For introductory information and definitions of biorisk and biorisk management, please see the Biosafety & Biocontainment FAQ.
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 Report of the 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.
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:
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.”
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.
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.
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.
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 has created both a security risk assessment tool and guidance documents on physical security for Select Agent laboratories.
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.
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.
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.
The 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.