Policy Statement

Date: August 18, 2017

Subject: FSAP Policy Statement: Non-Exclusion of Study-Related Activities Involving Naturally Infected Animals

The Federal Select Agent Program (FSAP) is a collaboration between the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Service (APHIS) Agriculture Select Agent Services (AgSAS) to regulate the possession, use, and transfer of biological agents listed in 7 C.F.R. Part 331, 9 C.F.R. Part 121, and 42 C.F.R. Part 73 (select agents and toxins).  The FSAP administers the select agents and toxins regulations in close coordination with the Federal Bureau of Investigation’s Criminal Justice Information Services Division (CJIS).

Authority:

The select agents and toxins regulations identify those biological agents and toxins which the HHS Secretary and APHIS Administrator have determined have the potential to pose a severe threat to human health and safety, animal or plant health, or animal or plant products (See 7 C.F.R. §331.3, 9 C.F.R. §§121.3, 121.4, and 42 C.F.R. §§73.3, 73.4). Any select agent or toxin that is in its naturally occurring environment is excluded from the requirements of the regulations, provided that agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. (See 7 C.F.R. §331.3(d)(1), 9 C.F.R. §§121.3(d)(1), 121.4(d)(1), and 42 C.F.R. §§73.3(d)(1), §73.4(d)(1)). 

Policy Statement:

Sections 73.3(d)(1), 73.4(d)(1) of title 42 of the Code of Federal Regulations [42 C.F.R. §§73.3(d)(1), §73.4(d)(1))]  and Sections 121.3(d)(1), 121.4(d)(1) of title 9 of the Code of Federal Regulations [9 C.F.R. §§121.3(d)(1), 121.4(d)(1)] provide for exclusion of select agents and toxins occurring in their natural environment.  Mere possession of an animal which is naturally infected with a select agent, either within its natural environment or having been transported to an artificially established environment, meets the criteria of this exclusion. 

However, it is the policy of the Federal Select Agent Program (FSAP) that

  • removal of an animal which is naturally infected with a select agent from its natural environment to an artificially established environment for the purpose of the intentional exposure or introduction of a select agent to a naïve or experimental animal, or
  • the introduction of a naïve animal to a natural environment where there is an animal which is naturally infected with a select agent for the purpose of the intentional exposure or introduction of a select agent to the naïve or experimental animal

does not meet the 9 C.F.R. §§121.3(d)(1), 121.4(d)(1), and 42 C.F.R. §§73.3(d)(1), §73.4(d)(1)) exclusion criteria. Accordingly, any work with an animal naturally infected with a select agent for the purpose of the intentional exposure or introduction of a select agent to any naïve or experimental animal may only be conducted after approval by DSAT or AgSAS for an entity or individual registered with DSAT or AgSAS for possession and use of such select agent.

If an animal is confirmed to be naturally infected with a select agent there may be additional transfer and/or transport restrictions based upon specific USDA and state requirements.

This policy statement will be provided to the Responsible Official via SA Gram for each registered entity on or before the effective date; and to the Responsible Official for each newly registered entity during the registration process. 

Any questions concerning this policy may be addressed by contacting the Federal Select Agent Program at lrsat@cdc.gov or AgSAS@aphis.usda.gov.