summarize this:
summarize this:
IV- ETHICAL CONSIDERATIONS AND THE REGULATORY LANDSCAPE
14. Societal acceptance is crucial to the wider adoption of synthetic biology and rests, inter alia,
on ethics, norms and attitudes (NATO STO, 2023c). From the outset, ethical considerations
accompanied technological advancements and sparked various reflection processes. In 2008, the
European Commission’s European Group on Ethics in Science and New Technologies (EGE) was
tasked with issuing an opinion on the technology’s ethical, legal, and societal consequences.
The EGE noted that synthetic biology raises fundamental questions about life and nature, including
the legitimacy of creating novel living organisms (EGE, 2009). In 2010, the Obama Administration
asked the Presidential Commission for the Study of Bioethical Issues (PCSBI) to draw up a report
on the ethics of synthetic biology published (PCSBI, 2010). The PCSBI “recommended revisiting the
moral objections to synthetic biology as the field advances, but we were not persuaded that synthetic
biology currently fails to respect the proper relationship between humans and nature” (Gutmann,
2011, p. 20).
15. Other ethical considerations include the potential ramifications of releasing synthetic biology
products into the environment. Concerns revolving around the environmental risk associated with
the release of synthetic biology agents, whether intentional or unintentional, are central to
discussions around biosafety and biosecurity (CRS, 2022a; EGE, 2009; Vergin, 2018). Questions of
ethics and norms also relate to the societal acceptance of synthetically altered organisms.
The general reservations and resistance towards genetically modified organisms (GMO) offer a
glimpse into potential public apprehension towards synthetic biology products.
16. As such, it comes as no surprise that the increasing relevance of synthetic biology goes hand
in hand with questions around governance and regulation. Regulatory questions centre on whether
synthetic biology is covered by existing regulations, sufficient for its safe application, or whether new
frameworks are required. Several countries draw on existing biotechnology frameworks. For
example, in 2018, the Central Committee on Biological Safety (ZKBS) in Germany concluded that
synthetic biology can be covered by the regulations applicable to GMOs (Hamilton et al., 2021;
Keiper & Atanassova, 2020). The United States regulates biotechnology on the federal level through
the Coordinated Framework for the Regulation of Biotechnology, which tasks several agencies with
regulatory oversight (CRS, 2022a). A review published in 2017 concluded that the Coordinated
Framework continues to be sufficient but questions remain as to whether the regulations in place
are appropriate for the various existing and future uses of synthetic biology (CRS, 2022a; NASEM,
2017). This chimes with the concerns of critics, claiming that “the current regulatory frameworks are
insufficient to cope with the complexities of engineering biology innovations and also do not take into
consideration building and maintaining trust in the regulation of engineered organisms” (OECD,
2023, p. 2).
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PRELIMINARY DRAFT REPORT – 059 STCTTS 24 E
17. The shared assessments of governments that existing biotechnology frameworks are sufficient
and applicable to synthetic biology do not imply regulatory coherence. Governments do not always
reach the same conclusions when it comes to the balance between ensuring safety and allowing
sufficient space for innovation (CRS, 2022a; Gronvall, 2018). Generally speaking, European
regulators tend towards the precautionary principle and their counterparts in the United States look
towards risk minimisation and cost-benefit analyses (DoD, 2015) and the UK historically has
possessed more stringent regulations for GMOs than the United States (Parks et al., 2017).
Other divergences emerge as the United States regulates products and European countries often
focus on the regulation on processes (CRS, 2022a; Parks et al., 2017). Such differences in
regulation, which are closely related to societal acceptability, carry implications for the adoption of
synthetic biology. In the eyes of commercial actors, it is, for instance, more likely that the food and
agriculture industry takes up synthetic biology products in the United States than in the EU (Parks et
al., 2017).
18. Given those differences, some analysts describe the regulatory architecture for synthetic
biology and biosecurity as “a ‘patchwork’ of international conventions, national laws, regulations,
guidelines, etc.” (Hamilton et al., 2021, p. 54). On the international level, governance issues are
discussed in various frameworks. Synthetic biology is a subject of interest for international
organisations, such as the World Health Organisation (WHO), the World Trade Organisation (WTO),
and the International Union for Conservation of Nature (IUCN). The topic also surfaces in the UN
Convention on Biological Diversity (CBD), the International Treaty on Plant Genetic Resources for
Food and Agriculture (ITPGRFA), the Biological and Toxin Weapons Convention (BWC) and the
Chemical Weapons Convention (CWC) (CRS, 2022a; Keiper & Atanassova, 2020; Trump et al.,
2021a). Discussions within the IUCN as well as the CBD, and its subsidiary Cartagena and Nagoya
Protocols, mirror more general debates regarding safety concerns and the suitability of existing
regulations (Keiper & Atanassova, 2020).The EU as well as the Organisation for Economic
Co-operation and Development (OECD)continue to consider the matter (Keiper & Atanassova,
2020). There are several non-governmental and multi-stakeholder initiatives that bring together
different actors within the field of synthetic biology. Moreover, there is a significant do-it-yourself
(DIY) biology community that overlaps and can go beyond existing academic and practitioner
initiatives (CRS, 2022a; OECD, 2023).