Restricted Experiments Guidance

Changes and Highlights

Revisions: This is a living document subject to ongoing improvement. Feedback or suggestions for improvement from registered select agent entities or the public are welcomed. Submit comments directly to the Federal Select Agent Program (FSAP) at:

CDC: LRSAT@cdc.gov
APHIS: AgSAS@aphis.usda.gov

Revision History:

  • August 30, 2013: Initial posting
  • March 27, 2014 (Revision 1): Added note that the restricted experiment provision dealing with toxins currently only applies to Botulinum neurotoxin. Other changes are editorial errors from previous version.
  • August 28, 2014 (Revision 2): Added language describing the types of experiments that may fall under the restricted experiment provisions described in Section 13. Modified restricted experiment definition to reflect technical amendment published in the Federal Register on May 12, 2014. Other changes are editorial errors from previous version.
  • February 27, 2015 (Revision 3): Added language under subheading “Request to conduct a restricted experiment” describing the criteria reviewed and considered by the FSAP when determining if gradient selection experiments or drug efficacy experiments meet the definition of a restricted experiment.
  • October 21, 2016 (Revision 4): Added language to clarify examples of potential restricted experiments, to add links to Form 1, and to clarify select agents and toxins that require occupational health and medical surveillance procedures.

Download PDF PDF version


Introduction

The information in this guidance document is meant to provide additional information to regulated entities in meeting the requirements for conducting a restricted experiment or possess the products resulting from a restricted experiment.

The use of select agents and toxins in “restricted experiments” is regulated by the following sections of the Code of Federal Regulations (CFR): 42 CFR § 73.13 (HHS), 7 CFR § 331.13 (APHIS-Plant Protection and Quarantine (PPQ)), and 9 CFR § 121.13 (APHIS-Veterinary Services (VS)).