D.O.T. Infectious Substance Label for Transportation of Hazardous Materials Class 6

It is common, and often necessary, to transfer biological materials while conducting biological research. Because of this, it is important to know that the movement of certain categories of biological agents is tightly regulated by federal agencies such as the CDC, USDA, APHIS, etc. Failure to comply with regulations when transporting regulated biological materials may result in shipment delays, destruction at the port of entry, refusal of the shipment by carriers, and may be subject to fines and/or criminal penalties.

This page will help you to determine if you need a permit, and if so, what kind of permit. Some materials may require multiple permits. Based on the type of material being imported, the CDC or USDA/APHIS may require a facility inspection prior to issuance of a permit.

Note: All importation and exportation of infectious biological agents must be processed through the Biosafety Office. Please contact safety@uvm.edu for assistance.

CDC Import Permit

The CDC regulates the importation of infectious biological agents, infectious substances, and vectors of human disease into the United States.

A CDC import permit may not be required in certain cases:

  • healthy human specimens
  • a diagnostic specimen that does not contain an infectious biological agent
  • a biological agent that has been rendered non-infectious
  • nucleic acids that cannot produce infectious forms of any infectious biological agent

However, a certification statement should accompany the shipment.

CDC Import Permit Applications and guidance documents

Also, an interactive step by step questionnaire created by CDC is a great tool to assist in determining whether an import permit is required.

Importation permits are issued only to the importer, who must be located in the United States. Additionally, the importer is legally responsible to ensure that the import-permitted material is packaged and shipped in accordance with all applicable shipping regulations by the party initiating the shipment.

The interstate transfer of an etiologic agent may or may not require a CDC import permit. If noted as a condition of the issued import permit, subsequent transfers of any infectious biological agent, infectious substance or vector within the United States will require an additional permit issued by the CDC.

There is no service charge for CDC import permits.

A CDC import permit is required prior to importing the following into the US:

Infectious biological agent - A microorganism (including, but not limited to, bacteria (including rickettsiae), viruses, fungi, or protozoa) or prion, whether naturally occurring, bioengineered, or artificial, or a component of such microorganism or prion that is capable of causing communicable disease in a human.

  • Infectious substance - Any material that is known or reasonably expected to contain an infectious biological agent.
  • Vector - Any animals (vertebrate or invertebrate) including arthropods or any noninfectious self-replicating system (e.g., plasmids or other molecular vector) or animal products that are known to transfer or are capable of transferring an infectious biological agent to a human.
  • Animals - Any member of the animal kingdom except a human, including an animal product (e.g., a mount, rug, or other display item composed of the hide, hair, skull, teeth, bones, or claws) unless it is accompanied by documentation confirming that it is not known to contain (or suspected or containing) an infectious biological agent, or has been rendered noninfectious.
  • Arthropods - Any living insect including crustaceans, spiders, scorpions, etc. capable of being a host or vector of human disease.
  • Snails - Any freshwater snails (phylum Mollusca, class Gastropoda) capable of transmitting schistosomiasis.
  • Bats - All live bats. Bats may also require a permit from the U.S. Department of Interior, Fish and Wildlife Service.
  • Non-human primate material - all non-human primate material (e.g. blood, plasma, cells, tissue, urine, feces) requires an import permit, unless it has been specifically treated and rendered non-infectious (documentation required).

More information & details:

USDA (United States Dept. of Agriculture) APHIS (Animal & Plant Health Inspection Services)

USDA APHIS issues permits to ensure the safe import and transport of materials related to the health and care of animals and plants, especially those that are vital agricultural commodities. These permits outline the controls necessary for the import, export, interstate transport and release of these regulated products.

The Veterinary Services branch of USDA APHIS issues the Veterinary Services (VS) Import, Export or Transport permits; and the Plant Protection and Quarantine branch of APHIS issues the PPQ permit. APHIS also regulates the movement of certain genetically engineered organisms through its Biotechnology Regulatory Services (BRS). VS permits have a service charge of $150, though this price can vary depending on number of revisions reviewed, need for facilities inspections, etc. There is no service charge for PPQ or BRS permits.

A VS permit is required for organisms and vectors of pathogenic diseases of livestock and poultry:

  • Certain live animals and animal products
  • Specimens from animals infected with pathogens or exposed to pathogens or vectors
  • Livestock and poultry pathogens. A partial list is available on the USDA APHIS website.
  • Cell cultures or cell culture products exposed to organisms that cause disease in livestock or poultry.
  • Vectors that can serve as the carrier of or have been exposed to an infectious disease of livestock or poultry
  • Human viruses and human vaccines intended for research use in livestock or poultry
  • Attenuated live viruses and vaccine strains for use in livestock or poultry

More details can be found on the APHIS Animal Health and
a list of materials that do not require a USDA.

 

A PPQ permit is required for the importation into and transit through the U.S. of regulated plants and plant products for consumption or propagation

Organisms and Soil

  • Insects, mites, bees, butterflies, moths
  • Earthworms, slugs, snails
  • Plant pathogenic bacteria, viruses, fungi, mycoplasmas, and nematodes
  • Federal noxious weeds and parasitic plants
  • Biocontrol organisms & entomopathogens
  • Plant growth enhancers
  • Widely prevalent regulated organisms
  • Soil of foreign origin

Plants and Plant Products

  • Plants, nursery stock, and seeds for planting
  • Fruits and vegetables, rice, maize, sugarcane, foreign cotton, cut flowers
  • Timber and timber products
  • Plants or plant products for experimental, therapeutic, or developmental purposes
  • Post-entry quarantine plants
  • Protected or rare plant species (CITES)

 

A BRS permit is required for genetically engineered organisms

US Fish & Wildlife

Shipping Biological Materials

Please refer to these pages for guidance:

Recordkeeping

All shippers are required to keep records on file five (5) years from the date of the export or expiration of an export license, which ever period is longer.