Industry Attacks IARC Scientists for Labelling Glyphosate a Probable Human Carcinogen



Dear Friends and Colleagues

Industry Attacks IARC Scientists for Labelling Glyphosate a Probable Human Carcinogen

Monsanto and CropLife America are driving efforts to cut off U.S. funding for the World Health Organization’s International Agency for Research on Cancer (IARC) after IARC scientists declared glyphosate (the chief ingredient in Monsanto’s best-selling Roundup herbicide brand and used widely in conjunction with GM herbicide-resistant crops) a probable human carcinogen in March 2015 (Item 1). The industry is demanding that the U.S. Environmental Protection Agency (EPA) fully repudiate the IARC classification and green-light the continued use of glyphosate herbicides.

The IARC issued a statement saying some members of the glyphosate-review working group of international scientists felt “intimidated” by the industry’s actions. Nevertheless, the working group defends its evaluation, saying that it "made the right decision based on the evidence” and that "the team’s work was solid and the industry attacks on the team’s credibility are unwarranted". Overall, the IARC concluded that there was “convincing evidence” that glyphosate can cause cancer in laboratory animals, and that there was more than enough evidence for the caveat “probably” carcinogenic for humans.

It is critical that independent research and international scientific findings should take precedence over the protection of a multi-billion-dollar agent like glyphosate. Meanwhile, the EPA’s re-evaluation of glyphosate as part of a re-registration review process will be completed in 2017.

As part of that process, meetings were held last week, bringing together scientists with expertise in epidemiology, toxicology and related expertise to advise the EPA on whether or not the agency has properly determined that the weight of evidence indicates glyphosate is “not likely to be carcinogenic” to humans, which runs counter to the IARC conclusions (Item 2). Concerns were raised by some of the experts about the quality of the EPA’s analysis.

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Item 1


Carey Gillam
31 October 2016

Don’t mess with Monsanto Co. That is the message being delivered right now by the agrichemical industry as it makes a full-fledged assault on the team of international 
cancer scientists who dared to declare cancerous connections to the widely used herbicide called glyphosate, the chief ingredient in Monsanto’s Roundup brand.

Industry swagger is on full display in Washington where Monsanto and its friends at CropLife America are driving efforts to cut off U.S. funding for the World Health Organization’s International Agency for Research on Cancer (IARC) after IARC scientists declared glyphosate a probable human carcinogen in March 2015. The industry is also demanding that the Environmental Protection Agency fully repudiate the IARC classification and green-light continued use of glyphosate herbicides, which spell billions of dollars in sales annually to Monsanto and the agrichemical brethren.

The EPA has been evaluating glyphosate as part of a re-registration review process for more than five years, and was initially expected to complete that review last year. The EPA then said it would complete the review by the end of 2016, and now says it will be 2017 before it offers a final report. The work has been drawn out as the EPA wrestles with the IARC classification, which has both legal and economic implications for the agrichemical industry. The EPA had planned to hold four days of public meetings – over industry objections– to examine scientific research on glyphosate. But the industry, which deemed the meetings “unnecessary” and “inappropriate,” successfully derailed those Oct. 18-21 public meetings by challenging certain scientists appointed by EPA to an advisory panel. The EPA has “postponed” the meetings and has yet to reschedule.

Now, industry ally U.S. Rep. Lamar Smith is taking EPA officials to task for engaging with IARC on glyphosate concerns, demanding that EPA instead rely on the “sound science” that the industry promotes. Smith, Chairman of the House Committee on Science, Space and Technology, accuses IARC of playing an “activist role” and EPA officials, of aiding that effort. In an Oct. 25 letter to EPA Administrator Gina McCarthy, Smith complained of “constant delays” by EPA in completing the re-registration of glyphosate, and demanded that EPA officials appear before his committee to explain themselves. Monsanto, which is fending off lawsuits by people who claim Roundup gave them cancer, has also been demanding IARC members turn over documents related to their work. The company has labeled the IARC findings as “junk science,” and claims the IARC members are part of an “unelected, undemocratic, foreign body.”

It’s all a bit overwhelming for the members of the IARC working group, who are not accustomed to assaults on their expertise. After all, these scientists that assembled for the glyphosate review were among the elite, routinely seen as independent experts, pulled from top institutions around the world. Frank Le Curieux, senior scientific officer at the European Chemicals Agency in Helsinki, Finland, and an expert in toxicology, was part of the team. So was French scientist Isabelle Baldi, who holds a Ph.D in epidemiology with a research specialty in environmental toxicology, and works as assistant professor in occupational epidemiology and public health at Bordeaux University. Experts also came from Australia, New Zealand, Canada, The Netherlands, and Nicaragua. Several came from the United States, including Matthew Martin, a biologist with the EPA’s National Center for Computational Toxicology who received awards for his work with toxicity data.Aaron Blair, a scientist emeritus at the National Cancer Institute, served as chairman of the IARC team. Blair has specialty knowledge in research that focused on evaluating cancer and other disease risks associated with agricultural exposures, as well as chemicals in the workplace and the general environment. He has received numerous awards over his career and has served on many national and international scientific review groups, including for the EPA. He has also authored more than 450 publications on occupational and environmental causes of cancer.

The fact that Monsanto and the agrichemical industry are coming after them has left them stunned. IARC issued a statement last week saying some also felt “intimidated” by the industry actions.

“We were not expecting this strong reaction and what happened,” said Francesco Forastiere, head of occupational epidemiology at the Lazio Regional Health Service in Italy who participated in glyphosate working group for IARC. “We were doing our job. We understood there were other issues… economic consequences. But none of us had a political agenda. We simply acted as scientists, evaluating the body of evidence, according to the IARC criteria.”

Another working group member, Australian epidemiologist Lin Fritschi, who has been part of other IARC classifications, said the team’s work was solid and the industry attacks on the team’s credibility are unwarranted.

“I definitely wasn’t expecting anything at all,” said Fritschi, who specializes in the occupational causes of cancer and holds the “distinguished professor” title at Curtin University in Australia. “We were independent and just looked at the science. We had strict rules on what was admissible and came to a conclusion based on that evidence. We made the right decision based on the evidence.”

The team was not charged with doing new research, but rather with reviewing research already conducted, trying to determine how the various findings added up. The members analyzed older research as well as more recent studies, weighed the methods used, the consistency of results and the levels of adherence to research standards. There were numerous animal studies to pore over, but fewer looking at glyphosate connections to health problems in humans. The evidence with respect to cancer in humans came from studies of exposures, mostly in agricultural settings. The group determined that the best research showed a distinct association between non-Hodgkin lymphoma (NHL) and glyphosate. The team also noted that there were ties linking glyphosate to multiple myeloma, but the evidence for that disease was not as strong as the evidence tying glyphosate to NHL, the group determined.

The team also evaluated several studies that showed animals developed rare kidney tumors and other health problems after exposure. Those studies combined to provide “sufficient evidence” of glyphosate’s carcinogenicity in laboratory animals, the IARC team found. On top of that, the IARC team concluded that there was strong evidence of genotoxicity and oxidative stress from glyphosate, including findings of DNA damage in the peripheral blood of exposed humans. The team also said it was noteworthy that in one study, people showed chromosomal damage after glyphosate formulations were sprayed nearby.

Overall, IARC concluded that there was “limited evidence” that glyphosate can cause non-Hodgkin lymphoma and “convincing evidence” that glyphosate can cause cancer in laboratory animals. The conclusion would have been for “sufficient” evidence of cancer problems for humans, but for one large U.S. study run by the federal government that did not show connections between cancer and glyphosate, Forastiere said.

The team ultimately decided the weight of the evidence was not strong enough to say glyphosate was definitively carcinogenic, but there was more than enough evidence for the caveat “probably” carcinogenic.

Blair, Forastiere and the others said after the fact that they felt quite comfortable with the work of the IARC team and proud of the thoroughness of what was a complicated undertaking. 
“We should all minimize our use as much as possible,” said Fritschi, “The people most at risk are people who use glyphosate a lot, such as farmers and gardeners, and they are the ones who should try and reduce their use,” she said.

Monsanto and other industry players can’t afford for that kind of talk to take root; which is exactly why we’re seeing these extraordinary efforts to undermine the scientists and push EPA to ignore cancer concerns. One letter in particularsubmitted by CropLife America to EPA this month shows the depths of the industry’s efforts to rein in EPA’s probe of glyphosate. CropLife told the EPA it was out of line for proclaiming a need for independent research on formulated glyphosate products – such as Roundup. The agency said in September it has been collaborating with the National Toxicology Program of the National Institute of Environmental Health Sciences to develop a research plan to evaluate the role of glyphosate in product formulations and the differences in formulation toxicity. But apparently, it neglected to get industry permission.

“We also question why EPA would collaborate and develop a research program with the National Toxicology Program without input from the registrant,” CropLife wrote. “Should data be required to address specific questions relevant to the registration or reregistration of a product, the registrant would be the appropriate source of those data.”

The industry message to EPA is loud and clear: Independent research and international scientific findings should not take precedence over protection of a multi-billion-dollar agent like glyphosate. The public can only watch, wait, and hope that the EPA doesn’t listen.

Item 2


Carey Gillam
12 December 2016

In terms of entertainment value, the Environmental Protection Agency had it all this week.

The agency held a four-day-long gatheringof scientists aimed at the rather dry task of analyzing numerous research studies connected to cancer concerns swirling around a chemical called glyphosate. Glyphosate is the world’s most widely used herbicide and is the key ingredient in Monsanto Co.’s Roundup brand. But along with the slicing and dicing of data came razor sharp debate, questions about chemical industry influence over regulators, and even a bit of theater as one group of environmental activists interrupted proceedings to break out in song. Their refrain? “Monsanto is the Devil. No Glyphosate.”

The meetings brought together a roster of scientistswith expertise in epidemiology, toxicology and related expertise to advise the EPA on whether or not the agency has properly determined that the weight of evidence indicates glyphosate is “not likely to be carcinogenic”to humans. The determination runs counter to the classification made in March 2015 by the International Agency for Research on Cancer (IARC), an arm of the World Health Organization. IARC said a review of scientific research shows that glyphosate is a “probable human carcinogen.”

The EPA’s determination is crucial on many fronts – Monsanto is currently defending itself against more thanthree dozen lawsuits claiming glyphosate-based Roundup gave people non-Hodgkin lymphoma (NHL), a type of blood cancer; both the EPA and the European Union are assessing re-registrations of glyphosate to determine if limits should be placed on the chemical; and Monsanto is attempting a $66 billion merger with German-based Bayer.

But while the EPA may have hoped for resounding support from the Scientific Advisory Panel (SAP) it assembled, from the outset of the meetings on Tuesday, concerns were raised by some of the experts about the quality of the EPA’s analysis. Some scientists were concerned that the EPA was violating its own guidelines in discounting data from various studies that show positive associations between glyphosate and cancer. Several of the SAP members questioned why the EPA excluded some data that showed statistical significance, and wrote off some of the positive findings to mere chance.

Monique Perron, a scientist in the Health Effects Division of EPA’s Office of Pesticide Programs, explained that “professional judgment” played a role in looking at the “weight of evidence” from various studies. The EPA looked at both published studies as well as unpublished studies conducted by industry players like Monsanto, according to Perron. The IARC review focused on published, peer-reviewed research.

The public comments portion of the agenda opened with an interesting twist as a representative from the Italy-based European Food Safety Authority and one from the German Federal Institute for Risk Assessment (BfR) took to the microphones to weigh in on their perceptions of glyphosate’s safety. Both said their own assessments were largely in line with the EPA view, that glyphosate is not a cause of cancer.

The BfR, which is part of the Federal Ministry of Food and Agriculture in Germany, advised EFSA and drafted the report that EFSA issued in November 2015 that declared glyphosate was “unlikely to be carcinogenic.” That report has been the subject of some controversy because the BfR relied on the advice of the Glyphosate Task Force, the consortium of chemical companies that includes Monsanto, when it did its evaluation.

The EPA did not invite either BfR or EFSA to travel to the United States to deliver the support for glyphosate safety, according to Steven Knott, the EPA official who oversaw the meeting logistics. The foreign scientists simply asked for the opportunity to appear, he said. Who invited them and/or arranged for their travel raised some eyebrows among onlookers.

Another element of the meetings that did more than raise a few eyebrows was the devotion of time given to industry presenters supportive of glyphosate versus representatives from non-profits or others who urged regulators to rein in use of glyphosate. Monsanto representatives were granted roughly 3-1/2 hours on Wednesday to make the case for glyphosate safety, and several other pro-glyphosate industry players were granted additional time as well. In comparison, most critics of glyphosate had comment periods that ranged from 5-15 minutes. Knott said speaking allotments were assigned based on how much time commentators asked for, but some glyphosate opponents said they were told they could not have more than a few minutes.

Monsanto used its time to present a defense of glyphosate’s value to agriculture, to offer detailed explanations for why the IARC analysis was flawed, and to explain why the company believes a host of data points found in various studies should be discounted, and/or are not relevant. Company representatives also argued that glyphosate residues found in numerous urine tests were nothing to worry about, and actually helped show that the chemical does not bio-accumulate in the human body. They also said reports of glyphosate residues found in human breast milk were “implausible.”

Groups concerned about glyphosate argued to the panel that the EPA was favoring industry studies over published literature, which is generally considered more authoritative, and was using flimsy protocols to shrug off statistical significance found in several studies.

Many of the participants from both sides of the debate spoke of a need for research on the safety of formulated products that have glyphosate as the active ingredient. The EPA evaluates only glyphosate and not the actual formulation in which it is applied, even though the formulations are increasingly being feared to be more potentially dangerous to human health than the active ingredient alone.

One particularly interesting story line that played out this week was the saga of Dr. Peter Infante, a nationally recognized epidemiologist who initially was invited and confirmed by EPA as one of the agency’s scientific advisory panel members for the glyphosate meetings. The meetings were slated for Oct. 18-21 but CropLife America, which represents the interests of Monsanto and other agribusinesses, sent a letter to the EPA on Oct. 12 calling for Infante to be completely disqualified, saying he had “patent bias.” Infante appeared to have impeccable credentials, having spent decades working for the Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health specializing in the determination of cancer risks associated with toxic substances. But CropLife insisted Infante be thrown off the panel. One of its reasons: Infante would give more weight to independent research than the industry’s own research.

The EPA did as the industry asked, but the ousting did not sit well with Infante, who had spent long hours studying the data EPA sent the panel members in advance. In part to defend his reputation, and also to offer his analysis, a somewhat disgruntled Infante showed up at the EPA meetings anyway, telling the SAP members there is “impressive evidence” of glyphosate ties to NHL that should not be ignored.

“There is clearly the evidence for the risk of non-Hodgkin lymphoma related to glyphosate exposure,” Infante said in an interview after he addressed the panel. “Is it conclusive? No, I don’t think so. But I think that EPA is concluding that there is no evidence. And that’s exactly wrong, according to their own criteria.” There is enough data to classify glyphosate as having “limited” evidence of carcinogenicity in humans,” Infante said.

By the time the singing broke out, the room seemed ready for the distraction. TheRev. Billy Talen, who leads a group of self-proclaimed “earth-loving urban activists” that frequently use performance as protest, took his turn at the microphone. Talen told the SAP members of his group’s concern about glyphosate applications made on playgrounds around the country and the danger this could pose to children.

“We’re very aware of the cancers that come from, we believe, from glyphosates,” he told the group.

Shortly after, Talen was warned his five minutes were up, and he and a small number of his followers started singing: “Monsanto is the devil. No glyphosate. Hey.”

Never a dull moment in this debate.

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