FSVP explained for importers and foreign suppliers.

The Foreign Supplier Verification Program (FSVP) rule makes US importers responsible for verifying that the food they bring in was produced with the same level of public health protection required of US manufacturers. It sits in 21 CFR Part 1, Subpart L, and FDA inspects importers against it.

Who is the FSVP importer?

The US owner or consignee of the food at the time of entry. If there is no US owner or consignee, it is the US agent or representative of the foreign owner or consignee, confirmed in a signed statement of consent. Customs brokers are not automatically the FSVP importer.

The six elements of an FSVP

1. Hazard analysis of known or reasonably foreseeable biological, chemical (including allergen) and physical hazards for each food.
2. Evaluation of the food and the foreign supplier: who controls each hazard, the supplier's procedures, regulatory compliance and food safety history.
3. Approval of suppliers, with written procedures so you import only from approved suppliers.
4. Verification that fits the risk. When a supplier controls a hazard with a reasonable probability of serious adverse health consequences or death, an annual on-site audit is the default unless you document why another method gives adequate assurance. Otherwise sampling and testing or review of the supplier's records may fit.
5. Corrective action when a supplier falls short, which can include stopping use of that supplier.
6. Reevaluation at least every three years, and sooner when you learn of new hazard or performance information.

An FSVP is needed for each food from each foreign supplier. Shared documents keep that manageable.

At the border: DUNS on every line entry

For each line entry, the importer's name, email address and an FDA-recognized unique facility identifier must be provided. FDA recognizes the DUNS number. Make sure your customs broker has the right DUNS for the right importer of record.

Records FDA will ask for

FSVP records must be made available to FDA promptly on request, with an English translation provided within a reasonable time if they are in another language. Records stored offsite must be retrievable within 24 hours, and FDA can ask for them to be sent electronically. Many FSVP inspections begin with a records request, so keep an index of every food, supplier and verification record.

Exemptions and modified requirements

Some foods are excluded or have modified requirements, including juice and seafood covered by their own HACCP rules, alcoholic beverages, certain USDA-regulated meat, poultry and egg products, and food for research or personal use. Very small importers and certain small foreign suppliers also have modified requirements. Confirm each food before assuming it's out of scope.

If you're the foreign supplier

Your US customer must evaluate and verify you before they can import. Have these ready:

• A hazard analysis and food safety plan that align with US Preventive Controls expectations.
• Current FDA food facility registration, renewed in October to December of even-numbered years.
• A recent audit report or GFSI certificate (SQF, BRCGS, FSSC 22000).
• Specifications, certificates of analysis and allergen statements covering all nine US major allergens.
• Corrective action records that show how you respond to problems.

Suppliers who package this well get approved faster and stay approved. See our FSVP services for both sides, and track reevaluation timing on the Compliance Calendar.

Sources: FDA, FSMA Final Rule on FSVP · 21 CFR Part 1, Subpart L