Imports

  • Permit needed1
    • CDC Import Permit 
  • Forms (all available on MSU/Biosafety or at links below)
  • Who to contact/submit form to2 
    • Quarantine Permit Service Office (QPSO), Division of Occupational Health and Safety (DOHS), NIH
  • Contact Information
  • Notes
    • Some material may also need a USDA permit
  • Permit needed1
    • APHIS/CDC Form 2 “Request to Transfer Select Agents and Toxins”
  • Forms (all available on MSU/Biosafety or at links below)
  • Who to contact/submit form to2 
    • Nancy Hoe, Responsible Official for Select Agents, RML OR Megan Morgan OR Rebecca Anderson, Alternate Responsible Officials
  • Contact Information
  • Notes
    • As of April 2013 separate CDC and USDA/APHIS permits are no longer required.
  • Permit needed1
    • Probably none, but due diligence required to rule out the need for a permit. Contact the QPSO. Certification letter from importer may be required.3, 4
  • Forms (all available on MSU/Biosafety or at links below)
    • See forms for other permits

  • Who to contact/submit form to2 
    • Quarantine Permit Service Office (QPSO)
  • Contact Information
  • Notes
  • Permit needed1
    • USDA/APHIS Import or In Transit Permit
  • Forms (all available on MSU/Biosafety or at links below)
  • Who to contact/submit form to2 
    • National Center for Import and Export
  • Contact Information
    • USDA-APHIS-NCIE
      4700 River Road, Unit 39
      Riverdale, MD 20737 Phone: (301) 851-3300, option 5
      Fax: (301) 734-8226 Email: [email protected]
  • Notes
    • Note this email is different from the one for importing infectious material. See also notes for USDA/APHIS Import/Transfer Permit.
  • Permit needed1
    • Various
  • Forms (all available on MSU/Biosafety or at links below)
  • Who to contact/submit form to2 
    • Quarantine Permit Service Office (QPSO)
  • Contact Information

Exports

Transfer

  • Permit needed1
    • CDC “Import” Permit (for specific circumstances - see notes)
  • Forms (all available on MSU/Biosafety or at links below)
    • See information for CDC Import Permit under Import above

  • Who to contact/submit form to2 
    • See information for CDC Import Permit under Import above
  • Contact Information
    • See information for CDC Import Permit under Import above

  • Notes
    • A separate CDC permit may be required (usually by the recipient) for subsequent distribution/transfer of a permitted agent. Check your current or past import permits and contact the QPSO.
  • Permit needed1
    • APHIS/CDC Form 2 “Request to Transfer Select Agents and Toxins”
  • Forms (all available on MSU/Biosafety or at links below)
  • Who to contact/submit form to2 
    • Nancy Hoe, Responsible Official for Select Agents, RML OR Megan Morgan OR Rebecca Anderson, Alternate Responsible Officials
  • Contact Information
  • Notes
    • As of April 2013 separate CDC and USDA/APHIS permits are no longer required.

Additional Notes:

1Many 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.

2Send a copy of all permits to Nancy Hoe: [email protected] In addition, RML Biosafety must be notified prior to any permit-related inspection of laboratories at RML.

3Material 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.

4Generally, 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.

Animal products that do not need a USDA import permit: http://www.cdc.gov/od/eaipp/importApplication/agents.htm

5See the Commerce Control List, Bureau of Industry and Security, Department of Commerce, Category 1, parts 1C351, 1C352, and 1C353 for material requiring an export license (a PDF is available on MSU/Biosafety) : http://www.bis.doc.gov/index.php/forms-documents/doc_view/437-category-1-materials- chemicals-microorganisms-and-toxins

This document is just a guide to help you with the permitting process. For any permits not listed here, or any questions, contact the Quarantine Permit Service Office (QPSO), Division of Occupational Health and Safety (DOHS), NIH: [email protected]

Reference: NIH Policy 1340-1 “Permits for Import or Export of Biological Materials”: http://oma1.od.nih.gov/manualchapters/management/1340-1/