April 24, 2018

April 24, 2018

Subscribe to Latest Legal News and Analysis

April 23, 2018

Subscribe to Latest Legal News and Analysis

FDA Guidance States Live Animals Processed Under USDA Regulations Do Not Need to Comply with FSVP Regulations

  • On March 21, 2018, the U.S. Food and Drug Administration (FDA) published guidance that live animals processed under Department of Agriculture (USDA) regulations do not need to comply with Foreign Supplier Verification Program (FSVP) requirements.

  • In general, live animals imported for use as food are regulated by FDA. However, they are required to be slaughtered under mandatory inspection by the USDA’s Food Safety and Inspection Services (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 explains that FDA 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. This means the agency does not intend to enforce the FSVP requirements that these importers would otherwise have to meet.

  • However, FDA’s 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, or to animals that are subject to FDA jurisdiction for slaughtering, but are slaughtered under voluntary inspection by FSIS.

© 2018 Keller and Heckman LLP

TRENDING LEGAL ANALYSIS


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

202-434-4100