As previously reported on this blog (see here, here and here), the U.S. Food and Drug Administration (FDA) has issued guidance documents, fact sheets, and a Q&A document on how to comply with the foreign supplier verification program (FSVP) final rule, under the Food Safety Modernization Act (FSMA). The FSVP regulation establishes requirements relating to: the use of qualified individuals to conduct FSVP activities, hazard analysis, food and supplier evaluation, foreign supplier verification, corrective actions, recordkeeping, and importer identification. On January 25, 2018, FDA released three additional guidance documents related to the FSVP.

The guidance document, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide, explains who is eligible to use FDA’s modified procedures for very small importers or importers of food from certain small foreign suppliers. It also discusses the actions that a small entity must take to comply with the rule.

The guidance document, Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities, explains FDA’s intent to exercise enforcement discretion for importers of grain raw agricultural commodities (RACs) that are solely engaged in the storage of grain intended for further distribution or processing and grain importers that do not take physical possession of the grain they import.

The draft guidance, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, includes information on how importers can meet the modified FSVP requirements for importers of dietary supplements, very small importers, importers of food from certain small foreign suppliers, and importers of food from countries whose food safety systems FDA has officially recognized as comparable or determined to be equivalent to that of the United States. This draft guidance also provides a different interpretation on two issues addressed in the preamble to the FSVP final rule.

• First, the preamble to the FSVP final rule states that waxing and cooling raw agricultural commodities, when done by a packing operation for purposes of storage or transport, may be considered a packing activity; while the draft guidance states that such activities may be packing activities and/or holding activities, depending on the circumstances.

• Second, FDA states in the preamble to the FSVP final rule importers may need to address hazards that may be intentionally introduced by acts of terrorism. The draft guidance clarifies that importers are not required under the FSVP regulation to consider in their hazard analysis hazards that are intentionally introduced to cause wide scale public health harm but should consider warning letters or other enforcement action taken by FDA against foreign suppliers for violation of FDA’s regulation on intentional adulteration as part of their evaluation of potential suppliers.

FDA will be accepting comments on the draft FSVP guidance until May 25, 2018 (instructions on how to submit comments can be found in the Federal Register notice announcing the availability of the draft guidance (83 FR 3445). We will continue to monitor and report on FDA’s activities to implement the FSVP rule and other FSMA related activities.