Biosafety

Woman wearing safety glasses

2024 H5 Influenza Research Information for Researchers

Work with H5 and other Highly Pathogenic 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 a CDC permit are required for the importation of both the viruses, as well as materials known to contain the viruses. A USDA permit is also required for the interstate transport of these materials. At present, these viruses are exempt from Select Agent Program registration for a period of approximately 1.5 years. Any investigator wishing to initiate research using any HPAI viruses, including H5 viruses, must contact the Biorisk Management Division (biosafe@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).

Biosafety Program

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 additional information on laboratory safety, refer to 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.

The Biorisk Management Division (BRM) 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 BRM 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 BRM 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 Biorisk Management Division at 412-624-1300 or visit the Federal Select Agent Program website.

University Biosafety Committees

Guidelines

Anthrax SOP (EHS 05-022)
Biohazardous Spill Cleanup (EHS 05-017)
Biological Safety Cabinets (EHS 05-004)
Biosafety Guidelines and Biosafety Levels (EHS 05 003)
Bloodborne Pathogens Exposure Control Plan (EHS 05 001)
Hantavirus Guidelines (BRM 033)
HPAI Guidelines (EHS 05-024)
Infectious and Biohazardous Waste Disposal (EHS 05-006)
Japanese Encephalitis SOP (EHS 05-021)
Lentivirus (EHS 05-016)
Measles Protection (EHS 05-012)
Microbiology Lab Guidelines (EHS 05-027)
Neisseria Meningitidis SOP (EHS 05-019)
Novel Coronaviruses (EHS 05-026)
Occupational Health Program for BSL-3 Workers (EHS 05-023)
Rabies (EHS 05-014)
Reporting Exposure to Potentially Infectious Material (EHS 05-005)
Research Registration for Animal and rDNA Protocols (EHS 05-009)
Responsibility and Resources for Biosafety (EHS 05 002)
Safety Engineered Sharps Device Initiative (EHS 05-008)
Select Agent Program (EHS 05-010)
Serum Surveillance Program (EHS 05-011)
Sharps Disposal Guidelines (EHS 05-007)
Tuberculosis Surveillance Program (BRM 013)
Using Tools/Equipment in BSL-3 Areas (EHS 05-018)
Vaccinia Virus (EHS 05-015)
Visitors to Animal Research Facilities (EHS 05-025)
Yellow Fever Virus SOP (EHS 05-020)