MSU Toxin Policy
This toxin policy has three parts: The purpose; what to do to possess a toxin at MSU; and the steps to take at MSU to ensure due diligence has been met before transferring a toxin to another individual or group. “Due diligence” is generally understood to be such a measure of prudence, activity, or assiduity, as is properly expected from, and ordinarily exercised by, a reasonable and prudent person under the particular circumstances; not measured by any absolute standard, but depending in the relative facts of the specific case."
This Toxin Use Policy has been developed to address the concern that someone might stockpile toxins excluded from CDC regulation by amount by receiving multiple orders below an 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; and
- Report to the Federal Select Agent Program if he/she detects a known or suspected violation of Federal law or become aware of suspicious activity related to the toxin.
2. What to do to possess a toxin at MSU
a. To possess any toxin at MSU the Principal Investigator must submit a biosafety protocol to the Institutional Biosafety Committee for review and approval. The protocol form can be found at https://apps.montana.edu/msupam/login.
b.All acquisition, use, and disposal of non CDC regulated toxins must be documented on the attached form.
c. . All acquisition, transfers, and destruction of excluded amounts of CDC regulated toxins must be documented on the attached form, including the transferor, the recipient, the agent/toxin, the amount/volume, date of activity, as well as documentation of the due diligence procedures used to verify the proper nature of the transfer. Copies of all such forms shall be provided to the Biosafety Officer. Accurate inventories of such toxins must also be maintained in MSU’s select agent inventory system once this system is implemented campus-wide.
3. Steps to take to transfer a toxin to another individual or group to ensure due diligence has been met
To document those individuals who have a legitimate purpose to handle and use such toxins, the transferor can either require the recipient to complete documentation stating their intended use of the toxins or the transferor can document their knowledge of the recipient’s legitimate need for the toxins. Information pertinent to the person requesting and using toxins includes the individual’s name, institution name, address, telephone number, and email address.
Other questions include:
What is the toxin for?
Do you already have it?
Are you using it or giving it to someone else?
Do you have a legitimate reason for using the toxin?
How often do you receive the toxin?
All documentation must be sent to the Biosafety Officer. The Biosafety Officer will distribute the documentation to the IBC for review. The IBC must determine that adequate due diligence has been met before a toxin can be transferred to anothe individual or group.Contact MSU’s Occupational Health Officer for help in developing a chemical hygiene plan for working safely with the toxins.
BMBL 5th Edition guidelines for working safely with toxins:
Section VIII –G: toxin agents
Appendix I—Guidelines for Work with Toxins of Biological Origin