Food-Contact Materials Should Not be Subject to a Foreign Supplier Verification Program

The U.S. Food and Drug Administration (FDA) should exclude food-contact substances from the requirements of the Foreign Supplier Verification Program (FSVP) component of the Food Safety Modernization Act (FSMA).

Under a final rule that FDA proposed for implementing FSVP (78 Fed. Reg. 45730 (July 29, 2013)), food-contact materials could fall within the scope of the regulations. The proposed regulations require importers to ensure that foreseeable hazards resulting from the manufacturing, processing, packaging, and holding of imported food are appropriately addressed to provide the same level of public health protection required under the hazard analysis and risk-based preventive controls (HARPC) and produce safety provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The proposed rule requires importers to develop, maintain, and follow a FSVP for each imported food, as defined in Section 201(f) of the FD&C Act, unless there is a specific exemption. FDA specifically excluded pesticides but not food-contact materials. However, the agency did request comments on the pesticide exclusion and whether there should be additional exclusions from the definition of food. (Comments were due January 27, 2014.)

Food-contact materials should be excluded from the requirements of the FSVP since:

• The manufacture of food-contact substances presents a low risk of concern for food safety;
• Packaging materials do not have a history of being a source of foodborne illnesses;
• The inclusion of food-contact substances would dramatically increase the number of covered companies, thereby misdirecting both FDA and food company resources from areas of greater importance for ensuring the safety of imported food; and
• It would ensure that the scope of the FSVP regulations is consistent with other FSMA requirements, as well as the goals of the FSVP program.

Safety of the Food Supply

Excluding food-contact substances from FSVP regulations will not adversely impact food safety since the risk of microbiological contamination is very low in finished food-contact articles, and chemical hazards are addressed in the premarket food-contact substances approval process.

FDA's regulations already require food-contact substances to be manufactured under good manufacturing practices and to be safe and suitable for their intended use. Consequently, if a substance used in the manufacturing process for a food contact material is expected to become a component of food at more than de minimis levels, it is required to be the subject of premarket clearance. This means that its use must be covered by a food additive regulation, Food Contact Notification, or by other premarket approval process that evaluates the safety of the substance for its intended use. Therefore, application of the FSVP to these substances would result in a lengthy and costly supplier verification program that would not increase the safety of the finished products when used in contact with food.

Consistent Regulations

The scope of the requirements of the FSVP should be consistent with the requirements of the HARPC provisions of FSMA, which only apply to a "food facility" that is required to register with FDA under Section 415 of the FD&C Act, while the FSVP provisions apply to "food." Section 415 of the FD&C Act was added by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) and requires facilities that manufacture, process, pack, or hold food for consumption in the U.S. to register with FDA. In its final rule on facility registration, FDA defined "food" to specifically exclude food-contact substances.

Since food-contact substances are exempt from the HARPC provisions but could be subject to the FSVP, importers of food-contact materials would be subject to different verification requirements than manufacturers of food-contact materials produced in domestic facilities. This could be a likely source of confusion and is contrary to the aim of the FSVP provisions to implement the same preventative controls to imported foods that apply to foods produced in the U.S.

In summary, requiring importers of food-contact materials to implement an FSVP would impose a significant burden on products that present a low risk to public health safety, and a risk which is already effectively managed by FDA regulations.