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Scientist writes to Juncker: new tumour evidence found in confidential glyphosate data

Transparency matters in science: first independent analysis of confidential industry data on glyphosate indicates serious flaws in EFSA and ECHA safety assessment

Major news on the glyphosate front: the first ever independent analysis of the complete confidential data set sent by industry to the EU for the re-licensing of glyphosate shows EFSA and ECHA's safety assessment would have failed to identify several cases of tumours and cancer following an exposure to the substance. It is high time the complete data set is published in full to enable scrutiny by the wider scientific community.

According to Christopher Portier, a leading environmental health and carcinogenicity specialist1 the public agencies who performed the scientific assessment of glyphosate's toxicity (the German Federal Institute for Risk Assessment BfR, the European Food Safety Authority EFSA and the European Chemicals Agency ECHA) in Europe have failed to identify eight cases of statistically significant increase in tumours following glyphosate exposure in the confidential data set provided by industry. Portier has been actively defending the assessment of glyphosate by the International Agency for Research on Cancer (IARC), part of the World Health Organization, in the glyphosate re-licensing process in the EU. IARC concluded the substance to be probably carcinogenic to humans.

On May 28 Dr Portier sent a letter detailing his findings to the President of the European Commission, Jean-Claude Juncker, copying most institutions involved in the EU glyphosate assessment. His work, he writes, shows that "eight instances where significant increases in tumor response following glyphosate exposure were not included in the assessment by either EFSA or EChA. This suggests that the evaluations applied to the glyphosate data are scientifically flawed, and any decisions derived from these evaluations will fail to protect public health."

This is the first ever analysis of this dataset by a scientist who has no financial links to the glyphosate industry and who has not participated in the official EU assessment2. This data set was obtained by Corporate Europe Observatory (CEO) and Green MEPs after an access to documents request, which took a year (and significant resources) for EFSA to process as industry opposed it and demanded many redactions.

Importantly, this data could only be shared with Dr Portier and other scientists privately, so that they could work on it if they wished to, but publishing the data remains impossible today without risking a lawsuit from industry.

Dr. Portier writes that, despite recent public statements made by EFSA that "EFSA and EU member states rely primarily on the original studies and the underlying raw data which they check themselves", his review of the data suggests this would not have been the case and that only 20 per cent of the significant tumour findings would have been identified in the first review by EU authorities (in this case, by Germany's Federal Risk Institute BfR).

This seems astonishing, but is it really? One needs to remember that the BfR, whose work fed the entire EU assessment process at EFSA and ECHA, did not write its own initial assessment but simply commented on the summaries of the studies provided by the Glyphosate Task Force, a Monsanto-led industry platform. Furthermore, the recent controversy about the intervention in the EFSA process of a former EPA expert exposed in the "Monsanto Papers" revived the previous debate (and Dr Portier's previous letter) about whether several significant findings of cancer in animals in the evidence had not been unduly dismissed to 'save' glyphosate, sometimes refered to as 'too big to ban'...

Dr Portier insists that "the glyphosate hazard classification appears to have been a good example of how lack of transparency regarding the scientific evidence that underlies important public health decisions can erode public trust and raise concerns".

If any doubt remained, today's letter by Dr Portier shows that publishing the data underlying the EU's assessment is absolutely essential, so that at long last this debate can take place on the grounds of published evidence that the wider scientific community can evaluate.

Obviously, if this data had been published in full at the beginning of the process, much time, energy and trust in the reliability of the EU's risk assessment system would have been saved. There now needs to be an overhaul of the EU's rules for assessing products such as pesticides towards a system where the costs of the assessment are borne by industry, but the studies themselves are commissioned by public authorities to independent laboratories, and published in peer-reviewed scientific literature (with the raw data being available on request).

Background information

Since the very beginning of the glyphosate re-licensing saga, CEO has been pointing to the permanent scandal that a large majority of the data used by the EU to assess the toxicity of the most widely used weed-killer in the world would be provided by glyphosate producers and not published anywhere. This situation is not specific to glyphosate, however: all regulated products on the market in the EU, including pesticides, are treated in this way.

In December 2015, after EFSA explained that one of the main differences between its assessment and that of IARC boiled down to it having access to more and better but confidential data provided by industry, we introduced an access to document request for some of these studies, in particular those which EFSA said had played a major role.

In March 2016, with the public controversy growing, four Green MEPs filed an access to documents request for the whole dataset (82 studies).

In June 2016, we published the results of an access to documents request showing the arguments industry was using to fight disclosure: "commercial confidentiality" and "investment protection"...

In September 2016, EFSA committed to disclose data to both CEO and the Green MEPs in a way which would "enable a third-party scientist to scrutinise the evaluation of glyphosate that was carried out by EFSA and EU Member States."

In December 2016, we finally obtained the raw data for three studies but with heavy redactions and in a format which made the reanalysis very difficult. We asked several scientists, including Dr. Portier, whether this disclosure was sufficient to enable an independent analysis of the way EFSA had interpreted the data. Their opinion was that while this data did enable interesting insights, as today's letter to Juncker seems to confirm, the fact that it was impossible to use for a publication made it very difficult for a scientist to use. Still, judging by today's events, it looks like EFSA has kept its word to enable third-party scrutiny. That said, if Dr Portier was able to perform an analysis of this data and the way EU agencies worked, he still cannot publish the evidence he is referring to in the public domain.

Picture: "Chafer Sentry applying glyphosate to stubbles in North Yorkshire on a sunny December day", Chafer Machinery, Attribution 2.0 Generic (CC BY 2.0)

  • 1. Dr. Christopher Portier is Former Director US National Center for Environmental Health, Former Director US Agency for Toxic Substances and Disease Registry, Former Associate Director, US National Institute of Environmental Health Sciences, Former Associate Director US National Toxicology Program, and a Fellow of the American Statistical Association and the International Statistics Institute. He is now retired, and working part-time for a US environmental NGO, the Environmental Defense Fund (but, he adds, not on glyphosate). He is also involved as an expert witness in a US court case in California that has triggered the disclosure of the "Monsanto Papers".
  • 2. He has been largely attacked and defamed already as a way to undermine the IARC assessment, to which he contributed as an "invited specialist", then for his subsequent defense of IARC's assessment towards the EU authorities (EFSA's Director was so furious about the criticism published by Portier and 96 other scientists that he told Members of the European Parliament that their letter was the "Facebook age of science"). One can expect that these new findings are not going to make him any more popular among industry trolls.
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