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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled “Questions and Answers About Requirements for Additional Traceability Records for Certain Foods.” The draft guidance answers questions about the final rule entitled “Requirements for Additional Traceability Records for Certain Foods,” which established additional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 The draft guidance is intended to answer questions to facilitate industry's understanding of the final rule.
Submit either electronic or written comments on the draft guidance by May 21, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov 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Submit written requests for single copies of the draft guidance to the Office of Surveillance Strategy and Risk Prioritization, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
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, Katherine.Vierk@fda.hhs.gov.
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.
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.
Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous ( printed page 8245) 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