption and that we
should include the process in the proposed rule.
2. Proposed Requirements
a. Circumstances for Withdrawal
Proposed Sec. 112.201 would establish the circumstances under
which FDA can withdraw an exemption applicable to a farm. Consistent
with Section 419(f)(3)(A) of the FD&C Act, it states

[[Page 3612]]

that we may withdraw your qualified exemption under proposed Sec.
112.5:
(1) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to your farm (proposed Sec.
112.201(a)); or
(2) If we determine that it is necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak based on
conduct or conditions associated with your farm that are material to
the safety of the food that would otherwise be covered produce grown,
harvested, packed or held at your farm (proposed Sec. 112.201(b)).
Proposed Sec. 112.201(a) would implement the statutory language of
section 419(f)(3)(A) of the FD&C Act. An outbreak of foodborne illness
is the occurrence of two or more cases of a similar illness resulting
from the ingestion of a common food. Food can become contaminated at
many different steps in the farm-to-table continuum: On the farm; in
packing, manufacturing/processing, or distribution facilities; during
storage or transit; at retail establishments; in restaurants; and in
the home. When foodborne illness is associated with food, an
investigation may enable us to directly link the illness to the farm
that grew, harvested, packed, and/or held the food.
Proposed Sec. 112.201(b) would also implement the statutory
language of section 419(f)(3)(A) of the FD&C Act, which provides that
FDA may withdraw a qualified exemption available to a farm under
section 419(f) ``if the Secretary determines that it is necessary to
protect the public health and prevent or mitigate a foodborne illness
outbreak based on conduct or conditions associated with a farm that are
material to the safety of the food produced or harvested at such
farm.'' We tentatively conclude that the food to which this standard
applies is food that would otherwise be covered produce, because that
is the food that would be subject to this proposed rule if a qualified
exemption is withdrawn. We also tentatively conclude that it is
reasonable to interpret the word ``produced'' in this standard to refer
to the activities within the farm definition other than harvesting,
because this proposed rule would apply only to activities within the
farm definition and the standard already uses the word ``harvested.''
Thus, proposed Sec. 112.201(b) would provide that FDA may withdraw the
qualified exemption applicable to a farm under proposed Sec. 112.5 if
FDA determines that it is necessary to protect the public health and
prevent or mitigate a foodborne illness outbreak based on conduct or
conditions associated with a farm that are material to the safety of
the food that would otherwise be covered produce grown, harvested,
packed, or held at such farm. As an example, we may receive reports to
the Reportable Food Registry under section 417 of the FD&C Act about
contamination of a food, and the reports may lead us to investigate a
farm that grew, harvested, packed or held the food. If our
investigation finds conduct or conditions associated with the farm that
are material to the safety of the food that would otherwise be covered
produce subject to proposed subparts B through O of this rule (for
example, conduct or conditions that likely led to the contamination of
the food), we would consider withdrawing the qualified exemption
applicable to the farm under proposed Sec. 112.5 if doing so would be
necessary to protect the public health and prevent or mitigate a
foodborne illness outbreak. Likewise, if during a routine inspection of
a farm to which the qualified exemption in proposed Sec. 112.5
applies, we discover conditions and practices that are likely to lead
to contamination of food that would otherwise be covered produce with
microorganisms of public health significance, we would consider
withdrawing the qualified exemption provided to the facility under
proposed Sec. 112.5 if doing so would be necessary to protect the
public health and prevent or mitigate a foodborne illness outbreak.
b. Procedure for Issuance of Withdrawal Order
Proposed Sec. 112.202(a) would provide that, if FDA determines
that a qualified exemption applicable to a farm under Sec. 112.5
should be withdrawn, any officer or qualified employee of FDA may issue
an order to withdraw the exemption. We intend to create and maintain a
written record of a determination that the withdrawal of an exemption
is warranted and to include the basis for the determination in the
written record. Proposed Sec. 112.202(b) would require that an FDA
District Director in whose district the farm is located (or, in the
case of a foreign farm, the Director of the Office of Compliance in the
Center for Food Safety and Applied Nutrition), or an FDA official
senior to such Director, must approve an order to withdraw the
exemption as part of the withdrawal determination procedure before the
order is issued. A Regional Food and Drug Director is an example of an
FDA official senior to a District Director. The Deputy Directors and
Director of the Center for Food Safety and Applied Nutrition are
examples of an FDA official senior to the Director of the Office of
Compliance. Requiring prior approval of a withdrawal order by a
District Director or an FDA official senior to a District Director is
consistent with the approval requirement for a detention order in part
1, subpart K (Administrative Detention of Food for Human or Animal
Consumption). Requiring prior approval of a withdrawal order by the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition is consistent with current FDA practices when dealing
with foreign firms. Proposed Sec. 112.202(c) would require that FDA
issue an order to withdraw the exemption to the owner, operator, or
agent in charge of the farm. We tentatively conclude that it would be
appropriate for FDA to issue an exemption withdrawal order to any of
these persons. Proposed Sec. 112.202(d) would require that FDA issue
an order to withdraw the exemption in writing, signed and dated by the
officer or qualified employee of FDA who is issuing the order.
c. Information Included in FDA's Withdrawal Order
Proposed Sec. 112.203(a) through (h) would require that an order
to withdraw a qualified exemption applicable to a farm under Sec.
112.5 include the following information:
(a) The date of the order (proposed Sec. 112.203(a));
(b) The name, address and location of the covered farm (proposed
Sec. 112.203(b));
(c) A brief, general statement of the reasons for the order,
including information relevant to:
(1) An active investigation of a foodborne illness outbreak that is
directly linked to the farm; or
(2) Conduct or conditions associated with a farm that are material
to the safety of the food that would otherwise be covered produce
grown, harvested, packed and held at such farm (proposed Sec.
112.203(c));
(d) A statement that the farm must comply with subpart B through
subpart O of this part on the date that is 60 calendar days after the
date of the order (proposed Sec. 112.203(d));
(e) The text of section 419(f) of the Federal Food, Drug, and
Cosmetic Act and of subpart R of the rule (proposed Sec. 112.203(e));
(f) A statement that any informal hearing on an appeal of the order
must be conducted as a regulatory hearing under part 16 (21 CFR Part
16), with certain exceptions described in proposed Sec. 112.208
(proposed Sec. 112.203(f));
(g) The mailing address, telephone number, email address, and
facsimile number of the FDA district office and

[[Page 3613]]

the name of the FDA District Director in whose district the farm is
located (or, in the case of a foreign farm, the same information for
the Director of the Office of Compliance in the Center for Food Safety
and Applied Nutrition); (proposed Sec. 112.203(g)); and
(h) The name and the title of the FDA representative who approved
the order (proposed Sec. 112.203(h)).
FDA tentatively concludes that the requirements that we propose in
Sec. 112.203 would provide the owner, operator, or agent in charge of
a farm subject to a withdrawal with adequate notice of the basis for
our determination to withdraw the exemption and of their opportunity to
appeal our determination and to request an informal hearing. The
proposed notification procedures are similar to and consistent with the
notification requirements in other regulations involving administrative
action, such as administrative detention of food under Sec. 1.393,
orders for diversion or destruction of shell eggs under the PHS Act
under Sec. 118.12(a)(i), and with procedures for an informal hearing
in part 16. We seek comments on the proposed process for withdrawal of
a qualified exemption.
d. Requirements When a Withdrawal Order Is Issued
Proposed Sec. 112.204 would require that the owner, operator, or
agent in charge of a farm that receives an order to withdraw an
exemption applicable to that farm under Sec. 112.5 either (a) comply
with applicable requirements of this part within 60 calendar days of
the date of the order or, if operations have ceased and will not resume
within 60 calendar days, before the beginning of operations in the next
growing season; or (b) appeal the order within 10 calendar days of the
date of the order in accordance with the requirements of Sec. 112.206.
We tentatively conclude that either of the two circumstances that could
result in our determination that an exemption should be withdrawn (as
described in proposed Sec. 112.201) warrant prompt compliance with the
rule in the interest of public health. We tentatively conclude that ten
calendar days for the submission of an appeal from the date of the
receipt of a withdrawal order is appropriate for purposes of the
efficient adjudication of the appeal of a withdrawal order and would
provide reasonable due process that comes to closure sufficiently in
advance of the effective date of the order to provide an opportunity
for the farm to come into compliance if we deny the appeal.
e. Procedure for Appealing a Withdrawal Order (Including Requests for
Informal Hearing)
Proposed Sec. 112.205(a) would establish that submission of an
appeal, including submission of a request for an informal hearing, will
not delay or stay any administrative action, including enforcement
action by FDA, unless the Commissioner of Food and Drugs, as a matter
of discretion, determines that delay or a stay is in the public
interest. For example, the submission of an appeal of a withdrawal
order with a request for an informal hearing would not prevent FDA from
simultaneously detaining food from the farm under section 304(h) of the
FD&C Act, seeking seizure of food from the farm under section 304(a) of
the FD&C Act, or seeking or enforcing an injunction under section 302
of the FD&C Act. Proposed Sec. 112.205(b) would require that, if the
owner, operator, or agent in charge of the farm appeals the order, and
FDA confirms the order, the owner, operator, or agent in charge of the
farm must comply with applicable requirements of this part within 60
calendar days of the date of the order or, if operations have ceased
and will not resume within 60 calendar days, before the beginning of
operations in the next growing season. Proposed Sec. 112.205(b) would
make clear that the 60 calendar day time frame for compliance applies
regardless of whether the owner, operator, or agent in charge of a farm
requests, and FDA grants, a hearing. As already discussed, FDA
tentatively concludes that the circumstances that lead to a
determination that an exemption should be withdrawn warrant prompt
compliance in the interest of public health.
Proposed Sec. 112.206(a) would require that, to appeal an order to
withdraw a qualified exemption applicable to a farm under Sec. 112.5,
the owner, operator, or agent in charge of the farm must: (1) Submit
the appeal in writing to the FDA District Director in whose district
the farm is located (or, in the case of a foreign farm, to the Director
of the Office of Compliance in the Center for Food Safety and Applied
Nutrition), at the mailing address, email address, or facsimile number
identified in the order within 10 calendar days of the date of the
order; and (2) respond with particularity to the facts and issues
contained in the order, including any supporting documentation upon
which the owner, operator or agent in charge of the farm relies.
Allowing the owner, operator, or agent in charge of the farm to submit
an appeal in person, by mail, email, or fax would provide for
flexibility as well as speed. For example, submitting in person would
give the owner, operator, or agent in charge direct knowledge that the
request for appeal had been delivered and received. Email and fax are
instantaneous, and overnight mail delivery services are readily
available to those who choose to use them; however, the ten day time
frame for appeal of the order would not require the use of overnight
mail delivery. For clarity, proposed Sec. 112.206(a)(1) would repeat
the 10 calendar day time frame that would be established in proposed
Sec. 112.204 and would not establish any new requirement. Any appeal
would need to be written in order for FDA to evaluate the basis for the
appeal. We are proposing that a written appeal would need to address
with particularity all of the issues raised in the withdrawal order and
include all supporting documentation so that we would be able to issue
a final determination as to the disposition of the appeal solely on the
basis of the materials submitted as part of the written appeal.
Proposed Sec. 112.206(b) would provide that, in a written appeal
of the order withdrawing an exemption provided under Sec. 112.5, the
owner, operator, or agent in charge of the farm may include a written
request for an informal hearing as provided in Sec. 112.207.
Requesting an informal hearing does not mean that a hearing will be
held, because we may deny the request (see discussion of proposed Sec.
112.207(b) below). However, if the owner, operator, or agent in charge
of the farm does not request an informal hearing at the time the
written appeal is submitted, the owner, operator, or agent in charge of
the farm will not be entitled to an informal hearing. Instead, FDA will
make a final decision based on the written appeal and its supporting
materials.
Proposed Sec. 112.207(a)(1) would provide that, if the owner,
operator, or agent in charge of the farm appeals the order, the owner,
operator, or agent in charge of the farm may request an informal
hearing. Proposed Sec. 112.207(a)(1) would restate an option that
would be included in proposed Sec. 112.206(b) to highlight the
opportunity to request an informal hearing. Proposed Sec.
112.207(a)(2) would require that, if the owner, operator, or agent in
charge of the farm appeals the order, the owner, operator, or agent in
charge of the farm must submit any request for an informal hearing
together with its written appeal submitted in accordance with Sec.
112.206 within 10 calendar days of the date of the order. We
tentatively conclude that requiring submission of a request for an
informal hearing in writing at the time

[[Page 3614]]

that the owner, operator, or agent in charge of the farm would be
required to submit a written appeal is appropriate for purposes of the
efficient adjudication of the appeal of a withdrawal order and would
provide reasonable due process that would come to closure sufficiently
in advance of the effective date of the order to provide an opportunity
for the farm to come into compliance if we deny the appeal.
Proposed Sec. 112.207(b) would establish that a request for an
informal hearing may be denied, in whole or in part, if the presiding
officer determines that no genuine and substantial issue of material
fact has been raised by the material submitted. Proposed Sec.
112.207(b) would also provide that if the presiding officer determines
that a hearing is not justified, written notice of the determination
will be given to the owner, operator, or agent in charge of the farm
explaining the reason for the denial. Under proposed Sec. 112.206(a),
a written appeal would be required to respond with particularity to the
facts and issues contained in the withdrawal order, including any
supporting documentation upon which the owner, operator or agent in
charge of the farm relies. If the materials submitted do not directly
address the facts and issues contained in the withdrawal order in a
manner that suggests that there is a genuine dispute regarding the
material facts contained in the order, the presiding officer may
determine that an informal hearing is not warranted. The presiding
officer may include written notice of the determination that a hearing
is not justified as part of the final decision on the appeal.
f. Procedure for Appeals (Including Informal Hearings)
Proposed Sec. 112.208(a) would establish that, if the owner,
operator or agent in charge of the farm requests an informal hearing,
and FDA grants the request, the hearing will be held within 10 calendar
days after the date the appeal is filed or, if applicable, within a
time frame agreed upon in writing by the owner, operator, or agent in
charge of the farm and FDA. We tentatively conclude that, if we grant a
request for an informal hearing, holding the hearing within 10 calendar
days, or within an alternative time frame as agreed upon in writing, is
appropriate for purposes of the efficient adjudication of the appeal of
a withdrawal order and would provide reasonable due process that would
come to closure sufficiently in advance of the effective date of the
order to provide an opportunity for the farm to come into compliance if
we deny the appeal.
Proposed 112.208(b) would establish that the presiding officer may
require that a hearing conducted under this subpart be completed within
1 calendar day, as appropriate. We tentatively conclude that, if we
grant a request for an informal hearing, limiting the time for the
hearing itself to be completed within 1 calendar day is appropriate for
purposes of the efficient adjudication of the appeal of a withdrawal
order and would provide reasonable due process that would come to
closure sufficiently in advance of the effective date of the order to
provide an opportunity for the farm to come into compliance if we deny
the appeal.
Proposed Sec. 112.208(c)(1) through (7) would establish that, if
the owner, operator or agent in charge of the farm requests an informal
hearing, and FDA grants the request, FDA must conduct the hearing in
accordance with part 16, except that:
(1) The order withdrawing an exemption under Sec. 112.5, rather
than the notice under Sec. 16.22(a), provides notice of opportunity
for a hearing under this section and is part of the administrative
record of the regulatory hearing under Sec. 16.80(a) of this chapter.
(2) A request for a hearing under this subpart must be addressed to
the FDA District Director (or, in the case of a foreign farm, the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition) as provided in the order withdrawing an exemption.
(3) Section 112.209, rather than Sec. 16.42(a), describes the FDA
employees who preside at hearings under this subpart.
(4) Section 16.60(e) and (f) of this chapter does not apply to a
hearing under this subpart. The presiding officer must prepare a
written report of the hearing. All written material presented at the
hearing will be attached to the report. The presiding officer must
include as part of the report of the hearing a finding on the
credibility of witnesses (other than expert witnesses) whenever
credibility is a material issue, and must include a proposed decision,
with a statement of reasons. The hearing participant may review and
comment on the presiding officer's report within 2 calendar days of
issuance of the report. The presiding officer will then issue the final
decision.
(5) Section 16.80(a)(4) of this chapter does not apply to a
regulatory hearing under this subpart. The presiding officer's report
of the hearing and any comments on the report by the hearing
participant under Sec. 112.208(c)(4) are part of the administrative
record.
(6) No party shall have the right, under Sec. 16.119 of this
chapter to petition the Commissioner of Food and Drugs for
reconsideration or a stay of the presiding officer's final decision.
(7) If FDA grants a request for an informal hearing on an appeal of
an order withdrawing an exemption, the hearing must be conducted as a
regulatory hearing pursuant to regulation in accordance with part 16,
except that Sec. 16.95(b) does not apply to a hearing under this
subpart. With respect to a regulatory hearing under this subpart, the
administrative record of the hearing specified in Sec. Sec.
16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 112.208(c)(5) constitutes
the exclusive record for the presiding officer's final decision. For
purposes of judicial review under Sec. 10.45 of this chapter, the
record of the administrative proceeding consists of the record of the
hearing and the presiding officer's final decision.
Under Sec. 16.1(b), the procedures in part 16 apply when a
regulation provides a person with an opportunity for a hearing on a
regulatory action under part 16. Section 419 of the FD&C Act does not
expressly provide for a hearing if circumstances lead FDA to determine
that a qualified exemption provided to a farm under proposed Sec.
112.5 should be withdrawn. However, we tentatively conclude as a matter
of agency discretion that providing an opportunity for a hearing by
regulation in this subpart of the proposed rule would provide
appropriate process to the owner, operator, or agent in charge of a
farm subject to withdrawal of the farm's qualified exemption. We also
tentatively conclude that the modified part 16 procedures contained in
this proposed rule would provide the owner, operator, or agent in
charge of a farm subject to a withdrawal order sufficient fairness and
due process while enabling FDA to expeditiously adjudicate an appeal of
a withdrawal order for which an informal hearing has been granted. We
seek comment on this proposed process.
Section 16.119 provides that, after any final administrative action
that is the subject of a hearing under part 16, any party may petition
the Commissioner for reconsideration of any part or all of the decision
or action under Sec. 10.33 or may petition for a stay of the decision
or action under Sec. 10.35. Proposed Sec. 112.208(c)(6) would specify
that these procedures for reconsideration and stay would not apply to
the process of withdrawing a qualified exemption provided under
proposed Sec. 112.5. The circumstances that may lead FDA to withdraw a
qualified exemption include

[[Page 3615]]

an active investigation of a foodborne illness outbreak that is
directly linked to a farm, or our determination that it is necessary to
protect the public health and prevent or mitigate a foodborne illness
outbreak based on conduct or conditions associated with a farm that are
material to the safety of the food that would otherwise be covered
produce grown, harvested, packed, or held at such farm. Such
circumstances require prompt action. Under Sec. 16.120, a farm that
disagrees with FDA's decision to withdraw an exemption provided under
Sec. 112.5 has an opportunity for judicial review in accordance with
Sec. 10.45.
g. Presiding Officer
Proposed Sec. 112.209 would require that the presiding officer for
an appeal, and for an informal hearing, must be an FDA Regional Food
and Drug Director or another FDA official senior to an FDA District
Director. Under Sec. 16.42(b), an officer presiding over an informal
hearing is to be free from bias or prejudice and may not have
participated in the investigation or action that is the subject of the
hearing or be subordinate to a person, other than the Commissioner, who
has participated in such investigation or action. An order for the
withdrawal of a qualified exemption applicable to a farm must be
approved by a District Director or an official senior to a District
Director. It is, therefore, necessary that appeals of a decision to
issue a withdrawal order should be handled by persons in positions
senior to the District Directors. The Regional Food and Drug Director
is such a person and could be from the same region where the farm is
located, provided that the Regional Food and Drug Director did not
participate in the determination that an exemption should be withdrawn
and is otherwise free from bias or prejudice. Alternatively, the
Regional Food and Drug Director could be from a different region than
the region where the farm is located, for example in the event the
Regional Food and Drug Director for the region in which the farm is
located is the FDA official who approved the withdrawal order. Any
Office Director of FDA's Office of Regulatory Affairs could preside at
a hearing, provided that the Office Director did not participate in the
determination that an exemption should be withdrawn and is otherwise
free from bias or prejudice.
h. Decisions on Appeals (Including Informal Hearings)
Proposed Sec. 112.210(a) would require that, if the owner,
operator, or agent in charge of a farm appeals the order without
requesting a hearing, the presiding officer must issue a written report
that includes a final decision confirming or revoking the withdrawal by
the tenth calendar day after the appeal is filed. Under proposed Sec.
112.201, FDA would issue a withdrawal order either in the event of an
active investigation of a foodborne illness outbreak that is directly
linked to a farm or if we determine that an exemption withdrawal is
necessary to protect the public health and prevent or mitigate a
foodborne illness outbreak based on conduct or conditions associated
with a farm that are material to the safety of the food that would
otherwise be covered produce grown, harvested, packed, or held by the
farm. We tentatively conclude that we will need 10 calendar days to
review the written appeal and the materials submitted with the written
appeal, and that a final decision confirming or revoking a withdrawal
order should be issued as quickly as possible in the interest of the
public health and to provide reasonable due process that would come to
closure sufficiently in advance of the effective date of the order to
provide an opportunity for the farm to come into compliance if we deny
the appeal.
Proposed Sec. 112.210(b)(1) would require that, if the owner,
operator, or agent in charge of a farm appeals the order and requests
an informal hearing and, if FDA grants the request for a hearing and
the hearing is held, the presiding officer must provide a 2 calendar
day opportunity for the hearing participants to review and submit
comments on the report of the hearing under Sec. 112.208(c)(4), and
must issue a final decision within the 10-calendar day period after the
hearing is held. We tentatively conclude that it is appropriate to
grant the owner, operator, or agent in charge of a farm subject to a
withdrawal order the opportunity to review and submit comments to the
presiding officer's report because the report is part of the record of
a final agency action (see discussion of proposed Sec. 112.211(d))
that is not subject to further reconsideration by FDA. The presiding
officer would have discretion to determine whether to revise the report
of the hearing in light of any comments that might be submitted by any
of the hearing participants.
Proposed Sec. 112.210(b)(2) would require that, if the owner,
operator, or agent in charge of a farm appeals the order and requests
an informal hearing and if FDA denies the request for a hearing, the
presiding officer must issue a final decision on the appeal confirming
or revoking the withdrawal within 10 calendar days after the date the
appeal is filed. We tentatively conclude that ten calendar days for the
presiding officer to issue a final decision is appropriate for purposes
of the efficient adjudication of the appeal of a withdrawal order,
would provide reasonable due process that would come to closure
sufficiently in advance of the effective date of the order to provide
an opportunity for the farm to come into compliance if we deny the
appeal, and is in the interest of public health.
i. Revocation of Withdrawal Order
Proposed Sec. 112.211(a) through (c) would establish that an order
to withdraw a qualified exemption applicable to a farm under Sec.
112.5 is revoked if:
(a) The owner, operator, or agent in charge of the farm appeals the
order and requests an informal hearing, FDA grants the request for an
informal hearing, and the presiding officer does not confirm the order
within the 10 calendar days after the hearing, or issues a decision
revoking the order within that time (proposed Sec. 112.211(a)); or
(b) The owner, operator, or agent in charge of the farm appeals the
order and requests an informal hearing, FDA denies the request for an
informal hearing, and FDA does not confirm the order within the 10
calendar days after the appeal is filed, or issues a decision revoking
the order within that time (proposed Sec. 112.211(b)); or
(c) The owner, operator, or agent in charge of the farm appeals the
order without requesting an informal hearing, and FDA does not confirm
the order within the 10 calendar days after the appeal is filed, or
issues a decision revoking the order within that time (proposed Sec.
112.211(c)).
We tentatively conclude that an order to withdraw an exemption may
be revoked in one of two manners. First, we are proposing that the FDA
officer responsible for adjudicating the appeal and presiding over a
hearing, if one is granted, may expressly issue a written decision
revoking the order within the specified 10 calendar day time frame.
Second, we are proposing that the failure of the FDA officer
responsible for adjudicating an appeal to issue a final decision
expressly confirming the order within the specified time frames will
also serve to revoke the order. We tentatively conclude that fairness
would warrant the revocation of a withdrawal order if FDA is unable to
meet the proposed deadlines for expressly confirming an order.
Proposed Sec. 112.211(d) would establish that confirmation of a
withdrawal order by the presiding

[[Page 3616]]

officer is considered a final agency action for purposes of section 702
of title 5 of the United States Code (5 U.S.C. 702). A confirmation of
an order withdrawing an exemption therefore would be reviewable by the
courts under section 702 of title 5 and in accordance with Sec. 10.45
(21 CFR 10.45).
3. Conforming Amendment to 21 CFR Part 16
We propose to amend Sec. 16.1(b)(2) to include part 112, subpart
R, relating to the withdrawal of a qualified exemption applicable to a
farm, to the list of regulatory provisions under which regulatory
hearings are available.

VI. Preliminary Regulatory Impact Analysis

A. Overview

FDA has examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub.
L.104-4). Executive Orders 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). FDA has developed a preliminary regulatory impact analysis
(PRIA) that presents the benefits and costs of this proposed rule (Ref.
265). FDA believes that the proposed rule will be an economically
significant regulatory action as defined by Executive Order 12866. FDA
requests comments on the PRIA.

B. Regulatory Flexibility Act

The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because many small businesses will need to implement
a number of new provisions, FDA acknowledges that the final rules
resulting from this proposed rule will have a significant economic
impact on a substantial number of small entities.

C. Small Business Regulatory Enforcement Fairness Act of 1996

The Small Business Regulatory Enforcement Fairness Act of 1996
(Pub. L. 104-121) defines a major rule for the purpose of congressional
review as having caused or being likely to cause one or more of the
following: An annual effect on the economy of $100 million or more; a
major increase in costs or prices; significant adverse effects on
competition, employment, productivity, or innovation; or significant
adverse effects on the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic or export markets.
In accordance with the Small Business Regulatory Enforcement Fairness
Act, the Office of Management and Budget (OMB) has determined that this
proposed rule is a major rule for the purpose of congressional review.

D. Unfunded Mandates Reform Act of 1995

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA expects that the
proposed rule will result in a 1-year expenditure that would exceed
this amount.

E. Paperwork Reduction Act of 1995

This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in the proposed
rule have been submitted to OMB for review under Section 3507(d) of the
Paperwork Reduction Act of 1995. FDA invites comments on: (1) Whether
the proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285,
or emailed to [email protected]. All comments should be
identified with the title ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption.'' In compliance
with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the
Agency has submitted the information collection provisions of this
proposed rule to OMB for review. These requirements will not be
effective until FDA obtains OMB approval. FDA will publish a notice
concerning OMB approval of these requirements in the Federal Register.

F. Public Access to the Analyses

The analyses that FDA has performed in order to examine the impacts
of this proposed rule under Executive Order 12866, Executive Order
13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4), and the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520) are available to the public
in the docket for this proposed rule (Ref. 265).

VII. Analysis of Environmental Impact

The agency has prepared a categorical exclusion determination
relying upon the categorical exclusion at 21 CFR 25.30(j) and the
determination that there are no extraordinary circumstances which raise
the potential for this rule to individually or cumulatively have a
significant effect on the human environment (Ref. 266). FDA requests
comment on its analysis and determination. As set out in more detail in
Section IX of this document, to the extent there are any environmental
effects that FDA should take into consideration as it prepares a final
rule, FDA requests public comment and supporting data or other
information (e.g., studies, data, reports). The agency will evaluate
the information and input received in response to this proposed rule,
including the specific questions listed in section IX of this document.
Although FDA finds that no EIS is necessary for this proposed rule, if
in response to comment received, FDA prepares an EA or EIS, it will
provide notice and an opportunity for public review and comment on any
such document.

VIII. Federalism

FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects on the States, on the relationship
between the National Government and

[[Page 3617]]

the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, the agency tentatively
concludes that the proposed rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

IX. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Comments on proposed provisions and related issues--We seek comment
on the need for, and appropriateness of, the various provisions
proposed in this rule and our accompanying rationale. Specifically, we
seek comment on the following issues:
Proposed provisions in subpart A, including:
[cir] proposed Sec. Sec. 112.1 and 112.2, including the produce
that would be covered or not covered by the rule; the list of produce
that would not be covered by the rule because it is rarely consumed raw
(including asparagus, bok choy, and cranberries); and the proposed
exemption for produce that receives commercial processing, including
the types of processing that should qualify for this exemption;
[cir] proposed definitions in Sec. 112.3(c), including those of
agricultural water, hazard, reasonably foreseeable hazard, produce,
humus, production batch of sprouts, and yard trimmings;
[cir] proposed definitions of small and very small businesses in
Sec. 112.3(b); as well as the proposed exclusion of certain farms from
the scope of this rule based sales in Sec. 112.4(a);
[cir] whether and how we should require farms that meet the
criteria for the qualified exemption to establish and maintain
documentation of the basis for their exemption;
[cir] the feasibility of the labeling provisions in proposed
112.6(b), particularly in the case of consolidating produce from
several farm locations.
Proposed general requirements in Sec. 112.11, including
on whether we should establish specific standards for any types of
hazards that would be covered in proposed Sec. 112.11 but for which we
have not proposed specific standards in proposed subparts C through O;
and the proposed allowance in Sec. 112.12 for alternatives to certain
specified requirements, including appropriateness of the list of
permitted alternatives. Are there other proposed provisions for which
we should permit alternatives and, if so, under what, if any,
additional or different criteria than those proposed in Sec. 112.12(b)
and (c)?
Proposed provisions in subparts C and D directed to
personnel training, and health and hygiene, including the proposed
requirements for training on principles of food hygiene and food
safety, and for the maintenance of adequate personal cleanliness and
hygienic practices when handling covered produce or food-contact
surfaces during covered activities, including the provisions relevant
to use of gloves and hand sanitizers;
Proposed provisions directed to water, including those
related to water quality, microbial indicators, and testing in
Sec. Sec. 112.41, 112.44, and 112.45; provision related to water
sourced from public water systems in Sec. 112.45(a); and recordkeeping
in Sec. 112.50; specifically:
[cir] Are the provisions in Sec. Sec. 112.44-112.46 appropriately
tailored to the risk posed by the manner in which the water is used?
[cir] Are the microbial standards specified in these provisions
appropriate for the specified intended uses? For example, are the
microbial standards appropriately tailored to uses such as direct
application of irrigation water?
[cir] Are the provisions related to treatment of water sufficiently
flexible to permit alternative safe uses of water that does not meet
the specified microbial standard for its intended use?
[cir] Is there a need for a provision specifically related to
disinfection treatment of re-circulated or single pass water used
during and after harvest?
[cir] Are there any alternative options not considered in the
proposed rule?
Proposed provisions in subpart F directed to soil
amendments, including those related to status, treatment, application
restrictions, minimum application intervals, and recordkeeping
(including the requirement related to documentation such as
Certificates of Conformance); our focus on biological soil amendments
of animal origin; any alternative options that we have not considered
in this proposed rule; and the risk presented by the use of biological
soil amendments in sprouting and whether that practice should be
prohibited;
Proposed provisions in subparts I, K, and L, including
proposed Sec. 112.81 related to the scope of applicability of subpart
I, proposed Sec. 112.114 related to dropped produce, and proposed
Sec. 112.115 related to measures to prevent formation of botulinum
toxin; specifically:
[cir] Do you agree with our proposal to apply the proposed
provisions in subpart I when covered activities take place in an
outdoor area or a partially-enclosed building where there is a
reasonable probability of contamination of covered produce, and our
tentative conclusion that, accordingly, crops that grow completely
underground would not be subject to the proposed provisions of subpart
I?
[cir] With respect to dropped produce, should proposed Sec.
112.114 apply to all commodities or should we provide for certain
exceptions (and, if so, under what criteria)? Does proposed Sec.
112.114 appropriately address produce (such as almonds) that is
intentionally dropped to the ground during harvesting and where such
harvesting does not cause bruising or damage to the produce? Should
produce with peelable skin be excluded?
[cir] Is proposed Sec. 112.115 a reasonably necessary measure to
ensure the safety of packaged covered produce? Are there specific types
or conditions of modified or reduced oxygen packaging methods that may
or may not increase the risk of formation of botulinum toxin?
Proposed provisions specific to sprouts in subpart M,
including treatment of seeds and beans; microbial indicators and
frequency of environmental monitoring; and requirement to establish and
implement a written environmental monitoring plan (Sec. 112.144(a))
and sampling plan for each production batch of sprouts (Sec.
112.146(a)); as well as whether soil-grown sprouts should be subject to
the proposed requirements, and whether and how to establish a supplier
approval and verification program for seeds and beans used for
sprouting;
Proposed provisions in subpart N, including methods and
allowance for alternative methods to be used provided they are at least
equivalent to the proposed method in accuracy, precision, and
sensitivity;
Proposed requirements related to documentation and records
in subpart O, including the requirement for a supervisor or responsible
party to review certain records, and whether there are any
circumstances that would warrant not applying part 11 to records that
would be required to be kept under part 112;
Proposed provisions in subpart P for variances, including
related process and scientific data and information to

[[Page 3618]]

support a request for variance, and circumstances for approval or
denial of a request for variance and for modification or revocation of
an approved variance; Are there any specific concerns that we should
consider in finalizing the procedures and processes for requests for
variances, as applicable to foreign governments?
Overall implementation and compliance strategy and
proposed provisions in subpart Q, including specific strategies we
should employ in order to best prioritize our implementation of the
rule, and coordination of education and enforcement activities by
relevant State, Territorial, tribal, and local authorities; and
Proposed provisions in subpart R for withdrawal of a
qualified exemption, including related process and timeframes for
actions to be taken by FDA or farms.
Regarding the scope of the recordkeeping requirements, are
there alternative options that should be considered?
Regarding the handwashing and toilet facility
requirements, are our proposals reasonably consistent with current
model practices or are there alternatives not considered in the
proposed rule?
Regulatory approach--As discussed in section IV of this document,
we have tentatively concluded that we should use a regulatory framework
based on practices, procedures, and processes associated with growing,
harvesting, packing, and holding of all covered produce. We considered
and rejected the option to develop a framework that (based solely on a
history of outbreaks or illnesses associated with the commodity) would
be applicable to individual commodities or classes of commodities.
Relevant references on the subject of produce safety, as well as the
QAR, identify common on-farm routes of contamination, such as personnel
training, health, and hygiene; domestic and wild animals; biological
soil amendments of animal origin; agricultural water; and equipment and
buildings. Procedures, processes and practices in each of these on-farm
routes of contamination have the potential to introduce biological
hazards into or onto any covered produce. Therefore, we are proposing
an integrated approach to prescribe standards for each of these on-farm
routes of contamination that we have tentatively determined are
reasonably necessary to prevent the introduction of known or reasonably
foreseeable biological hazards and to provide reasonable assurances
that produce is not adulterated under section 402 of the FD&C Act. We
also recognize the need for additional standards specifically tailored
to the growing, harvesting, packing and holding of sprouts, and have
proposed minimum necessary standards for sprouts. We seek comment on
our tentative conclusions related to this issue and the proposed
regulatory approach described in section IV of the document. In
addition, we seek comment on the following:
Are there any alternative approaches that we should
consider in establishing science-based minimum standards for the safe
production and harvesting of produce and to minimize the risk of
serious adverse health consequences or death?
Are there specific commodities or categories of
commodities that should be excluded from the scope of the rule, based
on data related to their relative risk considerations? (Note that under
our proposed integrated approach, we propose to exempt certain
commodities, including a specified list of produce that is rarely
consumed raw, and produce that receives commercial processing that
adequately reduces the presence of microorganisms of public health
significance; see section V.A.2.a. of this rule.)
For example, the QAR ranked certain produce commodities,
such as bananas and coconuts, as lower risk for illness, in part
because such commodities are peeled or shelled before consumption in a
manner that can be expected not to transfer contamination onto the
interior, edible portion of the commodity. Should such commodities be
covered by the rule? Is coverage of these commodities unnecessary?
Should they be covered but subject to a less stringent set of
requirements?
Certain commodities are ranked in the QAR as presenting a
relatively lower likelihood of exposure, in part because such
commodities have fewer potential routes of contamination and/or lower
potential for contamination. In addition, some commodities are not
known to have been associated with outbreaks. Some commodities (for
example, pears, grapefruit, oranges, and lemons) meet both of these
criteria, considering the rankings and outbreak data used in the QAR.
Should commodities that meet both of these criteria be covered by the
rule? Is coverage of these commodities unnecessary? Should they be
covered but subject to a less stringent set of requirements? How should
the rule address the changing nature of outbreak data over time?
How should we account for uncovered commodities in
considering a commodity-specific approach that relies on outbreak data?
Are there pathogen surveillance data from sampling
programs focusing on produce commodities that have no history of known
outbreaks that would be useful in considering a commodity-specific
approach?
Can commodity characteristics be used as a basis to
consider a commodity-specific approach? While the outbreak data show no
consistent pattern that can be matched to commodity characteristics
such as growth habit, our QAR shows that produce commodities that are
ranked as higher risk of illness and those ranked as lower risk of
illness do share some of the same characteristics. A further refinement
of our assessment might be helpful in developing a commodity-specific
approach based on commodity characteristics. Considering the
qualitative nature of our assessment, are there quantitative data sets
available that would enable a further refinement of our assessment?
We seek comment on our tentative conclusion that produce
in both direct market channels and other commercial channels are
subject to the same routes of contamination, although the number of
opportunities for contamination during packing and holding may be
greater for produce in other commercial channels as compared to produce
in direct market channels if there are greater numbers of touch points
and handlers in these channels than there are in direct market
channels.
We seek comment on our tentative conclusion that because
the statutory qualified exemption addresses market channels as a
possible risk factor, and because we identified no data that would
allow us to otherwise use market channels as a factor in covering and
regulating produce under this proposed rule, we should not otherwise
use market channels as a basis of risk categorization in this proposed
rule.
Are other data or information available that would be
otherwise useful in considering a commodity-specific approach?
We seek comment on the proposed effective and compliance
dates.
We seek comment on the appropriateness of the proposed
exemptions and partial exemptions. Are there additional exemptions and
relevant data to support such exemptions that we should consider?
Qualitative assessment of risk--We seek comment on the QAR,
conclusions drawn from that assessment, and our consideration of those
conclusions in developing the proposed requirements described in this
rule. We also request

[[Page 3619]]

you to submit any data or factual information that may help the agency
to conduct, as warranted, a thorough and robust quantitative assessment
of risk associated with produce production and harvesting practices.
Chemical, physical or radiological hazards--We seek comment on our
tentative conclusion that procedures, practices, and processes, which
are proposed in this rule, are reasonably necessary to prevent the
introduction of biological hazards only, and on whether, and to what
extent, chemical, physical or radiological hazards should be covered
within the scope of a final rule. Are there procedures, practices, or
processes that minimize the risk of serious adverse health consequences
or death and that are reasonably necessary to prevent the introduction
of known or reasonably foreseeable chemical, physical or radiological
hazards into produce or to provide reasonable assurances that produce
is not adulterated under section 402 of the FD&C Act?
Environmental testing for L. monocytogenes or Listeria spp for
covered produce other than sprouts--Proposed Sec. 112.143(a) would
require testing the growing, harvesting, packing, and holding
environment for sprouts for Listeria species or L. monocytogenes;
however, we have not proposed to require environmental testing for
other covered produce. A recent outbreak of listeriosis from
cantaloupes attributed to insanitary conditions at a facility that
washed, packed, cooled and held intact cantaloupes (Ref. 267) raises
the question as to whether specific measures are necessary to minimize
the risk posed by L. monocytogenes as an environmental pathogen. As
discussed in section V.A. of this document, this proposed rule would
not apply to off-farm facilities such as the facility associated with
this cantaloupe outbreak-- such facilities would instead be subject to
part 110 and may be subject to section 418 of the FD&C Act. However,
the same risk factors and potential measures for minimizing risk are
relevant to both on-farm and off-farm produce washing, packing,
cooling, and holding practices. Such measures could include
environmental testing for L. monocytogenes or Listeria spp. to verify
the adequacy of a covered farm's sanitation measures. Because L.
monocytogenes is a ubiquitous microorganism, an intact fruit or
vegetable could reasonably be expected to occasionally be positive for
L. monocytogenes. Many studies have shown the presence of L.
monocytogenes on fresh, intact produce, but there is limited
epidemiological evidence associating listeriosis with produce,
especially with intact fruits and vegetables (Ref. 268. Ref. 269. Ref.
270. Ref. 271. Ref. 272. Ref. 267). However, this recent outbreak
indicates that intact produce can be a vehicle for listeriosis. What is
not known is the extent to which, and under what circumstances, whole
produce contaminated with L. monocytogenes presents a risk to
consumers. The outbreak of listeriosis due to contamination of intact
cantaloupes appears to have occurred due to a combination of factors,
including pooled water on the floor of the facility, which was also
difficult to clean, poorly designed equipment that was previously used
for other commodities, no pre-cool step, a truck parked near the
packing area that had visited a cattle operation, and possible low
level contamination from the growing/harvesting operation (Ref. 273).
The contribution of internalization of the organism and growth within
the fruit is not known. Moreover, it is not known whether all of these
circumstances are needed for L. monocytogenes to present a risk on
produce or whether any one or more would have been sufficient. We also
do not know the prevalence of L. monocytogenes environmental
contamination of fruit and vegetable packing facilities (both on- and
off-farm), nor do we know the prevalence of L. monocytogenes on produce
washed, packed, cooled and stored in such facilities. We encourage
research to answer these questions. We request comment on whether we
should require, in a final rule, any or all covered farms that wash and
pack produce, or that only pack produce, to perform environmental
testing for L. monocytogenes or Listeria spp., and any criteria that
should be employed to determine which farms should be subjected to such
a requirement.
Operational assessment, food safety plans--As discussed in section
IV of this document, while we recommend that farms conduct an
operational assessment and develop a food safety plan, at this time, we
are not proposing to require them to do so. We request comment on
whether we should require, in a final rule, some or all covered farms
to perform operational assessments and/or develop a food safety plan,
and any criteria that should be employed to determine which farms
should be subjected to such a requirement.
Registration--We are also requesting comment about whether we
should require, in a final rule, that covered farms, as described in
proposed Sec. 112.4(a), register with FDA. We are not aware of a
nationwide database of farms, nor an accumulation of statewide
databases, that would enable us to identify the names and locations of
all entities subject to this proposed regulation. This would enable us
to better provide outreach and technical assistance to covered
entities. In addition, while inspection is intended to be only a
relatively minor part of our overall compliance effort (see section
V.Q. of the document for more information on our overall strategy), we
anticipate performing inspections for enforcement purposes. We would
use the covered farm registration information to create a database that
we would use to allocate inspection resources. We are also interested
in the existence of databases that could help us identify covered farms
in the absence of a registration system, and in the appropriate data
elements that should be collected in a registration system, should we
decide to set up such a system.
Environmental issues--Consistent with Sec. 25.50, FDA is involving
the public in implementing its NEPA procedures applicable to this
proposed rule. The agency will evaluate the information and input
received in response to this proposed rule, including the specific
questions below, to determine further actions, as appropriate.
Proposed subpart E would establish standards for an indicator
organism in agricultural water applied to covered produce, and
establish requirements for waters that do not meet those standards. We
are soliciting comments on potential means or mechanisms for meeting
the proposed standards. In your responses, please distinguish, to the
extent appropriate, between sprouts and other covered produce.
1. Do farms that would be covered by the proposed rule, if
finalized, currently treat water used for irrigation directly applied
to covered produce other than sprouts, or water used to irrigate
sprouts (whether or not it is directly applied)? We are seeking
comments on pesticides used to reduce concentration of organisms of
concern in water used for such irrigation and not pesticides used to
prevent biofouling (chemigation).
2. What actions are currently being taken by farmers, either on
their own or at the request of produce handlers or sellers to control
the bacterial loads in water? Please provide data to support the
information provided.
3. What water treatment methods do farmers use to clean their
irrigation systems, how broadly are they used, and what are the effects
on the environment? In what amounts or frequency are each of these
methods applied? Please

[[Page 3620]]

provide data to support the information provided.
4. Do farms currently use municipal water sources to irrigate
produce that would be covered by this proposed rule, if finalized? If
so, please provide data on the use rate and prevalence of this
practice, as well as data regarding effects on crop productivity of
disinfection byproducts in municipal water used to irrigate produce
that would be covered by the rule.
5. What sources of irrigation water (for example, municipal water,
surface water and groundwater) are most frequently used? If more than
one source is available, is there a preference for using one source
over another? Please explain why.
In addition, we seek comment on potential effects of actions taken
as a result of this rule on water rights/Tribal rights. Are water
rights or Tribal rights likely to be affected by actions taken as a
result of this rule? If so, how and to what extent?
Proposed subpart F would require the use of application method
restrictions, application intervals, and/or treatment of biological
soil amendments of animal origin to reduce exposure of covered produce
to organisms of public health concern. We recognize that the
requirements in this section may represent a departure from current
practices.
1. How do farms that would be covered by the proposed rule, if
finalized, currently manage solid animal waste? Manage liquid animal
waste?
2. What is the prevalence of composting on farms using methods
described in proposed subpart F? Please provide data or other available
information on the frequency of such composting.
3. Are composting methods other than those described in proposed
subpart F currently utilized on farms? To what extent? Please provide
data or other available information on the frequency of such
composting.
4. Are currently utilized methods of composting governed by state,
county or local laws, ordinances or regulations? Please identify in
your comments any relevant laws, ordinances, or regulations, and
include copies if reasonably feasible.
5. What are the current laws, ordinances, or regulations in produce
growing areas that govern manure handling and storage? How if at all do
such laws, ordinances, or regulations address potential environmental
effects from methane associated with manure? Ammonia? Nitrogen?
Phosphorus?
Under proposed subpart F, manure may be chemically treated as an
alternative to composting that would not require use of an application
interval. We are also soliciting comments on available chemical
treatment methods.
1. Do farms that would be covered by the proposed rule, if
finalized, currently utilize chemical treatments to prevent or minimize
pathogens in manure?
2. What types and quantities of chemicals are used for chemical
treatment of manure? Please describe the treatment protocols, including
application time, containment methods, and temperature requirements.
3. Please provide any data or other information relating to the
effectiveness, and the relative effectiveness, of these chemical manure
treatments, as well as any environmental effects of their use.
Proposed subpart I would apply when under the circumstances there
is a reasonable probability that animal intrusion will contaminate
covered produce. In such circumstances, proposed subpart I would
require monitoring of those areas that are used for a covered activity
for evidence of animal intrusion immediately prior to harvest and as
needed during the growing season. If significant evidence of animal
intrusion is found, these provisions would require farms to evaluate
whether the covered produce can be harvested in accordance with
proposed subpart K. Proposed subpart K would require taking reasonable
measures to identify, and not harvest, covered produce that is
reasonably likely to be contaminated, including steps to identify and
not harvest covered produce that is visibly contaminated with animal
excreta. We are soliciting comments on current practices relevant to
these provisions.
1. What measures, if any, are currently being implemented to
prevent harvest of produce contaminated by excreta deposited by wild
animals? If there are preferred measures, please explain the rationale
for such preference. Please provide data to support the information
provided.
2. Are farms removing vegetation bordering outdoor produce growing
areas or drainages in an effort to deter wildlife from entering growing
areas? If so, what is the current rate at which vegetation bordering
outdoor produce growing areas or drainages is currently being removed?
Are sediment basins or other conservation practices currently being
removed and at what rate? Please provide data or other information to
support the information provided.
3. To what extent have farmers taken action to exclude wildlife
from outdoor produce growing areas? What measures are being used for
these purposes, e.g. construction of fences or other physical barriers,
chemical deterrents, or other mechanisms around growing areas to
exclude wildlife? Please provide data or other information to support
the information provided.
4. Has the implementation of measures to prevent animal intrusion
negatively impacted habitat for rare or declining aquatic or
terrestrial wildlife species or migratory birds? Please provide
examples.

X. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)

1. U.S. Department of Health and Human Services and U.S. Department
of Agriculture. Dietary Guidelines for Americans, 2010. 2011.
www.health.gov/DietaryGuidelines/dga2010/DietaryGuidelines2010.pdf.
2. Food and Drug Administration. s.v. ``Draft Qualitative Assessment
of Risk to Public Health from On-Farm Contamination of Produce.''
Accessed 2012.
3. D'Lima, C., Vierk, K., and Food and Drug Administration,
``Memorandum to the Record'', 2011.
4. Smith, M. A. s.v. ``Memorandum to the Record.'' Accessed 2012.
5. Viazis, S. and Food and Drug Administration, ``Memorandum to the
Record'', 2011.
6. Centers for Disease Control and Prevention. ``Multistate
Outbreaks of Salmonella Infections Associated with Raw Tomatoes
Eaten in Restaurants--United States, 2005-2006.'' MMWR 56, no. 35
(2007): 909-911.
7. Beru, N. and Food and Drug Administration. s.v. ``Memorandum to
the Record.'' Accessed 2012.
8. ``Enforcement Reports.'' Food and Drug Administration. http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. Last
Modified 2011.
9. ``Sources of Ionizing Radiation.'' United Nations Scientific
Committee on the Effects of Atomic Radiation. UNSCEAR 2008 Report.
http://www.unscear.org/unscear/en/publications/2008_1.html. Last
Modified 2011.
10. ``Guidance for Industry: Guide to Minimize Microbial Food Safety
Hazards for Fresh Fruits and Vegetables.'' Food and Drug
Administration. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/produceandplanproducts/ucm064458.htm. Accessed November 30, 2011.
Last Modified 1998.
11. ``Letter to Firms that Grow, Pack, or Ship Fresh Lettuce and
Fresh Tomatoes.''

[[Page 3621]]

Food and Drug Administration. http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/GuidanceComplianceRegulatoryInformation/ucm118896.htm. Accessed
December 8, 2011. Last Modified 2004.
12. ``Letter to California Firms that Grow, Pack, Process, or Ship
Fresh and Fresh-cut Lettuce, November 4, 2005.'' Food and Drug
Administration. http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/GuidanceComplianceRegulatoryInformation/ucm118911.htm. Accessed
December 8, 2011. Last Modified 2011.
13. ``Guidance for Industry: Letter to Firms that Grow, Harvest,
Sort, Pack, or Ship Fresh Cilantro.'' Food and Drug Administration.
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm249401.htm. Accessed
December 8, 2011. Last Modified 2011.
14. ``Guidance for Industry: Reducing Microbial Food Safety Hazards
For Sprouted Seeds.'' Food and Drug Administration. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm. Accessed
December 1, 2011. Last Modified 1999.
15. ``Guidance for Industry: Sampling and Microbial Testing of Spent
Irrigation Water During Sprout Production.'' Food and Drug
Administration. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120246.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm--
term=sprout%20guidance&utm--content=2. Last Modified 2011.
16. ``Microbiological Safety Evaluations and Recommendations on
Sprouted Seed.'' National Advisory Committee on Microbiological
Criteria for Food. http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm078789.htm. Last
Modified 1999.
17. ``Letter from FDA to Seed Suppliers, Distributors, and
Sprouters.'' Food and Drug Administration. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm151758.htm. Accessed December 8,
2011. Last Modified 2009.
18. ``Letter from California Department of Public Health to Sprout
Manufacturers.'' Pettit, J. M. and California Department of Public
Health. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm152150.htm. Last Modified 2009.
19. ``Produce Safety From Production to Consumption: A Proposed
Action Plan to Minimize Foodborne Illness Associated with Fresh
Produce Consumption--June 2004.'' Food and Drug Administration.
http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/FDAProduceSafetyActivities/ProduceSafetyActionPlan/ucm056859.htm. Accessed December 8, 2011.
Last Modified 2009.
20. Association of Food and Drug Officials. Model Code for Produce
Safety, Association of Food and Drug Officials Model Code for
Produce Safety for State and Local Regulatory Agencies. Association
of Food and Drug Officials, 2009.
21. Crawford, W., Baloch, M., and Gerrity, K. Environmental
Assessment Report, FDA Foods Program, Non-O157 Shiga Toxin-Producing
E. coli (STEC). 2010. http://www.fda.gov/downloads/Food/FoodSafety/FoodborneIllness/UCM235923.pdf. Accessed 12-8-2011.
22. ``Leafy Greens Safety Inititiave--2nd Year.'' Food and Drug
Administration. http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/FDAProduceSafetyActivities/ucm115898.htm. Accessed December 9, 2011.
Last Modified 2009.
23. ``Tomato Safety Initiative.'' Food and Drug Administration.
http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/FDAProduceSafetyActivities/ucm115334.htm.
Accessed December 9, 2011. Last Modified 2009.
24. ``Memorandum of Understanding Between the United States Food and
Drug Administration and the United States Department of Agriculture,
Research, Education, and Economics.'' Food and Drug Administration.
http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm261929.htm. Accessed
February 28, 2012. Last Modified 2011.
25. ``International Outreach & Technical Assistance.'' Food and Drug
Administration. http://www.fda.gov/Food/InternationalActivities/ucm103051.htm. Accessed December 9, 2011. Last Modified 2009.
26. Gravani, R. B. Produce Safety Project Issue Brief: Farm Worker
Health and Hygiene. Georgetown University: Produce Safety Project,
2010. http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/Issue_Briefs/PSP_Worker-1.pdf. Accessed 11-29-2011.
27. Erickson, M., Critzer, F., and Doyle, M. Issue Brief on
Composting of Animal Manures, Composting Criteria for Animal Manure.
2010. http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/Issue_Briefs/PSP_PEW-PSP-Composting-Manure-Narrative-v4-2.pdf. Accessed 5-25-2012.
28. Lowell, K., Langholz, J., and Stuart, D. Safe and Sustainable:
Co-Managing for Food Safety and Ecological Health in California's
Central Coast Region. 2010. http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/Issue_Briefs/PSP_Summary-SS.pdf.
Accessed 12-9-2011.
29. Suslow, T. V. Standards for Irrigation and Foliar Contact Water.
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Produce.'' Food and Drug Administration. http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm232237.htm. Accessed December 28, 2011. Last Modified 2010.
272. ``Investigation of an Outbreak of Salmonella Saintpaul
Infections Linked to Raw Alfalfa Sprouts.'' Centers for Disease
Control and Prevention. http://www.cdc.gov/salmonella/saintpaul/alfalfa/archive/042709.html. Accessed December 28, 2011. Last
Modified 2009.
273. ``Information on the Recalled Jensen Farms Whole Cantaloupes.''
Food and Drug Administration. http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm272372.htm#report. Last Modified 2011.

List of Subjects

21 CFR Part 16

Administrative practice and procedure.

21 CFR Part 112

Foods, Fruits and vegetables, Incorporation by reference, Packaging
and containers, Recordkeeping requirements, Safety.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR Chapter I be amended to read as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for 21 CFR part 16 continues to read as
follows:

Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
0
2. In Sec. 16.1:
0
a. In paragraph (b)(1), add an entry in numerical order.
0
b. In paragraph (b)(2), add an entry in numerical order.
The additions read as follows:

Sec. 16.1 Scope.

* * * * *
(b) * * *
(1) * * *
Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act
relating to the modification or revocation of a variance from the
requirements of section 419 of the Federal Food, Drug, and Cosmetic Act
(see part 112, subpart P of this chapter).
* * * * *
(2) * * *
Sec. Sec. 112.201 through 112.211, (part 112, subpart R), relating
to withdrawal of a qualified exemption.
* * * * *
0
3. Add part 112 to read as follows:

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

Subpart A--General Provisions
Sec.
112.1 What food is covered by this part?
112.2 What produce is not covered by this part?
112.3 What definitions apply to this part?
112.4 Who is subject to the requirements of this part?
112.5 Who is eligible for a qualified exemption and associated
modified requirements based on average monetary value of all food
sold and direct farm marketing?
112.6 What modified requirements apply to me if I am eligible for a
qualified exemption in accordance with Sec. 112.5?
Subpart B--General Requirements
112.11 What general requirements apply to persons who are subject to
this part?
112.12 Are there any alternatives to the requirements established in
this part?
Subpart C--Standards Directed to Personnel Qualifications and Training
112.21 What requirements apply regarding qualifications and training
for personnel who handle (contact) covered produce or food-contact
surfaces?
112.22 What minimum requirements apply for training personnel who
conduct a covered activity?
112.23 What requirements apply regarding supervisors?
112.30 Under this subpart, what requirements apply regarding
records?
Subpart D--Standards Directed to Health and Hygiene
112.31 What measures must I take to prevent ill or infected persons
from contaminating covered produce with microorganisms of public
health significance?
112.32 What hygienic practices must personnel use?
112.33 What measures must I take to prevent visitors from
contaminating covered produce and food-contact surfaces with
microorganisms of public health significance?
Subpart E--Standards Directed to Agricultural Water
112.41 What requirements apply to the quality of agricultural water?
112.42 What measures must I take with respect to my agricultural
water sources, water distribution system, and pooling of water?
112.43 What treatment of agricultural water is required, and what
requirements apply to treating agricultural water?
112.44 What testing is required for agricultural water, and what
must I do based on the test results?
112.45 How often must I test agricultural water that is subject to
requirements of Sec. 112.44?
112.46 What measures must I take for water that I use during
harvest, packing, and holding activities for covered produce?
112.50 Under this subpart, what requirements apply regarding
records?
Subpart F--Standards Directed to Biological Soil Amendments of Animal
Origin and Human Waste
112.51 What requirements apply for determining the status of a
biological soil amendment of animal origin?
112.52 How must I handle, convey, and store biological soil
amendments of animal origin?
112.53 What prohibitions apply regarding use of human waste?
112.54 What treatment processes are acceptable for a biological soil
amendment of animal origin that I apply in the growing of covered
produce?
112.55 What microbial standards apply to the treatment processes in
Sec. 112.54?
112.56 What application requirements and minimum application
intervals apply to biological soil amendments of animal origin?
112.60 Under this subpart, what requirements apply regarding
records?
Subpart G--[Reserved]
Subpart H--[Reserved]
Subpart I--Standards Directed to Domesticated and Wild Animals
112.81 How do the requirements of this subpart apply to areas where
covered activities take place?
112.82 What requirements apply regarding domesticated animals that I
allow to graze in fields or use as working animals where I grow
covered produce?
112.83 What requirements apply regarding animal intrusion?
Subpart J--[Reserved]
Subpart K--Standards Directed to Growing, Harvesting, Packing, and
Holding Activities
112.111 What measures must I take if I grow, harvest, pack or hold
both covered and excluded produce?
112.112 What measures must I take during harvest activities?
112.113 How must I handle harvested covered produce during covered
activities?

[[Page 3629]]

112.114 What requirements apply to dropped covered produce?
112.115 What measures must I take when packaging covered produce?
112.116 What measures must I take when using food-packing (including
food packaging) material?
Subpart L--Standards Directed to Equipment, Tools, Buildings, and
Sanitation
112.121 What equipment and tools are subject to the requirements of
this subpart?
112.122 What buildings are subject to the requirements of this
subpart?
112.123 What requirements apply regarding equipment and tools
subject to this subpart?
112.124 What requirements apply to instruments and controls used to
measure, regulate, or record?
112.125 What requirements apply to equipment that is subject to this
subpart used in the transport of covered produce?
112.126 What requirements apply to my buildings?
112.127 What requirements apply regarding domesticated animals in
and around a fully-enclosed building?
112.128 What requirements apply regarding pest control in buildings?
112.129 What requirements apply to toilet facilities?
112.130 What requirements apply for hand-washing facilities?
112.131 What must I do to control and dispose of sewage?
112.132 What must I do to control and dispose of trash, litter, and
waste in areas used for covered activities?
112.133 What requirements apply to plumbing?
112.134 What must I do to control animal excreta and litter from
domesticated animals that are under my control?
112.140 Under this subpart, what requirements apply regarding
records?
Subpart M--Standards Directed to Sprouts
112.141 What requirements apply to seeds or beans used to grow
sprouts?
112.142 What measures must I take for growing, harvesting, packing,
and holding sprouts?
112.143 What testing must I do during growing, harvesting, packing,
and holding sprouts?
112.144 What requirements apply to testing the environment for
Listeria species or L. monocytogenes?
112.145 What actions must I take if the growing, harvesting,
packing, or holding environment tests positive for Listeria species
or L. monocytogenes?
112.146 What must I do to collect and test samples of spent sprout
irrigation water or sprouts?
112.150 Under this subpart, what requirements apply regarding
records?
Subpart N--Analytical Methods
112.151 What methods must I use to test the quality of water to
satisfy the requirements of Sec. 112.45?
112.152 What methods must I use to test the growing environment for
Listeria species or L. monocytogenes to satisfy the requirements of
Sec. 112.143(a) and Sec. 112.144?
Subpart O--Requirements Applying to Records That You Must Establish and
Keep
112.161 What general requirements apply to records required under
this part?
112.162 Where must I store records?
112.163 May I use existing records to satisfy the requirements of
this part?
112.164 How long must I keep records?
112.165 What formats are acceptable for the records I keep?
112.166 What requirements apply for making records available and
accessible to FDA?
112.167 Can records that I provide to FDA be disclosed to persons
outside of FDA?
Subpart P--Variances
112.171 Who may request a variance from the requirements of this
part?
112.172 How may a State or foreign country request a variance from
one or more requirements of this part?
112.173 What must be included in the Statement of Grounds in a
petition requesting a variance?
112.174 What data and information submitted in a petition requesting
a variance are publicly available?
112.175 Who responds to a petition requesting a variance?
112.176 What process applies to a petition requesting a variance?
112.177 Can an approved variance apply to any person other than
those identified in the petition requesting that variance?
112.178 Under what circumstances may FDA deny a petition requesting
a variance?
112.179 When does a variance approved by FDA become effective?
112.180 Under what circumstances may FDA modify or revoke an
approved variance?
112.181 What procedures apply if FDA determines that an approved
variance should be modified or revoked?
112.182 What are the permissible types of variances that may be
granted?
Subpart Q--Compliance and Enforcement
112.191 How do the criteria and definitions in this part apply to
the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act?
112.192 What is the result of a failure to comply with this part?
112.193 What are the provisions for coordination of education and
enforcement?
Subpart R--Withdrawal of Qualified Exemption
112.201 Under what circumstances can FDA withdraw a qualified
exemption in accordance with the requirements of Sec. 112.5?
112.202 What procedure will FDA use to withdraw an exemption?
112.203 What information must FDA include in an order to withdraw a
qualified exemption?
112.204 What must I do if I receive an order to withdraw a qualified
exemption applicable to my farm?
112.205 Can I appeal or request a hearing on an order to withdraw a
qualified exemption applicable to my farm?
112.206 What is the procedure for submitting an appeal?
112.207 What is the procedure for requesting an informal hearing?
112.208 What requirements are applicable to an informal hearing?
112.209 Who is the presiding officer for an appeal and for an
informal hearing?
112.210 What is the timeframe for issuing a decision on an appeal?
112.211 When is an order to withdraw a qualified exemption
applicable to a farm revoked?

Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243,
264, 271.

Subpart A--General Provisions

Sec. 112.1 What food is covered by this part?

(a) Unless it is excluded from this part under Sec. 112.2, food
that is produce within the meaning of this part and that is a raw
agricultural commodity (RAC) is covered by this part. This includes a
produce RAC that is grown domestically and a produce RAC that will be
imported or offered for import in any State or territory of the United
States, the District of Columbia, or the Commonwealth of Puerto Rico.
(b) For the purpose of this part and subject to the exemptions and
qualified exemptions therein, covered produce includes all of the
following:
(1) Fruits and vegetables such as almonds, apples, apricots,
aprium, asian pear, avocados, babaco, bamboo shoots, bananas, Belgian
endive, blackberries, blueberries, broccoli, cabbage, cantaloupe,
carambola, carrots, cauliflower, celery, cherries, citrus (such as
clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines,
tangors, and uniq fruit), cucumbers, curly endive, garlic, grapes,
green beans, guava, herbs (such as basil, chives, cilantro, mint,
oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, other
melons (such as canary, crenshaw and persian), mushrooms, nectarine,
onions, papaya, passion fruit, peaches, pears, peas, peppers (such as
bell and hot), pineapple, plums, plumcot, radish, raspberries, red
currant, scallions, snow peas, spinach, sprouts (such as alfalfa and
mung bean), strawberries, summer squash (such as patty pan, yellow and
zucchini), tomatoes, walnuts, watercress, and watermelon; and
(2) Mixes of intact fruits and vegetables (such as fruit baskets).

[[Page 3630]]

Sec. 112.2 What produce is not covered by this part?

(a) The following produce is not covered by this part:
(1) Produce that is rarely consumed raw, specifically the produce
on the following exhaustive list--arrowhead, arrowroot, artichokes,
asparagus, beets, black-eyed peas, bok choy, brussels sprouts, chick-
peas, collard greens, crabapples, cranberries, eggplant, figs, ginger
root, kale, kidney beans, lentils, lima beans, okra, parsnips, peanuts,
pinto beans, plantains, potatoes, pumpkin, rhubarb, rutabaga,
sugarbeet, sweet corn, sweet potatoes, taro, turnips, water chestnuts,
winter squash (acorn and butternut squash), and yams;
(2) Produce that is produced by an individual for personal
consumption or produced for consumption on the farm or another farm
under the same ownership; and
(3) Produce that is not a raw agricultural commodity.
(b) Covered produce is eligible for exemption from the requirements
of this part (except as noted in paragraphs (b)(1), (b)(2), and (b)(3)
of this section) under the following conditions:
(1) The covered produce receives commercial processing that
adequately reduces the presence of microorganisms of public health
significance. Examples of commercial processing that adequately reduces
the presence of microorganisms of public health significance are
processing in accordance with the requirements of parts 113, 114, or
120 of this chapter, treating with a validated process to eliminate
spore-forming microorganisms (such as processing to produce tomato
paste or shelf-stable tomatoes), and processing such as refining or
distilling produce into products such as sugar, oil, spirits, or
similar products;
(2) You must establish and keep documentation in accordance with
the requirements of subpart O of this part, of the identity of the
recipient of the covered produce that performs the commercial
processing described in paragraph (b)(1) of this section; and
(3) The requirements of this subpart and subpart Q of this part
apply to such produce.

Sec. 112.3 What definitions apply to this part?

(a) The definitions and interpretations of terms in section 201 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) apply to such
terms when used in this part.
(b) For the purpose of this part, the following definitions of very
small business and small business also apply:
(1) Very small business. For the purpose of this part, your farm is
a very small business if it is subject to this part and, on a rolling
basis, the average annual monetary value of food (as defined in
paragraph (c) of this section) you sold during the previous 3-year
period is no more than $250,000.
(2) Small business. For the purpose of this part, your farm is a
small business if it is subject to this part and, on a rolling basis,
the average annual monetary value of food (as defined in paragraph (c)
of this section) you sold during the previous 3-year period is no more
than $500,000; and your farm is not a very small business as provided
in paragraph (b)(1) of this section.
(c) For the purpose of this part, the following definitions also
apply:
Adequate means that which is needed to accomplish the intended
purpose in keeping with good public health practice.
Adequately reduce microorganisms of public health significance
means reduce the presence of such microorganisms to an extent
sufficient to prevent illness.
Agricultural tea means a water extract of biological materials
(such as humus, manure, non-fecal animal byproducts, peat moss, pre-
consumer vegetative waste, table waste, or yard trimmings), excluding
any form of human waste, produced to transfer microbial biomass, fine
particulate organic matter, and soluble chemical components into an
aqueous phase. Agricultural teas are held for longer than one hour
before application.
Agricultural tea additive means a nutrient source (such as
molasses, yeast extract, or algal powder) added to agricultural tea to
increase microbial biomass.
Agricultural water means water used in covered activities on
covered produce where water is intended to, or is likely to, contact
covered produce or food-contact surfaces, including water used in
growing activities (including irrigation water applied using direct
water application methods, water used for preparing crop sprays, and
water used for growing sprouts) and in harvesting, packing, and holding
activities (including water used for washing or cooling harvested
produce and water used for preventing dehydration of covered produce).
Animal excreta means solid or liquid animal waste.
Application interval means the time interval between application of
an agricultural input (such as a biological soil amendment of animal
origin) to a growing area and harvest of covered produce from the
growing area where the agricultural input was applied.
Biological soil amendment means any soil amendment containing
biological materials such as humus, manure, non-fecal animal
byproducts, peat moss, pre-consumer vegetative waste, sewage sludge
biosolids, table waste, agricultural tea, or yard trimmings, alone or
in combination.
Biological soil amendment of animal origin means a biological soil
amendment which consists, in whole or in part, of materials of animal
origin, such as manure or non-fecal animal byproducts, or table waste,
alone or in combination. The term ``biological soil amendment of animal
origin'' does not include any form of human waste.
Composting means a process to produce humus in which organic
material is decomposed by the actions of microorganisms under
thermophilic conditions for a designated period of time (for example, 3
days) at a designated temperature (for example, 131[deg]F (55 [deg]C)),
followed by a curing stage under cooler conditions.
Covered activity means growing, harvesting, packing, or holding
covered produce, provided that all covered produce used in covered
packing or holding activities is grown, raised, or consumed on that
farm or another farm under the same ownership. Covered activity does
not include manufacturing/processing within the meaning defined in this
chapter. This part does not apply to activities of a facility that are
subject to part 110 of this chapter.
Covered produce means produce that is subject to the requirements
of this part in accordance with Sec. Sec. 112.1 and 112.2. The term
``covered produce'' refers to the harvestable or harvested part of the
crop.
Curing means the maturation stage of composting, which is conducted
after much of the readily metabolized biological material has been
decomposed, at cooler temperatures than those in the thermophilic phase
of composting, to further reduce pathogens, promote further
decomposition of cellulose and lignin, and stabilize composition.
Direct water application method means using agricultural water in a
manner whereby the water is intended to, or is likely to, contact
covered produce or food-contact surfaces during use of the water.
Farm means a facility (as defined in Sec. 1.227 of this chapter)
in one general physical location devoted to the growing and harvesting
of crops, the raising of animals (including seafood) or both. Farm
includes:
(i) Facilities that pack or hold food, provided that all food used
in such activities is grown, raised, or consumed

[[Page 3631]]

on that farm or another farm under the same ownership; and
(ii) Facilities that manufacture/process food, provided that all
food used in such activities is consumed on that farm or another farm
under same ownership.
Food means food as defined in section 201(f) of the Federal Food,
Drug, and Cosmetic Act and includes seeds and beans used to grow
sprouts.
Food-contact surfaces means those surfaces that contact human food
and those surfaces from which drainage, or other transfer, onto the
food or onto surfaces that contact the food ordinarily occurs during
the normal course of operations. ``Food-contact surfaces'' includes
food-contact surfaces of equipment and tools used during harvest,
packing and holding.
Growth media means material that acts as a substrate during the
growth of covered produce (such as mushrooms and some sprouts) that
contains, may contain, or consists of components that may include any
animal waste (such as humus, manure, non-fecal animal byproducts or
table waste).
Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed by farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities on the
farm on which they were grown or raised, or another farm under the same
ownership. Harvesting does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Gathering,
washing, trimming of outer leaves of, removing stems and husks from,
sifting, filtering, threshing, shelling, and cooling raw agricultural
commodities grown on a farm or another farm under the same ownership
are examples of harvesting.
Hazard means any biological agent that is reasonably likely to
cause illness or injury in the absence of its control.
Holding means storage of food. Holding facilities include
warehouses, cold storage facilities, storage silos, grain elevators,
and liquid storage tanks. For farms and farm mixed-type facilities,
holding also includes activities traditionally performed by farms for
the safe or effective storage of raw agricultural commodities grown or
raised on the same farm or another farm under the same ownership, but
does not include activities that transform a raw agricultural
commodity, as defined in section 201(r) of the Federal Food, Drug, and
Cosmetic Act, into a processed food as defined in section 201(gg) of
the Federal Food, Drug, and Cosmetic Act.
Humus means a stabilized (i.e., finished) biological soil amendment
produced through a controlled composting process.
Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or
packaging. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting,
packing, or holding.
Manure means animal excreta, alone or in combination with litter
(such as straw and feathers used for animal bedding) for use as a soil
amendment.
Microorganisms means yeasts, molds, bacteria, viruses, protozoa,
and microscopic parasites and includes species having public health
significance. The term ``undesirable microorganisms'' includes those
microorganisms that are of public health significance, that subject
food to decomposition, that indicate that food is contaminated with
filth, or that otherwise may cause food to be adulterated.
Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) and activities
that require the establishment to be registered. An example of such a
facility is a ``farm mixed-type facility,'' which is an establishment
that grows and harvests crops or raises animals and may conduct other
activities within the farm definition, but also conducts activities
that require the establishment to be registered.
Monitor means to conduct a planned sequence of observations or
measurements to assess whether a process, point or procedure is under
control and, when applicable, to produce an accurate record of the
observation or measurement.
Non-fecal animal byproduct means solid waste (other than excreta)
that is animal in origin (such as meat, fat, dairy products, eggs,
carcasses, blood meal, bone meal, fish meal, shellfish waste (such as
crab, shrimp, and lobster waste), fish emulsions, and offal) and is
generated by commercial, institutional, or agricultural operations.
Packaging (when used as a verb) means placing food into a container
that directly contacts the food and that the consumer receives.
Packing means placing food into a container other than packaging
the food. For farms and farm mixed-type facilities, packing also
includes activities (which may include packaging) traditionally
performed by farms to prepare raw agricultural commodities grown or
raised on the same farm or another farm under the same ownership for
storage and transport, but does not include activities that transform a
raw agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
Pest means any objectionable animals or insects including birds,
rodents, flies, and larvae.
Pre-consumer vegetative waste means solid waste that is purely
vegetative in origin, not considered yard trash, and derived from
commercial, institutional, or agricultural operations without coming in
contact with animal products, byproducts or manure or with an end user
(consumer). Pre-consumer vegetative waste includes material generated
by farms, packing houses, canning operations, wholesale distribution
centers and grocery stores; products that have been removed from their
packaging (such as out-of-date juice, vegetables, condiments, and
bread); and associated packaging that is vegetative in origin (such as
paper or corn-starch based products). Pre-consumer vegetative waste
does not include table waste, packaging that has come in contact with
materials (such as meat) that are not vegetative in origin, or any
waste generated by restaurants.
Produce means any fruit or vegetable (including mixes of intact
fruits and vegetables) and includes mushrooms, sprouts (irrespective of
seed source), peanuts, tree nuts and herbs. A fruit is the edible
reproductive body of a seed plant or tree nut (such as apple, orange
and almond) such that fruit means the harvestable or harvested part of
a plant developed from a flower. A vegetable is the edible part of an
herbaceous plant (such as cabbage or potato) or fleshy fruiting body of
a fungus (such as white button or shiitake) grown for an edible part
such that vegetable means the harvestable or harvested part of any

[[Page 3632]]

plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots,
tubers, bulbs, stems, leaves, or flower parts are used as food and
includes mushrooms, sprouts, and herbs (such as basil or cilantro).
Produce does not include food grains meaning the small, hard fruits or
seeds of arable crops, or the crops bearing these fruits or seeds, that
are grown and processed for use as meal, flour, baked goods, cereals
and oils rather than for fresh consumption (including cereal grains,
pseudo cereals, oilseeds and other plants used in the same fashion).
Examples of food grains include barley, dent- or flint-corn, sorghum,
oats, rice, rye, wheat, amaranth, quinoa, buckwheat, cotton seed, and
soybeans.
Production batch of sprouts means all sprouts that are started at
the same time in a single growing unit (e.g., a single drum or bin, or
a single rack of trays that are connected to each other), whether or
not the sprouts are grown from a single lot of seed (including, for
example, when multiple types of seeds are grown in a single growing
unit).
Qualified end-user with respect to a food means the consumer of the
food; or a restaurant or retail food establishment (as those terms are
defined in Sec. 1.227) that is located:
(i) In the same State as the farm that produced the food; or
(ii) Not more than 275 miles from such farm. The term ``consumer''
does not include a business.
Raw agricultural commodity (RAC) means ``raw agricultural
commodity'' as defined in section 201(r) of the Federal Food, Drug, and
Cosmetic Act.
Reasonably foreseeable hazard means a potential hazard that may be
associated with the farm or the food.
Sanitize means to adequately treat cleaned food-contact surfaces by
a process that is effective in destroying vegetative cells of
microorganisms of public health significance, and in substantially
reducing numbers of other undesirable microorganisms, but without
adversely affecting the product or its safety for the consumer.
Sewage sludge biosolids means the solid or semi-solid residue
generated during the treatment of domestic sewage in a treatment works
within the meaning of the definition of ``sewage sludge'' in 40 CFR
503.9(w).
Soil amendment means any chemical, biological, or physical material
(such as elemental fertilizers, humus, manure, non-fecal animal
byproducts, peat moss, perlite, pre-consumer vegetative waste, sewage
sludge biosolids, table waste, agricultural tea and yard trimmings)
intentionally added to the soil to improve the chemical or physical
condition of soil in relation to plant growth or to improve the
capacity of the soil to hold water. The term soil amendment also
includes growth media that serve as the entire substrate during the
growth of covered produce (such as mushrooms and some sprouts).
Spent sprout irrigation water means water that has been used in the
growing of sprouts.
Static composting means a process to produce humus in which air is
introduced into biological material (in a pile (or row) covered with at
least 6 inches of insulating material, or in an enclosed vessel) by a
mechanism that does not include turning. Examples of structural
features for introducing air include embedded perforated pipes and a
constructed permanent base that includes aeration slots. Examples of
mechanisms for introducing air include passive diffusion and mechanical
means (such as blowers that suction air from the composting material or
blow air into the composting material using positive pressure).
Surface water means all water which is open to the atmosphere and
subject to surface runoff, including water obtained from an underground
aquifer that is held or conveyed in a manner that is open to the
atmosphere, such as in canals, ponds, other surface containment or open
conveyances.
Table waste means any post-consumer food waste, irrespective of
whether the source material is animal or vegetative in origin, derived
from individuals, institutions, restaurants, retail operations, or
other sources where the food has been served to a consumer.
Turned composting means a process to produce humus in which air is
introduced into biological material (in a pile, row, or enclosed
vessel) by turning on a regular basis. Turning is the process of
mechanically mixing biological material that is undergoing a composting
process with the specific intention of moving the outer, cooler
sections of the material being composted to the inner, hotter sections.
Water distribution system means a system to carry water from its
primary source to its point of use, including pipes, sprinklers,
irrigation canals, pumps, valves, storage tanks, reservoirs, meters,
and fittings.
We means the U.S. Food and Drug Administration (FDA).
Yard trimmings means purely vegetative matter resulting from
landscaping maintenance or land clearing operations, including
materials such as tree and shrub trimmings, grass clippings, palm
fronds, trees, tree stumps, untreated lumber, untreated wooden pallets,
and associated rocks and soils.
You means a person who is subject to some or all of the
requirements in this part.

Sec. 112.4 Who is subject to the requirements of this part?

(a) Except as provided in paragraph (b) of this section, if you are
a farm or farm mixed-type facility with an average annual monetary
value of food (as ``food'' defined in Sec. 112.3(c)) sold during the
previous 3-year period of more than $25,000 (on a rolling basis), you
are a ``covered farm'' subject to this part. If you are a covered farm
subject to this part, you must comply with all applicable requirements
of this part when you conduct a covered activity on covered produce.
(b) You are not a covered farm if you satisfy the requirements in
Sec. 112.5 and we have not withdrawn your exemption in accordance with
the requirements of subpart R of this part.

Sec. 112.5 Who is eligible for a qualified exemption and associated
modified requirements based on average monetary value of all food sold
and direct farm marketing?

(a) You are eligible for a qualified exemption and associated
modified requirements in a calendar year if:
(1) During the previous 3-year period preceding the applicable
calendar year, the average annual monetary value of the food (as
defined in Sec. 112.3(c)) you sold directly to qualified end-users (as
defined in Sec. 112.3(c)) during such period exceeded the average
annual monetary value of the food you sold to all other buyers during
that period; and
(2) The average annual monetary value of all food (as defined in
Sec. 112.3(c)) you sold during the 3-year period preceding the
applicable calendar year was less than $500,000, adjusted for
inflation.
(b) For the purpose of determining whether the average annual
monetary value of all food sold during the 3-year period preceding the
applicable calendar year was less than $500,000, adjusted for
inflation, the baseline year for calculating the adjustment for
inflation is 2011.

Sec. 112.6 What modified requirements apply to me if I am eligible
for a qualified exemption in accordance with Sec. 112.5?

(a) If you are eligible for a qualified exemption in accordance
with Sec. 112.5, you are subject to the requirements of:
(1) This subpart A; and
(2) Subparts Q and R of this part.
(b) In addition, you are subject to the following modified
requirements:
(1) When a food packaging label is required on food that would
otherwise

[[Page 3633]]

be covered produce under the Federal Food, Drug, and Cosmetic Act or
its implementing regulations, you must include prominently and
conspicuously on the food packaging label the name and the complete
business address of the farm where the produce was grown.
(2) When a food packaging label is not required on food that would
otherwise be covered produce under the Federal Food, Drug, and Cosmetic
Act, you must prominently and conspicuously display, at the point of
purchase, the name and complete business address of the farm where the
produce was grown, on a label, poster, sign, placard, or documents
delivered contemporaneously with the produce in the normal course of
business, or, in the case of Internet sales, in an electronic notice.
(3) The complete business address that you must include in
accordance with the requirements of paragraph (b)(1) or (b)(2) of this
section must include the street address or post office box, city,
state, and zip code for domestic farms, and comparable full address
information for foreign farms.

Subpart B--General Requirements

Sec. 112.11 What general requirements apply to persons who are
subject to this part?

You must take appropriate measures to minimize the risk of serious
adverse health consequences or death from the use of, or exposure to,
covered produce, including those measures reasonably necessary to
prevent the introduction of known or reasonably foreseeable hazards
into covered produce, and to provide reasonable assurances that the
produce is not adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 342) on account of such hazards.

Sec. 112.12 Are there any alternatives to the requirements
established in this part?

(a) You may establish alternatives to the following specific
requirements of this part, provided that you satisfy the requirements
of paragraphs (b) and (c) of this section:
(1) The requirements in Sec. 112.44(c) for testing water, and
taking action based on test results, when agricultural water is used
during growing operations for covered produce (other than sprouts)
using a direct water application method;
(2) Composting treatment processes established in Sec.
112.54(c)(1) and (c)(2);
(3) The minimum application interval established in Sec.
112.56(a)(1)(i) for an untreated biological soil amendment of animal
origin that is reasonably likely to contact covered produce after
application or for a compost agricultural tea that contains compost
agricultural tea additives; and
(4) The minimum application interval established in Sec.
112.56(a)(4)(i) for a biological soil amendment of animal origin
treated by a composting process that is reasonably likely to contact
covered produce after application.
(b) You may establish and use an alternative to any of the
requirements listed in paragraph (a) of this section, provided you have
adequate scientific data or information to support a conclusion that
the alternative would provide the same level of public health
protection as the applicable requirement established in this part
(including meeting the same microbiological standards, where
applicable), and would not increase the likelihood that your covered
produce will be adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act, in light of your covered produce, practices,
and conditions, including agro-ecological conditions and application
interval.
(c) Scientific data and information used to support an alternative
to a requirement listed in paragraph (a) of this section may be
developed by you, available in the scientific literature, or available
to you through a third party. You must establish and maintain
documentation of the scientific data and information on which you rely
in accordance with the requirements of subpart O of this part.

Subpart C--Standards Directed to Personnel Qualifications and
Training

Sec. 112.21 What requirements apply regarding qualifications and
training for personnel who handle (contact) covered produce or food-
contact surfaces?

All of the following requirements apply regarding qualifications
and training for personnel who handle (contact) covered produce or
food-contact surfaces:
(a) All personnel (including temporary, part time, seasonal, and
contracted personnel) who handle covered produce or food-contact
surfaces, or who are engaged in the supervision thereof, must receive
adequate training, as appropriate to the person's duties, upon hiring,
at the beginning of each growing season (if applicable), and
periodically thereafter.
(b) All personnel (including temporary, part time, seasonal, and
contracted personnel) who handle covered produce or food-contact
surfaces, or who are engaged in the supervision thereof, must have the
training, in combination with education or experience to perform the
person's assigned duties in a manner that ensures compliance with this
part.
(c) Training must be conducted in a manner that is easily
understood by personnel being trained.
(d) Training must be repeated as necessary and appropriate in light
of observations or information indicating that personnel are not
meeting standards established by FDA in subparts C through O of this
part.

Sec. 112.22 What minimum requirements apply for training personnel
who conduct a covered activity?

(a) At a minimum, all personnel who handle (contact) covered
produce during covered activities or supervise the conduct of such
activities must receive training that includes all of the following:
(1) Principles of food hygiene and food safety;
(2) The importance of health and personal hygiene for all personnel
and visitors, including recognizing symptoms of a health condition that
is reasonably likely to result in contamination of covered produce or
food-contact surfaces with microorganisms of public health
significance; and
(3) The standards established by FDA in subparts C through O of
this part that are applicable to the employee's job responsibilities.
(b) Persons who conduct harvest activities for covered produce must
also receive training that includes all of the following:
(1) Recognizing covered produce that should not be harvested,
including covered produce that may be contaminated with known or
reasonably foreseeable hazards;
(2) Inspecting harvest containers and equipment to ensure that they
are functioning properly, clean, and maintained so as not to become a
source of contamination of covered produce with known or reasonably
foreseeable hazards; and
(3) Correcting problems with harvest containers or equipment, or
reporting such problems to the supervisor (or other responsible party),
as appropriate to the person's job responsibilities.
(c) At least one supervisor or responsible party for your farm must
have successfully completed food safety training at least equivalent to
that received under standardized curriculum recognized as adequate by
the Food and Drug Administration.

Sec. 112.23 What requirements apply regarding supervisors?

You must assign or identify personnel to supervise (or otherwise be

[[Page 3634]]

responsible for) your operations to ensure compliance with the
requirements of this part.

Sec. 112.30 Under this subpart, what requirements apply regarding
records?

(a) You must establish and keep records required under this subpart
C in accordance with the requirements of subpart O of this part.
(b) You must establish and keep records of training that document
required training of personnel, including the date of training, topics
covered, and the persons(s) trained.

Subpart D--Standards Directed to Health and Hygiene

Sec. 112.31 What measures must I take to prevent ill or infected
persons from contaminating covered produce with microorganisms of
public health significance?

(a) You must take measures to prevent contamination of covered
produce and food-contact surfaces with microorganisms of public health
significance from any person with an applicable health condition (such
as a communicable illnesses that present a public health risk in the
context of normal work duties, infection, open lesion, vomiting, or
diarrhea).
(b) The measures you must take to satisfy the requirements of
paragraph (a) of this section must include all of the following
measures:
(1) Excluding any person from working in any operations that may
result in contamination of covered produce or food-contact surfaces
with microorganisms of public health significance when the person (by
medical examination, the person's acknowledgement, or observation) is
shown to have, or appears to have, an applicable health condition,
until the person's health condition no longer presents a risk to public
health; and
(2) Instructing personnel to notify their supervisor(s) (or a
responsible party) if they have, or if there is a reasonable
possibility that they have an applicable health condition.

Sec. 112.32 What hygienic practices must personnel use?

(a) Personnel who work in an operation in which covered produce or
food-contact surfaces are at risk of contamination with known or
reasonably foreseeable hazards must use hygienic practices while on
duty to the extent necessary to protect against such contamination.
(b) The hygienic practices that personnel use to satisfy the
requirements of paragraph (a) of this section when handling
(contacting) covered produce or food-contact surfaces during a covered
activity must include all of the following practices:
(1) Maintaining adequate personal cleanliness to protect against
contamination of covered produce and food-contact surfaces;
(2) Avoiding contact with animals other than working animals, and
taking appropriate steps to minimize the likelihood of contamination of
covered produce when in direct contact with working animals;
(3) Washing hands thoroughly, including scrubbing with soap and
running water that satisfies the requirements of Sec. 112.44(a) (as
applicable) for water used to wash hands, and drying hands thoroughly
using single-service towels, clean cloth towels, sanitary towel service
or other adequate hand drying devices:
(i) Before starting work;
(ii) Before putting on gloves;
(iii) After using the toilet;
(iv) Upon return to the work station after any break or other
absence from the work station;
(v) As soon as practical after touching animals (including
livestock and working animals), or any waste of animal origin; and
(vi) At any other time when the hands may have become contaminated
in a manner that is reasonably likely to lead to contamination of
covered produce with known or reasonably foreseeable hazards; and
(4) If you choose to use gloves in handling covered produce or
food-contact surfaces, maintaining gloves in an intact and sanitary
condition and replacing such gloves when no longer able to do so.

Sec. 112.33 What measures must I take to prevent visitors from
contaminating covered produce and food-contact surfaces with
microorganisms of public health significance?

(a) A visitor is any person (other than personnel) who enters your
covered farm with your permission.
(b) You must make visitors aware of policies and procedures to
protect covered produce and food-contact surfaces from contamination by
people and take all steps reasonably necessary to ensure that visitors
comply with such policies and procedures.
(c) You must make toilet and hand-washing facilities accessible to
visitors.

Subpart E--Standards Directed to Agricultural Water

Sec. 112.41 What requirements apply to the quality of agricultural
water?

All agricultural water must be safe and of adequate sanitary
quality for its intended use.

Sec. 112.42 What measures must I take with respect to my agricultural
water sources, water distribution system, and pooling of water?

(a) At the beginning of a growing season, you must inspect the
entire agricultural water system under your control (including water
source, water distribution system, facilities, and equipment), to
identify conditions that are reasonably likely to introduce known or
reasonably foreseeable hazards into or onto covered produce or food-
contact surfaces in light of your covered produce, practices, and
conditions, including consideration of the following:
(1) The nature of each agricultural water source (for example,
ground water or surface water);
(2) The extent of your control over each agricultural water source;
(3) The degree of protection of each agricultural water source;
(4) Use of adjacent or nearby land; and
(5) The likelihood of introduction of known or reasonably
foreseeable hazards to agricultural water by another user of
agricultural water before the water reaches your covered farm.
(b) You must adequately maintain all agricultural water sources
that are under your control (such as wells) by regularly inspecting
each source and keeping the source free of debris, trash, domesticated
animals, and other possible sources of contamination of covered produce
to the extent practicable and appropriate under the circumstances.
(c) You must adequately maintain all agricultural water
distribution systems as necessary and appropriate to prevent the water
distribution system from being a source of contamination to covered
produce, food-contact surfaces, areas used for a covered activity, or
water sources, including by regularly inspecting and adequately storing
all equipment used in the system.
(d) You must immediately discontinue use of a source of
agricultural water and/or its distribution system, and not use the
water source and/or its distribution system when you have determined or
have reason to believe that your agricultural water is not safe and of
adequate sanitary quality for its intended use, until you either:

[[Page 3635]]

(1) Re-inspect the entire agricultural water system under your
control, identify any conditions that are reasonably likely to
introduce known or reasonably foreseeable hazards into or onto covered
produce or food-contact surfaces, make necessary changes, and test the
water to determine if your changes were effective and to ensure that
your agricultural water is safe and of adequate sanitary quality for
its intended use; or
(2) Treat the water in accordance with the requirements of Sec.
112.43.
(e) As necessary and appropriate, you must implement measures
reasonably necessary to reduce the potential for contamination of
covered produce with known or reasonably foreseeable hazards as a
result of pooling of water. For example, such measures may include
using protective barriers or staking to keep covered produce from
touching the ground or using an alternative irrigation method.

Sec. 112.43 What treatment of agricultural water is required, and
what requirements apply to treating agricultural water?

(a) You must treat any agricultural water that you use (such as
with an EPA-registered antimicrobial pesticide product) if you know or
have reason to believe that the water is not safe and of adequate
sanitary quality for its intended use.
(b) Any method you use to treat agricultural water to satisfy the
requirement in paragraph (a) of this section must be effective to make
the water safe and of adequate sanitary quality for its intended use.
(c)(1) You must deliver any treatment of agricultural water
required by paragraph (a) of this section in a manner to ensure that
the treated water is consistently safe and of adequate sanitary quality
for its intended use.
(2) You must monitor any treatment of agricultural water at a
frequency adequate to ensure that the treated water is consistently
safe and of adequate sanitary quality for its intended use.

Sec. 112.44 What testing is required for agricultural water, and what
must I do based on the test results?

(a) You must test the quality of agricultural water according to
the requirements in Sec. 112.45 using a quantitative, or presence-
absence method of analysis provided in subpart N of this part to ensure
there is no detectable generic Escherichia coli (E. coli) in 100
milliliters (mL) of agricultural water when it is:
(1) Used as sprout irrigation water;
(2) Applied in any manner that directly contacts covered produce
during or after harvest activities (for example, water that is applied
to covered produce for washing or cooling activities, and water that is
applied to harvested crops to prevent dehydration before cooling),
including when used to make ice that directly contacts covered produce
during or after harvest activities;
(3) Used to make a treated agricultural tea;
(4) Used to contact food-contact surfaces, or to make ice that will
contact food-contact surfaces; or
(5) Used for washing hands during and after harvest activities.
(b) If you find that there is any detectable generic E. coli in 100
mL of water, you must immediately discontinue use of that source of
agricultural water and/or its distribution system for the uses
described in paragraph (a) of this section. Before you may use the
water source and/or distribution system again for the uses described in
paragraph (a) of this section, you must either re-inspect the entire
agricultural water system under your control, identify any conditions
that are reasonably likely to introduce known or reasonably foreseeable
hazards into or onto covered produce or food-contact surfaces, make
necessary changes, and retest the water to determine if your changes
were effective and to ensure that the water meets the requirements of
paragraph (a) of this section; or treat the water in accordance with
the requirements of Sec. 112.43.
(c) When agricultural water is used during growing activities for
covered produce (other than sprouts) using a direct water application
method you must test the quality of water in accordance with one of the
appropriate analytical methods in subpart N. If you find that there is
more than 235 colony forming units (CFU) (or most probable number
(MPN), as appropriate) generic E. coli per 100 mL for any single sample
or a rolling geometric mean (n=5) of more than 126 CFU (or MPN, as
appropriate) per 100 mL of water, you must immediately discontinue use
of that source of agricultural water and/or its distribution system for
the uses described in this paragraph. Before you may use the water
source and/or distribution system again for the uses described in this
paragraph, you must either re-inspect the entire agricultural water
system under your control, identify any conditions that are reasonably
likely to introduce known or reasonably foreseeable hazards into or
onto covered produce or food-contact surfaces, make necessary changes,
and retest the water to determine if your changes were effective; or
treat the water in accordance with the requirements of Sec. 112.43.
(d) You may establish and use alternatives to the requirements
established in paragraph (c) of this section, provided you satisfy the
requirements of Sec. 112.12.

Sec. 112.45 How often must I test agricultural water that is subject
to the requirements of Sec. 112.44?

(a) You must test any agricultural water that is subject to the
requirements of Sec. 112.44 at the beginning of each growing season,
and every three months thereafter during the growing season, except
that there is no requirement to test water when:
(1) You receive water from a Public Water System, as defined under
the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, that
furnishes water that meets the microbial requirements under those
regulations or under the regulations of a State approved to administer
the SDWA public water supply program, and you have Public Water System
results or certificates of compliance that demonstrate that the water
meets that requirement;
(2) You receive water from a public water supply that furnishes
water that meets the microbial requirement described in Sec.
112.44(a), and you have public water system results or certificates of
compliance that demonstrate that the water meets that requirement; or
(3) You treat water in accordance with the requirements of Sec.
112.43.
(b) If you use untreated surface water for purposes that are
subject to the requirements of Sec. 112.44, you must test the water as
specified in the table in this paragraph.

----------------------------------------------------------------------------------------------------------------
Then you must test the untreated surface
If the untreated surface water is-- water--
----------------------------------------------------------------------------------------------------------------
(1) From any source where a significant quantity of runoff is likely At least every 7 days during the growing
to drain into the source (for example, a river or natural lake). season.

[[Page 3636]]

(2) From any source where underground aquifer water is transferred At least once each month during the
to a surface water containment constructed and maintained in a growing season.
manner that minimizes runoff drainage into the containment (for
example, an on-farm man-made water reservoir).
----------------------------------------------------------------------------------------------------------------

Sec. 112.46 What measures must I take for water that I use during
harvest, packing, and holding activities for covered produce?

(a) You must manage the water as necessary, including by
establishing and following water-change schedules for re-circulated
water, to maintain adequate sanitary quality and minimize the potential
for contamination of covered produce and food-contact surfaces with
known or reasonably foreseeable hazards (for example, hazards that may
be introduced into the water from soil adhering to the covered
produce);
(b) You must visually monitor the quality of water that you use
during harvest, packing, and holding activities for covered produce
(for example, water used for washing covered produce in dump tanks,
flumes, or wash tanks, and water used for cooling covered produce in
hydrocoolers) for build-up of organic material (such as soil and plant
debris).
(c) You must maintain and monitor the temperature of water at a
temperature that is appropriate for the commodity and operation
(considering the time and depth of submersion) and is adequate to
minimize the potential for infiltration of microorganisms of public
health significance into covered produce.

Sec. 112.50 Under this subpart, what requirements apply regarding
records?

(a) You must establish and keep records required under this subpart
E in accordance with the requirements of subpart O of this part.
(b) You must establish and keep the following records:
(1) The findings of the inspection of your agricultural water
system in accordance with the requirements of Sec. 112.42(a);
(2) Documentation of the results of any analytical tests conducted
to determine whether agricultural water is safe and of adequate
sanitary quality for its intended use;
(3) Scientific data or information you rely on to support the
adequacy of a method used to satisfy the requirements of Sec.
112.43(b) and (c)(1);
(4) Documentation of the results of water treatment monitoring
under Sec. 112.43(c)(2);
(5) Documentation of the results of water testing you perform to
satisfy the requirements of Sec. 112.44; and
(6) Scientific data or information you rely on to support any
alternative to the requirements established in Sec. 112.44(c) for
agricultural water used during growing activities using a direct water
application method in accordance with the requirements of Sec.
112.44(d).
(7) Annual documentation of the results or certificates of
compliance from a public water system under 112.45(a)(1) or (a)(2), if
applicable.

Subpart F--Standards Directed to Biological Soil Amendments of
Animal Origin and Human Waste

Sec. 112.51 What requirements apply for determining the status of a
biological soil amendment of animal origin?

(a) A biological soil amendment of animal origin is treated if it
has been processed to completion to adequately reduce microorganisms of
public health significance in accordance with the requirements of Sec.
112.54, or, in the case of an agricultural tea, the biological
materials used to make the tea have been so processed and the water
used to make the tea satisfies the requirements of 112.44(a).
(b) A biological soil amendment of animal origin is untreated if
it:
(1) Has not been processed to completion in accordance with the
requirements of Sec. 112.54, or in the case of an agricultural tea,
the biological materials used to make the tea have not been so
processed or the water used to make the tea does not satisfy the
requirements of 112.44(a);
(2) Has become contaminated after treatment;
(3) Has been recombined with an untreated biological soil amendment
of animal origin;
(4) Is or contains a component that is untreated waste that you
know or have reason to believe is contaminated with a hazard or has
been associated with foodborne illness; or
(5) Is an agricultural tea that contains an agricultural tea
additive.

Sec. 112.52 How must I handle, convey, and store biological soil
amendments of animal origin?

(a) You must handle, convey and store any biological soil amendment
of animal origin in a manner and location such that it does not become
a potential source of contamination to covered produce, food-contact
surfaces, areas used for a covered activity, water sources, and water
distribution systems.
(b) You must handle, convey and store any treated biological soil
amendment of animal origin in a manner and location that minimizes the
risk of it becoming contaminated by an untreated or in-process
biological soil amendment of animal origin.
(c) You must handle, convey, and store any biological soil
amendment of animal origin that has become contaminated as if it was
untreated.

Sec. 112.53 What prohibitions apply regarding use of human waste?

You may not use human waste for growing covered produce, except
sewage sludge biosolids used in accordance with the requirements of 40
CFR part 503, subpart D, or equivalent regulatory requirements.

Sec. 112.54 What treatment processes are acceptable for a biological
soil amendment of animal origin that I apply in the growing of covered
produce?

Each of the following treatment processes are acceptable for a
biological soil amendment of animal origin that you apply in the
growing of covered produce, provided that the resulting biological soil
amendments are applied in accordance with the applicable requirements
of Sec. 112.56:
(a) A scientifically valid controlled physical process (for
example, thermal), chemical process (for example, high alkaline pH), or
combination of scientifically valid controlled physical and chemical
processes that has been demonstrated to satisfy the microbial standard
in Sec. 112.55(a) for Listeria monocytogenes (L. monocytogenes),
Salmonella species, and E. coli O157:H7;
(b) A scientifically valid controlled physical process, chemical
process, or combination of scientifically valid controlled physical and
chemical processes, that has been demonstrated to satisfy the microbial
standard in Sec. 112.55(b) for Salmonella and fecal coliforms; or
(c) A scientifically valid controlled composting process that has
been demonstrated to satisfy the microbial standard in Sec. 112.55(b)
for Salmonella and fecal coliforms. Scientifically valid controlled
composting processes include:
(1) Static composting that maintains aerobic (i.e., oxygenated)
conditions at a minimum of 131[emsp14][deg]F (55 [deg]C) for 3 days

[[Page 3637]]

and is followed by adequate curing, which includes proper insulation;
(2) Turned composting that maintains aerobic conditions at a
minimum of 131[emsp14][deg]F (55 [deg]C) for 15 days, with a minimum of
five turnings, and is followed by adequate curing, which includes
proper insulation; or
(3) Other scientifically valid, controlled composting processes,
provided you satisfy the requirements of Sec. 112.12, including that
the alternative process has been demonstrated to satisfy the microbial
standard in Sec. 112.55(b).

Sec. 112.55 What microbial standards apply to the treatment processes
in Sec. 112.54?

The following microbial standards apply to the treatment processes
in Sec. 112.54 as set forth in that section.
(a) For L. monocytogenes, Salmonella species, and E. coli O157:H7,
the relevant standards in the table in this paragraph or;

--------------------------------------------------------------------------------------------------------------------------------------------------------
For the microorganism-- The microbial standard is--
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) L. monocytogenes............................ Not detected using a method that can detect one colony forming unit (CFU) per 5 gram analytical
portion.
(2) Salmonella species.......................... Less than three most probable numbers (MPN) per 4 grams of total solids (dry weight basis).
(3) E. coli O157:H7............................. Less than 0.3 MPN per 1 gram analytical portion.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(b) Less than three MPN Salmonella species per four grams of total
solids (dry weight basis); and less than 1,000 MPN fecal coliforms per
gram of total solids (dry weight basis).

Sec. 112.56 What application requirements and minimum application
intervals apply to biological soil amendments of animal origin?

(a) Except as provided in paragraph (b) of this section, you must
apply the biological soil amendments of animal origin specified in the
first column of the table in this paragraph in accordance with the
application requirements specified in the second column of the table in
this paragraph and the minimum application intervals specified in the
third column of the table in this paragraph.

----------------------------------------------------------------------------------------------------------------
If the biological soil amendment of Then the biological soil amendment of And then the minimum application
animal origin is-- animal origin must be applied-- interval is--
----------------------------------------------------------------------------------------------------------------
(1)(i) Untreated...................... In a manner that does not contact 9 months.
covered produce during application
and minimizes the potential for
contact with covered produce after
application
(ii) Untreated........................ In a manner that does not contact 0 days.
covered produce during or after
application
(2) Treated by a scientifically valid In any manner (i.e., no restrictions) 0 days.
controlled physical or chemical
process, or combination of
scientifically valid controlled
physical and chemical processes, in
accordance with the requirements of
Sec. 112.54(a) to meet the
microbial standard in Sec.
112.55(a).
(3) Treated by a scientifically valid In a manner that minimizes the 0 days.
controlled physical or chemical potential for contact with covered
process, or combination of produce during and after application
scientifically valid controlled
physical and chemical processes, in
accordance with the requirements of
Sec. 112.54(b) to meet the
microbial standard in Sec.
112.55(b).
(4)(i) Treated by a composting process In a manner that minimizes the 45 days.
in accordance with the requirements potential for contact with covered
of Sec. 112.54(c) to meet the produce during and after application
microbial standard in Sec.
112.55(b).
(ii) Treated by a composting process In a manner that does not contact 0 days.
in accordance with the requirements covered produce during or after
of Sec. 112.54(c) to meet the application
microbial standard in Sec.
112.55(b).
----------------------------------------------------------------------------------------------------------------

(b) You may establish and use alternatives to the minimum
application intervals established in paragraphs (a)(1)(i) and (a)(4)(i)
of this section, provided you satisfy the requirements of Sec. 112.12.

Sec. 112.60 Under this subpart, what requirements apply regarding
records?

(a) You must establish and keep records required under this subpart
F in accordance with the requirements of subpart O of this part.
(b) For any biological soil amendment of animal origin you use, you
must establish and keep the following records:
(1) Documentation of the date of application of any untreated
biological soil amendment of animal origin (including raw manure) or
any biological soil amendment of animal origin treated by composting to
a growing area and the date of harvest of covered produce from that
growing area, except when covered produce does not contact the soil
after application of the soil amendment;
(2) For a treated biological soil amendment of animal origin you
receive from a third party, documentation (such as a Certificate of
Conformance) that:
(i) The process used to treat the biological soil amendment of
animal origin is a scientifically valid process that has been carried
out with appropriate process monitoring;
(ii) The applicable treatment process is periodically verified
through testing using a scientifically valid analytical method on an
adequately representative sample to demonstrate that the process
satisfies the applicable microbial standard in Sec. 112.55, including
the results of such periodic testing; and
(iii) The biological soil amendment of animal origin has been
handled, conveyed and stored in a manner and

[[Page 3638]]

location to minimize the risk of contamination by an untreated or in-
process biological soil amendment of animal origin;
(3) For a treated biological soil amendment of animal origin you
produce for your own covered farm(s), documentation that process
controls (for example, time, temperature and turnings) were achieved;
(4) Scientific data or information you rely on to support any
alternative composting process used to treat a biological soil
amendment of animal origin in accordance with the requirements of Sec.
112.54(c)(3); and
(5) Scientific data or information you rely on to support any
alternative minimum application interval in accordance with the
requirements of Sec. 112.56(b).

Subpart G--[Reserved]

Subpart H--[Reserved]

Subpart I--Standards Directed to Domesticated and Wild Animals

Sec. 112.81 How do the requirements of this subpart apply to areas
where covered activities take place?

(a) The requirements of this subpart apply when a covered activity
takes place in an outdoor area or a partially-enclosed building and
when, under the circumstances, there is a reasonable probability that
animals will contaminate covered produce.
(b) The requirements of this subpart do not apply when a covered
activity takes place in a fully-enclosed building.

Sec. 112.82 What requirements apply regarding domesticated animals
that I allow to graze in fields or use as working animals where I grow
covered produce?

At a minimum, if you allow animals to graze or use them as working
animals in fields where covered produce is grown, and under the
circumstances there is a reasonable probability that grazing or working
animals will contaminate covered produce, you must take the following
measures:
(a) An adequate waiting period between grazing and harvesting for
covered produce in any growing area that was grazed to ensure the
safety of the harvested crop; and
(b) If working animals are used in a growing area where a crop has
been planted, measures to prevent the introduction of known or
reasonably foreseeable hazards into or onto covered produce.

Sec. 112.83 What requirements apply regarding animal intrusion?

(a) If under the circumstances there is a reasonable probability
that animal intrusion will contaminate covered produce, you must
monitor those areas that are used for a covered activity for evidence
of animal intrusion:
(1) As needed during the growing season based on:
(i) Your covered produce; and
(ii) Your observations and experience; and
(2) Immediately prior to harvest.
(b) If animal intrusion, as made evident by observation of
significant quantities of animals, animal excreta or crop destruction
via grazing, occurs, you must evaluate whether the covered produce can
be harvested in accordance with the requirements of Sec. 112.112.

Subpart J--[Reserved]

Subpart K--Standards Directed to Growing, Harvesting, Packing, and
Holding Activities

Sec. 112.111 What measures must I take if I grow, harvest, pack or
hold both covered and excluded produce?

If you grow, harvest, pack or hold produce that is not covered in
this part (i.e., excluded produce in accordance with Sec. 112.2) and
also conduct such activities on covered produce, and the excluded
produce is not grown, harvested, packed or held in accordance with this
part, you must take measures during these covered activities, as
applicable, to:
(a) Keep covered produce separate from excluded produce; and
(b) Adequately clean and sanitize, as necessary, any food-contact
surfaces that contact excluded produce before using such food-contact
surfaces for covered activities on covered produce.

Sec. 112.112 What measures must I take during harvest activities?

You must take all measures reasonably necessary to identify, and
not harvest, covered produce that is reasonably likely to be
contaminated with a known or reasonably foreseeable hazard, including
steps to identify and not harvest covered produce that is visibly
contaminated with animal excreta.

Sec. 112.113 How must I handle harvested covered produce during
covered activities?

You must handle harvested covered produce in a manner that protects
against contamination with known or reasonably foreseeable hazards--for
example, by avoiding contact of cut surfaces of harvested produce with
soil.

Sec. 112.114 What requirements apply to dropped covered produce?

You must not distribute covered produce that drops to the ground
before harvest (dropped covered produce) unless it is exempt under
Sec. 112.2(b). Dropped covered produce does not include root crops
(such as carrots) that grow underground or crops (such as cantaloupe)
that grow on the ground.

Sec. 112.115 What measures must I take when packaging covered
produce?

You must package covered produce in a manner that prevents the
formation of Clostridium botulinum toxin if such toxin is a known or
reasonably foreseeable hazard (such as for mushrooms).

Sec. 112.116 What measures must I take when using food-packing
(including food packaging) material?

(a) You must use food-packing material that is adequate for its
intended use.
(b) If you reuse food-packing material, you must take steps to
ensure that food-contact surfaces are clean, such as by cleaning and
sanitizing, when necessary, food-packing containers or using a clean
liner.

Subpart L--Standards Directed to Equipment, Tools, Buildings, and
Sanitation

Sec. 112.121 What equipment and tools are subject to the requirements
of this subpart?

Equipment and tools subject to the requirements of this subpart are
those that are intended to, or likely to, contact covered produce; and
those instruments or controls used to measure, regulate, or record
conditions to control or prevent the growth of undesirable
microorganisms or other contamination. Examples include knives,
implements, mechanical harvesters, waxing machinery, cooling equipment
(including hydrocoolers), grading belts, sizing equipment, palletizing
equipment, and equipment used to store or convey harvested covered
produce (such as containers, bins, food-packing material, dump tanks,
flumes, and vehicles or other equipment used for transport that are
intended to, or likely to, contact covered produce).

Sec. 112.122 What buildings are subject to the requirements of this
subpart?

Buildings subject to the requirements of this subpart include:
(a) Any fully- or partially-enclosed building used for covered
activities, including minimal structures that have a roof but do not
have any walls; and
(b) Storage sheds, buildings, or other structures used to store
food-contact

[[Page 3639]]

surfaces (such as harvest containers and food-packing materials).

Sec. 112.123 What general requirements apply regarding equipment and
tools subject to this subpart?

All of the following requirements apply regarding equipment and
tools subject to this subpart:
(a) You must use equipment and tools that are of adequate design,
construction, and workmanship to enable them to be adequately cleaned
and properly maintained; and
(b) Equipment and tools must be:
(1) Installed and maintained as to facilitate cleaning of the
equipment and of all adjacent spaces, and
(2) Stored and maintained to protect covered produce from being
contaminated with known or reasonably foreseeable hazards and to
prevent the equipment and tools from attracting and harboring pests.
(c) Seams on food-contact surfaces of equipment and tools that you
use must be either smoothly bonded, or maintained to minimize
accumulation of dirt, filth, food particles, and organic material and
thus minimize the opportunity for harborage or growth of
microorganisms.
(d)(1) You must inspect, maintain, and clean and sanitize, when
necessary and appropriate, all food-contact surfaces of equipment and
tools used in covered activities as frequently as reasonably necessary
to protect against contamination of covered produce.
(2) You must maintain and clean all non-food-contact surfaces of
equipment and tools subject to this subpart used during harvesting,
packing, and holding as frequently as reasonably necessary to protect
against contamination of covered produce.
(e) If you use equipment such as pallets, forklifts, tractors, and
vehicles such that they are intended to, or likely to, contact covered
produce, you must do so in a manner that minimizes the potential for
contamination of covered produce or food-contact surfaces with known or
reasonably foreseeable hazards.

Sec. 112.124 What requirements apply to instruments and controls used
to measure, regulate, or record?

Instruments or controls you use to measure, regulate, or record
temperatures, hydrogen-ion concentration (pH), sanitizer efficacy or
other conditions, in order to control or prevent the growth of
undesirable microorganisms or other contamination, must be:
(a) Accurate and precise as necessary and appropriate in keeping
with their purpose;
(b) Adequately maintained; and
(c) Adequate in number for their designated uses.

Sec. 112.125 What requirements apply to equipment that is subject to
this subpart used in the transport of covered produce?

Equipment that is subject to this subpart that you use to transport
covered produce must be:
(a) Adequately clean before use in transporting covered produce;
and
(b) Adequate for use in transporting covered produce.

Sec. 112.126 What design and construction requirements apply to my
buildings?

All of the following design and construction requirements apply
regarding buildings.
(a) Buildings must be suitable in size, construction, and design to
facilitate maintenance and sanitary operations for covered activities
to reduce the potential for contamination of covered produce or food-
contact surfaces with known or reasonably foreseeable hazards.
Buildings must:
(1) Provide sufficient space for placement of equipment and storage
of materials;
(2) Permit proper precautions to be taken to reduce the potential
for contamination of covered produce, food-contact surfaces, or packing
materials with known or reasonably foreseeable hazards. The potential
for contamination must be reduced by effective design including the
separation of operations in which contamination is likely to occur, by
one or more of the following means: Location, time, partition, enclosed
systems, or other effective means; and
(3) Be constructed in such a manner that floors, walls, ceilings,
fixtures, ducts and pipes can be adequately cleaned and kept in good
repair, and that drip or condensate does not contaminate covered
produce, food-contact surfaces, or packing materials.
(b) You must provide adequate drainage in all areas where normal
operations release or discharge water or other liquid waste on the
ground or floor of the building.

Sec. 112.127 What requirements apply regarding domesticated animals
in and around a fully-enclosed building?

(a) You must take reasonable precautions to prevent contamination
of covered produce, food-contact surfaces, and food-packing materials
in fully-enclosed buildings with known or reasonably foreseeable
hazards from domesticated animals by:
(1) Excluding domesticated animals from fully-enclosed buildings
where covered produce, food-contact surfaces, or food-packing material
is exposed; or
(2) Separating domesticated animals in a fully enclosed building
from an area where a covered activity is conducted on covered produce
by location, time, or partition.
(b) Guard or guide dogs may be allowed in some areas of a fully
enclosed building if the presence of the dogs is unlikely to result in
contamination of produce, food-contact surfaces, or food-packing
materials.

Sec. 112.128 What requirements apply regarding pest control in
buildings?

(a) You must take those measures reasonably necessary to protect
covered produce, food-contact surfaces, and food-packing materials from
contamination by pests in buildings, including routine monitoring for
pests as necessary and appropriate.
(b) For fully-enclosed buildings, you must take measures to exclude
pests from your buildings.
(c) For partially-enclosed buildings, you must take measures to
prevent pests from becoming established in your buildings (such as by
use of screens or by monitoring for the presence of pests and removing
them when present).

Sec. 112.129 What requirements apply to toilet facilities?

All of the following requirements apply to toilet facilities:
(a) You must provide personnel with adequate, readily accessible
toilet facilities, including toilet facilities readily accessible to
growing areas during harvesting activities.
(b) Your toilet facilities must be designed, located, and
maintained to:
(1) Prevent contamination of covered produce, food-contact
surfaces, areas used for a covered activity, water sources, and water
distribution systems with human waste;
(2) Be directly accessible for servicing, be serviced and cleaned
on a schedule sufficient to ensure suitability of use, and be kept
supplied with toilet paper; and
(3) Provide for the sanitary disposal of waste and toilet paper.
(c) During growing activities that take place in a fully-enclosed
building, and during covered harvesting, packing, or holding
activities, you must provide a hand-washing station in sufficiently
close proximity to toilet facilities to make it practical for persons
who use the toilet facility to wash their hands.

Sec. 112.130 What requirements apply for hand-washing facilities?

All of the following requirements apply to hand-washing facilities:

[[Page 3640]]

(a) You must provide personnel with adequate, readily accessible
hand-washing facilities during growing activities that take place in a
fully-enclosed building, and during covered harvest, packing, or
holding activities.
(b) Your hand-washing facilities must be furnished with:
(1) Soap (or other effective surfactant);
(2) Running water that satisfies the requirements of Sec.
112.44(a) for water used to wash hands; and
(3) Adequate drying devices (such as single service towels, clean
cloth towels or sanitary towel service).
(c) You must provide for appropriate disposal of waste (for
example, waste water and used single-service towels) associated with a
hand-washing facility and take appropriate measures to prevent waste
water from a hand-washing facility from contaminating covered produce,
food-contact surfaces, areas used for a covered activity, agricultural
water sources, and agricultural water distribution systems with known
or reasonably foreseeable hazards.
(d) You may not use hand antiseptic/sanitizer or wipes as a
substitute for soap and water.

Sec. 112.131 What must I do to control and dispose of sewage?

All of the following requirements apply for the control and
disposal of sewage:
(a) You must dispose of sewage into an adequate sewage or septic
system or through other adequate means.
(b) You must maintain sewage and septic systems in a manner that
prevents contamination of covered produce, food-contact surfaces, areas
used for a covered activity, agricultural water sources, and
agricultural water distribution systems with known or reasonably
foreseeable hazards.
(c) You must manage and dispose of leakages or spills of human
waste in a manner that prevents contamination of covered produce, and
prevents or minimizes contamination of food-contact surfaces, areas
used for a covered activity, agricultural water sources, or
agricultural water distribution systems.
(d) After a significant event (such as flooding or an earthquake)
that could negatively impact a sewage or septic system, you must take
appropriate steps to ensure that sewage and septic systems continue to
operate in a manner that does not contaminate covered produce, food-
contact surfaces, areas used for a covered activity, agricultural water
sources, or agricultural water distribution systems.

Sec. 112.132 What must I do to control and dispose of trash, litter,
and waste in areas used for covered activities?

All of the following requirements apply to the control and disposal
of trash, litter, and waste in areas used for covered activities:
(a) You must convey, store, and dispose of trash, litter and waste
to:
(1) Minimize the potential for trash, litter, or waste to attract
or harbor pests; and
(2) Protect against contamination of covered produce, food-contact
surfaces, areas used for a covered activity, agricultural water
sources, and agricultural water distribution systems with known or
reasonably foreseeable hazards.
(b) You must adequately operate systems for waste treatment and
disposal so that they do not constitute a potential source of
contamination in areas used for a covered activity.

Sec. 112.133 What requirements apply to plumbing?

The plumbing must be of an adequate size and design and be
adequately installed and maintained to:
(a) Distribute water under pressure as needed, in sufficient
quantities, in all areas where used for covered activities, for
sanitary operations, or for hand-washing and toilet facilities.
(b) Properly convey sewage and liquid disposable waste;
(c) Avoid being a source of contamination to covered produce, food-
contact surfaces, areas used for a covered activity, or agricultural
water sources; and
(d) Not allow backflow from, or cross connection between, piping
systems that discharge waste water or sewage and piping systems that
carry water used for a covered activity, for sanitary operations, or
for use in hand-washing facilities.

Sec. 112.134 What must I do to control animal excreta and litter from
domesticated animals that are under my control?

(a) If you have domesticated animals, to prevent contamination of
covered produce, food-contact surfaces, areas used for a covered
activity, agricultural water sources, or agricultural water
distribution systems with animal waste, you must:
(1) Adequately control their excreta and litter; and
(2) Maintain a system for control of animal excreta and litter.
(b) [Reserved]

Sec. 112.140 Under this subpart L, what requirements apply regarding
records?

(a) You must establish and keep records required under this subpart
L in accordance with the requirements of subpart O of this part.
(b) You must establish and keep documentation of the date and
method of cleaning and sanitizing of equipment subject to this subpart
used in:
(1) Growing operations for sprouts; and
(2) Covered harvesting, packing, or holding activities.

Subpart M--Standards Directed to Sprouts

Sec. 112.141 What requirements apply to seeds or beans used to grow
sprouts?

In addition to the requirements of this part, all of the following
requirements apply to seeds or beans used to grow sprouts.
(a) If your farm grows seeds or beans for use to grow sprouts, you
must take measures reasonably necessary to prevent the introduction of
known or reasonably foreseeable hazards into or onto seeds or beans
that you will use for sprouting.
(b) If you know or have reason to believe that a lot of seeds or
beans have been associated with foodborne illness, you must not use
that lot of seeds or beans to produce sprouts.
(c) You must visually examine seeds and beans, and packaging used
to ship seeds or beans, for signs of potential contamination with known
or reasonably foreseeable hazards.

Sec. 112.142 What measures must I take for growing, harvesting,
packing, and holding sprouts?

You must take all of the following measures for growing,
harvesting, packing, and holding sprouts:
(a) You must grow, harvest, pack, and hold sprouts in a fully-
enclosed building.
(b) Any food-contact surfaces you use to grow, harvest, pack, and
hold sprouts must be cleaned and sanitized before contact with sprouts
or seeds or beans used to grow sprouts.
(c) You must treat seeds or beans that will be used to grow sprouts
using a scientifically valid method immediately before sprouting to
reduce microorganisms of public health significance. Prior treatment
conducted by a grower, handler, or distributor of seeds or beans does
not eliminate your responsibility to treat seeds or beans immediately
before sprouting at your covered farm.

Sec. 112.143 What testing must I do during growing, harvesting,
packing, and holding sprouts?

All of the following testing must be done during growing,
harvesting, packing, and holding sprouts:

[[Page 3641]]

(a) You must test the growing, harvesting, packing, and holding
environment for Listeria species or L. monocytogenes in accordance with
the requirements of Sec. 112.144.
(b) You must either:
(1) Test spent sprout irrigation water from each production batch
of sprouts for E. coli O157:H7 and Salmonella species in accordance
with the requirements of Sec. 112.146; or
(2) If testing spent sprout irrigation water is not practicable
(for example, for soil-grown sprouts), test each production batch of
sprouts at the in-process stage (i.e., while sprouts are still growing)
for E. coli O157:H7 and Salmonella species in accordance with the
requirements of Sec. 112.146.

Sec. 112.144 What requirements apply to testing the environment for
Listeria species or L. monocytogenes?

All of the following testing requirements apply for the growing,
harvesting, packing, and holding environment for Listeria species or L.
monocytogenes.
(a) You must establish and implement a written environmental
monitoring plan that is designed to identify L. monocytogenes if it is
present in the growing, harvesting, packing, or holding environment.
(b) Your written environmental monitoring plan must be directed to
sampling and testing for either Listeria species or L. monocytogenes.
(c) Your written environmental monitoring plan must include a
sampling plan that specifies:
(1) What you will test collected samples for (i.e., Listeria
species or L. monocytogenes);
(2) How often you will collect environmental samples, which must be
no less than monthly; and
(3) Sample collection sites; the number and location of sampling
sites must be sufficient to determine whether measures are effective
and must include appropriate food-contact surfaces and non-food-contact
surfaces of equipment, and other surfaces within the growing,
harvesting, packing, and holding environment.
(d) You must collect environmental samples and test them for
Listeria species or L. monocytogenes according to the method in Sec.
112.152.

Sec. 112.145 What actions must I take if the growing, harvesting,
packing, or holding environment tests positive for Listeria species or
L. monocytogenes?

You must take the following actions if you detect Listeria species
or L. monocytogenes in the growing, harvesting, packing, or holding
environment:
(a) Conduct additional testing of surfaces and areas surrounding
the area where Listeria species or L. monocytogenes was detected to
evaluate the extent of the problem, including the potential for
Listeria species or L. monocytogenes to have become established in a
niche;
(b) Clean and sanitize the affected surfaces and surrounding areas;
(c) Conduct additional microbial sampling and testing to determine
whether the Listeria species or L. monocytogenes has been eliminated;
(d) Conduct finished product testing when appropriate; and
(e) Perform any other actions necessary to prevent reoccurrence of
the contamination.

Sec. 112.146 What must I do to collect and test samples of spent
sprout irrigation water or sprouts?

All of the following requirements apply for collecting and testing
samples of spent sprout irrigation water or sprouts:
(a) You must establish and implement a written sampling plan that
identifies the number and location of samples (of spent sprout
irrigation water or sprouts) to be collected for each production batch
of sprouts to ensure that the collected samples are representative of
the production batch when testing for contamination.
(b) In accordance with the written sampling plan required under
paragraph (a) of this section, you must aseptically collect samples of
spent sprout irrigation water or sprouts, and test the collected
samples for E. coli O157:H7 and Salmonella species using a method that
has been validated for its intended use (testing spent sprout
irrigation water or sprouts) to ensure that the testing is accurate,
precise, and sensitive in detecting these pathogens.

Sec. 112.150 Under this subpart, what requirements apply regarding
records?

(a) You must establish and keep records required under this subpart
M in accordance with the requirements of subpart O of this part.
(b) You must establish and keep the following records:
(1) Documentation of your treatment of seeds or beans to reduce
microorganisms of public health significance in the seeds or beans, at
your farm;
(2) Your written environmental monitoring plan in accordance with
the requirements of Sec. 112.144;
(3) Your written sampling plan for each production batch of sprouts
in accordance with the requirements of Sec. 112.146(a);
(4) The results of all testing conducted in accordance with the
requirements of Sec. Sec. 112.143 and 112.144;
(5) Any analytical methods you use in lieu of the methods that are
incorporated by reference in Sec. 112.152; and
(6) The testing method you use in accordance with the requirements
of Sec. 112.146(b).

Subpart N--Analytical Methods

Sec. 112.151 What methods must I use to test the quality of water to
satisfy the requirements of Sec. 112.45

(a) You must test the quality of water using a method of analysis:
(1) As published in the ``Official Methods of Analysis of the
Association of Official Analytical Chemists (AOAC) International''
(18th ed., revision 4, 2011) which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the AOAC International, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html;
or
(2) As published in the Standards Methods for the Examination of
Water and Wastewater (21st ed., 2005), American Public Health
Association (APHA), which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the
APHA, 800 I St. NW., Washington, DC 20001, 202-777-2742. You may
inspect a copy at the Center for Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2163,
or at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html; or
(3) As prescribed in Chapter 4 of the FDA Bacteriological
Analytical Manual (BAM) (Edition 8, Revision A, 1998), as updated in
June 2011. The Director of the Federal Register approves the
incorporation by reference of FDA's BAM, Chapter 4 (Edition 8, Revision
A, 1998), as updated in June 2011, in accordance with 5 U.S.C. 552(a)
and 1 CFR part 5. You may obtain a copy of the method from Office of
Regulatory Science, Center for Food Safety and

[[Page 3642]]

Applied Nutrition (CFSAN), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 240-402-1990, or you may examine
a copy at CFSAN's Library, 5100 Paint Branch Pkwy., College Park, MD,
240-402-2163, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulation/ibr_locations.html; or
(4) That is at least equivalent to the appropriate method of
analysis in Sec. Sec. 112.151(a)(1), (a)(2) or (a)(3) in accuracy,
precision, and sensitivity.

Sec. 112.152 What methods must I use to test the growing environment
for Listeria species or L. monocytogenes to satisfy the requirements of
Sec. 112.143(a) and Sec. 112.144?

You must test the growing environment by testing for the presence
of Listeria species or L. monocytogenes in environmental samples using
the methods and procedures described in Chapter 10 of FDA's
Bacteriological Analytical Manual (BAM) April 2011, Edition (Edition 8,
Revision A, 1998), or a method that is at least equivalent in accuracy,
precision, and sensitivity. The Director of the Federal Register
approves the incorporation by reference of FDA's BAM, Chapter 10--
``Listeria monocytogenes, Detection and Enumeration of Listeria
monocytogenes in Foods,'' April 2011, in accordance with 5 U.S.C.
552(a) and 1 CFR part 5. You may obtain a copy of the method from
Office of Regulatory Science, Center for Food Safety and Applied
Nutrition (CFSAN), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240-402-1990, or you may examine a copy
at CFSAN's Library, 5100 Paint Branch Pkwy., College Park, MD, 240-402-
2163, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulation/ibr_locations.html.

Subpart O--Requirements Applying to Records That You Must Establish
and Keep

Sec. 112.161 What general requirements apply to records required
under this part?

(a) All records required under this part must:
(1) Include, as applicable:
(i) The name and location of your farm;
(ii) Actual values and observations obtained during monitoring;
(iii) An adequate description (such as the commodity name, or the
specific variety or brand name of a commodity, and, when available, any
lot number or other identifier) of covered produce applicable to the
record;
(iv) The location of a growing area (for example, a specific field)
or other area (for example, a specific packing shed) applicable to the
record; and
(v) The date and time of the activity documented;
(2) Be created at the time an activity is performed or observed;
(3) Be accurate, legible, and indelible; and
(4) Be dated, and signed or initialed by the person who performed
the activity documented.
(b) When records are required to be established and kept in
subparts C, E, F, L, and M of this part (Sec. Sec. 112.30, 112.50,
112.60, 112.140, and 112.150), you must establish and keep
documentation of actions you take when a standard in those subparts is
not met.
(c) Records required under Sec. Sec. 112.50(b)(4), 112.50(b)(5),
112.60(b)(1), 112.60(b)(3), 112.140, 112.150(b)(1), 112.150(b)(4), and
112.161(b), must be reviewed, dated, and signed, within a reasonable
time after the records are made, by a supervisor or responsible party.

Sec. 112.162 Where must I store records?

(a) Offsite storage of records is permitted after 6 months
following the date the record was made if such records can be retrieved
and provided onsite within 24 hours of request for official review.
(b) Electronic records are considered to be onsite at your farm if
they are accessible from an onsite location at your farm.

Sec. 112.163 May I use existing records to satisfy the requirements
of this part?

Yes. The regulations in this part do not require duplication of
existing records if those records contain all of the information
required by this part.

Sec. 112.164 How long must I keep records?

(a) You must keep records required by this part for 2 years past
the date the record was created.
(b) Records that relate to the general adequacy of the equipment or
processes being used by a farm, including the results of scientific
studies and evaluations, must be retained at the farm for at least 2
years after the use of such equipment or processes is discontinued.

Sec. 112.165 What formats are acceptable for the records I keep?

You must keep records as:
(a) Original records;
(b) True copies (such as photocopies, pictures, scanned copies,
microfilm, microfiche, or other accurate reproductions of the original
records); or
(c) Electronic records, in compliance with part 11 of this chapter.

Sec. 112.166 What requirements apply for making records available and
accessible to FDA?

(a) You must have all records required under this part readily
available and accessible during the retention period for inspection and
copying by FDA upon oral or written request, except that you have 24
hours to obtain records you keep offsite and make them available and
accessible to FDA for inspection and copying.
(b) If you use electronic techniques to keep records, or to keep
true copies of records, or if you use reduction techniques such as
microfilm to keep true copies of records, you must provide the records
to FDA in a format in which they are accessible and legible.
(c) If your farm is closed for a prolonged period, the records may
be transferred to some other reasonably accessible location but must be
returned to your farm within 24 hours for official review upon request.

Sec. 112.167 Can records that I provide to FDA be disclosed to
persons outside FDA?

Records required by this part are subject to the disclosure
requirements under part 20 of this chapter.

Subpart P--Variances

Sec. 112.171 Who may request a variance from the requirements of this
part?

A State or a foreign country from which food is imported into the
United States may request a variance from one or more requirements of
this part, where the State or foreign country determines that:
(a) The variance is necessary in light of local growing conditions;
and
(b) The procedures, processes, and practices to be followed under
the variance are reasonably likely to ensure that the produce is not
adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 342) and to provide the same level of public health
protection as the requirements of this part.

Sec. 112.172 How may a State or foreign country request a variance
from one or more requirements of this part?

To request a variance from one or more requirements of this part,
the

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competent authority (e.g., the regulatory authority for food safety)
for a State or a foreign country must submit a petition under Sec.
10.30 of this chapter.

Sec. 112.173 What must be included in the Statement of Grounds in a
petition requesting a variance?

In addition to the requirements set forth in Sec. 10.30 of this
chapter, the Statement of Grounds in a petition requesting a variance
must:
(a) Provide a statement that the applicable State or foreign
country has determined that the variance is necessary in light of local
growing conditions and that the procedures, processes, and practices to
be followed under the variance are reasonably likely to ensure that the
produce is not adulterated under section 402 of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 342) and to provide the same level of
public health protection as the requirements of this part;
(b) Describe with particularity the variance requested, including
the persons to whom the variance would apply and the provision(s) of
this part to which the variance would apply;
(c) Present information demonstrating that the procedures,
processes, and practices to be followed under variance are reasonably
likely to ensure that the produce is not adulterated under section 402
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) and to
provide the same level of public health protection as the requirements
of this part.

Sec. 112.174 What information submitted in a petition requesting a
variance or submitted in comments on such a petition are publicly
available?

We will presume that information submitted in a petition requesting
a variance and comments submitted on such a petition, including a
request that a variance be applied to its similarly situated persons,
does not contain information exempt from public disclosure under part
20 of this chapter and would be made public as part of the docket
associated with this request.

Sec. 112.175 Who responds to a petition requesting a variance?

The Director or Deputy Directors of the Center for Food Safety and
Applied Nutrition (CFSAN), or the Director, Office of Compliance,
CFSAN, responds to a request for a variance.

Sec. 112.176 What process applies to a petition requesting a
variance?

(a) In general, the procedures set forth in Sec. 10.30 of this
chapter govern our response to a petition requesting a variance.
(b) Under Sec. 10.30(h)(3) of this chapter, we will publish a
notice in the Federal Register, requesting information and views on a
filed petition, including information and views from persons who could
be affected by the variance if the petition were to be granted (either
because their farm is covered by the petition or as a person similarly
situated to persons covered by the petition).
(c) Under Sec. 10.30(e)(3) of this chapter, we will respond to the
petitioner in writing and will also make public a notice on FDA's Web
site announcing our decision to either grant or deny the petition.
(1) If we grant the petition, either in whole or in part, we will
specify the persons to whom the variance applies and the provision(s)
of this part to which the variance applies.
(2) If we deny the petition (including partial denials), our
written response to the petitioner and our public notice announcing our
decision to deny the petition will explain the reason(s) for the
denial.
(d) We will make readily accessible to the public, and periodically
update, a list of filed petitions requesting variances, including the
status of each petition (for example, pending, granted, or denied).

Sec. 112.177 Can an approved variance apply to any person other than
those identified in the petition requesting that variance?

(a) A State or a foreign country that believes that a variance
requested by a petition submitted by another State or foreign country
should also apply to similarly situated persons in its jurisdiction may
request that the variance be applied to its similarly situated persons
by submitting comments in accordance with Sec. 10.30 of this chapter.
These comments must include the information required in Sec. 112.173.
If FDA determines that these comments should instead be treated as a
separate request for a variance, FDA will notify the State or foreign
country that submitted these comments that a separate request must be
submitted in accordance with Sec. Sec. 112.172 and Sec. 112.173.
(b) If we grant a petition requesting a variance, in whole or in
part, we may specify that the variance also applies to persons in a
specific location who are similarly situated to those identified in the
petition.
(c) If we specify that the variance also applies to persons in a
specific location who are similarly situated to those identified in the
petition, we will inform the applicable State or foreign country where
the similarly situated persons are located of our decision in writing
and will publish a notice on our Web site announcing our decision to
apply the variance to similarly situated persons in that particular
location.

Sec. 112.178 Under what circumstances may FDA deny a petition
requesting a variance?

We may deny a variance request if it does not provide the
information required under Sec. 112.173 (including the requirements of
Sec. 10.30 of this chapter), or if we determine that the variance is
not reasonably likely to ensure that the produce is not adulterated
under section 402 of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
342) and to provide the same level of public health protection as the
requirements of this part.

Sec. 112.179 When does a variance approved by FDA become effective?

A variance approved by FDA becomes effective the date of our
written decision on the petition.

Sec. 112.180 Under what circumstances may FDA modify or revoke an
approved variance?

We may modify or revoke a variance if we determine that such
variance is not reasonably likely to ensure that the produce is not
adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 342) and to provide the same level of public health
protection as the requirements of this part.

Sec. 112.181 What procedures apply if FDA determines that an approved
variance should be modified or revoked?

(a) We will provide the following notifications:
(1) We will notify a State or a foreign country directly, in
writing at the address identified in its petition, if we determine that
a variance granted in response to its petition should be modified or
revoked. Our direct, written notification will provide the State or
foreign country with an opportunity to request an informal hearing
under part 16 of this chapter.
(2) We will publish a notice of our determination that a variance
should be modified or revoked in the Federal Register. This notice will
establish a public docket so that interested parties may submit written
submissions on our determination.
(3) When applicable, we will:
(i) Notify in writing any States or foreign countries where a
variance applies to similarly situated persons of our determination
that the variance should be modified or revoked;
(ii) Provide those States or foreign countries with an opportunity
to request

[[Page 3644]]

an informal hearing under part 16 of this chapter; and
(iii) Include in the Federal Register notice described in paragraph
(a)(2) of this section public notification of our decision to modify or
revoke the variance granted to States or foreign countries in which
similarly situated persons are located.
(b) We will consider submissions from affected States or foreign
countries and from other interested parties as follows:
(1) We will consider requests for hearings by affected States or
foreign countries under part 16 of this chapter.
(i) If FDA grants a hearing, we will provide the State or foreign
country with an opportunity to make an oral submission. We will provide
notice on our Web site of the hearing, including the time, date, and
place of hearing.
(ii) If more than one State or foreign country requests an informal
hearing under part 16 of this chapter about our determination that a
particular variance should be modified or revoked, we may consolidate
such requests (for example, into a single hearing).
(2) We will consider written submissions submitted to the public
docket from interested parties.
(c) We will provide notice of our final decision as follows:
(1) On the basis of the administrative record, FDA will issue a
written decision, as provided for under part 16 of this chapter.
(2) We will publish a notice of our decision in the Federal
Register. The effective date of the decision will be the date of
publication of the notice.

Sec. 112.182 What are the permissible types of variances that may be
granted?

Examples of permissible types of variances include:
(a) Variance from the requirements, established in Sec. 112.44(c),
when agricultural water is used during growing operations for covered
produce (other than sprouts) using a direct water application method.
(b) Variance from the process conditions, established in Sec.
112.54(c)(1), for static composting;
(c) Variance from the process conditions, established in Sec.
112.54(c)(2), for turned composting;
(d) Variance from the minimum application interval, established in
Sec. 112.56(a)(1), for an untreated biological soil amendment of
animal origin; and
(e) Variance from the minimum application interval, established in
Sec. 112.56(a)(4), for a biological soil amendment of animal origin
treated by a composting process in accordance with the requirements of
Sec. 112.54(c).

Subpart Q--Compliance and Enforcement

Sec. 112.191 How do the criteria and definitions in this part apply?

The criteria and definitions in this part apply in determining
whether a food is adulterated:
(a) Within the meaning of section 402(a)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)) in that the food has been
grown, harvested, packed, or held under such conditions that it is
unfit for food; or
(b) Within the meaning of section 402(a)(4) of the Federal Food,
Drug, and Cosmetic Act in that the food has been prepared, packed, or
held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious
to health. The criteria and definitions in this part also apply in
determining whether a food is in violation of section 361 of the Public
Health Service Act (42 U.S.C. 264).

Sec. 112.192 What is the result of a failure to comply with this
part?

The failure to comply with the requirements of this part, issued
under section 419 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350h), is a prohibited act under section 301(vv) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331(vv)).

Sec. 112.193 What are the provisions for coordination of education
and enforcement?

Under Section 419(b)(2)(A) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 350h(b)(2)(A)), FDA coordinates education and
enforcement activities by State, Territorial, tribal, and local
officials.

Subpart R--Withdrawal of Qualified Exemption

Sec. 112.201 Under what circumstances can FDA withdraw a qualified
exemption in accordance with the requirements of Sec. 112.5?

We may withdraw your qualified exemption under Sec. 112.5:
(a) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to your farm; or
(b) If we determine that it is necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak based on
conduct or conditions associated with your farm that are material to
the safety of the food that would otherwise be covered produce grown,
harvested, packed or held at your farm.

Sec. 112.202 What procedure will FDA use to withdraw an exemption?

(a) If FDA determines that a qualified exemption applicable to a
farm under Sec. 112.5 should be withdrawn, any officer or qualified
employee of FDA may issue an order to withdraw the exemption.
(b) An FDA District Director in whose district the farm is located
(or, in the case of a foreign farm, the Director of the Office of
Compliance in the Center for Food Safety and Applied Nutrition), or an
FDA official senior to such Director, must approve an order to withdraw
the exemption.
(c) FDA must issue an order to withdraw the exemption to the owner,
operator, or agent in charge of the farm.
(d) FDA must issue an order to withdraw the exemption in writing,
signed and dated by the officer or qualified employee of FDA who is
issuing the order.

Sec. 112.203 What information must FDA include in an order to
withdraw a qualified exemption?

An order to withdraw a qualified exemption applicable to a farm
under Sec. 112.5 must include the following information:
(a) The date of the order;
(b) The name, address and location of the farm;
(c) A brief, general statement of the reasons for the order,
including information relevant to:
(1) An active investigation of a foodborne illness outbreak that is
directly linked to the farm; or
(2) Conduct or conditions associated with a farm that are material
to the safety of the food that would otherwise be covered produce
grown, harvested, packed and held at such farm.
(d) A statement that the farm must comply with subparts B through O
of this part on the date that is 60 calendar days after the date of the
order;
(e) The text of section 419(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350(f)) and of this subpart;
(f) A statement that any informal hearing on an appeal of the order
must be conducted as a regulatory hearing under part 16 of this
chapter, with certain exceptions described in Sec. 112.208;
(g) The mailing address, telephone number, email address, and
facsimile number of the FDA district office and the name of the FDA
District Director in whose district the farm is located (or for foreign
farms, the same information for the Director of the Office of
Compliance in the Center for Food Safety and Applied Nutrition); and
(h) The name and the title of the FDA representative who approved
the order.

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Sec. 112.204 What must I do if I receive an order to withdraw a
qualified exemption applicable to my farm?

The owner, operator, or agent in charge of a farm that receives an
order to withdraw a qualified exemption applicable to that farm under
Sec. 112.5 must either:
(a) Comply with applicable requirements of this part within 60
calendar days of the date of the order or, if operations have ceased
and will not resume within 60 calendar days, before the beginning of
operations in the next growing season; or
(b) Appeal the order within 10 calendar days of the date of the
order in accordance with the requirements of Sec. 112.206.

Sec. 112.205 Can I appeal or request a hearing on an order to
withdraw a qualified exemption applicable to my farm?

(a) Submission of an appeal, including submission of a request for
an informal hearing, will not operate to delay or stay any
administrative action, including enforcement action by FDA, unless the
Commissioner of Food and Drugs, as a matter of discretion, determines
that delay or a stay is in the public interest.
(b) If the owner, operator, or agent in charge of the farm appeals
the order, and FDA confirms the order, the owner, operator, or agent in
charge of the farm must comply with applicable requirements of this
part within 60 calendar days of the date of the order, or, if
operations have ceased and will not resume within 60 calendar days,
before the beginning of operations in the next growing season.

Sec. 112.206 What is the procedure for submitting an appeal?

(a) To appeal an order to withdraw a qualified exemption applicable
to a farm under Sec. 112.5, the owner, operator, or agent in charge of
the farm must:
(1) Submit the appeal in writing to the FDA District Director in
whose district the farm is located (or in the case of a foreign farm,
the Director of the Office of Compliance in the Center for Food Safety
and Applied Nutrition), at the mailing address, email address, or
facsimile number identified in the order within 10 calendar days of the
date of the order; and
(2) Respond with particularity to the facts and issues contained in
the order, including any supporting documentation upon which the owner,
operator or agent in charge of the farm relies.
(b) In a written appeal of the order withdrawing an exemption
provided under Sec. 112.5, the owner, operator, or agent in charge of
the farm may include a written request for an informal hearing as
provided in Sec. 112.207.

Sec. 112.207 What is the procedure for requesting an informal
hearing?

(a) If the owner, operator, or agent in charge of the farm appeals
the order, the owner, operator, or agent in charge of the farm:
(1) May request an informal hearing; and
(2) Must submit any request for an informal hearing together with
its written appeal submitted in accordance with Sec. 112.206 within 10
calendar days of the date of the order.
(b) A request for an informal hearing may be denied, in whole or in
part, if the presiding officer determines that no genuine and
substantial issue of material fact has been raised by the material
submitted. If the presiding officer determines that a hearing is not
justified, a written notice of the determination will be given to the
owner, operator, or agent in charge of the farm explaining the reason
for the denial.

Sec. 112.208 What requirements are applicable to an informal hearing?

If the owner, operator or agent in charge of the farm requests an
informal hearing, and FDA grants the request:
(a) The hearing will be held within 10 calendar days after the date
the appeal is filed or, if applicable, within a timeframe agreed upon
in writing by the owner, operator, or agent in charge of the farm and
FDA.
(b) The presiding officer may require that a hearing conducted
under this subpart be completed within 1 calendar day, as appropriate.
(c) FDA must conduct the hearing in accordance with part 16 of this
chapter, except that:
(1) The order withdrawing an exemption under Sec. 112.5, rather
than the notice under Sec. 16.22(a) of this chapter, provides notice
of opportunity for a hearing under this section and is part of the
administrative record of the regulatory hearing under Sec. 16.80(a) of
this chapter.
(2) A request for a hearing under this subpart must be addressed to
the FDA District Director (or, in the case of a foreign farm, the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition) as provided in the order withdrawing an exemption.
(3) Section 112.209, rather than Sec. 16.42(a) of this chapter,
describes the FDA employees who preside at hearings under this subpart.
(4) Section 16.60(e) and (f) of this chapter does not apply to a
hearing under this subpart. The presiding officer must prepare a
written report of the hearing. All written material presented at the
hearing will be attached to the report. The presiding officer must
include as part of the report of the hearing a finding on the
credibility of witnesses (other than expert witnesses) whenever
credibility is a material issue, and must include a proposed decision,
with a statement of reasons. The hearing participant may review and
comment on the presiding officer's report within 2 calendar days of
issuance of the report. The presiding officer will then issue the final
decision.
(5) Section 16.80(a)(4) of this chapter does not apply to a
regulatory hearing under this subpart. The presiding officer's report
of the hearing and any comments on the report by the hearing
participant under Sec. 112.208(c)(4) are part of the administrative
record.
(6) No party shall have the right, under Sec. 16.119 of this
chapter to petition the Commissioner of Food and Drugs for
reconsideration or a stay of the presiding officer's final decision.
(7) If FDA grants a request for an informal hearing on an appeal of
an order withdrawing an exemption, the hearing must be conducted as a
regulatory hearing under regulation in accordance with part 16 of this
chapter, except that Sec. 16.95(b) does not apply to a hearing under
this subpart. With respect to a regulatory hearing under this subpart,
the administrative record of the hearing specified in Sec. Sec.
16.80(a)(1), (a)(2), (a)(3), and (a)(5), and Sec. 112.208(c)(5)
constitutes the exclusive record for the presiding officer's final
decision. For purposes of judicial review under Sec. 10.45 of this
chapter, the record of the administrative proceeding consists of the
record of the hearing and the presiding officer's final decision.

Sec. 112.209 Who is the presiding officer for an appeal and for an
informal hearing?

The presiding officer for an appeal, and for an informal hearing,
must be an FDA Regional Food and Drug Director or another FDA official
senior to an FDA District Director.

Sec. 112.210 What is the timeframe for issuing a decision on an
appeal?

(a) If the owner, operator, or agent in charge of a farm appeals
the order without requesting a hearing, the presiding officer must
issue a written report that includes a final decision confirming or
revoking the withdrawal by the 10th calendar day after the appeal is
filed.

[[Page 3646]]

(b) If the owner, operator, or agent in charge of a farm appeals
the order and requests an informal hearing:
(1) If FDA grants the request for a hearing and the hearing is
held, the presiding officer must provide a 2 calendar day opportunity
for the hearing participants to review and submit comments on the
report of the hearing under Sec. 112.208(c)(4), and must issue a final
decision within 10 calendar days after the hearing is held; or
(2) If FDA denies the request for a hearing, the presiding officer
must issue a final decision on the appeal confirming or revoking the
withdrawal within 10 calendar days after the date the appeal is filed.

Sec. 112.211 When is an order to withdraw a qualified exemption
applicable to a farm revoked?

An order to withdraw a qualified exemption applicable to a farm
under Sec. 112.5 is revoked if:
(a) The owner, operator, or agent in charge of the farm appeals the
order and requests an informal hearing, FDA grants the request for an
informal hearing, and the presiding officer does not confirm the order
within the 10 calendar days after the hearing, or issues a decision
revoking the order within that time; or
(b) The owner, operator, or agent in charge of the farm appeals the
order and requests an informal hearing, FDA denies the request for an
informal hearing, and FDA does not confirm the order within the 10
calendar days after the appeal is filed, or issues a decision revoking
the order within that time; or
(c) The owner, operator, or agent in charge of the farm appeals the
order without requesting an informal hearing, and FDA does not confirm
the order within the 10 calendar days after the appeal is filed, or
issues a decision revoking the order within that time.
(d) Confirmation of a withdrawal order by the presiding officer is
considered a final Agency action for purposes of 5 U.S.C. 702.

Dated: January 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00123 Filed 1-4-13; 11:15 am]
BILLING CODE 4160-01-P