Foreign Supplier Verification Programs

What Do Manufacturers/Processors Covered by the

PC Supply-Chain Program Need to know about FSVP?

A manufacturer/processor subject to the preventive controls (PC) requirements that uses imported raw materials 

or other ingredients may also be an importer covered by the Foreign Supplier Verification Programs (FSVP) rule. It’s 

important for these manufacturers/processors to know that

 they can be deemed in compliance with most of the FSVP requirements for foods they import if they 

implement preventive controls for the hazards in the food in accordance with applicable requirements or 

comply with the PC supply-chain program requirements, and

 they will still need to provide certain identification information when importing the food, as required in the 

FSVP rule. For example, they will need to provide a unique facility identifier (UFI) recognized as acceptable 

by the FDA for each line entry of food product offered for importation into the United States. 

The first major compliance date for FSVP is May 30, 2017. Compliance dates for both FSVP and the PC supply-chain 

requirements are staggered, based on the size of the supplier.

 For more information on PC compliance dates

Human Food: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

Animal Food: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm

 For more information on FSVP compliance dates 

https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm503822.htm

How do I know if I am subject to the FSVP rule?

You are subject to the FSVP rule if you meet the definition of importer under that rule. The FSVP importer is the 

U.S. owner or consignee of the food offered for import (i.e., owns the food, has purchased it, or has agreed in 

writing to purchase it at the time of U.S. entry). If there is no U.S. owner or consignee at time of entry, the FSVP 

importer is the U.S. agent or representative of the foreign owner or consignee, as confirmed in a signed statement 

of consent. 

What is required if I am an importer under the FSVP rule?

Like the supply-chain program requirements in subpart G of 21 CFR part 117 (for human food) and subpart E of 21 

CFR part 507 (for animal food), the FSVP rule provides that supplier verification activities must provide assurance 

that the hazards requiring a control in the food have been significantly minimized or prevented. In order not to 

impose duplicative requirements, manufacturers/processors are deemed in compliance with most FSVP 

requirements if: 

 they have established and implemented a supply-chain program in compliance with subpart G of 21 CFR 

part 117 (for human food) or subpart E of 21 CFR part 507 (for animal food); 
 they implement preventive controls for the hazards in the food in accordance with 21 CFR 117.135 (for 

human food) or 21 CFR 507.34 (for animal food); or 

 they are not required to implement preventive controls under the preventive controls rules in certain 

specified circumstances. Examples of such circumstances include when the type of food (e.g., such as coffee 

beans) could not be consumed without application of a preventive control, or when the customer will be 

significantly minimizing or preventing identified hazards,. The circumstances are specified in 21 CFR 

117.136 (for human food) and 21 CFR 507.36 (for animal food). 

Although a manufacturer/processor that is also an FSVP importer will be deemed in compliance with most of the 

FSVP requirements as specified above, under the FSVP rule, it still needs to provide its name, electronic mail 

address, and unique facility identifier (UFI) recognized as acceptable by the FDA for each line entry of food product 

offered for importation into the United States. 

(Note that manufacturers/processors subject to the preventive controls requirements have a choice about whether 

they wish to comply with the supply-chain program requirements in the preventive controls regulations, or if they 

prefer to comply with supplier verification requirements under the FSVP rule. Under the preventive controls 

regulations, receiving facilities that are importers in compliance with the FSVP requirements and have 

documentation of activities conducted under section 1.506(e) need not conduct verification activities for that raw 

material or other ingredient (see sections 117.405(a)(2) and 507.105(a)(2))). 

What is a UFI and how should an importer go about getting one?

The FDA has recognized the Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP. DUNS 

numbers, assigned and managed by DUN & Bradstreet, are available free of charge to importers by visiting 

FDAdunslookup.com. 

The FDA has also issued guidance stating that for FSVP importers temporarily unable to obtain a DUNS number, 

FDA intends to temporarily allow filers to transmit the value “UNK” (to represent “unknown”) in the UFI field. This 

option will be available beginning May 30, 2017 so that food offered for import can be processed through the 

Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system, even if the importer has not 

yet provided a DUNS number. We will update the guidance and communicate with importers at such time when we 

discontinue this use of the “UNK” value.

During the time that FDA and CBP allow the use of the “UNK” value for the UFI field, FDA intends to contact those 

FSVP importers for whom “UNK” was transmitted in place of the UFI. We will provide additional information to help 

ensure that FSVP importers understand this FSVP regulation requirement and take the appropriate steps to obtain 

a UFI.

For More Information

Guidance on Recognition of Acceptable UFI for FSVP

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm549623.htm

Guidance on Complying with UFI Requirement

https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm556661.htm