2024 H5 Influenza Research Information for Researchers
Work with H5 and other High Path Avian Influenza (HPAI) at the University of Pittsburgh falls under both University and Federal guidelines. These guidelines require that work with or culturing of HPAI viruses must be performed in a BSL-3 facility. Both a USDA permit and CDC permit is required for importation of both the viruses, as well as materials known to contain the viruses. A USDA permit is also required for interstate transport of these materials. At present, these viruses are exempt from Select Agent Program registration for a period of 3 years. Any investigator wishing to initiate research using HPAI H5 viruses must contact EHS (safety@pitt.edu). Work with recombinant H5 HPAI as well as nucleic acids from these organisms must also be registered with the University IBC (ibc_support@pitt.edu).
The Biosafety Program provides guidance for those who work with biological agents to maintain a safe and healthy working environment. Oversight includes:
- Identification of biological materials being used
- Evaluation of the usage procedures
- Design of programs to eliminate exposure or contamination
- Review of program effectiveness
- Registration for use of biological agents and biohazardous materials
- Management of safety-engineered sharps devices
- Guidelines for biological waste disposal
For more info on the Biosafety Program refer to Section V - Biosafety of the University Safety Manual.
Select Agent Program
The U.S. Dept of Health and Human Services (DHHS)/Centers for Disease Control and Prevention (CDC) and U.S. Dept of Agriculture (USDA) have regulations for the possession, use, and transfer of select biological agents and toxins that could pose a threat to human, animal, and plant health and safety.
The regulations establish a registration process for facilities possessing select agents and toxins, safety- and physical-security compliance requirements, exemption criteria, and restrictions upon persons eligible to be granted access to a select agent or toxin in accordance with the USA PATRIOT Act.
A complete list of select agents and genetic elements regulated under the Federal Select Agent Program (PDF) is available.
EH&S coordinates the Select Agent Program for the University of Pittsburgh.
Investigators that possess, use, or transfer any Select Agent at Pitt must be registered with EH&S and possibly the Federal Select Agent Program. Registration is mandatory.
Violations of the Select Agent Regulations can result in Federal civil and criminal penalties, including imprisonment and/or fines.
Investigators working with Select Agent Toxins may be exempt from Federal registration based on the quantities in their possession. These investigators must still be registered with EH&S and comply with the following Guidelines for Working with Select Agent Toxins (PDF). Refer to the Guideline on the Select Agent Program for details on registration, acquiring, or destroying select agents.
For additional information about the Select Agent Program contact the University Biosafety Officer at 412-624-8919 or visit the Federal Select Agent Program Website.