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Toxicological Assessment of Newly Expressed Proteins (NEPs) in Genetically Modified (GM) Plants

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This paper details the weight of evidence (WOE) and stepwise approaches used to assess the food and feed safety of newly expressed proteins (NEPs) in genetically modified (GM) plants, based on previously reported principles. The WOE approach is critical, as in a vast majority of cases no single assay or biochemical characteristic can identify a protein as a hazard. A stepwise approach is recommended to evaluate the safety of NEPs taking the totality of information into account. Potential triggers for the need for supplementary toxicology studies are discussed, and an alternative in vitro method for the acute toxicology study is proposed.






Jason Ropera, Elizabeth A. Lipscombb,∗, Jay S. Petrickc,∗, Rakesh Ranjanb,∗, Alaina Sauve-Ciencewickid,∗, Laurie Goodwine,∗∗


aCorteva Agriscience TM, Johnston, IA

bBASF Corporation, Research Triangle Park, NC cBayer, Crop Science Division, Chesterfield, MO dSyngenta, Crop Protection, LLC., Research Triangle Park, NC eCropLife International, Washington, DC