The US Food and Drug Administration issued an interim final rule amending its regulations on record-keeping by food and petfood companies be consistent with the agency's authority for access to records, which was expanded by the Food Safety Modernization Act.
The new interim final rule, effective March 1, makes the reference to records access in the food-firm record-keeping requirements under the Food Safety Modernization Act consistent with the current statutory language in the Federal Food, Drug and Cosmetic Act. The interim final rule also allows FDA access to records beyond those relating to specific suspect food articles, if the agency has a reasonable belief that other products are likely to be affected in a similar manner.
FDA published a new draft guidance, “Draft Guidance for Industry: FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act,” to provide more detailed information regarding the updated record-availability requirement. This latest draft guidance is a revision of FDA’s November 2005 guidance, “Guidance for Industry and FDA Staff Guidance for Records Access Authority Provided in Title III, Subtitle A, of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; Final Guidance.” FDA also published an updated "Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records (Edition 5)," to be consistent with new Food Safety Modernization Act requirements.