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Synthetic Biology has enhanced asymmetric Bio warfare and Bio terrorism threat posed by biological weapons, in response US launches Biodefence Strategy

The COVID-19 pandemic has demonstrated that significant biological threats can and will emerge from nature without warning, demonstrating that a single viral strain can have a profound impact on modern society. It has also demonstrated that infectious diseases can rapidly spread throughout a population without human engineering making them the ideal substrates from which to develop engineered weapons. Viruses and bacteria have been used as weapons for millennia. Biological weapons achieve their intended effects by infecting people with disease-causing microorganisms and other replicative entities, including viruses, infectious nucleic acids and prions. The chief characteristic of biological agents is their ability to multiply in a host over time.


The use of a pathogen for hostile purposes became a consuming concern to the American people soon after 9/11. About a half-dozen letters containing anthrax spores were mailed to journalists and politicians beginning one week after the jetliner attacks. In the end, at least 22 people had become infected, five of whom died. Meanwhile, scores of buildings were belatedly found to be contaminated with spores that had leaked from the letters. At least 30,000 people who were deemed at risk required prophylactic antibiotics. Millions more were fearful, many of them anxious about opening their own mail.


The threat posed by biological weapons—is especially challenging because of the unique character of these weapons. A prime distinction is the fact that exposure to minute quantities of a biological agent may go unnoticed, yet ultimately be the cause of disease and death. The incubation period of a microbial agent can be days or weeks; unlike a bombing, knifing, or chemical dispersion, a bioattack might not be recognized until long after the agent’s release. Accordingly, bioterrorism poses distinctive challenges for preparedness, protection, and response.


The threat is further compounded by growth of Synthetic biology.  In April 2019, small group of scientists at ETH (German: Eidgenössische Technische Hochschule) Zurich  developed a technology which modified a genome using computers within the time frame of one year at 120,000 Swiss francs which is a fraction of the cost of the previous experiments. They could achieve this in the Caulobacter genome, by synthesising 236 genome segments and inserting them into the bacterial genome after joining them together, a process which replaced about one-sixth of the genome. By doing so, the researchers demonstrated the ability to produce strains of bacteria that contained both the naturally occurring Caulobacter genome and also segments of the new artificial genome.


Researchers at the Medical Research Council Laboratory of Molecular Biology in Britain were similarly able to rewrite the DNA of the bacteria Escherichia coli and configure a synthetic genome four times larger and way more complicated than any previously created.  Such developments have great potential for the growth of synthetic organisms that have the capability of producing a wide variety of products such as DNA vaccines and other life-saving molecules. On the negative side, we could also use this technology for making bio-weapons. , say US New report .


In response, US has  launched its New Biodefence Strategy.  Biological threats emanate from many sources, and they know no borders, They have great potential to disrupt the economy, exact a toll on human life, and tear at the very fabric of society, according to the report.  Robert P. Kadlec, the Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response echoed this sentiment, saying, Whether a natural outbreak, an accidental release, or a deliberate attack, biological threats are among the most serious we face, with the potential for significant health, economic and national security impacts. Therefore, promoting our health security is a national security imperative.

Threat of traditional biological weapons like Anthrax

Historically, biological weapons were derived from natural sources, such as anthrax from herbivores and domesticated animals, and smallpox from rodents. Those pathogenic organisms that were found to be suitable for weaponization were cultured directly from the environment; they were then isolated, purified, stored, propagated, and used to fill biological munitions.


Threat of Anthrax

According to Centers for Disease Control and Prevention: “If a bioterrorist attack were to happen, Bacillus anthracis, the bacteria that causes anthrax, would be one of the biological agents most likely to be used”. Biological agents are germs that can sicken or kill people, livestock, or crops.


Anthrax is one of the most likely agents to be used because
• Anthrax spores are easily found in nature, can be produced in a lab, and can last for a long time in the environment.
• Anthrax makes a good weapon because it can be released quietly and without anyone knowing. The microscopic spores could be put into powders, sprays, food, and water. Because they are so small, you may not be able to see, smell, or taste them.
• Anthrax has been used as a weapon before.

Bacillus anthracis has been designated as a Tier 1 agent, because it present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety.


What Might an Anthrax Attack Look Like?

An anthrax attack could take many forms. For example, it could be placed in letters and mailed, as was done in 2001, or it could be put into food or water. Anthrax also could be released into the air from a truck, building, or plane. This type of attack would mean the anthrax spores could easily be blown around by the wind or carried on people’s clothes, shoes, and other objects. It only takes a small amount of anthrax to infect a large number of people.


If anthrax spores were released into the air, people could breathe them in and get sick with anthrax. Inhalation anthrax is the most serious form and can kill quickly if not treated immediately. If the attack were not detected by one of the monitoring systems in place in the United States, it might go unnoticed until doctors begin to see unusual patterns of illness among sick people showing up at emergency rooms.


The most recent of example of use of Bioweapons  was the production and stockpiling of numerous agents by the biological weapons program of the former Soviet Union. In this program pathogens were selected for specific characteristics directly from the natural environment, propagated, and stored for later use. While these pathogens have evolved in nature for the purpose of persisting, they are not optimized for maintenance, storage, and deployment in a military setting. Consequently, while biological agents have not been widely employed as strategic or tactical weapons by state or non-state actors, there are some examples of their use in conflicts. The most significant of these is the well-documented use of crude bacteriological agents by the Japanese army against China during the Second World War.

Threat of Weaponizing of Synthetic Biology

In 1997, a team of accomplished scientists within a group known as the JASON group met to discuss the future of biological warfare. They identified six emerging biological threats that needed to be monitored by military planners and strategists: (1) the development of binary weapons, (2) the construction of designer genes, (3) the use of gene therapy as a weapon, (4) the development of viruses that evade the immune response of the host, (5) the use of viruses that can move between insects, animals, and humans, and (6) the development of designer diseases. These threats were once considered to be futuristic and speculative. Advances in SynBio techniques, however, have moved many of these predicted contingencies from the realm of speculation into the realm of reality. As the molecular engineering techniques of the synthetic biologist become more robust and widespread, the probability of encountering one or more of these threats is approaching certainty.


Recently, the convergence of advances in computer science, engineering, biological science, and chemistry have made it possible to engineer living systems to optimize growth and increase pathogenicity (the propensity to cause disease). This interdisciplinary approach to providing novel biological functionality has had a positive impact on the biotechnological and biopharmaceutical industries. At the same time, these engineered bacteria and viruses can be co-opted for belligerent purposes. Indeed, the use of designer biological weapons could theoretically give a state or non-state actor an asymmetric advantage over an adversary that favors conventional weapons.


Synthetic biology (SynBio) is the scientific discipline that encompasses all aspects of the engineering of biological systems. The US Department of Defense has recently commissioned the National Academies of Sciences, Engineering, and Medicine to look at the biggest threats posed by the rapidly advancing field of “synthetic biology”. One of the most concerning threats, according to the report, is the ability to recreate known viruses in the lab. For example, scientists have already shown how it’s perfectly possible to re-create an eradicated virus like smallpox using just its DNA. In the wrong hands, this could mean serious trouble.


The report imagines an especially terrifying scenario involving the creation of a genetically-altering ordinary human gut bacteria to produce toxins. You would effectively be killed by your own microbiome, meaning the attack is subtle and extremely hard to detect. Equally, gene-editing could be abused to make an existing bacteria or virus even more deadly and contagious. Thanks to the burgeoning field of CRISPR gene editing, this has never been easier or cheaper. The report also identifies the threat of modifying the human immune system. It could be possible to develop a way of “purposely weakening a person’s immune system,” meaning even a usually innocent virus could wreak havoc on a population.


However, according to Emily Leproust is CEO of Twist Bioscience, weaponizing biology is hard. In any quest to weaponize biology, DNA synthesis is just a first step in a long, complex process. Weaponizing microbes requires even more complex, specialized work, such as milling particles to a specific size. Effective dispersal—through aerosolization or sprayers—poses further challenges. It’s difficult to accomplish without killing or disabling the microbe. The Soviet Union spent years trying to weaponize antibiotic resistant anthrax. As they added resistance genes, they found the bacteria lost virulence, ease of transmissibility and other “desirable” traits, writes Emily Leproust is CEO of Twist Bioscience. Each series of steps requires intense expertise in molecular and cell biology, chemistry and engineering—not to mention a building full of expensive equipment. In short, it’s extremely difficult to do in a garage. These barriers still apply to microbes engineered with synthetic biology techniques. Therefore in near term synthetic Biology poses greater threat from Biowarfare by states than from terrorists.


However, Beginning with the discovery of the chemical structure of DNA in the 1950s, SynBio tools such as recombinant DNA technologyc and genome editing tools have developed at a fast pace as the fundamental molecular mechanisms underlying biology are discovered. These SynBio tools are lowering the education, training, cost, time, and equipment threshold required to modify and employ pathogenic organisms as biological weapons.  It’s becoming possible that a group of bad actors use CRISPR-Cas9 gene editing or other tools to increase a microbe’s pathogenicity. However,  synthetic biology offers no advantages when weaponizing or dispersing the toxin.


Biotechnology is currently blowing up as a field of study, meaning it’s extremely hard for policy-makers to keep up with the latest developments. This in itself raises bioterrorism to an even more concerning threat than more conventional means of warfare. “The US government should pay close attention to this rapidly progressing field, just as it did to advances in chemistry and physics during the Cold War era,” study author Michael Imperiale, Professor of Microbiology and Immunology at the University of Michigan, explained in a statement. “It’s impossible to predict when specific enabling developments will occur; the timelines would depend on commercial developments as well as academic research, and even converging technologies that may come from outside this field,”  said Imperiale. “So it is important to continue monitoring advances in synthetic biology and other technologies that may affect current bottlenecks and barriers, opening up more possibilities.”


The extent and impact of SynBio on future state-on-state conflicts and terrorist violence will increase as the tools and techniques of this discipline continue to mature and diffuse throughout the scientific community, as well as among the novice citizen-scientists in the do-it-yourself biology labs that have emerged around the world in recent years. The ability to produce custom-designed bacterial and viral pathogens will enhance the ability of hostile state and non-state actors to develop and deploy relatively inexpensive and efficient biological weapons. Additionally, some of these weapons will likely be engineered with increased pathogenicity, environmental stability, and the ability to withstand the shock of the rapid changes in temperature and pressure that may accompany delivery by explosive warhead.


The asymmetric threat posed by biological weapons will continue to increase as new tools and techniques are developed and as terrorist organizations become aware of and inspired by the society-wide economic, emotional, and government-destabilizing impacts caused by the COVID-19 pandemic.  Indeed, it can be argued that the total cost of this pandemic—including the loss of life and the stress to the economy—could be rivaled only by the deployment of an atomic bomb. Therefore, developments in SynBio should be continually monitored and reassessed within the context of technological change and its capacity to shift the geopolitical paradigm.


Risk of proliferation of Biological Warfare Agents

A new report finds that the U.S. military mistakenly has shipped live anthrax samples to dozens of labs in the United States and to seven other nations for more than a decade. The Defense Department report, said that the U.S. military mistakenly sent live anthrax spores to 86 labs in 20 states and Washington, D.C., plus facilities in Australia, Britain, Canada, Germany, Italy, Japan and South Korea.


However this incident has exposed the risk of deadly biological agents like Anthrax being proliferated to terrorists who can use it as a weapon to create mass casualties. At a press briefing Deputy Defense Secretary Robert Work called the program ‘a failure’ that exposed ‘a major problem’ in the Defense Department’s handling of anthrax, a potentially deadly bacterium.


The deputy defense secretary, Robert O. Work, told reporters that mistakes at Dugway Proving Ground, the originating Army laboratory in Utah, included a failure to kill anthrax spores through radiation and a failure to confirm that spores had been killed before they were shipped out. It also exposes risk inherent during shipments, because they were thought to be dead, and were shipped under less rigorous conditions than the live agent protocol.


Spurred by the anthrax attacks in the United States in 2001, the number of labs working with risky microbes has risen to 1,500 from 400 in 2004, according to the Government Accountability Office. The agency warned Congress last year that as more labs took on such work, the risk of dangerous blunders or sabotage would increase.


Finding of GAO Study

After the 2001 Anthrax attacks, the FBI investigated an intentional release of B. anthracis, a bacterium that causes anthrax, which was identified as the Ames strain. GAO was asked to review the FBI’s genetic test development process and statistical analyses.


The study by GAO found that genetic tests that were conducted by the Federal Bureau of Investigation’s (FBI) lacked a comprehensive approach—or framework—that could have ensured standardization of the testing process. As a result, each of the contractors developed their tests differently, and one contractor did not conduct verification testing, a key step in determining whether a test will meet a user’s requirements, such as for sensitivity or accuracy.


Also, GAO found that the contractors did not develop the level of statistical confidence for interpreting the testing results for the validation tests they performed. The lack of an understanding of how bacteria change (mutate) in their natural environment and in a laboratory is a key scientific gap that remains and could affect testing conducted in future incidents. This gap affects both the development of genetic tests targeting such mutations and statistical analyses of the results of their use on evidentiary samples. GAO recommended that the FBI develop a framework for validation and statistical approaches for future investigations.


Policy Responses to the Potential Threats Posed by Synthetic Biology

An effective response to the threats posed by those using synthetic biology for nefarious purpose will require vigilance on the part of military planners, the development of effective medical countermeasures by the research community, and the development of diagnostic and characterization technologies capable of discriminating between natural and engineered pathogens. A 2002 biological warfare counterproliferation study identified six key basic biological research areas that should be emphasized to protect against the threat: human genomics; immunology and the development of methods for the boosting the immune response; bacterial and viral genomics; bacterial and viral assay development; vaccine development; and the development of novel antiviral agents and antibiotics. A continued research and education effort within the Department of Defense will be required to develop and maintain expertise in each of these areas.


The rapid availability of experienced civilian and military personnel is a prerequisite for effective incident response. Therefore, training and education in SynBio, biological engineering, and related disciplines should be emphasized and funded. Many organizations already exist to meet the threat of natural, man-made, and weaponized biological material. These organizations include the Defense Threat Reduction Agency (DTRA); the Chemical and Biological Center (CBC) at Edgewood, Maryland; the Defense Advanced Research Projects Agency (DARPA); the Biomedical Advanced Research and Development Authority (BARDA); the National Institutes of Health (NIH); the Centers for Disease Control (CDC); and United Stated Department of Agriculture-Agricultural Research Service (USDA-ARS) within the United States.


The World Health Organization (WHO), a specialized organization within the United Nations, and several research and response organizations in other countries have historically served similar purposes. Each of these entities deal with systems rooted in the natural world, and while some organizations restrict their focus to naturally occurring threats, they all deal—in one way or another—with the extraordinary pace of technology development unique to the biomedical community. Every advancement in biomedicine is dual-use, and so it is incumbent upon those privileged to work in the scientific field to predict the ways that these technologies might be used for nefarious purpose and to develop the technologies and systems necessary to undermine the efforts of those who might use these unique biological entities as weapons.


US launches National Biodefence Strategy

On September 18, 2018, President Trump unveiled the 2018 National Biodefense Strategy, designed to protect the American people from all types of biological threats. According to the President, the strategy builds “a more resilient and effective biodefense enterprise” by drawing on lessons learned from biological incidents – epidemics, pandemics, and deliberate attacks – in recent history. Such incidents include the 2001 anthrax attacks, the 2009 influenza pandemic, the Severe Acute Respiratory Syndrome (SARS) outbreak, the 2014 West Africa Ebola epidemic, and the Zika virus outbreak.


In a news briefing,  Secretary of Health and Human Services Alex Azar  told reporters that biological threats are “very real, and they’re growing.” He said this year’s strategy is the first by the U.S. to include naturally occurring threats. Previously, the national biodefense strategy focused on the weaponization of biological threats by enemy forces.


As stated in the 2018 National Biodefense Strategy, there are “five goals with associated objectives for strengthening the biodefense enterprise,” which will establish “a layered risk management approach to countering biological threats and incidents.” The five goals are as follows:

  • Enable risk awareness to inform decision-making across the biodefense enterprise.
  • Ensure biodefense enterprise capabilities to prevent bioincidents.
  • Ensure biodefense enterprise preparedness to reduce the impacts of bioincidents.
  • Rapidly respond to limit the impacts of bioincidents.
  • Facilitate recovery to restore the community, the economy, and the environment after a bioincident.


A series of objectives and concrete actions to facilitate actualization follows each of the five afore mentioned goals.

The Strategy concludes by saying, The risks from biological threats cannot be reduced to zero – but they can and must be managed. Wide-ranging threats require a comprehensive approach to minimizing the risks. Through this National Biodefense Strategy, the United States


Government will optimize its own efforts, and harness the work of essential partners—inside government and outside, domestically and internationally—to understand, prevent, prepare for, respond to, and recover from the full range of biological threats that can harm the American people and our partners.


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