[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)]
[Rules and Regulations]
[Pages 27557-27563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11581]
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Rules and Regulations
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Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Rules
and Regulations
[[Page 27557]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR part 417
[Docket No. FSIS-2009-0019]
HACCP Systems Validation
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice of availability.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
the availability of the final revision of the Compliance Guideline for
Hazard Analysis Critical Control Point (HACCP) systems validation and
responding to comments received on the draft guide that FSIS published
in May 2013 in the Federal Register. In addition, FSIS is announcing
its plans to verify that establishments meet all validation
requirements.
DATES: Establishments may start using the new guidance now. FSIS will
begin verifying that large establishments meet all validation
requirements on January 4, 2016. FSIS will begin verifying that small
and very small establishments meet all verification requirements on
April 4, 2016.
FOR FURTHER INFORMATION CONTACT: William K. Shaw, Jr., Ph.D., Office of
Policy and Program Development, FSIS, USDA, 1400 Independence Avenue
SW., Patriots Plaza 3, Mailstop 3782, Room 8-142, Washington, DC 20250.
Telephone: (301) 504-0852 Fax: (202) 245-4792. Email:
[email protected].
Background
FSIS administers the Federal Meat Inspection Act (FMIA) (21 U.S.C.
601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C.
451 et seq.) to protect the health and welfare of consumers by
preventing the distribution in commerce of meat or poultry products
that are unwholesome, adulterated, or misbranded. To reduce the risk of
foodborne illness from meat or poultry products, FSIS issued
regulations on July 25, 1996, that require that federally inspected
establishments adopt HACCP systems (61 FR 38806). These regulations
require that federally inspected establishments adopt measures to
prevent or control the occurrence of food safety hazards at each stage
of the production process where such hazards are reasonably likely to
occur.
The HACCP regulations in 9 CFR part 417 require that establishments
validate the HACCP plan's adequacy to control the food safety hazards
identified by the hazard analysis (9 CFR 417.4(a)). These regulations
prescribe requirements for the initial validation of an establishment's
HACCP plan and require that establishments ``conduct activities
designed to determine that the HACCP plan is functioning as intended.''
During this initial validation period, establishments are to
``repeatedly test the adequacy of the CCPs, critical limits, monitoring
and recordkeeping procedures, and corrective actions'' prescribed in
their HACCP plans (9 CFR 417.4(a)(1)). Validation under 9 CFR
417.4(a)(1) requires that establishments assemble two types of data:
(1) The scientific or technical support for the judgments made in
designing the HACCP system, and (2) evidence derived from the HACCP
plan in operation to demonstrate that the establishment is able to
implement the critical operational parameters necessary to achieve the
results documented in the scientific or technical support. The
establishment is to maintain the initial validation records for the
life of the HACCP system to meet the requirements of 9 CFR 417.5(a)(1)
and 9 CFR 417.5(a)(2).
The regulations also provide that ``[v]alidation . . . encompasses
reviews of the records themselves, routinely generated by the HACCP
system, in the context of other validation activities'' (9 CFR
417.4(a)(1)). Because the results obtained under prerequisite programs
could affect decisions made in the hazard analysis, an establishment is
required to maintain records associated with these programs as
supporting documentation for its hazard analysis (9 CFR 417.5(a)).
Thus, validation of the HACCP system involves validation of the
critical control points in the HACCP plan, as well as of any
interventions or processes used to support decisions in the hazard
analysis.
History of Validation Guidance
In March 2010, FSIS posted on its Web site an initial draft
guidance document to assist the industry, particularly small and very
small establishments, in complying with the requirements for HACCP
systems, pursuant to 9 CFR 417.4.
On June 14, 2010, FSIS held a public meeting to discuss the initial
draft HACCP validation guidance and received input from stakeholders.
The transcript of the June 2010 public meeting is available on the FSIS
Web site at: http://www.fsis.usda.gov/wps/wcm/connect/2708ef10-4996-4324-a2e2-3b6501ac81b1/Transcripts_HACCP_Validation_061410.pdf?MOD=AJPERES.
FSIS received over 2,000 comments on the initial draft guidance,
particularly with respect to the use of microbiological testing to
validate the effectiveness of HACCP systems in controlling biological
hazards. The Agency considered the issues raised by the comments
received in response to the May 2010 Federal Register notice and at the
June 2010 public meeting and developed an updated second draft of the
compliance guidance.
On September 22-23, 2011, FSIS shared the second draft of the HACCP
validation guidance with the National Advisory Committee on Meat and
Poultry Inspection (NACMPI). NACMPI reviewed the draft and provided
comments and suggestions to FSIS on how to improve the guidance. The
NACMPI report is available on the FSIS Web site at: http://www.fsis.usda.gov/wps/wcm/connect/c87523dc-44d4-446e-be03-a3e60b2f8e8f/Validation_Issue_Paper_Final.pdf?MOD=AJPERES. The Agency made
additional revisions to the draft guidance in response to the input
from NACMPI.
In a May 9, 2012, Federal Register notice (77 FR 27135), FSIS
announced the availability of, and requested comments on, the revised
draft guidance document (http://www.fsis.usda.gov/wps/wcm/connect/d000cb67-23bc-4303-8f7b-71dcba5e7cd7/2009-0019.pdf?MOD=AJPERES). In the
May 2012 Federal Register notice, the Agency also clarified its
requirements
[[Page 27558]]
for HACCP system validation and responded to the comments that it had
received on the initial draft guidance. FSIS received fifty-one (51)
comments on its May 2012 revised draft guidance.
FSIS carefully considered the comments and, in a May 2013 Federal
Register notice (78 FR 32186; May 29, 2013), announced a further
revised draft guidance document. In addition to responding to comments
and publishing the newly revised draft, FSIS also announced a final
public meeting, which was held on June 25, 2013. The transcript of the
June 2013 public meeting is available on the FSIS Web site at: http://www.fsis.usda.gov/wps/wcm/connect/d618094d-20f2-40a3-9103-a587b2fd8a01/Transcript-HACCP-Validation-062513.pdf?MOD=AJPERES.
Final Guidance
The final guidance is posted at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. FSIS
encourages establishments to use the guidance to assist them in
complying with validation requirements. This guide represents FSIS's
thinking and has been updated based on the most recent comments
discussed below. FSIS will update it as necessary in the future.
In response to the comments discussed below, the Agency made
several improvements to the final guidance to clarify scientific
support and in-plant data requirements. In addition to adding a
description of expert advice from a processing authority as an example
of an acceptable type of scientific support, the guidance now also
provides information on how to design challenge studies and on types of
microbiological data that should be included in the scientific support.
FSIS has also included a new section in the guidance on the types of
scientific support that could be used to validate prerequisite programs
and a description of best practice guidelines that may be used as
scientific or technical support. FSIS has provided additional
information on how establishments should address situations where their
scientific support does not include measurements of all critical
operational parameters. The guidance also clarifies the type of in-
plant data that establishments should collect to validate that a new
technology addresses hazards as intended. In addition, FSIS has added
information on how establishments should validate that a prerequisite
program works across multiple points or steps in the process. Finally,
the guidance now contains an additional example of scientific support
and in-plant data that can be used to validate storage temperature
prerequisite programs.
Response to Comments:
FSIS received twenty-one (21) comments on its May 2013 revised
draft guidance on HACCP validation from small and very small meat or
poultry processors, trade associations, corporations, a consumer
advocacy organization, a professional organization, and an individual.
The following summarizes and responds to the major issues raised in the
comments to the most recent draft guidance document.
1. Concerns about Validation, Its Applicability, and Cost
Comment: A few commenters questioned the need for, and purpose of,
the HACCP validation guidance, and several others sought additional
information about what FSIS hopes to achieve by publishing the
guidance. One commenter requested that, on an ongoing basis, FSIS
provide examples of inadequate validation.
Response: As addressed in response to comments in the May, 2013
Federal Register notice (78 FR 32186), the validation guidance is
necessary because the Agency has found that establishments have not
adequately validated their systems. For example, following a 2011
foodborne illness outbreak involving Lebanon bologna, FSIS found that
the establishment's scientific support on file did not match the
process the establishment was using to make the bologna. In 2012, FSIS
concluded that E. coli (non-O157) positives likely occurred because of
improperly designed interventions. Similarly, FSIS determined that an
outbreak involving chicken pot pies in 2007 and a 2011 outbreak from
turkey burgers may have occurred because of improperly validated
cooking instructions.
FSIS developed the guidelines particularly to help small and very
small establishments comply with the regulatory requirements for
validation. By periodically updating the guidance document, FSIS will
continue to share, and explain how to address, examples of inadequate
validation that are associated with food safety problems.
Comment: Many commenters stated that cost of validation is high.
One commenter said that the cost of validation may discourage meat
establishments from implementing new food safety strategies or
interventions.
Response: Validation requirements are not new. FSIS estimates that
costs associated with any new validation activities will be minimal. As
addressed previously in response to comments and in previous versions
of the guidance, microbiological testing is only necessary for in-plant
data in limited circumstances, and FSIS has provided low cost ways that
establishments can validate their systems in place of microbiological
testing. FSIS expects that many establishments will be able to gather
the necessary in-plant data from HACCP records already routinely being
generated as part of the HACCP system.
Comment: A few commenters stated that FSIS is altering the meaning
of ``validation,'' especially when looking at accepted HACCP validation
methods from 1996 to today. One commenter asked whether an
establishment could choose ``conventional'' command and control
inspection instead of meeting HACCP requirements, including validation
requirements, if the establishment has a history of producing a safe
product.
Response: The final version of the guidance document is consistent
with the principles of validation as outlined in the 1996 Pathogen
Reduction; Hazard Analysis and Critical Control Point Systems Final
Rule (HACCP Final Rule). The HACCP Final Rule stated that data
assembled to validate a HACCP plan are usually of two types: (1)
theoretical principles, expert advice from processing authorities,
scientific data, or other information demonstrating that particular
process control measures can adequately address specified hazards (such
as studies establishing the temperatures necessary to kill organisms of
concern); and (2) in-plant observations, measurements, test results, or
other information demonstrating that the control measures, as written
into a HACCP plan, can be implemented within a particular establishment
to achieve the intended food safety objective. FSIS recognizes that
there has been misunderstanding related to the principles of
validation, which is why the Agency has developed this compliance
guideline and will be issuing instructions to the field once
establishments have been given the time to assemble the necessary
documentation.
As explained in the May 2013 Federal Register notice, the HACCP
Final Rule has resulted in great improvements in food safety. The
Agency is not going back to a command and control inspection approach
because it does not provide establishments with the flexibility to
design innovative systems and puts the responsibility for ensuring food
safety on FSIS as opposed to the establishment.
Comment: One commenter recommended that the guidance clarify
[[Page 27559]]
that establishments need to validate that prerequisite programs work as
intended in the overall HACCP system to prevent hazards from occurring.
The commenter said that the guidance should discuss validation of
prerequisite programs as a complete system, where those controls are
intended to support a conclusion that a hazard is not reasonably likely
to occur.
Response: Validation is the process of demonstrating that the HACCP
system, as designed, can adequately control identified hazards to
produce a safe, unadulterated product. Prerequisite programs designed
to support a decision in the hazard analysis are part of the HACCP
system. When an establishment determines that a hazard is not
reasonably likely to occur because the prerequisite program prevents
the hazard, that prerequisite program becomes part of the HACCP system.
Therefore, as the commenter recommended, establishments need to
validate prerequisite programs designed to support decisions in the
hazard analysis (e.g. Sanitation Standard Operating Procedures,
purchase specifications, antimicrobial interventions) to ensure that
the overall system can operate effectively. FSIS agrees that HACCP
systems are generally designed to provide multiple hurdles of control.
However, establishments should be able to support that each hurdle
provides some level of prevention or control for the identified
hazards.
As explained in the guidance, in order to validate such programs,
establishments need to provide scientific documentation that supports
that the programs will work as intended and to collect in-plant data to
support that the programs can be implemented as designed. FSIS has
revised the guidance to provide more examples related to validation of
prerequisite programs.
Comment: Several commenters stated that some small establishments
produce products so infrequently that they may not be able to obtain 13
production days' worth of records within 90 calendar days. One
commenter said that FSIS should ensure that establishments are afforded
sufficient flexibility to tailor their HACCP systems to their specific
circumstances and questioned the need for a mandatory, fixed validation
period. One commenter asked for additional instruction on the
information to include with a request to the District Office for
additional time to collect in-plant data (e.g., longer than 90 days).
Another commenter requested clarification regarding whether the request
for an extension to obtain records necessary for validation applies
only to establishments under a conditional grant, or if it applies to
all establishments.
Response: The regulations provide that the initial validation
period is 90 calendar days (9 CFR 304.3(b) and (c) and 381.22(b) and
(c)). Ninety days is the period whether a new establishment is
operating under a conditional grant, or an existing establishment
begins producing new product. Under either situation, for the first 90
days, establishments validate that their system is working as intended
to address hazards. For large establishments, 90 calendar days equates
to approximately 60 production days. (See FSIS Directive 5220.1 and 78
FR 32187.) FSIS recognizes that many small and very small
establishments do not operate daily. Therefore, the guidance also
states that a minimum level of records from 13 production days within
those initial 90 calendar days should be used to initially validate a
small or very small establishment's HACCP system. This number is
consistent with FSIS Directive 5220.1 related to an establishment's
initial validation. The Agency is recommending small and very small
establishments review data from as few as 13 production days because it
recognizes that collecting 60 production days' worth of records may be
burdensome to small and very small plants.
If the establishment infrequently produces several products that
are each part of a separate HACCP category, there is inherent risk with
the processes if the establishment does not have experience in
producing them. Therefore, to determine whether the system is properly
designed and executed, even though the regulations provide 90 days for
initial validation, an establishment needing more than 90 days can ask
the District Office, in writing, for additional time to collect at
least 13 production days of records when it first starts operating,
when it begins producing new product, or for a modified HACCP plan if
the results of a reassessment indicate additional support is needed. In
the request, an establishment should state why more than 90 days are
needed to collect the in-plant validation data, and how it plans to
gather at least 13 production days worth of in-plant validation data
within the next 30 calendar days. The request will then be evaluated on
a case by case basis. The establishment should consider focusing
validation activities on the product produced most frequently within
each HACCP category. In addition, the establishment may consider
evaluating data collected for products across multiple HACCP categories
to determine whether the data together can support its ability to meet
critical operational parameters.
Small and very small establishments that do not currently have the
necessary in-plant demonstration data will have until April 4, 2016 to
collect the necessary documentation. Infrequent producers should be
able to collect data from 13 production days over this time-frame.
Comment: One commenter questioned whether small plants receiving
boxed beef components will be required to validate how their multiple
processes will address contamination introduced to the product before
arriving at the establishment.
Response: All establishments are required to validate that their
food safety systems address hazards. There is no one, absolute way in
which an establishment producing raw non-intact beef components is to
control or prevent Shiga-toxin producing Escherichia coli (STEC)
organisms in the product. An establishment may have Critical Control
Points (CCPs) in its HACCP plan to control the hazard, may use its
Sanitation Standard Operating Procedures or another prerequisite
program to prevent the hazard, or may use a combination of these
mechanisms. Establishments receiving product for grinding may have
purchase specifications requiring that all their suppliers have one or
more CCPs validated to eliminate or to reduce STEC organisms below
detectable levels. Establishments, as part of their purchase
specifications, may also receive certificates of analysis with each lot
of raw beef components stating that the product has been tested and is
negative for STEC organisms. In order to validate such pre-requisite
programs, establishments need to provide scientific documentation that
supports that the programs will work as intended and to collect in-
plant data to support that the programs can be implemented as designed.
In the guidance, the validation worksheets include an example of the
types of scientific support and in-plant data that can be used to
validate a prerequisite supplier program that is designed to prevent
the hazard from E. coli O157:H7 in raw ground beef or beef trim from
being reasonably likely to occur.
In-Plant Data
Comment: Two commenters stated that the Agency is trying to mandate
testing through enforcing validation requirements.
[[Page 27560]]
Response: As addressed in the May, 2013 Federal Register notice (78
FR 32189) and previous drafts of the guidance, microbiological testing
is needed for in-plant data in only limited circumstances where the
scientific support is inadequate. FSIS will not require establishments
to gather in-plant data before and after the application of an
intervention if the establishment has adequate scientific supporting
documentation, is following the parameters in the scientific support,
and can demonstrate that it can meet the critical parameters during
operation.
Scientific Support
Comment: One commenter stated that an establishment lacking
experience with a new technology should not have to collect additional
scientific support for its process and should be able to rely on
existing scientific support and in-plant data.
Response: The current version of the guidance clarifies that an
establishment introducing a new technology not established in the
literature or applying a standard technology in an unusual way (e.g.,
modifying critical operational parameters from the literature) should
gather scientific support and in-plant validation for its new or
modified HACCP system under commercial operating conditions. It also
clarifies that an establishment that lacks experience with a new
technology should also gather scientific and in-plant validation data
with the exception of when the effectiveness of the new technology has
already been studied, but the establishment lacks experience
implementing the technology. In this case, the effort to develop such
information may focus more on the collection on in-plant validation
data.
Comment: Many commenters stated that there will always be
differences between scientific studies and actual establishment
processes, and that critical operational parameters implemented in
actual processes may be missing from or different than those in the
supporting scientific studies. Some commenters were also worried that
it may be costly to conduct the necessary scientific research on the
specific process used in the establishment. One commenter also said
that the fact that the guidance states that ``equipment'' is a critical
operational parameter may lead some establishment personnel, as well as
FSIS inspection personnel, to assume that the equipment must be exactly
the same (e.g., same manufacturer or model number) as that used in the
scientific study. Another commenter asked whether establishments are
required to validate each piece of equipment. One commenter also
requested the Agency define ``process authority'' and state when
information from a processing authority would be acceptable scientific
support.
Response: As explained in the current and previous versions of the
guideline, critical operational parameters are the specific conditions
that the intervention must operate under in order for it to be
effective. Therefore, if the critical operational parameters
implemented in the actual process are consistent with those in the
supporting documentation, then establishments can expect to achieve
similar results as those found in the scientific support. FSIS has
identified a number of cases where differences in critical operational
parameters between an establishment's scientific support and those
implemented in the actual process led to food safety problems. For this
reason, it is important that the establishment's actual process follow
the critical operational parameters in its scientific support.
FSIS recognizes that there may be cases where levels of a critical
operational parameter in the scientific support may not match the level
used in the actual process but is still effective. In those cases, as
stated in the guidance, to document its scientific support the
establishment should document its scientific rationale for determining
that a different level would not affect the efficacy of the
intervention or process. Such a justification can be provided by a
process authority. However, as recommended in the guideline, the
justification should include reference to peer-reviewed scientific data
and should not rely on the processing authority's expert opinion alone
to ensure that the decision is science based. If the establishment does
not have a scientifically based rationale for why the different level
would not affect the efficacy of the intervention or process, then the
establishment would need to gather additional data.
When an establishment uses critical operational parameters from
multiple studies together in the same process, the establishment will
need to support that the new combination of parameters would be as
effective as those studied in the individual articles. An establishment
will also need additional support if its documentation does not contain
measurement of a critical operational parameter. For example, humidity
is known to be a critical operational parameter during cooking. If an
establishment's support for a heat treatment does not address humidity,
the establishment will need to document why this parameter is not
critical for that treatment. If no scientific justification can be
provided, then the establishment will likely need additional data to
support the undocumented process.
The guidance continues to state that equipment is a critical
operational parameter because the correct equipment is necessary to
achieve other critical operational parameters within the process. Based
on the comments, FSIS has clarified in the revised guidance that the
equipment is a critical operational parameter in situations when using
completely different equipment (e.g., a manual spray pump vs. a spray
cabinet or a commercial smokehouse vs. a home-style dehydrator) would
not achieve the critical parameters of the study (such as temperature,
pressure, duration, volume, relative humidity). In most cases, the same
equipment produced under a different model number or by a different
manufacturer (e.g., a spray cabinet or smokehouse produced by a
different manufacturer than that reported in the scientific support)
should not affect the establishment's ability to meet other critical
operational parameters such as temperature or pressure.
Comment: One commenter asked whether Agency personnel would accept
many commonly used supporting documents (e.g. Appendix A of the
Compliance Guidelines For Meeting Lethality Performance Standards For
Certain Meat And Poultry Products) as scientific support for validating
the establishment's process.
Response: Establishments may continue to use Appendix A as
scientific support to validate that their food safety system
effectively addresses hazards. FSIS included a Q&A in the previous and
current versions of the guidance that addresses this concern.
Specifically, the guidance reads, ``Question: If I use Appendix A as
the scientific support documentation for a fully cooked RTE process, do
I need additional scientific information? Answer: No, Appendix A has
been validated to achieve the performance standards for the reduction
of Salmonella contained in 9 CFR 318.17(a)(1) and 381.150(a)(1).
Therefore, provided all critical operational parameters can be met, no
additional support is needed.'' FSIS has and will continue to instruct
inspection program personnel (IPP) and Enforcement, Investigation, and
Analysis Officers (EIAOs) that FSIS guidance documents are a type of
scientific support that may be used by
[[Page 27561]]
establishments to meet the first element of validation.
Comment: One commenter questioned how an establishment could relate
the effectiveness of a food safety strategy to a specific pathogen and
adhere to the process that actually occurs in the plant, if pathogens
cannot be introduced into the establishment. The commenter references a
2002 guidance document titled ``Guidance for Minimizing the Risk of
Escherichia coli O157H:7 and Salmonella in Beef Slaughter Operations''
(http://www.fsis.usda.gov/wps/wcm/connect/74de2bea-74d6-491b-b2cf-0047650bf0c6/BeefSlauterGuide.pdf?MOD=AJPERES) and a discussion in the
guidance document regarding indicator testing. Another commenter stated
that the following statement may prevent innovation when scientific
support is not readily available: ``[i]n general, establishments should
not rely on scientific support containing data only from indicator or
surrogate organisms unless there is sufficient data to establish a
relationship between the presence or level of a pathogen or toxin and
the indicator organism.'' The commenter said that indicator or
surrogate organisms can be used in-plant, provided there is data to
establish a relationship between the two.
Response: The previous and current versions of the validation
guidance document address the use of indicator organisms during in-
plant validation studies (page 14). FSIS agrees that an establishment
may use an indicator or surrogate organism to validate a process in-
plant, provided there is data to establish a relationship between the
indicator or surrogate and pathogen. This fact is stated on page 14 and
is consistent with the discussion on indicator organisms in the
``Guidance for Minimizing the Risk of Escherichia coli O157H:7 and
Salmonella in Beef Slaughter Operations.'' FSIS does not agree that the
guidance will prevent innovation and is unclear why the commenter feels
it will prevent innovation.
Comment: Several commenters suggested that a consortium to identify
critical operational parameters would be useful. Commenters also
requested that FSIS provide a reference guide, pointing establishments
to scientific documents and guidance on support for monitoring
frequencies of CCPs be provided. One commenter asked where small and
very small plant owners should get assistance with validating their
HACCP plans and asked whether, and to what extent, the Agency's small
plant office will give guidance to plant operators.
Response: FSIS has several resources available to assist
establishments with identifying critical operational parameters from
scientific support documents including the askFSIS system and the small
plant help desk. FSIS has also identified HACCP contacts and
coordinators on its Web site that provide technical advice, assistance,
and resources and that conduct activities to support HACCP
implementation in small and very small plants.
Comment: Two commenters stated that the guidance that
establishments validate at least one product per HACCP category was not
helpful. One of the commenters said that the Agency is instructing the
meat industry to conduct its own individualized risk assessment of the
products produced and to make the appropriate determination without any
guidance from the Agency. The other commenter predicted that Agency
personnel will not accept in-plant data for one product within each
HACCP category as sufficient to validate the food safety system.
Response: The guidance explains how to properly validate by
identifying at least one product per HACCP category for which the
establishment collects in-plant data. FSIS has provided food science
principles that can be used to identify the products using a risk-based
framework. By using such principles establishments can select a product
most representative of a worst case scenario and therefore collect in-
plant data most protective of public health. FSIS recognized that
collecting data for more than one product within each HACCP category
could be burdensome. Therefore, the Agency requested input from NACMPI,
and the committee agreed with this approach.
Comment: A few commenters requested that the Agency include
examples of processes that may use Appendix A and Appendix B as
scientific support for validating their food safety system, since these
Agency documents are commonly utilized as scientific support.
Response: FSIS added examples of processes that can use Appendix A
or B as scientific support in the May 2013 guidance. Examples are
provided on pages 60 and 63 for processes using Appendix A and Appendix
B as scientific support.
Examples
Comment: One commenter asked why the roast beef example in the
validation worksheet (that used Appendix A as the scientific support)
did not identify dwell time.
Response: The example using Appendix A on page 63 does include a
dwell time of 112 minutes.
Comment: One commenter recommended that the worksheet examples be
more specific in terms of the type of data that should be collected.
Response: The guidance provides additional examples of the types of
scientific support and in-plant data that establishments could maintain
for different products and processes in Appendix 4. As explained in the
guidance, if an establishment has a specific question regarding the
type of data that should be collected for its process and product, it
can submit a question to the askFSIS system.
Comment: One commenter said that the ongoing verification
activities that are listed in the example on page 33 are unreasonable.
Based on a particular example, the commenter also expressed concern
that FSIS will require establishments to monitor all parameters on an
ongoing basis. One commenter recommended that FSIS explain that the
critical operational parameters are related to initial validation, and
that not all critical operational parameters need to be monitored on an
ongoing basis.
Response: The current and previous versions of the guidance
recognize that researchers may measure a number of parameters during a
scientific study. However, not all of these are critical to the
efficacy of the intervention studied. The establishment should document
and explain any differences in its production process relative to any
of the studies it used as supporting documentation. The current and
previous versions of the guideline also state that establishments may
only need to verify whether some of the critical operational parameters
are working as intended during the initial validation period (e.g.,
spatial configuration). The Agency does agree that in the cited example
in the guidance it was unclear (ongoing verification activities on page
32), and FSIS has better delineated the activities that are conducted
as part of monitoring vs. ongoing verification in the current guidance.
Agency Training and Implementation
Comment: Several commenters asked the Agency to identify who is
going to train all of the FSIS inspectors. The commenters also said
FSIS needs to ensure consistency in enforcing verification
requirements. One commenter requested that FSIS issue formal
instructions to field personnel on verifying that establishments meet
validation requirements. The
[[Page 27562]]
commenter also recommended that FSIS provide IPP with on-line training.
Response: FSIS will provide instructions to IPP and EIAOs on how to
verify validation requirements through FSIS Notices and Directives. The
Agency also plans to provide necessary training to IPP and EIAOs.
Comment: One commenter asked that Agency outreach staff conduct
regional sessions around the country to explain validation requirements
to industry.
Response: FSIS will be holding webinars with the industry to
communicate the recommendations in the final guidance document, clarify
the regulations, and explain how FSIS will verify that establishments
use both scientific support and in-plant data to validate that their
systems, as designed and implemented, are working to address hazards.
Comment: One commenter said that large establishments should be
given more than six months to assemble the necessary in-plant
validation documentation. The commenter stated that not all
establishments may produce all products under all HACCP plans during
the six-month period. Another commenter said that small and very small
plants should be given more than 3 months longer than large plants to
assemble the necessary documentation.
Response: FSIS will implement its new verification activities by
phasing them in based on establishment size. For large establishments,
the Agency plans to wait until January 4, 2016, to start verifying that
establishments meet all validation requirements, including maintaining
in-plant validation data. Thus, large establishments will have
approximately seven months to gather all necessary in-plant
demonstration documents. FSIS believes this timeframe is adequate for
large establishments to gather the necessary documentation because many
of these establishments will be able to gather in-plant data from HACCP
records that are already generated as part of the monitoring of
critical limits or parameters of prerequisite programs. In addition,
FSIS's implementation will correspond with establishments' annual
reassessment. As part of the annual reassessment, establishments will
review the data gathered during initial validation along with other
documents gathered as part of the implementation of the HACCP system to
evaluate the adequacy of the HACCP plan.
FSIS intends to begin verifying that small and very small
establishments meet all validation requirements beginning on April 4,
2016. Therefore, these establishments will have approximately ten
months to gather all necessary in-plant demonstration documents before
FSIS will verify and enforce the second element of validation.
Comment: Two commenters asked for information on who was going to
verify establishments meet validation requirements. These commenters
asked whether FSIS would ``approve'' establishments' validation
documentation. One commenter also asked whether the Public Health
Information System (PHIS) is programmed to have validation checks
recorded.
Response: FSIS does not approve an establishment's validation
records. FSIS verifies compliance with regulatory requirements. IPP,
including EIAOs, verify that establishments meet validation
requirements, and FSIS will be providing instructions for performing
verification for both types of personnel. Inspectors will verify that
establishments meet validation requirements during performance of the
Hazard Analysis Verification (HAV) tasks, and EIAOs will do a more in-
depth verification of establishment records to verify that
establishments meet the validation requirement during food safety
assessments. All Agency verification activities are documented in the
PHIS system. Routine verification of validation occurs during
performance of the HAV task, and findings related to validation are
documented in PHIS as part of that task.
Comment: One commenter expressed concern that the validation
guidance will unnecessarily increase the number of non-compliance
reports issued by FSIS inspection personnel.
Response: As explained in the May 2013 Federal Register notice, the
guidance is meant for establishments and does not set new requirements.
FSIS will ensure that IPP understand validation requirements and, as
stated above, will issue necessary instructions to field personnel so
that they are aware of the final guidance and share it with
establishments. FSIS will also issue necessary instructions and
training to field personnel for them to verify that establishments meet
all validation requirements.
Next Steps
FSIS will implement the new verification activities in a phased
approach based on establishment size. For large establishments,
verification of the second element of validation will be delayed until
January 4, 2016. For small and very small establishments, the Agency
will delay implementation until April 4, 2016. After establishments
have had time to collect the necessary in-plant validation data, IPP
will verify that establishments meet validation requirements during HAV
tasks, and EIAOs will do a more in-depth verification of establishment
records to verify that establishments meet validation requirements
during food safety assessments.
Until FSIS begins enforcing all validation requirements, FSIS
inspection personnel will continue to issue noncompliance records (NRs)
if an establishment lacks the required scientific or technical support
for its HACCP system, if the scientific or technical support is
inadequate, or if the establishment's control measures (CCPs or
prerequisite programs) do not incorporate the parameters described in
the scientific support, and the establishment does not have data to
support the technical adequacy of the control measures. FSIS will
continue to issue a Notice of Intended Enforcement if, taken together
with other relevant findings, an establishment's scientific or
technical support is inadequate, and the Agency can support a
determination that the establishment's HACCP system is inadequate for
any of the reasons provided in 9 CFR 417.6.
Moreover, if, in conducting a Food Safety Assessment (FSA), an EIAO
finds that an establishment has not collected in-plant data to
demonstrate that its HACCP process works as intended, the EIAO will
note this finding in the FSA and inform the establishment. Until FSIS
begins enforcing the in-plant data requirements, FSIS will not issue
NRs or take enforcement actions based solely on a finding that an
establishment lacks in-plant validation data.
USDA Non-Discrimination Statement
No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination any person in the United States under any program or
activity conducted by the USDA.
How To File a Complaint of Discrimination
To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your
authorized representative.
[[Page 27563]]
Send your completed complaint form or letter to USDA by mail, fax,
or email:
Mail: U.S. Department of Agriculture, Director, Office of
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410,
Fax: (202) 690-7442, Email: [email protected].
Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.), should contact
USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication on-line through the FSIS Web page located at:
http://www.fsis.usda.gov/federal-register.
FSIS also will make copies of this publication available through
the FSIS Constituent Update, which is used to provide information
regarding FSIS policies, procedures, regulations, Federal Register
notices, FSIS public meetings, and other types of information that
could affect or would be of interest to our constituents and
stakeholders. The Update is available on the FSIS Web page. Through the
Web page, FSIS is able to provide information to a much broader, more
diverse audience. In addition, FSIS offers an email subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export
information, regulations, directives, and notices. Customers can add or
delete subscriptions themselves, and have the option to password
protect their accounts.
Done at Washington, DC on: May 8, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-11581 Filed 5-13-15; 8:45 am]
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