ENVIRONMENTAL HEALTH & SAFETY

Risk Groups and working at BSL-1, BSL-2, or BSL-3

Risk Groups

In many countries, including the United States, biological agents are categorized in Risk Groups (RG) based on their relative risk. Depending on the country or organization, this classification system might take the following factors into consideration:

• Pathogenicity of the organism
• Mode of transmission and host range
• Availability of effective preventive measures (e.g., vaccines)
• Availability of effective treatment (e.g., antibiotics)
• Other factors

It is important to understand that biological agents are classified in a graded fashion such that the level of hazard associated with RG1 being the lowest and RG4 being the highest. EHS Biosafety follows the NIH Guidelines categorization of Risk Groups as follows:

• RG1 – Are not associated with disease in healthy adult humans or animals
• RG2 – Are associated with disease which is rarely serious and for which preventative or therapeutics is often available
• RG3 – Are associated with serious or lethal human disease for which preventative or therapeutics may be available
• RG4 – Are associated with lethal human disease for which preventative or therapeutics are not readily available

Microorganisms and their associate RG designation commonly used at UVA can be found at the ABSA website.

Biosafety Levels

In contrast to Risk Groups, Biosafety Levels (BSL) prescribe procedures and levels of containment for the particular microorganism or material (including Research Involving Recombinant or Synthetic Nucleic Acid Molecules). Similar to Risk Groups, BSL are graded from 1 – 4. Detailed descriptions of containment practices and biosafety levels can be found in the CDC-NIH Guidelines Biosafety in Microbiological and Biomedical Laboratories (BMBL).

The majority of work at UVA involves Biosafety Level 2 (BSL-2) practices. BSL-2 containment and practice is suitable for work with agents that are infectious to humans or animals where exposure may result in limited to moderate disease. The routes of exposure to these agents are typically through cuts and breaks in the skin, ingestion, and splashes to the mucous membranes (eyes, nose, and mouth). These agents or materials include:

1. Microorganisms (e.g., RG2 or higher)
2. Human blood, blood components, fluids, unfixed organs, tissues and cell lines (primary and established)
3. Non-Human Primate Derived Materials (including established cell lines)
4. Biotoxins (with and LD 50 of less than 100 micrograms per kilogram of body weight in vertebrates) requiring BSL-2 containment
5. Research Involving Recombinant or Synthetic Nucleic Acid Molecules as described by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (see UVA's Recombinant or Synthetic Nucleic Acid Molecules page for more information).

Contact Paul Skoglund at ps5d@virginia.edu or 243-0726 for more information.

NOTE about Human Derived Materials (#2 above): Human or clinical materials needing IRB approval must be sought before IBC approval.

Working at Biosafety Level 1 (BSL-1)

Before beginning work at BSL-1 researchers must…

• Be listed on an approved IBC Inventory and Activity Registration (IAR) (log-in)
• Complete either:
• Bloodborne Pathogen and Biosafety Training for Research Personnel (log-in)
• OR
• Biosafety Level 1 Training (log-in)

Working at Biosafety Level 2 (BSL-2)

Before beginning work at BSL-2 researchers must…

• Be listed on an approved IBC Inventory and Activity Registration (IAR) (log-in)
• Complete Bloodborne Pathogen and Biosafety Training for Research Personnel (log-in)
• Read and sign the BSL-2 Biosafety Manual
• May need to enroll in the Medical Surveillance Program and complete medical clearance (e.g., vaccination, respiratory clearance, etc.)*

For assistance, refer to the Checklist for New BSL-2 Personnel.

*Medical clearance is only necessary for work with agents that the IBC deems "high risk". The list can be found by contacting EHS Biosafety.

Biosafety Level 2 - Laboratory Training Requirements

All personnel must receive training on Biosafety Level 2 (BSL-2) laboratory practices prior to working in a BSL-2 laboratory. Principal Investigators (PIs) are responsible for adhering to the following:

1. The PI or supervisor must explain the nature of the risks associated with the agent(s) that are used in the lab, the possible routes of exposures, demonstrate the special handling, personal protective equipment (PPE), and decontamination practices that are used in the lab.
2. All personnel must:
   • read and sign the lab manual, and have the opportunity to ask questions.
   • complete the online training course Bloodborne Pathogens and Biosafety Training for Research Personnel (log-in). Please note that this training is distinct from hospital training courses and annual update training for Bloodborne pathogens.
3. Personnel who may be exposed to Human Derived Materials must complete annual update training for bloodborne pathogens. Automated email reminders are distributed to affected individuals approximately one month prior to training expiration.
4. Visitors and temporary personnel (i.e. 3 months or less) must also complete the online training course Bloodborne Pathogens and Biosafety Training for Research Personnel (log-in). In general, temporary personnel do not need to be added to the IBC registration document; however, temporary personnel who will conduct BSL-2 experiments involving animals must be added to the IBC registration.

Note: Completing the above steps does not entitle personnel to work with BSL-2 agents. It is the PI or supervisor’s responsibility to assess an individual’s readiness to work with BSL-2 agents, and also to directly demonstrate and train new personnel in the specific techniques and practices that are used in their lab.

Working at Biosafety Level 3 (BSL-3)

Work with agents or materials at Biosafety Level 3 (BSL-3) requires additional registration and approvals set forth by federal regulations, CDC/NIH guidelines, and University policy. Medical Surveillance and additional training is required. Please contact EHS Biosafety for more information. Biosafety Level 4 (BSL-4) experiments are not permitted at the University of Virginia.

Due to the overlap of Select Agent Regulations and many BSL-3 (Risk Group 3 agents) activities, you must contact EHS Biosafety before acquiring and/or working with agents at BSL-3.

Before initial BSL-3 work, seek IBC approval prior to:

• Acquiring BSL-3 agents or work
• Initiating experiments with a new infectious agent

For ongoing BSL-3 work seek IBC approval:

• Before changing the scope or location of your existing experiments
• When adding new personnel to your IAR
• Before providing BSL-3 agents to another investigator within or outside UVA
• Before arranging for visiting researchers to work in your BSL-3 laboratory