Biotechnology executive order opens door for regulatory reform and social acceptance of genetically engineered microbes in agriculture.

In the United States, regulatory review of genetically engineered microbes for agriculture falls under the Coordinated Framework for the Regulation of Biotechnology (CFRB). However, the lack of a centralized regulatory pathway and multiple oversight authorities can lead to uncertainty in regulatory review. Using three microbial-based technologies for agriculture as illustrative examples, this commentary identifies the weaknesses and challenges associated with the CFRB by assessing the current system and proposed changes to the system under a multi criteria decision analysis framework. In addition, it discusses opportunities for regulatory reform to improve clarity, efficiency, and public acceptance of genetically engineered microbes in agriculture under the CHIPS and Science Act and the 2022 Executive Order on the Bioeconomy.

Developing transmissible vaccines for animal infections.

Intrinsically safe designs and a staged transparent development process will be essential.

Parameters, practices, and preferences for regulatory review of emerging biotechnology products in food and agriculture.

This paper evaluates the U.S. regulatory review of three emerging biotechnology products according to parameters, practices, and endpoints of assessments that are important to stakeholders and publics. First, we present a summary of the literature on variables that are important to non-expert publics in governing biotech products, including ethical, social, policy process, and risk and benefit parameters. Second, we draw from our USDA-funded project results that surveyed stakeholders with subject matter expertise about their attitudes towards important risk, benefit, sustainability, and societal impact parameters for assessing novel agrifood technologies, including biotech. Third, we evaluate the regulatory assessments of three food and agricultural biotechnology case studies that have been reviewed under U.S. regulatory agencies and laws of the Coordinated Framework for the Regulation of Biotechnology, including gene-edited soybeans, beef cattle, and mustard greens. Evaluation of the regulatory review process was based on parameters identified in steps 1 and 2 which were deemed important to both publics and stakeholders. Based on this review, we then propose several policy options for U.S. federal agencies to strengthen their oversight processes to better align with a broader range of parameters to support sustainable agrifood products that rely on novel technologies. These policy options include 1) those that would not require new institutions or legal foundations (such as conducting Environmental Impact Statements and/or requiring a minimal level of safety data), 2) those that would require a novel institutional or cross-institutional framework (such as developing a publicly-available website and/or performing holistic sustainability assessments), and 3) those that would require the agencies to have additional legal authorities (such as requiring agencies to review biotech products according to a minimal set of health, environmental, and socio-economic parameters). Overall, the results of this analysis will be important for guiding policy practice and formulation in the regulatory assessment of emerging biotechnology products that challenge existing legal and institutional frameworks.

Genes drive organisms and slippery slopes.

The bioethical debate about using gene drives to alter or eradicate wild populations has focused mostly on issues concerning short-term risk assessment and management, governance and oversight, and public and community engagement, but has not examined big-picture- 'where is this going?'-questions in great depth. In other areas of bioethical controversy, big-picture questions often enter the public forum via slippery slope arguments. Given the incredible potential of gene drive organisms to alter the Earth's biota, it is somewhat surprising that slippery slope arguments have not played a more prominent role in ethical and policy debates about these emerging technologies. In this article, we examine a type of slippery slope argument against using gene drives to alter or suppress wild pest populations and consider whether it has a role to play in ethical and policy debates. Although we conclude that this argument does not provide compelling reasons for banning the use of gene drives in wild pest populations, we believe that it still has value as a morally instructive cautionary narrative that can motivate scientists, ethicists, and members of the public to think more clearly about appropriate vs. inappropriate uses of gene drive technologies, the long-term and cumulative and emergent risks of using gene drives in wild populations, and steps that can be taken to manage these risks, such as protecting wilderness areas where people can enjoy life forms that have not been genetically engineered.

Should Gene Editing Be Used to Develop Crops for Continuous-Living-Cover Agriculture? A Multi-Sector Stakeholder Assessment Using a Cooperative Governance Approach.

Continuous-living-cover (CLC) agriculture integrates multiple crops to create diversified agroecosystems in which soils are covered by living plants across time and space continuously. CLC agriculture can greatly improve production of many different ecosystem services from agroecosystems, including climate adaptation and mitigation. To go to scale, CLC agriculture requires crops that not only provide continuous living cover but are viable in economic and social terms. At present, lack of such viable crops is strongly limiting the scaling of CLC agriculture. Gene editing (GE) might provide a powerful tool for developing the crops needed to expand CLC agriculture to scale. To assess this possibility, a broad multi-sector deliberative group considered the merits of GE-relative to alternative plant-breeding methods-as means for improving crops for CLC agriculture. The group included many of the sectors whose support is necessary to scaling agricultural innovations, including actors involved in markets, finance, policy, and R&D. In this article, we report findings from interviews and deliberative workshops. Many in the group were enthusiastic about prospects for applications of GE to develop crops for CLC agriculture, relative to alternative plant-breeding options. However, the group noted many issues, risks, and contingencies, all of which are likely to require responsive and adaptive management. Conversely, if these issues, risks, and contingencies cannot be managed, it appears unlikely that a strong multi-sector base of support can be sustained for such applications, limiting their scaling. Emerging methods for responsible innovation and scaling have potential to manage these issues, risks, and contingencies; we propose that outcomes from GE crops for CLC agriculture are likely to be much improved if these emerging methods are used to govern such projects. However, both GE of CLC crops and responsible innovation and scaling are unrefined innovations. Therefore, we suggest that the best pathway for exploring GE of CLC crops is to intentionally couple implementation and refinement of both kinds of innovations. More broadly, we argue that such pilot projects are urgently needed to navigate intensifying grand challenges around food and agriculture, which are likely to create intense pressures to develop genetically-engineered agricultural products and equally intense social conflict.

Deficits of Public Deliberation in U.S. Oversight for Gene Edited Organisms.

Environmental releases of gene edited (GEdOs) and gene drive organisms (GDOs) will likely occur under conditions of high uncertainty and in complex socioecological systems. Therefore, public deliberation is especially important to account for diverse interpretations of safety, risks, and benefits; to draw on experiential and public wisdom in areas of proposed release; to ameliorate dangers of technological optimism; and to increase the public legitimacy of decisions. Yet there is a "democratic deficit" in the United States' oversight system for GEdOs and GDOs, as unconflicted experts, publics, and skeptical stakeholders are most often excluded from decision-making and unavailable to critically examine potential risks and benefits or raise broader concerns about socioeconomic or cultural impacts. This article argues for the need to open up decision-making for GEdOs and GDOs, discusses the challenges for doing so within the current oversight framework, and finally, proposes institutional, policy, and attitudinal changes that are likely important for overcoming barriers to public deliberation.

Responsible innovation of nano-agrifoods: Insights and views from U.S. stakeholders.

To date, there has been little published work that has elicited diverse stakeholder views of nano-agrifoods and of how nano-agrifoods align with the goals of responsible innovation. This paper aims to fill this research gap by investigating views of nano-agrifoods, how well their development adheres to principles of responsible innovation, and potential challenges for achieving responsible nano-agrifood innovation. Using an online engagement platform, we find that U.S. stakeholder views of responsible innovation were dominated by environmental, health, and safety (EHS) contexts, considerations of societal impacts, opportunities for stakeholder engagement, and responding to societal needs. These views overlap with scholarly definitions of responsible innovation, albeit stakeholders were more focused on impacts of products, while the field of responsible innovation strives for more "upstream" considerations of the process of innovation. We also find that views of nano-agrifoods differed across applications with dietary supplements and improved whitening of infant formula viewed least favorably, and environmental health or food safety applications viewed most favorably. These findings align with the larger body of literature, whereby stakeholders are expected to be more supportive of nanotechnology used in agricultural applications compared to directly within food and food supplements. Overall, participants indicated they held relatively neutral views on research and innovation for nano-agrifoods being conducted responsibly, and they identified key challenges to ensuring their responsible innovation that were related to uncertainties in EHS studies, the need for public understanding and acceptance, and adequate regulation. In light of these results, we recommend future research efforts on EHS impacts and risk-benefit frameworks for nano-agrifoods, better understanding stakeholder views on what constitutes effective regulation, and addressing challenges with effective regulation and responsible innovation practices.

Barriers to responsible innovation of nanotechnology applications in food and agriculture: A study of US experts and developers.

The use of nanotechnology and engineered nanomaterials in food and agriculture (nano-agrifood) sectors is intended to provide several potential benefits to consumers and society, such as the provision of more nutritious processed foods, edible food coatings to extend shelf lives of fresh cut produce, and more sustainable alternatives to traditional agrochemicals. The responsible innovation of nano-agrifoods may be particularly important to pursue given previous case studies involving other agrifood technologies that experienced significant public consternation. Here, we define responsible innovation following Stilgoej et al. (2013) that establishes processes to iteratively review and reflect upon one's innovation, engage stakeholders in dialogue, and to be open and transparent throughout innovation stages - processes that go beyond primary focuses of understanding environmental, health, and safety impacts of nano-enabled products and implementing safe-by-design principles. Despite calls for responsible nano-innovation across diverse sectors, it has not yet been clear what types of barriers are faced by nano-agrifood researchers and innovators in particular. This study therefore identifies and builds the first typology of barriers to responsible innovation as perceived by researchers and product developers working in nano-agrifood sectors in the United States. Our findings report 5 key barriers to responsible innovation of nano-agrifoods: Lack of Data (reported by 70% of all interview participants, and represented 34.6% of all barrier-related excerpts), Lack of Product Oversight (reported by 60% of participants, and represented 28.7% of excerpts), Need for Ensuring Marketability & Use (reported by 70% of participants, and represented 21.3% of all barrier-related excerpts), Need for Increased Collaboration (reported by 40% of participants, and represented 10.3% of excerpts), and finally Lack of Adequate Training & Workforce (reported by 30% of participants, and represented by 5.1% of excerpts). We also relate these key barriers across three main nano-innovation phases, including 1) Scientific and Technical R&D, 2) Product Oversight, and 3) Post-commercialization Marketability & Use, and discuss how these barriers may impact stakeholders as well as present opportunities to align with principles of responsible innovation. Overall, these findings may help illuminate challenges that researchers and innovators face in the pursuit of responsible innovation relevant for the field of nanotechnology with relevancy for other emerging food and agricultural technologies more broadly.

Wicked evolution: Can we address the sociobiological dilemma of pesticide resistance?

Resistance to insecticides and herbicides has cost billions of U.S. dollars in the agricultural sector and could result in millions of lives lost to insect-vectored diseases. We mostly continue to use pesticides as if resistance is a temporary issue that will be addressed by commercialization of new pesticides with novel modes of action. However, current evidence suggests that insect and weed evolution may outstrip our ability to replace outmoded chemicals and other control mechanisms. To avoid this outcome, we must address the mix of ecological, genetic, economic, and sociopolitical factors that prevent implementation of sustainable pest management practices. We offer an ambitious proposition.

Comparative, collaborative, and integrative risk governance for emerging technologies.

Various emerging technologies challenge existing governance processes to identify, assess, and manage risk. Though the existing risk-based paradigm has been essential for assessment of many chemical, biological, radiological, and nuclear technologies, a complementary approach may be warranted for the early-stage assessment and management challenges of high uncertainty technologies ranging from nanotechnology to synthetic biology to artificial intelligence, among many others. This paper argues for a risk governance approach that integrates quantitative experimental information alongside qualitative expert insight to characterize and balance the risks, benefits, costs, and societal implications of emerging technologies. Various articles in scholarly literature have highlighted differing points of how to address technological uncertainty, and this article builds upon such knowledge to explain how an emerging technology risk governance process should be driven by a multi-stakeholder effort, incorporate various disparate sources of information, review various endpoints and outcomes, and comparatively assess emerging technology performance against existing conventional products in a given application area. At least in the early stages of development when quantitative data for risk assessment remain incomplete or limited, such an approach can be valuable for policymakers and decision makers to evaluate the impact that such technologies may have upon human and environmental health.

Societal Risk Evaluation Scheme (SRES): Scenario-Based Multi-Criteria Evaluation of Synthetic Biology Applications.

Synthetic biology (SB) applies engineering principles to biology for the construction of novel biological systems designed for useful purposes. From an oversight perspective, SB products come with significant uncertainty. Yet there is a need to anticipate and prepare for SB applications before deployment. This study develops a Societal Risk Evaluation Scheme (SRES) in order to advance methods for anticipatory governance of emerging technologies such as SB. The SRES is based upon societal risk factors that were identified as important through a policy Delphi study. These factors range from those associated with traditional risk assessment, such as health and environmental consequences, to broader features of risk such as those associated with reversibility, manageability, anticipated levels of public concern, and uncertainty. A multi-disciplinary panel with diverse perspectives and affiliations assessed four case studies of SB using the SRES. Rankings of the SRES components are compared within and across the case studies. From these comparisons, we found levels of controllability and familiarity associated with the cases to be important for overall SRES rankings. From a theoretical standpoint, this study illustrates the applicability of the psychometric paradigm to evaluating SB cases. In addition, our paper describes how the SRES can be incorporated into anticipatory governance models as a screening tool to prioritize research, information collection, and dialogue in the face of the limited capacity of governance systems. To our knowledge, this is the first study to elicit data on specific cases of SB with the goal of developing theory and tools for risk governance.