Select Agent Program
The Biosafety Compliance Office provides oversight for the University of Hawaii Select Agent Program. Select Agent Regulations (42 CFR Part 72, 6 CFR Part 331, 9 CFR Part 221) and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 require all persons who have access to, possession or use select agents or toxins to be registered with the Select Agent Program (USDA/APHIS or CDC).
To determine if the agents or toxins you intend to conduct research activities with are regulated by the select agent program, review the list of select agents and toxins at this link;
Research activity involving any of the following will also require Intergovernmental Select Agents and Toxins Technical Advisory Committee (ISATAC) approval (42CFR 73.13);
- Experiments with rDNA involving the deliberate transfer of a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine or agriculture.
- Experiments involving the deliberate formation of rDNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD50 <100ng/kg body weight.