Serious scrutiny needed as EPA seeks input on cancer ties to Monsanto herbicide

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By Carey Gillam

The glyphosate geeks are gathering in Washington this week. After a two-month delay, the Environmental Protection Agency (EPA) is holding four days of meetings aimed at examining the evidence that does or does not tie the world’s most widely used herbicide — glyphosate — to cancer.

Scientists, activists and agricultural industry leaders are all expected to show up to either defend or attack the chemical that is currently at the center of international controversy. More than 250,000 public comments have been filed with the EPA ahead of the Dec. 13-16 meetings, and the agency is girding for more than 10 hours of personally delivered public comments before a specially appointed scientific advisory panel gets down to work.

The panel assignment: To offer advice on how the EPA should evaluate and interpret relevant data and how it all should translate into a EPA “carcinogen risk” classification for glyphosate.

The exercise is academic by design, but powerful economic forces are hard at work hoping to influence the outcome. Glyphosate is the billion-dollar-baby, the chief ingredient in Monsanto Co.’s branded Roundup herbicide as well as in hundreds of other herbicides sold around the world. It’s also the lynchpin to Monsanto’s top-selling, glyphosate-tolerant, genetically engineered crops.

An official regulatory nod to cancer concerns could be devastating to Monsanto’s bottom line, not to mention it’s planned $66 billion merger with Bayer AG, as well as to other agrichemical companies that sell glyphosate products. Monsanto is also facing more than three dozen lawsuits over glyphosate cancer concerns and needs EPA backing to defend against the court actions.

The questions about glyphosate and health issues are not new. Numerous scientific studies over multiple decades have raised concerns about harmful glyphosate impacts. Monsanto has always countered with its own studies and league of supportive scientists who say glyphosate is not carcinogenic and is one of the safest pesticides ever brought to market.

Last year the argument got more heated after a team of international cancer scientists working with the World Health Organization (WHO) said that there was sufficient evidence in the body of research to classify glyphosate as a probable human carcinogen. That news was particularly worrisome to consumers because glyphosate use is so pervasive that government researchers have documented the chemical as “widespread in the environment,”  found even in common foods like honey and oatmeal. It’s even found in urine samples of farmers and city dwellers alike.

The controversy has delayed re-authorization decisions not only in the United States, but also in Europe. Several European countries, including Italy and France, have called for an outright ban on glyphosate after glyphosate residues have been found in numerous foods there. Residues found in bread products prompted a “Not in Our Bread” campaign in Britain.

Numerous scientific studies over multiple decades have raised concerns about harmful glyphosate impacts.

But despite the consumer angst on both sides of the Atlantic, the EPA has already made it clear it largely agrees with Monsanto’s message that the international cancer scientists are wrong. The agency issued a report in September laying out the reasons it proposes to classify glyphosate as “not likely to be carcinogenic to humans.”

To get to that finding, the agency had to inappropriately discount the results of numerous human and animal studies showing evidence of ties to cancer, according to many scientists who are asking the EPA to reconsider its position.

“There are strong arguments for a classification of “Likely to be carcinogenic to humans” because there are multiple positive results in animals…  and positive epidemiologic studies strengthened by other lines of evidence (DNA and chromosomal damage in human cells and possibly exposed humans),” Maarten Bosland, professor of pathology at the University of Illinois at Chicago, wrote in comments submitted to the agency.

Bosland is one of more than 90 scientists who issued a detailed report identifying the research that ties glyphosate to cancer. They say available human evidence shows an association between glyphosate and non-Hodgkin lymphoma; while significant carcinogenic effects are seen in laboratory animals for rare kidney and other types of tumors.

History has given us numerous examples of chemicals that are declared safe for decades only to be proven dangerous after extended arguments like the one we’re now seeing over glyphosate. It’s been common practice for the corporate players who profit off chemical agents to fight tooth and nail for their continued use even as study after study builds a case of sometimes devastating environmental and human health costs. And it’s been equally common for weak-kneed regulators to do as industry bids.

That appears to be the path EPA has followed with glyphosate. Ever since the agency announced last July that it would hold these meetings, the agrichemical industry’s trade group CropLife America has been working to make sure that the EPA repudiates the cancer concerns. CropLife first suggested the EPA scrap the meetings altogether, arguing there was no “scientific justification” for a review. The association then outlined criteria for the EPA to use in selecting scientists who might serve on the panel. And then after the panel was in place, CropLife told the EPA it should remove epidemiologist Dr. Peter Infante. CropLife considered him biased against the industry. The EPA responded by removing Infante as CropLife asked, and then refusing to explain its decision to the public, issuing a ‘no comment” to those who inquired about Infante’s removal.

Infante, who has served as an expert consultant in epidemiology for the EPA and several world bodies, says allegations of bias are invalid, and he still plans to attend but in a different capacity. After the EPA kicked him off the advisory panel, the agency agreed to grant him a few minutes to address the panel during the public comment part of the agenda. He is slated to speak Thursday morning.

In another hint at industry favoritism, earlier this year, the EPA “inadvertently” publicly posted an internal glyphosate assessment on its website that made a case for the safety of glyphosate. The document was up long enough for Monsanto to issue a press release gleefully tout the documents’ findings and providing a link to a copy of the document before the agency pulled it down, explaining it wasn’t final.

The agency’s actions have left environmental and consumer activists disheartened and doubtful the EPA will listen to any serious independent scrutiny of glyphosate’s safety.

“Their track record is awful,” said Patty Lovera, assistant director of the advocacy group Food & Water Watch. “We don’t want to throw in the towel entirely. We want to try to hold them to their mission. But there is clearly evidence of industry influence. They aren’t doing anything to inspire confidence that they’re taking a serious look at this.”

Consumers rely on the EPA to prioritize their interests over corporate interests, and the EPA should not forget that, according to the public comment filed by Pamela Koch, executive director of the Laurie M. Tisch Center for Food, Education & Policy at Teachers College, Columbia University.

“We urge the EPA to apply the precautionary principle in this review…” Koch wrote. “We believe that caring for the public health is of the upmost importance and need regulations that protect farm workers, workers who apply glyphosate in non-agricultural settings, as well as the general public.”

This article originally appeared in The Hill

Carey Gillam is a veteran journalist, formerly with Reuters, who directs research for U.S. Right to Know, a nonprofit consumer education group focused on food safety and policy matters. Follow @CareyGillam on Twitter 

EPA Bows to Chemical Industry in Delay of Glyphosate Cancer Review

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By Carey Gillam

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This might have been a tough week for Monsanto Co. The Environmental Protection Agency was slated to hold four days of public meetings focused on essentially one question: Is glyphosate, the world’s most widely used herbicide and the lynchpin to Monsanto’s fortunes, as safe as Monsanto has spent 40 years telling us it is?

But oddly, the EPA Scientific Advisory Panel (SAP) meetings, called to look at potential glyphosate ties to cancer, were “postponed“ just four days before they were to begin Oct. 18, after intense lobbying by the agrichemical industry. The industry first fought to keep the meetings from being held at all, and argued that if they were held, several leading international experts should be excluded from participating, including “any person who has publicly expressed an opinion regarding the carcinogenicity of glyphosate.”

As the meetings drew near, CropLife America, which represents the interests of Monsanto and other agribusinesses, specifically took issue with at least two scientists chosen for the panel, alleging the experts might be unfavorably biased against industry interests. On Oct. 12, the group sent a letter to the EPA calling for Dr. Kenneth Portier of the American Cancer Society to be more deeply scrutinized for any “pre-formed conclusions” about glyphosate.

More notably, CropLife called for leading epidemiologist Dr. Peter Infante to be completely disqualified from panel participation: “EPA should replace Dr. Infante with an epidemiologist without such patent bias,” CropLife told EPA. The chemical industry group said Infante was unlikely to give industry-sponsored research studies the credibility the industry believes they deserve. CropLife said Infante has testified in the past for plaintiffs in chemical exposure cases against Monsanto. Croplife also argued that because Infante was the “only epidemiologist on the glyphosate SAP” he would have enhanced influence in the evaluation of epidemiological data about glyphosate and cancer.

The CropLife letter was dated last Wednesday, and by Friday the EPA announced it was looking for additional epidemiology expertise to ensure “robust representation from that discipline.” EPA also said one panelist had voluntarily departed, though the agency refused to say who that panelist was.

Challenging Infante’s role is a gutsy move. After all, Infante spent 24 years working for the Occupational Safety and Health Administration helping determine cancer risks to workers during the development of standards toxic substances, including asbestos, arsenic, and formaldehyde. His resume includes a stint at the National Institute for Occupational Safety and Health where he conducted epidemiological studies related to carcinogens, and he has served as an expert consultant in epidemiology for several world bodies, including the EPA and the World Trade Organization.

According to sources close to the situation, Infante remains a panelist as of this week, but there is no certainty when the meetings might be rescheduled, and what the panel membership might look like when they are rescheduled. The EPA has refused to discuss who remains on the panel and who does not at this point, and some onlookers said the EPA was clearly bowing to agrichemical industry interests.

“This is outrageous. The industry wants to say that our own government scientists, the top ones in their fields, aren’t good enough for these panels.”

“This is outrageous. The industry wants to say that our own government scientists, the top ones in their fields, aren’t good enough for these panels,” said Michael Hansen, senior staff scientist at the Consumers Union. “If the EPA wants to add extra epidemiologists that is great but why didn’t they do it before? They are doing this because of pressure from industry.”

The industry clearly has much at stake, as does the public. Glyphosate is the key ingredient in Monsanto’s branded Roundup herbicides as well as herbicides marketed by numerous agrichemical companies around the world. It is also the key to what has been 20 years of sales of genetically engineered glyphosate-tolerant crops developed by Monsanto. The future sales of both the chemical and the crops are being jeopardized by the mounting concerns that glyphosate can cause cancer and other illnesses or disease. Scientists around the world have been raising red flags for years over worrisome research findings, and last year the International Agency for Research on Cancer (IARC), said glyphosate was a probable human carcinogen. More than three dozen lawsuits have been filed against Monsanto by people claiming Roundup gave them non-Hodgkin lymphoma, and both European and U.S. regulators are evaluating the chemical for continued use.

Since the IARC classification, Monsanto has asked the EPA to back industry assurances that glyphosate is safe, and so far, the EPA has done exactly that, issuing a series of reports and memos that dovetail with Monsanto’s position. Monsanto also has sought to bolster arguments for glyphosate’s safety by pointing to supportive research papers published in late September in Critical Reviews in Toxicology. Monsanto hired the group that arranged for the panel, and most of the 16 scientists involved are former Monsanto employees or Monsanto consultants. At least one, Gary Williams, has also consulted for Monsanto on litigation matters involving glyphosate. Despite all those affiliations, the research is touted as “independent.”

It seems more than a little hypocritical that those scientists are presented as credible by the industry, but scientists like Infante and Portier are said to be unfit to advise EPA because of suspected bias. Like Infante, Portier has a long track record as an independent scientist. He is vice president of the Statistics & Evaluation Center at the American Cancer Society. He has participated in over 60 other SAP meetings and has served on expert and advisory panels for the National Institutes of Health, National Institute of Environmental Health Sciences, the National Toxicology Program, and the World Health Organization Food and Agriculture Organization.

Portier also would not comment about the industry concerns about him, the postponement or changes to the makeup of the SAP, other than to say that as of today, he remains on the panel.

EPA said it is “working to reschedule as soon as possible.” But the delay and the maneuvering by industry to influence panel participation does little bolster consumer confidence in an objective outcome.

This article was originally published in Huffington Post.