{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially 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 resulting from foods being adulterated or misbranded. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA).","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2022/11/21/2022-24417.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21}],"citation":"87 FR 70910","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":["https://www.federalregister.gov/api/v1/documents/C1-2022-24417"],"dates":"This rule is effective January 20, 2023. For the applicable compliance dates, see section VI \"Effective and Compliance Dates\" in the SUPPLEMENTARY INFORMATION section of this document.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-0053"],"dockets":[{"supporting_documents":[{"title":"Proposed Rule Reference List","document_id":"FDA-2014-N-0053-1331"},{"title":"Tab B - FDA Food Traceability- Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-1321"},{"title":"Reference 29 - FDA Guidance for Industry-The Seafood List July 2012 RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-1313"},{"title":"Reference 28 - FDA Memorandum - Seed Intended for Agricultural Purposes Sold for Sprouting October 2022 SIGNED 10-26-2022 RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-1312"},{"title":"Reference 18 - New Era of Smarter Food Safety FDAs Blueprint for the Future July 2020 RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-1303"},{"title":"Reference 16 - FDA - Food Traceability - Regulatory Impact Analysis November 9 2022 RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-1302"},{"title":"Reference 09 - FDAs Response to External Peer Review Model Review on FDAs Draft Report for Peer Review September 2015 August 2020 RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-1295"},{"title":"Reference 02 - FDA Report to Congress on Enhancing Tracking and Tracing of Food and Recordkeeping. Submitted Pursuant to Section 204 FDA FMSA Pub. 2016 RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-1288"},{"title":"PRIA Reference 16 - Smith et al 2015 - Product tracing in epidemiologic investigations of outbreaks RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-0127"},{"title":"PRIA Reference 18 - Blankenship et al 2020 - CORE Data for Economic Analysis Aug 2020 - SIGNED RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-0125"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-11-21","updated_at":"2023-02-27T19:57:06.640-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-N-0053-1285","allow_late_comments":null,"id":"FDA-2014-N-0053-1285","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":122,"id":"FDA-2014-N-0053","title":"Designation of High-Risk Foods for Tracing; Request for Comments and for Scientific Data and Information"}],"document_number":"2022-24417","effective_on":"2023-01-20","end_page":71088,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/11/21/2022-24417.xml","html_url":"https://www.federalregister.gov/documents/2022/11/21/2022-24417/requirements-for-additional-traceability-records-for-certain-foods","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-24417?publication_date=2022-11-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-11-21/2022-24417/mods.xml","not_received_for_publication":null,"page_length":179,"page_views":{"count":37643,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-11-21/pdf/2022-24417.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-24417.pdf?1668528919","publication_date":"2022-11-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/11/21/2022-24417.txt","regulation_id_number_info":{"0910-AI44":{"issue":"202204","html_url":"https://www.federalregister.gov/regulations/0910-AI44/requirements-for-additional-traceability-records-for-certain-foods","title":"Requirements For Additional Traceability Records For Certain Foods","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202204&RIN=0910-AI44&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AI44"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab B - FDA Food Traceability- Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-1321"},{"title":"Reference 21 - Chen Y. V.N. Scott,et al. Control of Salmonella in Low-Moisture Foods II-Hygiene Practices To Minimize Salmonella Contamination and Growth FPT 2009 RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-1306"},{"title":"FDA Tab B - Tracing PRIA - OMB redline changes 7-20-20 to 9-5-20 RE Requirements for Additional Tractability Records for Certain Foods (Proposed Rule)","document_id":"FDA-2014-N-0053-0167"},{"title":"FDA Tab A - Traceability NPRM 07-21-2020 RE Requirements for Additional Tractability Records for Certain Foods (Proposed Rule)","document_id":"FDA-2014-N-0053-0164"},{"title":"PRIA Reference 16 - Smith et al 2015 - Product tracing in epidemiologic investigations of outbreaks RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-0127"},{"title":"PRIA Reference 18 - Blankenship et al 2020 - CORE Data for Economic Analysis Aug 2020 - SIGNED RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-0125"},{"title":"PRIA Reference 25 - US Department of Health and Human Services 2016 - Guidelines RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-0118"},{"title":"PRIA Reference 27 - Fields et al 2020 - CORE TB Efficiences Memo updated 8-31-2020 - SIGNED RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-0116"},{"title":"PRIA Reference 33 - Mejia et al 2010 - Traceability (Product Tracing) in Food Systems Vol 2 RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-0110"},{"title":"PRIA Reference 41 - Ucar Yilmaz and Cakiroglu 2016 - Food safety - Problems and solutions RE Requirements for Additional Traceability Records for Certain Foods","document_id":"FDA-2014-N-0053-0102"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-0053","supporting_documents_count":117,"docket_id":"FDA-2014-N-0053","document_id":"FDA-2014-N-0053-1285","regulation_id_number":null,"title":"Designation of High-Risk Foods for Tracing; Request for Comments and for Scientific Data and Information","checked_regulationsdotgov_at":"2023-09-27T14:00:15Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":70910,"subtype":null,"title":"Requirements for Additional Traceability Records for Certain Foods","toc_doc":"Requirements for Additional Traceability Records for Certain Foods","toc_subject":null,"topics":["Cosmetics","Drugs","Exports","Food labeling","Imports","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":87}