The University of Iowa

C. Requirements for Working with Exempt Quantities of Toxins

Principal Investigators will ensure the requirements listed under Section V.C.  “A Principal Investigator Working with Exempt Quantities of Select Agent Toxins is Responsible for” are completed and that their staff understands any and all additional responsibilities required with Select Agent and Toxin use.

PIs working with exempt quantities of toxins should contact Haley Sinn, EHS, 335-9553. EHS will forward the CDC Select Agent Toxin Exemption Declaration which lists the maximum allowable toxin amount per PI. PIs will be asked to read this form and sign the declaration, acknowledging that prior permission from the CDC and RO is required to possess quantities in excess of these limits and that s/he will maintain an inventory below the permissible limit. After signing the CDC Select Agent Toxin Exemption Declaration, PIs who possess or will possess a toxin(s) should read the UI Requirements for Possession of Exempt Quantities of CDC Select Agent Toxins, outlining the UI’s requirements for such possession, and download a Select Agent Toxin Inventory Record for their use.

Toxin inventory and inventory records will be audited annually by EHS, normally during EHS’s annual laboratory audit. PIs wo;; revoew their current inventory during the audit, sign and date the form, and give a copy of the inventory to EHS personnel.

It is important to ensure that the total amount of toxin per PI is maintained below these limits at all times in order to remain exempt from registration with the CDC and the attendant restrictive requirements. Due to the severe penalties associated with non-compliance with the Select Agent Rules, it is imperative that each laboratory using and storing toxins maintains current inventory information for these substances. Failure to register non-exempt Select Agent toxin use is now a criminal offense, punishable by up to five years in prison and/or $500,000 in fines.

Exempt quantities of Select Agent Toxins can be transferred only after providing due diligence that the receiver has a legitimate need (reasonably justified by a prophylactic, protective, bona fide research or other peaceful purpose) to handle or use the toxin(s). The transferor must document that the receiver does have a legitimate need to possess the toxin(s) and this documentation is retained by the transferor; an exempt quantity transfer form has been developed by Biosafety staff for this purpose.