Overview
Introduction
A new final rule from the Food and Drug Administration (FDA) implementing part of the Food Safety Modernization Act (FSMA) requires US importers of food contact substances and other substances that may be directed to a food use to have a “Foreign Supplier Verification Program” (FSVP).1 The FSVP regulations make importers responsible for verifying that the food they import into the United States has been produced in a manner that meets US safety standards. Importantly, the “food” that is covered by this final rule covers not only food for consumption and food additives, but also includes food contact substances (FCS) and substances that have both food and non-food uses, if the substance is reasonably likely to be directed to a food use. As a result, most FCS importers will need to have an FSVP in place by May 29, 2017.
Food contact substances are defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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.”2 FDA considers the FSVP to apply to everything under this definition. On that basis, the final rule covers not only finished packaging (e.g., containers, cans, bottles, etc.) but all components (e.g., polymers, additives, paper) and processing aids (e.g., antimicrobials, boiler water additives). This alert briefly reviews the basic requirements of the FSVP final rule and analyses the implications for importers.
The Basics of FDA’s Foreign Supplier Verification Program
The FSVP rule imposes five primary requirements on importers: (1) to conduct an analysis of the hazards for each imported food that are known or reasonably likely to cause illness or injury and evaluate the risk of the hazard in the absence of a control;3 (2) to evaluate and approve foreign suppliers based on that hazard analysis and the supplier’s past performance (e.g., regulatory compliance); (3) to conduct activities verifying that approved suppliers are meeting requirements (e.g., audits4 or sampling); (4) to take corrective actions, when appropriate, to control a hazard; and (5) to maintain records of FSVP-related activities. It is a violation of the FD&C Act to import food if the importer does not have in place a compliant FSVP, which has implications not only for the FCS importer, but also any food manufacturers relying upon those products.5
The final rule defines “importer” as the US owner or consignee of an article of food that is being offered for import. The US owner or consignee is the person in the US who, at the time of entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food. If there is no US owner or consignee at the time of entry, the importer is the US agent or representative of the foreign owner or consignee.
The FSVP Rule for Importers of Food Contact Substances
The purpose of the FSVP is to ensure that imported food is subject to the same safety standards as food produced domestically. For decades, food contact substances marketed in the US have been subject to a regulatory scheme requiring premarket approval before a product can be added to or used in contact with food. Moreover, both food additives and food contact substances are subject to a good manufacturing practice (GMP) standard requiring safety.6 This premarket review process may result in an FDA regulation describing the permitted use(s) of the substance,7 an effective Food Contact Notification (FCN) signifying FDA approval,8 or documentation of a GRAS self-determination.9 If the premarket review concludes that an FCS complies with FDA law and regulations, it may be possible to conclude that the FSVP requirements of a hazard analysis and risk evaluation have been met. In some cases, additional hazards may need to be evaluated because they are not part of the premarket review process, such as biological hazards (e.g., microbiological hazards), chemical hazards (e.g., food allergens), physical hazards (e.g., stones, glass, metal, etc.),10 and hazards that may be intentionally introduced for purposes of economic gain. If relevant, these potential hazards would need to be identified and the risk of harm in the absence of a control evaluated.
Next we analyze the need for supplier approval and verification activities. Notably, foods for which there are no identifiable hazards requiring a control are exempt from the requirement to conduct foreign supplier approval and verification activities.11 Nevertheless, some supplier evaluation and verification activities may be needed because some hazards are controlled as part of the premarket review process, while other hazards are not part of the premarket review process. For supplier evaluations, importers should consider the foreign supplier’s food safety performance history, food safety protocols and procedures, and compliance status under applicable FDA or foreign regulations. Verification activities may include onsite audits, sampling and testing, and/or review of supplier’s relevant food safety records. As applied to food additives and FCSs, an importer may consider scrutinizing a supplier’s FDA compliance documentation, including the basis for a GRAS self-determination,12 requesting that product shipments include Certificates of Analysis and demonstrate continuing compliance with specifications, and even, potentially, evaluating a supplier’s manufacturing practices or testing product. The FSVP final rule requires importers to take corrective actions if the imported food is adulterated or misbranded. The specific corrective action will depend on the situation.
All activities related to designing, implementing, and managing an FSVP must be carried out by a qualified individual (or team of individuals, qualified for their respective roles), who must have the training, education, or experience (or some combination) necessary to undertake the FSVP activities. An importer may rely another entity’s (including the foreign supplier) hazard analysis of the food to be imported or evaluation of a foreign supplier for approval. In some cases, an importer may rely on another entity’s (excluding the foreign supplier) verification activities. In all cases, the importer must ensure that a qualified individual conducted the analysis and must document its review and assessment of that analysis. Importers also must maintain for two years signed and dated FSVP records, including records related to their hazard analysis, supplier evaluation and approval program, supplier verification activities, and any corrective actions undertaken to address identified food safety problems.
In conclusion, FCS importers will need to evaluate their existing programs to determine whether they sufficiently comply with FDA’s FSVP requirements. Each FSVP should be tailored to the importer and its products, and additional work may be needed to ensure compliance by May 2017.
1 Final Rule for Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, 80 Fed. Reg. 74226 (Nov. 27, 2015). The final rule is effective on January 26, 2016, with time for importer compliance implementation.
2 Section 409(h)(6) of the FD&C Act.
3 This includes naturally occurring hazards, as well as hazards that are unintentionally or intentionally (e.g., economically motivated adulteration) introduced.
4 Annual mandatory onsite audits, or documentation thereof, are required where exposure to a hazard will result in serious adverse health consequences of death, unless the importer has an adequate basis to determine that less frequent onsite audits are appropriate or that alternative verification activities are appropriate to ensure the hazard is controlled.
5 Section 301(zz) of the FD&C Act.
6 21 C.F.R. § 172.5(a)(2) requires food additives to be food grade, while 21 C.F.R. § 174.5(a)(2) requires food contact substances to be of a purity suitable for their intended use.
7 FDA’s regulations for food additives and food contact substances are located in 21 C.F.R. Parts 172-189.
8 FDA maintains an online Inventory of Effective Food Contact Substance Notifications.
9 Some GRAS self-determinations are submitted to FDA for its review, but FDA does not approve these submissions. View the inventory of GRAS Notifications (i.e., GRAS self-determinations submitted for FDA review) for human food and for animal food.
12 Of course, issues relating to confidential business information will need to be evaluated and addressed.