Biosecurity has multiple meanings and is defined differently according to various disciplines. The original definition of biosecurity started out as a set of preventive measures designed to reduce the risk of transmission of infectious diseases in crops and livestock, quarantined pests, invasive alien species, and living modified organisms (Koblentz, 2010). The emerging nature of biosecurity threats means that small scale risks blow up rapidly, thus an effective policy becomes a challenge for there are limitations on time and resources available for analysing threats and estimating the likelihood of their occurrence.
The term was first used by the agricultural and environmental communities. Starting from the late 1990s in response to the threat of biological terrorism, biosecurity encompasses the prevention of the intentional removal (theft) of biological materials from research laboratories. These preventative measures are a combination of systems and practices put into its place at bioscience laboratories to prevent the use of dangerous pathogens and toxins for malicious use, as well as by customs agents and agricultural and natural resource managers to prevent the spread of these biological agents.
Advances in technology have meant that many civilian research projects in medicine have the potential to be used in military applications (dual-use research) and biosecurity protocols are used to prevent dangerous biological materials from falling into the hands of malevolent parties. The National Academy of Sciences define 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". Biosecurity requires the cooperation of scientists, technicians, policy makers, security engineers, and law enforcement officials.
Controversial experiments in synthetic biology, including the synthesis of poliovirus from its genetic sequence, and the modification of H5N1 for airborne transmission in mammals, have 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.
Initially, health security or biosecurity issues have not been considered as an international security issue especially in the traditional view of international relations. However, some changes in trend have contributed to inclusion of biosecurity (health security) in discussions of security (Koblentz, 2010).
As time progressed, there was a movement towards securitization. Non-traditional security issues such as climate change, organized crime, terrorism, and landmines came to be included in the definition of international security (Koblentz, 2010). There was a general realization that the actors in the international system not only involved nation-states but also included international organizations, institutions, and individuals (Koblentz, 2010). Therefore, ensuring the security of various actors within each nation became an important agenda. Biosecurity is one of the issues to be securitized under this trend. In fact, on January 10, 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 recognize health issues as international security issue (Koblentz, 2010). Several instances of epidemics that followed such as SARS increased awareness of health security (biosecurity). Recently 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 globalizing force which is making the world more interdependent and more susceptible to spread of epidemics (Koblentz, 2010).
Some uncertainties about the policy implementation for biosecurity remain for future. In order to carefully plan out preventative 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(Koblentz, 2010). The policy choices they make to address an immediate threat could pose another threat in the future, facing an unintended trade-off. Policy makers are also constantly looking for a more effective way to coordinate international actors- governmental organizations and NGOs- and actors from different nations so that they could tackle the problem of resource overlap (Koblentz, 2010).
Components of a laboratory biosecurity program include:
Animal biosecurity is the product of all actions undertaken by an entity to prevent introduction of disease agents into a specific area. Animal biosecurity differs from biosecurity which are measures taken to reduce the risk of infectious agent theft and dispersal by means of bioterrorism. Animal biosecurity is a comprehensive approach, encompassing different means of prevention and containment. A critical element in animal biosecurity, biocontainment, is the control of disease agents already present in a particular area, and works to prevent novel transmissions. 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, an element of animal biosecurity, works to improve specific immunity towards already present pathogens.
Biosecurity means the prevention of the illicit use of pathogenic bioorganisms by laboratory staff or others. Biosafety means the protection of laboratory staff from being infected by pathogenic bioorganisms.
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.
The FDA runs a program called the FDA Medical Countermeasures Initiative ("MCMi"). The program helps support "partner"[a] agencies and organizations prepare for public health emergencies that could require MCMs.
The federal government provides funding for MCM-related programs. In June 2016, a Senate Appropriations subcommittee approved a bill that would continue funding four specific medical countermeasure programs:
The destruction of the World Trade Center in Manhattan on September 11, 2001 by terrorists and subsequent wave of anthrax attacks on U.S. media and government outlets (both real and hoax) led to increased attention on the risk of bioterrorism attacks in the United States. Proposals for serious structural reforms, national and/or regional border controls, and a single co-ordinated system of biohazard response abounded.
One of the major challenges of biosecurity is that harmful technology is becoming more available and accessible. Biomedical advances and the globalization 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.
The proliferation of high biosafety level laboratories around the world has many experts worried about availability of targets for those that might be interested in stealing dangerous pathogens. Emerging and re-emerging disease is also a serious biosecurity concern. The recent growth in containment laboratories is often in response to emerging diseases, many new containment labs' main focus is to find ways to control these diseases. By strengthening national disease surveillance, prevention, control and response systems, these labs are raising international public health to new heights.
Research into biosecurity & biosafety conducted by the United Nations University Institute for the Advanced Study of Sustainability (UNU-IAS) emphasizes "long-term consequences of the development and use of biotechnology" and need for "an honest broker to create avenues and forums to unlock the impasses."
In the October 2011 Bio-Response Report Card, the WMD Center stated that the major challenges to biosecurity are:
Communication between the citizen and law enforcement officials is imperative. 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 should be reported to law enforcement personnel promptly.
Communication between policymakers and life sciences scientists is also important.
The MENA region, with its socio-political unrest, diverse cultures and societies, and recent biological weapons programs, faces particular challenges.
|1984||Rajneeshee religious cult attacks, The Dalles, Oregon||Salmonella typhimurium||Contaminated restaurant salad bars, hoping to incapacitate the population so their candidates would win the county elections
751 illnesses, Early investigation by CDC suggested the event was a naturally occurring outbreak. Cult member arrested on unrelated charge confessed involvement with the event
|1990s||Aum Shinrikyo attempts in Tokyo, Japan||Bacillus anthracis, Clostridium botulinum||Dissemination: Aerosolization in Tokyo
Shoko Asahara was convicted of criminal activity Aum Shinrikyo ordered C. botulinum from a pharmaceutical company and attempted to acquire from Zaire outbreak under guise of a "humanitarian mission" Resulted in around 20 deaths and more than 4000 injuries
|2001||"Amerithrax"||Bacillus anthracis||Letters containing anthrax spores were mailed to media offices and senators
Suspected perpetrator was a US DOD scientist
22 infected, 5 deaths
|1995||Larry Wayne Harris, a white supremacist, ordered 3 vials of Yersinia pestis from the ATCC||Yersinia pestis|
|2003||Thomas C. Butler, United States professor||Yersinia pestis||30 vials of Y. pestis missing from lab (never recovered); Butler served 19 months in jail|
|1966||"Dr. X killings"||Curare||Dr. Mario Jascalevich was accused of poisoning 5 patients|
|1977-1980||Arnfinn Nesset, former nurse in Norway||succinylcholine||Confessed to killing 27 patients, may have killed as many as 138|||
|1987-1990||David J. Acer, Florida dentist||HIV||Infected 6 patients after he was diagnosed with HIV|
|1995||Debora Green, a Kansas physician||ricin||Convicted of trying to murder her estranged husband with ricin, later killed her family in a house fire|
|1998||Richard J. Schmidt, a gastroenterologist in Louisiana||HIV||Convicted of attempted second degree murder for infecting nurse Janice Allen with HIV by injecting her with blood from an AIDS patient|
|1999||Brian T. Stewart, a phlebotomist||HIV||Sentenced to life in prison for deliberately infecting his 11-month-old baby with HIV-infected blood to avoid child support payments|
|1964-1966||Dr. Mitsuru Suzuki, physician with training, Japan||Shigella dysenteriae and Salmonella typhi||Objective: Revenge due to deep antagonism to what he perceived as a prevailing seniority system
Dissemination: Sponge cake, other food sources Official investigation started after anonymous tip to Ministry of Health and Welfare. He was charged, but was not convicted of any deaths; later implicated in 200 – 400 illnesses and 4 deaths
|1996||Diane Thompson, clinical laboratory technician, Dallas, TX||Shigella dysenteriae Type 2||Removed Shigella dysenteriae Type 2 from hospital's collection and infected co-workers with contaminated pastries in the office breakroom
Infected 12 of her coworkers, she was arrested, convicted, & sentenced to 20 years in prison
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, but more particularly by the series of large-scale offensive biological warfare programmes 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 such as those identified above as being require for biosecurity. However, one of the essential ingredients in ensuring that the life sciences continue to generate great 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 compliment legal and regulatory measures that are being developed by states.
Antec International was formerly one of the world's largest biosecurity companies, specialising in production of disinfectants and cleansing agents. It played a minor but important role in controlling the 2001 UK foot and mouth crisis.
The company was acquired by DuPont in late 2003 and operated as a subsidiary of DuPont until July 2015 when it became part of spin-off of Chemours.Australian Quarantine and Inspection Service
The Australian Quarantine and Inspection Service (AQIS) was the Australian government agency responsible for enforcing Australian quarantine laws, as part of the Department of Agriculture.
Following a period operating under the name DAFF Biosecurity, it has since been absorbed into divisions in the Department of Agriculture and Water Resources.Autonomous detection system
Autonomous Detection Systems (ADS), also called biohazard detection systems, or autonomous pathogen detection systems, are designed to monitor air in the environment and to detect the presence of airborne chemicals, toxins, pathogens, or other biological agents capable of causing human illness or death. Currently under development, these systems monitor the air continuously and send real-time alerts to appropriate authorities in the event of an act of bioterrorism or biological warfare.
In the United States, an ADS system (BDS) was developed for the U.S. Postal Service following the anthrax scare of 2001. The detection systems were installed in 2006.Beekeeping in New Zealand
Beekeeping in New Zealand started as a home craft in the 1850s, not long after initial European settlement and is now an established industry as well as being a hobby activity.Biosecurity Act 1993
Biosecurity Act 1993 is an Act of Parliament in New Zealand. The Act is a restatement and reform of the laws relating to pests and other unwanted organisms. It was a world first.In the Act an unwanted organism is one that "is capable or potentially capable of causing unwanted harm to any natural and physical resources or human health" and a restricted organism means "any organism for which a containment approval has been granted in accordance with the Hazardous Substances and New Organisms Act 1996".
Part 5 of the Act provides for a National Pest Management Strategy and Regional Pest Management Strategy.Biosecurity Australia
Biosecurity Australia is an arm of the Australian Government Department of Agriculture, Fisheries and Forestry. It provides science-based quarantine assessments and policy advice to protect Australian agricultural industry, and to enhance Australia's access to international animal and plant related markets. Biosecurity Australia also provides policy advice to the Australian Quarantine and Inspection Service (AQIS) concerning the importation of quarantine risk material to Australia. AQIS ultimately sets the rules concerning the imports, not Biosecurity Australia.
Biosecurity Australia's headquarters is located in the Edmund Barton Building on Broughton Street in Barton, ACT.Biosecurity in New Zealand
Biosecurity in New Zealand guards against threats to agriculture and biodiversity with strict border control measures being taken to prevent unwanted organisms from entering the country.
New Zealand is an island nation that is geographically isolated from any significant landmass. For this reason the species that are present evolved in the absence of organisms from elsewhere and display a high degree of endemism. Notable is the lack of land based mammals, except for two species of bat. Indigenous species are at risk from population decline or extinction if any invasive species are introduced.
The Biosecurity Act 1993, which was a world first for biosecurity control, was passed to "restate and reform the law relating to the exclusion, eradication, and effective management of pests and unwanted organisms". The Ministry for Primary Industries is the government department in charge of overseeing New Zealand's biosecurity.
The National Animal Identification and Tracing system for tracing livestock was introduced in 2012, but in 2017 the Mycoplasma bovis outbreak investigation indicated that it was not being fully complied with.Coir
Coir (), or coconut fibre, is a natural fibre extracted from the husk of coconut and used in products such as floor mats, doormats, brushes and mattresses. Coir is the fibrous material found between the hard, internal shell and the outer coat of a coconut. Other uses of brown coir (made from ripe coconut) are in upholstery padding, sacking and horticulture. White coir, harvested from unripe coconuts, is used for making finer brushes, string, rope and fishing nets. It has the advantage of not sinking, so can be used in long lengths on deep water without the added weight dragging down boats and buoys.Department of Agriculture, Fisheries and Forestry (Australia)
The Department of Agriculture, Fisheries and Forestry (DAFF) was an Australian government department that existed between 1998 and 2013, when it was renamed as the Department of Agriculture. DAFF's role was to develop and implement policies and programs that ensure Australia's agricultural, fisheries, food and forestry industries remained competitive, profitable and sustainable.
DAFF policies and programs were to:
encourage and support sustainable natural resource use and management
protect the health and safety of plant and animal industries
enable industries to adapt to compete in a fast-changing international and economic environment
help improve market access and market performance for the agricultural and food sector
encourage and assist industries to adopt new technology and practices
assist primary producers and the food industry to develop business and marketing skills, and to be financially self-reliant.Department of Primary Industries (New South Wales)
The New South Wales Department of Primary Industries, a division of the New South Wales Government, is responsible for the administration and development for agriculture, fisheries, aquaculture, forestry, and biosecurity in New South Wales. The Department works to drive innovation in primary industries to improve resilience, productivity and sustainability, and to ensure risks are managed for natural resources, farming and food.Division of Select Agents and Toxins
The Division of Select Agents and Toxins (DSAT) of the Centers for Disease Control and Prevention is responsible for the Select Agent Program and the Etiologic Agent Import Permit Program. They inspect the laboratories of more than 300 organizations approved to use and transfer select agents, and put regulations in place to minimize risk in the use of these bacterial agents and toxins.DSAT investigates incidents related to the laboratory use of select agents and toxins and refers cases to the FBI and HHS Office of Inspector General when necessary.They also review experiments that are deemed "restricted experiments" because of their increased risk.Samuel S. Edwin became the director of the division in 2016. The office's 2016 budget was approximately $21.5 million.Dow University of Health Sciences
The Dow University of Health Sciences (initials: DUHS) Urdu: ڈائو یونیوسٹی آف ہیلتھ سائنس), is one of the oldest public sector universities in Pakistan. It is located in urban metropolitan area of Karachi, Sindh, Pakistan. The university comprises two leading health sciences undergraduate research institutes: Dow International Medical College and Dow Medical College . University also has a very strong department of Postgraduate studies which monitors various basic medical sciences and clinical sciences programs at DUHS.
Established in 1945, it is known for its strong emphasis on economics biomedical, health, and medical research programmes. It is one of the premium institutions of higher learning in Pakistan, and ranked among one of the top medical schools by HEC in 2010, 2011, 2012, 2013 and 2014. The university is named after its founder, Sir Hugh Dow, who laid the foundation of the institution in 1945. The institution offers undergraduate, post-graduate and doctoral programmes in almost all academic disciplines relating to medical sciences.Major initiatives were personally taken by Ishrat-ul-Ibad (the former Governor of Sindh) and a former Dow graduate, for the establishment of the Dow University of Health Sciences.Dutch Ruppersberger
Charles Albert "Dutch" Ruppersberger III (; born January 31, 1946) is an American politician serving as the U.S. Representative for Maryland's 2nd congressional district since 2003. A member of the Democratic Party, he previously served as an Assistant State Attorney of Maryland from 1972 to 1980, a Baltimore County Councilman from 1985 to 1994 and the Baltimore County Executive from 1994 until 2002. He was the Ranking Member of the United States House Permanent Select Committee on Intelligence from 2011 to 2015.Federation of American Scientists
The Federation of American Scientists (FAS) is a 501(c)(3) organization with the stated intent of using science and scientific analysis to attempt to make the world more secure. FAS was founded in 1945 by scientists who worked on the Manhattan Project to develop the first atomic bombs.
With 100 sponsors, FAS claims that it promotes a safer and more secure world by developing and advancing solutions to important science and technology security policy problems by educating the public and policy makers, and promoting transparency through research and analysis to maximize impact on policy. FAS projects are organized in three main programs: nuclear security, government secrecy, and biosecurity. FAS played a role in the control of atomic energy and weapons, as well as better international monitoring of atomic activities.Johns Hopkins Center for Health Security
The Johns Hopkins Center for Health Security (abbreviated CHS; previously the UPMC Center for Health Security, the Center for Biosecurity of UPMC, and the Johns Hopkins Center for Civilian Biodefense Strategies) is an independent, nonprofit organization of the Johns Hopkins Bloomberg School of Public Health that works in the area of health consequences from epidemics and disasters. It is a think tank that does policy research and gives policy recommendations to the United States government.Ministry for Primary Industries (New Zealand)
The Ministry for Primary Industries (MPI) (Māori: Manatū Ahu Matua) is the public service department of New Zealand charged with overseeing, managing and regulating the farming, fishing, food, animal welfare, biosecurity, and forestry sectors of New Zealand's primary industries. In December 2017, Agriculture, Food Safety and Biosecurity Minister Damien O'Connor announced that the Ministry of Primary Industries would be reorganised into four entities: Fisheries New Zealand, Forestry New Zealand, Biosecurity New Zealand and New Zealand Food Safety, existing within the one ministry.Ministry of Agriculture and Forestry (New Zealand)
The Ministry of Agriculture and Forestry (in Māori, Te Manatu Ahuwhenua, Ngāherehere) was a state sector organisation of New Zealand which dealt with matters relating to agriculture, forestry and biosecurity. It was commonly known by its acronym, "MAF".
In April 2012, it became part of the newly formed Ministry for Primary Industries.National Science Advisory Board for Biosecurity
The National Science Advisory Board for Biosecurity is a panel of experts that report 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..As of 2017, the ex officio members were:
Department of Commerce:
Jason Boehm, Ph.D., Office of Program Analysis and Evaluation, National Institute of Standards and Technology Division Head
Department of Defense :
David Christian Hassell, Ph.D., Deputy Assistant Secretary of Defense for Nuclear and Chemical and Biological Programs
Department of Energy:
Sharlene Weatherwax, Ph.D., Associate Director of Science for Biological and Environmental Research
Department of Health and Human Services
Anthony S. Fauci, M.D., Director, National Institute of Allergy & Infectious Disease
Sally Phillips, R.N., Ph.D., Deputy Assistant Secretary, Office of Policy and Planning, Office of the Assistant Secretary for Preparedness and Response
CAPT Carmen Maher, Deputy Director, Office of Counterterrorism and Emerging Threats (OCET), Office of the Commissioner, Food and Drug Administration
Michael W. Shaw, Ph.D., Senior Advisor for Laboratory Science, Office of Infectious Diseases, Centers for Disease Control and Prevention
Department of Homeland Security
Wendy Hall, Ph.D., Special Senior Advisor for Biological Threats, Office of Chemical, Biological, and Nuclear Policy
Department of the Interior
Anne E. Kinsinger, Associate Director for Biology, U.S. Geological Survey
Department of Justice
Edward You, Supervisory Special Agent, FBI Weapons of Mass Destruction Directorate
Department of State
Christopher Park, Director, Biological Policy Staff, Bureau of International Security and Nonproliferation
Department of Veterans Affairs
Brenda A. Cuccherini, Ph.D., M.P.H. Special Assistant to the Chief Research and Development Officer, Veterans Health Administration
Environmental Protection Agency,
Gregory Sayles, Ph.D., Acting Director, National Homeland Security Research Center
Executive Office of the President
Gerald Epstein, Ph.D., Assistant Director for Biosecurity and Emerging Technologies, National Security and International Affairs Division, Office of Science and Technology Policy
Amanda Dion-Schultz, Ph.D., Office of the Chief Scientist
Robert M. Miceli, Ph.D., Biological Issue Manager and Advisor to the Director, Office of the Director of National Intelligence
National Aeronautics and Space Administration
David R. Liskowsky, Ph.D., Director, Medical Policy & Ethics, Office of the Chief Health and Medical Officer
Department of Agriculture
Steven Kappes, Ph.D. Deputy Administrator, Animal Production and ProtectionSelect agent
Under United States law, "Biological Select Agents or Toxins" (BSATs) — or simply select agents for short — are bio-agents which since 1997 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.
The U.S. Centers for Disease Control and Prevention (CDC) regulates the laboratories which may possess, use, or transfer select agents within the United States in its Select Agent Program (SAP) — also called the Federal Select Agent Program (FSAP) — since 2001. The SAP was established to satisfy requirements of the USA PATRIOT Act of 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which were enacted in the wake of the September 11, 2001 attacks and the subsequent 2001 anthrax attacks.
Using BSATs in biomedical research prompts concerns about dual use. The federal government created the National Science Advisory Board for Biosecurity which promotes biosecurity in life science research. It is composed of government, education and industry experts who provide policy recommendations on ways to minimize the possibility that knowledge and technologies emanating from biological research will be misused to threaten public health or national security.