Notice2026-03332
Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
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Published
February 20, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection provisions of our regulations mandating the application of hazard analysis and critical control point (HACCP) principles to the processing of fruit and vegetable juices.
Full Text
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<title>Federal Register, Volume 91 Issue 34 (Friday, February 20, 2026)</title>
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[Federal Register Volume 91, Number 34 (Friday, February 20, 2026)]
[Notices]
[Pages 8251-8253]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03332]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0499]
Agency Information Collection Activities; Proposed Collection;
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 Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collection provisions of our
regulations mandating the application of hazard analysis and critical
control point (HACCP) principles to the processing of fruit and
vegetable juices.
DATES: Either electronic or written comments on the collection of
information must be submitted by April 21, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 21, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2026-N-0499 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Hazard Analysis and Critical
Control Point Procedures for the Safe and Sanitary Processing and
Importing of Juice.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#0c5c5e4d4e7e6d626f644c6a686d2264647f226b637a"><span class="__cf_email__" data-cfemail="0f5f5d4e4d7d6e616c674f696b6e2167677c21686079">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal
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Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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.
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
(<a href="https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp">https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp</a>) 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).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Total
21 CFR section; activity Number of records per 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); 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);
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).
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.
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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. 2026-03332 Filed 2-19-26; 8:45 am]
BILLING CODE 4164-01-P
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