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 tumors 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 scientific community.

According to Christopher Portier, a leading environmental health and carcinogenicity specialist who has been actively defending the IARC assessment in the glyphosate re-licensing process in the EU, the public agencies who performed the scientific assessment of glyphosate’s toxicity (BfR, EFSA and ECHA) would have failed to identify eight cases of statistically significant increase in tumors following glyphosate exposure in the confidential data set provided by industry.

Dr Portier has sent on May 28 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 assessment . This data set was obtained by 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 it remains impossible today without risking a lawsuit from industry.

Dr. Portier writes that, contrary to 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% of the significant tumor 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. 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 the 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’s 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 an absolute emergency, so that at long last this debate can take place on the grounds of published evidence that the whole 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 risk assessment system would have been saved. This begs for an overhaul of the EU’s rules for assessing products such as pesticides towards a system where the costs of the assessment is still borne by industry, but the studies themselves are commissioned to independent laboratories by public authorities, and published in the peer-review 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 at the permanent scandal that the 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. Not that this would be specific to glyphosate, however: all regulated products on the market in the EU, including pesticides, are “evaluated” in this way.

In December 2015, after EFSA explained that one of the main differences between their assessment and that of IARC boiled down to them having access to more, 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 raising, 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 the 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 publication 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, and this should be acknowledged. 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.