Biohazards include biological agents and toxins infectious to humans, animals, wildlife, or plants such as parasites, viruses, bacteria, fungi, prions; and biologically-active materials such as toxins, allergens, and venoms. In addition to causing disease in living organisms, biohazards can cause significant damage to the environment.
The Federal Government conducts, supports, and recognizes the importance of basic research to better understand infectious agents and toxins that cause diseases of public health and agricultural concern. This research provides the foundation for developing medical products and strategies to diagnose, treat, and prevent a wide range of diseases, whether those diseases emerge naturally or are deliberately introduced into a population through an act of bioterrorism. Medical products developed to prevent or treat human, animal, and plant health disease are called countermeasures. They include:
In order to continue medical countermeasure development, a nationwide system must be maintained to support biological research and the development of diagnostics, therapeutics, and vaccines. Important components of this nationwide system are research and clinical laboratories, where trained scientists and health-care professionals can safely work with infectious agents and toxins and other hazardous biological materials.
The U.S. Government agency responsible for the development of medical countermeasures is the Biomedical Advanced Research and Development Authority (BARDA), located within the HHS Office of the Assistant Secretary for Preparedness and Response. For more information, visit the BARDA website. Research at the National Institutes of Health and other laboratories also supports the development of knowledge and methods for the development of novel treatments and diagnostic tools.
People, animals, and the environment are protected from biohazards in the laboratory through the use of specific practices, training for laboratory staff, safety equipment, and specially designed buildings. The discipline which ensures that people, animals, and the environment are protected from biohazards in the laboratory is called laboratory biosafety.
Biosafety is a framework that describes the use of specific practices, training, safety equipment, and specially designed buildings to protect the worker, community, and environment from an accidental exposure or unintentional release of infectious agents and toxins. A biosafety program implements actions to identify biological hazards, evaluate the level of health-related risks the biological hazard presents to humans, agriculture (such as livestock and crops), wildlife, and the environment, and identify ways to reduce the health-related risks associated with the biological hazard. Biosafety is used in many laboratory settings including:
The use of biosafety practices and principles to reduce the health-related risks associated with handling infectious agents, toxins and other biological hazards is important in a laboratory setting. Examples of such measures include:
“Laboratory biosafety” describes the use of biosafety principles and practices in laboratories to reduce the health-related risks associated with handling infectious agents, toxins and other biological hazards arising from an accidental exposure or unintentional release. The types of laboratories using biosafety principles and practices include clinical and diagnostic, research, teaching and medical countermeasure production laboratories working with infectious microorganisms and other biological hazards affecting the health of humans, animals, and plants.
“Biosafety Levels” (BSLs) are designations applied to projects or activities conducted in laboratories in ascending order of containment based on the severity of the health-related risk associated with the work being conducted. In the United States, the designations BSL-1, BSL-2, BSL-3, and BSL-4 describe the minimum safe work practices, specially designed buildings, and safety equipment required to conduct work on infectious agents, toxins, and other biological hazards. BSL-4 is the highest biosafety level.
The appropriate BSL to be assigned to a project is determined by institutional biosafety committees (IBCs) or professionals, and reflects the specific combinations of specially designed buildings, safety equipment and safe work practices that laboratory workers must use. The BSL assigned to a project is based on a biological risk assessment that takes into account:
The “BSL” terms for laboratory work with infectious agents, toxins, or other biological hazards affecting plants are BL1-P, BL2-P, BL3-P, and BL4-P and are in ascending order of containment based on the degree of the health-related risk associated with the work being conducted.
The “BSL” terms for laboratory work with infectious agents, toxins, or other biological hazards affecting animals are ABSL-1, ABSL-2, ABSL-3, BSL3-Ag, and ABSL-4, and are in ascending order of containment based on the degree of the health or environmental-related risk associated with the work being conducted.
“Laboratory biocontainment” refers to the use of safety equipment and specially designed rooms and buildings which act as primary barriers to prevent the release of infectious agents, toxins, and other biological hazards into the environment.
Examples of primary biocontainment barriers include, but are not limited to:
Secondary biocontainment barriers include specially designed and constructed rooms and buildings. These buildings include several engineering features to keep, or “contain”, infectious agents, toxins, and biological hazards inside the laboratory workspace. These engineering features include, but are not limited to:
“High containment” is a term used to describe laboratories or facilities that operate at Biosafety Level 3 (BSL-3) conditions. “Maximum containment” is a term used to describe laboratories or facilities that operate at BSL-4 conditions. Some documents use the term “high containment” to refer to both BSL-3 and BSL-4 facilities.
Equivalent high and maximum containment facilities for animal and plant research also exist. They are:
The research activities that take place in high and maximum containment facilities include studies of high-risk infectious agents and toxins that can cause significant harm to humans, animals, or plants and can be transmitted by aerosol. Infectious agents or toxins studied in BSL-3 conditions may cause serious or fatal disease through inhalation exposure for which medical countermeasures may be available (e.g., bacteria that cause anthrax, plague, and tularemia). Infectious agents and toxins studied in BSL-4 conditions pose a high risk of aerosol-transmitted laboratory infections and life-threatening disease for which no vaccine or therapy is available (e.g., viruses that cause Ebola disease and smallpox).
All biocontainment designations are based on the degree of the health-related risk associated with the work being conducted.
Take a virtual tour of a BSL-4 facility at the NIAID Rocky Mountain Laboratories in Hamilton, Montana. To take the tour, click on “Take a tour of a BSL-4 lab at RML” under the “Stay Informed” heading.
“Biorisk” is a combination of the likelihood of an exposure to an infectious agent, toxin, or biological hazard that will cause harm, and the consequence, or severity, of that harm if exposure does occur. The higher the combination of likelihood and consequence of a harmful event resulting from exposure, the greater the risk will be. Biorisk can include risks from:
A biological risk assessment is a process that evaluates multiple factors to determine the risk to laboratory workers, the community, or the environment of working with an infectious agent, toxin, or other biological hazard. The biological risk assessment is used to determine the appropriate biosafety level for each project conducted within a laboratory. Factors that influence the likelihood of an exposure that causes harm include:
Factors that influence the consequence, or severity, of an exposure that causes harm include:
Understanding the nature of the infectious agent, toxin, or biological hazard and the way in which the infectious agent, toxin, or biological hazard causes disease is the first step in conducting a biological risk assessment. In the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the NIH has categorized several infectious microorganisms into “risk groups.” Risk groups are classifications of infectious agents and toxins that identify the relative likelihood and severity of disease an infectious agent or toxin can cause. There are four risk groups, in ascending order of severity:
Since an evaluation of any one factor in isolation will not give laboratory workers an adequate understanding of the risks associated with a given activity and infectious agent or toxin, the factors described above are examined together to determine the health-related risks associated with each individual project. A biological risk assessment is the most important process used to determine the appropriate biosafety level for each project conducted within a laboratory.
“Laboratory biorisk management” is a management system framework that describes a set of administrative practices that an institution can use to identify, monitor, and control the laboratory biosafety, biocontainment, and biosecurity aspects of its operation to create a safe and secure laboratory environment. Laboratory biorisk management is a useful tool to identify and implement appropriate laboratory safety and security measures. The laboratory biorisk management process includes:
This framework is frequently referred to as a “Plan, Do, Check, Act” (PDCA) process and is supported by many laboratory biosafety and biosecurity programs. The PDCA process strives to improve an organization’s laboratory biorisk management system through continuous evaluation.
Biosafety, biocontainment, and laboratory biosecurity are interrelated and necessary components of an effective laboratory biorisk management system.
Good biosafety and biocontainment practices contribute to effective laboratory biosecurity, and the disciplines of biosafety, biocontainment, and laboratory biosecurity are complementary in many aspects. Implementation of all three concepts is necessary to protect researchers, laboratory workers, the public, and the environment from biological hazards.
A culture of safety and responsibility in the laboratory helps ensure safe and responsible behaviors and practices. Individual and organizational attitudes about safety and responsibility will influence all aspects of laboratory conduct, including whether individuals will:
Every organization should strive to develop a culture of safety and responsibility that promotes transparent communication without fear of reprisal, encourages questions, and welcomes evaluation of its institutional practices. Laboratory workers should commit to supporting a culture of safety and responsibility, be aware of the risks associated with access to infectious agents and toxins, act in ways that strengthen safety and security, and engage in self-reflection to improve behaviors when needed. Laboratory workers understand that laboratory methods are often refined after observations are made, hypotheses are tested, findings are published, and technical progress is achieved. In the same way, as laboratory workers gain more knowledge about how to recognize and control risks associated with infectious agents, toxins, and other biological hazards, their safety and security practices should result in decreased risk, with the goal of constant improvement to reduce risk to the lowest possible level.
Laboratory workers have the responsibility to report their concerns to their managers and the right to express their concerns without fear of reprisal. Similarly, managers have the responsibility to address the concerns that are raised. Both laboratory workers and managers must work to maintain the highest standard of safety and responsibility.
The Federal entities that have primary regulatory oversight responsibility for organizations that possess, use, or transfer infectious agents, toxins, or other biological hazards are:
The Federal biosafety and biocontainment regulations most relevant to research and research related activities involving infectious agents, toxins, or other biological hazards are:
Federal guidelines pertaining to laboratory biosafety and biocontainment include:
For more than two decades, the BMBL and the NIH Guidelines have been the codes of practice for biosafety and biocontainment in the United States. Federal guidelines pertaining to plants and plant pests containing recombinant DNA-modified agents or toxins are described in Appendix P of the NIH Guidelines. These documents are amended and revised to reflect advances in science and technology.