The FDA Food Safety Modernization Act (FSMA) requires U.S. FDA to create two new programs for importers: the Foreign Supplier Verification Program (FSVP) and the Voluntary Qualified Importer Program (VQIP). The new law does not detail specific requirements or processes of these two programs but requires U.S. FDA to outline these new requirements in upcoming regulations.
U.S. FDA must promulgate regulations to provide the specific content for FSVP by January 4, 2012, at the latest. By this date, U.S. FDA must issue a guidance document to assist importers in developing foreign supplier verification programs. FSVP requires importers to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported is produced safely, unadulterated, and not mis-branded. An “importer,” for this program, is defined as the United States owner or cosignee of the article of food at the time of entry of such articles into the United States, or, if there is no United States owner or consignee, the importer is defined as the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry into the United States. FSMA states that verification activities may include monitoring records for shipments, lot-by-lot certification compliance, annual on-site inspections, checking the hazard analysis and risk-based preventative control plan of the foreign supplier, and periodically testing and sampling shipments. Importers are required to maintain records related to this program for two years and are required to allow a U.S. FDA inspector to review these records during an inspection. U.S. FDA is required to publish and maintain a list of FSVP participants that will display, at a minimum, the name and location of suppliers in the program. All of the new FSMA requirements for this program are required to be in place and functional by January 4, 2013.
On the other hand, VQIP is entirely voluntary. U.S. FDA must, in conjunction with the Secretary of the Department of Homeland Security (DHS), establish this program to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate. VQIP will also establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in the program. Under this program, an “importer” is defined as the person that brings food, or causes the food to be brought, from a foreign country into the United States. This is an important distinction from the definition of an importer under FSVP because it could mean that foreign manufacturers may be allowed to participate in this program. As with all new requirements under FSMA, the deciding factors will not be hammered out until the final regulations are issued. Indeed, FSMA does not define details of entities that are or are not allowed to participate in VQIP, nor does is outline the specific benefits and advantages of participating. FSMA merely states that importers may request to participate and that participation will provide an expedited review process. VQIP regulations are not required to be finalized by the U.S. FDA until July 4, 2013.
Both the Foreign Supplier Verification Program and the Voluntary Qualified Importer Program identify importers as the front line of contact for food safety awareness and hazard prevention. U.S. FDA has indicated that these two programs are of top priority amongst all new FSMA requirements as the two programs were key components discussed during U.S. FDA’s first series of Public Meetings. As more insight is gained into industry’s requests regarding the new act, U.S. FDA will issue regulation and guidance, hopefully incorporating concepts learned during these Public Meetings.