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Development of community of practice to support quantitative risk assessment for synthetic biology products: contaminant bioremediation and invasive carp control as cases

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Abstract

Synthetic biology has the potential for a broad array of applications. However, realization of this potential is challenged by the paucity of relevant data for conventional risk assessment protocols, a limitation due to to the relative nascence of the field, as well as the poorly characterized and prioritized hazard, exposure, and dose–response considerations associated with the development and use of synthetic biology-derived organisms. Where quantitative risk assessment approaches are necessarily to fulfill regulatory requirements for review of products containing genetically modified organisms, this paper reviews one potential avenue for early-stage quantitative risk assessment for biosafety considerations of synthetic biology organism deployment into the environment. Building from discussion from a March 2018 US Army Engineer Research and Development Center workshop on developing such quantitative risk assessment for synthetic biology, this paper reviews the findings and discussion of workshop participants. This paper concludes that, while synthetic biology risk assessment and governance will continue to refine and develop in the coming years, a quantitative framework that builds from existing practice is one potentially beneficial option for risk assessors that must contend with the technology’s limited hazard characterization or exposure assessment considerations in the near term.

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Funding

This work was funded in part by the US Army Environmental Quality Research Program (63372803E00).

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Authors and Affiliations

  1. ORISE, Concord, MA, USA

    Benjamin D. Trump

  2. US Army Engineer Research and Development Center, Environmental Laboratory, Concord, MA, USA

    Benjamin D. Trump

  3. US Army Corps of Engineers, Engineer Research and Development Center, Vicksburg, MS, USA

    Christy Foran, Taylor Rycroft, Matthew D. Wood, Fiona Crocker, Jan Jeffrey Hoover, Kaytee Pokrzywinski, Christopher Warner, Edward Perkins & Igor Linkov

  4. Aptima, Inc., Woburn, MA, USA

    Matthew D. Wood

  5. Office of the Secretary of Defense, Arlington, USA

    Nirzwan Bandolin

  6. School of Public and Environmental Affairs, Indiana University Bloomington, Bloomington, IN, USA

    Mariana Cains

  7. US Army Corps of Engineers, Engineer Research and Development Center, Hanover, NH, USA

    Timothy Cary

  8. Applied Biomathematics, New York, NY, USA

    Nicholas A. Friedenberg

  9. Drexel University, Philadelphia, PA, USA

    Patrick Gurian

  10. Arizona State University, Tempe, AZ, USA

    Kerry Hamilton

  11. Gryphon Scientific, LLC, Takoma Park, MD, USA

    Corey Meyer & Ryan Ritterson

  12. National Institute for Occupational Safety and Health, Cincinnati, OH, USA

    Paul Schulte

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Correspondence to Igor Linkov.

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Trump, B.D., Foran, C., Rycroft, T. et al. Development of community of practice to support quantitative risk assessment for synthetic biology products: contaminant bioremediation and invasive carp control as cases. Environ Syst Decis 38, 517–527 (2018). https://doi.org/10.1007/s10669-018-9710-9

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