13 April 2018
Some Imported Live Animals Get Exemption from Foreign Supplier Verification Programme
The Food and Drug Administration announced on 21 March steps to make the importation of certain live animals less burdensome. The FDA’s food supplier verification programme rule requires importers of food for humans or animals, with some exceptions, to verify that (i) their foreign suppliers use processes and procedures that provide the same level of public health protection as the U.S. preventive controls and produce safety regulations, where applicable; and (ii) the food they import is not adulterated and not misbranded with respect to food allergen labelling. Certain meat, poultry and egg products subject to certain USDA requirements at the time of importation are explicitly exempt from FSVP requirements, but that exemption does not include live animals imported for use as food. However, the FDA states, most such animals (e.g., cattle, poultry, swine) are required to be slaughtered under mandatory inspection by the U.S. Department of Agriculture’s Food Safety and Inspection Service and processed at USDA-regulated establishments that are subject to USDA-administered hazard analysis and critical control point requirements.
The FDA therefore 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 FDA does not intend to enforce the FSVP requirements that these importers would otherwise have to meet. Such importers should use the affirmation of compliance code FSX when filing in the Automated Commercial Environment.
The FDA notes that 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 jurisdiction.