Journal of Regulatory Science · 2021 · 10 citations · 23 references
AgricultureFood ScienceToxicologyFood SafetyGenetic EngineeringPlant BiotechnologyFeed Safety AssessmentFood Safety AssessmentFood Safety EngineeringFood Safety ToxicologyProteins In FoodsToxicology AssessmentAcute Toxicology ManagementAssayNovel Protein Safety AssessmentPlant-based Protein ExpressionStepwise DevelopmentToxicity Testing Of PlantsToxicological EvaluationTriggers
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. doi: 10.21423/jrs-v09i1roper
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Mike Mendelsohn, John Kough, Zigfridais Vaituzis et al. · Nature Biotechnology · 2003 · 381 citations