Histopathological Fixed Slides

Histopathological Fixed Slides

GUIDELINES FOR IMPORTATION #1123

Including:

This Guideline applies to histopathological fixed slides which contain:

  a.   Uninfected animal material
  b.   Animal material that is infected with microorganisms known to cause infectious, contagious, or communicable diseases of livestock or poultry which are fixed in 10% formalin; or
  c.   Animal material that is infected with Bovine Spongiform Encephalopathy (BSE) prions, Scrapie prions, or Chronic Wasting Disease (CWD) prions fixed in formic acid.


Does not include:

This Guideline does not apply to histopathological slides or other fixed slides which contain Foot and Mouth Disease virus or Rinderpest virus.

Introduction:

Microorganisms are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared at the port of arrival before entry into the United States. A USDA permit is required for any microorganisms that are known to cause infectious, contagious, or communicable diseases of livestock or poultry.

However, specimen slides that are fixed with 10% formalin for a minimum of 24 hours; or BSE, Scrapie, or CWD prion agents fixed in 96% absolute formic acid solution for a minimum of 30 minutes, followed by emersion in fresh 10% formalin for a minimum of 45 hours, may be imported into the US without a USDA Veterinary permit.

In the case of histopathological slides which contain Foot and Mouth Disease virus or Rinderpest virus, importers must apply for a USDA import permit and include the method of inactivation.

Procedures:

A USDA import permit will not be required for the importation of histopathological slides if the following is provided in the shipping documents:

A statement from the shipper/producer which clearly states:

  1.   Detailed and accurate description of the materials.
  2.   Confirming that the slides were fixed for a minimum of 24 hours in a 10% formalin solution; or slides with BSE, Scrapie, or CWD prions were fixed in 96% absolute formic acid solution for a minimum of 30 minutes, followed by emersion in fresh 10% formalin for a minimum of 45 hours.
  3.   The slides do not contain Foot and Mouth Disease virus or Rinderpest virus.

 

USDA, APHIS, VS recommends that this document be supplied on foreign producer/shipper letterhead, with the letterhead containing the physical address of the foreign producer/shipper. USDA, APHIS, VS further recommends that the documentation, written in a clear and concise manner, accompany each shipment, and be presented as a separate document for review by the DHS, CBP Agricultural Specialists at the U.S. port of arrival. We do not recommend that the foreign producer/shipper place this document inside the shipping containers.

Please instruct your shipper to provide this information. We further recommend that you provide a copy of this guideline to your foreign producer/shipper.

If the above information is not supplied, the shipment may be delayed. If the material to be imported cannot meet these criteria, then a USDA permit may be required.

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