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Navigating the Ethical Terrain of Synthetic Biology: Addressing Biosecurity, Environmental Impact, and Access


The rapid advancement of genetic engineering and synthetic biology has ushered in a new era of possibilities, from personalized medicine to sustainable agriculture. However, alongside these groundbreaking developments come profound ethical dilemmas that demand careful consideration. In this article, we explore the ethical concerns inherent in synthetic biology, ranging from biosecurity threats to environmental impact and issues of accessibility and equity.

The COVID-19 pandemic has underscored the vulnerability of modern society to biological threats, showcasing how a single viral strain can have a profound impact. The rapid spread of infectious diseases, whether natural or engineered, poses unique challenges, making them ideal substrates for developing biological weapons. Biological weapons leverage disease-causing microorganisms to infect populations, with the ability to multiply in hosts over time, making them difficult to detect and combat.

Synthetic biology has further complicated the landscape by providing tools to engineer biological agents with desired properties. Advances in molecular engineering have streamlined the process, allowing for the creation of novel organisms with enhanced biochemical properties. However, the dual-use nature of these technologies raises concerns about their potential misuse for bioterrorism purposes.

A notable example is the International Genetically Engineered Machine (iGEM) competition, where teams develop innovative biological systems. While intended for peaceful purposes, such competitions may inadvertently contribute to the proliferation of bioweapons technology. Additionally, state and non-state actors have attempted to acquire deadly pathogens and sensitive biological information, highlighting the need for robust biosecurity measures.


Accidents in laboratories further exacerbate the threat, as seen in incidents where researchers inadvertently created lethal pathogens. The proliferation of synthetic biology tools and the DIY biology community pose additional challenges, as individuals with limited training may lack awareness of safety protocols.

The potential threat of bioaccidents looms as a significant concern, encompassing both regulated research laboratories and the burgeoning do-it-yourself (DIY) biology community. In a high-level biosafety lab, researchers may inadvertently introduce risk while working on weakened strains of deadly viruses to decipher epidemiological characteristics and develop life-saving treatments. Notably, unforeseen consequences can arise, as exemplified by Australian scientists unintentionally creating a lethal mousepox virus in their attempts to genetically engineer infertility in lab mice. Similarly, the synthesis of the polio virus and the recreation of the infectious horsepox virus underscore the inherent challenges in manipulating pathogens, with the latter achieved by a team ordering DNA fragments online for a mere $100,000.

Accidents in regulated research labs have historically been manageable, with incidents like the accidental injection of an experienced Russian scientist with Ebola or the 2019 Brucellosis outbreak in China, both contained within the confines of formal institutions. However, the emergence of the DIY biology community introduces a new dimension of risk. Comprising individuals and small organizations without formal affiliations or regulatory oversight, this community explores genetics with limited training on safety and ethics. While no catastrophic incidents have occurred thus far, the absence of regulations governing this community raises concerns about the potential inability to contain and mitigate the impacts of any accidents that may arise from their experiments. As such, addressing this regulatory gap is imperative to ensure the responsible and safe exploration of biotechnology within the DIY community.

Ethical Concerns in Genetic Engineering:

The promise of genetic engineering brings to light ethical quandaries, particularly regarding human enhancement and the creation of “designer babies.” Questions of societal equity, accessibility, and the moral responsibilities associated with reshaping the genetic landscape of future generations must be carefully navigated to ensure ethical progress.

Personalized Medicine and Privacy:

While personalized medicine holds immense therapeutic potential, concerns about safeguarding individual privacy in the era of genomic data abound. An ethical framework must address issues of consent, data ownership, and the responsible use of sensitive genetic information to uphold individual autonomy and privacy rights.

Access to Biotechnological Innovations:

Equitable access to biotechnological advancements, particularly in healthcare, is an ethical imperative. Addressing affordability, geographical distribution, and global health disparities requires ethical guidelines that prioritize justice and fairness.

CRISPR Technology and Genome Editing:

The revolutionary CRISPR-Cas9 technology presents ethical challenges surrounding unintended consequences and human germline editing. Ethical guidelines and governance frameworks are essential for steering the responsible application of genome editing technologies.


The wide proliferation of synthetic biology technology further amplifies the bioterrorism threat.

With increasing accessibility to genetic engineering tools, even amateur scientists may have the capability to manipulate pathogens. Recent advancements, such as the reconstruction of horsepox virus, highlight the ease of recreating deadly infectious diseases.

The proliferation of synthetic biology (SynBio) technology has significantly heightened the threat of bioterrorism, challenging previous notions about the requisite expertise for manipulating biological agents. While some argue that complex techniques in biochemistry and molecular biology may limit amateur involvement, advancements in SynBio have simplified certain processes akin to following a recipe or using a computer mouse. Just as baking bread requires basic ingredients and instructions, manipulating bacterial and viral genes could soon become as accessible as operating a home computer. In a notable 2018 case, a Canadian research group constructed an infectious horsepox virus using publicly available genetic information, mirroring the genome of the devastating smallpox virus. This achievement underscores how SynBio has empowered both state-sponsored terrorists and talented non-state actors to potentially recreate deadly diseases with minimal resources.

The democratization of genetic engineering is evident in the education sector, where high school and undergraduate students routinely engage in sophisticated research projects once exclusive to advanced laboratories. Protocols for genetic engineering are freely accessible online and in educational textbooks, with many academic programs incorporating practical exercises in culturing and engineering microorganisms. The International Genetically Engineered Machine (iGEM) competition exemplifies the democratization of genetic engineering at the undergraduate level, providing participants with standardized techniques and a vast DNA parts library to create novel biological tools. While iGEM emphasizes biosafety, bioethics, and biosecurity, its dissemination of knowledge also presents opportunities for both state and non-state actors to exploit these techniques for malicious purposes, highlighting the dual-use nature of SynBio advancements.

Environmental Impact and Sustainable Biotechnology:

Biotechnological applications in agriculture raise concerns about unintended environmental consequences. Responsible stewardship and comprehensive evaluation of environmental repercussions are imperative to ensure ethical practices within sustainable biotechnology.

Informed Consent and Human Trials:

As biotechnological innovations progress to human trials, the ethical principle of informed consent assumes a central role. Ensuring participants have a comprehensive understanding of research objectives, procedures, risks, and benefits fosters autonomy and ethical integrity in research practices.

Synthetic Biology and Biosecurity:

The creative potential of synthetic biology introduces ethical challenges related to biosecurity. Synthetic biology enables the rapid production of custom-designed pathogens, enhancing the potential for bioterrorism. Modular genetic components allow for precise modifications, facilitating the creation of binary biological weapons. While challenges remain, such as the analog nature of biological systems, the advantages of bioweapons, including self-generation and ease of production, cannot be overlooked.

Biological weapons achieve their intended effects by infecting people with disease-causing microorganisms and other replicative entities, including viruses, bacteria, infectious nucleic acids and prions. The chief characteristic of biological agents is their ability to multiply in a host over time.

Balancing the promotion of beneficial applications with the mitigation of potential misuse requires robust international collaboration and ethical governance to navigate this complex terrain responsibly.

Synthetic Biology enhanced the threat of Biological Weapons

The evolving landscape of synthetic biology (SynBio) presents a looming challenge in future state-on-state conflicts and terrorist activities, as advancements in this field permeate both established scientific communities and burgeoning DIY biology labs worldwide. The capacity to tailor-make bacterial and viral pathogens will empower hostile actors, both state and non-state, to produce cost-effective and potent biological weapons. These weapons may exhibit heightened pathogenicity, environmental resilience, and resilience to the extreme conditions often associated with delivery mechanisms such as explosive warheads. As such, the asymmetric threat posed by biological weapons will likely escalate, especially as terrorist groups draw inspiration from the far-reaching societal impacts of events like the COVID-19 pandemic, which rivals the devastation of an atomic bomb in terms of loss of life and economic turmoil. Continuous monitoring and evaluation of SynBio developments are imperative to navigate the shifting geopolitical landscape influenced by technological advancements.

The threat landscape is constantly evolving as advances are made in materials, computational power and speed, and the bioengineering of viruses and cells. While there are challenges to weaponizing a biological system, including contending with the analog nature of biology, the advantages of bioweapons compared to relying on conventional explosives or nuclear weapons include their self-generating properties and the ease in creating a binary weapon allowing for safe production and assembly.


Thus, it is possible for an unsophisticated adversary to design biological weapons with enhanced virulence and infectivity. As already noted, one challenge to weaponizing a biological system is the analog nature of most metabolic circuitry (compared to the digital signals governing much of the electronic world). Further challenges are the presence of significant noise in the normal operation and response of these biochemical circuits and the difficulty in optimizing synthetic pathways while retaining the viability and reproducibility of the living system. However, the use of natural selection techniques in the lab preclude the need for detailed rational design so that an amateur scientist member of a terrorist organization can simply employ SynBio techniques for a large number of cells and select those that perform to the desired effect.


Cells are the fundamental unit of life containing all the molecular architecture required to engage in metabolism (transfer energy), grow, adapt to their environment, respond to stimuli, reproduce, and evolve. Under the right conditions, cells will replenish and increase their numbers if there exists enough food and space. A scientist who has engineered a cell with novel properties can keep producing that system by simply feeding the cells, clearing out the waste products, and harvesting cells when desired. Cell-based systems have co-evolved with viruses that target very specific cell types using lock-and-key-like receptor proteins on both the virus and cell. While viruses rely on cells to reproduce, it is standard lab practice to produce significant quantities of viruses using their cognate cells [cells taken over by the viruses] as hosts. Unlike conventional weapons, biological weapon development requires all the work up front and then the system will reproduce and provide the bad actor with a supply of the weapon as long as the growth-permissive environment is maintained.


SynBio also facilitates the development of binary biological weapons. Although the design and production of binary biological weapons may have been difficult in the past, the ability to engineer and ‘boot-up’ entire genomes has revolutionized the process. With modern synthetic biology tools, an undergraduate student could conceivably engineer and produce two related, non-lethal viruses that are individually harmless. However, following host infection with the two viruses, mixing of the two strains allows for a full restoration and production of highly infectious, pathogenic viruses. Importantly, such genetic mixing has also been documented in nature wherein two or more non-pathogenic poliovirus vaccine strains can recombine to form pathogenic recombinants. Thus, it is not difficult to imagine a non-state actor developing binary weapons consisting of components stored separately for safety in transport and then brought together in a biological munition prior to delivery.

Emerging Technologies, Governance & Responsible Innovation – Dr Filippa Lentzos


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.

Indian Vice Chief of Army Staff Lieutenant General S.K. Saini recently warned of a potential shift towards “zero cost wars,” wherein virulent pathogens could neutralize high-tech arsenals, highlighting the evolving nature of warfare. Concurrently, weaker militaries may seek asymmetric advantages in an era of unrestricted warfare, leveraging social media as a battleground for narratives. Instances of bioterrorism and state-sponsored efforts to procure deadly pathogens and sensitive biological information underscore the tangible threats posed by malicious actors. From individuals smuggling botulism and tetanus strains to nation-states attempting to steal coronavirus research data, these incidents emphasize the importance of vigilance in safeguarding against bioterrorism, which may exploit both external and internal channels within research organizations.

Synthetic Biology tools allow Bioweapons to be manufactured in fast timescales

What is Synthetic Biology and how is it related to biosafety and biosecurity?

The synthetic biology, the design and construction of biological devices and systems, promises  to augment biological life, in order to have it producing outcomes which we dictate. Synthetic biology represents an intersection of biology and engineering that focuses on the modification or creation of novel biological systems.Therefore, it combines the knowledge of genomics and chemical synthesis of DNA for the rapid production of catalogued DNA sequences. This branch of science  encompasses a wide range of methodologies from various sectors including biotechnology, computer engineering, control & biological engineering, genetic engineering, molecular biology, molecular engineering, systems biology, membrane science, biophysics, and evolutionary biology.


The advances in SynBio have not occurred in isolation. The increase in the understanding of biological systems and the development of the tools of molecular biology that occurred in the late 20th and early 21st centuries were paralleled by commensurate developments in automation, engineering, computer science, and information technology. In particular, the ease of scaling-up the production of bacteria and viruses has increased exponentially in recent decades due to the availability of inexpensive instrumentation for the growth, or culture, of biological material, and the development of standardized reagents such as bacterial growth media by commercial laboratories.


While the process of a virus acquiring pathogenicity has been occurring naturally through horizontal gene transfer for as long as these biological agents have existed, the use of SynBio molecular engineering tools provides a pathway to purposeful and precise changes in genomes on fast timescales not found in nature. Modular genes can be mixed and matched to increase the speed with which organisms can evolve and adapt, producing the type of functionality required of a given environment and providing the organism with a selective advantage compared to its competitors.


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 .


The Inherent Modularity of Biological Systems leads to Engineering of Bioweapons

Modularity is essential to the purposeful engineering of biological systems to create weapons. In general terms, modularity refers to the ability to replace or update a piece of equipment. For example, a set of interchangeable parts is what allows an individual to modify or optimize a complex piece of equipment, such as a home computer or an automobile. The genetic material (DNA or RNA) of any organism contains all of the information required for its proper functioning and is comprised of many modular components. Specific genes can be removed from one pathogen and inserted into another as a means of altering the activity of the recipient.


This modularity enables a measure of predictability of the effects on the complex network of genes when employing molecular engineering methods to insert a foreign gene into a host genome. For example, the modular nature of the non-pathogenic vaccine-strain of the poliovirus genome is what enables it to acquire pathogenicity genes from other viruses and revert to a pathogenic state (horizontal gene transfer). It has been postulated that molecular modularity evolved as a natural genomic tool, allowing biological systems to rapidly adapt to changing environmental conditions.

In 2005, a group of researchers from the U.S. Centers for Disease Control (CDC), the Mount Sinai School of Medicine, the Armed Forces Institute of Pathology, and the Southeast Poultry Research Laboratory reconstructed the 1918 pandemic influenza virus. This was a particularly striking example of how the modular nature of a viral genome could be used to manufacture a pathogen. The reconstruction was performed by first determining the genomic coding sequences of the virus from lung tissue specimens obtained from pandemic victims who were preserved in permafrost. The relevant DNA sequences were then inserted into a set of circular DNA strands known as plasmids, which were subsequently used to infect host human kidney cells. As predicted, fully functional and replicative viral particles emerged from the kidney cells.

The pathogenicity of the reconstructed virus was evaluated in mice, ferrets, and non-human primates, and it was found that the 1918 influenza strain was significantly more lethal than modern strains. It produced severe damage to the lungs, it stimulated an aberrant immune response, and it led to the development of high viral titers (levels of virus) in both the upper and lower respiratory tracts. The reconstruction procedure was conducted in a standard molecular biology laboratory setting, and all the materials needed for the construction of this viral particle are present in many university biology laboratories. The methods that were employed are not beyond the means of the talented amateur and therefore not beyond the means of a dedicated, well-resourced terrorist organization.


There is currently an effort underway to identify the minimal genome necessary for the survival of the simplest strain of bacteria. Once it is determined what genes are necessary for survival and reproducibility in bacteria, it may be possible to swap-out non-essential genes for genes conferring any number of desired characteristics. An increased understanding of the modularity of biological systems will impact the fields of biosecurity and military medicine by providing a “molecular toolkit” which can be used for peaceful purposes or by adversaries to design and manufacture biological agents.

Policy Responses

Policy responses to mitigate these threats include enhancing surveillance and response capabilities, investing in research and education, and strengthening international treaties and regimes. Organizations like the Biological Weapons Convention and the Australia Group play crucial roles in regulating biological materials and technologies.

Addressing the potential threats posed by synthetic biology requires a multifaceted approach involving various stakeholders. Military planners must remain vigilant, while the research community focuses on developing effective medical countermeasures and diagnostic technologies capable of discerning natural from engineered pathogens. Efforts should prioritize key biological research areas such as human genomics, immunology, bacterial and viral genomics, assay development, vaccine production, and novel antiviral agents and antibiotics. Continued investment in research and education within entities like the Department of Defense is crucial to maintain expertise in these areas.

Ensuring the rapid availability of trained personnel is essential for effective incident response. Therefore, emphasis should be placed on training and educating individuals in synthetic biology, biological engineering, and related disciplines. Numerous organizations exist to combat biological threats, including the Defense Threat Reduction Agency, the Centers for Disease Control, and various research institutes. Collaboration between civilian and military entities is vital in tackling natural, man-made, and weaponized biological materials.

International cooperation is also key to addressing biosecurity concerns. Organizations like the World Health Organization, along with research and response organizations worldwide, play essential roles in monitoring and responding to biological threats. However, limitations such as funding constraints and inadequate monitoring mechanisms must be addressed to bolster effectiveness.

Several international treaties and regimes aim to mitigate the risks associated with biotechnology. The Biological Weapons Convention (BWC), for instance, bans the development, production, and stockpiling of biological weapons. While the BWC lacks mechanisms for monitoring compliance, members can initiate consultations and report suspected violations to the UN Security Council. The Australia Group, a multilateral export control regime, assists countries in regulating substances that could contribute to the creation of biological or chemical weapons. However, challenges remain in monitoring and verifying compliance, underscoring the need for ongoing efforts to address biosecurity concerns.

In conclusion, addressing the threats posed by synthetic biology requires a coordinated effort at the global level. Enhanced surveillance, research, education, and international cooperation are essential to mitigate the risks associated with bioterrorism and ensure global biosecurity.

Ethical Education and Public Awareness:

Effective resolution of ethical concerns in biotechnology hinges on an informed and engaged public. Ethical education initiatives and public awareness campaigns play a crucial role in fostering ethical literacy and active participation in ethical decision-making.


The intersection of scientific progress and ethical responsibility defines the ethical landscape of synthetic biology. Collaboration among stakeholders and the establishment of robust ethical governance are essential for navigating the multifaceted challenges posed by biotechnological advancements. By embracing these challenges with thoughtful consideration and responsible innovation, we can unlock the full potential of synthetic biology while upholding ethical values and principles.

In conclusion, synthetic biology has revolutionized the landscape of biological warfare, presenting both opportunities and challenges. Vigilance, collaboration, and ethical oversight are essential to harnessing the potential of synthetic biology for beneficial purposes while mitigating the risks of bioterrorism. As technology continues to advance, policymakers and researchers must remain proactive in addressing emerging biosecurity threats to safeguard global health and security.





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