The goals of this paper are to: 1) define the process for identifying potential pathways to harm based on robust problem formulation; 2) provide an overview of data that inform the science-based ERA for cultivation approval; 3) provide examples of data that are routinely or occasionally required but do not inform the ERA; and 4) make recommendations for harmonization of global ERA data requirements. Refinement and harmonization of data requirements across global regulatory authorities will add transparency and predictability to the ERA of GM crops globally, while ensuring that each country’s protection goals are respected.
Jennifer Andersona,∗, Pamela Bachmanb, Andrea Burnsc, Suma Chakravarthyd,∗∗, Laurie Goodwind, Laura Privallee, Shuang Songc, Nicholas Storera
aCorteva Agriscience TM, Johnston, IA
bBayer, Crop Science Division, Chesterfield, MO cSyngenta, Crop Protection, LLC., Research Triangle Park, NC dCropLife International, Washington, DC
eBASF Corporation, Research Triangle Park, NC