title: Adaptation of the ToxRTool to Assess the Reliability of Toxicology Studies Conducted with Genetically Modified Crops and Implications for Future Safety Testing.
abstract: To determine the reliability of food safety studies carried out in rodents with genetically modified (GM) crops, a Food Safety Study Reliability Tool (FSSRTool) was adapted from the European Centre for the Validation of Alternative Methods' (ECVAM) ToxRTool. Reliability was defined as the inherent quality of the study with regard to use of standardized testing methodology, full documentation of experimental procedures and results, and the plausibility of the findings. Codex guidelines for GM crop safety evaluations indicate toxicology studies are not needed when comparability of the GM crop to its conventional counterpart has been demonstrated. This guidance notwithstanding, animal feeding studies have routinely been conducted with GM crops, but their conclusions on safety are not always consistent. To accurately evaluate potential risks from GM crops, risk assessors need clearly interpretable results from reliable studies. The development of the FSSRTool, which provides the user with a means of assessing the reliability of a toxicology study to inform risk assessment, is discussed. Its application to the body of literature on GM crop food safety studies demonstrates that reliable studies report no toxicologically relevant differences between rodents fed GM crops or their non-GM comparators.
authors.affiliation: a Monsanto Company, Product Safety Center , St. Louis , Missouri , USA.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Koch
authors.affiliation: b Exponent , Alexandria , Virginia , USA.
authors.forename: John M
authors.initials: JM
authors.lastname: DeSesso
authors.affiliation: b Exponent , Alexandria , Virginia , USA.
authors.forename: Amy Lavin
authors.initials: AL
authors.lastname: Williams
authors.affiliation: c Department of Microbiology, University of Alabama at Birmingham , Birmingham , Alabama , USA.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Michalek
authors.affiliation: a Monsanto Company, Product Safety Center , St. Louis , Missouri , USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Hammond
mesh_terms: D018556:Crops, Agricultural / Q000235:genetics* / Q000633:toxicity*; D059022:Food Safety / Q000379:methods*; D030841:Food, Genetically Modified / Q000592:standards / Q000633:toxicity*; D006801:Humans; D030821:Plants, Genetically Modified / Q000633:toxicity*; D014116:Toxicology / Q000379:methods*
keywords: GM food safety; data quality; herbicide tolerant; insect protected GM crops; protein safety; rat feeding study; study reliability