Restricted Experiments Guidance: Request to Possess the Product resulting from a Restricted Experiment

If the product was created prior to December 4, 2012, the product resulting from a restricted experiment does not require special approval for possession under section 13. However, if the product is a select agent or toxin, approval to possess, use, and transfer is required under section 7 of the regulations. If the product was created on or after December 4, 2012, the possession of the product from a restricted experiment is regulated under section 13 and section 7 of the regulations. Therefore, the entity must submit a written request to FSAP for 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.

The requirements outlined above apply to products resulting from a restricted experiment conducted inside of the United States as well as outside of the United States

Therefore, if a restricted experiment was performed outside of the U.S. after December 4, 2012, the possession of the product resulting from a restricted experiment is regulated under section 13 and section 7 of the regulations. If the experiment was conducted prior to December 4, 2012, the possession of the product resulting from a restricted experiment does not require special approval under section 13. However, the possession, use, and transfer of the product are required under section 7 of the regulations.

Please refer to Table 1 for more information regarding the regulation status of the possession of products resulting from a restricted experiment.