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Technical difficulties delayed public access to the renewal process, so FDA is offering a deadline extension.
Food manufacturers, if you haven’t yet renewed your facility registration-and are required to do so-for the 2012 cycle, FDA is granting more time to complete the process. Because of a delay in making available the registration renewal portal online, FDA will exercise enforcement discretion for all registration renewals it receive after December 31, 2012 for a period of 31 days ending January 31, 2013.
The decision is stated on FDA’s Food Safety Modernization Act (FSMA) homepage and in the agency’s newest, fifth edition of guidance for food facility registration. The guidance is worth a close look, too, since it includes amendments to Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by way of President Obama’s 2011 passage of FSMA. FDA even takes the time to list what these changes are:
Provides authority for FDA to require registration to be submitted in an electronic format. This authority does not take effect until 5 years from the date of enactment of FSMA (i.e., January 4, 2016). Requires biennial renewal of food facility registrations. Provides for an abbreviated biennial renewal process for facilities without information changes. Requires registrant to include in registration the e-mail address for the contact person of the facility. Or, for a foreign facility, the registration must include the e-mail address of the U.S. agent for the facility. Provides authority for FDA to determine and identify appropriate additional food categories to be included in the registration. Requires the registration to include an assurance that FDA will be permitted to inspect the facility. Amends the definition of “retail food establishment.” Defines “community supported agriculture program.” Clarifies that the term “consumer” does not include a business. Provides for FDA to suspend a food facility’s registration. Provides that food offered for import from a foreign facility with a suspended registration can be held at the port of arrival. Requires FDA to promulgate regulations to implement changes to section 415 regarding suspension of food facility registrations.