Biosafety for Researchers: Requirements

Risk Assessment and Registration

• Prior to beginning research with any biohazardous material, the Principal Investigator must assess the risk for handling the material taking into account, among other items, characteristics of the material, how it will be handled, quantities or concentrations desired, severity of its effects if exposed, and availability of prevention or treatment measures.
• Submission of a completed Biohazard Risk Assessment and Registration (doc) (BRAR) to the University Biosafety Officer for review and approval is required for:
  • all Risk Group 2 (ABSL2/BSL2) and Risk Group 3 (ABSL3/BSL3) agents;
  • toxins of biological origin;
  • human, non-human primate, and mammalian blood, blood products, cells, and unfixed tissue;
  • animal/plant pathogens and products, specific genetically engineered organisms and veterinary biologics; and
  • select agents and toxins.
• Approval of the BRAR serves to register that lab with the university for ABSL1/ACL1/BSL1, ABSL2/ACL2/BSL2, or ABSL3/ACL3/BSL3 research.
• Other approvals may be required from other safety committees if the research will also involve vertebrate animals, recombinant DNA/RNA, use of radiation or radioactive materials, or human subjects.

Facility/Research-Specific Safety Manual (Laboratory Practice and Technique)

• The Principal Investigator is responsible for ensuring that facility- and research-specific policies and procedures are developed to meet the BSL, ABSL, or ACL requirements determined from the risk assessment.
• The main objective of the manual is to communicate policies and procedures that will be utilized to mimimize or eliminate exposure of research personnel, other persons, and the outside environment to potentially hazardous materials.
• It is through a combination of facility design, safety equipment, engineering controls, personal protective equipment, and laboratory practice and technique that containment is achieved. There is no single, specific way to achieve containment and all contributing factors must be reviewed before the proper combination of containment strategies can be determined.
• Specfic policies and procedures must be incorporated into the manual for other hazards in the lab as well (e.g., chemical, radiological).
• All lab personnel with the potential for exposure for that particular facility or research project (e.g., lab personnel, animal care staff) must be familiar with the manual's location and its contents.
• Standard/special lab practices that must be included for BSL1, BSL2, and BSL3 facilities

Safety Equipment (Primary Barriers and Personal Protective Equipment)

• Biological Safety Cabinets (BSCs)
  • A Class II (the most commonly used) or Class III biosafety cabinet must be used for all manipulations of potentially infectious materials, whenever practical to minimize the risk of exposure to aerosols.
  • Biosafety cabinets must be certified at least annually, at installation, after any repair, or if moved over an extended distance.
  • Biosafety cabinets require internal and work surface decontamination prior to moving, maintenance, or disposal if used for Risk Group 2 or Risk Group 3 agents. Work surface decontamination with an appropriate disinfectant may be performed by lab personnel. Internal decontamination (via paraformadehyde gas or equivalent) must be arranged by EHSS.
  • Biosafety cabinets must be located away from doors, areas of high traffic, air supply registers, or other equipment that may create air movement.
  • Only minute quantities of volatile or toxic chemicals or radionuclides used as an adjunct to the research may be used in a biosafety cabinet. Small quantities of these materials may be used if the cabinet is exhausted to the outside.
  • The biosafety cabinet is the principal device used to contain infectious materials generated by many microbiological procedures. Its proper use is key to ensuring infectious aerosols are contained at the source.
    • Primary Containment of Biohazards: Selection, Installation, and Use of Biological Safety Cabinets (pdf)
    • ABSA Position Paper on Use of UV Light in Biosafety Cabinets (pdf)
• Physical Containment Devices
  • If it is impractical to work in a BSC, other physical containment devices must be used whenever possible to minimize the potential for exposure to biohazardous materials. For example, centrifuges must be used with safety buckets or sealed rotors with sealed centrifuge tubes.

Facility Design (Secondary Barriers)

• Each lab or animal room must meet the facility design requirements for the applicable biosafety or animal biosafety level as listed in:
  • Laboratory Biosafety Level Criteria (pdf) (BSL1, BSL2, and BSL3)
  • Vertebrate Animal Biosafety Level Criteria (pdf) (ABSL1, ABSL2, and ABSL3)
  • Arthropod Containment Guidelines (pdf) (ACL1, ACL2, and ACL3)

Program Evaluation

• EHSS will evaluate all Virginia Tech operated labs and animal research areas based on the risk of the agent/toxin used and the activities involved to ensure compliance with local, state, and federal regulations/guidelines. This will include a review of:
  • the lab, animal room, or arthropod facility and how its managed and maintained;
  • safety equipment;
  • PPE use and maintenance; and
  • facility-specific safety manuals and other appropriate records (e.g., training).
• Interviews of personnel will be conducted during evaluations to ensure personnel are aware of proper laboratory and emergency protocols and the hazards of the agents to which they may be exposed.
• In addition to EHSS evaluations, each Principal Investigator and Animal Facility Director must routinely inspect their own lab(s) or animal room(s) for deficiencies.