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Title: 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. more »« less
Paek, Andrew Y.; Brantley, Justin A.; Evans, Barbara J.; Contreras-Vidal, Jose L.
(, IEEE Systems Journal)
null
(Ed.)
Neurotechnology has traditionally been central to the diagnosis and treatment of neurological disorders. While these devices have initially been utilized in clinical and research settings, recent advancements in neurotechnology have yielded devices that are more portable, user friendly, and less expensive. These improvements allow laypeople to monitor their brain waves and interface their brains with external devices. Such improvements have led to the rise of wearable neurotechnology that is marketed to the consumer. While many of the consumer devices are marketed for innocuous applications, such as use in video games, there is potential for them to be repurposed for medical uses. How do we manage neurotechnologies that skirt the line between medical and consumer applications and what can be done to ensure consumer safety? Here, we characterize neurotechnology based on medical and consumer applications and summarize currently marketed uses of consumer-grade wearable headsets. We lay out concerns that may arise due to the similar claims associated with both medical and consumer devices, the possibility of consumer devices being repurposed for medical uses, and the potential for medical uses of neurotechnology to influence commercial markets related to employment and self-enhancement.
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.
Consumer mobile spyware apps covertly monitor a user's activities (i.e., text messages, phone calls, e-mail, location, etc.) and transmit that information over the Internet to support remote surveillance. Unlike conceptually similar apps used for state espionage, so-called stalkerware apps are mass-marketed to consumers on a retail basis and expose a far broader range of victims to invasive monitoring. Today the market for such apps is large enough to support dozens of competitors, with individual vendors reportedly monitoring hundreds of thousands of phones. However, while the research community is well aware of the existence of such apps, our understanding of the mechanisms they use to operate remains ad hoc. In this work, we perform an in-depth technical analysis of 14 distinct leading mobile spyware apps targeting Android phones. We document the range of mechanisms used to monitor user activity of various kinds (e.g., photos, text messages, live microphone access) — primarily through the creative abuse of Android APIs. We also discover previously undocumented methods these apps use to hide from detection and to achieve persistence. Additionally, we document the measures taken by each app to protect the privacy of the sensitive data they collect, identifying a range of failings on the part of spyware vendors (including privacy-sensitive data sent in the clear or stored in the cloud with little or no protection).
Weinberger, Adam B; Cortes, Robert A; Green, Adam E; Giordano, James
(, Creativity Research Journal)
Recent research indicates that transcranial electrical stimulation (tES) of specific brain regions can successfully improve various forms of creative cognition. Although the endeavor to increase human creative capacity is intriguing from a neuroscientific perspective, and of interest to the general public, it raises numerous neuroethico-legal and social issues (NELSI). This review explores these issues by considering (a) whether using brain stimulation to improve creative cognition qualifies as a ‘treatment’ or an ‘enhancement,’ (b) how direct-to-consumer (DTC) and do-it-yourself (DIY) use of tES should be regarded and regulated, and (c) what the developing landscape of creativity-related neurostimulation could (and should) become.
Ferrero, Vincenzo; Hoyle, Chris; DuPont, Bryony
(, ASME International Design Engineering Technical Conferences and Computers in Engineering Conference)
Global concerns about climate change and resource management have escalated the need for sustainable consumer products. In light of this, sustainable design methodologies that supplement the product design process are needed. Current research focuses on developing sustainable design curricula, adapting classical design methods to accommodate environmental sustainability, and sustainability tools that are applicable during the early design phase. However, concurrent work suggests that sustainability-marketed and innovative products still lack a reduction of environmental impact compared to conventional products. Life cycle assessment (LCA) has proven to be an exceptional tool used to assess the environmental impact of a realized product. However, LCA is a reactive tool that does not proactively reduce the environmental impact of novel product concepts. Here we develop a novel methodology, the PeeP method, using historical product LCA data with kernel density estimation to provide an estimated environmental impact range for a given product design. The PeeP method is tested using a series of case studies exploring four different products. Results suggest that probability density estimations developed through this method reflect the environmental impact of the product at both the product and component level. In the context of sustainable design research, the PeeP method is a viable methodology for assessing product design environmental impact prior to product realization. Our methodology can allow designers to identify high-impact components and reduce the cost of product redesign in practice.
@article{osti_10649883,
place = {Country unknown/Code not available},
title = {Governance Challenges for Direct-to-Consumer Genetically Engineered Organisms},
url = {https://par.nsf.gov/biblio/10649883},
DOI = {10.38126/JSPG260207},
abstractNote = {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.},
journal = {Journal of Science Policy & Governance},
volume = {26},
number = {2},
publisher = {Journal of Science Policy & Governance},
author = {Isabelle, Casey and George, Dalton},
}
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