FDA issues guidelines for facility registration

The FDA Food Safety Modernization Act (FSMA) provides that food facilities required to register with FDA must renew their registrations every other year, during the period beginning on Oct. 1 and ending on Dec. 31 of each even-numbered year.

Due to the delay in implementing the biennial registration renewal for the 2012 cycle, and because registration renewal did not become available until Oct. 22, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after Dec. 31, 2012 for a period of 31 days, until Jan. 31, 2013. FDA encourages facilities to renew their registrations early.

A set of guidance documents were released on December 12 called Guidance for Industry: What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide.

These documents were updated to reflect the FSMA amendments to the Food, Drug and Cosmetic Act, and contain information regarding: who is required to register and who may be exempt; how often facilities must register and renew registrations; when FDA may suspend a registration, and how facilities may submit their registrations and registration renewals to FDA.