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FSMA Foreign Supplier Verification Programs (A Global Perspective)



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The new food safety regulations in the U.S. are confusing, even for U.S.-based companies. This presentation will provide a foundation for the international viewer who knows there are changes to the rule, but does not yet have clarity on what they need to do. U.S. viewers will learn the concerns of their international suppliers, and get the answers to questions they may already be hearing.

As an FSPCA lead instructor for the FSMA Foreign Supplier Verification Programs regulation, I have trained many people (including FDA representatives), consulted with firms to assist with compliance and systems design, and assisted a client through an in-person routine FDA investigation that resulted in the ideal finding of no action indicated. In this presentation, I will answer the 10 most commonly asked questions from international suppliers who manufacture, process, pack, or hold food intended for consumption in the U.S. The questions will be answered directly and in plain language, and the concepts illustrated by real-life examples from a variety of industry sectors.

  • How is “food” defined under this regulation, and why does it matter?
  • Why should international businesses care what kinds of changes have been made to U.S. regulations?
  • Is this the same thing as the PCQI? How is it different?
  • If a facility has a certification from a GFSI-approved CPO (FSSC 22000, BRC, SQF, IFS, etc.) Is that sufficient proof their product is safe?
  • What is the difference between the Importer of Record and the new Importer field in the customs entry filing, and should the same name be entered for both?
  • What kinds of commodities are exempt from this regulation, and what should suppliers of those commodities do differently on the customs entry filing?
  • Do companies have to provide their confidential internal food safety documentation to the FDA to send food to the U.S.?
  • Will the FDA inspect international facilities if they send food to the U.S.? Isn’t that out of their jurisdiction?
  • Why are broker/distributors suddenly being asked to give away their suppliers’ information? The customer will just buy direct from the supplier to save money. How can brokers stay in business?
  • How and why are the requirements different for businesses of different sizes, or those located in certain countries?

As a courtesy to viewers of my presentation, I will provide three free downloadable form templates they can use to assist with FSVP program development: a food hazard analysis form, a supplier evaluation form, and a supplier product approval worksheet. I will also provide links to useful resources in the presentation. These will help international suppliers to provide the information their U.S. customers need quickly and efficiently so they can get back to business.

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