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Core and Supplementary Studies to Assess the Safety of Genetically Modified (GM) Plants Used for Food and Feed


Genetically modified (GM) plants used for food and feed have an established history of safe use over more than 25 years of their commercialization. Developers and regulatory authorities have accumulated extensive experience in evaluating their safety over time. The studies required for the safety assessment of GM plants used for food and feed should now be re-defined to leverage this experience and increased scientific knowledge. This paper, a companion paper for Waters et al. also published in this issue, presents a systematic approach for the safety assessment of newly expressed proteins (NEPs) in GM plants by evaluating the two components of risk: hazard and exposure.

Phil Brunea,∗, Suma Chakravarthyb,1,∗, Gerson Grasera,∗, Carey A. Mathesiusc,∗, Scott McClaina,2,∗, Jay S. Petrickd,∗, Alaina Sauve-Ciencewickia,∗, Barry Schaferc,∗, Andre Silvanovichd,∗, Kent Brinkc,∗∗, Kristina Burgina,∗∗, Dean Busheyd,∗∗, Matthew L. Cheevere,∗∗, Thomas Edringtond,∗∗, Huihua Fue,∗∗, Veerle Habexf,∗∗, Rod Hermanc,∗∗, Emir Islamovice,∗∗, Elizabeth A. Lipscombe,∗∗, Shawn Motykae,∗∗, Laura Privallee,∗∗, Rakesh Ranjane,∗∗, Jason Roperc,∗∗, Ping Songc,∗∗, Gregory Tiltond,∗∗, John Zhangc,∗∗, Stephen Watersg, Adela Ramosc, Angela Hendrickson Cullerd, Penny Hunste, Rachel Gasta, Debbie Mahadeod, Laurie Goodwinb,3

aSyngenta, Crop Protection, LLC., Research Triangle Park, NC bCropLife International, Washington, DC
cCorteva Agriscience TM, Johnston, IA
dBayer, Crop Science Division, Chesterfield, MO eBASF Corporation, Research Triangle Park, NC fBASF BBCC, Innovation Center Gent, Belgium gWaters International Consulting, Belgium