The Food and Drug Administration (FDA) has announced that it will extend the enforcement deadline for facility registration renewals under the Food Safety Modernization Act (FSMA). Under newly issued guidance, the FDA states that it will extend “enforcement discretion” for an additional 31 days, moving back the deadline from December 31, 2012 to January 31, 2013. The agency is extending the submission period because it did not make the renewal system available until October 22, 2012 rather than the original target date of October 1.
Under FSMA, all domestic and foreign facilities that manufacture, process, pack or hold food must submit a registration renewal every two years. In the updated guidance, the FDA also reiterates that failure to register or to renew, update or cancel a registration is a “prohibited act” under the federal Food, Drug and Cosmetic Act, punishable by a civil or criminal action. The agency also emphasizes that imported food cannot enter into commerce until the originating foreign facility is registered.
The revised registration period does not change the preexisting obligation for facilities to update their registration within 60 calendar days if there is any change to its required information. The FDA also says it plans to provide an abbreviated registration renewal process during future renewal cycles for facilities that have not made any changes to their information. However, the FDA could not do so this year because all facilities need to submit newly required, additional information under FSMA.
Notably, even if your facility is already registered, re-registration is required, complete with the newly required information. Re-registration itself involves no fee and can be completed online or via mail or fax.
Importantly, foreign facilities should take this opportunity to contact their U.S. Agents to confirm the agency status. Every foreign facility currently registered under FSMA has already selected a U.S. Agent on its original registration form for the purposes of facilitating emergency communication with the FDA. During the re-registration process, the facility must verify whether or not its U.S. Agent will continue to act in that role, for which the U.S. Agent can charge a fee. To change the selected U.S. Agent, a facility does not need to obtain a new registration number.
For further information and to register online, please go to the FDA’s food facility registration website.
For clarification, the FDA’s action in according enforcement discretion for 31 days beyond the December 31, 2012 deadline for facility registration is, in technical terms, not an extension of the deadline. While the FDA is effectively postponing mandatory enforcement through January 31, 2013, it is important to note that the deadline does not legally change, and so the agency can
exercise enforcement beyond December 31, 2012.