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Societal Impact Statement: A diverse portfolio of genetically engineered food crops, as well as animal livestock and fish, are currently being developed and commercialized. To ensure their contributions to long‐term sustainability, a broad range of environmental, health, ethical, and societal parameters should be used in their evaluations. This paper proposes a set of parameters to evaluate the sustainability of genetically engineered food and agriculture products and discusses mechanisms to improve their governance and oversight. With such holistic evaluations, genetic engineering applications that are deemed beneficial to sustainable agriculture could be identified in an effort to foster sustainability. Summary: To achieve international sustainable development goals, food and agricultural production need to rely on sustainable and resilient practices. Traditional breeding as well as the use of new agricultural technologies, including genetic engineering and gene editing, have the potential to help achieve sustainable agrifood production. Although numerous oversight mechanisms exist to guarantee the secure and sustainable advancement and utilization of genetically engineered agrifoods, the majority of these mechanisms heavily depend on a narrow set of parameters to assess risks and safety concerning human health and nontarget organisms. However, a more comprehensive range of parameters should be considered to promote environmental and social sustainability in a more holistic manner. This Opinion article argues that to achieve a more sustainable agrifood production that relies on genetic engineering, governance systems related to new agrifood biotechnologies should incorporate a broader array of environmental, health, ethical, and societal factors to ensure their sustainability in the long‐term. To facilitate this process, we propose a set of parameters to help evaluate the sustainability of agrifoods that rely on genetic engineering. We then discuss major challenges and opportunities for formalizing sustainability parameters in US governance policy and decision‐making systems. Overall, this work contributes to further developing a more comprehensive assessment framework that aims to minimize potential risks and maximize potential benefits of agrifood biotechnology while also fostering sustainability. [ABSTRACT FROM AUTHOR]

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Kuzma, Grieger, Cimadori, Cummings, Loschin and Wei.)

Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.