Regulations

USA’s policy and procedures are based on recommendations and requirements from government agencies. Below are links to the most pertinent materials.

Biosafety Regulations

• Biosafety in Microbiological and Biomedical Laboratories, 6^th edition (2020)
• Summary of Changes to the BMBL, 6^th edition (BMBL-6)
• Chemical and Biologicals Agents subject to Export Controls
• Importation Permits for Etiologic Agents (CDC)
• Interstate Shipment of Etiologic Agents ([42 CFR Part 72])
• NIH Awards Process involving Infectious Agents
• OSHA Bloodborne Pathogens (BBP)
• Primary Containment for Biohazards: Selection, Installation, and Use of Biological Safety Cabinets

Engineering Controls

National Institute for Occupational Safety and Health Sharps Disposal Containers

OHSA Needlestick Injuries

Select Agents

Public Health Security and Bioterrorism Preparedness Act of 2002-Public Law 107-877-July 12, 2002.

Many biological agents and toxins have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. There are sixty-eight (68) select toxins and agents regulated by the Federal Select Agent Program. 

Select Agents and Toxins List

The Federal Select Agent Program oversees the possession, use and transfer of select agents and toxins, which pose a threat to public, animal or plant health. The Program greatly enhances the nation’s oversight of the safety and security of select agents by:

• Developing, implementing, and enforcing the Select Agent Regulations
• Maintaining a national database
• Inspecting entities that possess, use, or transfer select agents
• Ensuring that all individuals who work with these agents undergo a security risk assessment performed by the Federal Bureau of Investigation/Criminal Justice Information Service
• Providing guidance to regulated entities on achieving compliance to the regulations through the development of guidance documents, conducting workshops and webinars
• Investigation of any incidents in which non-compliance may have occurred

Management of the Select Agents Program at the University of South Alabama is accomplished through the Department of Microbiology and Immunology.  If you will be performing research with select agents, you must first receive training.