The U.S. Food and Drug Administration (“FDA”) recently announced the availability of draft Compliance Policy Guide Sec. 100.250 Food Facility Registration—Human and Animal Food (the “Draft CPG”). The Draft CPG is intended to provide FDA staff with guidance on issues related to food facility registration, including the requirement that certain food facilities register with FDA, the requirement that registered facilities biennially renew their registrations with FDA, and the authority of FDA to suspend a food facility’s registration.
The Food, Drug & Cosmetic Act (the “Act”), as amended by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, requires the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures, processes, packs, or stores foods intended for marketing and sale in the United States to register with FDA. FDA relies on facility registration for purposes of identifying food manufacturers, packers, handlers and distributors for inspection purposes. Registration also allows FDA to quickly identify the source of a food product in the event of potential or actual contamination, food-related bioterrorism, or outbreaks of food-borne illness, and take appropriate action when necessary to prevent the spread of such contamination or outbreak. A facility must be registered prior to the start of manufacturing, processing, packing, or storing. Registration can be completed electronically—and quickly—via FDA’s website, or by mailing or faxing FDA Form 3537 to FDA. There is no fee for registering a food facility with FDA. Electronic registration is strongly encouraged by FDA.
The recently published Draft CPG is important for those involved in the U.S. food industry because it outlines FDA’s proposed regulatory approach for enforcing food facility registration and describes FDA’s current thinking on registration, renewal, and suspension. First, FDA will enforce the registration requirements, and for regulatory compliance purposes, FDA will consider a facility to be in violation of such registration requirements if (1) it has failed to register; (2) the facility’s registration is incomplete; or (3) the facility’s registration is expired by failing to renew the registration.
For foreign food facilities shipping food products into the United States, such as manufacturers in China, Japan or France, FDA intends to use its “prior notice” requirements to ensure compliance with facility registration. Under the Act, a foreign food company is required to provide FDA with prior notice of a shipment no less than four hours before the product arrives at the port of arrival (by air) and no less than eight hours before the product arrives at the port of arrival (by water). Prior notice may be submitted via FDA’s Prior Notice System Interface up to fifteen days before the anticipated date of arrival. Upon arrival in the United States, FDA inspectors review incoming shipments for regulatory compliance, including proper facility registration and food labeling requirements. If FDA determines that a foreign food facility is not registered, FDA will hold the food being imported at the port of entry.
Second, the Draft CPG states that FDA intends to closely monitor the biennial facility registration renewal requirement. If a registered food facility fails to renew such registration during the mandated time period (i.e., from October 1st through December 31st of each even-numbered year), FDA will consider the registration expired and will take appropriate regulatory enforcement action.
Finally, FDA has the authority to suspend a facility’s registration if it obtains evidence that the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and the facility either created, caused, or was otherwise responsible for such reasonable probability or knew or had reason to know of such reasonable probability and packed, received, or held food regardless of such knowledge. If a domestic facility that is subject to suspension introduces food into interstate or intrastate commerce, FDA may pursue enforcement action, including administration detention, seizure, injunction, mandatory recall, prosecution, or a combination thereof.
FDA is accepting public comments on the Draft CGP through May 6, 2013. You may submit comments electronically or via the mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.