United States Department of Agriculture

Animal and Plant Health Inspection Service

Veterinary Services National Center For Import And Export Import/Export Animals 4700 River Road, Unit 40 Riverdale, MD 20737-1231

GUIDELINES FOR IMPORTATION #1121 Including: pre-packaged kits and kit components (reagents, calibraters, controls) packaged for final use. Not including: kits used to diagnose infectious diseases of animals (excluding humans). Introduction: Test kits may contain small amounts of animal-derived components.  The animal-derived components are primarily from countries which the USDA considers to be free of exotic disease agents.  Most test kits are consigned to universities, diagnostic laboratories, or pharmaceutical companies which dispose of them by autoclaving and/or incineration.  Therefore, test kits that will not be used to diagnose infectious animal diseases present a negligible risk of exposure of U.S. animal populations to exotic disease agents and do not require a USDA, Veterinary Services (VS) import permit. Animal-derived kit components imported in bulk, i.e., not packaged for final use, will require an import permit unless there is an applicable guideline.  (For example, there is a guideline for the importation of rabbit antibodies.  If the antibodies are a kit component and they can meet the criteria in the guideline, they will not require a permit.) Test kits used to diagnose infectious diseases of animals require an import permit from USDA, VS, Center for Veterinary Biologics, Licensing, and Policy Development (CVB/LPD).  The telephone number in Riverdale, Maryland, is Area Code (301) 734-8245.  The telephone number in Ames, Iowa, is (515) 232-5785. Procedures: A USDA, VS import permit will not be required for test kits if the shipment can meet the following conditions: A statement on the manufacturer's letterhead must indicate that the test kits and/or kit components are not intended to be used to diagnose infectious diseases of animals; and The test kits and/or kit components are pre-packaged and ready for use. If the material cannot meet these criteria, then a USDA import permit may be required.  Permit applications may be obtained by calling  (301) 734-3277. Please instruct your shippers to supply the above information with the shipping documents for each shipment and ensure that it is available for the USDA Inspector's review at the port of arrival.  DO NOT put the documents INSIDE the shipping container.  If the above information is not supplied, the shipment may be subject to delays and import compliance fees.

VS - Safeguarding Animal Health Phone (301) 851-3300, FAX (301) 734-6402

http://www.aphis.usda.gov An Equal Opportunity Employer