The U.S. Food and Drug Administration's (FDA) proposed rule to implement the Foreign Supplier Verification Program (FSVP) component of the Food Safety Modernization Act (FSMA) (78 Fed. Reg. 45730 (July 29, 2013)) establishes the activities that importers of food must undertake to ensure that the food they bring into the United States is safe. Specifically, importers must work with their foreign suppliers to assure that foreseeable hazards resulting from the manufacturing, processing, packaging, and holding of food are appropriately addressed so as to provide the same level of public health protection as is required under the Hazard Analysis and Risk-Based Preventive Controls (HARPC) and produce safety provisions of the Federal Food, Drug, and Cosmetic Act (Sections 418 and 419 of the FD&C Act, respectively).
As background, FSMA Section 301, "Foreign Supplier Verification Program," amended the FD&C Act to add a new Section 805, which requires food importers to perform risk-based foreign supplier verification activities to confirm that the food being imported: (1) is produced in compliance with the HARPC or produce safety provisions of FSMA; (2) is not adulterated; and (3) is not misbranded (due to improper allergen labeling).
The proposed rule requires importers to develop, maintain, and follow a FSVP for each imported food, unless there is a specific exemption. In defining "food," the proposed rule references the broad definition contained in Section 201(f) of the FD&C Act, but adds that pesticides are not included. Food-contact materials could be considered to fall within the scope of the proposed rule; however, FDA has asked for comments on the types of "food" that should be excluded from the rule, which may provide an opportunity for the Agency to clarify whether the rule is specifically intended to cover food-contact materials.
The importer subject to the FSVP is either the U.S. owner or consignee of the food at the time of entry, or, if there is no U.S. owner or consignee at the time of entry, the U.S. agent or representative of the foreign owner or consignee. The importer must undertake several steps to properly verify the safe status of the food it imports, including: (1) establish the compliance status of the food and the potential foreign supplier, (2) analyze the hazards that are reasonably likely to occur for each food they import, (3) conduct activities to provide adequate assurances that these hazards are adequately controlled, (4) maintain a written list of its foreign suppliers and follow adequate written procedures for verification activities, and (5) review and investigate complaints and take corrective actions.
With respect to hazard analysis, FDA considers it necessary for importers to identify the hazards that are reasonably likely to occur with the foods they import to focus verification efforts. The proposed rule includes a number of factors that importers should consider in conducting a hazard evaluation. One of those factors is packaging and labeling activities (e.g., type of packaging material).
The proposed rule if adopted would make it a prohibited act to import or offer to import food without a verification program in place. Moreover, food can be refused admission to the U.S. if it appears that the importer is in violation of the FSVP requirements. The proposed rule allows for modified requirements for certain foods and exempted some other foods from FSVP requirements. Comments are due by November 26, 2013.
(For more information, see the KHlaw.com article, Overview of FDA's Proposed Rule to Implement FSMA's Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.)