Challenges and Solutions in Lot-Level Food Traceability; Public Meeting

Issuing agencies

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 "Requirements for Additional Traceability Records for Certain Foods" final rule and areas of concern, especially as they relate to lot-level tracking, and identify potential flexibilities to support compliance.

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<title>Federal Register, Volume 91 Issue 195 (Friday, October 9, 2026)</title>
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[Federal Register Volume 91, Number 195 (Friday, October 9, 2026)]
[Notices]
[Pages 64656-64658]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20720]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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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 ``Requirements for Additional Traceability Records for Certain 
Foods'' final rule and areas of concern, especially as they relate to 
lot-level tracking, and identify potential flexibilities to support 
compliance.

DATES: The public meeting will be held on November 6, 2026, from 12:00 
p.m. to 3:30 p.m. Eastern Time. Either electronic or written comments 
on this public meeting must be submitted by December 6, 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.
    You may submit comments as follows. 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 December 6, 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,'' 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

[[Page 64657]]

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#b6fdd7c2ded3c4dfd8d398e0dfd3c4ddf6d0d2d798dedec598d1d9c0"><span class="__cf_email__" data-cfemail="5813392c303d2a31363d760e313d2a33183e3c397630302b763f372e">[email&#160;protected]</span></a>; or Alissa Van Wie, Office of 
Regulations and International Programs, Human Foods Program, Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2378, <a href="/cdn-cgi/l/email-protection#084964617b7b69267e69667f616d486e6c692660607b266f677e"><span class="__cf_email__" data-cfemail="bafbd6d3c9c9db94ccdbd4cdd3dffadcdedb94d2d2c994ddd5cc">[email&#160;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 (FTL). The Food Traceability Rule requires lot-level 
tracking for foods on the FTL. Businesses that perform specific 
activities are required to assign unique codes, known as Traceability 
Lot Codes (TLCs), 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 FTL are required to record Key Data Elements 
(KDEs), such as the TLC, when they perform specific Critical Tracking 
Events (CTEs), such as initial packing, transformation, and shipping. 
Lot-level tracking enables rapid tracing of contaminated foods during 
recall events, allowing FDA to identify the source of the food faster, 
narrowing the scope of recalls and removing affected product from the 
supply chain more 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. The public meeting 
announced in this notice is part of a series of engagements being held 
to fulfill that directive. As part of the same series of engagements, 
we previously held a public meeting on June 15, 2026. Prior to that 
public meeting, we published a discussion paper titled ``Identifying 
Additional Flexibilities for Satisfying the Food Traceability Rule's 
Lot-Level Tracking Requirement'' (<a href="https://www.regulations.gov/document/FDA-2014-N-0053-1371">https://www.regulations.gov/document/FDA-2014-N-0053-1371</a>). We provided an opportunity for stakeholders to 
submit feedback on the ideas presented in the discussion paper. We 
received 26 comments on the discussion paper from industry, trade 
associations, and technology partners. We have provided a high-level 
summary of those comments below. All comments can be accessed by 
searching Docket No. FDA-2014-N-0053 on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    TLC Flexibilities: Many commenters supported flexibility for 
identification of TLCs by allowing for a reasonable range of TLCs or 
inferred TLCs to be used when shipping FTL foods from distribution to 
retail. With both options, several stakeholders noted the need for 
these flexibilities to be accompanied by guardrails, including 
documented operational practices, validation exercises, and an 
understanding that the reasonable range of TLCs or inferred TLCs be 
limited to the fewest TLCs possible. However, some commenters expressed 
concern that a flexibility for TLCs could reduce product-specific 
traceability and unnecessarily broaden the scope of a recall.
    Flexibility for Eaches, Returns, Reclamations, and Food Waste 
Recovery: There was broad support from stakeholders to provide 
flexibilities for eaches, returns, and reclamations as these account 
for a relatively small amount of product that has often been separated 
from the original case. There was also support for additional clarity 
on the exemption for donated food to ensure that food waste recovery is 
not discouraged due to the requirements of the rule.
    Intracompany Shipments: Some stakeholders noted continued confusion 
around the required records for intracompany shipments and requested 
clarification on these requirements. Some stakeholders also requested 
flexibility to track incoming and outgoing TLCs with records of 
internal movements of FTL foods that would be available upon request.
    Retail Transformer Shipments: There was broad support from 
commenters for a simplified, modified recordkeeping framework for 
retail-kitchen-to-affiliated-store shipments.
    Data Standardization: There was strong support among stakeholders 
for FDA to recognize GS1 as an acceptable data standard for use in 
identifying shipments of FTL foods. FDA recently posted a FAQ on data 
standards, which is available at <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/frequently-asked-questions-fsma-food-traceability-rule#TPTS3">https://www.fda.gov/food/food-safety-modernization-act-fsma/frequently-asked-questions-fsma-food-traceability-rule#TPTS3</a>.

II. Topics for Discussion at the Public Meeting

    The goal of this public meeting is for FDA to hear stakeholder 
perspectives on lot-level food traceability efforts and implementation 
challenges facing industry. FDA is interested in learning more about 
the challenges and potential solutions for satisfying the Food 
Traceability Rule's lot-level tracking requirements.
    Specifically, we are interested in feedback on the potential 
flexibilities in achieving compliance with the rule that have been 
identified to date and on the feedback received on the discussion paper 
in the docket. We encourage those participating in this public meeting 
to consider the questions posed in the discussion paper, stakeholder 
responses to these questions submitted to the docket, and any new ideas 
regarding flexibilities as you develop your

[[Page 64658]]

remarks for this meeting. We also welcome additional comments or 
presentation materials to be submitted to the docket for consideration.

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/news-events/fda-meetings-conferences-and-workshops">https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops</a>.
    The virtual public meeting is free and open to the public, but 
registration is necessary to attend. General registration will remain 
open until November 5, 2026. Individuals who want to speak during the 
public comment period must register by October 26, 2026. Same-day 
registration is not allowed. 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 the approximate time each oral 
presentation is to begin and will notify participants in advance by 
November 4, 2026. All requests to make oral presentations must be 
received by the close of speaker registration on October 26, 2026. All 
presentations must be given orally; we cannot accommodate slides or 
visuals on the virtual platform. No commercial or promotional material 
will be permitted to be presented or distributed at the public meeting.

    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. 2026-20720 Filed 10-8-26; 8:45 am]
BILLING CODE 4164-01-P


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