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Pesticides and public health: an analysis of the regulatory approach to assessing the carcinogenicity of glyphosate in the European Union

The present paper scrutinises the European authorities’ assessment of the carcinogenic hazard posed by glyphosate based on Regulation (EC) 1272/2008. We use the authorities’ own criteria as a benchmark to analyse their weight of evidence (WoE) approach. Therefore, our analysis goes beyond the compar...

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Autores principales: Clausing, Peter, Robinson, Claire, Burtscher-Schaden, Helmut
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6204965/
https://www.ncbi.nlm.nih.gov/pubmed/29535253
http://dx.doi.org/10.1136/jech-2017-209776
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author Clausing, Peter
Robinson, Claire
Burtscher-Schaden, Helmut
author_facet Clausing, Peter
Robinson, Claire
Burtscher-Schaden, Helmut
author_sort Clausing, Peter
collection PubMed
description The present paper scrutinises the European authorities’ assessment of the carcinogenic hazard posed by glyphosate based on Regulation (EC) 1272/2008. We use the authorities’ own criteria as a benchmark to analyse their weight of evidence (WoE) approach. Therefore, our analysis goes beyond the comparison of the assessments made by the European Food Safety Authority and the International Agency for Research on Cancer published by others. We show that not classifying glyphosate as a carcinogen by the European authorities, including the European Chemicals Agency, appears to be not consistent with, and in some instances, a direct violation of the applicable guidance and guideline documents. In particular, we criticise an arbitrary attenuation by the authorities of the power of statistical analyses; their disregard of existing dose–response relationships; their unjustified claim that the doses used in the mouse carcinogenicity studies were too high and their contention that the carcinogenic effects were not reproducible by focusing on quantitative and neglecting qualitative reproducibility. Further aspects incorrectly used were historical control data, multisite responses and progression of lesions to malignancy. Contrary to the authorities’ evaluations, proper application of statistical methods and WoE criteria inevitably leads to the conclusion that glyphosate is ‘probably carcinogenic’ (corresponding to category 1B in the European Union).
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spelling pubmed-62049652018-11-08 Pesticides and public health: an analysis of the regulatory approach to assessing the carcinogenicity of glyphosate in the European Union Clausing, Peter Robinson, Claire Burtscher-Schaden, Helmut J Epidemiol Community Health Essay The present paper scrutinises the European authorities’ assessment of the carcinogenic hazard posed by glyphosate based on Regulation (EC) 1272/2008. We use the authorities’ own criteria as a benchmark to analyse their weight of evidence (WoE) approach. Therefore, our analysis goes beyond the comparison of the assessments made by the European Food Safety Authority and the International Agency for Research on Cancer published by others. We show that not classifying glyphosate as a carcinogen by the European authorities, including the European Chemicals Agency, appears to be not consistent with, and in some instances, a direct violation of the applicable guidance and guideline documents. In particular, we criticise an arbitrary attenuation by the authorities of the power of statistical analyses; their disregard of existing dose–response relationships; their unjustified claim that the doses used in the mouse carcinogenicity studies were too high and their contention that the carcinogenic effects were not reproducible by focusing on quantitative and neglecting qualitative reproducibility. Further aspects incorrectly used were historical control data, multisite responses and progression of lesions to malignancy. Contrary to the authorities’ evaluations, proper application of statistical methods and WoE criteria inevitably leads to the conclusion that glyphosate is ‘probably carcinogenic’ (corresponding to category 1B in the European Union). BMJ Publishing Group 2018-08 2018-03-13 /pmc/articles/PMC6204965/ /pubmed/29535253 http://dx.doi.org/10.1136/jech-2017-209776 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Essay
Clausing, Peter
Robinson, Claire
Burtscher-Schaden, Helmut
Pesticides and public health: an analysis of the regulatory approach to assessing the carcinogenicity of glyphosate in the European Union
title Pesticides and public health: an analysis of the regulatory approach to assessing the carcinogenicity of glyphosate in the European Union
title_full Pesticides and public health: an analysis of the regulatory approach to assessing the carcinogenicity of glyphosate in the European Union
title_fullStr Pesticides and public health: an analysis of the regulatory approach to assessing the carcinogenicity of glyphosate in the European Union
title_full_unstemmed Pesticides and public health: an analysis of the regulatory approach to assessing the carcinogenicity of glyphosate in the European Union
title_short Pesticides and public health: an analysis of the regulatory approach to assessing the carcinogenicity of glyphosate in the European Union
title_sort pesticides and public health: an analysis of the regulatory approach to assessing the carcinogenicity of glyphosate in the european union
topic Essay
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6204965/
https://www.ncbi.nlm.nih.gov/pubmed/29535253
http://dx.doi.org/10.1136/jech-2017-209776
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