Roundup: how Monsanto (co-)wrote EU safety assessment

12-07-2016
Author: Vincent Harmsen
Source: OneWorld
Herbicides are sprayed over a field of crops. Photo: Sabine Joosten/Hollandse Hoogte
The European Union has decided to keep glyphosate on the market, as was announced in June this year. Despite the controversy surrounding its safety, the world’s most used herbicide was concluded not to be carcinogenic. But how did the EU arrive at this conclusion? Apparently, the risk assessment for glyphosate was written by Monsanto itself.
Investigation – 

How many litres of Roundup does the Antwerp factory supply? “That’s a question we’re often asked”, says chemical engineer Gert Callaerts who has been “with Monsanto for 25 years”, and whose reflective boiler suit and safety helmet would not make him seem out of place on a drilling platform out on the open sea. “But that’s a secret.” Behind him, litre bottles of the popular weed killer are flying across the conveyor belt. “These ones are going to Poland”, Callaerts says, his voice almost drowned out by the roar of the machines. “In here, we work 24 hours a day, 7 days a week, 365 days a year.”

Glypho...what?

 

Glyphosate is the most used herbicide in the world, and sold by the American agricultural multinational Monsanto under the brand name Roundup. The herbicide interferes with the growth of plants, and is thus an effective extinguisher of weeds. Glyphosate is used on crops such as wheat, maize, oilseed rape and sugar beet. Farmers often spray their field with glyphosate before sowing to avoid the growth of unwanted plants. It is also used to dry out crops before harvesting them. In 2013 the urine of residents of 18 European cities was examined. In 44 percent of the urine samples researchers found traces of glyphosate. According to the Dutch Bureau of Statistics the use of glyphosate has more than doubled in the past twelve years. 

 

Here, on the banks of the Schelde river, where the skyline is dominated by enormous cooling towers and the salty air mingles with the smell of burnt rubber, these bottles are transported to farmers all over the world: to the Netherlands and Poland, but also farther away, to South-Africa, Saudi Arabia and Japan. Roundup is the agricultural giant’s best seller: it generates a turnover of billions, partly because its sales outside of Europe are combined with the sale of genetically manipulated soy and corn that has been made resistant ('Roundup Ready') against the agricultural toxin. “It is cheap for farmers”, a Monsanto spokesperson states during a media presentation. “And it has a track record of 40 years of safe use.”

Glyphosate probably carcinogenic

Faced with annual ‘marches against Monsanto' and with polls that rank it as one of the world’s most unpopular multinationals, the American company from St. Louis is used to a fair bit of criticism. However, in March 2015 an existential PR-crisis occurs when a working group of the World Health Organisation (WHO) publishes a report that threatens to turn Monsanto’s revenue model upside down: glyphosate, the main ingredient in Roundup, likely causes cancer in humans it states.

One of the key studies on which the working group, called IARC, bases its conclusion is a study carried out by Monsanto itself in 1983. This report already questioned the safety of the herbicide 33 years ago. Monsanto researchers gave mice an ascending dose of glyphosate. The result: depending on the dosage, the animals more often developed tumours.

It's the type of study that can really give you pause, because this type of cancer is so rare that it is absolutely unlikely to be due to chance.


''The study showed a very rare tumour with mice", Kathryn Guyton of IARC explains over telephone from her office in Lyon, France. ''It's the type of study that can really give you pause, because this cancer is so rare that it is absolutely unlikely to be due to chance. In total we had two studies that showed these kinds of rare tumours in mice.'' In addition to these animal studies, IARC states that several other studies also suggest glyphosate is carcinogenic to humans. For this conclusion IARC relies heavily on three epidemiological studies – from Sweden, Canada and the U.S.. These studies show that farmers who spray their crops with herbicides that contain glyphosate more often develop non-Hodgkin lymphoma: a rare form of cancer.

Europe is working on a renewal of marketing authorisation

IARC’s conclusions arrive at a precarious moment. In March 2015, the European Union is working on its own investigation into the safety of glyphosate. Their research is part of the renewal of marketing authorisation for glyphosate, applied for by producers such as Monsanto. If glyphosate proves to be carcinogenic, European law states this authorisation cannot go ahead

However, on November 12th 2015, it seems that the industry can breathe a sigh of relief. Science wins!!'', tweets Robb Fraley, chief technology officer at Monsanto. On that same day, the European food authority EFSA publishes its conclusions: ''Glyphosate is unlikely to pose a carcinogenic hazard to humans.'' It seems the EFSA’s positive judgment has reduced the official European authorisation of glyphosate to a mere formality. But how can this judgment deviate so strongly from the conclusions drawn by IARC?

The literal text in the evaluation report has been written by the industry itself.

The answer to that question takes us to Germany and more specifically to the Max-Dohrn Strasse in Berlin. There, on the banks of the Spree, we find the German Bundesinstitut für Risikobewertung (BfR), or: the Federal Institute for Risk Assessment. The BfR is responsible for the report on which the EFSA has based its judgment. Why the BfR? Apparently, they have been singled out by the producers of glyphosate, who strive for renewed European authorisation and are united in a consortium led by Monsanto: the Glyphosate Task Force (GTF). An EU-regulation allows producers to choose their own institute.

However, choosing the BfR is not the only way the industry manages to safeguard its own interests. The hefty report written by the German national institute shows that the literal text in the evaluation has been written by GTF, the industry in other words, supplemented with commentary by the BfR. And their influence stretches even further. The GTF also made the selection of scientific literature. “European law states that companies that want approval of a herbicide or pesticide should compile their own dossier” says Peter Clausing, who worked as a toxicologist for the American food authority FDA for many years and now works as a researcher for the Pesticide Action Network in Germany. “It gives these companies a great deal of power. They can emphasize certain studies, while others disappear into the background.”

Three epidemiological studies which show an increase of non-Hodgkin lymphoma in farmers are deleted 


It is possible to determine the exact studies chosen by Monsanto and its associates. The GTF has deleted the three epidemiological studies that show an increase of non-Hodgkin lymphoma in farmers and are considered key evidence by the WHO. “Not reliable” and “not significant” in outcome according to industry. The BfR accepts these conclusions, as can be read in the commentary they will later add to the document.

In addition to population studies, the GTF also presents a selection of animal studies. This selection includes the two studies with mice and rare tumours; studies the WHO deemed important. However, the GTF also presents the BfR with three other studies involving mice. It concerns industry-based studies whose outcomes have been classified as trade secrets up until this day. Their results have only been shared with the BfR confidentially.

Kathryn Guyton of the IARC: “Based on the BfR report, I cannot say what the outcomes of these animal studies are. When we were working on our report about glyphosate we asked industry to disclose these data. When we came up against a brick wall, we decided not to include them in our evaluation. IARC only works with studies that are publicly accessible and can be assessed by independent researchers.”

Every year there are worldwide protests organized against Monsanto.


The inclusion of these industry-based studies means glyphosate is now considered safe: ''It should be avoided to base any conclusion only on the statistical significance of an increased tumour incidence identified in a single study'', the BfR report states. ''The weight of evidence suggests that there is no carcinogenic risk.''

Surprising professional connections

Who at BfR is responsible for this conclusion? Contrary to the IARC report, the BfR does not mention the names of its authors. “We have asked the BfR to name the authors of the evaluation”, says Heike Moldenhauer of BUND, a German environmental organisation. “We were told that no records have been kept about this. What we do know is that the Abteilung Sichterheit von Pestiziden (the Department of Pesticides Safety red.) is responsible for the report. Dr. Roland Solecki leads this department and was already involved in the first EU market authorisation of glyphosate 15 years ago.”

When we asked who the authors were of the glyphosate evaluation, we were told that no records have been kept about this.


BUND investigated Roland Solecki and discovered a few remarkable professional links. Solecki’s name emerges alongside the names of researchers employed by chemical companies, among which Monsanto, in a scientific article from 2006. Interestingly enough, it concerns a study that pleads for a more accessible European authorisation of herbicides and pesticides. The study has been paid for by ILSI, an institute financed by the world’s largest food and agriculture companies, among which -once again- Monsanto.

“To provide science that improves human health and well-being”, is how ILSI formulates its mission. However, the organisation supposedly also has a more sinister side. Between 1983 and 1998 it has deliberately tried to sow doubts within the WHO about the dangers of smoking; a scandal that came to light in an American court case against tobacco producers in the late 1990s. According to critics, the aim of ILSI is nothing less than the infiltration of agencies that safeguard public health; also referred to as ‘regulatory capture’.

Several BUND documents show that Solecki was an active member of ILSI until at least 2015. Together with scientists employed by chemical companies such as Monsanto, he looked at the rules governments should create to handle potentially dangerous chemicals like glyphosate. While Solecki has to judge whether or not our health is at risk, Monsanto has sizeable commercial interests. Apart from Solecki, the list of participants also includes employees of other agencies such as the RIVM, an organisation that advises the Dutch government on public health and the environment. According to BUND, such contacts cause a clear conflict of interests as they might affect the objectivity of public agencies such as the BfR and the RIVM, which exist solely to safeguard and promote public health.

Links between the BfR and the Glyphosate Task Force?

Roland Solecki is not available for comment, but the BfR reacts by stating that the way in which glyphosate has been assessed is standard procedure for all European herbicides and pesticides: ''It is a correct assumption that the applicants of the dossier [the GTF] (...) did the initial study evaluation and wrote the text on the studies in his dossier. Additionally, the BfR has evaluated each original study with its experts. (…) At no time BfR was in contact with the applicant.''

But is that latter statement factually correct? Located a few kilometres further along the river Spree, past the Tiergartenpark, is the German Bundestag, where a very different story is offered. “Employees of the BfR have told me they have been more or less continuously in touch with the Glyphosate Task Force”, says Harald Ebner, German parliamentarian for Bündnis 90/Die Grünen, a green political party in Germany. “They called this a ‘normal and necessary’ part of the evaluation.” Harald Ebner also discovered something else. The Glyphosate Task Force was allowed access to a confidential version of the BfR report. It concerns the final version that Roland Solecki’s department worked on and that was sent to the industry on February the 2nd 2015, two months before EFSA receives the definitive report. Ebner tracks down these facts after colleagues point him to a study in which Monsanto is involved and which mentions a concept version of the BfR report in a footnote.

At first, the German government denies the allegations: 'The federal government is not familiar with any ways,' writes Peter Bleser, deputy minister of agriculture on December 8th 2015 in response to written questions posed by Ebner, 'in which the mentioned authors had access to the draft version of the report'. However, on the 8th of February 2016, Peter Bleser finally reluctantly admits that the report has fallen into the hands of the industry through a German consultant who works for the Glyphosate Task Force. “My colleagues and I were flabbergasted”, Ebner says. “All versions of the report that appeared after 2013 had been marked ‘confidential’ by the BfR, and could not even be accessed by members of the German Bundestag.”

In view of their close ties with the industry, Harald Ebner has serious doubts about the BfR’s credibility as an independent research institute. According to him, this German evaluation cannot be the basis on which the entire EU renews the authorisation of glyphosate.

However, on June the 28th the European Commission decides to extend the license for glyphosate, ignoring public opposition by France and Germany who state to oppose reapproval. To accommodate these critical member states, who point to the questions that are still raised by the IARC report, the herbicide is only authorised for 1.5 years, instead of the 15 years Brussels had originally intended. After 1.5 years, the European Chemicals Agency (ECHA) will carry out a survey to assess the safety of glyphosate once more, the Commission promises it's critics.

On June the 28th the European Commission decides to extend the license for glyphosate, thereby ignoring the governments of both France and Germany, who openly protest against this decision. 


The EU Commission has been reinforced in its decision to keep glyphosate on the market by a last-minute judgment from another WHO working group. It concerns an evaluation that has been produced by the JMPR, an expert panel that looks at the risks of herbicide and pesticide residues on food. On the 16th of May, the JMPR concludes that it is ‘unlikely’ that glyphosate causes cancer in humans. This leads to a highly unusual situation, in which two different WHO panels,  the IARC and the JMPR, directly contradict each other regarding the safety of an agricultural toxin.

However, the conclusions drawn by the JMPR,  which are published when the EU countries are discussing glyphosate in Brussels, are undermined when The Guardian reveals that the chair of the work group, professor Alan Boobis, is an executive member of ILSI, an organisation that received half a million worth of donations from Monsanto in 2012. Boobis also leads the ILSI work group that includes Roland Solecki from the German BfR, who is responsible for the European risk assessment of glyphosate. Together with industry scientists, this working group looks at ways for governments to regulate dangerous chemicals.

 “Professor Alan Boobis has fulfilled different functions within ILSI throughout his career”, says Hans Muilerman of the NGO Pesticide Action Network. “ILSI is one hundred percent industry-funded. In my opinion, someone like Boobis should not be allowed to participate in a WHO work group. These groups should only include scientists who are financially independent.” Muilerman worries about the European authorisation of glyphosate: “Population studies show that employees and local residents are at risk. No one should be exposed to carcinogenic substances and that is exactly what European legislation dictates.”

In a press statement the Glyphosate Task Force expresses its disappointment in what it calls the “politicisation” of the debate surrounding the agricultural toxin. “The safety of glyphosate is beyond all doubts”, it says, and according to the GTF the herbicide should have been reauthorised unconditionally: ''Considering the extensive scientific evaluation carried out by the relevant EU agencies which concluded that glyphosate poses no unacceptable risks either to human health or to the environment, the renewal should have […] resulted in a standard 15-year renewal.''

Vincent Harmsen

Vincent Harmsen is an investigative journalist at OneWorld with a focus on...

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