Modernizing and Harmonizing Regulatory Data Requirements for Genetically Modified Crops -Perspectives from a Workshop Provisionally Accepted

Nicholas P. Storer¹ Abigail R. Simmons^2* Jordan Sottosanto³ Jennifer A. Anderson⁴ Ming H. Huang⁵ Debbie Mahadeo⁶ Carrie A. Mathesius⁴ Mitscheli Sanches da Rocha³ Shuang Song⁵ Ewa Urbanczyk-Wozniak⁶

• ¹Corteva Agriscience (US), United States
• ²CropLife International, United States
• ³BASF Corporation, United States
• ⁴Corteva Agriscience, United States
• ⁵Syngenta Seeds LLC, United States
• ⁶Bayer Crop Sciences (United States), United States

Genetically modified (GM) crops that have been engineered to express transgenes have been in commercial use since 1995 and are annually grown on 200 million hectares globally. These crops have provided documented benefits to food security, rural economies, and the environment, with no substantiated case of food, feed, or environmental harm attributable to cultivation or consumption. Despite this extensive history of advantages and safety, the level of regulatory scrutiny has continually increased, placing undue burdens on regulators, developers, and society, while reinforcing consumer distrust of the technology. CropLife International held a workshop at the 16th International Society of Biosafety Research (ISBR) Symposium to examine the scientific basis for modernizing global regulatory frameworks for GM crops. Participants represented a spectrum of global stakeholders, including academic researchers, GM crop developers, regulatory consultants, and regulators. Concurrently examining the considerations of food and feed safety, along with environmental safety, for GM crops, the workshop presented recommendations for a core set of data that should always be considered, and supplementary (i.e., conditional) data that would be warranted only on a case-by-case basis to address specific plausible hypotheses of harm. Then, using a casestudy involving a hypothetical GM maize event expressing two familiar traits (insect protection and herbicide tolerance), participants were asked to consider these recommendations and discuss if any additional data might be warranted to support a science-based risk assessment or for regulatory decision-making. The discussions during the workshop highlighted that the set of data to address the food, feed, and environmental safety of the hypothetical GM maize, in relation to a conventional comparator, could be modernized compared to current global regulatory requirements. If these Internal scientific approaches to modernize data packages for GM crop regulation were adopted globally, GM crops could be commercialized in a more timely manner, thereby enabling development of more diverse GM traits to benefit growers, consumers, and the environment.