Toxin Due Diligence
Permissible Toxin Amounts
The following select agent toxins are exempt from federal registration and regulations if the amount under the control of a Principal Investigator (PI) does not exceed, at any time, the amounts indicated in the table below.
|HHS Toxins [42 CFR Part73.3(d)(3)||Amount|
|Botulinum neurontoxins||1 mg|
|Short, paralytic alpha conotoxins||100 mg|
|Diacetoxyscirpenol (DAS)||10,000 mg|
|Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)||100 mg|
|T-2 Toxin||10,000 mg|
Toxin Due Diligence Requirements
All OSU PIs in possession of the select agent toxins listed above must maintain a record of all transfers of these toxins outside of their laboratory (i.e., institution name, address, telephone number, and email address). This documentation must include the following:
Name and contact information of the recipient;
Toxin name and quantity transferred; and
Knowledge of recipient’s legitimate need (i.e., prophylactic, protective, bona fide research etc...) to handle or use the toxin.
Reporting Suspected Violations or Suspicious Activity
If an OSU PI detects a known or suspected violation of Federal law or becomes aware of suspicious activity related to a select agent toxin, he or she must immediately notify the OSU Responsible Official or an Alternate Responsible Official using the contact information below. These individuals will then contact the Federal Select Agent Program.
Vice President for Research
Kenneth Sewell, Ph.D. Vice President for Research | Responsible Official203 Whitehurst HallOffice: firstname.lastname@example.org
Ashleigh Hall Assistant Biological Safety Officer | Alternate Responsible Official