USDA Permits for Livestock and Poultry Pathogens

Q.  What agents require a USDA permit? Is there a list of permitted strains of agents to which investigators can refer?

A.   Regulation 9 CFR 122 Organisms and vectors is under review to actually indicate which agents need an import/transport permit.  Currently the USDA requires permits for all materials that may represent a health risk to livestock and poultry and ranging from prions to macroscopic nematodes.

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

A.  It will be narrowed to high risk materials.

Q.  Who needs the transport permit?

A.  The person that receives the material = permittee.  Please note that the regulation applies to interstate or foreign importation of materials.  We do not regulate intrastate transport of materials, unless it is a Select Agent as defined under 9 CFR 121.  The shipper will be identified if needed. Applicants usually have multiple suppliers so the USDA does not list them specifically on the permit, but they may be included in the application (VS Form 16-3).

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

A.   The USDA regulates the transport and use of the materials.  If the material is considered high risk and it is not a Select Agent, for example low pathogenicity influenza virus, West Nile virus, PRRSV, and others, they will request that the USDA Field inspector evaluate the level of containment of the applicant facility.  Most laboratory or animal facilities are BSL-2 based upon the recommendations/guidelines of the BMBL (HHS).  The USDA will issue the permit once they receive a satisfactory report from the USDA Field inspector.

Q.  Do agents or pathogens purchased from a commercial source, such as the ATCC, require a USDA permit?

A.  Yes.  The ATCC catalog will indicate if a USDA transport permit is required for purchasing the material.  In general, if the material can be classified as a health risk to livestock and poultry, 9 CFR 122 is applicable and a permit is required.

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

A.  The new permit can be issued to more than one person on campus. When applying for the permit, the individual should list the collaborators in the importer section. If the material is shared after the permit is issued, the USDA can amend the permit to allow local movement.  The pertinent statement is changed to indicate that the material will be shared provided the permittee keeps records of the movement and provides documentation to USDA if needed.

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

A.  It depends upon the material. If the permittee is working with high risk material, such as avian influenza virus low path, a USDA BSL-2 inspection and an active permit are required; for lower risk material the USDA does not consider the permit expired unless the investigator intends to receive more material. The USDA considers the permit active or “on” even with an expired date and they do not search for expired permits.  It is not necessary to renew the permits every year unless there are changes to the permittee section, like a new address.  However, USDA recommends that permits remain current, in case there is an incident with the strain.

Q. If the permittee wishes to ship an agent that has been inactivated, or wishes to ship extracted DNA from organisms that would require a permit, would the permit need to reflect these items as well?

A.  Yes, the USDA would issue a broad permit stating the species, as well as derivatives including nucleic acids, are included.

Q. If the permittee wishes to receive nucleic acids encoding for Select Agents or Select Agent Toxins that have been generated synthetically, is a permit required?

A.  Yes, since the material is regulated under 9 CFR 121.3 or 9 CFR 122.