For Assistance with Select Agent and Toxin consultation and registration –
- Haley Sinn, Biosafety Officer/Responsible Official, 335-9553
- Nyree Mortensen, Assoc. Biosafety Officer/Alternate Responsible Official, 353-5679
The Select Agent and Toxin Use program outlines the registration procedures and responsibilities for individuals who work with select agents and toxins (list of Select Agent and Toxins). The University of Iowa and all individuals involved with select agent and toxins are required to comply with the Select Agent Program established by the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS). Compliance is required under Federal Law; non-compliance can result in substantial penalties for both an individual and the University. All individuals must register with the University and possibly the Federal government prior to possessing any select agent or toxin.
Please refer to the Select Agent and Toxin Use Manual for an overview of the regulations and registration procedures for U of IA faculty/staff.
In addition to the Select Agent Program, the United States Government has placed additional regulatory requirements on researchers working with a select 15 of these agents. Should a PI’s research with such agents produce, aim to produce, or can be reasonably anticipated to produce one or more of the effects listed in seven categories of experiments, the research must be evaluated for Dual Use Research of Concern (DURC). A list of the 15 agents and seven experimental categories along with additional information can be found in the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” (US Government Policy). As required by the US Government Policy, the University has developed an Institutional Policy and Program for Oversight of DURC.
In order to ensure each Principal Investigator (PI) who possesses exempt quantities of CDC Select Agent Toxins understands the allowable maximum exempt quantities s/he can possess, as specified by the federal regulations on Select Agents (42 CFR Part 73), all PIs are asked to sign a declaration form. Please refer to the UI Requirements for Possession of Exempt Quantities for more information.
PIs wishing to dispose of exempt quantities of toxins can refer to the Toxin Inactivation Information document.