2017
DOI: 10.1021/acs.jafc.7b01492
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Safety Assessment of Food and Feed from GM Crops in Europe: Evaluating EFSA’s Alternative Framework for the Rat 90-day Feeding Study

Abstract: Regulatory-compliant rodent subchronic feeding studies are compulsory regardless of a hypothesis to test, according to recent EU legislation for the safety assessment of whole food/feed produced from genetically modified (GM) crops containing a single genetic transformation event (European Union Commission Implementing Regulation No. 503/2013). The Implementing Regulation refers to guidelines set forth by the European Food Safety Authority (EFSA) for the design, conduct, and analysis of rodent subchronic feedi… Show more

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Cited by 23 publications
(50 citation statements)
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“…Whereas, displaying the confidence intervals indeed gives a richer view on the results than just reporting yes/no decisions, the scale of the SES plots does not seem the best choice for equivalence assessments. As Hong et al (2017) remark, the value of SES to support data interpretation is limited. Alternatively scaled effect sizes, such as those presented in section 4.1 ( Figure 6 -Figure 9) can be preferred, because the scaling factor (the equivalence limit) is based on data analysis of in this case historical data, rather than being an arbitrary value.…”
Section: Summary and Discussionmentioning
confidence: 99%
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“…Whereas, displaying the confidence intervals indeed gives a richer view on the results than just reporting yes/no decisions, the scale of the SES plots does not seem the best choice for equivalence assessments. As Hong et al (2017) remark, the value of SES to support data interpretation is limited. Alternatively scaled effect sizes, such as those presented in section 4.1 ( Figure 6 -Figure 9) can be preferred, because the scaling factor (the equivalence limit) is based on data analysis of in this case historical data, rather than being an arbitrary value.…”
Section: Summary and Discussionmentioning
confidence: 99%
“…For comparison, the proposed target effect sizes of Hong et al (2017), see Table 15, are included in the plots as horizontal and vertical lines (together with lines at ratio 1 for reference). It can be noted that similar plots could have been made using the equivalence limit scaled differences (ELSDs) as presented in Figure 6 -Figure 9.…”
Section: Methodsmentioning
confidence: 99%
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“…Recently, Hong et al 2 published an evaluation of the European Food Safety Authority (EFSA) framework for safety assessment of genetically modified (GM) crops using a rat 90 day feeding study, 3 which is a compulsory part of the safety assessment according to current European Union (EU) legislation. 4 The appropriateness of these animal studies and the EFSA framework on how to conduct such studies are both under discussion.…”
mentioning
confidence: 99%
“…Another currently ongoing EU research project is G-TwYST (), which is evaluating two 90 day studies and one combined chronic/carcinogenicity (2 year) study. Hong et al 2 also assessed the appropriateness and applicability of the EFSA recommendations using a 90 day study and a battery of statistical approaches, including retrospective and prospective power analyses. This comment is not the place to give a full appraisal of all aspects of this discussion.…”
mentioning
confidence: 99%