Registration Renewal for Food Facilities Under the Food Safety Modernization Act

The Food and Drug Administration (FDA) has published new information regarding the biennial food facility registration renewal required under Section 102 of the Food Safety Modernization Act (FSMA). FSMA Section 102 amended Section 350(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) to require all food facilities to renew their facility registration between October 1 and December 31 of each even-numbered year. Section 102 also directs FDA to establish an abbreviated registration renewal process for registrants that have not experienced any changes to their registration information since the preceding registration or renewal. On June 14, 2012, FDA updated its list of FSMA Frequently Asked Questions (FAQ) to provide information on the registration renewal process.^[1]

Food facilities currently are required to register with FDA using Form 3537. FDA has now clarified that the registration renewal process also will use Form 3537 and has advised that the form is being updated to meet registration renewal needs.^[2] Facilities will be able to renew their registrations beginning on the statutorily mandated date of October 1, 2012. The registration application will be available for submission online at www.fda.gov/furls from 7 am - 11 pm, Eastern Standard Time, although registration may also be completed by mail or fax. For businesses with multiple facilities, the registration may be completed on a CD-ROM and submitted by mail.

FDA is encouraging use of the online application, advising that the system will assist the registration process by rejecting any incomplete applications and providing an applicant with confirmation of submission and a registration number upon completion.