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FDA Issues Interim Rule on Record Access

The U.S. Food and Drug Administration issued an interim final rule on record-keeping by food firms to make current regulation consistent with FDA’s expanded access to records, which was granted by the FDA Food Safety Modernization Act in January 2011.

According to FDA, the new interim 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 agency’s records access authority and the record-keeping requirements were first established by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

“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,” said the agency Thursday.

A new draft guidance, “Draft Guidance for Industry: FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act,” was published to provide more detailed information on 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. 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

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