The global market for a synthetic biology industry is predicted to grow to $10.8 billion by 2016, with the largest share of growth in the chemicals and energy sectors. A preliminary inventory compiled by the Woodrow Wilson International Center for Scholars indicates a broad array of products moving towards commercialization over the next five years. Inevitably, some of the applications necessitate the intentional release of synthetically engineered organisms into the environment. There is a need to address the potential risk to the environment and society from large-scale production scenarios using synthetically modified organisms. This project takes advantage of an opportunity to develop, fund, and execute an interdisciplinary research agenda that will enable a broader understanding of the evolutionary and ecological implications of synthetic biology.
Intellectual Merit: This project seeks to bring together the "upstream" scientists that develop synthetic biology applications and the "downstream" scientists who focus on risk assessment. Traditionally, these groups have somewhat diverging perceptions of the technologies and the potential risk they pose. A key aspect of this workshop is to explore funding models for synthetic biology that incorporate direct input from evolutionary and environmental biologists. The hope is that these interactions will lead to the development of environmentally benign organisms capable of producing useful bio products.
Broader Impact: The expectation is that the project will first, build productive, on-going collaborations between synthetic biology researchers and evolutionary biologists, ecologists, and environmental scientists, to assess the knowledge gaps and uncertainties related to the ecological impacts of synthetic biology. Second, the project will create a research agenda for the ecological implications of synthetic biology based on existing, near-, and long-term applications of engineered organisms and achieve buy-in and support for the research from key stakeholder groups. Ultimately, the proposed activities should help ensure that synthetic biology investments achieve broad societal benefits while mitigating potential environmental risks.
This project developed an interdisciplinary research agenda to improve understanding of potential environmental effects of commercial applications of synthetic biology. The research agenda was developed through consultations among synthetic biologists, evolutionary biologists, ecologists, and environmental scientists with participation by regulators, firms and civil society. It was based on workshops that focused on near- and medium-term applications of synthetic biology, with scenarios based on the intentional and unintentional release of engineered organisms. The prompts used for development of the research agenda included a Kickstarter funded glowing plant, nitrogen fixating non-legumes (MIT), bioremediation and minerals extraction (Universal Biomining), and RNA gene drives for modification of populations of animals and plants in the wild (Harvard). Intellectual Merit: The project identified the following areas as hurdles to understanding potential ecological effects associated with the release of organisms modified using synthetic biology. Comparators: Synthetic biology’s pursuit of producing novel organisms challenges the established framework of comparing a modified organism to its wild-type "parent." How does this affect risk assessments? What alternative testing schemes are needed for "no analog" organisms possibly even in "no analog" ecosystems? Phenotypic characterization: How can one identify and prioritize traits of concern? Which phenotypes are most relevant for assessing ecological interactions and consequences in the short and long term? Fitness, genetic stability, and lateral gene transfer: These properties define and are defined by the interaction of organisms with environments. How does one measure these properties and interactions with each other with consistency, reliability, and confidence? What metrics are needed for these properties? Control of organismal traits: What degrees of biological and physical control should be required in advance of deployment of an organism? How do environmental conditions affect the need for intrinsic and external controls? Monitoring and surveillance: Should monitoring be broad-based, targeted or both? How can existing monitoring systems be used in this effort? What new systems are needed? What role should baseline data play in these efforts? Who manages and curates data? Who manages access? Computational modeling: What modeling tools exist and are they sufficient? Can existing models be combined across disciplines or are new approaches needed to integrate natural, physical, and social sciences with engineering? Standardization of methods and data: Should there be standards for testing methods, data reporting, and organism characterization? How should data collection and integration be handled? Who is responsible for developing, promoting and enforcing standards? Broader Impacts: The ultimate impact of the project will hinge on whether synthetic biologists and environmental scientists act to propose and fund research to fill gaps in understandings on environmental effects of synthetic biology and om whether regulators, industry and civil society incorporate evidence from such research into public debates over the governance of environmental implications. To this end, the project engaged with the research community, industry, civil society and government to access findings through multiple channels. Government: NSF Division Directors and Program Officers requested an informal distillation of preliminary findings on research priorities on accelerated basis for internal use. PIs Kenneth Oye and Todd Kuiken and facilitator James Collins provided a memorandum in January 2014, with further development and dissemination of recommendations through publications. Oye and Kuiken were invited to present on this project to National Academy of Sciences forums with representatives of EPA, DARPA, FDA, USDA, FBI, NIH, the White House OSTP and the Congress; and at two UN forums with significant intergovernmental representation. Research Community: The MIT-Wilson Center team produced a formal report entitled "Creating a Research Agenda on Ecological Implications of Synthetic Biology" in May 2014, 36 pp; an article "Shaping Ecological Risk Research for synthetic Biology" in the Journal of Environmental Studies and Sciences, May 2014; and a Policy Forum in Science on "Regulating Gene Drives" in August 2014. PIs Oye and Kuiken were invited to deliver presentations on ecological effects and the research agenda in numerous forums, including the Plant Synthetic Biology Conference, SEED and the Society for Risk Analysis, Publics and Civil Society: Research recommendations and the principle of early scientifically informed engagement with implications of synthetic biology resonated with the media and broader public. Oye, Kuiken, Esvelt and Church conducted interviews with Nova, WBUR, Fox News Network, Boston Globe, New York Times, Scientific American, Technology Review and other media outlets.
