Standard Requirements

The Foreign Supplier Verification Program (FSVP) rule is a component of FSMA that addresses the safety of foreign food that is imported into the United States.  This rule was published on November 27, 2015 and gave importers the added responsibility of ensuring that the food they import meets the same level of food safety standards as products made in the United States.

Who does this Rule Apply To?

  • Domestic manufacturing facilities that import food for processing
  • Food brokers that import food
  • Food distribution centers that import food
  • Foreign manufacturers that arrange for the export of food into the US

What Does an Importer Have to Do?

Food Importers must now identify an FSVP Importer on the customs and border protection entry filing and have a DUNS number. The FSVP Importer must be domiciled in the United States. If a foreign company does not have a representative in the United States, they must name a US Agent who has agreed in writing to be an FSVP Importer.  The FSVP Importer is the person the FDA will hold legally responsible for complying with the FSVP rule. The rule allows the FSVP Importers to identify Qualified Individuals who have the education, experience, and training necessary to carry out all FSVP requirements.

What Does the Qualified Individual Need to Do?

The two main elements of the FSVP rule are an initial foreign supplier performance evaluation and then on-going verification to ensure imported food is safe. These activities are detailed below:

Initial Evaluation:
  • Conduct a hazard analysis of the food products
  • Identify potential food safety hazards
  • Ensure food safety hazards are adequately controlled
  • Conduct an evaluation of the foreign supplier’s food safety performance
  • Ensure the supplier is complying with FSMA Requirements if Applicable
    • Preventive Controls for Human Food
    • Preventive Controls for Animal Food
    • Produce Safety rule
  • Approve the foreign supplier
  • Establish written procedures to ensure food is only imported from approved suppliers
  • Determine appropriate verification activities based on risk level
  • Retain records of initial approval and SOPs

Ongoing Verification:

  • Review third party audits, COAs, test results, etc.
  • Do corrective actions when necessary
  • Reanalyze the food safety plan every 3 years or when a change occurs
  • Retain verification records

Modified Requirements

Some imported products are subject to modified requirements and do not have to undergo a full review.  Modified requirements apply under the following circumstances:

  • Very Small Importers
  • Importers buying from certain small foreign suppliers
  • Importers of dietary supplements or dietary supplements components
  • Imported food from countries with food safety systems recognized as comparable to the United States:
    • Canada
    • New Zealand
    • Australia

These importers may still be subject to:
  • Conducting supply chain controls under FSMA Preventive Controls for Human and Animal Food
  • Monitoring their suppliers to ensure they stay in good standing with the regulations in their country
  • Re-reviewing their small foreign suppliers to make sure they are still exempt
  • Taking corrective actions when necessary.

What Imported Items are INCLUDED?

Most FDA regulated food products
Dietary supplements
Food contact packaging
Food contact substances (plates, utensils, conveyor belts, etc.)

What Imported Items are EXEMPT?

Seafood
Juice
Alcohol
Meat, poultry, and eggs under the USDA
Food for research use
Food for personal consumption
Food imported for processing that will be exported later
Food that is transshipped throughout the U.S.
Food that is imported and then exported without further processing

FSMA-FSVP-Coverage-FlowchartDownload