GM Free Cymru

Crucial Paper 31:
Teratogenic Effects of Glyphosate-Based Herbicides: Divergence of Regulatory Decisions from Scientific Evidence

M Antoniou, MEM Habib, CV Howard, RC Jennings, C Leifert, RO Nodari, CJ Robinson and J Fagan

J Environ Anal Toxicol S4:006. doi:10.4172/2161-0525.S4-006

Note: This new study demonstrates corrupt science at the heart of the regulatory process, associated with the approval of Roundup in germany and the EU. The German authorities introduced irrelevant data to 'disappear' significant findings of birth defects associated with Roundup, and even went so far as to redefine a birth defect as a 'developmental variation'. According to Clare Robinson, one of the authors, "Germany set – and the EU authorities accepted – a 'safe' level for glyphosate exposure that may not be safe at all." The new study's findings back those of a separate study published in September by a team led by Professor Gilles-Eric Seralini. Seralini found increased incidence of tumours, mortality, and organ damage in rats fed with low levels of Roundup and a GM maize genetically engineered to tolerate the herbicide. The levels of Roundup that were toxic were well below levels permitted in drinking water and feed. We support calls for the toxicity of Roundup to be immediately reassessed -- there is now far too much evidence of serious toxicity in the public domain, and Roundup residues are everywhere in the food supply. Roundup should be banned.

Abstract 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 These rebuttals relied partly on unpublished industry-sponsored studies commissioned for regulatory purposes, which, it was claimed, showed that glyphosate is not a teratogen or reproductive toxin.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.

(NB The full text with references is available online)

Conclusion Studies published in the peer-reviewed scientific literature have raised major concerns regarding the potential for glyphosate and its commercial formulations to cause birth defects and other reproductive problems. In addition, a debate has emerged over the reported effects on human health of herbicide application in regions that produce GM glyphosate-tolerant crops and about the safety of food and feed produced from these crops. Regulatory authorities and industry affiliates have defended the use of glyphosate largely by citing the industry-sponsored toxicological tests conducted for regulatory purposes, which they claimed showed no evidence of teratogenicity. However, the German authorities' draft assessment report revealed that even these industry tests contained clear evidence of glyphosate-mediated teratogenicity and reproductive toxicity. Many of the malformations observed in these studies are of the type associated with the retinoic acid signalling pathway. Paganelli et al. [1] showed that this was the mechanism through which glyphosate and Roundup exercise their teratogenic effects. It is noteworthy that these industry tests were commissioned by the same companies that stand to profit from regulatory authorization. Regrettably, this system possesses an inherent risk of bias and makes it especially important that the regulatory assessment is rigorous. Yet in the EU, the evidence suggests that this was not the case. The significance of clear teratogenic effects of glyphosate in rabbits and rats found in tests commissioned by industry were minimized by German regulators. A scientifically rigorous assessment was further impeded by the outdated design of the standard tests, which are not sufficiently sensitive to detect effects from realistic exposures. As a result, the German authorities suggested, and the EU adopted, an acceptable daily intake (ADI) for glyphosate that is unreliable and could potentially result in exposures that cause harm to humans. Another relevant factor is that the industry teratogenicity tests were on glyphosate, the presumed active ingredient of the herbicide, and not on the herbicide formulations as sold and used, even though studies indicate that the formulations are more toxic for certain endpoints than glyphosate alone. A substantial body of evidence demonstrates that glyphosate and Roundup cause teratogenic effects and other toxic effects on reproduction, as well as genotoxic effects. From an objective scientific standpoint, attempts by industry and government regulatory bodies to dismiss this research are unconvincing and work against the principle that it is the responsibility of industry to prove that its products are safe and not the responsibility of the public to prove that they are unsafe. The precautionary principle would suggest that glyphosate and its commercial formulations should undergo a new risk assessment, taking full account of the entirety of the peer-reviewed scientific literature as well as the industry-sponsored studies. Experience to date suggests that the new risk assessment should be conducted with full public transparency by scientists who are independent of industry.