Call comes within days of EU Parliamentary hearing on the “Monsanto papers” and glyphosate’s toxicity
On 16 October a cross-party group of MEPs demanded a phase-out of glyphosate by December 2020. They want a ban on non-professional use of the herbicide and use in public parks or playgrounds after 15 December 2017, when the current authorisation expires. The MEPs want the Commission to withdraw its proposal for a 10-year renewal.
The MEPs also want a ban on agricultural application after 15 December 2017 in cases where integrated plant protection methods are sufficient. They are asking for Common Agricultural Policy (CAP) funds to be made available to farmers to support the transition to more sustainable methods of weed control.
In addition, the MEPs asked for a complete overhaul of the EU's risk assessment of pesticides. They want the REFIT reform of EU regulations to be used to ensure that the scientific evaluation of pesticides for regulatory approval is based only on published, peer-reviewed and independent studies commissioned by competent public authorities.
The MEPs' demands appeared in a draft resolution that will be debated and voted on 19 October in the ENVI Committee.
These developments come ahead of the planned vote on the renewal of the authorisation for glyphosate in the Standing Committee (Plants, Animals, Food and Feed) on 23 October.
Parliamentary hearing on the Monsanto papers
The MEPs’ draft resolution follows shortly after a joint ENVI/AGRI committee hearing in the European Parliament on the "Monsanto papers" and glyphosate, held on 11 October. You can watch videos of all the presentations here.
The hearing focused on the scientific basis for the risk assessment of glyphosate, as well as the influence of industry on this assessment in the US and the EU. Of central interest were the so-called Monsanto papers, internal company documents released in a US court case brought by plaintiffs claiming that they got cancer due to glyphosate exposure. The Monsanto papers suggest that the scientific assessment of glyphosate might have been influenced by Monsanto.
The hearing took place against the background of the ongoing debate over the renewal of glyphosate's approval. The current EU approval expires on 15 December 2017, and the Commission has proposed a renewal for ten years. The hearing was intended to provide Parliament with the necessary information to decide on possible follow-up action.
The event was remarkable in showing the strength of mistrust among MEPs of glyphosate’s safety and its assessment by the EU agencies.
The German Federal Institute for Risk Assessment, BfR, which prepared the report on glyphosate that formed the basis of the EU assessment, refused to attend, as did Monsanto.
EFSA and ECHA defend their assessments
The European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) rejected claims that the EU regulatory system is fundamentally flawed and insisted that their verdict that glyphosate is safe was based on conclusive science.
Jose Tarazona, head of EFSA’s pesticides unit, denied that its evaluation had been "copied and pasted" from the findings of industry-funded studies, saying the criticisms had come from "people who don't understand the process". He said it was "normal practice" that if EFSA believed a summary of a study was valid, the summary could be included in the assessment report.
However, Mr Tarazona’s view is not shared by Dr Stefan Weber, an Austrian expert on plagiarism. Dr Weber analysed BfR’s report on glyphosate, on which EFSA’s report was closely based. He concluded that BfR’s actions in copy-pasting the Monsanto report without giving citations or distinguishing between Monsanto’s and the BfR authors’ own assessments equates to “serious scientific misconduct”.
Tim Bowmer of ECHA said there was "no evidence” that the glyphosate assessment has been “subverted".
Mr Bowmer said it did not matter that some of the industry studies on which the EU based its assessment of glyphosate were confidential. He said the two studies that had found tumours in mice fed glyphosate were "not strong enough by themselves to warrant classification (of glyphosate as a carcinogen)".
However, an analysis by the German toxicologist Dr Peter Clausing found that seven out of twelve of industry’s carcinogenicity studies found an increased tumour incidence. A substance is to be considered carcinogenic if two independently conducted animal studies show an increased tumour incidence.
Glyphosate is magnifying glass onto corporate misdeeds
Martin Pigeon of Corporate Europe Observatory said that the glyphosate issue is a “magnifying glass” onto corporate influence on regulatory processes, a problem that reaches far beyond this single chemical. Citing Monsanto’s refusal to attend the hearing on the grounds that the process should be strictly scientific but had become politicized, Mr Pigeon said science was being used by Monsanto “to keep democracy at bay”. Monsanto was in effect saying, “Go away, MEPs,” Mr Pigeon said. He pointed to a statement by a Monsanto employee, revealed in the Monsanto papers, to the effect that “Data generated by academics has always been a major concern for us in the defence of our products”.
One of the key concerns raised at the hearing was the reliance of ECHA and EFSA on secret industry studies which are not peer-reviewed or published. Mr Pigeon lamented that EFSA doesn’t have the resources to commission its own science and that the agency was also bound by EU laws, which state that the basis for pesticide approvals is secret industry studies. He called for EFSA to have a higher budget and the power to commission its own studies.
Speaking to MEPs just after the Parliamentary hearing, the executive director designate of ECHA, Bjorn Hansen, said he sees no "major obstacle" to agencies commissioning independent scientific studies rather than relying on industry studies. He said that this was an issue for the European Commission and the regulators, adding he could see no major problems though increased staffing levels would be needed.
Professor denies Monsanto money affected his findings
Another speaker at the Parliamentary hearing was Prof David Kirkland, a scientist who was paid thousands of euros by Monsanto to review evidence of the safety of glyphosate. He denied that the money influenced his findings.
Prof Kirkland, who is a consultant for Monsanto, was an author on two reviews in 2012 and 2015 of the scientific literature on glyphosate which were submitted by industry to support the re-authorisation of the herbicide in the EU.
Prof Kirkland denied that receiving €18,000 from Monsanto for a review was unethical or harmed his scientific credibility. He said it was no different to an accountant or lawyer being paid for work by a client. He added, “Just because you are being paid does not mean your opinions can be bought or influenced.”
He was challenged by two MEPs. The Belgian Green MEP, Bart Staes, asked him, “Is this what you call science? Is it ethically acceptable?" The Belgian Socialist, Marc Tarabella, echoed Mr Staes’s concerns, asking, "Are you credible as a scientist?"
Prof Kirkland also denied that he had been involved in putting his name to scientific articles about glyphosate that were ghost-written by Monsanto.
The allegation of ghost-writing came from an internal Monsanto email released as part of the Monsanto papers, in which a company executive, Bill Heydens, suggested to colleagues that Prof Kirkland should be invited to put his name to a review ghost-written by its own staff.
Prof Kirkland dismissed Heydens’ words as “naive". He said that he and his co-authors had taken a weight-of-evidence approach and that their findings were not influenced by Monsanto. He said, “If those conclusions were what Monsanto wanted to hear then I assume they were quite happy. But if the conclusions had been something Monsanto hadn't wanted to hear we would have told Monsanto that glyphosate was a genotoxic risk. But that is not what we found.”
EU agencies missed half the tumours in animal studies
Prof Chris Portier, an invited expert to the IARC review that declared glyphosate a probable carcinogen, accused EFSA and ECHA of failing to perform due diligence in their assessments of the chemical. Prof Portier said they had only discussed half of the significant tumours in the relevant studies, and that in most cases they had had failed to examine the original data but had merely relied on industry reports.
He said, “Nobody went back and verified the findings of the original studies. That cascaded through the entire review process such that you don't have an answer based on the best science."
Prof Portier said the assessment process was "scientifically flawed" and that it was time to set up "an independent panel to referee the way the scientific evidence is reviewed”. He added, "If IARC had not done its review, today I would not be here telling you that half the tumours in the studies were missed in the report. I would not be here telling you that this process is flawed."
He said that all the studies considered for the assessment should be made available for public scrutiny, a point also made by Kate Guyton of IARC, who said her agency only considered studies for which all the data was openly published and that its mandate forbids it from considering “secret” studies.
Calculated deceit
US Right to Know’s Carey Gillam gave powerful testimony about Monsanto's manipulation of science, media, regulators and policy makers regarding the safety of glyphosate, as revealed in the Monsanto papers. Ms Gillam said, “I can confidently tell you that the story of the company's top selling chemical glyphosate is not one of truth, but one of deceit – carefully calculated and choreographed deceit. There is overwhelming evidence of attempts to deceive and to do so in ways that manipulate the press and attempt to manipulate policy makers like you."
Ms Gillam explained: “Monsanto has ghostwritten research papers that assert glyphosate’s safety for regulatory reviews, and provided alternative assessments for studies that indicate harm, to try to convince regulators to discount evidence of safety problems.
“They’ve developed a network of EU and US scientists to push glyphosate safety messages to regulators while appearing to be independent of industry. They’ve utilised public relations teams to ghostwrite articles and blogs that appear on different websites and publications, using the names of scientists who again appear to be independent. They work to form front groups that work to discredit journalists and scientists who publicise safety concerns.
“They have a very close relationship with EPA, so close that they felt comfortable providing the EPA with talking points after the IARC classification, for the EPA to use in dealing with the press. They have a close enough relationship with the EPA that they successfully pushed the EPA to remove a top epidemiologist from the scientific advisory panel on glyphosate. They successfully enlisted at least three top EPA officials to block a 2015 glyphosate review that was to be done by another agency…. and we know Monsanto said internally that they were worried that this agency would agree with IARC.”
Unanswered questions
After the hearing, the two Socialist MEPs who initiated it, Marc Tarabella and Eric Andrieu, said many questions remained unanswered and renewed their call for the Parliament to launch a committee of inquiry.
Mr Andrieu expressed concern over EFSA’s statement that it was normal to copy and paste industry documents, saying there needed to be an investigation. Mr Tarabella said Monsanto's refusal to attend was a rebuff to 500 million anxious European citizens. Mr Andrieu condemned the faith that he said the European agencies had placed in industry studies. He said, "Listening to Dr Tarazona... you'd think the copy and paste method was completely normal practice in EFSA's evaluation reports. You wonder if you're not dreaming."