Guidance on the Regulation of SARS‑CoV/SARS‑CoV-2 Chimeric Viruses: Request to Possess the Product Resulting from a SARS-CoV/SARS-CoV-2 Chimeric Virus Restricted Experiment

Section 13 of the select agent regulations provides that the possession of the product from a restricted experiment is regulated. Therefore, an entity must submit a request through the eFSAP information system for permission to possess the product. If the possession of the product from a restricted experiment is approved, the entity must submit a request to amend their registration to update the relevant information in accordance with Section 7 of the regulations. This includes updating the entity’s work objectives and designating a Principal Investigator that would possess the product.

The requirements outlined above apply to products resulting from a restricted experiment conducted inside of the United States or products imported into the United States.

Possession of a product resulting from a restricted experiment requires pre-approval from FSAP before a transfer request is approved. The potential receiver must submit the following documentation to FSAP for review prior to transfer:

• Synopsis of the proposed experiments (if applicable) and the intended objectives.
• Description of biosafety level including facility containment, equipment, and special practices to be utilized for the proposed experiments.
• Synopsis of any planned animal experiments (if applicable) or other relevant animal work.
• Description of the transferor (e.g., entity, name of person initiating transfer, point of contact information).
• Description of occupational health and medical surveillance procedures (applicable to non-Tier 1 select agents as recommended in Biosafety in Microbiological and Biomedical Laboratories (BMBL) (e.g., SARS–CoV).
• Scientific references or supporting documentation, particularly with respect to the biosafety aspects of the proposed experimental product. The supporting documentation should reflect the safety measures in place that would support the request to acquire the product of a restricted experiment from another entity.

If the request to possess the product from a restricted experiment is approved, the entity should then request to amend their registration by submitting the appropriate APHIS/CDC Form 1 section updates.

In addition, the APHIS/CDC Form 2, Request to Transfer Select Agents and Toxins, must be completed and submitted through the eFSAP information system prior to transferring any select agent(s). Please refer to the APHIS/CDC Form 2 instructions and guidance documents for more information.