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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. 

As anthropogenic compounds are released into the environment at unprecedented rates, there is an ever-growing need for robust remediation strategies. Bioremediation, a method of immobilizing or transforming contaminants, is cost-competitive, environmentally friendly, and effective. With the global bioremediation market anticipated to grow by $8.29 billion between 2023 and 2028, this method of reducing pollutants represents a rapidly expanding sector of the bioeconomy. Millions of tons of pollutants now contaminate soil and groundwater, posing severe threats to human and environmental health. At the same time, as contaminants of emerging concern such as microplastics, pharmaceuticals, pesticides, and per- and polyfluorinated alkyl substances (PFAS) resist treatment with naturally occurring organisms, it may be useful to expand bioremediation’s toolkit to include genetically engineered microbes for bioremediation (GEMBs). There has been long-standing interest in developing GEMBs to enable faster remediation times and address a wider range of contaminants. Despite decades of investigation and development of GEMBs, none have been commercialized to date. Historically, the perceived need for GEMBs has not been sufficient to overcome the investment and risk in the context of an uncertain regulatory environment and a paucity of fundamental knowledge of GEMBs. However, as industries, environments, and human health experience disruptions from increasingly recalcitrant, widespread, and hazardous contaminants, the value proposition of GEMBs is more compelling than ever before. The contemporary challenges with managing environmental contamination coupled with advances in genetic engineering methods and renewed interest from researchers, developers, and policymakers signal an opportunity to realize the potential of GEMBs. To support safe and efficient development, characterization, and commercialization of GEMBs as a means of urgently addressing environmental contamination, we propose clarifying and restructuring the risk assessment process for GEMBs, establishing an interagency coordination office, collaboratively addressing critical knowledge gaps, and leveraging public-private partnerships. 

SUMMARY Engineered microbes are being programmed using synthetic DNA for applications in soil to overcome global challenges related to climate change, energy, food security, and pollution. However, we cannot yet predict gene transfer processes in soil to assess the frequency of unintentional transfer of engineered DNA to environmental microbes when applying synthetic biology technologies at scale. This challenge exists because of the complex and heterogeneous characteristics of soils, which contribute to the fitness and transport of cells and the exchange of genetic material within communities. Here, we describe knowledge gaps about gene transfer across soil microbiomes. We propose strategies to improve our understanding of gene transfer across soil communities, highlight the need to benchmark the performance of biocontainment measuresin situ, and discuss responsibly engaging community stakeholders. We highlight opportunities to address knowledge gaps, such as creating a set of soil standards for studying gene transfer across diverse soil types and measuring gene transfer host range across microbiomes using emerging technologies. By comparing gene transfer rates, host range, and persistence of engineered microbes across different soils, we posit that community-scale, environment-specific models can be built that anticipate biotechnology risks. Such studies will enable the design of safer biotechnologies that allow us to realize the benefits of synthetic biology and mitigate risks associated with the release of such technologies. 

Advances in engineering biology, together with growing interest and investment in supporting a bio-based economy in the US, are fueling research and development efforts into genetically engineering organisms for all kinds of different applications. While many of these applications involve using genetically engineered microorganisms in contained, bioreactor-like environments, there is also increasing interest in designing organisms (microbes, plants, insects, animals) for release and deployment in the open environments. This includes genetically modified crops, as well as direct-to-consumer probiotics and organisms designed for environmental remediation. Historically, examples of genetically engineered organisms released in open environments in the US remain limited, aside from GM crops. Industry enthusiasm for releasing genetically engineered microorganisms in particular waned at least partly in response to public controversy surrounding the field testing of Frostban “ice-minus” bacteria on strawberry crops in 1987. Development of living engineered products, together with publicly funded research on environmental transport and fate of engineered microorganisms in open environments, stalled. As a result, our approach to managing engineered microorganisms over the past 40 years has largely defaulted to the biosafety framework for genetic engineering in laboratory contexts, which emerged from the storied 1975 Asilomar meeting. This biosafety framework focuses on technological containment, a framing that prioritizes separation between genetically engineered organisms and the wider world. In this report, we argue that technological containment is insufficient for robust discussion and evaluation of genetically engineered organisms in open, complex environments. We introduce and make the case for a broader lens—which we call social containment—to be included alongside discussions of technological containment. Social containment directs our attention to how the cultural, environmental and political context around a genetically engineered organism (the sociotechnical system) is held together or challenged through its development and commercialization process. In this report, we use the lens of social containment to tell the stories of 11 genetically engineered organisms designed for deliberate release in the US. The cases cover historical and contemporary examples, genetically engineered microbes, plants and animals, and different application contexts. Through these stories, we show how technological, social, economic, legal, spatiotemporal and environmental considerations interact to smooth or disrupt the development process. We argue that this more holistic approach to understanding the relationships between genetically engineered organisms and the world is important in the context of recent, renewed interest in pursuing deliberate release applications. High-level findings emerging across the case studies include: 1) Development and commercialization pathways can look very different across genetically engineered organisms. There isn’t one, single factor that systematically emerges as the most important in determining the fate of a product. Some products have faced significant disruption in their developmental trajectories from different combinations of factors, while others have been more smoothly managed. Across the case studies, we identify factors that can work together to enable or constrain product trajectories. 2) The presence or absence of explicit, technological biocontainment strategies is not a reliable indicator of a successful product. Arguably, the absence of engineered biocontainment has resulted in more successful commercializations across our case studies than products with genetic biocontainment strategies engineered into them. 3) Public and stakeholder views on genetically engineered organisms are highly context-specific. We observe that public trust varies substantially across the case studies in this report, and should not necessarily be seen as a disruptive factor. Sensitivity to existing cultural norms and power dynamics is a key part of successful product development. Through this set of stories, we hope to open up ways for researchers and policy practitioners to think about containment as more than a simple technological concern. We encourage others to use our proposed framework to study their own genetically engineered organisms of interest—historical or contemporary, US-based or international—and we invite reflection on the variety of technological AND social processes by which genetically engineered organisms are controlled and managed in our society.