Report says between 2012 and 2016, pesticide companies sponsored a series of review articles published in scientific journals, all of which conclude that glyphosate and its commercial formulations are not carcinogenic

To download the new report, which is co-authored by GMWatch’s Claire Robinson, and for more information, go to
http://www.gmwatch.org/news/latest-news/17518

1. Green NGOs blame Monsanto for “buying science” to save glyphosate
2. European regulators “didn't even read” risk studies on Monsanto pesticide glyphosate
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1. Green NGOs blame Monsanto for "buying science" to save glyphosate

By Sarantis Michalopoulos
EURACTIV.com, 25 Mar 2017
http://www.euractiv.com/section/agriculture-food/news/green-ngos-blame-monsanto-for-buying-science-to-save-glyphosate/

A new report accuses glyphosate producers of “buying science” in order to secure the substance’s position in the EU market.

According to the Buying Science report published by GLOBAL 2000 (Friends of the Earth Austria member of Pesticide Action Network-PAN) with the support of Avaaz, BUND, Campact, CEO, GMWatch, (PAN) Europe, PAN Germany, and Umweltinstitut München, Monsanto and other glyphosate manufacturers allegedly “distorted scientific evidence” on the public health impacts of the pesticide.

The authors of the report claim that, between 2012 and 2016, the companies sponsored a series of review articles published in scientific journals, all of which conclude that glyphosate and its commercial formulations are not carcinogenic.

Scandalous

“Glyphosate producers have used every trick in the book to enable regulatory authorities around the world to play down the alarming health effects of glyphosate. The fact that the agencies accepted their ‘assistance’ is nothing less than scandalous,” insisted Helmut Burtscher, one of the study’s authors.

Earlier this month (15 March), the European Chemicals Agency (ECHA) concluded that glyphosate weedkiller should not be classified as a carcinogen.

Environmentalist NGOs reacted strongly, with Greenpeace saying that the ECHA “sweeps glyphosate cancer evidence under the carpet”.

The Health and Environment Alliance (HEAL) went further, claiming that the decision contradicted the world’s most authoritative cancer research agency, the World Health Organisation’s International Agency for Research on Cancer (IARC), which classified glyphosate as a “probable carcinogen” in 2015.

Scientific flaws

The NGOs claim that these reviews proving glyphosate is safe contain “fundamental scientific flaws spanning from apparently calculated omissions and the introduction of irrelevant data to the violation of OECD guidance for the evaluation of rodent cancer studies”.

“The reviews also consistently assign greater weight to unpublished industry studies than to studies that were peer-reviewed and published in scientific journals,” the report noted.

The report stressed that regulatory authorities like Germany’s Federal Institute for Risk Assessment (BfR), the European Food Safety Authority (EFSA) and the US Environmental Protection Agency (EPA) have all drawn on such review articles, which have concluded that glyphosate was not carcinogenic, have actually referred to these industry-sponsored review articles.

“In contrast, IARC refused to consider the unpublished industry studies summarised in industry-sponsored reviews in its assessment of glyphosate, stating that the data presented therein were insufficient and important details were lacking […] IARC generally does not accept unpublished scientific evidence,” the authors of the report concluded.

Positions

European Commission Spokesperson Enrico Brivio recently told EURACTIV that the EU executive “took notice” of ECHA’s opinion, which was “based on scientific evidence”.

“The submission of the final opinion to the Commission is expected before the summer break […] After submission of the final opinion, the Commission Services will re-start their discussions with the member states as regards the approval of glyphosate as an active substance in Plant Protection Products (PPPs).”

“A decision has to be taken within 6 months of receipt of the RAC Opinion from ECHA, or by the end of 2017 – at the latest,” he added.

An EFSA spokesperson said, after this article was published, that "EFSA is the first to defend the importance of reliable science as it forms the basis of all our risk assessments", adding "from an initial glance at the "Purchased Science" report, it is clear that the majority of mentioned studies were published after EFSA had completed its assessment of glyphosate. In other words, they did not play any role in the EFSA assessment of glyphosate".

"There are two scientific reviews mentioned in the report (Williams et al 2000, Kier and Kirkland 2013) that were among the 700 references considered in the EU assessment for glyphosate. EFSA and EU member states rely primarily on the original studies and the underlying raw data which they check themselves. The weight given to reviews of scientific studies (like the ones mentioned in the report) is limited," they added.

"There are no grounds to suggest that reviews of scientific studies, sponsored directly or indirectly by industry, improperly influenced the EU risk assessment for glyphosate," the spokesperson concluded.

Background

The European Food Safety Authority (EFSA) said in November 2015 that glyphosate was unlikely to cause cancer in humans and proposed higher limits on the amount of residue of the weedkiller deemed safe for humans to consume.

The EFSA advises EU policymakers and its conclusion were expected to pave the way for the 28-member European Union to renew approval for glyphosate, which was brought into use by Monsanto in the 1970s and is used in its top selling product Roundup as well as in many other herbicides around the world.

Environmental groups have been calling for a ban after the International Agency for Research on Cancer (IARC), part of the World Health Organisation, said in March 2015 that glyphosate was “probably carcinogenic to humans”.

A campaign group said that 1.4 million people had signed a petition calling on the European Union to suspend glyphosate approval pending further assessment.

The EFSA said it had carried out a thorough analysis and taken account of the IARC’s findings. Greenpeace, for its part, called the EFSA’s report “a whitewash”.
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2. European regulators “didn't even read” risk studies on Monsanto pesticide glyphosate

DW, 23 Mar 2017
http://www.dw.com/en/european-regulators-didnt-even-read-risk-studies-on-monsanto-pesticide-glyphosate/a-38087834

* German and European regulators never undertook a critical assessment of the cancer risks of the herbicide active agent, glyphosate. That's the view of environmental chemist Dr Helmut Burtscher

DW: Dr. Burtscher, your initiative "Global 2000" has published a study into the approval process for the pesticide and herbicide active ingredient, glyphosate. What are the main findings?

Dr. Helmut Burtscher: The current legal framework in Europe requires regulators to consider independent literature and research in the approval process of chemicals. We've discovered that chemicals manufacturers - in this case predominantly Monsanto - have taken that to mean that can produce their own independent studies. And they have commissioned and paid scientists to do that.

There are emails, published in the US, showing how they even thought about paying scientists to put their names to "independent" studies, which were written by Monsanto. All these studies went into the decision-making process in the US and EU, and the regulators there accepted them - with thanks - as a way to wipe critical studies from the table. Those were studies that were disadvantageous for glyphosate's approval chances, because they showed a risk of cancer or genotoxicity (a risk to DNA).

Scientists are meant to be able to repeat or replicate studies to test and verify them - what's called "peer review" - and that should provide a certain transparency. So how is it possible to alter the interpretation of a study, or make it appear either negative or positive at its core?

That's how science works. But regulatory studies are the exact opposite. Regulatory studies aren't published. Monsanto does its own toxicity studies with rats and mice, it also does its own studies on genotoxicity, or they commission labs to do the work for them. They then declare the results to be company secrets before submitting them to the regulators. There are no third-party scientists who get a chance to view the data and say, "Hold on, it doesn't work like that!"

So your only hope is that some regulator has a proper look at the studies. But we now know that Germany's Federal Institute for Risk Assessment (BfR) didn't do that. It took the studies that showed a significant increase in tumors, dependent on the dose of glyphosate, and interpreted that to mean there were non indications of a risk of cancer. The World Health Organization's International Agency for Research on Cancer (IARC) took these very same studies from the 1980s and 1990s to arrive at the conclusion that glyphosate was "probably carcinogenic."

When the BfR was asked how it had drawn a completely different assessment it had to admit that it had relied on the statistical analyses submitted by the manufacturers. And when you look at these statistical analyses, you notice that they do not refer to the OECD standards, which are recognized everywhere, as to how you should interpret such data.

Numerous other regulators have said they agree with the assessment that glyphosate poses no risk of cancer. Apart from the BfR there is the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA) and their American counterparts. That leaves IARC, which seems isolated in its view. How can that be?

That's Monsanto's favorite argument, and they're always wheeling it out. They say all the world regulators - whether it's in Canada, Japan, the USA, or Europe - have repeatedly stated, "Glyphosate is not carcinogenic." And then there's IARC who says, "It is carcinogenic. So who's right?"

The fact is that all these regulators get Monsanto's studies and those from other companies. And they get the conclusions delivered at the same time. It's not just that Monsanto pays for the studies or that, to an extent, they conduct the studies. It's also that they write the study reports. And that would allow the industry to have made every regulator in the world their friend.

But the BfR also deserves to be blamed for having misled the public by declaring, "We've concluded this and so have other regulatory authorities."

If, however, you take a closer look, you notice how the BfR held the reins in all of the regulators. That's how the BfR did the first European assessment in the 1990s, and again through the EFSA it evaluated its own, earlier assessment.

It was even the same people. Then, in 2004, they wrote the recommendation for a joint meeting on pesticide residues held by the UN's Food and Agriculture Organization (FAO). They did it again five years later. And they're doing it yet again now in this EU re-approval process. When it comes to assessing glyphosate, they are the ones in charge almost everywhere.

Dr. Helmut Burtscher is a bio and environmental chemist with the initiative, Global 2000. He has spent 15 years there working on the toxicological effects of pesticides and other chemicals on the environment and humans.