FAQs

What is biosafety?

Biosafety is the application of knowledge, techniques and equipment to prevent personal, laboratory and environmental exposure to potentially infectious agents or biohazards. It applies to the protection of human, animal and plant health.

Biosafety defines the containment conditions under which infectious agents can be safely manipulated. Two critical principles in biosafety are risk assessment and containment.

How is risk in biosafety facilities minimized?

There are four primary biosafety controls aimed at minimizing risks to researchers and staff, the community and the environment.

  • Engineering Controls including inward directional airflow, single-pass air systems (e.g., air is not re-circulated), biosafety cabinets, autoclaves, interlocked door systems, double-door entry, easily cleanable surfaces such as coved floors and epoxy-painted walls, and hands-free sinks.
  • Administrative controls including medical surveillance programs, training, vaccinations, occupational health programs, and personnel background checks.
  • Personal Protective Equipment (PPE) including gloves, respirators, eye and ear protection, booties, and protective clothing.
  • Work Practices (Standard Operating Procedures (SOPs) including emergency evacuation protocols, waste management, entry and exit protocols, and establishing procedures that reduce the likelihood of generating an aerosol.

The four controls of biosafety work together to provide for the containment of biohazard agents.

What are risk groups?

Infectious agents are categorized in risk groups (RG) based on their relative risk.

  • RG1: Not associated with disease in healthy human adults or animals. No or low individual risk. No or low individual or community risk. An example of an RG1 pathogen is Lactobacillus bulgaricus (used in the production of yogurt).
  • RG2: Associated with human or animal disease that is rarely serious, and, for which, preventive or therapeutic interventions are often available. Moderate individual risk. Low community risk. Example: Salmonella.
  • RG3: Associated with serious or lethal human or animal disease for which preventive or therapeutic interventions may be available. Many RG3 agents do not ordinarily spread from one infected individual to another. High individual risk. Low community risk. Example: Mycobacterium tuberculosis.
  • RG4: Associated with serious or lethal disease in humans or animals for which preventive or therapeutic interventions are not usually available. Many RG4 pathogens can readily spread from one infected individual to another. High individual risk. High community risk. Example: Ebola virua. RG4 work is not conducted at UGA.

How are risk groups for a biological agent determined?

Generally speaking, they are determined by
• Pathogenicity of the organism
• Mode of transmission and host range
• Availability of effective preventive measures (e.g., vaccines)
• Availability of effective treatments (e.g., antibiotics)

What is a “biosafety level?”

Biosafety levels describe the level of biosafety precautions necessary to contain infectious agents. Like risk groups (RGs), the levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). Biosafety controls – work practices, equipment, and facilities – increase as the scale of risk increases.

The essential elements of the four biosafety levels and the type of work associated with them are described below.

  • BSL-1:
    • Laboratory has doors for access control and a sink for handwashing; surfaces are easy to clean; windows are screened (much like a kitchen).

Appropriate for work with microorganisms not known to consistently cause disease in healthy adult humans.

    • BSL-2: BSL-1 lab plus the door is self-closing and lockable for restricted access; the sink is located near the exit; there is access to an autoclave or other waste decontamination method; an eyewash station is present. All work that might create aerosols of infectious materials is done in a biosafety cabinet.

      Appropriate for agents associated with human disease resulting from percutaneous injury (cuts, needle sticks), ingestion, mucous membrane exposure.

       

    • BSL-3:BSL-2 lab plus the lab is separated or isolated from the main building traffic flow; double door entry is provided; inward directional airflow is provided with visual indicators; all work with viable agent is performed in a biosafety cabinet or other equipment designed to contain aerosols; sinks are hands-free or automatically operated; seams, floors, walls & ceilings are sealed to facilitate space decontamination; waste decontamination systems are available in the facility but preferred to be in the lab.

      Appropriate for agents with potential for aerosol transmission; disease may have serious or lethal consequences.

 

  • BSL-4:BSL-3 lab plus the lab is in a separate building or a clearly demarcated and isolated zone within a building; provides a chemical shower and personal shower for exiting; has a double door/pass through autoclave present in the lab; rooms are tightly sealed for no passage of air; doors for entry are interlocked so they can not be opened at the same time; liquids are decontaminated through engineered system; a multi-level facility with redundancies in engineering controls such as HVAC. When dealing with biological hazards at this level, PPE with a self-contained oxygen supply is mandatory. BSL-4 work is not conducted at UGA.

    Appropriate for dangerous/exotic agents that pose a high risk of life-threatening disease, aerosol-transmitted lab infections; or related agents with unknown risk of transmission, and for which there is no available vaccine or therapy.

Four biosafety levels are also established and defined for infectious disease work with vertebrate animals: Animal Biosafety Levels (ABSL) 1, 2, 3 and 4. These biosafety levels provide increasing levels of protection to personnel and the environment through combinations of biosafety controls.

A special biosafety level called BSL-3-Agriculture (or BSL 3-Ag) applies to a list of foreign animal disease agents designated “high consequence” by the USDA, meaning they can have a significant impact on our economy. BSL 3-Ag facilities are specially engineered for work with loose-housed animals infected with these pathogens, (e.g., the laboratory facility itself acts as a primary barrier to prevent release of infectious agents into the environment).

Biosafety levels also are defined for work with arthropods (e.g., mosquitoes and ticks) and genetically modified organisms (e.g., transgenic plants and animals). Biosafety levels applied to arthropods are Arthropod Containment Levels (ACL) 1, 2, 3, and 4.

What levels of biosafety laboratories operate at UGA?

The University of Georgia has BSL-1, BSL-2 and BSL-3 laboratories; ABSL-1, ABSL-2, ABSL-3 and BSL-3Ag (specially designed animal facilities); and ACL-1 and ACL-2 (insectaries). Transgenic plant and animal research is performed in BSL-1 laboratories.

BSL-3 and BSL-4 labs are often referred to as “high-containment laboratories” because they have the highest level of controls in place to minimize risk to researchers, the community and the environment. UGA does not have the facilities for BSL-4 research, and therefore does not conduct research at this level.

Has there ever been an accident in the United States involving the public at a BSL-3 or BSL-4 facility?

No. We cannot find a documented incident of a release in the U.S. that has caused illness or infection among the public. A number of BSL-3 and BSL-4 facilities have operated safely in the United States for 30 years. Needlestick injuries and other sharps related injuries, which expose workers to bloodborne pathogens, have caused exposures in laboratory staff. However, timely treatment of any person thought to have been exposed reduces the risk of danger to other workers or to the community.

What is the AHRC?

The Animal Health Research Center (AHRC) is a state-of-the art biomedical research facility where scientists can safely conduct basic and applied research on vaccines, diagnostics and treatments for a variety of infectious diseases that affect animal and human health. In addition, the AHRC serves as a learning environment for students and science professionals with interests in combating infectious diseases.

The AHRC houses BSL-2, BSL-3, ABSL-2, ABSL-3 and BSL-3Ag facilities. “ABSL” means the facility is specially designed for animals. “BSL-3Ag” means that large animals are used in research with high-consequence pathogens that can significantly impact our economy, thereby requiring more stringent engineering controls.

How are pathogens contained in the AHRC?

Multiple levels of safety and security have been incorporated into the design and construction of the AHRC to ensure that pathogens are contained and that the scientists handling the agents remain safe.

Engineering controls include single-pass air systems with HEPA-filtered exhausts and pass-through autoclaves.

Special work practices for some experiments include showering out of the lab before exiting, wearing dedicated facility scrubs instead of street clothes in the lab, and always loading and unloading centrifuge tubes in a biosafety cabinet when handling a RG3 pathogen.

Specialized equipment includes the use of Class IIA2 Biosafety Cabinets and air-tight, fully sealed tubes or rotors for centrifugation.

In BSL-3Ag facilities, the room itself provides the first line of containment for keeping the agent out of the community and environment. These rooms have inflatable gaskets on doors, double-exhaust HEPA filtration, HEPA-filtered supplied air, air-tight rooms that are pressure tested, and cook tanks to treat effluent and liquid waste from the room providing onsite waste management.

In BSL-3 and ABSL-3 laboratories, the equipment like the biosafety cabinet provides primary containment. Work and animals are kept inside HEPA-filtered equipment such as a biosafety cabinet. For these labs, the room provides a secondary level of containment.

In addition, for research involving certain high-consequence pathogens, personnel given access to high-containment spaces are first cleared through the FBI. The Office of Biosafety manages access to these labs. Strict access and inventory controls and video surveillance provide additional security layers.

What is studied in UGA high-containment facilities?

Examples of RG3 pathogens studied at UGA high-containment facilities include Mycobacterium tuberculosis, SARS Co-V, avian influenza virus, and Burkholderia species.

Who provides oversight for UGA high-containment facilities?

The Office of Biosafety manages the Athens campus Select Agent and Toxin program, coordinates the Institutional Biosafety Committee (IBC), and provides general oversight for UGA high-containment facilities. The Office of Biosafety reports to the Office of the Vice President for Research.

The Select Agent and Toxin program ensures that UGA is in compliance with Federal laws regulating use of high-consequence public health and agricultural agents.

The IBC reviews all projects involving recombinant DNA (rDNA) research (including transgenic plants and animals), human pathogens, select agents and toxins, animal disease pathogens that must be reported to the State, and plant pathogens not indigenous in the state of Georgia. PIs cannot begin their research until a protocol has been approved by the IBC. In addition, the AHRC User’s Committee decides which projects will be performed in the high-containment laboratories (BSL-3, ABSL-3 and BSL-3Ag laboratories) on the first floor.

Which governmental agencies have authority over UGA high-containment facilities?

What kind of training do personnel working in biocontainment facilities receive?

The researchers and support personnel working in such labs are the ones most at risk. Consequently, they are carefully trained and drilled on how to follow research protocols and safety procedures specific to the agents and research in their laboratories.

These include: How to enter and exit laboratories, how to work in a biosafety cabinet, how to dispose biohazardous agents including sharps (needles), how to ship infectious agents, how to don and doff personal protective equipment (PPE), how to clean up spills, and what to do in case of a fire, and medical or weather-related emergency.

The Office of Biosafety and laboratory personnel work closely with UGA Office of Security and Emergency Preparedness, UGA Police, Athens-Clarke County emergency responders, and public health officials and medical administrators to assure an emergency response plan is in place in the unlikely event of an accident. Drills are conducted with UGA and community emergency responders, researchers and facility operations staff at UGA high-containment facilities to test and validate procedures, plans, equipment and working relationships of all participants.

How are hazardous biological agents transported to or from our labs?

Risk group 3 agents that are transferred from one lab to the other on campus are properly packaged and contained in a sealed, unbreakable triple-packed container as approved by the Department of Transportation (DOT).

In accordance with DOT regulations, only personnel who have current Dangerous Goods shipping training may package and transport biohazardous materials on campus or off-campus. Shipments off campus are made only by DOT-approved carriers and must be cleared through the CDC, and/or USDA. Transfers of a select agent or toxin on campus are made only to CDC-registered locations for that specific agent or toxin and must be authorized by the Responsible Official (RO) or Alternate Responsible Official (ARO). Chain-of-custody is documented for all select agent or toxin transfers.

What happens if a researcher is exposed to an infectious agent?

The UGA Occupational Health and Safety (OHSP) Program works to provide a safe workplace for all personnel involved in research or instruction using animals or biohazardous agents. The Office of Animal Care and Use and the Office of Biosafety administer the OHSP with the assistance of Regional FirstCare’s Occupational Health Service.

Any researcher who is exposed or thinks he/she exposed to an infectious agent contacts the UGA occupational health physician for medical assistance. The PI or lab supervisor and the Office of Biosafety is notified to assist in the risk assessment for the incident. High-containment labs at UGA have agent-specific medical surveillance and response plans that are implemented in the event of an exposure or potential exposure. Personnel are trained on use of these plans.

If there is an incident, how is the public notified?

In the unlikely event that there is a risk to the community from an incident, institutional emergency response and notification plans provide for response teams and prompt communication within UGA and to local and regional governments and agencies.

The UGA Biosafety Community Liaision Committee (BCLC) is provided information on campus incidents involving high-containment labs when there is an incident that may affect the community. The committee is notified of all incidents, whether or not they may affect the community, at regularly scheduled meetings. The BCLC web site includes information about any incident that presents risk to the public.

The Office of Security and Emergency Preparedness (OSEP) provides campus-wide notifications, when necessary, through the UGA Alert system. UGA’s Media Relations Office provides information to the media and the public. The press center works closely with an Emergency Response Center manager to monitor and assess developments, and to prepare and distribute communications to employees, the public, and the news media. Employees are notified of actions they are to take via email, the UGA web site, and public media.

Why is this kind of research important to Georgia and the nation?

With the increasing pace of globalization, people and goods are traveling over greater distances in shorter periods of time. Frequently, pathogens and insect pests are hitchhikers on these journeys. The frequent mixing of hosts, pathogens, and vectors has resulted in the emergence of new diseases, and known diseases appearing in new places. These pathogens and pests threaten our animal- and plant-based agricultural systems, and ultimately human health, as well as damage local, regional and national economies. Research on disease-causing pathogens is necessary to develop preventive measures (e.g., vaccines), as well as treatments.

Who do I contact for more information?

Email bclc@uga.edu