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Unpacking and Evaluating Regulatory Policy Pathways for Gene-edited Agricultural Products

Presented by Dr. Jennifer Kuzma

Gene editing is quickly advancing in research and becoming a reality in the marketplace. The first gene-edited foods have been consumed in restaurants, and many other gene-edited agricultural products are being developed. These are diverse, coming from plants and animals; designed for food, fiber, biofuel, and chemical production; and purporting benefits like improved yield, lower costs, animal welfare, better nutrition, and environmental sustainability.

Given the breadth of potential gene-edited agricultural products, multiple laws, rules, and policy processes are applicable to their oversight. To further complicate matters, the amount and origins of altered DNA may affect whether a gene-edited agricultural product is reviewed at all prior to market entry, depending on the specific product and its regulatory pathway. New regulations are pending under the U.S. Coordinated Framework for the Regulation of Biotechnology, and old ones are being reviewed in light of gene editing. It is a dynamic and evolving context for governance, layered upon the backdrop of a contentious history with GM foods, which was at least in part due to a lack of public trust and confidence in oversight systems.

As such, this paper and presentation will unpack some of this complexity by describing recent changes to US oversight of gene edited plants and standing policies on gene edited animals for agriculture. It will ask the question of whether oversight systems in the U.S. are keeping pace with advances in gene editing according to several substantial (e.g. health and environmental protection) and procedural criteria. The paper will conclude by highlighting stronger and weaker examples of responsible and inclusive governance for gene editing in agriculture.


Dr. Kuzma is a Goodnight-NCGSK Foundation Distinguished Professor in the School of Public and International Affairs at North Carolina State University, and co-founder and co-director of the Genetic Engineering and Society (GES) Center at NC State University. She has over 140 scholarly publications on emerging technologies, risk analysis, regulatory policy, and governance and has been studying these areas for over 30 years.

Prior to her current position, Kuzma was associate professor of science and technology policy at the Humphrey School of Public Affairs, University of Minnesota (2003-2013). Before that (1997-2003), she served as program and study director for several U.S. National Academy of Sciences reports related to biotechnology governance and bioterrorism and as an American Association for the Advancement of Science (AAAS) Risk Policy Fellow at the U.S. Department of Agriculture (USDA) Office of Risk Assessment and Cost Benefit Analysis. Her recent work on biotechnology governance has been funded by the Alfred P. Sloan Foundation, National Science Foundation, and US Department of Agriculture. She is currently coPI of a new NSF-National Research Traineeship interdisciplinary graduate program on Agricultural Biotechnology in Food, Energy and Water Systems (AgBioFEWS).

In 2014, she received the SRA Sigma Xi Distinguished Lecturer Award for her contributions to the field of risk analysis and in 2017-2018 she was awarded the Fulbright Canada Research Chair in Science Policy. In 2019 she was elected a lifetime Fellow of AAAS for her distinguished work in anticipatory governance of new technologies, and methods for oversight policy analysis.

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