The term ‘synthetic biology’ refers to the science of using genetic sequencing, editing, and modification of genes to create unnatural organisms or organic molecules, which could function in living systems.
Synthetic biology could also mean ‘re-programming’ natural organisms to perform a task to have new abilities just as computers can be re-programmed or customised for specific functions. Synthetic biology integrates different technologies to enable various applications that have enormous potential. Though these technologies were once restricted to specialised institutions, they are now freely available online through kits, bioinformatics tools, and data, and has increased access to these technologies for legitimate purposes. However, adequate security has to be designed in the availability of these technologies to avoid their misuse, such as the ‘home-brewing’ of recreational drugs or generating peoples’ portraits from discarded DNA samples, etc. Howsoever low may be the rate of incidents of bio-crime, the risks should not be ignored as their impacts could be severe.
Applications and Advantages of Synthetic Biology
Synthetic biology enables scientists to design and synthesise new sequences of DNA from scratch. Synthetic biology has got a variety of applications in various fields such as developing synthetic organisms for vaccination; creating natural products in a lab such as vanillin (the organic compound extracted from vanilla seeds); making natural compounds such as artemisinin, used for the treatment of malarian, and chimeric antigen receptor (CAR) T-Cell therapy for the treatment of cancer; delivering fixed nitrogen to plants instead of using fertilisers; engineering microbes to create food additives or brew proteins, etc. Besides, synthetic biology has many promising and useful applications, and can positively transform society in many application areas.
However, the cons of synthetic biology include some wrongdoings as well such as illegal gene editing, home-cooked drugs, and neuro-hacking. This neuro-hacking came to limelight in 2001 after the ‘anthrax attacks’, in which people received letters laced with anthrax, a killer bacterium developed by an American microbiologist Dr Bruce Ivins.
In the present era, handling deadly pathogens need not have a large set-up, a lot of money, or high levels of technical expertise. This is an era of do-it-yourself (DIY) and home-made drugs which could be both beneficial and harmful. In the last few years, scientists have raised certain concerns but, by all accounts, nobody is sure how to counter them.
According to a paper titled Criminogenic Potential of Synthetic Biology published in ‘Frontiers in Bioengineering and Biotechnology’, cybercrime that has emerged following the advent of the internet, bio-crime could adversely impact society and peoples’ health. Though systematic evidence, quantifying the crime opportunities posed by synthetic biology, has been limited, eight potential crime categories have emerged from the studies—(i) illegal gene editing; (ii) home-made bad drugs; (iii) genetic blackmail; (iv) neuro-hacking; (v) bio-hacking; (vi) bio-discrimination; (vii) cyber bio-crime; and (viii) bio-malware.
Risks Associated with Synthetic Biology
Any crime related to synthetic biology would likely require multidisciplinary expertise to detect and prevent, involving collaborations with, for instance, computer scientists, bioinformaticians, molecular biologists, and information technologists. As more connections between traditionally isolated systems are developed, more security controls must be considered in order to mitigate risks and reduce vulnerabilities. In view of high stakes, the risks associated with bio-crimes must be assessed, and preparations be made and brought in to prevent them as soon as possible.
Tools of Synthetic Biology
Though the concept of synthetic biology has been in use since decades, two factors have made it easily accessible. One is ‘next generation sequencing’ (NGS), which means ultra-quick genome sequencing. The NGS determines the order of nucleotides in entire genomes, or targeted regions of DNA or RNA. Also, the cost of genome sequencing has come down drastically from thousands of dollars earlier to a few hundred dollars due to NGS. The second tool is known as gene editing tool, namely, Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR). CRISPR helps to alter a DNA and modify gene functions. This technology has rather democratised genetic engineering. Another gene editing tool is Transcription Activator-Like Effector Nuclease (TALEN). These genome editing kits are now openly available for purchase, online. Skilled amateurs as well as professional scientists could experiment with gene editing technology.
Each of these categories has the ability to spawn a class of criminals specialising in it. For instance, banned psychoactive drugs like poppy could be made at home by understanding the biosynthesis pathway. A blackmailer could easily obtain the saliva samples of a father and son, do a paternity test, and could resort to blackmail if the test is found negative. A neuro-hacker could manipulate the gut biome of a person and control the person’s brain, due to a connection between the activities of the bacteria in the gut and the brain. It is also suggested that synthetic biology presents substantial new offending opportunities. Therefore, more effective engagement, such as ethical hacking, is needed now to prevent a crime harvest from developing in the future.
How to Combat Bio-crime
Current measures are incomplete as they are limited to the use of biological agents in isolation. Modern biotechnology comprises integrated workflows that are increasingly dependent upon computer-controlled and automated systems. Although this creates efficiencies, it also paves the way for bio-crime. Present biosecurity is outdated. If dedicated resources are not allocated to address these crime types as something distinct, the crime would be outpaced.
The researchers of the study have also proposed that increase of ‘ethical hacking’ is a way to move away from reactive changes, and towards proactive governance in the field of health security and biosecurity. Also, experiments on new synthetic biology technologies must be performed by generating a dynamic understanding of their security limitations.
India and Synthetic Biology
In February 2022, the Department of Biotechnology, Government of India, had brought out an insightful ‘Foresight Paper’ and called for a policy on synthetic biology. As per the paper, synthetic biology is a field of learning from nature about various genetic pathways. However, it could also have adverse impacts such as escaping into the environment and recombining with existing biodiversity. The paper recognised the inadequacy of regulatory tools to deal with the emerging situation. It has stressed the need for a national polity that could consolidate India’s stand on the issue. The paper has also stated that India should avoid conflicting stands on science as well as policy.
The paper looked at the global policies and protocols regarding developing a policy. It attempts to define synthetic biology and how intellectual property rights would be applicable to resulting processes and products. Benefits of the products developed using synthetic biology, and the risks posed to biodiversity must be considered.
This document would help in creating a national policy. The paper locks at how synthetic biology has to be governed as it is a new field, and the definition of what would be included and what would not be, is still not clear. Many of the existing regulatory frameworks have been developed in the context of traditional fields such as biotechnology and genetic engineering. However, these frameworks may have to be revised to address fresh challenges.
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