[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.
                                  ------------------------------------------------------------------------------
    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


