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May Importer Rely Upon Foreign Food Safety Authorities to fulfill FDA FSVP Requirements?

An important issue of the FSVP for which FDA has requested comment is if importers may rely upon the activities of foreign food safety authorities (such as a foreign food safety authority’s inspection of a foreign food facility) as fulfilling certain FSVP requirements. This may be possible because the current FSVP proposal DOES NOT require foreign government employees functioning as “qualified individuals” to be accredited. As such, the FDA writes:

Proposed § 1.500 states that an employee of a foreign government may be a qualified individual. We believe that this provision is appropriate because foreign food safety authorities might conduct certain activities on which an importer might rely in complying with its FSVP requirements. For example, as part of an importer’s supplier verification activities, the importer might rely on the results of an onsite audit of a foreign supplier conducted by an employee of the food safety authority in that country. Although a foreign food safety authority could be an accredited third-party auditor under section 808 of the FD&C Act, an importer’s use of foreign government employees as qualified individuals would not be limited to such accredited auditors. FDA requests comment on ways in which importers might rely on the actions of foreign government employees in complying with FSVP requirements.”

Comments regarding the extent to which importers may reply upon the activity of foreign food safety authorities as fulfilling FSVP requirements must be submitted by November 26, 2013. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

You may submit comments on the proposed Foreign Supplier Verification Program rule, identified by Docket No. FDA-2011-N-0143 and/or Regulatory Information Number (RIN) 0910-AG64 at this link: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0143-0023 . On July 26, 2013, FDA issued the new proposed regulation, the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP), in accordance with section 301 of the Food Safety Modernization Act (FSMA). In the proposed rule, FDA has asked interested parties to comment on various aspects of the proposed regulation.

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