Environmental Health and Safety

USDA Animal and Plant Health Inspection Service (APHIS) Permits

APHIS is the branch of the USDA that provides leadership in ensuring the health and care of animals and plants, especially those that are vital agricultural commodities. Biological materials that may pose a risk to plants and/or animals or their environment are tightly regulated by APHIS. APHIS permits are granted by one of three agencies based on the biological material involved and the at-risk population (i.e. plants or animals):

• Veterinary Services (VS; 9 CFR, Part 122 inter alia)
• Plant Protection and Quarantine (PPQ; 7 CFR, Part 330 inter alia)
• Biotechnology Regulatory Services (BRS; 7 CFR, Part 340)
  

Veterinary Services (VS) is dedicated to preventing, controlling and/or eliminating animal diseases, and monitoring and promoting animal health and productivity. VS provides permits for the import, interstate movement, and export of materials derived from animals or exposed to animal-source materials. Examples include:

• Animal tissues including blood, cells or cell lines of livestock or poultry origin
• Animal semen, ova or embryos
• RNA/DNA extracts
• Hormones and enzymes
• Monoclonal antibodies for in vivo use in non-human species and certain polyclonal antibodies/antisera
• Microorganisms including bacteria, viruses, protozoa, and fungi
  

VS permits have a service charge of $137, though this price can vary depending on number of revisions reviewed, need for facilities inspections, etc.

Related websites

• General information on the USDA APHIS Animal Health program
• Veterinary Services permit information and application forms
  

Plant Protection and Quarantine safeguards agriculture and natural resources from the risks associated with the entry, establishment, or spread of animal and plant pests and noxious weeds to ensure an abundant, high-quality, and varied food supply. PPQ provides permits for the import, interstate movement, and export of:

• Plant pests and pathogens including insects, mites, bees, butterflies and moths, earthworms, entomopathogens/biocontrol agents, snails and slugs, earthworms, bacteria, fungi, nematodes, viruses, live arthropods for display or education, and noxious weeds. More information on plant pests and pathogens permits and PPQ Form 526.
• Plants and plant products including fruits, vegetables, rice, maize, sugarcane and associated products, foreign cotton, cut flowers, and miscellaneous products associated with Khapra beetle. More information on plants and plant products permits and PPQ Form 587.
• Timber and timber products including unfinished lumber. More information on timber and timber products permits and PPQ Form 585.
• Prohibited plants/plant products for purposes of research only. More information on permits for the research use of prohibited plants/plant products and PPQ Form 588.
• Plants or plant products for transit through the U.S. More information on transit permits and PPQ Form 586.
• Protected or rare plant species. More information on rare and endangered plants, CITES, and PPQ Form 621.
• Soil of foreign origin. More information on soil permits and PPQ Form 525A.
• Post-entry quarantine materials. More information on post-entry quarantine and PPQ Form 546 [PDF].
  

There is no service charge for PPQ permits.

Related websites

• General information on the USDA APHIS Plant Health program
• General information on PPQ permits
  

Biotechnology Regulatory Services (BRS) protects America’s agriculture and environment using a dynamic and science-based regulatory framework that allows for the safe development and use of genetically engineered (GE) organisms. BRS regulates genetically engineered organisms including plants, plant pests, and transgenic arthropods through either a notification or permit system.

BRS Notifications constitute an expedited permitting process for GE plants that BRS has extensive experience regulating in the past.

• GE plants must meet six eligibility requirements that are related to safety. BRS notification requirements and guidance [PDF]
• Performance standards are established and applicants must comply with these for movement, planting, growing, harvesting, and isolation.
• BRS reviews the application for meeting eligibility requirements and assesses whether performance standards can be met, taking up to 30 days to process.
• Notifications require submission of a letter to BRS or e-submission (see below).
• More information on the BRS notification criteria and process
  

BRS Permits are used for crops that don’t meet current notification criteria including pharmaceutical and industrial products, plants with a high potential to persist outside the field site, and multi-year field trials.

• Permits require up to 120 days to process for the science review of conditions and confinement protocols.
• BRS authorizes the procedures for field production and isolation in the permit.
• All organisms and all traits are eligible.
• More information on BRS permits and application forms
  

There is no service charge for BRS notifications or permits.