Whitewash
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And those urine tests? EFSA has reassuring words for anyone worried about what the weed killer might be doing to their bodies. The safety agency said that absorbed glyphosate is “poorly metabolised, widely distributed in the body … and is rapidly eliminated; showing no potential for bioaccumulation.”14 Jose Tarazona, head of EFSA’s Pesticides Unit, said the conclusions followed “an exhaustive process—a full assessment that has taken into account a wealth of new studies and data.”15 What Tarazona did not say publicly was that EFSA’s conclusions also came after the EPA’s Jess Rowland, the official who Monsanto considered a reliable friend inside the agency, engaged in a teleconference with EFSA in September 2015, explaining why EFSA should reject a 2001 study that found a causal link between glyphosate exposure and tumors in Swiss albino mice. Records show the agency did exactly that.16 It was that same month, in an e-mail dated September 3, 2015, that Monsanto’s regulatory affairs leader, Dan Jenkins, wrote to colleagues how “useful” Rowland could be in “ongoing glyphosate defense.”17 EFSA said there was no industry attempt to improperly influence its assessment of glyphosate, but skeptics were not satisfied.
Monsanto, which stood to lose an estimated $100 million in sales if its license for glyphosate were not renewed in Europe, applauded the BfR’s and EFSA’s safety findings.
EFSA’s conclusions, which came eight months after IARC said glyphosate was probably carcinogenic, provided much-needed ammunition for Monsanto and the other chemical companies as they headed into 2016, when glyphosate’s registration would expire and the European Commission would be deciding about reauthorization.
The BfR and EFSA were so enthusiastic about glyphosate safety that they sent representatives to the United States in December 2016 to appear before the EPA’s Scientific Advisory Panel on glyphosate and tell the group how safe both agencies found glyphosate to be. The EPA said it did not request that either EFSA or the BfR appear; instead, the agencies themselves said they decided to travel across the ocean to make their arguments.
So where did the BfR get the data for its report to EFSA? From none other than the Glyphosate Task Force, a consortium of chemical companies, including Monsanto, that had joined forces with the stated goal of winning renewal of glyphosate’s registration in Europe.18 The BfR acknowledged as much, saying the health evaluation prepared for glyphosate was based on publications and other “relevant information” submitted by the industry consortium as well as on older studies that were part of previous EU evaluations. The BfR also claimed that because so many studies were submitted, it was unable to look at them all in detail, so it relied on the industry consortium “descriptions and assessments” of the studies rather than going through each independently.
The revelation outraged some who saw the circumstances as a blatant example of industry interests taking precedence over protection of public safety. Greenpeace called EFSA’s report a “whitewash” that relied heavily on unpublished studies commissioned by glyphosate producers while dismissing published peer-reviewed evidence that glyphosate causes cancer. “EFSA has defied the world’s most authoritative cancer agency in order to please corporations like Monsanto,” said Greenpeace EU’s food policy director, Franziska Achterberg.19 Other environmental and consumer groups also complained that the findings lacked independent scrutiny.
“We know that Monsanto and other companies provided their own assessment of the scientific evidence, much of it industry-sponsored unpublished studies, and then handed that pig off to Germany for some lipstick,” said Jennifer Sass, a senior scientist with the Natural Resources Defense Council. That “industry-dominated” finding of unlikely cancer ties should be discounted because its credibility was too compromised, she said.20
A group of ninety-six scientists, including some members of IARC’s panel, penned a critical letter to the EU’s commissioner for health and food safety, a man named Vytenis Andriukaitis, imploring the European Commission to “disregard the flawed EFSA finding on glyphosate … and to call for a transparent, open and credible review of the scientific literature.” The scientists, who hailed from several countries, including New Zealand, Australia, Germany, Switzerland, France, Italy, Russia, and the United States, said that IARC’s decision was the truly credible one because it relied on “open and transparent procedures by independent scientists who completed thorough conflict-of-interest statements and were not affiliated or financially supported in any way by the chemical manufacturing industry.” In contrast, the scientists wrote, the BfR’s and EFSA’s work “is not credible because it is not supported by the evidence and it was not reached in an open and transparent manner.”
Among other problems, the scientists said, it appeared that EFSA was disregarding significant positive trend findings in animal studies that showed links between glyphosate and tumors in mice and rats, that it was differing from standard scientific practices, and that it was ignoring “unequivocal” evidence of the carcinogenicity of glyphosate in laboratory animals. And particularly troubling to the scientists was the lack of information about unpublished studies the government agencies seemed to be relying on.21 The criticisms of the European regulators were nearly identical to those lobbed at the EPA. “Due to the potential public health implications of this extensively used pesticide it is essential that all scientific evidence be freely available, reviewed openly in an objective manner, and that financial support, conflicts of interest and affiliations of authors be fully disclosed,” the scientists wrote.22
One of the signatories, Xaver Baur, senior professor at the Charité Institute of Occupational Medicine in Berlin, made a detailed presentation to the European Parliament stressing the research tying glyphosate to rising rates of non-Hodgkin lymphoma and describing the various other cancers and disorders his clinic sees in farmers and agricultural workers exposed to glyphosate and other pesticides. He said there are potential parallels between the glyphosate situation and that of asbestos, which chemical industry players defended for decades despite what became overwhelming evidence of asbestos’s ties to lung cancer. “Precaution is strongly recommended,” he told the gathering, saying the cumulative impacts of exposure through food and the environment are currently unknown. Glyphosate and its formulations represent “a new potentially hazardous internal load to the human body and the health risk is incalculable at present.”23
Such widespread skepticism led to demands from consumer advocates and MEPs for EFSA to release the actual unpublished studies provided by Monsanto and other industry players to show glyphosate was not cancer-causing. The hope was that by looking at the studies themselves, rather than the industry-aided interpretation, outsiders could determine whether or not EFSA’s assessment was accurate. A group called Corporate Europe Observatory, a watchdog organization that tracks corporate lobbying in the EU, was among those seeking the studies. The group said that clinical trial data for new medicines is routinely made public to enable scientific scrutiny, and the same should be done for agrochemicals such as glyphosate. Similar requests had been made over the years to other global regulatory authorities, which commonly cited business confidentiality restrictions imposed by the industry in refusing to make the data public. The studies were trade secrets, according to Monsanto, even though they were used in multiple countries to seek approvals for products sold to, and used by, the public.
A chink was notched into that argument’s armor in 2013 when the Court of Justice of the European Union ruled on a legal complaint filed by environmental groups that challenged the secrecy over glyphosate. The court ordered that any document containing information about emissions into the environment needed to be released to the public.
The ruling made it difficult for EFSA to keep the data secret, but the agency still showed reluctance to full disclosure. E-mail communications obtained through public access requests in Europe showed that EFSA went to Monsanto and the other pesticide companies who owned the relevant studies to seek permission to release certain documents, including a feeding study of mice that
had been dosed with glyphosate. As was expected, the companies objected to the disclosures. Monsanto was adamantly opposed to letting members of the public view its research results and analysis, arguing that its work represented intellectual property and such information could aid competitors by supplying them with “key commercial information.” The company underlined some of its objections in a letter to EFSA. The following are a few excerpts:
Monsanto hereby formally objects to the disclosure of the entirety of the Study….
Our objections are also grounded by legitimate economic interests protected by the confidentiality.
The Study represents a material investment in time and money for Monsanto….
… Should EFSA still consider granting access to the document to the third party, Monsanto would insist on making The Study available to the third party in a closed data room, without any possibility to make copies, reproduction or communication of the information and under logistical conditions to be agreed with Monsanto….
Prior to the third party viewing The Study, Monsanto would request an opportunity to sanitise The Study….24
Despite Monsanto’s objections, the political pressure on EFSA would eventually force the agency to release the raw data, sending the genotoxicity and carcinogenicity studies it used in its assessment to a group of MEPs who had submitted a formal request for the information. Before sharing it, however, EFSA blacked out numerous sections, saying it had to balance the public’s “right to know” with its obligations to protect “commercially sensitive information.”25
Industry influence also colored a report from another group that weighed in to support glyphosate. This group of eighteen scientists, officially known as the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), made their analysis as part of a program administered by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). They were generally considered to be experts in their fields and independent of industry influence. But the group that was called to meet in Geneva, Switzerland, in May 2016 to review IARC’s work on glyphosate did not exactly meet the latter standard. The JMPR group included several scientists who were members of, or who worked for, the chemical industry. There was little surprise when the JMPR scientists declared that, like EFSA’s, their review determined that glyphosate was probably not carcinogenic to humans. But there was plenty of condemnation. “There is a clear conflict of interest here if the review of the safety of glyphosate is carried out by scientists that directly get money from industry,” said Vito Buonsante, an attorney with the nonprofit environmental law group ClientEarth.26
The complaints about the chemical and the secretive studies behind the regulatory approval were so unrelenting in early 2016 that the European Commission, which was planning a vote on glyphosate’s reauthorization for March, found itself facing what The Guardian newspaper dubbed a “mutiny.”27 The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) was among those leading the revolt, issuing a report in February that contradicted EFSA, saying that its own assessment of the research showed glyphosate could “arguably” be classified as “suspected of being carcinogenic to humans.”28 ANSES said there were serious concerns not just about glyphosate but also about the other chemicals, the co-formulants, used along with it in herbicide products. The French agency said it was launching a new review of glyphosate and polyethoxylated tallow amine (POEA) combinations, and it called on the European Chemicals Agency (ECHA) in Helsinki, Finland, to step in to review the research on glyphosate. Government representatives from the Netherlands also called for any relicensing to be put on hold until completion of ECHA’s evaluation. Italy and Sweden joined forces with France and the Netherlands in a show of opposition that was sufficient to convince the European Commission to postpone the March vote until May. But opposition only grew stronger, and that vote was again postponed when Germany said it would abstain from voting because of a divide within its ruling coalition. The dissent left the European Commission without a majority needed to either relicense or ban the chemical.
By the end of June, just days before the authorization for glyphosate was to expire, the European Commission said it would postpone any decision on glyphosate for at least a year, granting an eighteen-month extension for glyphosate products while authorities awaited the results of the new evaluation. During the extension, glyphosate use should be minimized on playgrounds and in parks, the EU member states decided.
Amid the uproar, the Germany-based chemical conglomerate Bayer AG made a takeover bid for Monsanto, an overture that eventually would lead to a $66 billion proposed deal, which is still pending as of this writing. And angry Europeans organized a citizens’ initiative seeking a ban on glyphosate.
By early 2017, European uncertainty regarding glyphosate safety had only grown deeper. ECHA announced in March that after reviewing “extensive scientific data,” it had concluded glyphosate should not be classified as a carcinogen, and it said it took into consideration both published studies and the original reports of studies conducted by industry.29
That failed to reassure many MEPs, however, and in April 2017 thirty of them penned a letter to the president of the European Commission, Jean-Claude Juncker, questioning the trustworthiness of the data relied on by regulators to vouch for glyphosate safety. They cited the internal Monsanto documents revealed through the U.S. cancer lawsuits as cause for alarm. The group was particularly upset about Monsanto communications that discussed ghostwriting research and the fact that at least one study that regulators trusted appeared to have been authored by a scientist who Monsanto had recruited and paid specifically to attach added credibility to the work.
The MEPs also pointed to internal company documents that surfaced in the court case showing the company wrestling with how to handle genotoxicity concerns about glyphosate and Roundup. The corporate records showed that in the late 1990s the company was very worried about scientific research indicating that Roundup was genotoxic, including a mouse study by Italian scientists published in 1997 that saw DNA damage in the livers and kidneys of animals treated with the weed killer. “Despite the many positive aspects of glyphosate use, there are some data that indicate its technical formulation, Roundup, is a potential toxic agent. The formulated commercial product, Roundup, seems to be rather more toxic than the parent compound,” the scientists concluded.30
To try to beat back growing concerns about its herbicide, in 1999 Monsanto brought in a genotoxicity expert named James Parry—an authority in the field of mutagenicity in the United Kingdom—to lend his opinion. After reviewing both published studies on glyphosate and Monsanto’s unpublished in-house studies, Parry did not deliver the resoundingly positive findings Monsanto had hoped for. Instead, he concluded that glyphosate showed at least some potential to be genotoxic, damaging to human health. Parry recommended that Monsanto undertake additional tests. But rather than follow Parry’s advice, Monsanto executives declared they would not do such studies and discussed finding another expert to dig them out of a “genotoxic hole.” Executives questioned whether Parry had “ever worked with industry before.”31
In one internal e-mail, Monsanto scientist William Heydens wrote:
We want to find/develop someone who is comfortable with the genetox profile of glyphosate/Roundup and who can be influential with regulators and Scientific Outreach operations when genetox issues arise. My read is that Parry is not currently such a person, and it would take quite some time and $$$/studies to get him there.
Even if we think we can eventually bring Parry around closer to where we need him, we should be currently looking for a second/back-up genetox supporter. We have not made much progress and are currently very vulnerable in this area. We have time to fix that, but only if we make this a high priority now.32
As well, the documents revealed that for many years Monsanto employed a Belgian toxicology expert named Mark Martens to advise the Belgian government and the EU on pesticide registratio
n issues and provide a “toxicology defence of Monsanto products in the EU.” Monsanto would later recognize Martens for working to “protect Monsanto’s bottom line” and for the development of “data to gain key EU scientific support that the reported genotoxicity of Roundup herbicide was due to secondary consequences unrelated to glyphosate, thereby preventing adverse effect on Roundup business.”33
The revelations in the e-mails worried the MEPs enough that they urged Juncker to “fully investigate whether Monsanto has deliberately falsified studies on the safety of glyphosate” and to set up a “black list of the companies which use lies as a common policy.” The MEPs also asked for a ban on undisclosed contacts between European Commission officials and any Monsanto lobbyists.34 Juncker dismissed the MEPs’ concerns and said there was no reason to question the regulatory assessments of safety. As of this writing, the European Commission was proposing to reauthorize glyphosate for ten years, even as critics argued that doubts about the chemical’s safety should not be ignored.
In Italy, a country known for its wine and pasta, the battle over glyphosate, or glifosato, as the Italians call the chemical, is as passionate as it is political. Farmers such as Rolando Manfredini, who raises fodder for cattle and sheep in the mountainous Modena Apennines region, have seen worries about the herbicide steadily rising across Italy for years. Vineyard operators, fruit and vegetable growers, cereal grain producers, and ranchers have started casting a more wary eye on the weed killer. In a country renowned for both natural beauty and fresh, wholesome foods, growers fear that glyphosate residues are a shadow over both human health and the vitality of the soil and water.
“Farmers are very worried about the safety of this chemical,” said Manfredini, who oversees food safety issues for Coldiretti, the country’s main farmers’ organization. Coldiretti, founded in 1944, counts among its members more than 1.5 million farmers and a number of Italian companies engaged in agriculture. “Italy has leadership in terms of food safety. Italian farmers are very concerned about its residues, for their health but also for consumers and the environment.”35