The last 18 months have seen a flurry of regulatory activity as the FDA has finalized and begun enforcing a number of new regulations based on the Food Safety Modernization Act (FSMA). Among these regulatory schemes is the Foreign Supplier Verification Program (FSVP) which, in essence, requires importers of food products to ensure that their suppliers in foreign countries apply the same food safety practices required for domestic food companies.
As the food industry is aware, FSVP requires food importers to ensure that foreign suppliers implement and follow a Hazard Analysis and Risk-Based Preventive Control Food Safety Plan, or HARPC food safety plan. Generally, this means that a U.S. importer must ensure that its imported products are safe for introduction into the U.S. food supply and are produced under food safety programs applying HARPC principles. Additionally, the applicability of FSVP directly impacts HARPC supply chain programs because FSVP only applies to the last foreign company to process the food before it is exported to the U.S. The FSVP and HARPC supply chain regulations require domestic importing companies to identify hazards in their products no matter where they arise in the supply chain and ensure that they are addressed using a preventive control. The issue, of course, is who has the immediate responsibility. In the case of imported foods, it’s the importer of record.
However, the applicability of these rules has been a point of contention and confusion within the food industry and, in particular, the food packaging industry. This industry is asking whether the FSVP applies to them at all and, if so, how. To answer this question, we need to look both to the language of the FSVP and the pre-existing regulations on food-related goods.
Food contact substances
The FDA has defined a hierarchy of goods related to food that are not food themselves but are regulated because of the goods’ contact with food. This hierarchy progresses from Food Contact Substances to Food Contact Materials to Food Contact Articles, and the FDA defines them as follows:
- Food Contact Substance (FCS) (the subject of a Food Contact Notification) is a single substance, such as a polymer or an antioxidant in a polymer. As a substance, it is reasonably pure (the chemist's definition of substance). Even though a polymer may be composed of several monomers, it still has a well-defined composition. (Example: the individual thermoplastic polymers used in making plastics.)
- Food Contact Material (FCM) is made with the FCS and (usually) other substances. It is often (but not necessarily) a mixture, such as an antioxidant in a polymer. The composition may be variable. (Example: Sheets of plastic.)
- Food Contact Article (FCA) is the finished film, bottle, dough hook, tray, or whatever that is formed out of the FCM. (Example: Formed plastic plates made of plastic sheets.) These FCA’s include final-form food containers.
Thus, FCAs (food packaging and containers) are created from FCMs which are composed of FCSs. The differences between these different compounds are important, as they have effects that echo into the FDA regulatory requirements under FSMA. First and foremost, FCSs, specifically, are subject to FDA premarket notification requirements via the Food Contact Notification system, or alternatively, GRAS certification. FCMs and FCAs are not, as they are manufactured with FCSs that, ostensibly, are the subject of an FCN or GRAS notification. The fact that a product’s status definition defines how it is regulated is important, as the regulations under FSMA are extraordinarily definition-dependent. This is particularly true of the FSVP.
FSVP and the meaning of food
While we have covered the FSVP in the past, one aspect of the rule bears revisiting to answer our questions regarding FSVP and food packaging: its scope. According to the rule, it generally applies “to all food imported or offered for import into the United States and to the importers of such food.” (21 C.F.R. § 1.201.) While there are exceptions, the rule by its terms, applies to food. Similarly, under 21 C.F.R. § 1.500, food “has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act.” In other words, food is, “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”
However, when the FSVP rule was released, the FDA included a discussion in a comment and response in the Federal Register that has created confusion among members of the industry. The Federal Register Notice for the FSVP rule, found at 80 FR 74225, states that several comments received by the FDA during the rulemaking process indicated that the industry asked the agency to:
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.
Unfortunately, the comment’s response does not provide much clarity in whether the FDA was broadening the definition of food for the purposes of the new rule. In providing its response, the FDA stated that it was not using the same definition for “food” used for facility registrations (21 C.F.R. § 1.227) and from the HARPC regulation, which excludes food contact substances. However, the agency remained silent as to whether or not its FSVP definition included FCMs or FCAs. While the FDA indicated it does not think it is appropriate to exclude packaging in its response, the agency went no further in its reasoning.
As part of its response to the comments, the FDA points to two very old cases that nonetheless do not support the idea that packaging is covered by the definitions of “food” found in the Federal Food, Drug, and Cosmetic Act (FDCA) or FSMA, but may support the argument that certain substances that become part of food can be considered food under the FDCA. A close read of those cases points out that contaminants in packaging that leach into food are technically food additives because they become part of the food, hence the reason that substances used in packaging are subject to either GRAS requirements or the FCN system. It is worth noting that neither case cited nor the response itself stands for the concept that packaging is food. Although comments to final rules can be helpful to map out where the FDA’s thinking is currently on a topic, ultimately responses are just that: responses to comments made on the language of the rule, and, as such, those responses to comments do not carry the weight of a final rule or law.
Finally, it is likely that the FDA did not go any further in its statements to include food contact articles as it could find no support in its own regulations or the FDCA. The regulatory system in place already has controls for regulating the components that make up the final-form packaging or food contact articles through its food contact substances regulations. The FDCA defines a food contact substance as:
any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food …
(21 U.S.C. § 321.) As noted above, these substances are regulated to ensure that, to the extent those items make contact with a food, they are safe even before these substances are used to create the food contact article. Therefore, since the things that go into creating the final packaging are regulated, there is no need to then regulate the final form packaging itself to ensure a safe food supply.
Thus, based on the terms of the FDCA, a plain reading of the FSVP’s terms, and the case law cited by the FDA, the FSVP does not appear to apply to food containers.
Are FCSs and FCAs considered food under FSVP?
To clear up this confusion, Life Sciences Decoded reached out to the FDA’s Technical Assistance Network (TAN), a group of private and public sector subject-matter specialists at the FDA whose sole job is to explain FMSA rules to the industry. When we contacted TAN and asked whether FSVP applied to food packaging, this was their response:
[Food] containers are not involved in the HARPC/GMPs of FSMA, because they are not food. These containers are not consumed by humans. The FSVP does not pertain to food containers.
The FSVP is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.
Food containers and packaging are required to be comprised of food contact substances, which are defined in the Federal Food, Drug and Cosmetic Act (section 409(h)(6) ) as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.
(Emphasis added.) Note that the TAN representative also draws a distinction between food contact substances and finished food containers. Based on this statement, it is clear that between the passage of FSVP in 2015 and January 2017, the FDA has clarified its application of FSVP to food containers. As a result, companies that import food containers are not subject to FSVP. However, it is possible, under the reading of the rule’s comments and the terms of the TAN response that companies importing FCSs for use in creating food contact materials and eventually food contact articles (including containers and packaging) may be subject to FSVP requirements.
This stance was echoed during an FDA open meeting with the industry in March 2016 in which Brian Pendleton, Senior Policy Advisor at the Office of Policy at FDA, answered a similar question in regard to pots and pans:
food contact substances, to the extent that they fall within the definition of “food” under the act, they are subject to the FSVP regulation, where we have received a lot of inquiries about exactly how FSVP will apply to food contact substances, as they are imported. And so, we are working through some of those questions.
Note that the FCA must fall within the definition of food in order to be subject to the terms of the FSVP. This point echoes the position that TAN has taken when questioned about the applicability of FSVP to food contact articles.
Therefore, because food contact articles, including finished food packaging, are not food under the FDCA (though the FCSs that comprise it may be), it is highly unlikely that the FDA can, without amending the rule, apply FSVP to domestic companies importing food packaging or more accurately food contact articles.
Thompson Coburn has a team of attorneys with experience navigating the sometimes confusing world of FDA regulations and regulatory requirements and how they impact our clients’ industries. If you have any questions about this article, FSVP, FSMA or any other FDA regulatory issue, please contact us.