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

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Despite their innovative promise, there are currently no standardized global frameworks to assess and manage their risks, particularly those concerning ecological disruption, misuse, and public acceptance. Therefore, this study explored the dual nature of synthetic cells as a tool for ecological restoration. Method This study conducted stakeholder perception analysis through seven expert interviews and surveys involving 70 respondents, primarily from academia and the environmental policy sector. Thematic analysis was used to extract the key concerns. Results Stakeholders highlighted the strong support for the potential of technology in pollutant degradation and climate mitigation. However, major concerns have emerged regarding unintended gene transfer, containment failure, dual-use risks, and a lack of international regulation. The thematic analysis revealed the need for risk assessment strategies, containment measures, and regulatory oversight. Conclusion Recommendations include the development of standardized risk assessment protocols, lifecycle containment strategies, transparent public engagement, and international collaboration. Policymakers must act early to ensure that the environmental benefits of this emerging technology can be realized while mitigating the associated risks. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/14-915/v1", "name": "Risk Assessment of Synthetic Cell Technology in Environmental Remediation:..." } } ] } Home Browse Risk Assessment of Synthetic Cell Technology in Environmental Remediation:... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Simon A, Toro Pineda I, Muñoz-Solórzano L and Vats I. Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :915 ( https://doi.org/10.12688/f1000research.165103.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Policy Brief Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis [version 1; peer review: 1 approved, 1 approved with reservations] Anguzu Simon https://orcid.org/0009-0004-9726-7584 1-3 , Iván Toro Pineda 1,4,5 , Luis Muñoz-Solórzano 1,6 , Isha Vats 1 Anguzu Simon https://orcid.org/0009-0004-9726-7584 1-3 , Iván Toro Pineda 1,4,5 , Luis Muñoz-Solórzano 1,6 , Isha Vats 1 PUBLISHED 12 Sep 2025 Author details Author details 1 iGEM Community, Paris, France 2 Department of Research & Innovations, SynBio4All Africa Initiative, Kampala, Uganda 3 Department of Innovations, SynBio Eco, Kampala, Uganda 4 University of Málaga, Málaga, Spain 5 Spanish Institute of Oceanography, Madrid, Spain 6 Costa Rica Institute of Technology, Cartago, Costa Rica Anguzu Simon Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Software, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Iván Toro Pineda Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Luis Muñoz-Solórzano Roles: Conceptualization, Investigation, Methodology, Writing – Original Draft Preparation Isha Vats Roles: Investigation, Methodology, Writing – Original Draft Preparation OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Public Health and Environmental Health collection. Abstract Background Synthetic cells have emerged as promising tools for targeted, efficient, and sustainable environmental cleanup, and there is a growing need to understand not only their technical potential but also the biosafety, biosecurity, and governance implications of their deployment in natural ecosystems. Despite their innovative promise, there are currently no standardized global frameworks to assess and manage their risks, particularly those concerning ecological disruption, misuse, and public acceptance. Therefore, this study explored the dual nature of synthetic cells as a tool for ecological restoration. Method This study conducted stakeholder perception analysis through seven expert interviews and surveys involving 70 respondents, primarily from academia and the environmental policy sector. Thematic analysis was used to extract the key concerns. Results Stakeholders highlighted the strong support for the potential of technology in pollutant degradation and climate mitigation. However, major concerns have emerged regarding unintended gene transfer, containment failure, dual-use risks, and a lack of international regulation. The thematic analysis revealed the need for risk assessment strategies, containment measures, and regulatory oversight. Conclusion Recommendations include the development of standardized risk assessment protocols, lifecycle containment strategies, transparent public engagement, and international collaboration. Policymakers must act early to ensure that the environmental benefits of this emerging technology can be realized while mitigating the associated risks. READ ALL READ LESS Keywords Synthetic Cells, Environmental Bioremediation, Biosecurity, Emerging technologies, Governance, Risk assessment and Mitigation Corresponding Author(s) Anguzu Simon ( [email protected] ) Close Corresponding author: Anguzu Simon Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2025 Simon A et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Simon A, Toro Pineda I, Muñoz-Solórzano L and Vats I. Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :915 ( https://doi.org/10.12688/f1000research.165103.1 ) First published: 12 Sep 2025, 14 :915 ( https://doi.org/10.12688/f1000research.165103.1 ) Latest published: 12 Sep 2025, 14 :915 ( https://doi.org/10.12688/f1000research.165103.1 ) 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. Synthetic cells in environmental remediation: Anticipated capabilities Although synthetic cell technology is still under research and development, it has great potential for applications in various sectors, including environmental monitoring and remediation ( Cameron et al., 2014 ). However, these applications raise concerns about the need to proactively address governance, biosafety, and biosecurity. For a better understanding of this technology, this policy research was guided by the following questions. • What are the differing and overlapping perceptions of stakeholders regarding the potential risks, benefits, and technological preparedness of synthetic cell technologies in environmental remediation? • What are the key emerging risks associated with synthetic cell technology in environmental remediation and how can we effectively identify, prioritize, and assess them? • What are the key regulatory gaps and major technical limitations involved in the deployment of synthetic cells for environmental remediation? Future applications of synthetic cells in environmental remediation Synthetic cell technology is still in the early stages of development. However, most participants, most of whom were from academia, had a positive perception of this as a promising and good approach due to more promising advantages and capabilities for addressing environmental remediation ( Aminian-Dehkordi et al., 2023 ). From the survey results, 67% of the participants supported the use of synthetic cells for targeted pollutant degradation, noting the advantages over traditional chemical or mechanical remediation methods. The main applications include the following. • Pollutant Degradation : This method could be very effective for degrading various environmental pollutants, such as industrial wastes with hydrocarbons and heavy metals, into less harmful substances ( Cameron et al., 2014 ). Among the experts interviewed, one noted that “ this capability could revolutionize industrial cleanup processes, especially in high-risk zones where traditional methods fall short .” • Nutrient Recovery and Recycling : This method is also recommended for wastewater treatment and agricultural runoff, as it could reduce environmental harm and promote sustainability ( Cameron et al., 2014 ). However, a few interviewees predicted the dual benefit of mitigating pollution and contributing to circular economy goals, describing synthetic cells as “ multi-functional tools with both environmental and economic advantages. ” • Carbon Sequestration : Some experts predict that synthetic cells could be used to capture and store carbon dioxide, describing them as “ a next-generation approach to climate change mitigation. ” Biosecurity and biosafety implications of synthetic cell technology Advances in synthetic cell capabilities offer significant potential benefits for medicine, industrial economic development, and the environmental sector. However, this brings about risks that need to be mitigated through proper risk-mitigation measures ( Millett & Alexanian, 2021 ). Expert interviews and survey results emphasize the need for proactive measures. These advances also raise important questions regarding unintended ecosystem interactions and potential misuse. Key questions guide this discussion: • What are the biosecurity and biosafety implications of the increasing capabilities of synthetic cells? • How urgently must governments, researchers, and industry act to mitigate these risks? Biosecurity concerns ❖ Potential for misuse : Like any other emerging technology, synthetic cells also present dual-use concerns that could be taken advantage of by malicious people. Survey participants highlighted that easier access to synthetic cells without proper oversight could lead to their misuse of bioterrorism. This can be easily mitigated through strong DNA synthesis screening for research laboratories carrying out synthetic cell research to prevent bioweapon development. An expert mentioned that, “ The dual-use nature of synthetic cells requires strict controls to prevent their weaponization, even in low-tech settings .” Therefore, this topic discussion highlighted the establishment of a robust oversight of this technology, which is essential for the mitigation of foreseen misuse risks. Environmental biosafety strategies ❖ Lifecycle management and containment . This is another key strategy for biocontainment. Expertise recommended that researchers in the field look at biocontainment using synthetic genes developed to act as “ kill switches ” for the cell that triggers deactivation and/or self-destruction. This ensures that cells become inactive after fulfilling their intended purpose or after a specific period. Therefore, this triggerion has encouraged policymakers and synthetic cell researchers to mandate lifecycle management plans in every research study protocol for environmental release. ❖ Unintended ecological interactions : There can be unintended negative consequences of deploying synthetic cells in any environmental medium. The policy survey results showed that 68% of participants identified potential ecological disruption as the most significant risk factor. In addition, the expert interviewees expressed more concerns about the need to prevent unintentional transfer of engineered genes to native species, as this can lead to unpredicted changes in ecosystems. One expert remarked, “ The possibility of synthetic cells integrating into natural microbial communities could fundamentally alter ecological balances in unforeseen ways .” Therefore, this discussion suggests prioritizing the need to understand gene transfer dynamics and to manage synthetic cell persistence in various ecosystems. ❖ Uncontrolled Proliferation : This study finds this to be a major concern for stakeholders if these cells are released without any in-built mechanisms. Most participants expressed concerns about containment measures and the management of proliferation in the environment. Experts have shown concern about synthetic cells having greater adaptability due to a lack of evolutionary constraints compared to biologically engineered microbes. This discussion presented built-in bio-containment strategies, such as programmed deactivation or environmental sensitivity, as the main means for establishing a controlled deployment of synthetic cells for their specific role for a specific period without any proliferation that can increase environmental persistence. ❖ Standardized Risk Assessment Protocols : This been of great concern even to the current engineered microbes, as mentioned by an expert who noted, “ Current frameworks are ill-equipped to evaluate the dynamic nature of engineered cells in real-world environments. ” This shows that such standardized protocols are needed because they can make modifications for specific related technologies, such as synthetic cells, much easier. Protocols ranging from computational models and simulations to field trials and ongoing monitoring, especially for early stage research, are crucial in the evaluation of short- and long-term biosafety impacts. ❖ Integration with existing biosafety frameworks : With current regulations focusing mainly on the evaluation of similar but different technologies, updated and specific regulations are required. Participants emphasized the need to tailor the existing GMO regulations to include specifics for microbe engineering and synthetic cells to address the unique risks they present. Therefore, a key action item is to regularly update existing biosafety frameworks to ensure consistency in regulatory approaches while avoiding regulatory redundancies. Global preparedness With the good perception expressed, advantages highlighted, and positive feedback expressed by the study participants, research and advancements in bioremediation worldwide will shift from the current use of chemical, physical, or engineered microbes to the use of synthetic cells. Therefore, the study participants called for quick action by governments and bio-risk management organizations to act now by establish preventive measures that will enable proper use of benefits while mitigating any risks. As one expert noted, “ Biosecurity risks are not hypothetical; they are inevitable without proper governance. ” In conclusion, the discussion around biosecurity and biosafety risks generated insights into global collaboration through organizations, promotion of research into bio-containment strategies, and adapting exciting frameworks to include synthetic cell technology’s specific concerns. Regulatory and governance concerns Emerging technologies, such as synthetic cells, require the development of regulatory and governance frameworks to address biosecurity and biosafety risks that arise from their applications ( Committees, n.d. ). Therefore, this study highlights the critical need for proactive policy development to ensure that the safe use of benefits mitigates risks. The main questions explored in this section are as follows: • What governance measures can safeguard the bio-risks posed by the use of synthetic cells in bioremediation? Regulatory measures ❖ The establishment of standardized protocols based on the uses and areas of application was key to the study findings. One expert mentioned “ comprehensive risk assessment frameworks addressing environmental and health impacts ,” while another suggested “ tiered risk assessments based on the complexity and potential exposure of each application.” To make this easier, a point that came up was the need for adaptive governance structures that involve making changes to include new technologies, such as basing existing GMOs’ regulations on synthetic cell regulations, thus enabling timely updates to regulatory measures. ❖ Monitoring and bio-containment strategies. Participants and experts highlighted the need for monitoring systems to track post-release consequences over time and have corrective actions based on testing results in laboratory-controlled environments. This is evidenced by the 60% survey responses emphasizing such, with one expert recommendation of “ tracking systems for synthetic cells post-release and accessible disclosure of testing data. ” ❖ The lack of international frameworks for synthetic cell governance can be a significant barrier to achieving global standards ( Cameron et al., 2014 ). One expert advocated for “ an international treaty governing synthetic cell technology interventions ,” while another suggested “ standardization of monitoring protocols under international norms. ” This will harmonize risk assessment while balancing local ecological concerns. ❖ Export controls have also been proposed for synthetic cell-related products, particularly for those integrated into ecosystems. These controls could ensure that use is restricted to countries whose biosafety norms accept and can thus manage them. ❖ Future-proofing governance measures must therefore be able to anticipate future challenges and remain adaptable, but immediate policy actions must start with establishing baseline regulations, especially at the research level, as well as on bio-containment and monitoring while looking at the development of internationally standardized protocols and frameworks. Although a great deal of helpful information was gleaned, this study has some limitations. The sample, although diverse, was populated largely by academic stakeholders, potentially skewing the favor of technical and governance orientations over social or economic ones. Second, while perceptions were satisfactorily represented in this study, none of the hypothesized risk reduction measures were experimentally validated, which leaves an arena for further confirmation through computational modeling, controlled experimentation, or ecological simulations. Therefore, a cooperative and multidisciplinary approach is required. Scientists, policymakers, and public stakeholders must collaborate to co-design governance mechanisms that are adaptive, inclusive, and responsive to the evolving synthetic biology dynamics. As global interest in environmental biotechnologies grows, integration of stakeholder-involved risk assessment procedures within international oversight frameworks, such as those promoted by the International Biosecurity and Biosafety Initiative for Science (IBBIS), will be essential to ensuring responsible innovation. In summary, this study confirmed both the promise and complexity of the application of synthetic cell technologies for environmental remediation. With anticipatory, inclusive governance and international cooperation, these technologies can be powerful tools in addressing the environmental crises of the future—if, and only if, their development is followed by strict ethical and safety protocols. Conclusion Key findings These findings represent the perceptions, capabilities, and potential concerns regarding the use of synthetic cell technology in the environmental sector, which will evolve with time to replace the current use of engineered microbes and physical and chemical methods with advancements in synthetic biology. • With more research directed towards environmental remediation, synthetic cell technology has great capabilities for the degradation of various environmental pollutants. Based on the current use of engineered microbes for bioremediation, it is easier to use synthetic cells that can be more effective for targeted bioremediation applications than existing methods. • The main biosafety concerns raised were unintended ecological impacts, containment failure, disruption of native microbial populations, and difficulty in monitoring long-term effects. This is also found to have dual-use potential, that is, the potential for positive applications such as environmental remediation, while posing negative applications such as bioterrorism or the creation of hazardous synthetic cells within the ecosystem, thus necessitating biosecurity measures. • Misinformation regarding emerging technologies has always been a significant barrier to societal acceptance. Thus, a significant number of survey participants supported the continuous, transparent communication and inclusive public engagement strategies needed to build trust. • Currently, there are no formal guidelines for international oversight of synthetic cell technology. There is only voluntary regulation and governance by synthetic cell researchers, such as Build A Cell, which implies the need for collaboration by biosecurity boards to work on a risk assessment framework for this technology in this early stage before applications increase ( Frischmon et al., 2021 ). 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. ❖ Developing a written comprehensive framework that clearly outlines a standardized protocol of risk assessment in order to evaluate synthetic cell applications based on specific intended use. • This should be science-informed, involving experts in synthetic cell research and environmental remediation, as well as policymakers. The priority should be containment, lifecycle management, and post-deployment monitoring. • To make this faster, there is a need to modify the existing GMO regulatory framework to include aspects of synthetic biology, especially emerging technologies. of synthetic cells in this case (Committees, n.d.). More specific to synthetic cell regulation are policies that need to address issues such as gene transfer and ecological interactions. ❖ For safe application of synthetic cells that mitigates any biosecurity and biosafety concerns raised in this report, there is a need for robust ecological safety protocols that need to be developed by biosafety officials. • A key aspect of ecological concerns is cell guardrails, especially programmed deactivation after a standard period of time to ensure that there is no proliferation or persistence beyond their intended use period. The use of advanced techniques that enable genetic confinement, such as kill switches and terminator genes, can affect this outcome. • Robust monitoring systems must be developed for easy tracking after deployment in a specific area. • As this also presents dual-use concerns, the establishment of a dedicated biosecurity board in countries that use technology is needed to assess dual-use concerns and enforce safeguards against the misuse of synthetic cell technologies. ❖ Early and inclusive communication as well as engagement strategies are key for building trust that will enable public acceptance once the application becomes feasible. • As emerging technologies and applications are disclosed, they often face misinformation about various aspects; thus clear and clear evidence-based science communication to engage diverse audiences by the government enables acceptance by citizens. • First, there is a need for industries in this sector to engage local communities in the planning processes. This can generate significant insights from communities for better and acceptable application practices ( Stirling et al., 2018 ). • Before any application is made, there is a great need for scientists to publicly disclose risk assessment data, clear deployment plans, monitoring results, and safety measures established for building societal trust ( Normandin et al., 2022 ). ❖ To support the development of this synthetic cell technology, better applications and risk assessment studies, prioritization of its research to optimize that raised concerns and make the better innovations possible. • Research institutions should consider conducting more computational modeling and simulation research on ecological modeling to predict synthetic cell behavior and interactions in complex ecosystems, thereby reducing experimental uncertainties. • Incorporating AI-driven simulations into this type of research is crucial for predicting long-term ecological effects and behavioral changes in ecosystems ( Stirling et al., 2018 ). • Private funders, such as philanthropic organizations and synthetic biology venture capital firms, should encourage research funding in environmental projects to ensure better innovation and risk assessment studies. • Partnerships between synthetic biologists, ecologists, and computational scientists are also needed to develop holistic solutions to environmental challenges. • Research institutions are required to conduct controlled, small-scale deployments of synthetic cells in well-controlled laboratory environments to minimize the accidental release of potentially wrongly designed cells. This will also enable the refinement of risk mitigation strategies before large-scale implementation. ❖ International collaboration through organizations, such as the International Biosecurity and Biosafety Initiative for Science (IBBIS), to promote global biosecurity measures for synthetic cell technology and ensure an international oversight approach. • Through global efforts, the development of standardized regulations has become cheaper and more comprehensive, owing to diverse perspectives. • The main organizations concerned with the environment, such as the United Nations Environment Programme (UNEP), should establish an advisory board on synthetic cell technology for more in-depth discussions. Ethics and integrity statements Ethics This study did not receive formal ethical approval from an institutional review board (IRB) or independent ethics committee. However, the data collection was approved and overseen by the iGEM Policy Research Project Head, who confirmed that the study aligned with iGEM Community guidelines for policy research. The study involved minimal risk, and participation was entirely voluntary. Ethics approval statement This study was approved by the iGEM Community Policy Research Team. All survey participants had to acknowledge the purpose, procedures, and voluntary nature of the study and agree to proceed before submitting any responses. Informed consent statement Participation in this study was voluntary, and all participants were adults. Informed consent was stated for all participants prior to participation. Due to the online nature of the survey and interviews, written consent was not collected; instead, participants were provided with detailed information about the study, including its purpose, procedures, and data handling, and were required to indicate their agreement before proceeding. Permission to reproduce material from other sources This study does not contain any reproduced material from other sources. Data availability statement All data underlying the results presented in this article are openly available in the Zenodo repository: https://zenodo.org/records/16418760 ( Anguzu, S., et al., 2025 ), and are accessible under a Creative Commons Attribution (CC-BY 4.0) license. The dataset includes: fully anonymized survey responses, expert interview summaries, values supporting all statistical results, graphs, and figures and extended data such as the original survey questionnaire. These materials are provided to ensure transparency and to enable further study and analysis for more insights. Acknowledgments The authors of this article acknowledge the full support of those who were instrumental in the entire development of the project, including the interviewees in policy, synthetic biology, and environmental remediation expertise, who generously shared their knowledge and gave time and expertise to the project. The iGEM Community Policy Research Project Head, Jo Yi Chow, and iGEM Community Program Coordinator Yorgo El Moubayed contributed to the review of each step of the study. We are grateful to the iGEM Community for supporting this project. References Adamala KP, Martin-Alarcon DA, Guthrie-Honea KR, et al. : Engineering genetic circuit interactions within and between synthetic minimal cells. Nat. Chem. 2017; 9 (5): 431–439. PubMed Abstract | Publisher Full Text | Free Full Text Aditya C, Bertaux F, Batt G, et al. : Using single-cell models to predict the functionality of synthetic circuits at the population scale. Proc. Natl. Acad. Sci. 2022; 119 (11): e2114438119. 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PubMed Abstract | Publisher Full Text | Free Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 12 Sep 2025 ADD YOUR COMMENT Comment Author details Author details 1 iGEM Community, Paris, France 2 Department of Research & Innovations, SynBio4All Africa Initiative, Kampala, Uganda 3 Department of Innovations, SynBio Eco, Kampala, Uganda 4 University of Málaga, Málaga, Spain 5 Spanish Institute of Oceanography, Madrid, Spain 6 Costa Rica Institute of Technology, Cartago, Costa Rica Anguzu Simon Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Software, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Iván Toro Pineda Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Luis Muñoz-Solórzano Roles: Conceptualization, Investigation, Methodology, Writing – Original Draft Preparation Isha Vats Roles: Investigation, Methodology, Writing – Original Draft Preparation Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 12 Sep 2025, 14:915 https://doi.org/10.12688/f1000research.165103.1 Copyright © 2025 Simon A et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Simon A, Toro Pineda I, Muñoz-Solórzano L and Vats I. Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :915 ( https://doi.org/10.12688/f1000research.165103.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 12 Sep 2025 Views 0 Cite How to cite this report: Gustave W. Reviewer Report For: Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :915 ( https://doi.org/10.5256/f1000research.181701.r443502 ) The direct URL for this report is: https://f1000research.com/articles/14-915/v1#referee-response-443502 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 09 Jan 2026 Williamson Gustave , University of The Bahamas, Nassau, Bahamas Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.181701.r443502 The manuscript by Simon et al. examines stakeholder perceptions of synthetic cell technology for environmental remediation, with a focus on biosafety, biosecurity, and governance considerations. Using surveys and expert interviews, the study explores perceived benefits, risks, and regulatory gaps associated ... Continue reading READ ALL The manuscript by Simon et al. examines stakeholder perceptions of synthetic cell technology for environmental remediation, with a focus on biosafety, biosecurity, and governance considerations. Using surveys and expert interviews, the study explores perceived benefits, risks, and regulatory gaps associated with the potential deployment of synthetic cells in natural ecosystems. The topic is timely and of clear policy relevance, and the manuscript adds value by bringing stakeholder perspectives into discussions of anticipatory governance; however, the analysis remains largely descriptive, and several claims extend beyond what is directly supported by the data. The introduction provides a broad and well-referenced overview of synthetic cells, anticipatory governance, and environmental risk, but the specific knowledge gap addressed by this study is not clearly articulated. While the authors repeatedly state that governance frameworks are lacking and that risks are insufficiently understood, it is not clear what is missing from existing stakeholder or policy-focused studies that this work uniquely addresses. The authors are encouraged to sharpen the study’s aim and more explicitly state how this perception analysis advances current understanding, rather than reiterating well-established concerns in the literature. Additionally, the framing of the work as a “multi-criteria decision analysis” is somewhat misleading, as the study appears to rely primarily on thematic analysis of perceptions rather than a formal MCDA framework. The methodology section requires further detail to ensure transparency and reproducibility. The survey distribution strategy is described only in general terms, and the sampling approach (e.g., convenience or snowball sampling) is not clearly stated, making it difficult to assess representativeness. Similarly, the survey instrument itself is not sufficiently described in the main text, and the authors should summarize the core questions and scales used or clearly direct readers to supplementary materials. The use of GPT-4o to assist with thematic analysis is mentioned but not adequately explained; the authors should clarify how AI-assisted coding was supervised, validated, and integrated with human judgment to meet academic standards. A more serious concern relates to ethical oversight. Although informed consent and anonymity are addressed, the study explicitly states that it did not receive approval from an institutional review board or independent ethics committee, relying instead on approval from the iGEM Community Policy Research Team. Given that the study involved human participants, this warrants a more careful justification and a clearer discussion of limitations, particularly for an international audience accustomed to formal IRB processes. The results and discussion sections largely summarize stakeholder opinions and align them with existing literature, but they offer limited critical interpretation. Several claims about the future role of synthetic cells in replacing existing remediation approaches go beyond what perception data can support. The discussion would benefit from a clearer distinction between stakeholder expectations and empirically demonstrated technological capabilities. In addition, many discussion subsections read as policy position statements rather than analytical interpretations of the study’s findings. The authors are encouraged to more explicitly link each governance recommendation to specific survey or interview results and to discuss areas of uncertainty or disagreement among participants. Finally, while the authors acknowledge that the sample is heavily weighted toward academic respondents, the implications of this bias are not sufficiently explored. Greater reflection on how perspectives might differ among regulators, local communities, or industry stakeholders would strengthen the manuscript’s credibility and policy relevance. Does the paper provide a comprehensive overview of the policy and the context of its implementation in a way which is accessible to a general reader? Yes Is the discussion on the implications clearly and accurately presented and does it cite the current literature? Partly Are the recommendations made clear, balanced, and justified on the basis of the presented arguments? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Expertise includes environmental biogeochemistry and environmental health, with a research focus on soil and water contamination, risk assessment, and the environmental implications of emerging technologies. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Gustave W. Reviewer Report For: Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :915 ( https://doi.org/10.5256/f1000research.181701.r443502 ) The direct URL for this report is: https://f1000research.com/articles/14-915/v1#referee-response-443502 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Shen L. Reviewer Report For: Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :915 ( https://doi.org/10.5256/f1000research.181701.r414376 ) The direct URL for this report is: https://f1000research.com/articles/14-915/v1#referee-response-414376 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 03 Oct 2025 Liguo Shen , Zhejiang Normal Universty, Jinhua, China Approved VIEWS 0 https://doi.org/10.5256/f1000research.181701.r414376 The topic of the article is cutting-edge and significant, closely aligning with the core concepts of "responsible innovation" and "predictive governance". The use of a mixed research method (questionnaires and interviews) to capture the perspectives of diverse stakeholders is appropriate. ... Continue reading READ ALL The topic of the article is cutting-edge and significant, closely aligning with the core concepts of "responsible innovation" and "predictive governance". The use of a mixed research method (questionnaires and interviews) to capture the perspectives of diverse stakeholders is appropriate. The article successfully identified and thoroughly discussed the application potential of synthetic cell technology in environmental remediation, the main risks (biological safety, regulatory gaps, etc.) and the governance requirements. 1. The introduction section can further strengthen the logical progression from "technical potential" to "risk concerns" and then to "the necessity of research". 2. Some of the assertions require stronger evidence from reliable sources. For instance, when referring to "the absence of a global standard framework", one could cite authoritative reviews or reports that discuss the gaps in the governance of synthetic biology or emerging technologies. 3. Although explanations were provided for "synthetic cells" and "predictive governance", they could be made more concise. Ensure that the clearest definition is given for the first time it is mentioned. 4. It is necessary to describe how the questionnaire was distributed (the specific platform and group), as well as the sampling method used (such as snowball sampling). This will help readers assess the representativeness of the sample. 5. It is recommended to provide the full questionnaire in the supplementary materials, or to describe the core questions, scale options, etc. in more detail in the main text. 6. A brief description of the core theme or question outline of the interview should be given. 7. The author mentioned using GPT-4 for auxiliary analysis, which is acceptable. However, the specific process and human supervision must be detailed to comply with academic standards. 8. You have pointed out that the sample is biased towards the academic community, which is an important limitation. It is necessary to discuss more thoroughly how this might affect the generalizability of the results. Additionally, the exploratory nature of the study can be mentioned, as well as the need for larger-scale and more quantitative research in the future to validate these findings. Does the paper provide a comprehensive overview of the policy and the context of its implementation in a way which is accessible to a general reader? Yes Is the discussion on the implications clearly and accurately presented and does it cite the current literature? Yes Are the recommendations made clear, balanced, and justified on the basis of the presented arguments? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Emergency management, chemical safety management I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Shen L. Reviewer Report For: Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :915 ( https://doi.org/10.5256/f1000research.181701.r414376 ) The direct URL for this report is: https://f1000research.com/articles/14-915/v1#referee-response-414376 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 12 Sep 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 1 12 Sep 25 read read Liguo Shen , Zhejiang Normal Universty, Jinhua, China Williamson Gustave , University of The Bahamas, Nassau, Bahamas Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2026 Gustave W. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 09 Jan 2026 | for Version 1 Williamson Gustave , University of The Bahamas, Nassau, Bahamas 0 Views copyright © 2026 Gustave W. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The manuscript by Simon et al. examines stakeholder perceptions of synthetic cell technology for environmental remediation, with a focus on biosafety, biosecurity, and governance considerations. Using surveys and expert interviews, the study explores perceived benefits, risks, and regulatory gaps associated with the potential deployment of synthetic cells in natural ecosystems. The topic is timely and of clear policy relevance, and the manuscript adds value by bringing stakeholder perspectives into discussions of anticipatory governance; however, the analysis remains largely descriptive, and several claims extend beyond what is directly supported by the data. The introduction provides a broad and well-referenced overview of synthetic cells, anticipatory governance, and environmental risk, but the specific knowledge gap addressed by this study is not clearly articulated. While the authors repeatedly state that governance frameworks are lacking and that risks are insufficiently understood, it is not clear what is missing from existing stakeholder or policy-focused studies that this work uniquely addresses. The authors are encouraged to sharpen the study’s aim and more explicitly state how this perception analysis advances current understanding, rather than reiterating well-established concerns in the literature. Additionally, the framing of the work as a “multi-criteria decision analysis” is somewhat misleading, as the study appears to rely primarily on thematic analysis of perceptions rather than a formal MCDA framework. The methodology section requires further detail to ensure transparency and reproducibility. The survey distribution strategy is described only in general terms, and the sampling approach (e.g., convenience or snowball sampling) is not clearly stated, making it difficult to assess representativeness. Similarly, the survey instrument itself is not sufficiently described in the main text, and the authors should summarize the core questions and scales used or clearly direct readers to supplementary materials. The use of GPT-4o to assist with thematic analysis is mentioned but not adequately explained; the authors should clarify how AI-assisted coding was supervised, validated, and integrated with human judgment to meet academic standards. A more serious concern relates to ethical oversight. Although informed consent and anonymity are addressed, the study explicitly states that it did not receive approval from an institutional review board or independent ethics committee, relying instead on approval from the iGEM Community Policy Research Team. Given that the study involved human participants, this warrants a more careful justification and a clearer discussion of limitations, particularly for an international audience accustomed to formal IRB processes. The results and discussion sections largely summarize stakeholder opinions and align them with existing literature, but they offer limited critical interpretation. Several claims about the future role of synthetic cells in replacing existing remediation approaches go beyond what perception data can support. The discussion would benefit from a clearer distinction between stakeholder expectations and empirically demonstrated technological capabilities. In addition, many discussion subsections read as policy position statements rather than analytical interpretations of the study’s findings. The authors are encouraged to more explicitly link each governance recommendation to specific survey or interview results and to discuss areas of uncertainty or disagreement among participants. Finally, while the authors acknowledge that the sample is heavily weighted toward academic respondents, the implications of this bias are not sufficiently explored. Greater reflection on how perspectives might differ among regulators, local communities, or industry stakeholders would strengthen the manuscript’s credibility and policy relevance. Does the paper provide a comprehensive overview of the policy and the context of its implementation in a way which is accessible to a general reader? Yes Is the discussion on the implications clearly and accurately presented and does it cite the current literature? Partly Are the recommendations made clear, balanced, and justified on the basis of the presented arguments? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Expertise includes environmental biogeochemistry and environmental health, with a research focus on soil and water contamination, risk assessment, and the environmental implications of emerging technologies. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Gustave W. Peer Review Report For: Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :915 ( https://doi.org/10.5256/f1000research.181701.r443502) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-915/v1#referee-response-443502 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Shen L. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 03 Oct 2025 | for Version 1 Liguo Shen , Zhejiang Normal Universty, Jinhua, China 0 Views copyright © 2025 Shen L. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The topic of the article is cutting-edge and significant, closely aligning with the core concepts of "responsible innovation" and "predictive governance". The use of a mixed research method (questionnaires and interviews) to capture the perspectives of diverse stakeholders is appropriate. The article successfully identified and thoroughly discussed the application potential of synthetic cell technology in environmental remediation, the main risks (biological safety, regulatory gaps, etc.) and the governance requirements. 1. The introduction section can further strengthen the logical progression from "technical potential" to "risk concerns" and then to "the necessity of research". 2. Some of the assertions require stronger evidence from reliable sources. For instance, when referring to "the absence of a global standard framework", one could cite authoritative reviews or reports that discuss the gaps in the governance of synthetic biology or emerging technologies. 3. Although explanations were provided for "synthetic cells" and "predictive governance", they could be made more concise. Ensure that the clearest definition is given for the first time it is mentioned. 4. It is necessary to describe how the questionnaire was distributed (the specific platform and group), as well as the sampling method used (such as snowball sampling). This will help readers assess the representativeness of the sample. 5. It is recommended to provide the full questionnaire in the supplementary materials, or to describe the core questions, scale options, etc. in more detail in the main text. 6. A brief description of the core theme or question outline of the interview should be given. 7. The author mentioned using GPT-4 for auxiliary analysis, which is acceptable. However, the specific process and human supervision must be detailed to comply with academic standards. 8. You have pointed out that the sample is biased towards the academic community, which is an important limitation. It is necessary to discuss more thoroughly how this might affect the generalizability of the results. Additionally, the exploratory nature of the study can be mentioned, as well as the need for larger-scale and more quantitative research in the future to validate these findings. Does the paper provide a comprehensive overview of the policy and the context of its implementation in a way which is accessible to a general reader? Yes Is the discussion on the implications clearly and accurately presented and does it cite the current literature? Yes Are the recommendations made clear, balanced, and justified on the basis of the presented arguments? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Emergency management, chemical safety management I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Shen L. Peer Review Report For: Risk Assessment of Synthetic Cell Technology in Environmental Remediation: A stakeholder policy perception analysis [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :915 ( https://doi.org/10.5256/f1000research.181701.r414376) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-915/v1#referee-response-414376 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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