What is FSVP?

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On November 27, 2015 FDA published the Final Rule on FSVP, a significant provision of the Food Safety Modernization Act (FSMA) signed by President Obama in 2011. FSVP shifts the burden of certifying the safety of food imports from FDA to the Importers themselves. A FSVP is a program that importers (or their Agents)[1] must have in place to ensure that food suppliers are complying with the food safety standards that FDA requires of domestic food manufacturers (HARPC and Standards for Produce Safety).

Prior to FSVP, the U.S. Food and Drug Administration (FDA) had to find some evidence that imported food appeared to violate the law before it could reject or refuse admission of the imported food. FSVP turns all of that around. Under FSVP, for a company to import food, it must have a program in place to verify that both the imported food and the foreign supplier comply with U.S. law. If 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 foreign supplier is 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.

Under FSVP importers are responsible to:

  1. Anticipate known or foreseeable hazards associated with particular types of food.
  2. Evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance. The particular food risks as well as the foreign supplier’s performance must be reevaluated every 3 years or when new information comes to light.
  3. Use the data to approve foreign suppliers and design appropriate methods of supplier verification. The importer is free to tailor the verification processes to the unique characteristics of a food or a supplier’s situation.
  4. Conduct corrective actions to maintain the integrity of their supply chain.

The new regulation puts an additional burden on importers since it requires them to establish and follow written procedures for verifying foreign suppliers and correcting any violations of FDA standards. Additionally, a separate FSVP must be developed for each food and each foreign supplier (even if the same food is obtained from a number of suppliers). Proper documentation is essential to maintaining access to U.S. food markets since this will be the primary means by which FDA will establish compliance with FSVP.

FDA has given importers 18 months to comply. Delaying implementation could be costly. The team at FSVP.com expertly assists firms with FSVP compliance. We can help you avoid delays and confusion, develop relationships promoting transparency, and protect your international business transactions by:

  1. Evaluating current food safety plans for your facilities and those of your suppliers to ensure that they meet the requirements of FSVP as well as other FDA and CBP authorities.
  2. Performing a gap analysis to identify major weaknesses that need correcting prior to FDA’s implementation dates.
  3. Working with you and your suppliers to fill food safety gaps under FDA and CBP.
  4. Assisting with the establishment of documenting systems for maintaining regulatory compliance with all FDA, USDA, CBP, and state authorities.

Contact us today to learn about how we can help your business comply with FSVP and all other FDA regulations.

[1] 21 U.S.C. §384(a)(2) specifies that in the instance when “there is no United States owner or consignee…the United States agent or representative of a foreign owner or consignee” is the party responsible to have an FSVP in place.