[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12939-12941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04174]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1427]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Hazard Analysis and
Critical Control Point Procedures for the Safe and Sanitary Processing
and Importing of Juice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by March 31, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0466. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Hazard Analysis and Critical Control Point (HACCP) Procedures for the
Safe and Sanitary Processing and Importing of Juice--21 CFR Part 120
OMB Control Number 0910-0466--Extension
This information collection supports regulations in part 120 (21
CFR part 120) which mandate the application of HACCP procedures to the
processing of fruit and vegetable juices. HACCP is a
[[Page 12940]]
preventative system of hazard control designed to help ensure the
safety of foods. The regulations were issued under FDA's statutory
authority to regulate food safety under section 402(a)(4) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
342(a)(4)). Under section 402(a)(4) of the FD&C Act, a food is
adulterated if it is prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with filth or rendered
injurious to health. The Agency also has authority under section 361 of
the Public Health Service Act (42 U.S.C. 264) to issue and enforce
regulations to prevent the introduction, transmission, or spread of
communicable diseases from one State, territory, or possession to
another, or from outside the United States into this country. Under
section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to
issue regulations for the efficient enforcement of the FD&C Act.
Under HACCP, processors of fruit and vegetable juices establish and
follow a preplanned sequence of operations and observations (the HACCP
plan) designed to avoid or eliminate one or more specific food hazards,
and thereby ensure that their products are safe, wholesome, and not
adulterated, in compliance with section 402 of the FD&C Act.
Information development and recordkeeping are essential parts of any
HACCP system. The information collection requirements are narrowly
tailored to focus on the development of appropriate controls and
document those aspects of processing that are critical to food safety.
In an effort to reduce burden and assist respondents, our website
(https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp) offers guidance for industry, training and education, and
background information to assist the food industry in developing and
implementing a juice HACCP. Included in this information are guidance
documents entitled ``Juice HACCP and the FDA Food Safety and
Modernization Act'' (December 2021) (available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-haccp-and-fda-food-safety-modernization-act) and ``Juice HACCP
Hazards and Controls Guidance--First Edition'' (March 2004) (available
at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first). All Agency guidance
documents are issued in accordance with our good guidance practice
regulations in 21 CFR 10.115, which provide for public comment at any
time
In the Federal Register of October 7, 2022 (87 FR 61087), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section; activity Number of records per Total annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
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120.6(c) and 120.12(a)(1) and 1,875 365 684,375 0.1 (6 minutes).... 68,438
(b); require written monitoring
and correction records for
Sanitation Standard Operating
Procedures.
120.7, 120.10(a), and 2,300 1.1 2,530 20................. 50,600
120.12(a)(2), (b)-(c); require
written hazard analysis of food
hazards.
120.8(b)(7) and 120.12(a)(4)(i) 1,450 14,600 21,170,000 0.01 (1 minute).... 211,700
and (b); require a recordkeeping
system that documents monitoring
of the critical control points
and other measurements as
prescribed in the HACCP plan.
120.10(c) and 120.12(a)(4)(ii) 1,840 12 22,080 0.1 (6 minutes).... 2,208
and (b); require that all
corrective actions taken in
response to a deviation from a
critical limit be documented.
120.11(a)(1)(iv) and (a)(2) and 1,840 52 95,680 0.1 (6 minutes).... 9,568
120.12 (a)(5) and (b); require
records showing that process
monitoring instruments are
properly calibrated and that end-
product or in-process testing is
performed in accordance with
written procedures.
120.11(b)-(c) and 120.12(a)(5) 1,840 1 1,840 4.................. 7,360
and (b); require that every
processor record the validation
that the HACCP plan is adequate
to control food hazards that are
likely to occur.
120.11(c) and 120.12(a)(5) and 1,840 1 1,840 4.................. 7,360
(b); require documentation of
revalidation of the hazard
analysis upon any changes that
might affect the original hazard
analysis (applies when a firm
does not have a HACCP plan
because the original hazard
analysis did not reveal hazards
likely to occur).
120.14(a)(2), (c)-(d), and 308 1 308 4.................. 1,232
120.12(b); require that
importers of fruit or vegetable
juices, or their products used
as ingredients in beverages,
have written procedures to
ensure that the food is
processed in accordance with our
regulations in part 120.
120.8(a)-(b) and 120.12(a)(3), 1,560 1.1 1,716 60................. 102,960
(b)-(c); require written HACCP
plan.
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Total........................ ............. .............. .............. ................... 461,426
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 1 provides our estimate for the next 3 years for the total
annual recordkeeping burden of our regulations in part 120. Based on
our experience with the information collection over the past 3 years,
our burden estimate
[[Page 12941]]
remains unchanged since our last review of the information collection.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04174 Filed 2-28-23; 8:45 am]
BILLING CODE 4164-01-P