FAQ: Restricted Experiments | Compliance | Federal Select Agent Program

A request for approval to conduct a restricted experiment should be submitted by the entity’s Responsible Official and sent to the Federal Select Agent Program through the electronic information system. The request will be reviewed by the Federal Select Agent Program. We recommend that it not be submitted as part of an amendment as doing so may delay approval of other changes proposed in the amendment while the restricted experiment request is under review.

It depends on the circumstance. Although not all antibiotic resistance markers confer resistance to drugs used to control or prevent diseases associated with select agents and toxins, we highly recommend that all experiments involving the introduction of antimicrobial resistance into a select agent be reviewed by FSAP to determine if the proposed experiment meets the definition of a restricted experiment. If the introduction of such a marker compromises the control of disease agents (e.g., in the event of an accidental exposure), it may meet the definition of a restricted experiment requiring prior approval. All restricted experiment requests are reviewed on a case-by-case basis.

Yes. The request must describe all methods used for selection, including all intermediate vectors containing drug resistant markers or potential drug resistant traits. Refer to the Restricted Experiment Guidance Document for more information regarding submission of restricted experiment requests to the Federal Select Agent Program.

It depends on the circumstance. If the product of a restricted experiment is itself a select agent or toxin, the same approval to possess, use, and transfer the restricted experiment product is required under section 7 of the select agent regulations as for any other select agent or toxin. As to whether the product requires specific approval under section 13 of the regulations, it depends on when the product of the restricted experiment was created. If the product was created prior to December 4, 2012, the product of a restricted experiment does not require special approval for possession under section 13 of the select agent regulations. If the product was created on or after December 4, 2012, the possession is regulated under section 13 of the select agent regulations. For those regulated restricted experiment products, the entity must submit a written request to the Federal Select Agent Program asking permission to possess the product. If the possession of the product from a restricted experiment is approved, the entity must update the relevant information as an amendment to their select agent registration. In addition, the subsequent Principal Investigator (PI)’s work objective should be submitted for review, and the entity could expect that any approval would be subject to the same restrictions and biosafety requirements as were imposed by the initial “restricted experiment” approval. Please refer to the Restricted Experiment Guidance Document for more information regarding the regulation status of the possession of products from restricted experiments.

Yes. The entity must submit a written request to FSAP asking 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. Only passive selection experiments conducted on or after December 4, 2012 are regulated under Section 13 of the select agent regulations. Please refer to the Restricted Experiment Guidance Document for more information regarding the regulation status to conduct restricted experiments using passive selection or utilizing recombinant DNA.

Yes. Restricted experiment decisions are determined by the specific work objectives and protocols submitted. If there are any changes in the work objectives or protocols, you should notify FSAP and amend your select agent registration in accordance with section 7(h) of the select agent regulations.

Botulinum neurotoxin is the only select toxin that meets this definition.