Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis

Introduction

Emerging Synthetic biology technology Synthetic cells offer great solutions to environmental problems, such as environmental remediation, but there is a great need to assess the potential consequences of their release (Warner et al., 2020). Synthetic cells have already shown promise for environmental remediation, including the degradation of toxic chemicals, sequestration of heavy metals, and restoration of the nutrient balance in polluted ecosystems (Rylott & Bruce, 2020; Webster et al., 2024).

Synthetic cells are supramolecular chemical systems designed to mimic the behavior, function, and structure of living cells (Noireaux et al., 2011). The first synthetic cell coming to life will be the only organism on Earth that has not been shaped by evolution over the last 4 billion years (Frischmon et al., 2021). Being man-made organisms, they are designed to replicate the design and function of natural biological cells, are made up of inert molecular parts, and are able to carry out life-like activities such as metabolism, replication, and adaptive response (Elani, 2021). They constitute a novel class of biological organisms with programmable features that provide enhanced control and predictability for biotechnological processes than natural organisms (Adamala et al., 2017). In contrast to genetically modified organisms (GMOs), synthetic cells are not taken from living organisms, but are created de novo from bottom-up strategies, such as through the utilization of lipid vesicles, genetic circuits, and minimal genomes (Göpfrich et al., 2018; Schwille, 2011).

Synthetic cells can provide researchers with more control over the desired properties of a biological system; thus, they can be used in various applications, such as environmental remediation (Guindani et al., 2022). This involves significant biosafety and biosecurity concerns, as artificial cells have the potential to introduce new traits or molecular mechanisms into the environment that could evolve in unpredictable ways or become integrated into resident organisms (Anyshchenko & Yarnold, 2021; Dana et al., 2012). Furthermore, widening access to synthetic biology components amplifies the dual-use threat possibility, where the technology created for positive applications can also be exploited for malicious objectives (Trump et al., 2020).

Therefore, it raises biosecurity and biosafety concerns that can potentially cause ecological disruptions or transfer engineered genes to native species. Thus, there is a need for researchers to address this proactively before full applications of such living cells can be realized (Frischmon et al., 2021). Thus, the need for “anticipatory governance,” a concept about the management of emerging technologies in their early stages of development, through the use of such mechanisms as foresight, engagement, integration, feedback, and adaptation (Guston, 2014). Despite these promising uses, there is a pressing need to examine the possible unintended effects of their deliberate or accidental release into natural ecosystems (Warner et al., 2020). These concerns include unplanned ecological interactions, competition with native organisms, horizontal gene transfer, and disruption of microbial community dynamics (Coyte et al., 2022; Yang et al., 2024). Assessing emerging technologies such as synthetic cell applications in the environment is crucial for anticipatory governance. However, the main challenge is the limited quantitative information on the risks and benefits (Bates et al., 2016). Risk evaluation of synthetic cells remains particularly challenging owing to the lack of empirical and long-term ecological information (Tait, 2009; Trump, 2020).

Therefore, this study used a survey and thematic analysis of various stakeholder interviews to provide a multi-criteria decision analysis (MCDA) (Government Analysis Function, 2024). MCDA is an important tool for evaluating emerging technologies because of the scarcity of data, thus allowing the proper integration of quantitative and qualitative data for better expert judgment and policy-making due to limited data (Bates et al., 2016). This enhances the transparency and inclusiveness of decision-making processes (Kiker et al., 2005; Linkov & Moberg, 2011) because this technology is so new that anticipatory governance is required. Anticipatory governance is the governance of new technologies from the beginning through processes such as foresight, public engagement, interdisciplinary integration, feedback, and policy revisions to ensure responsible innovation (Stilgoe et al., 2013).

It aims to align innovation with societal values and environmental sustainability before its widespread deployment. In addition to expert judgment, this risk assessment can best be achieved through predictive modeling and simulations of the applications of these synthetic organisms in natural ecosystems to help identify potential risks and benefits. To enhance the robustness of risk assessments, methods such as predictive ecological modeling, agent-based modeling, and scenario analysis have been explored to assess the environmental dynamics around the release of synthetic cells (Aditya et al., 2022; Zomorrodi & Segrè, 2016). These methods are key to delineating likely risk hotspots, informing containment strategies, and establishing agendas for further research.

Finally, the evaluation of synthetic cell applications in environmental remediation needs to incorporate ethical, regulatory, and societal factors because public trust and acceptability are the foundations of their correct development and usage (Jimenez et al., 2022; Quinlan et al., 2016; Torgersen & Schmidt, 2013). Scientists, policymakers, environmentalists, and ethicists should collaborate to ensure that the advancement of synthetic cell technology is within a framework capable of anticipating possible dangers, ensuring sustainability, and being of societal benefit.

Methodology

This study used a mixed-methods approach with quantitative and qualitative data gathering. An online survey questionnaire was crafted and dispatched to 70 respondents with backgrounds in academia, bioscience, and environmental policy. The survey questionnaire consisted of a blend of Likert-scale, multiple-choice, and open-ended questions, intended to gather stakeholders’ opinions regarding synthetic cell technology for environmental remediation. The survey was accessible for four weeks and advertised through professional networks, academic discussion groups, and iGEM-related messaging channels.

Simultaneously, seven in-depth semi-structured interviews were conducted with experts selected on the basis of their professional expertise in synthetic biology, environmental remediation, science policy, and biosecurity. These were conducted for 45–60 min using video conferencing tools. Interviewees were selected to span a broad range of geographical locations and institutional affiliations in order to achieve a broader policy perspective. The collected information was analyzed using thematic analysis.

The responses were coded and categorized under key themes, including risk perception, governance gaps, biosafety issues, and regulatory suggestions. Qualitative observations were triangulated using survey responses to examine whether there was convergence or divergence in stakeholder views. No specialized qualitative analysis software was used, but the theme generation conformed to the qualitative research standards. With the help of GPT-4o, we were able to extract and refine recurrent themes and points from the interviewee reports and survey insights. Informed consent was obtained from all the participants before participation. Research was approved by the iGEM Community Policy Research Team and conformed to ethical requirements such as anonymity, voluntariness, and freedom to withdraw at any moment.

Results

This study polled a diverse group of actors involved with or familiar with environmental remediation, synthetic biology, and related policy areas. The present data collection amounted to approximately 70 survey responses that were obtained through a combination of age groups (18-56+ years) and geographic locations throughout the Americas, Europe, Africa, and Asia. The survey results are complemented by the visual summaries presented in Figures 1–6.

Figure 1. Chart showing Sector of the survey participants with Academia and industry bring most insights.

Figure 2. Perception on using synthetic cells in Environmental remediation.

Figure 3. Main environmental biosafety strategies for the deployment of synthetic cells for environmental applications.

Figure 4. Main advantages presented using synthetic cells over other traditional methods.

Figure 5. Participants familiarity with Environmental bioremediation.

Figure 6. Particpants response to the need for public engagement in policy developments.

Participant Profile. Most participants represented the academic community, followed by international organizations, government and international government agencies, NGOs, and industry. This allows for a diverse platform to gather multiple perspectives on the risks and opportunities inherent in synthetic cell technologies. Attendees indicated moderate to significant familiarity with the challenges inherent in environmental remediation, bioremediation, and synthetic biology. However, familiarity with the specific applications of synthetic cell technologies varied, with answers ranging from “very familiar” to “not at all familiar.”

Perceptions of Synthetic Cell Technology. When asked if the use of synthetic cell technology for environmental remediation is a “good idea,” the majority of respondents agreed or strongly agreed. However, some participants responded neutrally or negatively, reflecting ongoing uncertainty or concern about associated risks.

Respondents identified several key advantages of synthetic cells over traditional remediation methods. Their ability to target specific environmental pollutants with precision is the most commonly mentioned advantage, which would facilitate targeted and efficient treatment. Numerous participants have also highlighted the increased control that synthetic cells provide over biological processes, which would enable better flexibility in response to a variety of pollutants and environmental conditions. Additionally, several responses also indicated the potential of synthetic cells to usher in more efficient and scalable remediation processes, noting their potential to accelerate clean-up processes, reduce long-term operating costs, and minimize the environmental footprint as compared to conventional chemical or mechanical approaches.

Perceived Risk and Concerns. The respondents also indicated a range of concerns regarding the use of synthetic cell technologies in environmental contexts. The top risk cited by approximately 65–70% of the participants was the potential for unanticipated ecological interactions, such as interference with native microbial communities and the inadvertent spread of engineered genes. Others have expressed concerns regarding the impracticalities of sustaining effective containment and extended monitoring of synthetic cells once released into nature. In addition, some respondents pointed out the dual-use nature of this technology and reported that without proper regulation, synthetic cells could be used for nefarious ends. In light of this, the general consensus was in favor of creating extensive risk mitigation. These were complemented by the application of biocontainment practices, such as kill switches programmed into cells or environmental sensitivity triggers, to prevent uncontrolled proliferation and the design of continuous surveillance systems to track ecological impacts over time.

Additionally, most participants highlighted the lack of comprehensive international governance structures, advocating the establishment of standardized risk assessment protocols and ethical regulation mechanisms tailored for synthetic cell applications.

Discussions

This study provides timely insights into stakeholders’ attitudes towards synthetic cell technologies in terms of environmental remediation. While the technology is in an embryonic stage, findings are marked by cautious optimism among stakeholders and experts, who generally embrace its potential to offer more efficient, targeted, and sustainable solutions for remediation than traditional methods. However, there are concerns about ecological risks, biosecurity, and inadequate, well-established governance frameworks.

Respondents reiterated the benefits of synthetic cells to include precision targeting of contaminants, better control of biological processes, and greater scalability and efficiency. These findings are in accordance with the existing literature that places synthetic cells in a future toolkit that can effectively address intricate environmental issues where the conventional method cannot hold (Aminian-Dehkordi et al., 2023). More challenging environmental remediation is becoming, and such abilities can lead to breakthrough revolutions in ecological reconstruction.

However, the survey results also identified deep-seated anxieties—namely, about unforeseen ecological effects, such as gene transfer to native organisms or microbial ecosystem disruption. This anxiety has been well documented in previous research on new biotechnologies, (Stirling et al., 2018; Warner et al., 2020) and our evidence confirms the importance of anticipatory governance (Guston, 2014). Stakeholders have also questioned the long-term containment of synthetic cells, echoing concerns in the regulation of other synthetic biology products (Millett & Alexanian, 2021). These risks necessitate the implementation of strict biosafety measures such as programmed cell deactivation and continuous environmental surveillance.

The most glaring theme that emerged was the dual-use capacity of synthetic-cell technologies. While they offer clear environmental benefits, experts warned that, if not properly regulated, such tools could be diverted to aid malicious purposes. This highlights the need to incorporate DNA synthesis screening, biosecurity training, and export control into governance structures. Furthermore, the absence of international harmonization in regulations was deemed a significant vulnerability. They strongly supported the establishment of internationally accepted science-based protocols for synthetic cells, separate from, but supplementing, existing GMO regulations.

Conclusion

Policy recommendations

To support the development of anticipatory governance for future applications of synthetic cell technology in environmental remediation applications, this policy research project provides the following recommendations based on the findings of this report. The findings of this report were based on extensive research, survey results, and expert interviews with policymakers and environmental remediation scientists. However, the final recommendations were developed by the authors alone and slightly represented a consensus of project participants in the survey, as well as thematic analysis of the expert interview reports.