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

Synthetic biology (synbio) represents a new and emerging scientific discipline which lies at the intersection of engineering, computational modelling, and biological sciences. It is based on an engineering approach to biology with the aim of designing and developing biological systems that do not exist in Nature or redesigning existing ones from scratch. Because of its powerful and unprecedented profile, synbio is considered as the new frontier of genetic engineering. However, unlike conventional genetic engineering, which deals with the manipulation of natural/existing genetic material, synbio creates computer- and-chemical-based DNA sequences starting from known or invented genes. Synbio is becoming increasingly prominent in a number of fields as its applications hold promise for addressing some of the major societal challenging, including for what it concerns the energy (advanced biofuels), health (better drugs with lower side effects) and environmental (less harmful pesticides) sectors. New gene-editing tools, like CRISPR-Cas9, labelled as 'razor-sharp genetic scissors', further increase the potential of synbio by boosting its intersectional nature. In early 2019, UC Berkeley scientists advanced the possibility to use carbon nanotubes to deliver CRISPR-based DNA modifications into plant cells, with no trace of foreign DNA left in final product. With great promises though come great perils. Major risks include: potential harm to the environment and biodiversity (e.g. the failed attempt to eliminate malaria-carrying mosquitoes through CRISPR gene drive), ethical concerns (e.g. those on the gene-edited babies in China) including bioterrorism threats, and fair access and equitable sharing of synbio's benefits. This interdisciplinary and comparative project intends to reflect on an appropriate regulatory framework that can ensure a safe and responsible development of synbio while preventing adverse effects on human health and the environment. The analysis focuses on two main legal regimes, the EU/EEA (including Norway) and the US one; and the status of synbio within the Convention on Biological Diversity (CBD) and its Protocols.

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Synbio is a convergent technology, combining biology and engineering, often overlapping with bioengineering and biomedical engineering, and yet maintaining a distinct and separate profile. It holds the promise of remedying to some of the most pressing global and societal challenges ranging from the sustainable production of biofuels to environmental decontamination and cleaning-up, and from new medical treatments to novel and powerful plant breeding techniques. Importantly, this form of extreme genetic engineering differs significantly from conventional genetic engineering in the techniques, scale and the manipulation of novel and synthetic genetic material: instead of slicing and dicing gene sequences from a natural organism in order to implant them in 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. The difficult task that lies ahead of regulators worldwide is to adopt regulations on synbio that strike the right balance between the need to allow responsible and ethically-sound research to flourish in this controversial area, while ensuring high levels of human health and environmental protection. This project focuses on two main legal regimes of the EU and the US. The project argues that an international coordination of the regulatory approach to synbio is to be preferred. It suggests also that any such effort shall be nested in the recognition of the new category of risk posed by synbio that is to be regulated by specific institutions and liability regimes. The three features this new risk category should possess are: designed-in ethical principles, strong precautionary imprint with a default placement of the burden of proof on the industry, and high transparency and democratic participation in decision-making. As to the CBD, this project holds that the adoption of a new Protocol has become necessary.