Description
On February 23, 2012, the Food and Drug Administration (FDA) published an interim final rule (IFR) in the Federal Register (77 FR 10658) that amended its regulation on the availability of records to be consistent with the amendments to section 414(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by section 101 of the FDA Food Safety Modernization Act (FSMA) (Public Law 111-353). The IFR became effective on March 1, 2012. On April 4, 2014, FDA issued a final rule in the Federal Register adopting without change the requirements in the IFR.
Scope & Applicability
Product Classes
3exemption from section 403(w) misbranding requirements; Food intended for animal consumption, including pet food.; scope of sanitary transportation regulation; not considered dietary supplements under section 201(ff); category for very small importer threshold; Calculation of annual sales for importer status
subject to 21 CFR parts 106 and 107
subject to 21 CFR part 111; Foods not subject to preventive controls requirements; Specific product category with modified FSVP requirements.; Included in human food sales calculation; foods not covered under systems recognition arrangements
Stakeholders
4persons who have possession, custody, or control of an article of food in the U.S. for the sole purpose of transporting
Identify the immediate non-transporter subsequent recipients of all foods released
Excluded unless they transport food in the U.S.
Persons who own, hold, manufacture, process, pack, import, or receive food.
Regulatory Context
Attributes
1The period for which the records must be retained depends on the perishability of the food
Identified Hazards
Hazards
2Risk threshold for suspect and illegitimate product definitions
Records help address credible threats to human or animal health.
See Also (8)
- Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Status: Final)
- Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (Status: Final)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- CPG Sec. 100.950 International Partnership Agreements for Compliance Activities (Status: Final)
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
- Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (Status: Final)
- French Translation of Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (Questions et Réponses relatives au Registre des aliments à signaler) (Status: Final)
- Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage (Status: Final)