What are the human health and environmental risks posed by synthetic biology research and development (R&D) for energy applications? We found it surprisingly difficult to answer this seemingly straightforward question in our review of the risk-related synthetic biology literature. To our knowledge, no entity to date has published a comprehensive review of this literature. Thus, this analysis aims to fill that void and, at a high level, answer the question that we pose. Risk-related synthetic biology literature addresses risk from different perspectives. Much of the literature that we reviewed treats the concept of risk in synthetic biology R&D broadly, enumerating few specific risks. Nevertheless, after reviewing >200 documents, we identified 44 discrete risk issues; 18 of those related to human health and 26 to the environment. We clustered these risk issues into categories that reflect and summarize their content. We categorized human health risk issues as follows: allergies, antibiotic resistance, carcinogens, and pathogenicity or toxicity. Environmental risk issues were categorized as follows: change or depletion of the environment, competition with native species, horizontal gene transfer, and pathogenicity or toxicity. Our efforts to understand what the synthetic biology R&D-related risk issues are stemmed from a larger research project in which we used risk issues identified in the literature as a point of departure in interviews with biosafety professionals and scientists engaged in synthetic biology R&D. We wrote this article after multiple biosafety professionals told us that accessing our risk-related literature analysis would aid them in their work.

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Factors that shape actual research practices - 'social and institutional context' - typically are missing from considerations of synthetic biology R&D-related risk and containment. We argue that analyzing context is essential in identifying circumstances that create, amplify, or diminish risk, and in revealing new opportunities for avoiding or managing those risks.