7 Oct 2016
Food Facilities Required to Re-Register with FDA by 31 December
Food facilities required to register with the Food and Drug Administration must renew their registrations between 1 October and 31 December 2016. Food being imported or offered for import into the United States from a foreign facility for which registration has not been submitted or renewed must be held at the port of entry and may not be delivered to the importer, owner or consignee until the foreign facility is registered. Failure to register or renew a registration can also expose facilities to civil or criminal action.
Under Section 102 of the Food Safety Modernization Act, all domestic and foreign facilities that manufacture, process, pack or store food, food ingredients, pet foods or dietary supplements are required to renew their registration with the FDA every even-numbered year. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located within, or maintains an office in, the United States and acts as the domestic representative for the foreign facility through which all communication with the FDA takes place.
Information that must be provided during the registration process includes the type of registration (foreign or domestic and initial registration or registration renewal); facility name/address information; preferred mailing address information (optional); parent company name/address information; facility emergency contact information; trade names; U.S. agent; seasonal facility dates of operation; general product categories (human/animal/both); general product categories (food for human consumption and type of activity conducted at the facility); general product categories (food for animal consumption and type of activity conducted at the facility); owner, operator or agent in charge information; inspection statement acknowledging that the FDA will be permitted to inspect the facility at the time and in the manner permitted; and certification statement.
After a foreign facility completes its registration or updates its U.S. agent information as part of its registration renewal, the FDA will verify that the person identified as the U.S. agent for the facility has agreed to serve as such. The FDA will not confirm the registration or renewal or provide a registration number until such confirmation has been obtained. In addition, the U.S. agent of a foreign facility may view the information submitted in that facility’s registration.
The FDA states that it is continuing to use the version of the food facility registration form (Form FDA 3537) that was in use prior to a 17 July final rule making various amendments to the registration requirements and that this version does not include all of the data elements required by that rule. The FDA plans to implement a revised version of the form shortly. Facilities can register on-line, via mail or by fax (although the FDA encourages on-line registration) or may authorise third parties to register for them.
Meanwhile, the FDA has updated the food product categories that foreign and domestic facilities that manufacture, process, pack or hold food for human or animal consumption in the United States can select when registering with the FDA. Food facilities will be required to select from these updated categories during the registration renewal period.
According to the FDA, updates include the following.
- acidified foods and low acid canned foods are no longer listed as food product categories because they are now activity types
- molluscan shellfish is now a food product category (previously, molluscan shellfish establishment was listed among the optional activity types)
- new animal food categories include botanicals and herbs, direct fed microbials, animal protein products (replacing animal derived products), forage products, human food by-products not otherwise listed, processed animal waste products (replacing recycled animal waste products) and technical additives
The FDA states that detailed and accurate information about the categories of food a facility manufactures or distributes helps the agency to (i) conduct investigations and surveillance operations in response to food-related emergencies, (ii) quickly alert facilities potentially affected by such an incident if it receives information indicating the type of food affected, and (iii) verify that imported products are correctly identified by where and when they were produced.