Recent FDA public meeting addressed FSMA import implications.
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The FDA Food Safety Modernization Act (FSMA) includes several import-focused components, such as the Foreign Supplier Verification Program (FSVP) and the still-under-development Voluntary Qualified Importer Program (VQIP). The general compliance date for the FSVP is May 28, 2017. The VQIP is expected to be open for applications in January 2018.
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On March 21, FDA hosted a public meeting focusing on the implementation of FSMA’s import-related provisions. Copies of the meeting materials (agenda and slide presentations) are available here. To highlight a few substantive notes from the meeting:
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The Grocery Manufacturers Association (GMA) and the International Dairy Foods Association (IDFA) cited concerns related to 21 C.F.R. § 1.507. Section 1.507 of the FSVP regulations exempts importers of food from evaluating and verifying a foreign supplier where a particular food cannot be consumed unless its hazards are controlled or where the food’s hazards will be controlled after importation. Both GMA and IDFA stated that Section 1.507 imposes documentation burdens to establish the existence of these prerequisites that will prove too onerous in reality.
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FDA stated that it is making progress with evaluating the food safety systems of Canada and Australia for purposes of determining whether these countries have systems that provide an equivalent level of public health protection as the U.S. system. FDA also indicated it has recently accepted an application from the European Union (EU) to evaluate the equivalency of the EU food safety system. Importers of food from countries with food safety systems that are officially recognized by FDA as equivalent are largely exempt from the FSVP requirements pursuant to 21 C.F.R. § 1.513. Currently, only New Zealand has a food safety system that is recognized as equivalent by FDA.
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FDA reiterated that food-contact substances (FCS) also are subject to the FSVP requirements, although we anticipate that the Agency will issue further clarification in the coming weeks or months regarding what “FSVP compliance” will look like for FCS importers.
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Although the FSVP compliance date is not imminent, importers should be familiarizing themselves with the new requirements and assessing the benefits of participation in the VQIP. Although FDA is anticipated to issue FSVP guidance in the coming months, there is no clear time frame for this action, and the industry should at least begin to prepare for compliance.
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