FDA Issues Interim Final Rule on Records Access

The FDA has issued an interim final rule, that went into effect on March 1, amending its regulations on record keeping by food firms to be consistent with FDA’s access to records. FDA’s authority for access to records was expanded by the Food Safety Modernization Act (FSMA).

The new interim final rule makes the reference to records access in the food-firm record-keeping requirements under FSMA consistent with the current statutory language in the Federal Food, Drug, and Cosmetic Act. The interim final rule allows FDA access to records beyond those relating to specific suspect food articles if the agency reasonably believes that the other products are likely to be affected in a similar manner.

This new interim final rule is FDA’s latest step in implementing the FSMA. The expanded records-access authority is expected to improve FDA’s ability to respond to and contain safety problems with the human and animal food supply.

A new “Draft Guidance for Industry: FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act” has been published to provide more detailed information pertaining to the updated record-availability requirement. FDA also published an update to its Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4), to ensure the guidance is consistent with the new FSMA requirements. Public comments on the interim final rule may be submitted electronically to the docket through www.regulations.gov. More information is available at www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm292745.htm.