Governance Challenges for Direct-to-Consumer Genetically Engineered Organisms

In this briefing, we propose that direct-to-consumer (DTC), live genetically engineered (GE) organisms represent a novel and non-obvious category of biotechnology. The context of use for these products raises new governance and regulatory questions. Unlike most GE organisms to date, which have been marketed to large agro-industrial players, DTC GE organisms are marketed directly to individuals. DTC GE organisms are often directed towards at-home lifestyle, ornamental, or wellness applications, as shown through the four case examples explored in this briefing, which include the Glofish, Firefly Petunia, Norfolk Purple Tomato, and ZBiotics probiotic. Challenges for governing these products in society include 1) limited information is available to consumers about broader risks, impacts, and responsible use; 2) deployment and stewardship are under the purview of the individual consumer in society and without explicit containment mechanisms; and 3) accountability or responsibility for addressing any unintended consequences is unclear. We suggest that these challenges could be addressed by considering the context of use as a key part of federal agency product reviews, supporting more comprehensive post-market surveillance of these products, and creating greater transparency mechanisms via a public registry for DTC GE organisms.