- Does the "due diligence" provision required under Section 16 apply to only registered individuals or entities or does it apply to entities or individuals not registered with the Federal Select Agent Program?
- Is a Principal Investigator who possesses a regulated amount of a select toxin able to transfer an unregulated amount of a toxin to fellow co-workers without getting prior approval?
- Is a company that manufactures and possesses regulated amounts of a toxin able to transfer less than regulated amounts to an unregistered entity without getting prior approval?
- Are there any specific documents required to meet the "due diligence" provision under Section 16?
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The "due diligence" provision required under Section 16 applies to anyone (registered or unregistered individuals or entities) that transfers toxin listed under Section 73.3 in amounts that otherwise would be excluded from the select agent regulations. The Federal Select Agent Program developed the provision to address the concern that someone might stockpile toxins by receiving multiple orders below the excluded amount. The "toxin due diligence" provision requires a person transferring toxins in amounts which would otherwise be excluded from the provisions to: (1) use due diligence to assure that the recipient has a legitimate need to handle or use such toxins; and (2) report to Federal Select Agent Program if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to the toxin.
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Yes, but with these caveats:
- If the "fellow co-worker" is someone supervised by the Principal Investigator, the toxin remains under the control of the Principal Investigator and has not really been transferred. In such cases, the "fellow co-worker" would have to be SRA approved and the room where the toxin located registered.
- The Principal Investigator must maintain accurate inventory records of the select toxin, including the transfer of unregulated amounts of the toxin.
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Yes, the company may transfer toxins in amounts which would otherwise be excluded from the provisions of the regulations as long as the company uses due diligence to determine that the recipient has a legitimate need to handle or use such toxins.
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There are no federal forms that are required to be completed. The regulations only require that the transferor “documents that the recipient has a legitimate need to handle or use” the toxins being transferred. The transferor can either require the recipient to complete documentation stating their intended use of the toxins; or self-document their knowledge of the recipient’s legitimate need for the toxins; or a combination of both. In addition to a description of the intended use, we suggest that the following information be maintained: the individual’s name, institution name, address, telephone number, date of transfer, amount to be transferred, and e-mail address.
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