Restricted Experiments Guidance: Request to Conduct a Restricted Experiment Using Synthetic Nucleic Acids or Passive Selection

If an experiment using synthetic nucleic acids or passive selection (e.g. transfer of drug resistant traits through gradient or step-wise selective pressure as a method to select for drug resistance traits in select agents) was conducted prior to December 4, 2012, the experiment is not subject to the requirements of section 13 of the select agent regulations. However, all requests to conduct a restricted experiment using synthetic nucleic acids or passive selection on or after December 4, 2012 are subject to the select agent regulations under section 13.

A request to conduct a restricted experiment should be submitted by the entity’s RO and sent through eFSAP requesting permission to conduct the experiment. If the request to perform the experiment is approved, the entity must update the relevant information as an amendment to their select agent registration.

Please refer to Table 1 for more information regarding the regulation status to conduct restricted experiments using synthetic nucleic acids, passive selection, or utilizing recombinant DNA.