Recommendations for Assessing Human Dietary Exposure to Newly Expressed Proteins in Genetically Modified Crops

Risk assessment of genetically modified (GM) crops includes an evaluation of hazard and exposure to newly expressed crop constituents, exempli- fied herein by newly expressed proteins (NEPs). Guidance directing dietary exposure assessments (DEAs) is limited and/or globally inconsistent. Best practices for conducting DEAs are presented and include a preliminary problem formulation step to determine if a formal DEA is necessary to support the risk assessment. If a formal DEA is deemed necessary, the type of exposure (acute or chronic) and the availability of food con- sumption data relevant to the targeted population should be identified.

Carey A. Mathesiusa, Alaina Sauve-Ciencewickib,∗, Jennifer Andersona, Cheryl Clevelandc, Carrie Flemingd, Gregory E. Frierdiche, Laurie Goodwinf, Mark Grunenwaldg, Frank Laporteh, Elizabeth A. Lipscombc, Regina Oberdoerferi, Jay S. Petricke, Patricia A. Baumanb

aCorteva AgriscienceTM, Johnston, IA 50131, USA
bSyngenta, Crop Protection, LLC, Research Triangle Park, NC 27709, USA cBASF Plant Science L.P., 26 Davis Drive, Research Triangle Park, NC 27709, USA dCorteva AgriscienceTM, Indianapolis, IN 46268, USA
eBayer, Crop Science Division, Chesterfield, MO, 63017, USA
fCropLife International, Washington, DC, USA
gSyngenta Crop Protection LLC, Greensboro, NC 27419, USA
hBayer, Crop Science Division, Lyon, France 69009
iBASF Agricultural Solutions GmbH, 67063 Ludwigshafen, Germany