The Transnational Governance of Synthetic Biology Zhang, J.Y.

Introduction

Conflicting narratives: New industrial revolution or old wine in new bottles?

Existing discussions on synthetic biology often depict two different stories On the one hand, synthetic biology is portrayed as the force for a “new industrial revolution” (RAEng, 2009) delivering an

Synthetic biology presents a unique set of technological solutions with significant economic potential across various sectors, including renewable energy, biosensors, and biomedical devices, with market forecasts predicting growth exceeding $3.5 billion in the next decade However, the current market outlook is challenging, as pharmaceutical and biotechnology companies are not significantly investing in synthetic biology, largely due to the lengthy translation research process and the necessity for public funding to create foundational tools The Royal Society of Edinburgh emphasizes the irreplaceable role of government sponsorship in advancing this field.

The economic significance of synthetic biology is met with inconsistent assessments and conflicting views on regulatory frameworks Some advocate for a bottom-up governance approach that includes partnerships with civil society, social scientists, and ethicists to better address critical issues and develop relevant regulations Conversely, many recommendations still emphasize the necessity of a strong governmental role in regulating synthetic biology While there is support for a pluricentric governance model involving multiple stakeholders, the government remains a dominant force in current regulatory discussions.

The field of synthetic biology has sparked a debate regarding its novelty and the associated risks Proponents argue that it signifies a significant scientific paradigm shift, with the potential to simplify biological engineering through the creation of standardized, modular biological parts that can be designed via computer systems However, this advancement raises concerns about unlicensed individuals potentially synthesizing harmful viral genomes Experts emphasize the need to address ethical and safety issues early on to ensure public support for future developments Conversely, critics argue that many risks linked to synthetic biology already exist due to the accessibility of basic techniques The SB2.0 conference highlighted that most biosafety and biosecurity concerns predate synthetic biology, suggesting that merely renaming existing technologies does not introduce new hazards.

Turning the debate back onto its feet

In analyzing synthetic biology, stakeholders often emphasize its novelty and the unique industrial and governance challenges it presents, while others view it as merely a rebranding of existing technologies There is no straightforward relationship between the social groups involved—such as regulatory bodies, the scientific community, NGOs, and companies—and their perspectives on synthetic biology Opinions on whether synthetic biology should adhere to past experiences or be treated as a distinct entity can vary even within the same document, influenced by the specific topic under consideration, whether financial, ethical, or environmental Ultimately, the ongoing debates illustrate that synthetic biology can be seen as both a continuation of previous biotechnologies and a radically new field, with interpretations shifting based on the context of the discussion.

Evolving synthetic biology research presents significant challenges to existing regulatory frameworks, as noted by various organizations (OECD & the Royal Society, 2010; NEST, 2005; Parens et al., 2009) However, these challenges may be addressed by adapting existing national and international regulations related to GMOs, stem cells, chemicals, cosmetics, biotechnologies, data protection, and risk management (EGE, 2009).

The current regulatory framework for synthetic biology is deemed effective, as noted by the Royal Academy of Engineering (2009) Despite the calls for action due to the innovative and transformative aspects of synthetic biology, a closer look at the regulatory discussions reveals a consensus that no additional measures are necessary at this time.

Many reports on emerging technologies, particularly synthetic biology, fail to acknowledge their 'trans-scientific' nature, leading to a governance approach that is overly reliant on established policy categories This results in a tendency to 'fill the prescription' by adapting problems to fit existing solutions Notably, reports from organizations such as the Royal Academy of Engineering and the European Group on Ethics in Science follow a similar structure: they begin with technical aspects, proceed to regulatory issues like biosecurity and biosafety, address ethical and social implications, and conclude with calls for public engagement This linear progression reflects a prevailing belief that governance should be grounded in scientific evidence, relegating ethical and social concerns to a later stage in the innovation process.

This paper reorients the discussion on synthetic biology governance by emphasizing the importance of understanding its current dynamics instead of merely categorizing issues It highlights the technical and social contexts that allow for conflicting perspectives to coexist and uses this understanding to address key governance challenges and potential solutions Effective governance aims to promote quality scientific research while ensuring that transparency and accountability are prioritized through clear regulations, fostering trust in the scientific community.

Identifying sources of concern

Scientific uncertainty

Modern scientific inquiries have expanded social choices and developmental promises while simultaneously fostering a social consciousness among stakeholders regarding the limitations and fallibility of scientific knowledge (Beck, 1992).

Synthetic biology is recognized by the International Risk Governance Council as a source of emerging risks, highlighting its potential consequences in scientific practice.

Risk management for synthetic biology faces challenges due to its reliance on traditional risk assessment methods, which compare engineered organisms to their natural counterparts This approach focuses on the traits of the recipient, donor, and vector organisms, but as genetic components can now be designed and synthesized via computer, the relevance of these classifications diminishes Furthermore, synthetic biology enables the creation of entirely new life forms, such as minimal cells, which lack natural comparators and pose unique risks Even when all components of a synthetic microorganism are identified, predicting unexpected emergent properties remains difficult These uncertainties are frequently overlooked in policy discussions, which can be overly influenced by rigid scientific frameworks.

In its 2009 proposal for biological risk assessment, the Royal Society identified three main areas of the "risk spectrum": naturally occurring risks, unintended risks such as dual-use research findings, and the deliberate weaponization of biological agents These concerns extend to synthetic biology, where issues of "bioterror" and "bioerror" arise While "bioterror" refers to intentional misuse of scientific advancements, "bioerror" highlights the potential for unforeseen harmful consequences stemming from legitimate research conducted by authorized institutions Both terms underscore the importance of addressing security and safety risks associated with synthetic biology.

“bioerror” calls into question existing institutional estimation of technical control and conventional assessments on the validity of ‘evidences’

Acknowledging scientific uncertainty involves recognizing the limitations and partiality of knowledge, as well as an acute awareness of what remains unknown, including provisional unknowns and willful ignorance (Beck, 2007 [2009]:115-128) Effective governance of science must address not only the production and application of knowledge but also the regulation of uncertainty, ignorance, and indeterminacy (Stirling, 2008 and 2010; Wynne, 1992) This highlights the governance challenge presented by both knowledge and the aspects of non-knowing, which is further explored in Section 5.1.

Cross-borderness

Synthetic biology is characterized by significant scientific uncertainty and a notable aspect known as 'cross-borderness.' To grasp the complexities of synthetic biology, it is essential to recognize how it transcends the boundaries of various scientific disciplines, industrial sectors, and geopolitical regions.

Synthetic biology integrates various research disciplines, including engineering, biology, chemistry, and nanotechnology, by applying engineering principles to living systems The European Commission's New and Emerging Science and Technology programme identified the primary challenge of synthetic biology as the effective integration of these existing disciplines In the UK, funding initiatives emphasize the importance of developing a cohesive, cross-disciplinary community to advance synthetic biology research.

Synthetic biology is recognized as an emerging hybrid discipline that integrates elements of engineering and science to engineer synthetic organisms, addressing the challenge of overcoming the research language barrier (BBSRC, 2007; Adrianantoandro et al., 2006).

Synthetic biology does not simply transcend existing disciplinary boundaries; it requires more than just overcoming language barriers to form innovative inter- or multi-disciplinary partnerships Different scientific disciplines possess distinct "epistemic cultures," which encompass varying perceptions of knowledge, its production, and application This is especially evident in the interplay between biology and engineering, where historical attempts to merge these fields have often encountered challenges.

Despite the introduction of new postgraduate courses aimed at cultivating a first generation of synthetic biologists, the field is likely to continue relying on contributions from established "parent disciplines" in the near future The Royal Academy of Engineering (2009) highlights that due to the extensive expertise required, aspiring synthetic biologists must first be trained in a core discipline before engaging in interdisciplinary research As a result, many researchers may remain committed to their original fields, where they receive primary peer support and recognition.

From a governance perspective, it is essential to acknowledge the potential challenges that synthetic biology may face in bridging various scientific disciplines, rather than assuming a seamless integration of all fields This inter-disciplinary cross-borderness is identified as a significant governance challenge As noted by Drew Endy, a prominent synthetic biologist at Stanford University, effectively addressing biosafety and biosecurity issues hinges on the ability to communicate and comprehend identified risks across different disciplinary boundaries.

The influx of individuals into synthetic biology primarily consists of physicists, computer scientists, and electrical engineers rather than traditional biologists This shift brings a unique cultural perspective, but it also highlights a significant gap in microbiological safety experience To advance in this field, it is essential to bridge both generational and cultural divides by sharing knowledge effectively.

(Endy in Lentzos et al., 2009: 319)

Scientists like Drew Endy emphasize that synthetic biology does not effortlessly bridge disciplinary divides; instead, practitioners must navigate these differences daily Collaborating across various fields requires effort and intentionality, as access is not guaranteed Furthermore, knowledge must be effectively communicated and translated, addressing both generational gaps and cultural divides.

Discussions about intellectual property (IP) regimes for synthetic biology also highlight difficulties arising from its position “at the confluence of biotechnology and computing” (Rai and Boyle, 2007:

Software does not neatly fit into the intellectual property frameworks of patents or copyrights, a complexity that is only compounded by attempts to categorize it under both (Balmer and Martin, 2008:23) A prominent group of synthetic biologists advocates for an open-source culture, inspired by advancements in computer software, through initiatives like the Registry of Standard Biological Parts, iGEM, and the BioBrick Foundation's BioBrick Public Agreement (BPA) However, during a recent workshop at LSE, both social scientists and synthetic biologists concurred that the current research practices in synthetic biology have not yet undergone a significant transformation towards this open-source model They noted that existing research infrastructures, such as the MIT Registry and the BPA, still facilitate traditional patenting of biological components Consequently, future synthetic devices are expected to integrate both unpatented and patented elements from various industrial sectors.

IP discussions highlight two significant types of 'cross-borderness' that pose challenges for regulators Firstly, there is a cultural clash at the industrial level, as different sectors—such as pharmaceuticals, chemicals, academia, and semiconductors—view intellectual property rights through distinct lenses, making it difficult to reconcile their interests Secondly, while patent rules are largely consistent globally, patents themselves are typically confined to national or regional jurisdictions, leaving inventors to decide where to seek protection This creates complexities and uncertainties regarding the patentability of synthetic biology, which not only affects domestic scientific progress but also impacts transnational compatibility and competitiveness.

Synthetic biology is prompting industries, once governed by distinct regulatory bodies and priorities, to converge at a unified policy discussion The emergence of "garage biology," where individuals can buy DNA sequencing tools online and experiment at home, blurs the lines between personal hobby and public responsibility As highlighted in a joint workshop report by the OECD and the Royal Society, synthetic biology is evolving both within established scientific and technological frameworks and in non-traditional settings.

Synthetic biology exemplifies multi-lateral interdisciplinary research by fostering collaboration among diverse fields of expertise, integrating various aspects of social and economic practices This approach necessitates the involvement of a wide range of social actors to address related challenges, highlighting the significance of accountability beyond one's primary discipline Furthermore, the cross-borderness of synthetic biology not only refers to the collaboration across different sectors but also emphasizes the importance of international cooperation in scientific research that transcends national and geographic boundaries.

Global development of synthetic biology

The US: A lead in the initial industrialisation of research

The United States is a leader in synthetic biology, often regarded as having an "established" research field, unlike many other countries where it is still developing It excels in scientific publications, training research personnel, and securing funding from both public and private sectors, positioning itself at the forefront of the initial industrialization of synthetic biology.

The Woodrow Wilson Center has identified 184 synthetic biology-related institutions in the U.S., with 80% being universities and companies Significant funding for pharmaceutical applications, such as the malaria drug artemisinin, comes from venture capital and philanthropic foundations like the Bill & Melinda Gates Foundation Specialized companies, including LS9, Amyris, OPX Biotechnologies, Solazyme, Gevo, and Synthetic Genomics, are focused on commercializing biofuels Since 2005, the U.S government has invested approximately $430 million in synthetic biology research, primarily through the Department of Energy, alongside support from the National Institutes of Health, National Science Foundation, and Department of Agriculture.

Only 4% of US government funding for synthetic biology is dedicated to exploring its ethical, legal, and social implications, particularly focusing on biosecurity (Woodrow Wilson Center, 2010: 2) The National Science Advisory Board for Biosecurity (NSABB) has responded to dual-use concerns by issuing two sets of guidelines in 2006 and 2010 A notable aspect of SynBERC, a leading research center, is the involvement of social and human scientists in its "Human Practices" initiative (Rabinow and Bennett, 2009).

The UK: Building research networks

Unlike the US, the UK has not demonstrated significant industrial activity in synthetic biology, with only one commercial DNA synthesis company in 2008 compared to 24 in the US The House of Commons Science and Technology Committee highlighted in 2010 that although research funding is adequate, there is a lack of strategic planning for translating synthetic biology advancements, such as developing DNA synthesis capabilities Without addressing these issues, the UK risks failing to leverage its strong research base and falling behind in the global synthetic biology landscape.

Since 2005, funding for synthetic biology in the UK has ranged from $30 million to $53 million, as reported by the Woodrow Wilson Center, with financial support coming from government research councils and medical charities like the Wellcome Trust In testimony to the House of Lords select committee on Science and Technology, the UK Research Councils revealed that approximately £20 million was allocated to synthetic biology during the 2007-08 fiscal year.

In 2008, the UK launched its first funding initiative for synthetic biology, the "Networks of Synthetic Biology," supported by four research councils: EPSRC, BBSRC, ESRC, and AHRC, with a budget of £891k to establish seven UK Networks led by various universities These Networks aim to foster interdisciplinary partnerships and create a cohesive community in synthetic biology Additionally, in 2009, the EPSRC granted £5 million to Imperial College and the London School of Economics to establish the Centre for Synthetic Biology and Innovation (CSynBI), further promoting advancements in this field.

“build new activity in areas of national strategic importance”

The UK has made significant contributions to grey literature on synthetic biology, with at least 11 reports published by UK organizations over the past four years A notable aspect of this field in the UK is the active involvement of social scientists, with around 40 affiliated with various networks, including the London School of Economics (LSE) as a partner in CSynBI While the exact role of these researchers remains somewhat ambiguous, their participation aims to ensure that societal issues are integrated into the discussion from the outset.

China: The “Big Question” approach

Synthetic biology research in China is still in its early stages, characterized by limited national funding and a lack of industrial participation Most funding is sourced from national agencies, particularly the National Natural Science Foundation of China and the Ministry of Science and Technology (MOST) Despite being designated as a priority area in MOST’s funding scheme since 2010, there have been no successful applications for financial support in this field.

China's engagement in synthetic biology has been significantly influenced by student participation in the iGEM competition, which began in 2007 with four teams primarily from the Beijing-Tianjin area By 2010, the competition saw eleven teams from nine universities across six provinces and municipalities in China This growth in iGEM involvement has paralleled the establishment of synthetic biology research programs in the Beijing-Tianjin region, Anhui Province, and Shanghai, predominantly driven by universities and research institutions affiliated with the Chinese Academy of Sciences (CAS).

Recent fieldwork in China highlights the discussion of a "Big Question" approach within the synthetic biology community, reminiscent of the nation's collaborative efforts in synthesizing crystallized bovine insulin in 1965 This strategy aims to unify dispersed national expertise around a central research question crucial for advancing the field Supporting research areas and specific topics will be assigned to various universities and research institutions, fostering nationwide synergies focused on a common objective Scientists believe that this top-down organizational model could incentivize research and provide sustained financial support for achieving intermediary results Currently, this initiative is in the consultation phase under the supervision of the Ministry of Science and Technology (MOST).

In China, public discourse on synthetic biology is limited, with media coverage predominantly favorable However, the Chinese scientific community appears to be heeding past experiences in life science development, recognizing the importance of addressing global ethical concerns to avoid the negative perception of being the "Wild East" of biology.

Many in China argue that external perspectives often overlook the significant progress made in establishing laws, regulations, and guidelines for biotechnology, particularly in biomedicine Although synthetic biology research is still in its early stages, a national conference addressing the ethical and biosafety concerns of this field was held in June 2010 in Suzhou, organized by the China Association for Science and Technology, the Chinese Society of Biotechnology, and the Beijing Institutes of Life Science.

A fuller picture of the global development of synthetic biology

The development of synthetic biology varies significantly across different countries, highlighting the diverse challenges stakeholders may encounter However, to gain a comprehensive understanding of this field, it is essential to consider transnational activities, as many nations' advancements in synthetic biology are deeply intertwined with international collaboration and efforts.

The globalization of synthetic biology research is significantly driven by transnational funding programs Notably, China's inaugural synthetic biology project received its funding from international sources rather than domestic ones.

The "Programmable Bacteria Catalyzing Research (PROBACTYS)" initiative, funded by the European Commission’s Sixth Framework Programme, highlights significant international collaboration in synthetic biology research In 2009, the US National Science Foundation (NSF) and the UK Engineering and Physical Sciences Research Council (EPSRC) jointly supported a "sandpit" event, leading to the development and funding of five US-UK research projects Additionally, Europe has fostered international research through the European Commission’s New and Emerging Science and Technology (NEST) Sixth Framework Programme (FP6) and the EuroSYNBIO programme by the European Science Foundation.

Transnational developments are also visible in several governance initiatives, such as the workshop organised jointly by the OECD, the US National Science Foundation and the UK Royal Society in

In 2009, a collaborative initiative between the Austrian Science Fund (FWF) and the National Natural Science Foundation of China (NSFC) focused on assessing the biosafety and risk management needs of synthetic biology in both Austria and China This ongoing project involves six science and engineering academies from the USA, UK, and China Additionally, governance-related efforts are evident within the European Research Area, such as the NEST FP6 program, which includes the TESSY "roadmap," and the European Academies Advisory Science Council's 2010 report on synthetic biology (EASAC).

The influence of transnational research interactions is more than simple financial backing and resource exchange, but has also explicitly and implicitly changed the dynamics of global scientific governance

The "International Genetically Engineered Machines" (iGEM) competition represents a significant transnational initiative in synthetic biology While Section 6.4 provides an in-depth analysis of its governance implications, a visit to an iGEM team in China illustrates the global nature of this field.

In 2010, we discovered that communication among domestic iGEM teams was quite active, with formal national training camps and conferences taking place Additionally, students organized a nationwide workshop in Shanghai to collaboratively test their ideas This led us to inquire about the possibility of establishing a "national bank" to archive past designs from iGEM teams across China for the benefit of future teams However, both the tutor and team members questioned the necessity of such an initiative.

The BIONET project, led by the London School of Economics (LSE), provides valuable insights into the ethical governance of research in the life sciences and biomedicine For more information, visit their official website at http://www.bionet-china.org/.

BioBricks offer a seamless way to access desired parts, providing direct connections to data generated by iGEM teams globally, including those in China Establishing a national bank would simply replicate this system on a smaller scale.

The BioBricks Foundation’s Registry faces challenges regarding the quality of its parts and concerns related to its open-source nature To tackle these issues, initiatives are underway to establish both public and private "BioFabs."

In the US and the UK, research is often shaped by professional scientists rather than undergraduate students, highlighting a distinct perspective among grassroots scientists and emerging researchers regarding national versus international frameworks These researchers tend to view national research infrastructure, like a national iGEM bank, as less essential, favoring transnational institutions such as the MIT Registry for more effective research facilitation.

The global development of synthetic biology reflects a blend of national characteristics and intricate international connections While most research activities and funding are predominantly national, with the USA leading the field, the impact of these cross-border collaborations is substantial This interconnectedness has important implications for governance in synthetic biology, highlighting the need for a nuanced understanding of both local and global dynamics in this rapidly evolving science.

National characteristics in research are still evident, influenced by regional contexts and development paths However, there is an increasing trend of governance initiatives emerging from multinational groups, cross-border financing strategies, and transnational management of research infrastructure and data This shift indicates that as transnational communication becomes integral to scientific research, non-state actors are gaining an enhanced capacity to govern.

There is a noticeable shift in how local, national, and international authorities perceive problems and define their objectives, strategies, and techniques Effective governance of synthetic biology requires nation-states to delegate authority to various civil institutions and networks, as well as to engage with transnational agents like international conferences and cross-border research initiatives, such as iGEM This necessity for a change in governance ethos and practices will be further explored in Section 6 of this paper, addressing the governance challenges discussed.

Key Governance Challenges

The salience of both knowledge and non-knowing

The regulatory challenges posed by scientific uncertainty in synthetic biology have been widely acknowledged, leading to expanded policy consultations and enhanced scientific and ethical reviews Some experts advocate for the precautionary principle, which suggests that society should intervene in the development of emerging technologies when there is substantial concern about potential serious harm This interpretation posits that such interventions can only be lifted when further scientific evidence indicates no risk While strategies to address scientific uncertainty in synthetic biology share a common goal of improving regulation through continuous knowledge acquisition, this approach can lead to an endless cycle of seeking more information In reality, the uncertainties inherent in modern science often stem from the complexities of existing knowledge rather than a lack of it.

The focus on evidence-based policy in life sciences and nanotechnology has limited the understanding of governance possibilities, often reducing complex governance issues to mere public acceptance of technological advancements GeneWatch UK highlights that an excessive reliance on scientific expertise can lead to "political entrapment," where policymakers view challenges solely as obstacles requiring more education and policies to ensure technology adoption Additionally, a DEMOS report emphasizes that governance is inherently a process filled with ambiguity, involving compromises and continuous renegotiation, rather than a straightforward decision-making process It is crucial to acknowledge that in the realm of science and technology, policy-making is influenced by factors beyond scientific evidence alone, and the timelines for policy formation and implementation are multifaceted.

Given that scientific certainty can seldom be achieved, some have argued that in policy-making,

The reliance on scientific authority in policy-making can be problematic, as highlighted by Salter (2007), who argues that it may exacerbate issues rather than resolve them While it is essential to base policies on comprehensive scientific evidence, there are inherent limitations Sheila Jasanoff (2003) describes this over-reliance as leading to “technologies of hubris,” where the unknown and indeterminate aspects of scientific and technological advancements are neglected Consequently, current regulatory practices often overlook these critical factors, reducing complex debates to narrowly defined risks (Stirling, 2008 and 2010; Wynne, 1992).

Current discussions on synthetic biology often exhibit "technologies of hubris," leading to a narrowing of focus primarily on narrowly defined risks While it's acknowledged that synthetic organisms fall under existing regulations for genetically modified organisms (GMOs), this perspective overlooks broader societal implications and changes associated with the development and commercialization of GM technologies Additionally, the risk assessment practices for GMOs, established in the 1990s, have faced significant scrutiny and have evolved to address public concerns, incorporating indirect, delayed, and cumulative long-term effects on health and the environment, as well as impacts on agricultural and natural habitats.

In conclusion, governance centered on knowledge is essential, but it cannot solely address the uncertainties inherent in synthetic biology To enhance governance effectiveness, it is crucial to incorporate approaches that acknowledge the unknown elements of the field By 'opening up' these uncertainties, we can ensure they are explicitly integrated into governance frameworks, thereby improving overall governance capabilities.

The cultivation of external accountability

Synthetic biology necessitates enhanced external accountability due to its reliance on collaborative efforts from diverse fields This accountability refers to the obligation to those outside the organization whose lives are impacted by its activities, as emphasized by Keohane (2003:141).

Internal accountability refers to a structured chain of command regarding financial resources, where a principal investigator is accountable to commissioning institutions like the DOE in the US, Research Councils in the UK, and MOST in China for project completion and research authenticity In contrast, external accountability involves recognizing the concerns of those outside the practitioner's immediate field, acknowledging the influence or impact of their actions on various social actors, including individuals, groups, or organizations.

Synthetic biology is a multi-disciplinary field that necessitates external accountability among various stakeholders, including scientists, engineers, biologists, chemists, civil society groups, and industry representatives from sectors like pharmaceuticals and petroleum Many researchers still align themselves with traditional disciplines, making cross-disciplinary collaboration essential yet challenging Practitioners in synthetic biology must engage with experts from diverse fields and seek financial, technical, and political support from previously external sources While internal accountability remains significant, this paper emphasizes the critical need for enhanced external accountability in synthetic biology.

This need is partially recognised in a worry summarised in a Woodrow Wilson Center report that

Even highly motivated and skilled scientists can overlook risk factors beyond their expertise and may overestimate their control over certain situations (Rodemeyer, 2009: 29) This concern is highlighted in the BBSRC/EPSRC Public Dialogue Report on Synthetic Biology, emphasizing the importance of recognizing these limitations in scientific practice.

“regarding regulations there was the need to open up control to the scrutiny of others” (Bhattachary, 2010: 13)

Good governance in synthetic biology necessitates the establishment of norms within research institutions and enhancing accountability within the profession It is crucial to enable horizontal supervision and ensure external accountability to stakeholders, including partner institutions, patient groups, and private investors While discussions on broadening policy debates and incorporating public engagement have emerged, they often focus narrowly on an ill-defined 'general public' as the primary 'outsider' to engage, addressing limited issues such as biosafety, biosecurity, and vaguely defined social and ethical concerns.

Recognizing the importance of integrating external perspectives differs significantly from creating a formal system for external accountability The former focuses on channeling information into a single entity, like the government, which centralizes initiatives around one main actor In contrast, the latter involves fostering communication and mutual trust among multiple entities, such as governments, scientific communities, and civil society organizations.

The regulatory frameworks for synthetic biology can be categorized into three main approaches: first, government-led oversight and controls; second, a strong emphasis on bottom-up initiatives like self-governance; and third, an effective blend of self-regulation and government regulation These frameworks highlight the diverse strategies employed to manage and oversee the development of synthetic biology.

Although each framework possesses its own advantages, we contend that they currently fall short in effectively promoting and guiding the external accountabilities of social actors Specifically, government-led oversight and controls are essential in addressing these inadequacies.

Despite the emphasis on incorporating civil group opinions in synthetic biology governance, many view the government as the primary regulatory authority In the UK, the government adheres to the Haldane Principle, which promotes broad consultation and peer review in scientific decision-making rather than imposing priorities This approach decentralizes power, with the government establishing an overarching strategy that is implemented by various regulatory bodies, such as BBSRC, EPSRC, and MRC, creating a structured authority chain that extends from the government to different institutions and ultimately to researchers.

This government-led approach integrates various social sectors into the decision-making process, allowing for the institutionalization of social practices under a single authority However, this model relies on established institutional frameworks to effectively incorporate feedback and convert it into political action, which may not always be present Additionally, it may fall short in fostering accountability and mutual support among individual social groups.

Addressing the challenge of transmitting knowledge across cultural divides in research requires more than just decentralizing power; it necessitates genuine collaboration among established communities like biology, engineering, and computing If authority merely shifts from a central point without fostering support among organizations, motivation for collaboration diminishes For instance, despite UK Research Councils promoting joint-funding initiatives across various sectors, the Royal Academy of Engineering criticizes current funding schemes, indicating that they fail to facilitate meaningful cooperation among disciplines.

“familiarising the awardees with the working culture of another discipline” and failing to facilitate individual researchers to develop more substantive roles across disciplinary borders (RAEng, 2009:

While government-led oversight and controls can enhance external accountability, the current proposals inadequately address the need for accountability among social institutions Merely integrating external opinions and decentralizing authority from the government may not sufficiently tackle the complexities of cross-border issues in synthetic biology Additionally, self-governance remains a crucial aspect that must be considered in regulatory frameworks.

In contrast to government-led regulations, a bottom-up approach has been suggested, notably through the self-regulation initiative introduced at the SB2.0 conference, inspired by the Asilomar model However, this proposal was ultimately retracted following strong opposition from thirty-five civil society organizations.

The opposition to synthetic biology governance was primarily triggered not by the concept of self-governance itself, but by specific proposals such as George Church's "synthetic biohazard non-proliferation proposal" (2004) and the Craig Venter Institute's joint governance options for synthetic genomes (Garfinkel et al., 2007) Additionally, insights from the Industry Association of Synthetic Biology's workshop report further fueled the debate.

Technical solutions for biosecurity in synthetic biology, as discussed by Bernauer et al (2008), exemplify self-governance initiatives within the field However, these initiatives did not face the same level of opposition as the SB2.0 conference, which garnered significant controversy.

Fragmentation of social authorities

A significant challenge in synthetic biology arises from scientific uncertainty and cross-border issues, leading to a fragmentation of social authorities This field reshapes the traditional dynamics between regulators and the regulated, as well as decision-makers and those impacted by their choices, highlighting the complexities inherent in governing synthetic biology.

A comprehensive review by Rodemeyer (2009) highlights the persistent challenges in American administrative frameworks for biotechnology over the past thirty years, particularly the lack of information and the adequacy of resources for regulatory agencies To address these issues, experts suggest that good governance of synthetic biology should include enhanced public engagement, especially in the early stages, strategic funding for interdisciplinary collaboration, the maintenance of open-source repositories, and the facilitation of standardization efforts.

In 2009, significant advancements were made in international biosecurity, including the establishment of a global biosecurity clearinghouse and the segmentation of research processes into various regulatory divisions Additionally, licensing and registration procedures for DNA sequencing firms were introduced, paving the way for a successful European synthetic biology roadmap However, similar to many cross-border governance initiatives, the main challenge lies not in the absence of rules but in the lack of consensus on which rules should be implemented.

The ongoing debate over which rules to follow highlights a fragmentation of social authority, as the decline of a unified scientific authority has led to the rise of competing authorities with varied agendas In the realm of synthetic biology, some argue that governance must align with scientific principles, as emphasized by the Royal Society of Chemistry, which states that effective policy-making requires sound scientific advice to avoid creating technically unacceptable or unfeasible policies Conversely, there is a growing call for end-users to play a crucial role in influencing research directions and decisions.

A European study highlights that regulatory criteria for synthetic biology should be developed collaboratively by academia and industry rather than imposed top-down by political institutions (Gaisser and Reiss, 2009) Additionally, some experts view synthetic biology as a product of human practices, emphasizing the need for its operation within the broader community's conditions (Rabinow and Bennett, 2009) NGOs advocate for civil society's involvement at all levels to effectively evaluate and plan responses to synthetic biology's emergence (ETC, 2007: 50) Furthermore, the BBSRC/EPSRC Public Dialogue Report calls for a new type of engagement that includes citizens and consumers throughout the entire process, rather than just at its conclusion (Bhattachary, 2010: 12).

Different social actors are recognized as vital participants in the governance of synthetic biology; however, their legitimacy is always partial While proximity to research experience, market access, resources, or political legitimacy offers some influence, it does not ensure comprehensive authority Consequently, the power of any social institution to govern research practices is limited and transient, leading to a fragmented authority landscape.

Implications for international governance

This working paper focuses on exploring governance strategies for synthetic biology across nations rather than providing single-issue solutions like risk assessment or IP protection It does not aim to critique individual policy concerns but acknowledges that specialized discussions are more suitable for such topics The report avoids establishing common principles for synthetic biology regulations, recognizing that diverse social authorities will make value judgments based on their unique contexts and traditions Notably, the US Presidential Commission for the Study of Bioethical Issues has outlined five comprehensive principles for regulating synthetic biology: public beneficence, responsible stewardship, intellectual freedom and responsibility, democratic deliberation, and justice and fairness.

This article examines strategies for establishing and maintaining international governance to effectively guide the development of emerging technologies.

This paper outlines the governance context for synthetic biology, highlighting two main features: scientific uncertainty and cross-borderness It identifies three significant challenges: the balance between knowledge and non-knowledge, the need for external accountability, and the fragmentation of authorities While the challenges posed by synthetic biology appear intensified due to its widespread applications across various industries, they are not exclusive to this field or particularly new in the realm of transnational initiatives.

The existing successes and failures in the global management of nanotechnology and climate change are crucial for understanding how to effectively address these challenges Both areas, similar to synthetic biology, intersect with various social sectors such as health, energy, trade, agriculture, security, and innovation, indicating that their impacts extend beyond traditional institutions and national borders Consequently, international initiatives in nanotechnology and climate change have revealed three overarching perspectives on how to better organize the actions and interactions of global stakeholders.

The essential change needed is primarily institutional rather than organizational Research on long-term global environmental changes indicates that simply forming new international agencies or expanding existing programs has limited effectiveness Instead, it is crucial to properly institutionalize the identification, recognition, and processing of the rights, roles, interactions, and decisions of stakeholders involved.

A study commissioned by Chatham House on nanotechnology found that the emergence of new global innovations does not automatically create a demand for new international governance structures This suggests that, at present, there is no immediate need for changes in governance in response to these advancements.

“political energies would be better spent on strengthening existing forums for international coordination and adjusting domestic regulatory frameworks where needed” (Faulkner et al, 2009: 7)

In short, in handling these transnational regulatory challenges, it is the governance ethos rather than organisational designs that are in more urgent need of change

Effective cross-border governance necessitates a collection of authorities and a built-in adaptability to specific contexts Lessons from international environmental regulations highlight this need; for instance, the Montreal Protocol is deemed the "most successful international agreement" due to its approach as a "portfolio of specific agreements" that caters to various technologies and allows for flexible enforcement Conversely, the Kyoto Protocol's failure is often linked to its rigid, one-size-fits-all targets and reliance on nation-state hierarchies Furthermore, contemporary studies emphasize the importance of adaptable regulatory systems that can respond to technical uncertainties and evolving social needs The Royal Commission on Environmental Pollution's report on nanotechnology underscores the significance of "social intelligence," which involves deliberation among diverse groups and the public In summary, successful global governance requires guidelines that are directive yet flexible.

Thirdly, any sustainable global initiative should consider the reality of innovation and international trade In responding to the US Presidential Commission’ ethical stands on synthetic biology (PCSBI,

2010), 58 interests groups jointly criticise the Commission’s replacing the precautionary principle with

There is a pressing need for "prudent vigilance" and a call for a moratorium on the release and commercial use of synthetic organisms until comprehensive studies on their environmental and socio-economic impacts are conducted (ETC, 2010) Previous experiences with nanotechnology indicate that a moratorium alone is insufficient; instead, a proactive approach is required to assess society's commitment to such technologies and the challenges of remediation if issues arise (RCEP, 2008) Additionally, the EU's environmental leadership must be viewed not only as a normative power based on ideals but also as influenced by national economic interests, which can sometimes hinder progress (Falkner, 2007) Ultimately, effective international initiatives should be informed by a realistic understanding of and engagement with these competing interests.

Discussions highlight the limitations of traditional evidence-based policy, as the necessary evidence is often unavailable when needed for effective governance Comparative global governance initiatives suggest a shift in governance ethos, emphasizing the need for flexibility and responsiveness to real-world conditions We propose that, alongside a scientifically informed bureaucracy, governance should embrace an artistic approach, recognizing that effective governance amidst scientific uncertainty requires adaptability rather than rigid regulation This approach fosters good science and promotes open, transparent regulation to build trust and accountability.

The art of governance and governance as an art

What is the subject of artistic governance?

The definition of synthetic biology is crucial for evidence-based policy, as effective regulation requires a clear understanding of what is being regulated The European Group on Ethics in Science and New Technologies emphasizes the need for an internationally recognized definition to ensure sound regulation However, the pursuit of a universally agreed definition may hinder regulatory development, as current regulations are often deemed adequate despite the challenges in neatly defining new fields For instance, the regulation of genetically modified organisms (GMOs) illustrates that, despite initial efforts to categorize GMOs, ongoing controversies regarding key distinctions—such as GMO versus non-GMO—have led to evolving and increasingly ambiguous regulatory categories to reflect real-world complexities.

Rather than linking governance development to the pursuit of a flawless definition, an alternative perspective is to view governance as a series of interactions rather than a mere object This approach emphasizes the dynamic nature of governance, aligning with the principles of effective government practices.

Synthetic biology is often referred to as "chemistry" or "genetic research" by various experts Rather than seeking consensus among electronic engineers and geneticists on terminology, a more effective governance strategy could involve providing stakeholders with the necessary tools to facilitate collaboration across diverse and unfamiliar disciplines.

To enhance current scientifically informed policies, it may be beneficial to integrate and unify the fragmented regulatory frameworks that exist across various parent fields of synthetic biology Rather than solely providing definitions and formal guidelines for research practices, a more effective approach could involve developing a cohesive set of principles that guide practitioners in their activities.

Guide questions serve a dual purpose: they enhance communication among stakeholders by outlining essential information they need to be aware of and entitled to know, while also clarifying their accountabilities by defining the conditions under which their responsibilities begin and end This approach effectively addresses overlapping concerns related to stakeholder engagement and accountability.

What is the purpose of governance when performed as a form of art?

Good governance goes beyond merely including reflexiveness in legislative texts; it actively encourages ongoing reflection among stakeholders Similar to traditional art forms like cinema and literature, which stimulate public discourse by exploring various scenarios, effective governance invites audiences to contemplate and create real-world alternatives Thus, the essence of governance lies not in dictating how things must be, but in embracing scientific uncertainty and uncovering potential pathways for future possibilities.

Similar empirical initiatives specifically directed at science policy-making remain scarce Some relevant examples can be found in a group of approaches that provide alternatives to traditional

Technology assessment encompasses various approaches, including constructive technology assessment (CTA), interactive technology assessment (iTA), and real-time technology assessment (RTTA) These methodologies, developed by Rip et al (1995), Grin et al (1997), and Guston and Sarewitz (2002), emphasize the importance of collaboration among diverse stakeholders, such as laboratory scientists, funders, regulators, end-users, and affected communities By incorporating scenario building, these assessments foster creative thinking about multiple future possibilities Rather than merely seeking compromise among interested parties, these approaches aim to achieve a "joint construction" of developmental plans, facilitating more inclusive and effective technological advancement.

A significant example of fostering reflexiveness in synthetic biology is the public consultation organized by BBSRC and EPSRC, which included stakeholder interviews and workshops (Bhattachary et al, 2010) This initiative led to the identification of five essential questions that scientists should consider: "What is the purpose?"; "Why do you want to do it?"; "What are you going to gain from it?"; "What else is it going to do?"; and "How do you know you are right?" (Bhattachary et al, 2010: 7, 12) The interdisciplinary dialogue not only enhances public understanding but also promotes the co-production of knowledge Additionally, the final report emphasizes the importance of addressing critical questions raised by those developing the field (Bhattachary et al, 2010).

89, emphasis added), which set the direction and accountability premises for regulatory undertakings

When governance is approached as an art form, the objective may extend beyond creating widely accepted, scientifically grounded, and politically feasible "orientational knowledge" (Kropp and Wagner, 2010: 824) It is equally vital to focus on identifying constructive elements that contribute to effective governance.

‘orientational questions’, which provide an alternative perspective in conceptualising and responding to science in-the-making

An 'artistic' governance approach fosters social resilience to the unpredictability of scientific development by encouraging reflections on alternative scenarios, rather than attempting to impose rigid definitions and strategies This aligns with Stirling’s advocacy for an "open up" governance model that embraces the complexities of technical evolution.

To effectively navigate the complexities of synthetic biology, stakeholders must engage in a proactive social appraisal of technology, as highlighted by Stirling (2008) This involves identifying critical questions and potential scenarios to prepare for future challenges Governance, therefore, transcends mere reflexiveness; it fosters ongoing dialogue among stakeholders Rather than relying solely on hierarchical structures or treaties, effective global governance may emerge from collaborative efforts to formulate 'orientational questions.' By integrating artistic approaches, governance shifts from an endless pursuit of scientific certainty to a meaningful political engagement with uncertainty.

What may be better presented?

Governance involves the dynamic interaction between government power structures and civil society, facilitating decision-making within a public realm (Stoker, 1998; Abdellatif, 2003; Hyden et al., 2004) In the context of synthetic biology, public engagement initiatives play a crucial role, similar to experiences with GMOs, stem cell research, and nanotechnology A study by the Woodrow Wilson Center highlights that "upstream engagement" can shape research priorities, offer essential feedback on future applications, and establish mechanisms to address emerging issues, effectively positioning public engagement as a form of governance (Parens et al., 2009).

Calls for improved public engagement in the UK and Europe aim to amplify the voices of non-specialists in shaping research development (RAEng, 2009; EGE, 2009; House of Commons, 2010) However, studies indicate that the impact of committee reports and civil group recommendations on the European synthetic biology community is inadequate (Kelle, 2007), and recent public dialogues have faced similar criticisms (Wakeford and Haq, 2010) Torgersen (2009) critiques the current European regulatory culture for merely involving stakeholders in discussions about governance, rather than genuinely integrating public opinions into research governance Consequently, despite increased focus on public engagement, existing practices often resemble broad conversations or public education initiatives, offering limited contributions to the governance of research practices (Wallace, 2010b).

The gap between scientific communication and public deliberation can be effectively addressed through an artistic approach As highlighted in the Royal Society of Edinburgh's report, a sustained public relations campaign is essential due to the fragmentation of social authorities in the face of scientific uncertainty and cross-border issues While current policies may include various public inputs, if regulation merely homogenizes diverse opinions, it undermines the connections among social actors Therefore, traditional methods of evidence collection must evolve from merely documenting statements to tracing relationships and actions among stakeholders.

In any forum where individuals can genuinely influence the behavior of others, possessing power-leverage is essential Equally important is the visualization of this power-leverage, which involves clearly demonstrating how public opinion is integrated into governance strategies This includes identifying the methods and locations of such integration, showcasing the long-term effects, and adapting practices and mechanisms based on experiential insights.

What should be left to network actors to ‘improvise’?

This section highlights that the 'art of governance' emphasizes the importance of both interactions and actions, advocating for the inclusion of scientific uncertainty and the visualization of interconnectedness in regulatory strategies However, it does not dictate which social institutions should govern scientific practices As synthetic biology evolves, it increasingly draws on diverse social actors, leading to a governance model that resembles a 'palaver model' rather than a traditional 'technocratic decision model,' where it remains uncertain who is excluded from the discussion (Beck, 2007[2009]:125).

The governance of science, technology, and risk raises critical questions about who should be included and excluded from decision-making processes, particularly regarding the roles of pressure groups, activists, and religious minorities Traditional hierarchical models, which rely on a fixed chain of command among institutions like government and the scientific community, are inadequate for addressing the complexities of new technologies, where social authority is often dispersed and contested A governance framework based on a 'power with' model, rather than 'power over,' is more effective, as evidenced by the UK's approach to stem cell research The UK’s Human Tissue Authority exemplifies this by participating in various networks that integrate scientific, ethical, regulatory, and industrial perspectives, demonstrating the advantages of collaborative governance.

Apart from strengthening governance capacity by broadening regulatory networks, the cross- borderness and novelty of synthetic biology may further add a ‘temporal’ dimension to the idea of

Effective governance requires an inclusive approach that not only embraces established professional groups but also recognizes and integrates emerging, unforeseen governance bodies It is crucial to remain open to new stakeholders who may become relevant in discussions about the governance of emerging technologies, ensuring that no potential participant is excluded from the dialogue.

The iGEM competition, initiated in 2004 alongside the first international synthetic biology conference, highlights the growing importance of integrating scientific research with societal considerations As a global platform for young scientists, iGEM has become a strategic initiative for nations like China and the UK to advance their life sciences sectors The annual performances of undergraduates in iGEM are seen as key metrics for evaluating national policies, sparking discussions on what constitutes effective "human practices." Additionally, iGEM fosters international dialogue on critical issues such as biosafety, biosecurity, intellectual property, ethics, and public engagement in synthetic biology Countries like China and Japan, which have historically overlooked these discussions, are now actively addressing them through their participation in iGEM.

The growing impact of iGEM on the global advancement of synthetic biology challenges traditional governance models in several ways Primarily, iGEM functions as a "scientific building block," relying significantly on the contributions of "beginners"—students and their mentors—rather than solely on established experts This notion aligns with findings in nanotechnology and climate change, where a transnational framework is essential for defining new materials and establishing standards In synthetic biology, the evolution of standards and BioBrick classifications is heavily influenced by the iGEM competition, rather than just conventional scientific bodies As noted by Ron Weiss during the SB4.0 conference, the iGEM initiative plays a crucial role in educating newcomers about synthetic biology, suggesting that the future of the field is tied to the progress of iGEM Thus, the normalization of synthetic biology is increasingly driven by novices rather than seasoned scientists.

iGEM, while fundamentally a scientific competition, significantly contributes to the social development of future scientists It fosters an open-source culture through its connection with the Registry of Standard Biological Parts, encouraging collaboration and innovation among participants.

iGEM is recognized as a significant catalyst for transforming the global open access culture, as highlighted by the OECD and the Royal Society Additionally, it plays a crucial role in enhancing public awareness of synthetic biology, as noted by the Royal Academy of Engineering, through its incorporation of specific requirements and a dedicated prize.

The iGEM competition emphasizes the integration of "Human Practices" with scientific excellence, encouraging students to consider the social implications of their research Social scientists actively engage in the competition as team participants, advisors, observers, and judges for the Human Practices prize This approach contrasts with traditional methods that compartmentalize scientific and ethical governance, highlighting the innovative practices developed by iGEM in regulating technology.

The influence of iGEM is not derived from political support by nation-states or professional communities, but rather has developed through its external accountability with global stakeholders Initially, the idea of an undergraduate competition contributing to the governance of synthetic biology seemed unlikely However, contemporary policy analyses recognize iGEM's significant role in shaping the international research culture within this emerging field.

The iGEM case exemplifies the shift in conventional governance approaches driven by synthetic biology While it's too early to determine iGEM's lasting impact on global governance in this field, its increasing international attention highlights the potential for innovative, non-expert-led collaborations to influence scientific governance Instead of imposing rigid regulatory frameworks, adopting an open-ended regulatory structure may foster organic network interactions that shape the future of science governance.

For effective governance in synthetic biology, it is more beneficial to focus on closely monitoring and adapting to the evolving roles of various regulatory bodies rather than establishing fixed international institutions National and transnational organizations are well-positioned to conduct extensive long-term oversight Instead of debating which institution should lead or receive more regulatory authority, continuous tracking and periodic reviews of the diverse regulatory landscape can enhance understanding for smaller domestic stakeholders This approach will provide clearer guidance for transnational coordination and a better grasp of the global developments in emerging science.

Concluding words

New technologies often present unique challenges, but they typically share core characteristics with existing innovations, leading to similar governance issues Social scientists and policymakers suggest that aligning seemingly disparate social discussions can be more effective in creating a cohesive strategy that addresses these common themes.

The governance of synthetic biology provides a good opportunity to develop such a general approach

Synthetic biology, as an emerging technology, requires the exploration of new governance strategies and the establishment of a comprehensive regulatory framework This field intersects various research disciplines, which may intensify unresolved governance issues while necessitating a reevaluation of previously settled matters Instead of pursuing numerous disparate issues, it's crucial to focus on the common themes underlying these challenges Additionally, the presence of conflicting narratives surrounding synthetic biology indicates that traditional evidence-based governance by nation-states is insufficient to fully understand and address these complexities Therefore, there is a pressing need to revise regulatory perspectives and adopt complementary governance approaches.

This paper aims to explore the underlying causes of key issues rather than simply listing them and proposing individual solutions By identifying core challenges and discussing general approaches to address them, it effectively reviews numerous regulatory initiatives and highlights prevalent concerns Ultimately, this groundwork sets the stage for future research and offers foundational guidance for developing more specific regulations.

This paper identifies three primary challenges to the global governance of synthetic biology: the governance of non-knowing, the cultivation of external accountability, and the fragmentation of social authority It suggests that alongside a scientifically informed bureaucracy, there is a need to reintroduce a sense of art into governance, which can offer direction while encouraging exploration The findings emphasize the importance of integrating creative approaches to enhance the governance framework in the field of synthetic biology.

Incorporating non-knowing into governance is as crucial as leveraging existing scientific knowledge, as it addresses knowledge gaps and inadequacies indirectly To tackle non-knowing directly, regulatory practices must evolve to foster social resilience by promoting continuous reflexiveness among all stakeholders This approach can enhance effective global governance of synthetic biology through the transnational collaborative generation of 'orientational questions.'

Synthetic biology operates as a loosely connected network characterized by cross-border collaboration and scientific uncertainty, where authority is fragmented and temporary This fragmentation extends beyond national borders and traditional hierarchical structures, involving a diverse range of stakeholders, including those related to national sovereignty In forums where social actors can genuinely influence one another, possessing power leverage is essential Equally important is the ability to visualize this power leverage, particularly in understanding how public opinion is integrated into governance strategies.

The international landscape of synthetic biology integrates diverse disciplines and sectors, making it impossible to pre-determine the legitimacy and political influence of stakeholders in its governance Instead, legitimacy must be established through ongoing cross-border communication and collaboration Rather than creating fixed international governance institutions, it may be more effective to closely monitor and adapt to the changing regulatory roles of various interest-related organizations A more beneficial approach to synthetic biology involves tracking, periodically reviewing, and publicizing the evolving array of regulatory bodies involved in the field.

Effective governance in synthetic biology requires regulators to address fundamental questions This paper's findings suggest that by integrating an 'artistic' approach to governance, we can better manage scientific uncertainty and cross-border issues, enhancing the current scientific bureaucracy.

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Reports related to the governance of synthetic biology

A Synthetic Biohazard Non-proliferation Proposal (18Jun 2004; updated 21May 2005)

2005 Europe NEST (New and Emerging Science and

Synthetic biology: Applying engineering to biology, Report of a NEST High-Level Expert Group

2006 Sept Europe SYNBIOLOGY An Analysis of Synthetic Biology Research in

Europe and North America: Final Report on Analysis of Synthetic Biology Sector

(National Science Advisory Board for Biosecurity)

Addressing biosecurity concerns related to the synthesis of select agents

2006 Dec Europe Rathenau Institute Constructing life: Early social reflections on the emerging field of synthetic biology

2007 Jan Canada ETC Group Extreme genetic engineering: An introduction to synthetic biology

2007 Europe NEST Synthetic biology: A NEST pathfinder initiative

2007 Oct US J Craig Venter Institute, Massachusetts

Institute of Technology, and Centre for Strategic and International Studies

Synthetic genomics: Options for governance

2007 Nov UK Royal Society Synthetic biology call for views - submissions

2007 Nov Europe IDC (Organization for International Dialogue and Conflict Management)

Synthetic biology & biosecurity: Awareness in Europe

2007 Nov Europe Rathenau Institute Constructing life: The world of synthetic biology

2008 Jan UK POST (UK Parliamentary Office of Science and Technology)

2008 Apr Europe IASB (Industrial Association Synthetic

Technical solutions for biosecurity in synthetic biology

2008 May Europe SYNBIOSAFE Background document for the SYNBIOSAFE e- conference

2008 Jun UK Royal Society Synthetic biology: Scientific discussion meeting summary

2008 Jun UK BBSRC Synthetic biology: Social and ethical challenges

2008 Oct UK BBSRC Synthetic Biology Regulators’ Meeting: Public statement

2008 Oct Canada ETC Group Commodifying Nature’s Last Straw? Extreme

Genetic Engineering and the Post-Petroleum Sugar Economy,

2008 Sept USA Woodrow Wilson Centre Awareness of and attitudes towards nanotechnology and synthetic biology: a report of findings

2008 Dec USA Woodrow Wilson Centre Trends in American and European press coverage of synthetic biology: Tracking the last five years of coverage

2008 Dec Europe TESSY (Towards a European Strategy for

TESSY Achievements and Future Perspectives in Synthetic Biology

2009 Mar USA Woodrow Wilson Centre New life, old bottles: regulating first-generation products of synthetic biology

2009 Jun UK Royal Academy of Engineering Synthetic biology: Public dialogue on synthetic biology

2009 Jun USA Woodrow Wilson Centre Ethical issues in synthetic biology: An overview of the debates