Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 1</CFR> <DEPDOC>[Docket No. FDA-2014-N-0053]</DEPDOC> <RIN>RIN 0910-ZC21</RIN> <SUBJECT>Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration is proposing to extend the compliance date for the final rule, “Requirements for Additional Traceability Records for Certain Foods,” due to concerns about the amount of time affected entities will need to implement the requirements of the rule. If finalized, this rule would extend the compliance date by 30 months from January 20, 2026, to July 20, 2028. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Either electronic or written comments on the proposed rule must be submitted by September 8, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments on the extension of the compliance date as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 8, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> 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 <E T="03">https://www.regulations.gov.</E> • 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”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • 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.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2014-N-0053 for “Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • 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 <E T="03">https://www.regulations.gov.</E> 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: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents, the plain language summary of the proposed rule of not more than 100 words as required by the “Providing Accountability Through Transparency Act,” or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> 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. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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, <E T="03">Katherine.Vierk@fda.hhs.gov,</E> 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, <E T="03">Alissa.VanWie@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents </HD> <EXTRACT> <FP SOURCE="FP-2">I. Background</FP> <FP SOURCE="FP1-2">A. The Food Traceability Rule</FP> <FP SOURCE="FP1-2">B. Proposed Compliance Date</FP> <FP SOURCE="FP-2">II. Legal Authority</FP> <FP SOURCE="FP-2">III. Description of Proposed Rule</FP> <FP SOURCE="FP-2">IV. Preliminary Economic Analysis of Impacts</FP> <FP SOURCE="FP-2">V. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">VI. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">VII. Federalism</FP> <FP SOURCE="FP-2">VIII. Consultation and Coordination With Indian Tribal Governments</FP> <FP SOURCE="FP-2">IX. References</FP> </EXTRACT> <HD SOURCE="HD1">I. Background</HD> <HD SOURCE="HD2">A. The Food Traceability Rule</HD> The Food and Drug Administration (FDA, the Agency, or we) published the final rule, “Requirements for Additional Traceability Records for Certain Foods” (87 FR 70910) (Food Traceability Rule), on November 21, 2022. The final rule establishes additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL) based on risk. The final rule requires these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods (FTL foods), such as initial packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death. The requirements will reduce the harm to public health caused by foodborne illness outbreaks and limit adverse impacts on industry sectors affected by these outbreaks by improving the ability to quickly and efficiently trace the movement through the supply chain of FTL foods identified as causing illness, identify and remove contaminated foods from the marketplace, and develop mitigation strategies to prevent future contamination. The final rule had an effective date of January 20, 2023 (60 days after publication of the final rule), and a compliance date of January 20, 2026 (3 years after the effective date). The Food Traceability Rule establishes first of its kind national standards for supply chain traceability from farm to restaurant/retail, for certain foods based on risk. The rule requires covered entities to maintain and share specific data elements for FTL foods throughout supply chains (and with FDA upon request). Entities along a supply chain must therefore coordinate to share relevant data elements with subsequent entities in the chain, in a compatible and timely manner. Since issuing the Food Traceability Rule in 2022, FDA has conducted extensive stakeholder outreach and education on the rule, in addition to providing technical assistance, tools, and other resources to assist industry with implementation. As the regulated industry has worked to comply with the rule's requirements, entities from across the supply chain have voiced strong concerns with the initial 3-year implementation timeframe, stating that they need more time to come into compliance. Specifically, FDA has heard concerns from industry that some of the required data elements are not routinely maintained or shared throughout supply chains, nor are many data systems currently interoperable throughout supply chains. Industry has also expressed concerns about the volume of data certain entities in the supply chain (particularly distributors and retailers) would be required to manage and challenges with implem ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 29k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━