Notice2026-03363
Questions and Answers About Requirements for Additional Traceability Records for Certain Foods; Draft Guidance for Industry; Availability
Primary source
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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The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled "Questions and Answers About Requirements for Additional Traceability Records for Certain Foods." The draft guidance answers questions about the final rule entitled "Requirements for Additional Traceability Records for Certain Foods," which established additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The draft guidance is intended to answer questions to facilitate industry's understanding of the final rule.
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 8243-8245]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03363]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-2837]
Questions and Answers About Requirements for Additional
Traceability Records for Certain Foods; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Questions and Answers About Requirements for Additional Traceability
Records for Certain Foods.'' The draft guidance answers questions about
the final rule entitled ``Requirements for Additional Traceability
Records for Certain Foods,'' which established additional recordkeeping
requirements for persons who manufacture, process, pack, or hold foods
the Agency has designated for inclusion on the Food Traceability List.
The draft guidance is intended to answer questions to facilitate
industry's understanding of the final rule.
DATES: Submit either electronic or written comments on the draft
guidance by May 21, 2026 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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
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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-D-2837 for ``Questions and Answers About Requirements for
Additional Traceability Records for Certain Foods: Guidance for
Industry.'' Received comments 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.gpo.gov/fdsys/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Office of Surveillance Strategy and Risk Prioritization, Human
Foods Program, Food and Drug Administration, 5001 Campus Dr., College
Park, MD 20740. Send two self-addressed adhesive labels to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Katherine Vierk, Office of
Surveillance Strategy and Risk Prioritization, Human Foods Program,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-2122, <a href="/cdn-cgi/l/email-protection#e3a882978b86918a8d86cdb58a869188a3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="8cc7edf8e4e9fee5e2e9a2dae5e9fee7cceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Questions and Answers About Requirements for Additional
Traceability Records for Certain Foods: Guidance for Industry.'' The
FDA final rule entitled ``Requirements for Additional Traceability
Records for Certain Foods'' (Food Traceability Rule) (87 FR 70910,
November 21, 2022) was issued under section 204(d)(1) of the FDA Food
Safety Modernization Act (FSMA), which directed FDA to establish
recordkeeping requirements, in addition to the requirements under
section 414 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350c) and FDA regulations in 21 CFR part 1, subpart J, for persons who
manufacture, process, pack, or hold foods that FDA designates under
section 204(d)(2) of FSMA as high-risk foods. FDA identifies such
designated foods on the Food Traceability List (FTL). The new
requirements established by the final rule will allow for faster
identification and rapid removal of potentially contaminated food from
the market, resulting in fewer foodborne illnesses and deaths.
We are issuing this draft guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on implementing
the Food Traceability Rule. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternate approach if it satisfies the requirements of the applicable
statutes and regulations.
At the core of the Food Traceability Rule is a requirement that
persons subject to the rule who manufacture, process, pack, or hold
foods on the FTL maintain records containing key data elements
associated with specific critical tracking events. The rule also
requires covered entities to maintain a traceability plan, which
describes a firm's traceability procedures and how they identify the
FTL foods that they handle. The final rule covers domestic firms as
well as foreign firms producing food for U.S. consumption, along the
entire food supply chain.
This draft guidance includes questions and answers to assist
industry in understanding the scope of the Food Traceability Rule and
meeting applicable requirements. Topics covered in this draft guidance
include additional information on requirements for farms, food obtained
from fishing vessels, raw molluscan shellfish, retail food
establishments and restaurants, commingling, initial packing of a food,
transformation of a food, the traceability plan, recordkeeping, and the
FTL.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
II. Paperwork Reduction Act of 1995
While this draft guidance contains no collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 1, subpart S, have been approved under OMB control
number 0910-0560.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed in the previous
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sentence to find the most current version of the guidance.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03363 Filed 2-19-26; 8:45 am]
BILLING CODE 4164-01-P
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