The U.S. Food and Drug Administration (FDA) today issued a final rule, "Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements," as well as two Guidance for Industry documents to help food companies comply with the regulation.
The Guidances are entitled “What You Need To Know About Establishment, Maintenance, and Availability of Records—Small Entity Compliance Guide” (Docket No. FDA-2013-N-1421) and "FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act" (Docket No. FDA-2011-D-0674-0044). The FDA is accepting comments on both documents, electronically via Regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
The new rule and guidances are amended versions of previously existing documents. They were developed because the Food Safety Modernization Act (FSMA) required changes to the Federal Food, Drug, and Cosmetic Act, expanding FDA's access to food company records that are:
- related to any food product reasonably believed to be adulterated and to present a threat of serious adverse health consequences or death to humans or animals;
- related to any other article of food that FDA reasonably believes is likely to be affected in a similar manner;
- related to articles of food for which the Secretary believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that the FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals.
FDA officials said the expanded records access is designed to enhance FDA’s ability to respond to and contain threats of serious adverse health consequences or death to humans or animals.
For more information on the Final Rule and the Guidances, see:
- Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records
- Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act
- Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide