Application of the Foreign Supplier Verification 
Program Regulation to the Importation of Live 
Animals: 
 
Guidance for Industry 
 
 
 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to https://www.regulations.gov. Submit written comments to Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.  All comments should be identified with the docket number FDA-2018-
D-0721 listed in the notice of availability published in the Federal Register.  
 
For questions regarding this document, contact the Office of Foods and Veterinary Medicine 
(OFVM), at 301-796-4500. 
 
 
 
 
 
 
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 
 
 
 
March, 2018   
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  Table of Contents 
 
 
I. Introduction ................................................................................................................................. 3 
 
II. Background ................................................................................................................................ 3 
III. Discussion ................................................................................................................................. 5 
 
   
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  Application of the Foreign Supplier Verification 
Program Regulation to the 
Importation of Live Animals: 
 
Guidance for Industry 
 
 
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 Office of Foods and Veterinary Medicine as 
listed on the title page. 
 
 
I. Introduction 
 
The purpose of this document is to state the Food and Drug Administrations (FDAs or the 
Agencys) intent to exercise enforcement discretion regarding application of the regulation on 
foreign supplier verification programs (FSVPs) to importers of live animals that are required to 
be slaughtered and processed at U.S. Department of Agriculture (USDA)-regulated 
establishments subject to USDA-administered hazard analysis and critical control point 
(HACCP) requirements (or at state-inspected establishments subject to requirements equivalent 
to the federal standards). 
We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 
CFR 10.115).  This guidance is immediately effective because FDA has determined that prior 
public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).  
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
 
This guidance provides information to facilitate understanding of the applicability of the FSVP 
requirements to the importation of live animals.  The pronouns I, me, and you are used in 
this guidance to refer to the importer.  Agency and the pronouns we and our are used to 
refer to FDA.   
 
II. Background  
 
Many live animals are imported into the United States for consumption as food.  Most imported 
live animals (e.g., cattle, poultry, and swine) that are for use as food are slaughtered under 
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  mandatory inspection by USDAs Food Safety and Inspection Service (FSIS) and are processed 
at USDA-regulated establishments subject to USDA-administered HACCP requirements.1  The 
slaughter and processing of other live animals (e.g., farmed bison, farmed wild boar, and elk) is 
under FDAs jurisdiction and is subject to FDAs current good manufacturing practice (CGMP) 
and, unless an exemption applies, preventive controls requirements (21 CFR Part 117).  Some 
animals under FDA jurisdiction (FDA animals) are slaughtered under voluntary inspection by 
USDA-FSIS. Note that establishments that slaughter animals under mandatory FSIS inspection 
must have HACCP plans that address hazards associated with the animals.  Further, an FSIS 
inspector must be present during these slaughter operations.  In contrast, establishments that 
slaughter animals under voluntary FSIS inspection must comply with some, but not all, FSIS 
regulations; for example, such establishments are not required to comply with FSIS HACCP 
requirements.  See FSIS Directive 12,600.1, Revision 1, Amendment 2 (July 2007).   
The importation into the United States of live animals for food use is subject to certain supplier 
verification requirements established in the FDA Food Safety Modernization Act (FSMA) (Pub. 
L. 111-353).  FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add, 
among other food safety requirements, provisions requiring verification of the safety of food 
imported from foreign suppliers.   
 
Section 805(c) of the FD&C Act directs FDA to issue regulations on the content of FSVPs.  We 
issued the FSVP final rule on November 27, 2015 (80 FR 74225).   
 
The FSVP regulation requires food importers to develop, maintain, and follow an FSVP that 
provides adequate assurances that the foreign supplier uses processes and procedures that 
provide the same level of public health protection as those required under the preventive controls 
or produce safety provisions of FSMA (if applicable) and regulations implementing those 
provisions, as well as assurances that the imported food is not adulterated and that human food is 
not misbranded with respect to allergen labeling (21 CFR 1.502(a)).  Among other things, in 
many cases, the FSVP regulation (21 CFR 1.500-1.514) requires food importers to do the 
following: 
 
  Analyze the hazards for the foods they import (21 CFR 1.504);  
  Evaluate the performance of their potential foreign suppliers and the risk posed by the 
foods to be imported (21 CFR 1.505); and 
  Determine and conduct appropriate foreign supplier verification activities, such as onsite 
auditing of foreign suppliers, sampling and testing, and review of supplier food safety 
records (21 CFR 1.506). 
                                                 
1 USDA-regulated establishments have the option to apply for Federal or for state inspection under an inspection 
program that a State operates under a cooperative agreement with FSIS.  State programs must enforce requirements 
at least equal to those imposed under the Federal Meat Inspection Act, Poultry Products Inspection Act, and 
Humane Methods of Slaughter Act of 1978 (see 21 U.S.C. 661 and 21 U.S.C. 454).  However, products produced 
under such equivalent state requirements are limited to intrastate commerce, unless a state opts into an additional 
cooperative program, the Cooperative Interstate Shipment Program.  (See 
https://www.fsis.usda.gov/wps/portal/fsis/topics/inspection/state-inspection-programs.)  
 
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  The FSVP regulation applies (with certain exceptions2) to the importation of food as defined in 
section 201(f) of the FD&C Act (except that food for FSVP purposes does not include 
pesticides as defined in 7 U.S.C. 136(u)) (see 21 CFR 1.500).  Live animals that are not 
reasonably likely to be directed to food use (e.g., animals imported for showing or breeding) are 
not subject to FSVP.  Although the FSVP regulation explicitly exempts food regulated by USDA 
at the time of importation (i.e., certain meat, poultry, and egg products), this exemption does not 
include live animals that are for use as food. 
   
FSIS and USDAs Animal and Plant Health Inspection Service (APHIS) have comprehensive 
regulatory requirements, including HACCP requirements, that control food safety hazards in live 
animals that must be slaughtered and processed in official USDA establishments (those requiring 
a grant of inspection to operate).  Such establishments are required to conduct a hazard analysis 
and consider the food safety hazards that might be expected to arise from, for example, drug 
residues, and are also required to develop systems to guard against these hazards.  In addition, 
FSIS oversees the requirements related to the identification and control of hazards, collects 
samples of meat, poultry, and egg products, and analyzes the samples at FSIS laboratories for 
chemical residues of veterinary drugs, among other contaminants.  Thus, when slaughter and 
process establishments are subject to USDA-administered HACCP and other requirements, the 
hazards associated with the live animals processed at such establishments ordinarily would be 
identified and controlled and the food resulting from the slaughter and processing of those live 
animals could not be consumed without such controls.  The same would be true for 
establishments that slaughter and process subject to equivalent requirements but under state 
inspection. 
   
III. Discussion  
 
The food resulting from the slaughter and processing of certain live animals cannot be consumed 
without slaughter and processing at establishments subject to USDA-administered HACCP 
requirements (or equivalent state programs).  In light of the role of another Federal agency with 
regard to these animals, FDA intends to exercise enforcement discretion with respect to the 
FSVP regulation for importers of live animals that are imported for slaughter and processing at 
USDA-regulated establishments subject to USDA-administered HACCP requirements, or 
imported for slaughter and processing under state requirements that are at least equivalent to the 
requirements for USDA-regulated establishments, including designated feeder animals.3  This 
means that we will not expect FSVP importers of live animals that are slaughtered and processed 
at USDA-inspected establishments subject to USDA-administered HACCP requirements (or 
state-inspected establishments subject to equivalent requirements) to meet any of the FSVP 
requirements. 
 
This intent to exercise this enforcement discretion is consistent with the exemption from the 
FSVP requirements for foods that are under USDA jurisdiction, as imported live animals heading 
to slaughter and processing at USDA-regulated establishments subject to USDA-administered 
                                                 
2 For example, note that importation of live seafood (e.g., mussels, lobsters) is covered by the importer provisions of 
FDAs seafood HACCP regulation (21 CFR 123.12) and, therefore, is exempt from FSVP under 21 CFR 
1.501(b)(1). 
3 By feeder animals we mean animals going to feedlots for finishing before slaughter. 
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  HACCP requirements (or slaughter and processing under state requirements that are at least 
equivalent to the requirements for USDA-regulated establishments) are the predecessor of the 
meat and poultry products that are already under USDA jurisdiction when they cross the border.  
This intent to exercise enforcement discretion with respect to the FSVP regulation does not apply 
to importers of live animals for food use that fall under FDA jurisdiction.  These animals are not 
processed at USDA-regulated slaughter and processing establishments under HACCP 
requirements (or state-inspected establishments with equivalent requirements).  An importer of 
such animals would be subject to FSVP and would need to conduct foreign supplier verification 
with respect to such animals if the importer determined there were drug residues or other hazards 
requiring supplier control. We will consider revising our intent to exercise enforcement 
discretion if, for example, there are changes to the information upon which our intent to exercise 
enforcement discretion is based or if new information becomes available regarding safety 
concerns associated with the importation of these live animals. 
 
Data requirements at entry 
When a food product under FDA oversight is offered for entry into the United States, the U.S. 
Customs and Border Protection (CBP) Automated Commercial Environment (ACE) system will 
prompt the filer to transmit an entity role code or affirmation of compliance code related to 
FSVP.  The entity role code FSV indicates that the entry line is subject to the FSVP regulation 
and currently subject to FSVP enforcement, so the importer must provide its name, electronic 
mail address, and unique facility identifier recognized as acceptable by FDA (see 21 CFR 1.509).  
If the food entry line is exempt from the requirements of the FSVP regulation, not yet subject to 
the regulation, or FDA has provided guidance that the Agency intends to exercise enforcement 
discretion for the relevant shipment with respect to the FSVP regulation, the filer should transmit 
the applicable Affirmation of Compliance code.  FSX should be used if FDA has provided 
guidance that the agency intends to exercise enforcement discretion for the relevant shipment 
with respect to the FSVP regulation.  
 
Therefore, importers of live animals for food use and imported for slaughter and processing at 
USDA-regulated establishments subject to USDA-administered HACCP requirements (or for 
slaughter and processing at state-inspected establishments with equivalent requirements), 
including designated feeder animals, should transmit the affirmation of compliance code FSX 
when making entry in the United States.  Importers of all other live animals for food use subject 
to the FSVP regulation should transmit the entity role code FSV.  For more information on 
importer identification, consult FDAs guidance on Compliance with Providing an Acceptable 
Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation, available 
at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm556661.htm. 
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