The University of Iowa
Environmental Health and Safety

Select Agents and Toxins

The Select Agent and Toxin Use program outlines the registration procedures and responsibilities for individuals who work with select agents and select toxins (link to the list Select Agent and Toxins provided below). The University of Iowa and all individuals involved with select agent and select toxins are required to comply with the Federal 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 select toxin.

Please refer to the Select Agent and Toxin Use Manual for an overview of the regulations and registration procedures for University of Iowa faculty/staff.

Dual Use Research of Concern

In addition to the Federal Select Agent Program, the United States Government has placed additional regulatory requirements on researchers working with a subset of select 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 (linked below under “Documents”).

2025 Update:

A new policy and implementation guidance for research involving Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) was released by the Federal Government in May 2024. This new U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential will supersede the 2012 and 2014 DURC Policies and the 2017 HHS P3CO Framework, beginning on May 6, 2025.

The new policy is a unified federal oversight framework for the oversight of certain types of federally funded life sciences research involving biological agents and toxins. This policy addresses oversight of research on biological agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security, or national security.

Effective May 1, 2025, The University of Iowa will adopt the United States Government Policy for Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“USG DURC/PEPP Policy”) and follow the USG Implementation Guidance for identification, review, and oversight of life sciences research that is within Category 1 and Category 2 as defined by that policy. Additional details will be made available on the new UI DURC/PEPP web page (currently under construction) prior to the effective date. 

Permissible Toxin Amounts

In order to ensure each Principal Investigator (PI) who possesses exempt quantities of Select Toxins understands the maximum permissible 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.

Contact information and areas of expertise can be found on the Contact Us page.

Documents 

Training 

Toxins, Select Agent Quantity - W006BO

  • This course is required initially and recommended annually.
  • Audience: Principal investigators and lab personnel working with exempt quantities of select agent toxins, e.g., tetrodotoxin, conotoxin, botulinum toxin, etc.

For further training and registration information go to EHS Safety Training.

Resources 

External Links 

Biological