Synthetic biology – engineering biology and a need for regulation

As the first project of its kind in the field of law, Nertila Kuraj’s project on regulation of synthetic biology (SynBio) was recently awarded funding under the FRIPRO Mobility grant scheme. This year, only four projects in the humanistic and social science disciplines were funded on a national level. This project will commence 1 November 2018.

Postdoctoral researcher Nertila Kuraj. Copyright: S. Kuraj.

Nertila Kuraj is currently a postdoctoral researcher at the Faculty of law, UiO. After finishing her PhD thesis on environmental regulation of nanotechnology, she has now moved to the field of synthetic biology.

What is synthetic biology?

On one side we have Genetically Modified Organisms (GMO) were parts of genetic material of, for example, seeds or plants is altered. Synthetic biology on the other hand sets out to build the entire organism by synthetizing the DNA from scratch. Kuraj sums it up like this:

- Synthetic biology is considered a form of ‘extreme genetic engineering’. It is ‘extreme’ in that it differs significantly from ‘conventional’ genetic engineering in the technique, scale and the manipulation of novel and synthetic genetic material. More flatly stated, instead of slicing and dicing gene sequences from a natural organism in order to implant them into another natural organism to attain a specific function, which is roughly what bioengineering currently does, synbio creates computer-and-chemical-based DNA sequences starting from known or invented genes.

Playing God

For non-scientist, understanding how synthetic biology works, is still complicated. An event from 2010 and the moment many refer to as when artificial life was first created may illustrate what synthetic biology is, and why it is so controversial.

In 2010 the geneticist Craig Venter and his team at the Craig Venter Institute in California, made headlines by announcing that they had synthetized the genome of a brand new cell dubbed Synthia. By using chemicals, the team constructed the full genome of a bacterium in their lab, and then implanted this synthetic DNA into the empty cell of a related microbe. 

Because of the enormous consequences the ability to create artificial life might have, the team of scientists have been accused of “playing God” and “tampering with the essence of life”.

SynBio is also considered a form of ‘engineered molecular tinkering’, a tinkering that seems to be at odds with natures evolution. Because of this unprecedented nature, SynBio invites cautious and careful considerations not only on its normative aspects, but on ethical and philosophical aspects as well. For instance, future developments and application of synthetic biology will seriously challenge fundamental concepts such as the nature of life and the principle of human dignity. Law will consequently be called on to adequately respond to challenges emerging from these profound and unprecedented developments of science and technology.

Regulating life in a Petri dish

The notion of being able to create life in a laboratory sparks the interest and apprehension of many. What made you choose to focus your research on this field?

As a lawyer researching the regulatory aspects of new and emerging technologies, the field of synthetic biology immediately captured my attention and professional curiosity. In a way, synthetic biology is a natural continuation of my PhD research, since nanotechnology developments provide the ‘tools’ for the advancement of synthetic biology. At the same time though, synthetic biology is different from my previous research because the focus is shifted from the area of chemical law and into the area of bioengineering.

Synthetic biology holds promises of remedying to some of the most pressing global and societal challenges, but poses equally concerning risks to humans and the environment. Therefore, it is crucial that the law grapples with the nature, magnitude and severity of such risk now, while SynBio is still in its infancy.

For the next three years, Kuraj will focus on the area of biodiversity protection, as the food and agricultural sector represent a major area of early application of SynBio. This way, one of the first synbio products to hit the market was synbio vanillin, synthetized by the Swiss-based Company, Evolva, by using synthetic DNA and reprogrammed, genetically engineered yeast. This synbio version of vanillin, Evolva claims, is better than the one derived by petrochemicals, in terms of both taste and sustainability. Yet, these kinds of applications are also cause for  of great concern.  

Risk related to such applications are high and include the possibility of intentional or accidental escape of synbio products into the environment. This can lead to genetic contamination of wild species, disruption of natural ecosystems and release of synthetic chemicals.

In addition to environmental harm, there is also the potential for negative impacts on farming communities. This raises concerns that go beyond the risks posed to environmental and biodiversity protection, including the access to synbio genetic resources and the fair and equitable sharing of its benefits. It is no coincidence that the attention of the policymakers and regulators is placed on laws and statutes that already deal with biodiversity protection goals in relation to biotechnology products such as GMOs.

Comparing laws and regulations

Kuraj’s  project is still at an early stage and the project will certainly lead to important insights on the topic. To begin with, how do you plan to work on mapping the regulatory needs in this novel yet very important field of research?

In the present situation, it is important to have a clear oversight of synbio under the main existing legal instruments dealing with biodiversity protection aims, chiefly the Convention on Biological Diversity and its protocols, and the EU directives and regulations on GMOs.

With the aim of moving the discussion forward, Kuraj will compare the regulatory landscape in the US to the EU/EEA, including Norway.

This choice derives not only from the fact that the two entities are frontrunners in the Research & Development initiatives concerning synbio, but also from the different approaches that the two jurisdictions apply to the regulation of conventional bioengineering and GMO products –approaches that are likely to be applied for synbio as well. This comparative take, in addition to the interdisciplinary nature of the project, will arguably result in a thorough analysis of the environmental risks posed by synbio and on how to weight such risk against the prospected beneficial applications of the technology, in the light of the legal principle of precaution.

Timely and very useful for society as a whole

The project Kuraj has undertaken is not small, and the review committee at the Research Council deemed the project “not only a very timely, but also a very useful project for the society as a whole”.

To grapple the legal aspects, Kuraj will have to familiarize herself with  the science behind the law, i.e. on the scientific and technical aspects of concerning synthetic biology. The United States lead the field of research and development on synbio, and therefore she will spend the first two years of the project period at UC Berkeley, in Berkeley Californiao.

Over the next three years, Kuraj will produce several scholarly works and attend and organize a number of conferences and workshops. She aims to bring together scientists, lawyers, ethicists and philosophers to discuss what she calls a “complex, multifaceted and fascinating technology”.

Kuraj sees the project as a starting point for other research projects and has already started drafting a proposal in collaboration with UC Berkeley for the NANO2021 program of the Research Council of Norway.

If the application is successful, it will allow for the financing of a couple of PhD and postdoc positions in the legal field working on the regulatory aspects of other convergent technologies such as bio-informatics, human enhancement and military applications and biomedicine. The Norwegian government and the Research Council place particular emphasis on research from humanities and the law disciplines dealing with the challenges posed by the emergence of new and complex technologies. It is therefore necessary to foster such research and secure funds that will allow faculties to enlarge their research portfolio in line with such priorities. This project is a stepping-stone in this regard, and I hope that it will enable the establishment of bigger projects in the future.

Before embarking on her current project, Kuraj has a clear vision of what the next three years will generate: New ways of thinking about some of the most urgent legal aspects related to the unprecedented nature of synthetic biology.

For more project information, please refer to Nertila Kuraj's project web page: The case for Regulation of Synthetic Biology and the Need for a New Category of Risk. An Interdisciplinary analysis between the EU and the US.

By Anne-Marie Gulichsen
Published Sep. 28, 2018 10:45 AM - Last modified Oct. 2, 2018 11:02 AM