CFSAN Constituent Update - Food Facility Biennial Registration Renewal

Food facilities required to register with FDA must renew their food facility registrations this year during the period beginning on October 1, 2014 and ending on December 31, 2014. FDA encourages food facilities to renew their registrations early on in the three-month renewal period.

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended the food facility registration requirements of section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apply to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year.

FDA has three guidance documents available to provide assistance to registrants with the registration process, including information on biennial registration renewal. These guidance documents are listed below.

The Guidance for Industry: What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide was updated in 2012 to reflect FSMA amendments to the FD&C Act, and contains 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.

The Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition)was updated in 2012 and contains helpful questions and answers regarding food facility registration. Updates to questions in this edition are based on FSMA amendments.

The Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrationcontains information regarding food-product categories included in the food facility registration form.