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SMALL ENTITY COMPLIANCE GUIDE

Small Entity Compliance Guide: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation May 2023

Download the Final Small Entity Compliance Guide Read the Federal Register Notice
Final
Docket Number:
FDA-2023-D-1336
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

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On January 4, 2011, President Obama signed the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) into law.  As a component of FSMA’s overhaul of U.S. food safety law to better ensure the safety and security of the nation’s food supply, section 204(d) of FSMA requires that FDA establish recordkeeping requirements for facilities that manufacture, process, pack, or hold foods the Agency designates as high-risk to facilitate the rapid and effective traceability of such foods.  These recordkeeping requirements are additional to the food traceability requirements under section 414 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (added to the FD&C Act in title III, subtitle A, section 306, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188)) and the implementing regulations in subpart J of part 1 of title 21 of the Code of Federal Regulations (§§ 1.326 to 1.368) (the subpart J regulations). In section 204(d)(1) of FSMA, Congress directed FDA to adopt additional recordkeeping requirements to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death to humans or animals resulting from certain foods being adulterated under section 402 of the FD&C Act or misbranded with respect to allergen labeling under section 403(w) of the FD&C Act.

On November 21, 2022, FDA published the final rule entitled, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Rule) (87 FR 70910). The regulation can be found at 21 CFR part 1, subpart S (§§ 1.1300-1.1465).

We have prepared this Small Entity Compliance Guide (SECG) in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document is intended to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule as established in 21 CFR part 1, subpart S. The regulations are binding and have the full force and effect of law.  

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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All written comments should be identified with this document's docket number: FDA-2023-D-1336.

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