FDA to waive FSVP requirements for imported live animals under USDA jurisdiction

The latest guide, Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals: Guidance for Industry, points to another policy area where FDA has opted to exercise enforcement discretion in implementing the Food Safety Modernization Act (FSMA).

Live animals imported for use as food are regulated by FDA. But most live animals intended for food, such as cattle, poultry and swine, must be processed at establishments that are subject to USDA’s Hazard Analysis and Critical Control Point (HACCP) requirements, or at state-inspected establishments with equivalent requirements.

While the FSVP regulation under FSMA exempts meat, poultry and egg products subject to USDA requirements at the time of import, the exemption does not include live animals that are imported for use as food, FDA explains in a March 21 Constituent Update.

FDA says its intent to exercise enforcement discretion for live animals under USDA’s jurisdiction “accounts for the role of another Federal agency with regards to these animals. This is also consistent with the exemption in the FSVP rule for certain USDA-regulated products.”

USDA’s Food Safety and Inspection Service (FSIS) and 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, which require a grant of inspection to operate, the March 21 guidance states. The same holds true for establishments that slaughter and process under state inspection with equivalent requirements.

The North American Meat Institute (NAMI) advocated for this move and submitted comments to FDA on it last year, Eric Mittenthal, the group’s spokesman told IEG Policy. “The FDA decision makes sense because every slaughter facility has to conduct a hazard analysis regarding animals processed so the FSVP rule was unnecessary for animals that would be processed subject to USDA inspection. This decision eliminates duplicative regulatory requirements.”

While importers of live cattle, poultry and swine will not have to comply with the FSVP requirements under FDA’s new guidance, FDA says its intent to exercise enforcement discretion does not apply to importers of other live animals intended for use as food that are slaughtered and processed under FDA’s jurisdiction, such as farmed bison, deer and elk.

“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,” the six-page guidance states.

FDA’s enforcement discretion for the FSVP requirements also won’t apply to the importation of animals that are subject to FDA jurisdiction for slaughtering, but are slaughtered under voluntary inspection by FSIS.

• Analyze the hazards for the foods they import;
• Evaluate the performance of their potential foreign suppliers and the risk posed by the foods to be imported, 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.

The first FSVP mandates have been in effect for the larger food processing suppliers since May 30, 2017, but small food producers – those with fewer than 500 full-time equivalent (FTE) staff positions – had to come into compliance by March 19. Most food facilities would be categorized as small, John Johnson, a senior associate attorney at FDAImports.com, told IEG Policy earlier this month.

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 guidance states.

The entity role code “FSV” indicates that food or live animal is subject to the FSVP regulation and enforcement, and requires the importer to provide its name, electronic mail address, and unique facility identifier, FDA notes.

FDA asks importers of live animals that are covered by its intent to exercise enforcement discretion to use the affirmation of compliance code “FSX” when filing with the ACE system to show that FDA will waive the FSVP requirements for them. Importers of all other live animals for food use subject to the FSVP regulation should use the entity role code “FSV.”