Source: https://www.phe.gov/s3/BioriskManagement/biosafety/Pages/Biosafety-FAQ.aspx
Timestamp: 2019-10-21 15:16:56
Document Index: 58150436

Matched Legal Cases: ['§ 654', '§ 1910', 'art 73', 'art 121', 'art 331', '§ 71']

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Back to: S3: Science Safety Security > Biorisk Management > Biosafety > Biosafety FAQs
Biosafety Levels​
Biosafety Terms
What are biological hazards or biohazards?
Why is research on biohazards important?
How do we ensure that people, animals and the environment are protected from biohazards in the laboratory?
What is laboratory biosafety?
What are biosafety levels?
What is laboratory biocontainment?
What do the terms high and maximum containment mean?
Biological Risk, Assessment, and Management
What is biorisk?
What is a biological risk assessment?
What is laboratory biorisk management?
How do laboratory biosafety and biocontainment relate to biorisk management?​
What is meant by a culture of safety and responsibility in the laboratory?
What Federal Government entities are responsible for oversight of laboratory biosafety and biocontainment?
What Federal Government regulations and guidelines pertain to laboratory biosafety and biocontainment?
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:
vaccines, antibiotics, antivirals, and anti-toxins; and
equipment and products used in medical treatment (such as ventilators and personal protective equipment).
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.
How do we ensure that people, animals, and the environment are protected from biohazards in the laboratory?
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:
human and veterinary clinical and diagnostic laboratories;
biological research and production laboratories (academia, industry, government, etc);
environmental research and analytical laboratories; and
academic and teaching laboratories.
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:
personal protective equipment including masks, gloves, safety glasses, and lab coats;
hand washing; and
procedures for safe use of chemicals.
“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 nature of the infectious agent, toxin, or biological hazard, including:
Its ability to cause disease and the way in which it causes disease (transmissibility and pathogenicity);
How much of it is required to cause disease (infectious dose);
How many different organisms are susceptible to it (host range); and
It’s prevalence in the community (epidemiology);
The specific laboratory activity or activities being performed; and
The availability of preventive medical coun​termeasures (i.e. vaccines) or effective treatment (i.e., post-exposure vaccination and/or use of antimicrobials, antivirals and chemotherapeutic agents).​​
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.
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“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:
biosafety cabinets; and
sealed containers such as containment centrifuges and special animal caging systems.
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:
sealed rooms;
self-closing, lockable doors; and
specialized air handling and decontamination systems.
“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:
small animal facilities (or vivaria) that operate in Animal Biosafety Level-3 and -4 (ABSL-3 and ABSL-4) conditions;
large animal facilities that operate in Biosafety Level-3 agricultural (BSL-3-Ag) conditions; and
plant facilities that operate in Biosafety Level-3 and -4 Plant (BL3-P and BL4-P) conditions.
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:
accidental infection, toxic response, or allergic response;
accidental release to the community or environment; and
unauthorized access, theft, or misuse by an individual who intends to cause harm.
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:
the nature of the infectious microorganism or biological hazard, including:
the ability to cause disease and the way in which it causes disease (transmissibility and pathogenicity)
how much of it is required to cause disease (infectious dose)
how many different organisms are susceptible to it (host range)
it’s prevalence in the community (epidemiology)
the specific laboratory activity or activities being performed
the training of the laboratory worker
Factors that influence the consequence, or severity, of an exposure that causes harm include:
the dose of an agent the worker is exposed to
the availability of vaccines, antibiotics, antivirals, and anti-toxins
the potential for the disease to spread in the community or environment
the health of the laboratory worker
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:
Risk Group 1: organisms that are not associated with disease in healthy human adults.
Risk Group 2: organisms that may cause mild disease for which medical countermeasures are available.
Risk Group 3: organisms that may cause serious or deadly disease for which medical countermeasures may be available, and which have low potential to spread in the community or environment
Risk Group 4: organisms that will cause serious or deadly disease for which medical countermeasures are unlikely to be available, and which have high potential to spread in the community or environment
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:
developing biosafety, biocontainment, and biosecurity policies and procedures;
applying the policies and procedures to the laboratory or facility environment;
evaluating how well the policies work and are followed; and
improving the policies, as needed, to strengthen laboratory safety and security.
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.
How do laboratory biosafety and biocontainment relate to biorisk management?
Biosafety, biocontainment, and laboratory biosecurity are interrelated and necessary components of an effective laboratory biorisk management system.
The term “biosafety” refers to the use of specific practices, safety equipment, and specially designed buildings to ensure that workers, the community, and the environment are protected from accidental exposure or unintentional release of infectious agents, toxins, and other biological hazards.
The term “biocontainment” refers to the use of safety equipment and specially designed buildings to prevent the accidental release of infectious agents, toxins, and other biological hazards into the environment.
The term “laboratory biosecurity” refers to the use of specific practices and specially-designed buildings to protect infectious agents, toxins and other biological hazards from loss, theft, diversion, or intentional misuse (see Biosecurity FAQ​ for more information).
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:
comply with safety and security measures and procedures;
report biosafety or biosecurity concerns;
respond appropriately to incidents; and
communicate risks to each other and to managers in a timely and accurate manner.
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:
Department of Labor (DOL), Occupational Safety and Health Administration (OSHA)
Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC) and National Institute for Health (NIH)
U.S. Department of Agriculture, Animal and Plant Health Inspection Service (APHIS)
The Federal biosafety and biocontainment regulations most relevant to research and research related activities involving infectious agents, toxins, or other biological hazards are:
Occupational Safety and Health Administration (OSHA) General Duty Clause (15 USC § 654; Duties of employers and employees), Bloodborne Pathogens Standard (29 CFR § 1910.1030), and Personal Protective Equipment Standards
HHS and USDA Select Agent Regulations (42 CFR part 73, 9 CFR part 121, 7 CFR part 331)
USDA regulations that require permits for work with high-consequence animal and plant pathogens
HHS/CDC regulations that require a permit for the import of any infectious agent known or suspected to cause disease in humans (HHS/CDC Foreign Quarantine Regulations; 42 CFR § 71.54)
Federal guidelines pertaining to laboratory biosafety and biocontainment include:
NIH and CDC manual entitled Biosafety in Microbiological and Biomedical Laboratories (BMBL)
Office of Science Technology Policy, Department of Homeland Security and EPA “Planning Guidance for Recovery Following Biological Incidents”
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.
This page last reviewed: April 26, 2017