Compliance with Providing an Acceptable 
Unique Facility Identifier for the Foreign 
Supplier Verification Programs for Food 
Importers Regulation: Guidance for 
Industry 
 
Additional copies are available from: 
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Office: 301-796-0356 
 
 
You may submit electronic or written comments regarding this guidance at any time. Submit 
electronic comments to http://www.regulations.gov. Submit written comments on the guidance 
to the Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with 
the docket number FDA-2011-N-0143. 
 
For questions regarding this document, you may contact the FSMA Technical Assistance 
Network online at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-
technical-assistance-network-tan, by mail at Food and Drug Administration; 5001 Campus 
Drive; Wiley Building HFS-009; Attn: FSMA Outreach; College Park, MD 20740, or by 
phone at 1-888-SAFEFOOD (1-888-723-3366). 
 
 
U.S. Department of Health and Human Services  
Food and Drug Administration 
Office of Regulatory Affairs 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
 
April 2022   
Table of Contents 
 
 
I.  Introduction 
 
II.  Background 
 
III.  Discussion 
 
IV.  Guidance History 
 
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Compliance with Providing an Acceptable 
Unique Facility Identifier for the Foreign 
Supplier Verification Programs for Food 
Importers Regulation: Guidance for 
Industry1
 
 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA, the 
 
Agency, or we) on this topic. It does not establish any rights for any person and is not binding 
 
on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 
 
  applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
 
I.  Introduction 
 
This guidance provides information on the requirement under the Foreign Supplier Verification 
Programs for Food Importers (FSVP) regulation for the importer of a food to ensure that for each 
entry line of food offered for importation into the United States the unique facility identifier 
(UFI) recognized as acceptable by FDA for importer identification2 is provided electronically 
when filing entry with U.S. Customs and Border Protection (CBP). The UFI initially recognized 
as acceptable by FDA for importer identification is a Dun & Bradstreet (D&B) Data Universal 
Numbering System (DUNS) number. The pronoun you is used in this guidance to refer to the 
FSVP importer as defined in the FSVP regulation (21 CFR 1.500). 
 
This guidance replaces FDAs Compliance with Providing an Acceptable Unique Facility 
Identifier for the Foreign Supplier Verification Programs Regulation: Guidance for Industry 
issued March 2018.   
 
The March 2018 guidance provided for the temporary use of the entity role code UNK (to 
represent unknown) in lieu of a DUNS number, to be provided in the Entity Number field for 
 
1 This guidance was jointly prepared by the Office of Compliance in the Center for Food Safety and Applied 
Nutrition, the Office of Surveillance and Compliance in the Center for Veterinary Medicine, and the Division of 
Import Operations in the Office of Regulatory Affairs at the U.S. Food and Drug Administration. 
 
2 The FSVP regulation requires the submission of a UFI recognized as acceptable by FDA and does not specify DUNS 
numbers in the regulation to give FDA the flexibility to recognize alternative UFIs as appropriate in the future through 
guidance.  We stated in the final FSVP rule that we anticipated issuing guidance specifying which UFI(s) we 
recognized as acceptable and that we expected to recognize DUNS numbers as being acceptable (80 FR 74226 at 
74301).  FDA subsequently issued guidance recognizing DUNS numbers as acceptable UFIs for purposes of 21 CFR 
1.509(a).  
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importer identification when filing entry with CBP for a food subject to FSVP.  FDA explained 
that while the agency expected all importers to provide their UFI in accordance with 21 CFR 
1.509(a), the agency recognized that this was a new requirement and some factors may have 
prevented importers from doing so.  Therefore, FDA provided that for FSVP importers 
temporarily unable to obtain a DUNS number, FDA intended to allow filers to transmit the value 
UNK in the UFI field for the FSVP importers.    
 
This guidance updates the March 2018 guidance by removing the temporary policy of permitting 
the use of the entity role code UNK in lieu of a DUNs number.  Needs and circumstances have 
changed since FDA announced its temporary policy, as FSVP importers have now had ample 
time to familiarize themselves with the requirements in 21 CFR 1.509(a).  Accordingly, 
beginning on July 24, 2022, FSVP importers must comply with the requirement in 21 CFR 
1.509(a) of providing a unique facility identifier recognized as acceptable by FDA when filing 
entry with CBP.  This guidance also provides additional information for what importers should 
do when they have multiple DUNS numbers. 
 
Beginning July 24, 2022, the use of the entity identification code UNK will no longer be an 
option.  Consistent with 21 CFR 1.509(a), the FSVP importer will be required to ensure that their 
valid, 9-digit DUNS number is provided in the Entity Number field.  CBP will reject an entry 
line of a food subject to the FSVP regulation when the importers DUNS number is not provided 
in the Entity Number field. 
 
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law. FDAs 
guidance documents, including this guidance, should be viewed only as recommendations, unless 
specific regulatory or statutory requirements are cited. The use of the word should in Agency 
guidance means that something is suggested or recommended, but not required. 
 
II.  Background 
 
The FSVP regulation was established in Title 21 of the Code of Federal Regulations, part 1, 
subpart L, as part of our implementation of the FDA Food Safety Modernization Act (FSMA; 
Pub. L. 111-353). FDA issued the final rule on FSVP for importers of food for humans and 
animals on November 27, 2015 (80 FR 74225). The FSVP regulation, codified in 21 CFR 1.500 
through 1.514, specifies the foods and importers to which the FSVP regulation applies and 
establishes various requirements. Among other requirements, section 1.509(a) of the FSVP 
regulation requires that, for each entry line of food subject to FSVP, offered for importation into 
the United States, you must ensure that your name, electronic mail address, and UFI recognized 
as acceptable by FDA are provided electronically when filing entry with CBP. 
 
On March 31, 2017, FDA issued guidance recognizing the DUNS number as the acceptable UFI 
for the FSVP regulation (see FDAs guidance Recognition of Acceptable Unique Facility 
Identifier (UFI) for the Foreign Supplier Verification Programs Regulation).  A DUNS number 
is a nine-digit unique number assigned by Dun and Bradstreet (D&B), a commercial company.  
This guidance provides additional information on the requirement for you to ensure that your 
DUNS number is provided when filing an entry line with CBP for a food subject to the FSVP 
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regulation. 
 
III.  Discussion 
When a food under FDA oversight subject to FSVP regulation is offered for entry into the United 
States, CBPs Automated Commercial Environment (ACE) system will require the filer to transmit 
either the FSVP Importer information or an appropriate Affirmation of Compliance code (A of C 
Code): 
 
(1) Entity role code FSV indicating the entry line is subject to the FSVP regulation; or 
 
(2) One of two Affirmation of Compliance codes (FSX, RNE) indicating the importer is 
exempt from the FSVP regulation at the time of entry. 
 
For line entries that use the entity role code FSV, the following information must be provided:  
the FSVP importers name, email address, and DUNS number.  (See 21 CFR 1.509(a)). 
 
If the food entry line is exempt from the requirements of the FSVP regulation or FDA has 
provided guidance that the Agency intends to exercise enforcement discretion for the food 
offered for entry with respect to the FSVP regulation, the filer should transmit the A of C code 
FSX, instead of the entity role code FSV.  
 
If the food is exempt from the FSVP regulation in accordance with 21 CFR 1.501(c) because it 
will be used for research or evaluation, the filer should transmit the A of C code RNE instead 
of the entity role code FSV. FDA requires a specific RNE A of C code for food imported for 
research or evaluation because the final FSVP regulation specifically requires that a food be 
accompanied, when filing entry with CBP, by an electronic declaration that the food will be used 
for research or evaluation purposes and will not be sold or distributed to the public to qualify for 
this exemption (21 CFR 1.501(c)(4)). By entering the RNE A of C code, filers would be 
providing such a declaration. 
 
If one of these three codes (FSV, FSX, or RNE) is not transmitted for an imported food under 
FDA oversight, the ACE system will reject the entry line. Similar to all rejections in the ACE 
system, the rejection will generate an error message to the filer. After the filer receives an error 
message, they can make the appropriate adjustments to the entry submission and retransmit the 
entry line. 
 
The ACE system will reject a food entry if the filer does not transmit the importers UFI (i.e., 
DUNS number), along with the other data elements required for products that require entity 
role code FSV. Thus, for the Entity Number field, your valid, nine-digit DUNS number must 
be provided. The ACE system will reject an entry line for which the filer enters UNK or an 
inappropriate syntax combination in the Entity Number field (e.g., not 9 digits or non-numeric 
characters).  
 
You may obtain a DUNS number from D&B free of charge within 30 business days or longer. 
D&B also provides for expedited delivery of a DUNS number for a one-time charge. To obtain 
a DUNS number, please contact D&B directly by phone at 866-705-5711 or at 
  5  https://www.dnb.com/duns-number/get-a-duns.html. If you already have a DUNS number, you 
should use that DUNS number as your importer identification UFI. You do not need to obtain a 
separate DUNS number for FSVP.  
The DUNS number, which is location specific, must correspond to your U.S. location. If you 
have multiple U.S. locations and, thus, multiple DUNS numbers, you may choose to provide 
the DUNS number that applies to the location at which you maintain your FSVP records. FDA 
investigators may conduct FSVP records reviews at the location associated with the DUNS 
number you provide to CBP at entry. For example, if you maintain your FSVP records at your 
corporate headquarters, you may choose to provide the DUNS number of your headquarters 
when you identify yourself at entry as the FSVP importer. However, because the FSVP 
regulation permits importers to store records offsite if they can be retrieved and provided to us 
within 24 hours of request (see 21 CFR 1.510(b)(2)), you may instead provide the DUNS 
number for another of your locations. Once chosen, the same DUNS number should be used for 
all of the importers FSVP entries, to the extent the DUNS number is applicable to an entry 
line. 
If you have questions about the FSVP requirement to provide a DUNS number, you may 
contact FDAs Division of Import Operations via email at FDAImportsInquiry@fda.hhs.gov. 
We will issue updated guidance to announce any changes, including if FDA recognizes 
additional UFIs as acceptable.   
IV. Guidance History
Status of  Date  Type of  Description of Changes 
Guidance  Revisions 
Final  May 2017  Level 2  First version 
guidance 
Final  March 2018  Level 2  Edits made to reflect additional use of entity role code 
guidance  FSX for products which FDA has announced its intent to 
exercise enforcement discretion 
Final  April 2022  Level 2  Edits made to reflect removal of the option to use the 
guidance  entity role code UNK in lieu of providing a DUNS 
number and to provide information for when an FSVP 
importer has multiple DUNS numbers. 
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