Biorisk generally refers to the risk associated with biological materials and/or infectious agents, also known as pathogens. The term has been used frequently for various purposes since the early 1990s. [1] [2] The term is used by regulators, laboratory personnel and industry alike and is used by the World Health Organization (WHO). [3] WHO/Europe also provides tools and training courses in biosafety and biosecurity. [4]
An international Laboratory Biorisk Management Standard developed under the auspices of the European Committee for Standardization, defines biorisk as the combination of the probability of occurrence of harm and the severity of that harm where the source of harm is a biological agent or toxin. [5] The source of harm may be an unintentional exposure, accidental release or loss, theft, misuse, diversion, unauthorized access or intentional unauthorized release.
Biorisk reduction involves creating expertise in managing high-consequence pathogens, by providing training on safe handling and control of pathogens that pose significant health risks. [6]
Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents are bacteria, viruses, insects, fungi or toxins, and may be in a naturally occurring or a human-modified form, in much the same way as in biological warfare. Further, modern agribusiness is vulnerable to anti-agricultural attacks by terrorists, and such attacks can seriously damage economy as well as consumer confidence. The latter destructive activity is called agrobioterrorism and is a subtype of agro-terrorism.
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety is used to protect from harmful incidents. Many laboratories handling biohazards employ an ongoing risk management assessment and enforcement process for biosafety. Failures to follow such protocols can lead to increased risk of exposure to biohazards or pathogens. Human error and poor technique contribute to unnecessary exposure and compromise the best safeguards set into place for protection.
Safe trade is a slogan advocated by Greenpeace in its desire to "green" the World Trade Organization and the Doha Development Round. It is designed to compete with "free trade" as a concept.
Biosecurity refers to measures aimed at preventing the introduction and/or spread of harmful organisms to animals and plants in order to minimize the risk of transmission of infectious disease. In agriculture, these measures are aimed at protecting food crops and livestock from pests, invasive species, and other organisms not conducive to the welfare of the human population. The term includes biological threats to people, including those from pandemic diseases and bioterrorism. The definition has sometimes been broadened to embrace other concepts, and it is used for different purposes in different contexts.
A biosafety level (BSL), or pathogen/protection level, is a set of biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels. In the European Union, the same biosafety levels are defined in a directive. In Canada the four levels are known as Containment Levels. Facilities with these designations are also sometimes given as P1 through P4, as in the term P3 laboratory.
A biological hazard, or biohazard, is a biological substance that poses a threat to the health of living organisms, primarily humans. This could include a sample of a microorganism, virus or toxin that can adversely affect human health. A biohazard could also be a substance harmful to other animals.
A chemical hazard is a (non-biological) substance that has the potential to cause harm to life or health. Chemicals are widely used in the home and in many other places. Exposure to chemicals can cause acute or long-term detrimental health effects. There are many types of hazardous chemicals, including neurotoxins, immune agents, dermatologic agents, carcinogens, reproductive toxins, systemic toxins, asthmagens, pneumoconiotic agents, and sensitizers. In the workplace, exposure to chemical hazards is a type of occupational hazard. The use of protective personal equipment(PPE) may substantially reduce the risk of damage from contact with hazardous materials.
The National Microbiology Laboratory (NML) is part of the Public Health Agency of Canada (PHAC), the agency of the Government of Canada that is responsible for public health, health emergency preparedness and response, and infectious and chronic disease control and prevention.
Under United States law, Biological select agents or toxins (BSATs) — or simply select agents for short — are bio-agents which have been declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety". The agents are divided into (1) HHS select agents and toxins affecting humans; (2) USDA select agents and toxins affecting agriculture; and (3) overlap select agents and toxins affecting both.
One use of the concept of biocontainment is related to laboratory biosafety and pertains to microbiology laboratories in which the physical containment of pathogenic organisms or agents is required, usually by isolation in environmentally and biologically secure cabinets or rooms, to prevent accidental infection of workers or release into the surrounding community during scientific research.
The National Biodefense Analysis and Countermeasures Center (NBACC) is a government biodefense research laboratory created by the U.S. Department of Homeland Security (DHS) and located at the sprawling biodefense campus at Fort Detrick in Frederick, MD, USA. The NBACC is the principal U.S. biodefense research institution engaged in laboratory-based threat assessment and bioforensics. NBACC is an important part of the National Interagency Biodefense Campus (NIBC) also located at Fort Detrick for the US Army, National Institutes of Health and the US Department of Agriculture.
The Johns Hopkins Center for Health Security is an independent, nonprofit organization of the Johns Hopkins Bloomberg School of Public Health. The Center works to protect people’s health from epidemics and pandemics and ensures that communities are resilient to major challenges. The Center is also concerned with biological weapons and the biosecurity implications of emerging biotechnology.
The National Science Advisory Board for Biosecurity (NSABB) is a panel of experts that reports to the Secretary of the United States Department of Health and Human Services. It is tasked with recommending policies on such questions as how to prevent published research in biotechnology from aiding terrorism, without slowing scientific progress.
Biosecurity in the United States is governed by the Bureau of Western Hemisphere Affairs, which is part of the US Department of State. It obtains guidance and advice on specific matters relating to biosecurity from various other government agencies.
The American Biological Safety Association (ABSA) was founded in 1984 to promote biological safety as an essential principle and serve the needs of biosafety professionals. The Association's goals are to represent the interests and desires of practitioners of biosafety, and to be a dispenser of biosafety information.
Biotechnology risk is a form of existential risk that could come from biological sources, such as genetically engineered biological agents. The origin of such a high-consequence pathogen could be a deliberate release, an accidental release, or a naturally occurring event.
The hazards of synthetic biology include biosafety hazards to workers and the public, biosecurity hazards stemming from deliberate engineering of organisms to cause harm, and hazards to the environment. The biosafety hazards are similar to those for existing fields of biotechnology, mainly exposure to pathogens and toxic chemicals; however, novel synthetic organisms may have novel risks. For biosecurity, there is concern that synthetic or redesigned organisms could theoretically be used for bioterrorism. Potential biosecurity risks include recreating known pathogens from scratch, engineering existing pathogens to be more dangerous, and engineering microbes to produce harmful biochemicals. Lastly, environmental hazards include adverse effects on biodiversity and ecosystem services, including potential changes to land use resulting from agricultural use of synthetic organisms.
The Global Biorisk Advisory Council® (GBAC), a Division of ISSA, is a network of international leaders in the field of microbial-pathogenic threat analysis, mitigation and response and recovery. GBAC provides services intended to assist individuals, institutions, companies and governments in assessing preparedness. It also offers education and training to respond and recover in critical biohazardous events with an emphasis on microbial containment and psychological surety.
Gain-of-function research is medical research that genetically alters an organism in a way that may enhance the biological functions of gene products. This may include an altered pathogenesis, transmissibility, or host range, i.e. the types of hosts that a microorganism can infect. This research is intended to reveal targets to better predict emerging infectious diseases and to develop vaccines and therapeutics. For example, influenza B can only infect humans and harbor seals. Introducing a mutation that would allow influenza B to infect rabbits in a controlled laboratory situation would be considered a "gain of function" experiment as the virus did not previously have that function. That type of experiment could then help reveal which parts of the virus are responsible for its host range, enabling the creation of antiviral medicines which block this function.
A laboratory-acquired infection or LAI is an infection that is acquired in a laboratory, usually as part of a medical research facility or hospital.