Regulatory review and governance gaps for genetically engineered microbes

Living genetically engineered microorganisms (GEMs) are increasingly used in consumer products and environmental applications, yet U.S. biotechnology regulation relies on statutes that predate their development or are designed for other types of products. This article examines oversight of living GEMs through 3 case studies of consumer and environmental GEM applications. Across these cases, federal premarket review was very limited or absent because oversight depended on distinctions such as the type of modification, the developer’s product classification, or marketing claims. These regulatory pathways may not always align uniformly with the potential health and environmental risk profiles. While not all GEMs require the same level of oversight, current regulatory gaps have allowed for the large-scale, open release of these GEMs without substantial federal oversight. The article recommends baseline federal notification, changes to statutes or regulations to strengthen regulatory foundations, greater transparency, independent evaluation, and post-market monitoring, while also preserving efficient pathways for lower-risk applications. These enhancements to the regulation of GEMs will become increasingly important for effective risk governance as consumer and environmental products incorporate advanced synthetic biology approaches.