TY - JOUR
T1 - Development of community of practice to support quantitative risk assessment for synthetic biology products
T2 - contaminant bioremediation and invasive carp control as cases
AU - Trump, Benjamin D.
AU - Foran, Christy
AU - Rycroft, Taylor
AU - Wood, Matthew D.
AU - Bandolin, Nirzwan
AU - Cains, Mariana
AU - Cary, Timothy
AU - Crocker, Fiona
AU - Friedenberg, Nicholas A.
AU - Gurian, Patrick
AU - Hamilton, Kerry
AU - Hoover, Jan Jeffrey
AU - Meyer, Corey
AU - Pokrzywinski, Kaytee
AU - Ritterson, Ryan
AU - Schulte, Paul
AU - Warner, Christopher
AU - Perkins, Edward
AU - Linkov, Igor
N1 - Publisher Copyright:
© 2018, This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - 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.
AB - 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.
KW - Risk assessment
KW - Synthetic biology
KW - Technology governance
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U2 - 10.1007/s10669-018-9710-9
DO - 10.1007/s10669-018-9710-9
M3 - Article
AN - SCOPUS:85056081397
SN - 2194-5403
VL - 38
SP - 517
EP - 527
JO - Environment Systems and Decisions
JF - Environment Systems and Decisions
IS - 4
ER -