Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry titled "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants." The draft guidance states that, at this time and based on our current understanding of the risks, FDA does not intend to enforce certain regulatory requirements as they apply to certain entities and/or activities. The applicable requirements are established in our regulation titled "Requirements for Additional Traceability Records for Certain Foods."

Full Text

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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)]
[Proposed Rules]
[Pages 64629-64631]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2025-D-6952]


Requirements for Additional Traceability Records for Certain 
Foods: Enforcement Policy for Certain Retail Food Establishments and 
Restaurants; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification 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announcing the availability of a draft guidance for industry titled 
``Requirements for Additional Traceability Records for Certain Foods: 
Enforcement Policy for Certain Retail Food Establishments and 
Restaurants.'' The draft guidance states that, at this time and based 
on our current understanding of the risks, FDA does not intend to 
enforce certain regulatory requirements as they apply to certain 
entities and/or activities. The applicable requirements are established 
in our regulation titled ``Requirements for Additional Traceability 
Records for Certain Foods.''

[[Page 64630]]


DATES: Submit either electronic or written comments on the draft 
guidance by November 23, 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 FDA 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 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, Room 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-6952 for ``Requirements for Additional Traceability Records 
for Certain Foods: Enforcement Policy for Certain Retail Food 
Establishments and Restaurants: Draft 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, 
Room 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 guidance to the 
Office of 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Katherine Vierk, Office of 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#763d17021e13041f181358201f13041d36101217581e1e0558111900"><span class="__cf_email__" data-cfemail="0d466c7965687f646368235b64687f664d6b696c2365657e236a627b">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
titled ``Requirements for Additional Traceability Records for Certain 
Foods: Enforcement Policy for Certain Retail Food Establishments and 
Restaurants: Guidance for Industry.'' 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 final rule titled ``Requirements 
for Additional Traceability Records for Certain Foods'' (see 21 CFR 
Part 1, Subpart S). 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. In the Federal Register of November 21, 2022, we published 
a final rule titled ``Requirements for Additional Traceability Records 
for Certain Foods'' (87 FR 70910) (Food Traceability Rule) as part of 
our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. 
L. 111-353). The purpose of this draft guidance for industry is to 
state that FDA, at this time and based on our current understanding of 
the risk, does not intend to enforce certain regulatory requirements as 
they apply to certain entities subject to the Food Traceability Rule.
    The Food Traceability Rule has a full exemption for small retail 
food establishments (RFEs) and restaurants with an average annual 
monetary value of food sold or provided during the previous 3-year 
period of no more than $250,000 (on a rolling basis), adjusted for 
inflation using 2020 as the baseline year for calculating the 
adjustment (21 CFR 1.1305(i)) (``small retail and restaurant 
exemption''). Since the issuance of the final rule, regulated entities 
from the RFE and restaurant industries have brought to light challenges 
associated with complying with the rule for small businesses that are 
not small enough to be eligible for the small retail and restaurant 
exemption. Therefore, FDA intends to exercise enforcement discretion 
for all requirements in the Food Traceability Rule for RFEs and 
restaurants that have an average annual monetary value of food sold or 
provided during the previous 3-year period of greater than $250,000 but 
no more than $1,000,000

[[Page 64631]]

(on a rolling basis), adjusted for inflation using 2020 as the baseline 
year for calculating the adjustment.
    The draft guidance represents 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.
    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 part 21 have been approved under OMB control number 0910-0560.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either <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 
sentence to find the most current version of the guidance.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20721 Filed 10-8-26; 8:45 am]
BILLING CODE 4164-01-P


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