CFSAN Constituent Update - Live Animals Processed Under USDA Regulations Do Not Need to Comply with FSVP Regulation, FDA Explains

Live Animals Processed Under USDA Regulations Do Not Need to Comply with FSVP Regulation, FDA Explains

Today, the U.S. Food and Drug Administration took steps to make the importation of certain live animals less burdensome.

Live animals imported for use as food are regulated by FDA. However, most live animals (e.g., cattle, poultry, swine) intended for use as food, including those that are imported, are required to be slaughtered under mandatory inspection by the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS), and processed at USDA-regulated establishments that are subject to USDA-administered hazard analysis and critical control point (HACCP) requirements. While the FSVP regulation explicitly provides an exemption for certain food (i.e., certain meat, poultry, and egg products) that is subject to certain USDA requirements at the time of importation, the exemption does not include live animals that are imported for use as food.

The guidance issued today explains that the agency intends to exercise enforcement discretion regarding the application of the FSVP rule to importers of live animals that must be slaughtered and processed at establishments regulated by USDA and subject to HACCP requirements (or at State-inspected establishments subject to requirements equivalent to the federal standards). This means the agency does not intend to enforce the FSVP requirements that these importers would otherwise have to meet. This intent to exercise enforcement discretion 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.

This intent to exercise enforcement discretion does not apply to importers of other live animals intended for use as food (e.g., farmed bison, deer, elk), the slaughtering and processing of which is under FDA’s jurisdiction. Some animals that are subject to FDA jurisdiction for slaughtering are slaughtered under voluntary inspection by FSIS. This intent to exercise enforcement discretion does not apply to the importation of such animals either.

Importers of live animals that are covered by this intent to exercise enforcement discretion should use the affirmation of compliance code “FSX” when filing with the U.S. Customs and Border Protection (CBP) Automated Commercial Environment (ACE) system. This will indicate that FDA intends to exercise enforcement discretion with regards to the FSVP requirements.

More Information on the FSVP Regulation