We Discuss:

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Food importers (not subject to an exemption) are required to have an FSVP in place – which means they are obligated to have for FDA review. Each of the below are covered by an FDA CFR. (This became law 18 March 2018.):

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1. A Food Safety Hazard Analysis, (HACCP Plan),

2. A Food Safety Plan, (Any 3rd Party Scheme, usually GFSI or certified level),

3. Appropriate verification procedures to demonstrate their foreign suppliers are complying with FDA’s food safety regulations, (Your Supplier Verification Program),

4. Verification demonstrating compliance of their foreign suppliers with FDA’s food safety regulations, (Your Supplier Verification Program),

5. Documentation that they are using a qualified individual capable of performing and monitoring these steps, (There are no strict standards in place for a (Qualified Individual, usually the QA and this would be at a minimum a HACCP and PCQI certification),

6. A corrective action plan, (Part of a GFSI level program or an added PRP to a certified program),

7. A food Good Manufacturing Practice System, (Strange requirement since all GFSI programs are essentially GMP’s).
    

All food importers are required to have documentation demonstrating the above steps were completed or why the food importer and its food shipments remain exempt from the provisions (See below).

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• A separate FSVP must be developed for each food and each foreign supplier (even if the same food is obtained from different suppliers) This may be integrated into the Supplier Approval Program according to the FDA.

• If FDA finds any evidence that indicates it appears the importer does not have an adequate FSVP, FDA can stop the importation of that importer’s shipments, even if the food is safe and the imported food and the foreign supplier are both in compliance. The law does not require FDA to prove the importer violates FSVP to stop the importation of a food. Instead, FDA only has to prove that it appears the importer violates FVSP, which is a low standard, even for the FDA.

 

Exemptions:

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• An agent can perform these functions for you; I do not believe we have an agent, but I will check.  In any event, the agent would have to collect and maintain the above documentation.

• “Very small business" as defined by the FDA or importers of animal food.