What are my responsibilities as an importer of biological specimens that are intended for testing in a clinical laboratory or for basic scientific research only?

You are responsible for complying with the requirements of all other federal agencies, as appropriate. In addition, if the person to whom the product is shipped (the consignee) is not using the samples for testing, but instead is processing or manufacturing biologics with these samples, then the products are subject to FDA jurisdiction and must meet FDA's requirements for biologics.

The Centers for Disease Control and Prevention (CDC); the US Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS); and the US Customs and Border Protection have regulations that may apply to biological specimens.

If the material is suspected or known to contain etiologic agents or has not been tested for etiologic agents, a CDC Etiologic Agent Import Permit (see http://www.cdc.gov/od/eaipp/) may be required. CDC can be contacted at:

The U. S. Department of Agriculture (USDA), Animal and Plant health Inspection Service (APHIS), Veterinary Services (VS), regulates the importation of all animal-origin materials, that could represent a disease risk to U.S. livestock, and the import and transport of infectious organisms and vectors of disease agents. This includes not only animal products and by products, but biological materials that contain or have been in contact with certain organisms and animal materials (including cell cultures). USDA/APHIS can be contacted at:

The US Customs and Border Protection (CBP) has primary responsibility for regulating and facilitating international trade, collecting import duties, and enforcing U.S. trade laws. All goods imported or offered for importation into the United States must first pass through CBP control. CBP can be contacted at: