Notice2025-22277
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
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Published
December 9, 2025
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 information collection provisions of our recordkeeping and records access requirements for food facilities.
Full Text
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<title>Federal Register, Volume 90 Issue 234 (Tuesday, December 9, 2025)</title>
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[Federal Register Volume 90, Number 234 (Tuesday, December 9, 2025)]
[Notices]
[Pages 57074-57077]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22277]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-4250]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Establishment, Maintenance, and Availability of
Records; Additional Traceability Records for Certain Foods
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 information collection provisions of
our recordkeeping and records access requirements for food facilities.
DATES: Either electronic or written comments on the collection of
information must be submitted by February 9, 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 February 9, 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-2025-N-4250 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Establishment, Maintenance, and
Availability of Records; Additional Traceability Records for Certain
Foods.'' 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#3f6f6d7e6c4b5e59597f595b5e1157574c11585049"><span class="__cf_email__" data-cfemail="19494b584a6d787f7f597f7d783771716a377e766f">[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
[[Page 57075]]
provide information to a third party. Section 3506(c)(2)(A) of the PRA
(44 U.S.C. 3506(c)(2)(A)) requires Federal 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.
Establishment, Maintenance, and Availability of Records; Additional
Traceability Records for Certain Foods--21 CFR Part 1, Subparts J and S
OMB Control Number 0910-0560--Extension
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 added section 414 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 350c), which requires that persons
who manufacture, process, pack, hold, receive, distribute, transport,
or import food in the United States establish and maintain records
identifying the immediate previous sources and immediate subsequent
recipients of food. These requirements are codified in the agency's
general enforcement regulations at 21 CFR part 1, subpart J. The FDA
Food Safety Modernization Act (FSMA) signed in 2011, required FDA to
establish additional recordkeeping requirements for facilities that
manufacture, process, pack, or hold foods the Agency designates as
high-risk to facilitate the rapid and effective traceability of such
foods. These requirements are codified in the agency's general
enforcement regulations at 21 CFR part 1, subpart S. Part 1, subpart J
(21 CFR 1.326 through 1.368) sets forth the requirements for
recordkeeping and records access. Part 1, subpart S (21 CFR 1.1300
through 1.1465) provides additional recordkeeping requirements for
persons who manufacture, process, pack, or hold foods FDA has
designated as high-risk in accordance with factors specified by
Congress; we have listed these foods on the Food Traceability List
(FTL) on our website at <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list">https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list</a>. The requirement to
establish and maintain records improves our ability to respond to, and
further contain, threats of serious adverse health consequences or
death from contaminated of food.
Part 1, Subpart J
Information maintained under these regulations helps us identify
and quickly locate contaminated or potentially contaminated food and
inform the appropriate individuals and food facilities of specific
terrorist threats. Our regulations require that records for non-
transporters include the name and full contact information of sources,
recipients, and transporters; an adequate description of the food,
including the quantity and packaging; and the received and shipping
dates (Sec. Sec. 1.337 and 1.345). Required records for transporters
include the names of consignor and consignee, points of origin and
destination, date of shipment, number of packages, description of
freight, route of movement and name of each carrier participating in
the transportation, and transfer points through which shipment moved
(Sec. 1.352). Existing records may be used if they contain all the
required information and are retained for the required time period.
The information collection provisions of Sec. 1.361 are exempt
from OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR
1320.4(a)(2) as collections of information obtained during the conduct
of an administrative action, investigation, or audit involving an
agency against specific individuals or entities. The regulations at 5
CFR 1320.3(c) provide that the exception in 5 CFR 1320.4(a)(2) applies
during the entire course of the investigation, audit, or action, but
only after a case file or equivalent is opened with respect to a
particular party. Such a case file would be opened as part of the
request to access records under Sec. 1.361. Accordingly, we have not
included an estimate of burden hours associated with Sec. 1.361.
Part 1, Subpart S
Part 1, subpart S, in accordance with FSMA, establishes additional
recordkeeping requirements for persons who manufacture, process, pack,
or hold foods that the Agency has designated as high-risk foods (i.e.,
placed on the ``Food Traceability List'' (FTL)) in accordance with
section 204(d)(2) of FSMA. Persons are required to maintain records
containing information on critical tracking events in the supply chain
for FTL foods. Part 1, subpart S will help the Agency rapidly and
effectively identify recipients of foods to prevent or mitigate
foodborne illness outbreaks and address credible threats of serious
adverse health consequences or death resulting from foods being
adulterated or misbranded. These additional recordkeeping requirements
strengthen public health protections by documenting the movement of
foods on the FTL throughout the supply chain, enabling FDA to more
rapidly and effectively identify the source of contaminated foods and
aid in the removal of contaminated products from the market. Records
required under this subpart must be maintained for 2 years from the
date they were created or obtained. For more information about
requirements for additional traceability records for certain foods
visit our website at <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods">https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods</a>, which also includes a guide that
provides key data elements for recordkeeping (<a href="https://www.fda.gov/media/163132/download?attachment">https://www.fda.gov/media/163132/download?attachment</a>).
The information and records required under part 1, subpart S vary
depending on the type of supply chain activities performed with respect
to an FTL food. For harvesting and cooling of foods on the FTL, records
must include information about the location for the immediate
subsequent recipient, commodity, quantity, location of farm and harvest
area or cooling area, date of harvest or cooling, and the reference
document type and reference document number (Sec. 1.1325). For the
initial packing of a raw agricultural commodity on the FTL, including
sprouts, for each traceability lot you initially pack, records must
include and link the traceability lot to information about the
commodity, date harvested and received, quantity, location of farm and
harvest and/or cooling area, name and phone number of harvester, and
the reference document type and reference document number (Sec.
1.1330). For the first land-based receiver of food on the FTL, for each
traceability lot obtained from a fishing vessel, records must include
and link the traceability lot to the traceability lot code assigned,
[[Page 57076]]
product description, quantity, harvest date range and locations,
location of land-based receiver, date the food landed, and the
reference document type and reference document number (Sec. 1.1335).
For each traceability lot of a food on the FTL that you ship or
receive, records must include and link the traceability lot to the
traceability lot code, product description, quantity, location
description of either the immediate subsequent recipient or the
immediate previous source, location description of either from which
you shipped or for where the food was received, date the food was
shipped or received, location description for the traceability lot code
source, and the reference document type and reference document number
(Sec. Sec. 1.1340 and 1.1345). For each traceability lot of food that
is on the FTL that is transformed, records must include and link the
traceability lot to the traceability lot code, product description,
quantity, date transformed, and the reference document type and
reference document number (Sec. 1.1350). Part 1, subpart S also
requires that persons who manufacture, process, pack, or hold foods
listed on the FTL to maintain records demonstrating the creation and
establishment of a traceability plan (Sec. 1.1315).
A respondent may submit a citizen petition to FDA to request
modified requirements or exemptions from the requirements of subpart S
(Sec. 1.1370). In addition to the requirements of a citizen petition
(21 CFR 10.30), a respondent must: (a) specify the food or type of
entity to which the modified requirements or exemption would apply; (b)
specify the proposed modifications to the requirements; and (c) provide
information demonstrating that the proposed modification or exemption
of the requirements are not necessary to protect the public health.
A respondent may submit to FDA a written request or a citizen
petition to waive one or more requirements (Sec. Sec. 1.1415 and
1.1425). In addition to the requirements for submitting a citizen
petition (Sec. 10.30), a respondent must: (a) specify the type of
entity to which the waiver would apply; (b) provide information
demonstrating why the requirements requested to be waived would result
in an economic hardship for the entity, including information about the
unique circumstances faced by the entity that result in unusual
economic hardship from the application of these requirements; and (c)
why the waiver will not significantly impair FDA's ability to rapidly
and effectively identify recipients of a food to prevent or mitigate a
foodborne illness outbreak or to address credible threats of serious
adverse health consequences or death to humans or animals as a result
of such food being adulterated under section 402 of the FD&C Act or
misbranded under section 403(w) of the FD&C Act; and (d) provide
information demonstrating that the waiver would not otherwise be
contrary to the public interest.
The information collection provision of Sec. 1.1455(c)(3)(ii) is
exempt from OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR
1320.4(a)(2) as collections of information obtained during the conduct
of an administrative action, investigation, or audit involving an
agency against specific individuals or entities. The regulations at 5
CFR 1320.3(c) provide that the exception in 5 CFR 1320.4(a)(2) applies
during the entire course of the investigation, audit, or action, but
only after a case file or equivalent is opened with respect to a
particular party. Such a case file would be opened as part of the
request to access records for which there is a requirement to provide
the records in an electronic sortable spreadsheet under Sec.
1.1455(c)(3)(ii). Accordingly, we have not included an estimate of
burden hours associated with Sec. 1.1455(c)(3)(ii).
Description of Respondents: Respondents to this collection of
information are persons that manufacture, process, pack, hold, receive,
distribute, transport, or import food in the United States who are
required to establish, maintain, and provide records, including persons
that engage in both interstate and intrastate commerce.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity; 21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Requests for modified 5 1 5 10 50
requirements and exemptions;
1.1370.........................
Requests for waivers; 1.1415 and 15 1 15 10 150
1.1425.........................
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Total....................... .............. .............. 20 .............. 200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity; 21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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Records maintenance; 1.337, 1.345, and 1.352. 379,493 1 379,493 7........................................ 2,656,451
Create and establish traceability plan; 212,368 1 212,368 8........................................ 1,698,944
1.1315.
Records for harvesting or cooling; 1.1325.... 9,570 575 5,502,750 0.07 (4 minutes)......................... 385,193
Records for initial packer; 1.1330........... 4,313 865 3,730,745 0.07 (4 minutes)......................... 261,152
Records for first land-based receiver; 1.1335 367 1,471 539,857 0.03 (2 minutes)......................... 16,196
Records for shipper and receiver; 1.1340 and 502,000 5,900 2,961,800,000 0.006 (20 seconds)....................... 17,770,800
1.1345.
Transformer; 1.1350.......................... 8,574 1,101 9,439,974 0.03 (2 minutes)......................... 283,199
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Total.................................... .............. .............. 2,981,605,187 ......................................... 23,071,935
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 57077]]
The revised estimated annual burden reflects updates to the
consideration of burden. We believe that the burden for part 1, subpart
J was inadvertently omitted from the previous approval, so we are
adding it here. However, we believe some of the considerations for
burden should have been incorporated with PRA activities instead of
being considered independently. Lastly, considerations of burden for
Sec. Sec. 1.1465(a) and 1.1455(c)(3)(ii) do not apply to the PRA so we
have removed this burden. Section 1.1465(a) is a general solicitation
for comment, which is not considered ``information'' under the PRA
regulations (5 CFR 1320.3(h)(4)). Activities under Sec.
1.1455(c)(3)(ii) applies to an investigation, audit, or action after a
case file is opened for a specific party, which is exempt from OMB
review as discussed earlier in this document (5 CFR 1320.4(a)(2)).
Our estimated burden for the information collection reflects an
overall increase of 4,227,299 hours but a corresponding decrease of
4,973,420 records. We attribute the increase in hours to the return of
burden for part 1, subpart J along with adjustments to the average
burden per recordkeeping. We attribute the decrease of records due to
the reconsideration of activities such as learning new requirements and
training staff and incorporating the time for these activities as part
of the actual information collection.
Lowell M. Zeta,
Acting, Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22277 Filed 12-8-25; 8:45 am]
BILLING CODE 4164-01-P
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