Imports

Biological Imports

Certain biological materials are regulated by federal agencies for international importation and interstate transfer. Permits may be required from these agencies. Exempt materials must meet specific criteria and be accompanied by shipping documentation for US Customs and Border Patrol review to avoid confiscation or delays.

The Office of Sponsored Programs requests ancillary review of Material Transfer Agreements of biological materials, which includes animals, viruses and vectors, cell lines, plasmids, and bacterial agents.

If an MTA is not necessary, import review is still required to determine necessary permitting requirements. Email kmc35@pitt.edu before shipment.

Import Review will determine the permits required and guide the investigator to the appropriate permitting tools. As the permits are done through online systems, the investigator must apply for the permits themselves.

Please note that all permits MUST be under the receiving investigators name and should match the MTA, if applicable.

The following is not an exhaustive list of materials that may require documentation or permits. If you have any questions please contact kmc35@pitt.edu.

If you are exporting biological materials to another country, export regulations may apply. https://www.tradecompliance.pitt.edu/procedures/shipments

 

 

Permitting Agencies

Centers for Disease Control (CDC)

International Movement

Oversight: Materials that are or may be infectious to humans

Examples : Human samples (blood, tissues, body fluids)

       Vectors of human disease (bats, arthropods, snails)

                    Human or non-human primate remains

LINK: www.cdc.gov/cpr/ipp/index.htm

 

United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS)

International and Interstate Movement

APHIS Veterinary Services (VS)

Oversight: animals or animal products

Examples: Animals (transgenic animals, tissues, embryos or sperm)

                  Animal Products (FBS, albumin)

   Cell Lines (including Monoclonal antibodies, cell culture supernatants, ascitic fluid, cell extracts, hybridomas)

      Recombinant Materials (bacteria, viruses, yeasts/fungi, proteins, hormones, extracts, plasmids, DNA, RNA)

LINK: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/import-animals-products/ct_import_animal_products
 

 

APHIS Organisms and Vectors (OV)

Oversight: Livestock and Poultry Pathogens

Examples: Some avian influenzas, Candida albicans, Enterococcus spp, Klebsiella pneumoniae

Full List here: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/organisms-vectors/livestock-poultry-pathogens

LINK: https://www.aphis.usda.gov/aphis/ourfocus/importexport/organism-vectors

 

APHIS Biotechnology Regulatory Services (BRS)

Oversight: GMO plant pathogens

Examples: any organisms developed using genetic engineering that may pose a risk to plant health

LINK: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology


 APHIS Plant Protection and Quarantine (PPQ)

Oversight: Plants and Plant Products

Examples: Plant Pathogens or Pests (plant feeding insects, mites, snails, slugs, and plant pathogenic bacteria, viruses, fungi)

                   Soil           

                  Seeds

LINK: https://www.aphis.usda.gov/aphis/ourfocus/planthealth
 

 

Federal Select Agent Program (FSAP) 

International and Interstate Movement

Oversight: possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products

Examples: Botulinum neurotoxins, Marburg virus, Rift Valley Fever virus

Full list here: https://www.selectagents.gov/sat/list.htm

**Must also have approval from University of Pittsburgh Responsible Official https://www.ehs.pitt.edu/lab-safety/biosafety-program

LINK: https://www.selectagents.gov/sat/index.htm

 

 

Food and Drug Administration (FDA)

International Movement

Oversight: all materials covered by FDA in the US are also subject to FDA import review

Examples: Medical products (drugs, vaccines, devices, and biological products)

                   Radiation emitting devices

                    Tobacco products

LINK: https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/import-basics

 

United States Fish and Wildlife Service (FWS)

International and Interstate Movement

Oversight: conserve, protect and enhance fish, wildlife, and plants and their habitats

Examples: wild mammals, bird, reptile, amphibian, fish, mollusk, crustacean, arthropod

LINK: www.fws.gov/le/businesses.html

 

 Convention of International Trade in Endangered Species of Wild Fauna and Flora (CITES) 

International Movement

Oversight: International trade in specimens of endangered or threatened wild animals and plants

Examples: Endangered species and their materials (animals and plants)

Full List here: https://cites.org/eng/app/appendices.php

LINK: www.cites.org/eng/disc/how.php

 

 

Helpful Office of Trade Compliance Links:

Session 1: Overview of the Importing Process 

Session 2: CDC and USDA Permitting Review

 

Helpful YouTube Links:

CDC Importing Biologics and Vectors (5 min)

https://www.youtube.com/watch?v=OVORk6Xw3b8

 

CDC Biological Imports Webinar (32 min)

https://www.youtube.com/watch?v=OUE6HFEzCls

 

USDA eFILE Permitting Assistant Tutorial (4 min)

https://www.youtube.com/watch?v=r-LkAgRc9pQ

 

USDA Organisms and Vectors Webinar  (14 min)

https://www.youtube.com/watch?v=jBF0ubFAXkg

 

FDA Import Process (11 min)

https://www.youtube.com/watch?v=PwF-ki-oIDw