Imports

  • Permit Needed
    • APHIS/CDC Form 2: “Request to Transfer Select Agents and Toxins”
  • MSU Requirements
    • Staff must contact the MSU Biosafety Officer/Responsible Official prior to requesting select agent or toxin
  • Forms
    • APHIS/CDC Form 2
    • Also available through MSU Biosafety Officer/Responsible Official
  • Questions/Contact Information
  • Additional Notes
    • As of April 2013, separate CDC and USDA/APHIS permits are no longer required.

  • Permit Needed
    • Possibly none, but it is recommended to confirm prior to receiving materials.
  • Forms
    • See forms for other permits
  • Questions/Contact Information
    • MSU Biosafety Officer
  • Additional Notes
    • The e-tool and guidance documents can help determine if a permit is required.
    • APHIS may issue a letter of no jurisdiction if no permit is required.

Exports

Transfer

  • Permit Needed
    • APHIS/CDC Form 2: “Request to Transfer Select Agents and Toxins”
  • MSU Requirements
    • Staff must contact the MSU Biosafety Officer/Responsible Official prior to requesting select agent or toxin
  • Forms
    • APHIS/CDC Form 2
    • Also available through MSU Biosafety Officer/Responsible Official
  • Questions/Contact Information
  • Additional Notes
    • As of April 2013, separate CDC and USDA/APHIS permits are no longer required.
    • A Material Transfer Agreement (MTA) or Testing Service Agreement (TSA) may be required prior to sending/receiving materials. Contact MSU BSO and TTO to verify requirements.
    • Certain transfers to non-U.S. persons and entities, whether domestic or abroad, may require further review and an export license.

  • Permit Needed
    • APHIS/CDC Form 2: “Request to Transfer Select Agents and Toxins”
  • MSU Requirements
    • Staff must contact the MSU Biosafety Officer/Responsible Official prior to requesting select agent or toxin
  • Forms
    • APHIS/CDC Form 2
    • Also available through MSU Biosafety Officer/Responsible Official
  • Questions/Contact Information
  • Additional Notes
    • As of April 2013, separate CDC and USDA/APHIS permits are no longer required.
    • A Material Transfer Agreement (MTA) or Testing Service Agreement (TSA) may be required prior to sending/receiving materials. Contact MSU BSO and TTO to verify requirements.
    • Certain transfers to non-U.S. persons and entities, whether domestic or abroad, may require further review and an export license.

Additional Notes:

Many permits come with specific conditions such as specifying the laboratory room(s) and biosafety level for working with the material, or requiring additional authorization for subsequent distribution of the material. You are responsible for knowing and adhering to the conditions of your permit.

Material requiring a CDC import permit:

  1. 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.
  2. Infectious substance - Any material that is known or reasonably expected to contain an infectious biological agent.
  3. Vector - Any animals (vertebrate or invertebrate) including arthropods or any noninfectious self-replicating system (e.g., plasmids or other molecular vector) or animal products (e.g., a mount, rug, or other display item composed of the hide, hair, skull, teeth, bones, or claws of an animal) that are known to transfer or are capable of transferring an infectious biological agent to a human.
  4. 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).
  5. Arthropods – Any living insect including crustaceans, spiders, scorpions, etc. capable of being a host or vector of human disease.
  6. Snails – Any freshwater snails (phylum Mollusca, class Gastropoda) capable of transmitting schistosomiasis.
  7. Bats – All live bats. See below for further information on obtaining an import permit for live bats. Bats may also require a permit from the U.S. Department of Interior, Fish and Wildlife Service. For additional information, see http://www.fws.gov/permits/importexport/importexport.shtml
  8. Non-human primate material – all non-human primate material (e.g. blood, plasma, tissue, urine, feces) requires an import permit, unless it has been specifically treated and rendered non-infectious.

CDC import permits are NOT required for the importation of:

  1. Diagnostic specimen (e.g. human blood, serum, plasma, urine, cerebrospinal fluid, or other materials of human origin) not known by the importer to contain, or suspected by the importer of containing, an infectious biological agent and is accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent, or has been rendered noninfectious. Also includes peptides, proteins, formalin-fixed tissues, or sterile cell cultures.
  2. Animal or animal product being imported for educational, exhibition, or scientific purposes and is accompanied by documentation confirming that the animal or animal product is not known to contain (or suspected of containing) an infectious biological agent or has been rendered noninfectious.
  3. Nucleic acids that cannot produce infectious forms of any infectious biological agent and the specimen is accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent.

Generally, a USDA veterinary permit is needed for materials derived from animals or exposed to animal-source materials. Materials which require a permit include, animal tissues, blood, cells or cell lines of livestock or poultry origin, RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for IN VIVO use in non-human species, certain polyclonal antibodies, antisera, bulk shipments of test kit reagents, and microorganisms including bacteria, viruses, protozoa, and fungi. Exceptions to this requirement are human and non-human primate tissues, serum, and blood.