Federal Select Agent Program - Policy Statement: Requests for Transfer of Select Agents and Toxins

Policy Statement

Date: February 8, 2018

Subject: AgSAS Policy Statement: Biosafety Level Requirements for Virulent Newcastle Disease Virus

Authority:

The Agriculture Select Agent Services (AgSAS) regulates the possession, use, and transfer of biological agents listed in 7 C.F.R. Part 331 and 9 C.F.R. Part 121 that have the potential to pose a severe threat to animal or plant health or animal or plant products (select agents and toxins).

An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use. Further, biosafety and containment procedures must be sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards) (See 9 C.F.R §121.12).

Policy Statement:

It is AgSAS policy that an individual or entity conducting work with any non-exempted virulent Newcastle disease virus isolate, including Newcastle disease virus (NDV) GB Texas strain, must do so within a biosafety level 3 (BSL-3) or animal biosafety level 3 (ABSL-3) space, consistent with the Biosafety in Microbiological and Biomedical Laboratories (BMBL) recommendation for such agents. The BMBL, 5th Edition, provides recommendations that any moderate or highly virulent forms of NDV be handled in vitro in a BSL-3 laboratory with enhancements as required by the USDA and in vivo in a USDA-approved BSL-3-Ag facility for loosely housed animals.

If BSL-3 or ABSL-3 space is not available, the individual or entity may request a variance to this policy by submitting the request to AgSAS by email at AgSAS@aphis.usda.gov.  The request should be accompanied by a risk assessment providing details of enhancements and preventive measures implemented to address the increased risk and biosafety issues related to working in a lower containment space.