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FSMA Final Foreign Verification Rule Includes Food-Contact Materials

The U.S. Food and Drug Administration (FDA) has issued final rules to implement three major provisions of the FDA Food Safety Modernization Act (FSMA). The Foreign Supplier Verification Programs [FSVP] for Importers of Food for Humans and Animals final rule applies to importers of food. Importantly, the FSVP rule also defines "food" as provided in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), except that food does not include pesticides as defined in 7 U.S.C. 136(u). Food-contact substances qualify as food under section 201(f) of the FD&C Act and, therefore, are subject to the provisions of the FSVP.

At a minimum, the FSVP requires importers of food-contact substances to conduct a hazard analysis for all known or reasonably foreseeable hazards to determine whether there is a need to implement any measures to control those hazards. FDA notes that a hazard analysis must consider: (1) biological hazards (including microbiological hazards); (2) chemical hazards (including, among others, unapproved additives, food allergens, and pesticide and drug residues); and (3) physical hazards (e.g., stones, glass, metal, etc.). In addition, importers of food-contact substances must document and maintain records of their hazard analysis, and the hazard analysis must be performed by an individual qualified through appropriate training or experience (or some combination thereof). Depending on the outcome of one's hazard analysis, additional requirements under the rule may apply. These additional requirements include, but are not limited to, determining what appropriate measures must be taken to control those hazards and verifying suppliers to ensure that those hazards are, in fact, adequately controlled. Corrective actions may also be necessary if it is determined that a foreign supplier is producing a food-contact substance in a manner that does not provide for the adequate protection of the public's health.

Importantly, food-contact substance manufacturers are not required to comply with FSMA's Hazard Analysis and Risk-Based Preventative Controls (HARPC) regulation. The HARPC regulation is designed to ensure that domestic food facilities are producing safe food through a focus on identification and prevention of potential food safety hazards. However, the HARPC regulation applies to food facilities that must register pursuant to the Bioterrorism Act, not food itself. Facilities that only manufacture food-contact substances are not required to register under the Bioterrorism Act.

The FSVP rule is designed to ensure that importers institute a FSVP that provides adequate assurances that imported food is produced in a manner that provides an equivalent level of public health protection as the HARPC rule. Notwithstanding this fact, FDA decided that importers of food-contact substances produced overseas must comply with the FSVP. In doing so, foreign manufacturers of food-contact substances are subject to an additional layer of regulation that some producers of domestic food-contact substances will largely escape, simply because they produce their food-contact substances in a facility that does not have to register under the Bioterrorism Act. As a justification for its conclusion that the FSVP rule should encompass food-contact substances, FDA indicated that it relied on the language in FSMA that directs FDA to implement a FSVP for imported food. FDA further noted there was no evidence that Congress intended to exclude food-contact substances in the context of the FSVP regulation.

FDA also issued pre-publication versions of its final rules on Produce Safety and Accredited Third-Party Certification