{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule would require these entities to establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods. The proposed requirements are intended to 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 proposed rule in accordance with the FDA Food Safety Modernization Act (FSMA).","action":"Proposed 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/2020/09/23/2020-20100.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1","title":21}],"citation":"85 FR 59984","comment_url":"http://www.regulations.gov/commenton/FDA-2014-N-0053-0056","comments_close_on":"2021-01-21","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by January 21, 2021. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 23, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-0053"],"dockets":[{"supporting_documents":[{"title":"Reference 1 Discussion Paper","document_id":"FDA-2014-N-0053-1371"},{"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"}],"agency_name":"FDA","documents":[{"comment_count":327,"comment_start_date":"2020-09-23","updated_at":"2025-07-25T01:56:40.325-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-N-0053-0056","allow_late_comments":true,"id":"FDA-2014-N-0053-0056","comment_end_date":"2021-01-22","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":124,"id":"FDA-2014-N-0053","title":"Designation of High-Risk Foods for Tracing; Request for Comments and for Scientific Data and Information"}],"document_number":"2020-20100","effective_on":null,"end_page":60038,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/09/23/2020-20100.xml","html_url":"https://www.federalregister.gov/documents/2020/09/23/2020-20100/requirements-for-additional-traceability-records-for-certain-foods","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-20100?publication_date=2020-09-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-09-23/2020-20100/mods.xml","not_received_for_publication":null,"page_length":55,"page_views":{"count":26785,"last_updated":"2026-06-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-09-23/pdf/2020-20100.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-20100.pdf?1600702392","publication_date":"2020-09-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/09/23/2020-20100.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":"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"}],"comments_count":327,"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":122,"docket_id":"FDA-2014-N-0053","document_id":"FDA-2014-N-0053-0056","regulation_id_number":null,"title":"Designation of High-Risk Foods for Tracing; Request for Comments and for Scientific Data and Information","checked_regulationsdotgov_at":"2025-07-26T08:55:03Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2014-N-0053-0056","significant":true,"signing_date":null,"start_page":59984,"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":"Proposed Rule","volume":85}