FDA Adopts Interim Regulations on Access to Food Records
The Food and Drug Administration issued a final rule adopting in full its interim regulations expanding the agency’s access to food records. FDA had implemented the Food Safety Modernization Act recordkeeping changes in a February 2012 interim final rule (see 12022320). Under the now-adopted interim regulations, FDA not only has the right to access company records on an article of food that presents a food safety risk, but also any article FDA “reasonably believes” is affected in a similar manner, as well as any food for which FDA believes there is a “reasonable probability” of food safety risks.
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As it adopted its interim regulations as final, FDA also posted minor updates to its guidances on recordkeeping requirements for food. The agency slightly revised its compliance guide for small entities titled “Guidance for Industry: What You Need To Know About Establishment, Maintenance, and Availability of Records” (here). It also updated its guidance “Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act” (here).
(Federal Register 04/04/14)