[Federal Register Volume 91, Number 83 (Thursday, April 30, 2026)]
[Notices]
[Pages 23276-23278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-08417]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0499]
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) 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 June 1, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written
[[Page 23277]]
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: Christopher Colburn, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8758,
[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 FDA's regulations in part 120
(21 CFR part 120), which govern the application of HACCP principles to
the processing of fruit and vegetable juices. HACCP is a 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)). Specifically,
regulations in 21 CFR 120.12 provide for records documenting the
establishment, implementation, and continued application of a HACCP
system. The rationale in establishing a HACCP system of preventive
controls is to design and check the process so that the final product
is not contaminated. 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.
HACCP records are retained by respondents and presented to FDA upon
inspection. We use the information to determine compliance with
applicable requirements. Products not in compliance with applicable
statutory and regulatory requirements may be adulterated under the FD&C
Act and subject to enforcement action.
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. All agency guidance documents are issued in
accordance with our good guidance practice regulation in 21 CFR 10.115,
which provides for public comment at any time.
Description of Respondents: Respondents to this information
collection are processors of fruit and vegetable juices (plants
identified in our official establishment inventory plus very small
apple juice and very small orange juice manufacturers).
In the Federal Register of February 20, 2026 (91 FR 8251), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR section; activity Number of records per Total annual 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); 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) and (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); 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); document all
corrective actions taken in
response to a deviation from a
critical limit.
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); 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) and (c); and 1,840 1 1,840 4............... 7,360
120.12(a)(5) and (b); record
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); document 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).
[[Page 23278]]
120.14(a)(2), (c), and (d) and 308 1 308 4............... 1,232
120.12(b); 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), 120.8(b), and 1,560 1.1 1,716 60.............. 102,960
120.12(a)(3), (b), and (c);
written HACCP plan.
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Total...................... ................ ................ 21,980,369 ................ 461,426
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since its last OMB
approval, we have made no adjustments to our burden estimate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08417 Filed 4-29-26; 8:45 am]
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