Biosecurity is set of measures aimed at preventing the introduction and/or spread of harmful organisms, in order to minimise the risk of transmission of infectious diseases to people, animals and plants caused by viruses, bacteria or other microorganisms. In agriculture, it aims to protect food crops and livestock by keeping pests, invasive species and other organisms which may harm the welfare of the human population. The term includes biological threats to people, including 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.
The COVID-19 pandemic is a recent example of a threat which has needed to engage biosecurity measures in all countries of the world.
The term "biosecurity" has been defined differently by various disciplines. The term was first used by the agricultural and environmental communities to describe preventative measures against threats from naturally occurring diseases and pests, later expanded to introduced species. Australia and New Zealand, among other countries, had incorporated this definition within their legislation by 2010.New Zealand was the earliest adopter of a comprehensive approach with its Biosecurity Act 1993. In 2001, the US National Association of State Departments of Agriculture (NASDA) defined biosecurity as "the sum of risk management practices in defense against biological threats", and its main goal as "protect[ing] against the risk posed by disease and organisms".
In 2010, the World Health Organization (WHO) provided an information note describing biosecurity as a strategic and integrated approach to analysing and managing relevant risks to human, animal and plant life and health and associated risks for the environment.In another document, it describes the aim of biosecurity being "to enhance the ability to protect human health, agricultural production systems, and the people and industries that depend on them", with the overarching goal being "to prevent, control and/or manage risks to life and health as appropriate to the particular biosecurity sector".
Measures taken to counter biosecurity risks typically include compulsory terms of quarantine, and are put in place to minimise the risk of invasive pests or diseases arriving at a specific location that could damage crops and livestock as well as the wider environment.
In general, the term is today taken to include managing biological threats to people, industries or environment. These may be from foreign or endemic organisms, but they can also extend to pandemic diseases and the threat of bioterrorism, both of which pose threats to public health.
The definition has sometimes been broadened to embrace other concepts, and it is used for different purposes in different contexts. A 2016 draft handbook on biosecurity education produced by the Bradford Disarmament Research Centre at Bradford University in the UK, where the focus is on the dangers of "dual-use" research, defines the term as meaning "successful minimising of the risks that the biological sciences will be deliberately or accidentally misused in a way which causes harm for humans, animals, plants or the environment, including through awareness and understanding of the risks".
From the late 1990s, in response to the threat of biological terrorism, the term started to include the prevention of the theft of biological materials from research laboratories, called "laboratory biosecurity" by WHO.The term laboratory biosafety refers to the measures taken "to reduce the risk of accidental release of or exposure to infectious disease agents", whereas laboratory biosecurity is usually taken to mean "a set of systems and practices employed in legitimate bioscience facilities to reduce the risk that dangerous that dangerous biological agents will be stolen and used maliciously". Joseph Kanabrocki (2017) source elaborates: "Biosafety focuses on protection of the researcher, their contacts and the environment via accidental release of a pathogen from containment, whether by direct release into the environment or by a laboratory-acquired infection. Conversely, biosecurity focuses on controlling access to pathogens of consequence and on the reliability of the scientists granted this access (thereby reducing the threat of an intentional release of a pathogen) and/or access to sensitive information related to a pathogen’s virulence, host-range, transmissibility, resistance to medical countermeasures, and environmental stability, among other things".
In the US, the National Science Advisory Board on Biosecurity was created in 2004 to provide biosecurity oversight of "dual-use research", defined as "biological research with legitimate scientific purpose that may be misused to pose a biological threat to public health and/or national security". In 2006, the National Academy of Sciences defined biosecurity as "security against the inadvertent, inappropriate, or intentional malicious or malevolent use of potentially dangerous biological agents or biotechnology, including the development, production, stockpiling, or use of biological weapons as well as outbreaks of newly emergent and epidemic disease".
A number of nations have developed biological weapons for military use, and many civilian research projects in medicine have the potential to be used in military applications (dual-use research), so biosecurity protocols are used to prevent dangerous biological materials from falling into the hands of malevolent parties.
Components of a laboratory biosecurity program include:
Threats to animals and plants, in particular food crops, which may in turn threaten human health, are typically overseen by a government department of agriculture.
Animal biosecurity encompasses different means of prevention and containment of disease agents in a specific area. A critical element in animal biosecurity is biocontainment – the control of disease agents already present in a particular area and work to prevent transmission.Animal biosecurity may protect organisms from infectious agents or noninfectious agents such as toxins or pollutants, and can be executed in areas as large as a nation or as small as a local farm.
Animal biosecurity takes into account the epidemiological triad for disease occurrence: the individual host, the disease, and the environment in contributing to disease susceptibility. It aims to improve nonspecific immunity of the host to resist the introduction of an agent, or limit the risk that an agent will be sustained in an environment at adequate levels. Biocontainment works to improve specific immunity towards already present pathogens.
Direct threats to human health may come in the form of epidemics or pandemics, such as the 1918 Spanish flu pandemic and other influenza epidemics, MERS, SARS, or the 2019-2020 COVID-19 pandemic, or they may be deliberate attacks (bioterrorism). The country/federal and/or state health departments are usually responsible for managing the control of outbreaks and transmission and the supply of information to the public.
Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats.
In the US, the Food and Drug Administration (FDA) runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by the federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs.
Various international organisations, international bodies and legal instruments and agreements make up a worldwide governance framework for biosecurity.
Standard-setting organisations include the Codex Alimentarius Commission (CAC), the World Organisation for Animal Health (OIE) and the Commission on Phytosanitary Measures (CPM) develop standards pertinent to their focuses, which then become international reference points through the World Trade Organization (WTO)'s Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), created in 1995.This agreement requires all members of the WTO to consider all import requests concerning agricultural products from other countries. Broadly, the measures covered by the agreement are those aimed at the protection of human, animal or plant life or health from certain risks.
Other important global and regional agreements include the International Health Regulations (IHR, 2005), the International Plant Protection Convention (IPPC), the Cartagena Protocol on Biosafety, the Codex Alimentarius, the Convention on Biological Diversity (CBD) and the General Agreement on Tariffs and Trade (GATT, 1947).
The the UN Food and Agriculture Organization (FAO), the International Maritime Organization (IMO), the Organisation for Economic Co-operation and Development (OECD) and WHO are the most important organisations associated with biosecurity.
The IHR is a legally binding agreement on 196 nations, including all member states of WHO. Its purpose and scope is "to prevent, protect against, control, and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks and that avoid unnecessary interference with international traffic and trade", "to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide".
For a long time, health security or biosecurity issues were not considered as an international security issue, especially in the traditional view of international relations. However, some changes in trend have contributed to the inclusion of biosecurity (health security) in discussions of security. As time progressed, there was a movement towards securitisation. Non-traditional security issues such as climate change, organised crime, terrorism, and landmines came to be included in the definition of international security. There was a general realisation that the actors in the international system not only involved nation-states but also included international organisations, institutions, and individuals, which ensured the security of various actors within each nation became an important agenda. Biosecurity is one of the issues to be securitised under this trend. On 10 January 2000, the UN Security Council convened to discuss HIV/AIDS as a security issue in Africa and designated it a threat in the following month. The UNDP Millennium Development Goals also recognise health issues as international security issue.
Several instances of epidemics such as SARS increased awareness of health security (biosecurity). Several factors have rendered biosecurity issues more severe: there is a continuing advancement of biotechnology, which increases the possibility for malevolent use, evolution of infectious diseases, and globalising force which is making the world more interdependent and more susceptible to spread of epidemics.
Controversial experiments in synthetic biology, including the synthesis of poliovirus from its genetic sequence, and the modification of flu type H5N1 for airborne transmission in mammals, led to calls for tighter controls on the materials and information used to perform similar feats.Ideas include better enforcement by national governments and private entities concerning shipments and downloads of such materials, and registration or background check requirements for anyone handling such materials.
Diseases caused by emerging viruses are a major threat to global public health.The proliferation of high biosafety level laboratories around the world has resulted in concern about the availability of targets for those that might be interested in stealing dangerous pathogens. The growth in containment laboratories is often in response to emerging diseases, and many new containment labs' main focus is to find ways to control these diseases. By strengthening national disease surveillance, prevention, control and response systems, the labs have improved international public health.
One of the major challenges of biosecurity is that harmful technology has become more available and accessible.Biomedical advances and the globalisation of scientific and technical expertise have made it possible to greatly improve public health; however, there is also the risk that these advances can make it easier for terrorists to produce biological weapons.
Communication between the citizen and law enforcement officials is important. Indicators of agro-terrorism at a food processing plant may include persons taking notes or photos of a business, theft of employee uniforms, employees changing working hours, or persons attempting to gain information about security measures and personnel. Unusual activity is best handled if reported to law enforcement personnel promptly.Communication between policymakers and life sciences scientists is also important.
The MENA (Middle East and North Africa) region, with its socio-political unrest, diverse cultures and societies, and recent biological weapons programs, faces particular challenges.
Biosecurity requires the cooperation of scientists, technicians, policy makers, security engineers, and law enforcement officials.
The emerging nature of newer biosecurity threats means that small-scale risks can blow up rapidly, which makes the development of an effective policy challenging owing to the limitations on time and resources available for analysing threats and estimating the likelihood of their occurrence.It is likely that further synergies with other disciplines, such as virology or the detection of chemical contaminants, will develop over time.
Some uncertainties about the policy implementation for biosecurity remain for future. In order to carefully plan out preventive policies, policy makers need to be able to somewhat predict the probability and assess the risks; however, as the uncertain nature of the biosecurity issue goes it is largely difficult to predict and also involves a complex process as it requires a multidisciplinary approach. The policy choices they make to address an immediate threat could pose another threat in the future, facing an unintended trade-off.
Philosopher Toby Ord, in his 2020 book The Precipice: Existential Risk and the Future of Humanity , puts into question whether the current international conventions regarding biotechnology research and development regulation, and self-regulation by biotechnology companies and the scientific community are adequate.
The advance of the life sciences and biotechnology has the potential to bring great benefits to humankind through responding to societal challenges. However, it is also possible that such advances could be exploited for hostile purposes, something evidenced in a small number of incidents of bioterrorism, particularly by the series of large-scale offensive biological warfare programs carried out by major states in the last century. Dealing with this challenge, which has been labelled the "dual-use dilemma," requires a number of different activities. However, one way of ensuring that the life sciences continue to generate significant benefits and do not become subject to misuse for hostile purposes is a process of engagement between scientists and the security community, and the development of strong ethical and normative frameworks to complement legal and regulatory measures that are developed by states.
Biological warfare (BW)—also known as germ warfare—is the use of biological toxins or infectious agents such as bacteria, viruses, insects, and fungi with the intent to kill or incapacitate humans, animals or plants as an act of war. Biological weapons are living organisms or replicating entities. Entomological (insect) warfare is a subtype of BW.
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 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 later destructive activity is called agrobioterrorism and is 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.
Biodefense refers to measures to restore biosecurity to a group of organisms who are, or may be, subject to biological threats or infectious diseases. Biodefense is frequently discussed in the context of biowar or bioterrorism, and is generally considered a military or emergency response term.
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.
The National Microbiology Laboratory (NML) is part of the Infectious Disease Prevention and Control Branch 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.
Michael T. Osterholm is an American infectious disease epidemiologist, regents professor, and director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
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.
Agroterrorism, also known as agriterrorism and agricultural terrorism, is a malicious attempt to disrupt or destroy the agricultural industry and/or food supply system of a population through "the malicious use of plant or animal pathogens to cause devastating disease in the agricultural sectors". It is closely related to the concepts of biological warfare, chemical warfare and entomological warfare, except carried out by non-state parties.
Signed into effect on 12 June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act, (PHSBPRA) was signed by the President, the Department of Health and Human Services (DHHS) and the U.S. Department of Agriculture (USDA).
The Global Health Security Initiative (GHSI) is an informal international partnership among countries in order to exchange information and coordinate practices for confronting new threats and risks to global health. It was formed to respond to threats of biological, chemical, or radio-nuclear terrorism (CBRN), with pandemic influenza added to the scope a year later.
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, and part of the Environmental Health and Engineering department. It is concerned with the areas of health consequences from epidemics and disasters as well as averting biological weapons development, and implications of biosecurity for the bioeconomy. It is a think tank that does policy research and gives policy recommendations to the United States government as well as the World Health Organization and the UN Biological Weapons Convention.
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. It is composed of non-voting ex officio and appointed voting members. The current Chair of the NSABB is Samuel L. Stanley, Jr., M.D..
Biosecurity in Australia is governed and administered by two federal government departments, the Department of Health and the Department of Agriculture, Water and the Environment. The Biosecurity Act 2015 and related legislation is administered by the two departments. The Act aims to manage biosecurity risks to human health, agriculture, native flora and fauna and the environment. It also covers Australia's international rights and obligations, and lists specific diseases which are contagious and capable of causing severe harm to human health. Each state and territory has additional legislation and protocols to cover biosecurity in their jurisdiction, and must liaise with the federal government in times of national emergency.
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 United States biological defense program—in recent years also called the National Biodefense Strategy— refers to the collective effort by all levels of government, along with private enterprise and other stakeholders, in the United States to carry out biodefense activities.
The Alliance for Biosecurity is a consortium of companies that develop products to respond to national security threats, including bioterrorism pathogens and emerging infectious diseases. It is headquartered in Washington DC.
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.
This is an edited extract from The Precipice: Existential Risk and the Future of Humanity