The use, possession, or transfer of a biological material listed as a Select Agent and/or Select Agent Toxin, and not listed as an exempt strain or quantity requires registration through the Federal Select Agent program. Researchers must notify EHS (Responsible Official) before working with Select Agent or Toxins. The University will initiate a Laboratory Registration for Select Agents and Toxins with the National Select Agent Registry. Laboratory registrations for Select Agents and Toxins will be maintained by the Responsible Official (RO) in the Office of Environmental Health and Safety (EHS).
Per the federal regulations, each principal investigator (PI) may possess up to a specified amount of Select Agent Toxin and not be required to register with the CDC or USDA. 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 maintains current inventory information for these substances.
Requirements for the possession of exempt quantities of Select Agent Toxins
- Research using Select Agent Toxins must be registered with the IBC
- Researchers that work with exempt quantities of select toxins must complete an annual self-evaluation.
- Working with Select Agent Toxin (Exempt Quantities) SOP
Failure to register a Select Agent toxin is a criminal offense, punishable by up to five years in prison and/or $500,000 in fines (Public Health Security & Preparedness Response Act of 2002).
Dual use research of concern (DURC) is a subset of dual use research defined as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (IODURC) outlines the criteria for what qualifies as Dual Use Research of Concern (DURC), listing specific agents and toxins and descriptions of types of experiments, when combined define the parameters for research considered as DURC and subject to oversight under the policy.
It is the responsibility of the Principal Investigator to identify his or her research involving one or more of the agents or toxins listed in IODURC Section 6.2.1 and notify the IBC of that research to be reviewed for its DURC potential.