Notice2026-10603
Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments
Primary source
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Published
May 28, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting titled "Challenges and Solutions in Lot- Level Food Traceability." The purpose of the meeting is to provide a forum for the public to share information on continued implementation of the Food Traceability Rule and areas of concern, especially as they relate to lot-level tracking, and identify potential flexibilities to support compliance. In addition, FDA has developed a discussion paper titled "Identifying Additional Flexibilities for Satisfying the Food Traceability Rule's Lot-Level Tracking Requirement" that includes potential flexibilities for lot-level food traceability and questions we have regarding those flexibilities. This discussion paper may be helpful to speakers as they develop remarks for the public meeting. We are also providing an opportunity for all stakeholders to submit feedback on the discussion paper.
Full Text
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<title>Federal Register, Volume 91 Issue 102 (Thursday, May 28, 2026)</title>
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[Federal Register Volume 91, Number 102 (Thursday, May 28, 2026)]
[Notices]
[Pages 31723-31725]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0053]
Challenges and Solutions in Lot-Level Food Traceability; Public
Meeting and Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting and request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public meeting titled ``Challenges and Solutions in Lot-
Level Food Traceability.'' The purpose of the meeting is to provide a
forum for the public to share information on continued implementation
of the Food Traceability Rule and areas of concern, especially as they
relate to lot-level tracking, and identify potential flexibilities to
support compliance. In addition, FDA has developed a discussion paper
titled ``Identifying Additional Flexibilities for Satisfying the Food
Traceability Rule's Lot-Level Tracking Requirement'' that includes
potential flexibilities for lot-level food traceability and questions
we have regarding those flexibilities. This discussion paper may be
helpful to speakers as they develop remarks for the public meeting. We
are also providing an opportunity for all stakeholders to submit
feedback on the discussion paper.
DATES: The public meeting will be held on June 15, 2026, from 12:00-
3:30 p.m. Eastern Time. Either electronic or written comments on this
public meeting or discussion paper must be submitted by July 15, 2026.
See the SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public meeting will be held virtually, and login
instructions will be provided at registration.
[[Page 31724]]
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 July 15, 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-2014-N-0053 for ``Challenges and Solutions in Lot-Level Food
Traceability: Public Meeting.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' will be 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: 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#e0ab8194888592898e85ceb68985928ba0868481ce888893ce878f96"><span class="__cf_email__" data-cfemail="b5fed4c1ddd0c7dcdbd09be3dcd0c7def5d3d1d49bddddc69bd2dac3">[email protected]</span></a>; or Alissa Van Wie, Office of
Policy and International Engagement, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-654-7524,
<a href="/cdn-cgi/l/email-protection#93d2fffae0e0f2bdc5f2fde4faf6d3f5f7f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="cc8da0a5bfbfade29aada2bba5a98caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA final rule, ``Requirements for Additional Traceability
Records for Certain Foods'' (87 FR 70910, November 21, 2022) (Food
Traceability Rule), establishes enhanced recordkeeping requirements for
those who manufacture, process, pack, or hold foods on FDA's Food
Traceability List. The Food Traceability Rule requires lot-level
tracking for foods on the Food Traceability List. Businesses that
perform specific activities are required to assign unique codes, known
as Traceability Lot Codes, that must be passed along unchanged (unless
the food is transformed) as the food moves through the supply chain.
Entities that handle foods on the Food Traceability List are required
to record Key Data Elements (KDEs), such as the Traceability Lot Code,
when they perform specific Critical Tracking Events (CTEs) like initial
packing, transformation, and shipping. Lot-level tracking enables rapid
tracing of contaminated foods during recall events, allowing FDA to
find the source of the food faster, narrowing the scope of recalls, and
removing affected product from the supply chain quickly, resulting in
fewer foodborne illnesses and deaths.
The original compliance date for all persons subject to the
recordkeeping requirements of the Food Traceability Rule was January
20, 2026. FDA proposed to extend the compliance date for the rule by 30
months to July 20, 2028 (90 FR 38084, August 7, 2025). Subsequently,
the Continuing Appropriations, Agriculture, Legislative Branch,
Military Construction and Veterans Affairs, and Extensions Act of 2026
(Pub. L. 119-37) (Continuing Appropriations Act) directed FDA not to
enforce the Food Traceability Rule prior to that same date of July 20,
2028. FDA intends to comply with this Congressional directive.
Section 780 of the Continuing Appropriations Act also directed FDA
to engage quarterly with regulated entities to identify and implement,
as appropriate, additional flexibilities for satisfying the Food
Traceability Rule's lot-level tracking requirement. This public meeting
is part of a series of engagements being held to fulfill that
directive. Congress further stated that within 180 days of the
Continuing Appropriations Act's enactment, FDA should provide industry
stakeholders with recommendations for these additional flexibilities.
At present, with most of the quarterly engagements still ahead of us,
we have not made a decision about the scope of flexibilities
[[Page 31725]]
that would best address the challenges being faced by regulated
entities while still protecting public health and maintaining the
benefits of the Food Traceability Rule. However, we recognize
Congress's desire for FDA to be transparent with stakeholders about
this process, and specifically about where things stand approximately
180 days after enactment of the Continuing Appropriations Act. One goal
of the discussion paper, ``Identifying Additional Flexibilities for
Satisfying the Food Traceability Rule's Lot-Level Tracking
Requirement,'' is to provide that transparency.
II. Topics for Discussion at the Public Meeting
The goal of this public meeting is for FDA to hear stakeholder
feedback on lot-level food traceability efforts and implementation
challenges facing industry. FDA is interested in hearing about the
challenges and potential solutions for satisfying the Food Traceability
Rule's lot-level tracking requirements.
We are also making available a discussion paper, ``Identifying
Additional Flexibilities for Satisfying the Food Traceability Rule's
Lot-Level Tracking Requirement,'' that includes potential flexibilities
and questions we have around those flexibilities (Ref. 1). We intend
for this discussion paper to further dialogue with regulated entities
and other stakeholders, including at this public meeting, and help
advance progress toward successful implementation of the Food
Traceability Rule. We encourage those participating in this public
meeting to consider the questions in this discussion paper as you
develop your remarks for this meeting.
We want to provide all stakeholders with an opportunity to actively
engage with FDA on this topic. We therefore invite and encourage all
interested parties to submit feedback on the discussion paper to
<a href="https://www.regulations.gov">https://www.regulations.gov</a>, Docket No. FDA-2014-N-0053. Comments do
not need to cover every question that is asked in the document; you are
encouraged to focus on whichever aspects of the discussion paper are of
the most interest to you. To ensure that we can fully consider your
feedback as we work to expeditiously identify flexibilities to
implement, please submit your comments no later than July 15, 2026.
Please note that the discussion paper does not reflect an
exhaustive list of options that FDA plans to consider. New ideas may
emerge as a result of this public meeting and our other upcoming
engagements with stakeholders. The document is meant to capture the
areas where we currently have the most questions, or where we think
further dialogue would be especially helpful. Please also note that the
order in which the topics are listed is not meant to represent a
prioritization or a preference for any topic.
III. Participating in the Public Meeting
Registration: Please visit the following website for additional
information and to register for the public meeting: <a href="https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/fda-public-meeting-challenges-and-solutions-lot-level-food-traceability-06152026?utm_medium=email&utm_source=govdelivery">https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/fda-public-meeting-challenges-and-solutions-lot-level-food-traceability-06152026?utm_medium=email&utm_source=govdelivery</a>.
The virtual public meeting is free and open to the public, but
registration is necessary to attend. General registration will remain
open until June 14, 2026. Individuals who want to speak during the
public comment period must register by June 5, 2026. Same-day
registration is not allowed. Individuals that have already registered
through the Partnership for Food Traceability website do not need to
register again. Instructions for joining the virtual meeting will be
provided upon registration.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during the public comment session. We
will do our best to accommodate all requests to make public comments.
Following the close of registration, we will determine the amount of
time allotted to each presenter and will notify participants in
advance. All requests to make oral presentations must be received by
the close of registration on June 5, 2026. All presentations must be
given orally; slides or visuals will not be able to be accommodated on
the virtual platform. No commercial or promotional material will be
permitted to be presented or distributed at the public meeting.
IV. References
1. Food and Drug Administration, ``Discussion Paper: Identifying
Additional Flexibilities for Satisfying the Food Traceability Rule's
Lot-Level Tracking Requirement''. 2026.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10603 Filed 5-27-26; 8:45 am]
BILLING CODE 4164-01-P
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