Food

FDA Issues Interim Final Rule on Record Access Requirements for Food Firms

CFSAN Constituent Update

February 23, 2012

The U.S. Food and Drug Administration (FDA) has issued an interim final rule 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 FDA Food Safety Modernization Act (FSMA) on January 4, 2011.

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. FDA's records access and the record-keeping requirements were first established by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

The interim final rule also 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A new draft guidance, “Draft Guidance for Industry: FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act,” published to provide more detailed information pertaining to the updated record-availability requirement. This new draft guidance is a revision of FDA’s November 2005 guidance entitled “Guidance for Industry and FDA Staff Guidance for Records Access Authority Provided in Title III,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 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. See Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5). 

The new interim final rule is effective March 1, 2012. Public comments on the interim final rule may be submitted electronically to the docket through http://www.regulations.gov. In addition, public comments to the guidance mentioned above may also be submitted electronically to http://www.regulations.gov.

Comments may be submitted by mail to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments on the IFR must include the docket number, FDA-2002-N-0153. All comments to the guidance documents must include the docket number listed in the appropriate Notice of Availability published in the Federal Register. 

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