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 ensuring the safety of imported food from FDA to the Importers themselves. A FSVP is a program that importers (or their Agents)[1] must have in place to ensure that foreign food suppliers are meeting the food safety standards FDA requires of domestic food manufacturers (HARPC and Standards for Produce Safety).

But a food importer’s FSVP is only strong as the quality and expertise of its selected qualified individual, the firm’s hazard analysis, its food safety plans, the food safety programs of all of its foreign suppliers, and the selection, implementation and documentation of the proper levels of verification. Don’t wait to get these into place.

URGENT UPDATES: Next Important FSVP Implementation Dates:

The next compliance date is in March 2018. Importers should spend this time developing the programs as it takes time to work with Foreign Suppliers to build a robust FSVP program.

WHAT’S NEW? As of May 30, 2017 …

• For all imported food shipments of food subject to the Preventive Control rule or the Standards for Produce Safety rule, at the time of entry FDA requires the food importer to declare through Customs’ and FDA’s electronic entry filing systems the Name, the Facility Address, and the Unique Identifier (the DUNS#) of the person designated as the “FSVP importer” for the shipment (in most cases, the importer’s selected customs broker will perform this submission). There are important exemptions to this requirement.

• 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 (when inspected):

o A Food Safety Hazard Analysis

o A Food Safety Plan

o An array of appropriate verification procedures to demonstrate their foreign suppliers are complying with FDA’s food safety regulations

o Verification demonstrating compliance of their foreign suppliers with FDA’s food safety regulations

o Documentation that they are using a qualified individual capable of performing and monitoring these steps

o A corrective action plan

o A food Good Manufacturing Practice System

• 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

• FDA is inspecting many food importers to ensure compliance with the new requirements

What’s Same Old- Same Old?

  • • FDA’s ordinary import screening, risk-based targeting for food safety risks (using PREDICT), FDA’s import sampling, testing and label reviews for imported food shipments (and all other shipments).
  • • FDA’s Import Alert and Automatic Detention programs
  • • FDA’s implementation of all other food-based regulatory compliance programs

Who might be your FSVP Importer?

In most cases, the Customs Importer of Record will be the FSVP Importer for FDA purposes. But the FSVP importer could be another person. In any event, the FSVP Importer must be a U.S. party and must have a direct financial interest in the imported food. This will usually be:

  • • The U.S. owner or consignee of the imported food product at the time of entry. This includes the party in the U.S. who is the actual owner or purchaser of the food at the time of entry. This could include a U.S. party who has agreed in writing to purchase the food.
  • • If at the time of entry there is no U.S. owner or consignee, FSVP Importer will be a U.S. Agent (not necessarily the FDA registration U.S. Agent) appointed by the foreign owner of the imported food designated to be responsible for ensuring that FSVP-required activities are conducted for each imported food. The FSVP agent must be designated in a written document and must consent to the appointment.

Prior to FSVP, 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. Although FDA continues to perform import inspections looking for violations, under FSVP, food importers must have a program in place to verify that both the imported food and the foreign supplier comply with U.S. law. 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.

Under FSVP food importers must:

  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 FSVP rule requires food importers to establish and follow written procedures for verifying the compliance status of their foreign suppliers and correcting any known violations.The person responsible for compliance with FSVP is the FSVP Importer – which might not be the importer of record. The FSVP Importer is the U.S. owner or consignee of the food or the U.S. party who has purchased or agreed to purchase the food.

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).Note, FDA prefers the FSVP program be integrated to reduce duplication (for FDA’s sake as well as the importer’s). Proper documentation throughout the international supply web is critical for foreign food manufacturers and shippers to maintain access to U.S. food markets. FDA will primarily use the importer’s documentation to establish compliance with FSVP – but also to target additional import inspections and foreign inspections.

Delaying your firm’s FSVP implementation will be costly. With nearly 100 years of former FDA and FDA/Customs experience, the team at FSVP.com expertly assists its clients with their FSVP compliance. We can help you avoid delays and confusion, develop commercial 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.
  5. Training your staff how to perform the required FSVP steps.

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.