Importers of Housewares are Subject to New FDA Regulations
The Foreign Supplier Verification Programs (FSVP) regulation is just one of multiple requirements implementing the Food Safety Modernization Act (FSMA).
SGCDpro became aware of implications of the recently implemented Food Safety Modernization Act when a member company was notified that its products were subject to a provision under the law. The association researched the issue and assembled the following information to importers of products that have food contact surface applications.
The U.S. Food & Drug Administration (FDA) website notes that “The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.”
The Foreign Supplier Verification Programs (FSVP) regulation is just one of multiple requirements implementing that law. Although most of the regulation went into effect on May 30, 2017, the effective date for the section dealing with food contact surfaces was delayed until May 28, 2019.
“It is clear that housewares, including ceramicwares, that are meant for serving or containing food are subject to the FSVP regulations,” said Richard Jacobs, retired FDA scientist and frequent speaker at SGCDpro conferences. This applies when food has contact with the surface of the ware.
“Contrary to the difficulties in meeting the regulations for food, ceramicware would appear to have an easier task, since the identified hazards, lead and cadmium, are largely not used anymore in many countries that export to the U.S.,” noted Jacobs. “The fact that China has an existing factory certification program may also lessen the difficulties in meeting FSMA and FSVP rules for importers who import Chinese manufactured wares.”
Comments and Responses
Specific information relating to food contact surfaces appeared in the FDA’s published response to comments submitted during the comment period. “Comment 5): Several comments request that we exclude food contact substances from the definition of food because facilities that manufacture, process, pack, or hold food contact substances are not required to register with FDA and therefore are not subject to the proposed regulations on preventive controls. One comment suggests that we either exclude food packaging from the FSVP regulation or establish modified requirements for packaging.
“Response 5): We do not agree that it is appropriate to exclude food contact substances (including food packaging), as defined in section 409(h)(6) of the [Food, Drug & Cosmetics (FD&C) Act from the definition of ‘food’ for FSVP purposes. The definition of ‘food’ in § 1.227, for the purposes of food facility registration, excludes food contact substances as defined in section 409(h)(6) of the FD&C Act. Consequently, a facility that manufactures/processes, packs, or holds food contact substances is not required to be registered. Because section 418 of the FD&C Act only applies to establishments that are required to register, facilities involved in the manufacturing/processing, packing, and holding of food contact substances are not subject to the preventive control regulations implementing section 418.
“Section 805 of the FD&C Act, however, is not similarly limited to facilities that are required to register. Instead, section 805 applies to imports of ‘food.’ The term ‘food’ is defined in section 201(f)(3) of the FD&C Act to include articles used as components of food, and the case law interpreting the definition makes clear that many substances that meet the definition of food contact substances under section 409(h)(6) of the FD&C Act also meet the definition of food (see, e.g., Natick Paperboard v. Weinberger, 525 F.2d 1103 (1st Cir. 1975) (paperboard containing PCBs intended for food use is adulterated food); U.S. v. Articles of Food 688 Cases of Pottery (Cathy Rose), 370 F. Supp. 371 (E.D. Mi. 1974) (ceramic pottery that leaches lead is adulterated food). Further, we do not believe there is any evidence that Congress intended to exclude food contact substances from being considered ‘food’ for purposes of section 805 and the FSVP regulation.
“Importers subject to the FSVP rule have an additional two years to meet the requirements of the rule for the importation of food contact substances. (A food contact substance is any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if the substance is not intended to have any technical effect on the food.) The agency will consider how best to address feasibility concerns for the application of FSVP to these substances. In doing so, the FDA noted the relatively rare occurrence of significant safety concerns associated with the manufacture of food contact substances and the agency’s existing, extensive premarket approval and review processes for these substances provide some assurances regarding safety during this time. The earliest compliance date is May 28, 2019.”
SGCDpro will monitor developments as the food contact requirements are advanced. Watch for updates as they become available.
Any views or opinions expressed in this column are those of the author and do not represent those of Ceramic Industry, its staff, Editorial Advisory Board or BNP Media.