FDA opens biennial food facility registration
by Laurie Gorton
After a 3-week delay, the Food and Drug Administration (FDA) began accepting mandatory biennial renewals through its food plant registry program on Oct. 22. Under the Food Safety Modernization Act (FSMA), all food plants must register with FDA, with renewals due in even-numbered years.
The normal window for this activity would have been Oct. 1 to Dec. 31. Registration is available online, by mail or fax. The agency recommends online renewals as the most efficient and least error-prone approach. Forms are available at www.fda.gov/furls.
FSMA, signed into law Jan. 4, 2011, continues the registration practice begun by the Bioterrorism Act of 2002. That directive requires all domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the US to register with FDA, starting Dec. 12, 2003.
The new law, however, adds more provisions, one being disclosure of the categories of food handled at each facility. FDA issued a new draft guidance document in August that discussed the specifics of food facility registration, outlining the law’s requirements and food categories affected.
Also new under FSMA is the requirement that every facility must commit to allow FDA inspection if the agency deems it necessary. “This could be a game changer for many food companies whose legal counsel formerly directed their facility managers to refer FDA inspectors to the corporate office,” wrote Declan Conroy, editor of EASeNews, an e-newsletter published by EAS Consulting Group, Alexandria, VA.
Proposed regulations implementing FSMA were to have been issued this past July but are still under review at the White House Office of Management and Budget (OMB). Many observers believe that these rules will be released soon after the November federal election.
FSMA has been described as the most sweeping change in the way the US food supply is regulated since original enactment of the Federal Food, Drug and Cosmetic Act in 1938. It aims to ensure that the US food supply is safe by shifting the focus from responding to contamination to preventing it. FDA assembled a food safety portal at its website, www.fda.gov/food/foodsafety.