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Biosafety - Federal Permits for Biological Materials
Federal Permits for Biological Materials
Federal permits may be required for importing and/or transporting human pathogens and possible vectors of human disease, animal pathogens, animals or animal products, plant pathogens or plant pests, and plants or plant products. Permits may also be required for the release of specific transgenic materials that have the potential to produce detrimental effects on the environment.
Principal Investigators are responsible for obtaining all required Federal permits prior to the initiation of research
The Centers for Disease Control and Prevention’s Etiological Agent Import Permit Program, regulates the importation of etiologic agents (i.e., microbes and their associated byproducts that cause disease in humans), hosts, and vectors of human disease in order to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the U.S.
Materials that require an Etiological Agent Import Permit:
- Etiologic agents – microorganisms that cause disease in humans
- Animals – any animal capable of being a host or vector of human disease
- Bats – all live bats
- Arthropods – any living insect capable of being a host or vector of human disease
- Snails – any freshwater snails capable of transmitting schistosomiasis
- All non-human primate materials and trophies (unless specifically treated and rendered non-infectious)
Materials that do not require Etiological Agent Import Permit:
- Non-infectious material (e.g., formalin-fixed slides, etc.)
- Human or animal diagnostic specimens that do not contain an etiologic agent
- Treated (i.e., rendered non-infectious) non-human primate material and trophies
- Genomic material (except positive strand viruses capable of producing the infectious agent)
- Material that is non-pathogenic to humans
- FDA-approved vaccines
- Laboratory mice, rats, and hamsters reared under specific pathogen-free (SPF) conditions
Etiological Agent Import Permit Exemptions:
- Select agents and toxins
- Diagnostic specimens not known to contain an infectious biological agent if the specimen is accompanied by a certification statement
- An animal being imported for education or exhibition purposes
- Nucleic acids that cannot produce infectious forms of any infectious biological agent if the specimen is accompanied by a certification statement
A product that is cleared, approved, or licensed
- Federal Food, Drug, and Cosmetic Act
- Section 351 of the Public Health Service Act pertaining to biological products
- The Virus-Serum-Toxin Act
Additional Information & Permit Applications: http://www.cdc.gov/od/eaipp/
Pathogens & Pests of Agricultural Significance
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) regulates the importation and transport of materials that have the potential to harm U.S. agricultural products such as livestock or crops. Thus, an APHIS permit may be required for:
- Import, export, and/or transport of animal or plant pathogens, soil samples, or insects
- Import or export of animals, animal products, and plants or plant products
- Transport of introduction of genetically modified organisms into the environment.
APHIS Plant Protection and Quarantine (PPQ)
PPQ permits are required for the importation and interstate transport of plant materials, plant pests, plant pathogens, and soils.
- PPQ 525 – Application for Permit to Receive Soil
PPQ 526 – Permit to Move Live Plant Pests, Biological Control Agents, Bees, Parasitic Plants, Federal Noxious Weeds, or Soil
Note: A PPQ 526 permit is required anytime that a researcher transports a pathogenic organism into Oklahoma, even if the organism already occurs naturally in the state.
- PPQ 546 – Agreement for Postentry Quarantine State Screening Notice
- PPQ 585 – Application for Permit to Import Timber or Timber Products
- PPQ 586 – Application for Permit to Transit Plant and/or Plant Products, Plant Pests, and/or Associated Soil Through the United States
- PPQ 587 – Application for Permit to Import Plants and Plant Products
- PPQ 588 – Application for Controlled Import Permit to Import Restricted or Not Authorized Plant Material
- PPQ 621 – Application for Protected Plant Permit to Engage in the Business or Importing, Exporting, or Re-exporting Terrestrial Plants or Plant Products that are Protected
APHIS Veterinary Services (VS)
VS permits are required for the importation and interstate transport of pathogens of livestock and poultry, and anything biologically-derived from or exposed to pathogens of livestock and poultry.
- APHIS Form 2005 – Application for U.S. Veterinary Biological Product Permit (Veterinary Vaccine or Diagnostic test)
VS Form 16-3 – Application for Permit To: Import or Transport Controlled Material or Organisms or Vectors
Note: A VS 16-3 permit is required anytime that a researcher transports a livestock or poultry pathogen into Oklahoma, even if the organism already occurs naturally in the state.
- VS Form 17-129 – Application for Import or In Transit Permit (Animals, Animal Semen, Animal Embryos, Birds, Poultry, or Hatching Eggs)
APHIS Biotechnology Regulatory Services (BRS)
BRS notifications and permits are required for the importation, interstate movement and/or environmental release of genetically modified plants, plant pests, and plant pathogens.
- APHIS Form 2000 - BRS Permit for the Introduction of Genetically Engineered Organisms
- BRS Notification of Introduction of Genetically Engineered Plants – an administratively-streamlined alternative to a permit
Additional Information & Permit Applications: https://www.aphis.usda.gov/aphis/resources/permits