If you are transferring ANY AMOUNT of a Select Agent or Toxin to a colleague (intramural or extramural), you MUST submit the "Request to Transfer Exempt Amounts of a Select Agent" form.
Policy statements in Sections 3 and 16 pertain to the Toxin Due Diligence Provision. (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121). Section 42 CFR § 73.3(d)(3) specifies the select toxin amounts under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor that are excluded from the requirements of the select agent regulations (Exempt Amounts).
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:
- Use due diligence to assure that the recipient has a legitimate need to handle or use such toxins.
- The Office of Environmental Health and Radiation Safety (EHRS) is responsible for ensuring compliance with Select Agent regulations at Penn. It is our joint responsibility to report to the Federal Select Agent Program any known or suspected violation of Federal law or when we become aware of any suspicious activity related to select agent toxins.
In order to assist Penn faculty working with Exempt Amounts in complying with the Toxin Due Diligence Provision, EHRS requires that transfer of ANY AMOUNT of a select agent toxin MUST be documented prior to transfer.