State and Federal Permits that May be Required

Most biological materials require an import permit for entry into the US.

  • Human disease agents (naturally occurring or engineered), vectors of human disease, material known or reasonably expected to contain human disease agents: CDC Import Permit
  • Livestock disease agents (naturally occurring or engineered), derivatives of livestock disease agents, material known or reasonably expected to contain livestock disease agents, vectors of livestock diseases, animal products, materials containing animal products: USDA AHIS Veterinary Services (VS) Permit
  • Naturally occurring or engineered organisms that impact plants directly or indirectly (naturally occurring or engineered), plants, plant products, plant pests, noxious weeds, soil: USDA APHIS Plant Protection and Quarantine (PPQ) Permit, and for engineered material: Biotechnology Regulatory Services (BRS) Import Permit.

Many materials need permits for inter-state movement in the US.

  • Livestock disease agents (naturally occurring or engineered), derivatives of livestock disease agents, material known or reasonably expected to contain livestock disease agents, vectors of livestock disease: USDA AHIS Veterinary Services (VS) Permit
  • Naturally occurring or engineered organisms that impact plants directly or indirectly, plant pests, noxious weeds, soil, plants: USDA APHIS Plant Protection and Quarantine (PPQ) Permit, and for engineered material: Biotechnology Regulatory Services (BRS) Permit.

Some require permits for possession.

  • Naturally occurring or engineered organisms that impact plants directly or indirectly, plant pests, noxious weeds, soil, plants: USDA APHIS Plant Protection and Quarantine (PPQ) Permit
  • Select agents

A field release of an engineered organism (e.g. field trial) will require: Biotechnology Regulatory Services (BRS) Permit or Notification.

The State of Florida regulates the intra-state movement of any organism which may pose a risk to Florida agriculture, become a nuisance, threaten native Florida wildlife, or pose a serious medical hazard to humans or livestock. Examples include: arthropods, nematodes, noxious weeds or plant pathogens, quarantined plant material. A Florida Department of Agriculture and Consumer Services (FDACS) permit is required.

The PI is responsible for obtaining and maintaining any permit. Inspections by the regulatory body may be required.

If you have a permit or notification, you must submit the completed Permit Registration form to the Biosafety Office. We need to know who is working with regulated materials. We can also ensure you are meeting all permit conditions or performance standards and can provide guidance on how to do so.

Common misconceptions about permits

  • The fine print is not important. Wrong! Permit conditions can be quite stringent; make sure you can meet the requirements
  • The agent is endemic so there’s no need for a permit. Wrong! …examples: Ralstonia solanacearum, Citrus canker
  • It’s non-pathogenic so there’s no need for a permit. Wrong! …examples: Liberibacter crescens, GE Agrobacterium
  • State and Federal regulators copy EH&S Biosafety on all permits, so they’re aware I have a permit. We aren’t!
  • Federal or State approval trumps UF approval, so there’s no need to inform Biosafety. Not true – additional “local” requirements may be in place (previous problems, proximity of susceptible hosts, shared research space – all factor in to approval of research).

Consult the Biosafety Manual or contact the Biosafety Office for more information and regulatory contacts.