Teratogenic effects of glyphosate-based herbicides: Divergence of regulatory decisions from scientific evidence

The publication of a study in 2010, showing that a glyphosate herbicide formulation and glyphosate alone caused malformations in the embryos of Xenopus laevis and chickens through disruption of the retinoic acid signalling pathway, caused scientific and regulatory controversy. Debate centred on the effects of the production and consumption of genetically modified Roundup Ready® soy, which is engineered to tolerate applications of glyphosate herbicide. The study, along with others indicating teratogenic and reproductive effects from glyphosate herbicide exposure, was rebutted by the German Federal Office for Consumer Protection and Food Safety, BVL, as well as in industry-sponsored papers. These rebuttals relied partly on unpublished industry-sponsored studies commissioned for regulatory purposes, which, it was claimed, showed that glyphosate is not a teratogen or reproductive toxin. However, examination of the German authorities’ draft assessment report on the industry studies, which underlies glyphosate’s EU authorisation, revealed further evidence of glyphosate’s teratogenicity. Many of the malformations found were of the type defined in the scientific literature as associated with retinoic acid teratogenesis. Nevertheless, the German and EU authorities minimized these findings in their assessment and set a potentially unsafe acceptable daily intake (ADI) level for glyphosate. This paper reviews the evidence on the teratogenicity and reproductive toxicity of glyphosate herbicides and concludes that a new and transparent risk assessment needs to be conducted. The new risk assessment must take into account all the data on the toxicity of glyphosate and its commercial formulations, including data generated by independent scientists and published in the peer-reviewed scientific literature, as well as the industry-sponsored studies.