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Self-Contained Test Kits Containing Animal-Derived Ingredients

Updated February, 2013

GUIDELINES FOR IMPORTATION #1121

Introduction:

Test kits may contain small amounts of animal-derived components. Most test kits are consigned to universities, diagnostic laboratories, or pharmaceutical companies which dispose of them by autoclaving and/or incineration. Therefore, applicable imported test kits 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.

Procedures:

Test Kits Not Requiring a USDA Import Permit:

A USDA Import Permit is not required for test kits if the shipment meets the following conditions and it is recommended that the shipment be accompanied by:

  1. A statement on manufacturer's letterhead, or other information used as proof that: the test kits cannot diagnose infectious diseases of animals; and
  2. The test kits are pre-packaged and ready for use.

If the material to be imported cannot or does not meet the criteria outlined above on this Guideline, then a USDA, VS or USDA, CVB Import Permit is required.

USDA, VS Import Permit

Test Kits and material(s) that require a USDA, VS import permit:

  1. Test Kit Components shipped in bulk: i.e. reagents, calibrators, controls, etc.;
  2. Media (such as selective media), petri dishes, filtration units;
  3. Kits that do not contain everything for use and/or that are not pre-packed for ready for final sale

USDA, VS Import Permit applications may be obtained several ways:

  1. On-line at: http://www.aphis.usda.gov/animal_health/permits/
  2. By writing to:
    USDA, APHIS, VS
    National Center for Import and Export
    4700 River Road, Unit 40
    Riverdale, MD 20737
    (301) 851-3300 telephone, option 5
    (301) 734-6402 fax

USDA, CVB Import Permit

Test Kits that can diagnose infectious diseases of animals, imported for any purpose, or for any type of research require a Research and Evaluation Permit from USDA, VS, Center for Veterinary Biologics, Policy, Evaluation and Licensing (CVB, PEL).

  1. The telephone number for CVB in Riverdale, Maryland is (301) 851-3609
  2. The CVB ePermits portal can be found at the following website:
    http://www.aphis.usda.gov/animal_health/permits/vet_bio_permits.shtml

Please include the information recommended/required by this Guideline along with the shipping documents for each shipment and ensure that it is available for review by USDA authorized inspectors at the port of entry. DO NOT put documents INSIDE the shipping container. If the above information is not available, the shipment may be subject to delays and import compliance fees.

Other Agencies

The Food and Drug Administration and/or the Centers for Disease Control should be contacted for information regarding the import of kits that diagnose human disease.

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1A self-contained test kit includes everything needed to use the kit assembled in a pre-packaged kit ready for final use.



Additional Information