Frequently Asked Questions

S3: Science Safety Security

Biorisk Management

Definitions and Purpose

What are biological hazards or biohazards?

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.

Why is research on biohazards important?

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:

diagnostic tools;
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 Administration for Strategic 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.

What is 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:

biosafety cabinets;
personal protective equipment including masks, gloves, safety glasses, and lab coats;
hand washing; and
procedures for safe use of chemicals.

What is laboratory biosafety?

“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.

What are biosafety levels?

“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 countermeasures (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.

Biocontainment

What is laboratory biocontainment?

“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.

What do the terms high and maximum containment mean?

“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.

Biological Risk, Assessment, and Management

What is biorisk?

“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.

What is a biological risk assessment?

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 ability to cause disease and the way in which it causes disease (transmissibility and pathogenicity)
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.

What is laboratory biorisk management?

“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.

Oversight

What is meant by a culture of safety and responsibility in the laboratory?

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.

What Federal Government entities are responsible for oversight of laboratory biosafety and biocontainment?

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)
U.S. Department of Transportation (DOT)
U.S. Department of Commerce (DOC)

What Federal Government regulations and guidelines pertain to laboratory biosafety and biocontainment?

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)
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
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.

Biosecurity

What is laboratory biosecurity?

Laboratory biosecurity refers to the protection, control of, and accountability for high-consequence biological agents and toxins, and critical relevant biological materials and information within laboratories to prevent unauthorized possession, loss, theft, misuse, diversion, and accidental or intentional release. Please see the Executive Order 13486 Working Group on Strengthening the Biosecurity of the United States for more information.

Biosecurity has many definitions in literature and guidance documents. The use of the term “laboratory biosecurity” on this website refers to the definition above and aligns with the definition adopted by the World Health Organization and the American Biological Safety Association. The use of the term laboratory biosecurity on this website does not refer to the practice of agricultural biosecurity, or the prevention of entry of a pathogen or pest into a susceptible population of plants or animals, or other expanded definitions of biosecurity.

What is biosafety?

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.

biosafety cabinets;
personal protective equipment including masks, gloves, safety glasses, and lab coats;
hand washing; and
procedures for safe use of chemicals.

What is the relationship between laboratory biosecurity and biosafety?

The fifth edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL) describes biosafety and biosecurity as “... related, but not identical, concepts. Biosafety programs reduce or eliminate exposure of individuals, the environment, and experimental materials to potentially hazardous infectious agents and toxins. Biosafety is achieved by implementing various degrees of laboratory control and containment, through laboratory design and access restrictions, personnel expertise and training, use of containment equipment, and safe methods of managing infectious materials in a laboratory setting.”

The BMBL describes biosecurity as it applies to work with biological hazards that affect human and animal health: “The objective of biosecurity is to prevent loss, theft, or misuse of microorganisms, biological materials, and research-related information. This is accomplished by limiting access to facilities, research materials and information. While the objectives are different, biosafety and biosecurity measures are usually complementary.”

What are Select Agents?

Select agents are Federally-regulated biological agents and toxins (BSAT) that have the potential to pose a severe threat to public, animal, or plant health, or to animal or plant products and whose possession, use, and transfer are regulated by the Select Agent Regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73). The DNA sequences of some infectious agents and toxin producing genes on the Select Agent List are also covered by the regulations. Please see the Federal Select Agent Program’s page on nucleic acids for more information on which sequences are covered.

The Centers for Disease Control and Prevention (CDC) within HHS regulate the possession, use, and transfer of BSAT that have the potential to pose a severe threat to public health and safety. The US Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS) regulates the possession, use, and transfer of BSAT that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. BSAT that are regulated by both HHS/CDC and USDA/APHIS are referred to as "overlap" BSAT. A list of BSAT can be found on the Select Agents website.

What is the Federal Select Agent Program?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Agricultural Bioterrorism Protection Act of 2002 require entities (which may be institutions, laboratories, or companies) to register with HHS or USDA if they possess, use, or transfer BSAT that could pose a severe threat to public health and safety; to animal or plant health; or animal or plant products. These Acts also require increased safeguards and security measures for these agents and toxins, including controlling access, screening entities and personnel (e.g., security risk assessments), and establishing a comprehensive and detailed national database of registered entities. The Acts also impose criminal and civil penalties for the unlawful possession, use, and transfer of BSAT. Additional information can be found on the Federal Select Agent Program website.

What is personnel reliability/suitability?

Personnel Reliability/Suitability involves a process to determine if laboratory staff are reliable, loyal, trustworthy, honest, free from emotional or mental instability, possess sound judgment, be free of conflicting allegiances and potential for coercion, and possess a willingness to abide by safety regulations. The Federal Select Agent Program provides additional personnel suitability assessment questions and answers and guidance on the Select Agent website.

What is physical security?

Physical security encompasses the application of operational and security equipment, personnel and procedures used to protect facilities, and information, documents or material for preventing or responding to theft, sabotage, diversion, or other terrorist or criminal acts. CDC developed guidance documents on physical security for Select Agent laboratories.

What is information security?

Information security, which includes cybersecurity or data security, aims to protect information from unauthorized release and ensure that the appropriate level of confidentiality is preserved. Information may include experimental data, laboratory blue prints, lists of agents in the facility, and many other types of information. It is critical to the security of laboratory equipment and materials, personal employee information, and physical security measures. Information, like physical property, is considered to be critical infrastructure and must be properly protected and secured because of its value to institutions and its potential for misuse.

What is a Security Risk Assessment (SRA)?

An SRA is the electronic records check performed by the Federal Bureau of Investigation (FBI) Criminal Justice Information Services Division (CJIS) to determine whether an entity or an individual who wishes to register with the Federal Select Agent Program to possess, use, or transfer a BSAT, or an individual who has been identified by a registered entity as having a legitimate need to access a BSAT meets one of the statutory restrictors which would either prohibit registration or restrict access, respectively.

The results of an SRA will assist the Federal Select Agent Program in its determination that the entity may possess, use, or transfer BSAT; or that an individual may have access to BSAT. The Federal Select Agent Program lists additional detailed SRA questions and answers on the Select Agent website.

What is Dual Use Research of Concern (DURC)?

Dual use research of concern (DURC), is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security. The U.S. Government has released multiple policies for oversight of specific types of DURC research.

What is the National Science Advisory Board on Biosecurity?

The National Science Advisory Board on Biosecurity (NSABB) is a Federal advisory committee chartered to provide advice, guidance, and leadership regarding biosecurity oversight of dual use research to all Federal departments and agencies with an interest in life sciences research. The NSABB advises on and recommends specific strategies for the efficient and effective oversight of federally conducted or supported dual use biological research, taking into consideration national security concerns and the needs of the research community. The NSABB is a critical component of a set of federal initiatives to promote biosecurity in life sciences research. More information about the NSABB, including its Charter and reports, can be found on the NSABB website.

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