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

Frontiers in Bioengineering and Biotechnology

Bioengineering and Biotechnology

Wei Wei¹  Nick Loschin¹  Khara Grieger²  Christopher L. Cummings³  Jennifer Kuzma⁴  Ilaria Cimadori⁵ 

[1] Department of Applied Ecology, North Carolina State University, Raleigh, NC, United States;Genetic Engineering and Society Center, North Carolina State University, Raleigh, NC, United States;North Carolina Plant Science Initiative, North Carolina State University, Raleigh, NC, United States;Genetic Engineering and Society Center, North Carolina State University, Raleigh, NC, United States;Department of Applied Ecology, North Carolina State University, Raleigh, NC, United States;North Carolina Plant Science Initiative, North Carolina State University, Raleigh, NC, United States;Genetic Engineering and Society Center, North Carolina State University, Raleigh, NC, United States;Engineering Research and Development Center, United States Army Corps of Engineers, Vicksburg, MS, United States;Gene Edited Foods Project, Iowa State University, Ames, IA, United States;Genetic Engineering and Society Center, North Carolina State University, Raleigh, NC, United States;School of Public and International Affairs, North Carolina State University, Raleigh, NC, United States;Yale School of the Environment, Yale University, New Haven, CT, United States;

关键词: regulation;    risk assessment;    governance;    biotechnology;    gene editing;   

DOI  :  10.3389/fbioe.2023.1256388

 received in 2023-07-10, accepted in 2023-09-15,  发布年份 2023

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

Unknown   
Copyright © 2023 Kuzma, Grieger, Cimadori, Cummings, Loschin and Wei.