USDA Permits for Materials Representing a Health Risk to Agriculture

Q.  What plant pest organisms require a USDA permit? Is there a list of permitted organisms to which investigators can refer?

A.   Regulation 7 CFR 330 covers the authority of the USDA to regulate plant health and plant pest movements.  Currently the USDA requires permits for all materials that may represent a health risk to agriculture. There are no lists that investigators can look at. We regulate pest permits based on type and risk on a case by case basis. According to 7 CFR 330.200 to 330.221 “a plant pest means any living stage of any insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof, viruses, or any organisms similar to or allied with any of the foregoing, or any infectious substances which can directly or indirectly injure or cause disease or damage in any plants or parts thereof, or any processed, manufactured, or other products of plants."

Q.  Is a USDA permit required for any and all pathogens of plants or can this be narrowed down?

A.  It is narrowed to higher risk materials.

Q.  Who needs the transport permit?

A.  The person that receives the regulated organism would be the permittee.  Please note that the regulation applies to interstate or foreign importation of materials.  We do not regulate intrastate transport of materials. The shipper will be identified if needed.

Q.  Does the transport permit also regulate USE or work with the permitted organism?

A.   The USDA regulates the transport and use of the regulated organisms.  If the regulated organism is considered a significant risk and it is not a Select Agent, they will request that the USDA inspectors evaluate the level of containment of the applicant facility.  Most laboratory facilities are BSL-2. The USDA will evaluate the permit application once they receive a satisfactory report from the USDA inspectors.  The USDA issues a permit if the applicant can meet the permit conditions.

Q.  Do agents or pathogens purchased from a commercial source require a USDA permit?

A.  Yes.

Q.  May the permit holder share the permitted organism(s) with collaborators on campus?

A.  Generally no. Insects are can if the work is being done by the same lab or in the same facility on organism and intended use.

Q.  If the permittee is still working with the permitted organism and the permit is about to expire, must the permit be renewed?

A.  Yes. Currently, it is suggested that permittees start the renewal process for their permits at least 3-4 months early. If a new containment facility is necessary, then the permittee/applicant should start the process 6 months early.

Q. If the permittee wishes to ship an organism that is dead or wishes to ship extracted DNA from organisms that would require a permit, would a permit need to be obtained?

A.  No, the USDA does not require permits for dead organisms or extracted nucleic acids.

Q. If the permittee wishes to receive plant pest organisms that have been generated synthetically, is a permit required?

A.  Yes, those permits are handled through USDA; APHIS; BRS.

Q. Can the permittee hand-carry regulated organisms into this country? If so, what is needed?

A.  Yes. A hand-carry event can only occur if:

  • The permittee has a permit which allows hand carry.
  • The hand carrier is named on the permit.
  • There is a 20 day notice to PPB that includes: hand carrier passport, return itinerary, description of how samples will be transported and a third party confirmation of organisms/soil arrived at designated facility.