18 Nov 2016
FDA Issues Updated Q&A Document on Food Facility Registration
The Food and Drug Administration has issued an updated guidance for industry with questions and answers on the food facility registration requirements. The draft guidance contains 15 sections of a multi-section document intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act. Interested parties may submit comments on this document by 6 February 2017.
As previously reported, food facilities required to register with the FDA must renew their registrations by 31 December. 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. Food 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 for 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.
The FDA notes in the Q&A document that when a food facility submits a registration renewal via mail or fax it will be asked to provide its facility registration number and pin number. For electronic submissions, account holders in FURLS will not need to provide a registration number or pin because that information is linked to the account. The agency adds that if a food facility registration or renewal registration is submitted (or postmarked, for paper submissions) on or before the renewal deadline and includes all required information, the FDA will not consider such a registration to be expired.
The FDA is providing an abbreviated registration renewal process for facilities that do not have any information changes since the submission of their preceding registration, registration renewal or update. If the abbreviated registration renewal process is used, the facility must confirm that no changes have been made to the required information and certify that the information submitted is truthful and accurate. Each electronic abbreviated registration renewal must include the name of the individual submitting the abbreviated renewal. For registrations submitted by mail or fax, each abbreviated registration renewal must also include the individual’s signature. For abbreviated registration renewals not submitted by the owner, operator or agent in charge of the facility, the renewal must provide the email address of the individual who authorised submission of the abbreviated renewal, unless the FDA has granted a waiver.
For registrations or registration renewals not submitted by the owner, operator or agent in charge of the facility, the FDA will verify that the individual identified as having authorised the submission in fact authorised that submission on behalf of the facility. The agency will not confirm a registration, provide a registration number or provide confirmation of a registration renewal until that individual confirms that he or she authorised the submission. The same general principle will apply when confirming information about U.S. agents.
In most circumstances, the agency will conduct this verification step by sending an email to the individual identified as having authorised the submission. In some circumstances, however, the FDA may determine that it is appropriate to use other methods to conduct the verification step such as U.S. mail or phone. The agency will provide the owner, operator or agent in charge of the facility, or the person identified as the U.S. agent, as applicable, 30 calendar days to respond to its verification request. If the FDA does not receive a response within that time, the registration, registration renewal, update or cancellation submission will be removed from the agency’s database and a new submission will be required. If the FDA has previously verified that the authorising individual has authorised the individual submitting the renewal to make registration submissions on behalf of the facility, it will not re-verify that status. The FDA will also continue its current practice of individually contacting facilities if specific questions arise regarding the facility’s registration.