FDA Updates Compliance Policy Guide on Food Facility Registration
The Food and Drug Administration has made available on its Web site an updated compliance policy guide on food facility registration. This document provides the following guidance regarding enforcement of the food facility registration provisions of section 415 of the Federal Food, Drug and Cosmetic Act, including the requirement that certain food facilities register with the FDA, the requirement that registered facilities biennially renew their registrations, and the FDA’s authority to suspend facility registrations.
Registration. The owner, operator or agent in charge of a domestic or foreign facility that manufactures, processes, packs or holds food for human or animal consumption in the U.S. is required to register the facility with the FDA, unless an exception applies. The Food Safety Modernization Act requires registrants to submit additional registration information to the FDA, including the email address of the contact person for a domestic facility, the email address of the U.S. agent for a foreign facility, and an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. The FDA may consider a facility to not be registered if (a) it has not submitted a registration, (b) its registration is incomplete, or (c) its registration has expired because it failed to renew its registration.
If the FDA determines that a foreign food facility is not registered, the Division of Food Defense Targeting (formerly known as the Prior Notice Center) should be advised for future shipment targeting. In addition, the food being imported or offered for import from the unregistered facility is subject to being held at the port of entry unless U.S. Customs and Border Protection concurrence is obtained for the export of the food and the food is immediately exported from the port of arrival. Food held in this circumstance will not be entered or delivered to the importer, owner or ultimate consignee until the foreign facility is registered and the appropriate registration number is provided in prior notice. The FDA may allow the food held at the port of entry to be moved to a secure facility but ordinarily will not allow it to be transferred by any person from the port of entry into the U.S. or from the secure facility.
With respect to domestic facilities, during an inspection the investigator should determine whether the facility is registered and whether information in the registration is accurate and current. If a registration violation is found, the investigator should (a) advise the facility’s management of the requirement to register or update mandatory elements of the registration, (b) provide the management with FDA’s guidance, “What You Need to Know About Registration of Food Facilities,” (c) document in the establishment inspection report the information obtained regarding the facility’s registration, and (d) document information provided to the management of the unregistered facility regarding the registration requirements.
Renewals. FSMA requires food facilities to renew registrations biennially. The FDA states that if a food facility that previously submitted a registration does not submit a renewal during the period beginning on Oct. 1 and ending on Dec. 31 of each even-numbered year, the registration for that facility will be considered expired and the registrant for the facility will be notified accordingly. The FDA will consider a food facility with an expired registration to have failed to register, which is a prohibited act.
Suspensions. FSMA provides that if the FDA determines that food manufactured, processed, packed, received or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, it may suspend the registration of a facility that (a) created, caused or was otherwise responsible for such reasonable probability or (b) knew of, or had reason to know of, such reasonable probability and packed, received or held such food. Examples of circumstances in which priority consideration should be given to recommending suspension include the following.
- inspectional or other evidence (e.g., evidence of Class 1 recall situation or evidence of food associated with foodborne illnesses) indicates that the firm has significant violations of the FD&C Act and has not permanently corrected the source of the problem
- the firm is subject to a prehearing order to cease distribution and give notice under FDA’s mandatory recall authority
- the firm is subject to an emergency permit order under 21 CFR part 108 or the FDA is considering a recommendation to issue an emergency permit order to the firm
- the firm is a foreign facility and food from the firm is subject to an Import Alert that provides for detention without physical examination because the food may cause serious adverse health consequences or death to humans or animals
If the registration of a food facility is suspended, no person can import or export, offer to import or export, or otherwise introduce food from that facility into interstate or intrastate commerce in the U.S. While a suspension order is in effect for a domestic facility, the district in which the facility is located should take appropriate actions to ensure that food from that facility is not introduced into interstate or intrastate commerce. The FDA should advise the Division of Food Defense Targeting when a suspension order is issued to a foreign facility for future shipment targeting.
If an article of food being imported or offered for import into the U.S. is from a foreign facility for which a registration has not been submitted or has been suspended, the article 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. If a domestic facility that is subject to a registration suspension order introduces food from such facility into intrastate or interstate commerce, the FDA may pursue enforcement action such as administrative detention, seizure, injunction, mandatory recall, prosecution or a combination thereof if the applicable legal requirements are satisfied.