Press Release: How EU authorities manoeuvered classification of Glyphosate as a probable carcinogen to keep it on the market

A new report by toxicologist Dr Peter Clausing explains how EU authorities, in plain violation of their own rules, disregarded scientific evidence to reach the “predetermined” conclusion that glyphosate does not cause cancer.

In March 2015, the World Health Organisation’s International Agency for Research on Cancer (IARC) – known for its strict independence policy and high-quality research - classified glyphosate as “probably carcinogenic to humans”. This conclusion was based strictly on well-documented, publicly available studies revealing “sufficient evidence” for cancer in animal models, “limited evidence” in humans (particularly non-Hodgkin’s lymphoma) and “strong mechanistic evidence” for gene and cellular toxicity.

However, three different EU institutions - namely the German Federal Institute for Risk Assessment (BfR acting as the rapporteur member state for the assessment of glyphosate in the EU), the European Food Safety Authority (EFSA), and the European Chemicals Agency (ECHA) - all reached the conclusion that glyphosate is not carcinogenic to humans. The new report by German Toxicologist Dr Peter Clausing, published by PAN Europe’s member Global 2000, reveals that this conclusion was achieved not because there was not enough evidence on cancer but because the EU institutions, in plain violation of the scientific principles, dismissed or disregarded each set of cancer evidence, one by one.

Thus, the EU institutions had all the scientific data necessary to classify glyphosate as a probable carcinogen. According to European law, this would result in the withdrawal of glyphosate from the market, which would inevitably have a financial impact on the 22 companies that sell glyphosate-based products and have formed the EU glyphosate task force consortium, including Monsanto.
Dr Clausing expressed his concern that the authorities’ actions could put public health at risk: “In Europe cancer incidences have doubled and tripled in recent decades, depending on the tumour type. I am worried that the skyrocketing use of glyphosate has contributed to that and will continue to do so if no action is taken”.

The editor of the report, Claire Robinson from the UK-based NGO GMWatch, added “On July 19th–20th, the European Commission has invited the EU member state representatives to discuss the re-approval of glyphosate at the meeting of the Standing Committee on Plants, Animals, Food and Feed (SC PAFF). All participants should read the report and respond before this discussion takes place. Following science appears to leave them with only one possible course of action: to refuse to renew the authorisation for glyphosate”.

Environmental Toxicologist Dr. Angeliki Lyssimachou from PAN Europe added: “Dismissing and not reporting cancer evidence of pesticide active ingredients is highly dangerous and completely illegal. The report opens our eyes to the fact that, aside from glyphosate, many other pesticide substances, which are also applied on open spaces and end up on our food, may also be threatening public health and deteriorating our environment but people have been kept in the dark. This is unacceptable, the public institutions’ duty is to protect public health and not the pesticide market”.

Main findings of the report:

  • According to the EU pesticides regulation, a substance is to be considered carcinogenic if two independently conducted animal studies show an increased tumour incidence in exposed animals.
  • In the case of glyphosate, at least seven out of twelve such long-term studies found an increased tumour incidence.
  • Initially, BfR failed to recognise numerous significant tumour incidences, due to its failure to apply the appropriate statistical tests stipulated by the OECD and ECHA. BfR had instead relied on statistical tests applied by the industry, which had only indicated a significant carcinogenic effect of glyphosate for a single type of tumour in a single study.
  • Due to the IARC monograph on glyphosate, published in 2015, the BfR re-assessed its own evaluation and acknowledged the above-mentioned significant incidences in seven out of twelve studies.
  • Nevertheless, the BfR – and EFSA and ECHA, which relied on the BfR’s groundwork – failed to notice a further eight significant tumour effects, which were recently identified (http://www.gmwatch.org/files/Letter_Juncker_28_May_2017.pdf) by Prof Christopher Portier, former associate director of the National Institute of Environmental Health Sciences (NIEHS) in the US.
  • BfR, EFSA and ECHA made a biased selection of studies (also known as cherry-picking) in their glyphosate assessments. They took into full consideration two studies that did not find that glyphosate caused malignant lymphoma – but which contain such obvious deficiencies that they should have been excluded from the evaluation. In contrast, they downplayed a study that found that glyphosate did cause malignant lymphoma by citing an alleged viral infection in the animals – for which there is no evidence, as admitted by ECHA. The sole source for this alleged infection is Jess Rowland, a former US EPA official, who made the claim in a teleconference with EFSA. An investigation has confirmed (https://corporateeurope.org/food-and-agriculture/2017/06/did-efsa-lie-pr...) that EFSA had no evidence for the alleged infection beyond Rowland’s remark. Monsanto internal emails disclosed in a US lawsuit suggest that Rowland was an eager helper of the chemical company who boasted (https://www.bloomberg.com/news/articles/2017-03-14/monsanto-accused-of-g...) that he should “get a medal” if he succeeded in killing another agency’s investigation into glyphosate’s health effects.
  • BfR, EFSA and ECHA played off one type of statistical test against another, arguing that glyphosate was not carcinogenic because significance in cancer incidence was only achieved in one type of test and not in another. This violates OECD guidance, which states that significance in either test is sufficient to reject the notion that the cancers occurred by chance.
  • BfR, EFSA and ECHA violated restrictions on the use of historical control data (the compiled data from untreated control animals in previous studies) set by the OECD, to dismiss the carcinogenic effects of glyphosate.
  • BfR, EFSA and ECHA avoided mentioning dose-response relationships that strengthened the evidence that tumour effects were caused by glyphosate and not by random chance. This suggests that the authorities tried to cover up evidence for the carcinogenic effects of glyphosate.

Please also find versions in other languages: ItalianFrenchSpanishGerman

This is the second report, of the series Glyphosate and Cancer, the first being Buying Science.

 

Contact:

  • Peter Clausing - pcl [at] jpberlin.de, +49 (0)176 4379 5932
  • Angeliki Lysimachou, angeliki [at] pan-europe.info,  +32 (0) 2318 62 55

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© Pesticide Action Network Europe (PAN Europe), Rue de la Pacification 67, 1000, Brussels, Belgium, Tel. +32 2 318 62 55

Pesticide Action Network Europe (PAN Europe) gratefully acknowledges the financial support from the European Union, European Commission, DG Environment, LIFE programme. Sole responsibility for this publication lies with the authors and the funders are not responsible for any use that may be made of the information contained herein.