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Guidance on How the Foreign Supplier Verification Program Applies to the Importation of Live Animals

May 7, 2018

The Food and Drug Administration (FDA) released guidance for industry on the application of Foreign Supplier Verification Program (FSVP) regulations for the importation of live animals and their intent to exercise enforcement discretion.




The FDA Food Safety Modernization Act (FSMA) established regulations for supplier verification requirements for the import of live animals into the U.S. which is known as FSVP.  FSVP requires food importers to create, maintain and practice an FSVP and the program was established in order to protect U.S. consumers and ensure that foreign suppliers are using processes and procedures that provide a comparable level of public health protection as seen in FSMA. FSVP further protects consumers from adulteration and misbranded allergen labeling for products imported into the U.S. FSVP regulation ensures the safety of food by (i) analyzing hazards for food imported, (ii) evaluating foreign suppliers and hazards linked to the foods imported, and (iii) conducting verification activities for foreign suppliers, such as auditing, sampling and testing, or reviewing supplier food safety records.


Certain meat, such as farmed bison or farmed wild boar, falls under FDA jurisdiction and thus is subject to FDA current good manufacturing practice (CGMP).  However, most live animals that are imported into the U.S., such as cattle and poultry, and are used for food are subject to U.S. Department of Agriculture (USDA) regulations. These foods are slaughtered, subject to mandatory inspection by USDA’s Food Safety and Inspection Service (FSIS), and are processed at USDA-regulated establishments under USDA Hazard Analysis and Critical Control Point (HACCP) requirements.


FDA stated that they will not expect FSVP importers who import live animals for slaughter and processing at the aforementioned USDA regulated establishments to meet any of the FSVP requirements. This enforcement discretion is consistent with foods under USDA jurisdiction as the food products are byproducts of the live animals that are imported under USDA jurisdiction. However, this enforcement discretion does not apply to importers of live animals for food under the FDA’s jurisdiction because they are not required to be processed at a USDA regulated facility under HACCP requirements. Importers of food that fall under FDA jurisdiction would need to conduct foreign supplier verification and have an FSVP.


There are also differences for importers of live animals when offered entry into the U.S. The U.S. Customs and Border Protection (CBP) Automated Commercial Environment (ACE) system will ask the filer to transmit an entity role code or affirmation of compliance code relating to FSVP. The filer will transmit their applicable entity role code, or affirmation of compliance code, but if they are subject to FSVP regulations, the entity role code will be “FVS”. If the FDA intends to exercise enforcement discretion for a shipment based on FSVP regulation, then they will use the code “FSX”.


Reference: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm601208.htm

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