Emerging governance considerations for the deployment of genetically engineered microbes

In this review, we identify emerging trends in the governance and policy landscape surrounding the real-world deployment of genetically engineered microbes (GEMs), focusing on the United States and Europe. A recent wave of commercialized GEMs in the US suggests that interest in developing GEMs for open release might be on the rise, after a 40-year period of very low commercial activity. GEMs are receiving renewed attention for their potential roles in agriculture, sustainable manufacturing, biosensing, environmental restoration, energy production, and human health. Advances in genetic modification technologies, combined with the growing number of possible open release applications for GEMs, stand to challenge existing governance frameworks in several ways. First, the feasibility of either strict product- or process-based regulatory frameworks for biotechnology is being increasingly tested. Second, the desirability of long-term persistence and ecological action of GEMs in some application contexts complicates the logic of typical risk assessments for deliberate release of genetically modified organisms. Synergistic, long-term, and indirect impacts of open release are challenging to reliably predict and call for risk assessment methods able to accommodate high levels of uncertainty or ignorance. Third, increasing variety in application types for GEMs is likely to yield new business models and routes to market. Approaches such as direct-to-consumer marketing raise challenging questions around stewardship, consent, transborder movement, and monitoring of GEMs. This constellation of issues will benefit from interdisciplinary research and stakeholder deliberation at local, national, and international levels to promote robust and adaptable GEM governance in the coming decades.