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 

New Data on Pesticides in Food Raises Safety Questions

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As Americans gather their families to share a Thanksgiving meal this week, new government data offers a potentially unappetizing assessment of the U.S. food supply: Residues of many types of insecticides, fungicides and weed killing chemicals have been found in roughly 85 percent of thousands of foods tested.

Data released last week by the U.S. Department of Agriculture shows varying levels of pesticide residues in everything from mushrooms to potatoes and grapes to green beans. One sample of strawberries contained residues of 20 pesticides, according to the “Pesticide Data Program” (PDP) report issued this month by the USDA’s Agricultural Marketing Service. The report is the 25th annual such compilation of residue data for the agency, and covered sampling the USDA did in 2015

Notably, the agency said only 15 percent of the 10,187 samples tested were free from any detectable pesticide residues. That’s a marked difference from 2014, when the USDA found that over 41 percent of samples were “clean” or showed no detectable pesticide residues. Prior years also showed roughly 40-50 percent of samples as free of detectable residues, according to USDA data. The USDA said it is not “statistically valid” to compare one year to others, however, because the mix of food sampled changes each year. Still the data shows that 2015 was similar to the years prior in that fresh and processed fruits and vegetables made up the bulk of the foods tested.

Though it might sound distasteful, the pesticide residues are nothing for people to worry about, according to the USDA. The agency said “residues found in agricultural products sampled are at levels that do not pose risk to consumers’ health and are safe…”

But some scientists say there is little to no data to back up that claim. Regulators do not have sufficient comprehensive research regarding how regular, repeated consumption of residues of multiple types of pesticides impact human health over the long term, and government assurances of safety are simply false, say some scientists.

“We don’t know if you eat an apple that has multiple residues every day what will be the consequences 20 years down the road,” said Chensheng Lu, associate professor of environmental exposure biology at the Harvard School of Public Health. “They want to assure everybody that this is safe but the science is quite inadequate. This is a big issue.”

The USDA said in its latest report that 441 of the samples it found were considered worrisome as “presumptive tolerance violations,” because the residues found either exceeded what is set as safe by the Environmental Protection Agency (EPA) or they were found in foods that are not expected to contain the pesticide residues at all and for which there is no legal tolerance level. Those samples contained residues of 496 different pesticides, the USDA said.

Spinach, strawberries, grapes, green beans, tomatoes, cucumbers and watermelon were among the foods found with illegal pesticide residue levels. Even residues of chemicals long banned in the United States were found, including residues of DDT or its metabolites found in spinach and potatoes. DDT was banned in 1972 because of health and environmental concerns about the insecticide.

Absent from the USDA data was any information on glyphosate residues, even though glyphosate has long been the most widely used herbicide in the world and is commonly sprayed directly on many crops, including corn, soy, wheat, and oats. It is the key ingredient in Monsanto Co.’s branded Roundup herbicide, and was declared a probable human carcinogen last year by a team of international cancer scientists working with the World Health Organization. But Monsanto has said glyphosate residues on food are safe. The company asked the EPA to raise tolerance levels for glyphosate on several foods in 2013 and the EPA did so.

The Food and Drug Administration also annually samples foods for residues of pesticides. New documents obtained from the FDA show illegal levels of two types of insecticides – propargite, used to kill mites, and flonicamid, usually aimed at killing aphids and whiteflies – were recently found in honey. Government documents also show that DEET, a common insect repellant, was recently detected by regulators in honey, and the herbicide acetochlor was found on mushrooms.

FDA scientists also reported illegally high levels of the neonicotinoid thiamethoxam found in rice, according to information from the agency. Syngenta has asked the Environmental Protection Agency to allow for higher residues of thiamethoxam permitted in numerous crops because the company wants it to have expanded use as a leaf spray. That request with EPA is still pending, according to an agency spokeswoman.

The most recent public residue report issued by the FDA shows that violation rates for pesticide residues have been climbing in recent years. Residue violations in domestic food samples totaled 2.8 percent for the year 2013; double the rate seen in 2009. Violations totaled 12.6 percent for imported foods in 2013, up from 4 percent in 2009.

Like the USDA, the FDA has skipped glyphosate in decades of testing for pesticide residues. But the agency did launch a “special assignment” this year to determine what levels of glyphosate might be showing up in a small group of foods. An FDA chemist reported finding glyphosate residues in honey and several oatmeal products, including baby food.

Private testing data released this month also reported the presence of glyphosate residues in Cheerios cereal, Oreo cookies and a variety of other popular packaged foods.

QUESTIONS ON CUMULATIVE IMPACTS

Whether or not consumers should worry about food containing pesticide residues is a matter of ongoing dispute. The trio of federal agencies involved in pesticide residue issues all point to what they refer to as “maximum residue limits” (MRLs), or “tolerances,” as benchmarks for safety. The EPA uses data supplied by the agrichemical industry to help determine where MRLs should be set for each pesticide and each crop the pesticides are expected to be used with.

As long as most of foods sampled show pesticide residues in food below the MRLs, there is no reason to worry, the USDA maintains. “The reporting of residues present at levels below the established tolerance serves to ensure and verify the safety of the Nation’s food supply,” the 2015 residue report states. The agrichemical industry offers even broader assurances, saying there is nothing to fear from consuming residues of the chemicals it sells farmers for use in food production, even if they exceed legal tolerances.

But many scientists say the tolerances are designed to protect the pesticide users more than consumers. Tolerances vary widely depending upon the pesticide and the crop. The tolerance for the insecticide chlorpyrifos on an apple, for instance, is very different than the amount of chlorpyrifos allowed on citrus fruits, or on a banana or in milk, according to government tolerance data.

In the case of chlorpyrifos, the EPA has actually said it wants to revoke all food tolerances because studies have linked the chemical to brain damage in children. Though the agency has long considered residues of chlorpyrifos safe, now the agency says, they may not be.

The “EPA cannot, at this time, determine that aggregate exposure to residues of chlorpyrifos, including all anticipated dietary exposures and all other non-occupational exposures for which there is reliable information, are safe,” the EPA said last year. Dow AgroSciences, which developed chlorpyrifos in the 1960s, is protesting the EPA efforts, arguing chlorpyrifos is a “critical tool” for farmers. In the latest USDA residue report, chlorpyrifos was found in peaches, apples, spinach, strawberries, nectarines and other foods, though not at levels considered to violate tolerances.

The EPA defends its work with tolerances, and says it has been complying with the Food Quality Protection Act that requires the EPA to consider the cumulative effects of residues of substances “that have a common mechanism of toxicity.” The agency says to set a tolerance for a pesticide, it looks at studies submitted by pesticide companies to identify possible harmful effects the chemical could have on humans, the amount of the chemical likely to remain in or on food and other possible exposures to the same chemical.

But critics say that is not good enough – assessments must consider more realistic scenarios that take into account the broader cumulative impacts of many different types of pesticide residues to determine how safe it is to consume the mixtures seen in a daily diet, they say. Given that several pesticides commonly used in food production have been linked to disease, declines in cognitive performance, developmental disorders, and attention-deficit/hyperactivity disorder in children, there is an urgent need for more in-depth analysis of these cumulative impacts, according to many scientists. They point to the National Research Council’s declaration years ago that “dietary intake represents the major source of pesticide exposure for infants and children, and the dietary exposure may account for the increased pesticide-related health risks in children compared with adults.”

“With the ubiquitous exposure to chemical mixtures, assurances of safety based on lists of individual toxicity thresholds can be quite misleading,” said Lorrin Pang, an endocrinologist with the Hawaii Department of Health and a former advisor to the World Health Organization.

Tracey Woodruff, a former EPA senior scientist and policy advisor who specializes in environmental pollutants and child health, said there is a clear need for more research. Woodruff directs the Program on Reproductive Health and the Environment at the University of California San Francisco School of Medicine.

“This is not a trivial matter,” she said. “The whole idea of looking at cumulative exposures is a hot topic with scientists. Evaluating individual tolerances as if they occur in solo is not an accurate reflection of what we know – people are exposed to multiple chemicals at the same time and the current approaches do not scientifically account for that.”

Critics say scrutiny of pesticide safety is likely to only soften given President-elect Donald Trump’s decision to name Myron Ebell to oversee transition efforts at the EPA. Ebell, director of the Center for Energy and Environment at the Competitive Enterprise Institute, is a staunch advocate of pesticides and their safety.

“Pesticide levels rarely, if ever, approach unsafe levels. Even when activists cry wolf because residues exceed federal limits that does not mean the products are not safe,” states the SAFEChemicalPolicy.org website Ebell’s group runs. “In fact, residues can be hundreds of times above regulatory limits and still be safe.”

The mixed messages make it hard for consumers to know what to believe about the safety of pesticide residues in food, said Therese Bonanni, a clinical dietitian at Jersey Shore University Medical Center.

“Although the cumulative effect of consuming these toxins over a lifetime is not yet known, short-term data suggests there is certainly a reason to be cautious,” she said. “The message to consumers becomes very confusing.”

(Article first appeared in The Huffington Post)

IARC Scientists Defend Glyphosate Cancer Link; Surprised by Industry Assault

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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 character.  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 is 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 particular submitted 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.

(Article first appeared in The Huffington Post)

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.

Upcoming EPA Meetings on Safety of Monsanto Weed Killer Drawing Scrutiny

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By Carey Gillam

Bayer better be paying attention to this.

The German company’s intended $66 billion acquisition of Monsanto Co. comes amid growing concern over the future of the company’s top-selling weed killer, a chemical called glyphosate that Monsanto introduced to the world 40 years ago as the active ingredient in its Roundup herbicide. Monsanto reaps billions of dollars annually, roughly a third of its sales, from those products.

So it’s no small matter that in mid-October the Environmental Protection Agency (EPA) plans to spend four days holding public meetings with a scientific advisory panel on the topic of whether or not glyphosate can cause cancer. The idea of shining a public spotlight on this mounting concern about the world’s most widely used herbicide has not set well with Monsanto and the rest of the industry that profits from glyphosate products like Roundup. Agrichemical interests have gone so far as to tell the EPA that the meetings should not be held at all, and have said that if they are, many of the world’s top scientists should be excluded from participating.

The industry clearly does not welcome the public scrutiny the meetings bring, but it should be satisfied that the EPA has made it clear it has no intention of contradicting Monsanto’s claims of glyphosate’s safety. After all, in a Sept. 12 report issued to the public, the EPA offered a 227-page evaluation of glyphosate’s cancer-causing potential that ended with a “proposed” conclusion that glyphosate was ‘“not likely to be carcinogenic to humans’ at doses relevant to human health risk assessment.” All of this before the meetings are held.

To its credit, the EPA did issue several caveats in that report, acknowledging that some research does link glyphosate to cancer, but offering various explanations as to why the agency doesn’t believe those study results are significant, and/or are outweighed by other studies. The agency also added a host of qualifiers, stating that with respect to epidemiological studies, the data is limited and outdated. Because there has been such an “increased use of glyphosate following the introduction of glyphosate-tolerant crops in 1996, there is a need for more recent studies since a large number of studies were conducted prior to 1996,” the EPA stated. The agency also said that research needs to be done on glyphosate formulations, not just glyphosate alone.

And the agency included a specific caveat with respect to research tying glyphosate to non-Hodgkin lymphoma (NHL), saying: “There are conflicting views on how to interpret the overall results for NHL. Some believe that the data are indicative of a potential association between glyphosate exposure and risk of NHL.” The agency added: “Due to study limitations and contradictory results across studies… a conclusion regarding the association between glyphosate exposure and risk of NHL cannot be determined based on the available data.”

There is obviously a lot at stake – Monsanto is currently being sued by dozens of people who say the company’s Roundup herbicide gave them or their family members NHL, and the company is fighting a court battle with the state of California over regulatory efforts to add glyphosate to a list of known or probable carcinogens. And there remains the matter of the EPA’s long overdue environmental and health risk assessment for glyphosate, in which the EPA could add restrictions to the use of glyphosate if the agency deems those are necessary. That risk assessment was due out in 2015. Then the agency said it would be released in 2016. Now the agency says it may be completed by spring of 2017.

With the Bayer acquisition, the lawsuits and the risk assessment looming, Monsanto has been pulling out all the stops to defend glyphosate. The pressure on the EPA to defend glyphosate began immediately after the World Health Organization’s International Agency for Research on Cancer (IARC) declared in March 2015 that research showed glyphosate was “probably” carcinogenic to humans. The IARC decision was announced on Friday, March 20, 2015 and by the following Monday morning, Monsanto’s Dan Jenkins, the company’s regulatory affairs leader, was already calling and emailing EPA officials demanding they “correct” the record on glyphosate. Emails obtained through Freedom of Information request show Jenkins submitted “talking points” to the EPA to try to contradict IARC. And since then Monsanto has only intensified its efforts to invalidate the findings of the IARC group, attacking the veteran scientists as an “unelected, undemocratic, unaccountable and foreign body.”

Monsanto has also subpoenaed emails and other records from the chairman of that IARC committee, Aaron Blair, a scientist emeritus at the National Cancer Institute, who served as chairman of the IARC team. Blair has a long career of accolades and appointments that acknowledge his expertise, and he has served on numerous national and international scientific review groups, including for the EPA. But Monsanto has deemed Blair’s work suspect.

And Monsanto’s apparently has done some arm-twisting in Congress. On Monday, the chairman of the House Committee on Oversight and Government Reform wrote to the National Institutes of Health, reciting many of the complaints Monsanto and its allies have made about IARC and challenging grants the NIH has made to IARC.

The EPA’s appearance of aligning with Monsanto angers many in the scientific community who say the EPA is straying from established scientific principles and ignoring key evidence so it can keep the corporate interests who profit from glyphosate herbicides happy.

“This chemical is a probable human carcinogen by any reasonable definition. It is nonsense to say otherwise,” said Christopher Portier, former director of the National Center for Environmental Health and Agency for Toxic Substances and Disease Registry at the U.S. Centers for Disease Control and Prevention (CDC). Prior to that role, Portier spent 32 years with the National Institute of Environmental Health Sciences (NIEHS), where he served as the NIEHS associate director, director of the Environmental Toxicology Program, and associate director of the National Toxicology Program. In retirement, Portier, who was an “invited specialist” to the IARC review on glyphosate, has done some part-time work for the Environmental Defense Fund.

Portier and more than 90 other international scientists have issued a detailed report laying out the specific research that ties glyphosate to cancer both in animal studies and in human observations. The scientists said the only way for regulators to discount the evidence is to bend well-established rules for scientific evaluations. They say available human evidence does show 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. There is also “strong evidence of genotoxicity and oxidative stress,” including findings of DNA damage in the peripheral blood of people exposed to glyphosate, the scientists said.

“The most appropriate and scientifically based evaluation of the cancers reported in humans and laboratory animals as well as supportive mechanistic data is that glyphosate is a probable human carcinogen,” the report states. “On the basis of this conclusion and in the absence of evidence to the contrary, it is reasonable to conclude that glyphosate formulations should also be considered likely human carcinogens.”

“The EPA is in a bad spot with this. The pushback really has come out of the industry based on things that are not scientifically sound,” said Maarten Bosland, one of the authors of the report on glyphosate research. Bosland is director of the Center for Global Health Outreach Department of Pathology at The University of Illinois at Chicago, and holds a Ph.D. in experimental pathology. “The amount of money that is involved in this compound is gigantic. It’s a worldwide conglomerate of financial interests that are affected by this.”

It seems more than coincidental that the EPA’s rationale for dismissing scientific studies that IARC said showed cancer links closely dovetails with the findings of a 16-member Monsanto-funded panel. That group of 16 scientists, all but four of whom had previously worked either as employees or consultants for Monsanto, issued a report in December that supported Monsanto’s contention that there is no real evidence that glyphosate can cause cancer. Leading the work was Gary M. Williams, director of environmental pathology and toxicology at New York Medical College, and a consultant to Monsanto. Williams has a history of publishing positive findings about glyphosate; he was an author of one of Monsanto’s most-touted studies, a 2000 research report that concluded glyphosate is not only not a carcinogen, but “is considered to be practically nontoxic.”

That panel is preparing to release five articles supporting glyphosate safety in the journal Critical Reviews of Toxicology soon, according to Intertek Scientific & Regulatory Consultancy, which was paid by Monsanto to arrange the panel.

In the EPA report, the one bright spot for critics of glyphosate is that the EPA does call for more testing. Specifically, the agency acknowledges the need to explore the fears that glyphosate formulations may be more toxic than glyphosate alone. The EPA is developing a “research plan” with the National Institute of Environmental Health Sciences to “evaluate the role of glyphosate in product formulations and the differences in formulation toxicity,” the EPA said.

Fresh answers can’t come soon enough for consumers who worry about persistent levels of glyphosate in the food they eat. The FDA this year found high levels of glyphosate in U.S. honey, some levels more than double what is considered safe in the European Union.

The meetings in Washington run Oct. 18-21, and are expected to draw a variety of attendees – lawyers, activists, farmers, environmentalists and corporate allies are all making their travel plans.

It should be interesting.

(Article first appeared in The Huffington Post)

What Is Going On With Glyphosate? EPA’s Odd Handling of Controversial Chemical

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By Carey Gillam

The Environmental Protection Agency’s ongoing risk assessment of the world’s most widely used herbicide is starting to generate more questions than answers. On Monday, it also generated a giant “oops” from the EPA.

On Friday, April 29, the EPA posted on its website a series of documents related to its long-awaited risk assessment for glyphosate, the active ingredient in Monsanto’s Roundup herbicide and other weed-killing products sold around the world. The risk assessment started in 2009 and was supposed to conclude in 2015. But questions about whether or not glyphosate may cause cancer are dogging the agency’s review, and have slowed the process.

On Monday, after the contents of the documents started to generate questions from media, EPA yanked those documents from its website:

An agency spokeswoman said this:

“Glyphosate documents were inadvertently posted to the Agency’s docket. These documents have now been taken down because our assessment is not final. EPA has not completed our cancer review. We will look at the work of other governments as well as work by HHS’s Agricultural Health Study as we move to make a decision on glyphosate. Our assessment will be peer reviewed and completed by end of 2016.”

The EPA said it was “working through some important science issues on glyphosate, including residues of the chemical in human breast milk;” an “in-depth human incidents and epidemiology evaluation;” and a preliminary analysis of glyphosate toxicity to milkweed, a critical resource for the monarch butterfly.

Inadvertent or not, one of those documents posted and then withdrawn was a doozy, a heavy hammer that seeks to knock down worries about glyphosate ties to cancer. The agency released an Oct. 1, 2015 internal EPA memorandum from its cancer assessment review committee (CARC) that contradicts the March 2015 finding by the World Health Organization’s International Agency for Research on Cancer (IARC) classifying glyphosate as a probable human carcinogen. EPA found instead that glyphosate is “Not Likely to be Carcinogenic to Humans.”

The memorandum stated that the classification was based on “weight-of-evidence considerations.”

CARC said this:

“The epidemiological evidence at this time does not support a causal relationship between glyphosate exposure and solid tumors. There is also no evidence to support a causal relationship between glyphosate exposure and the following non-solid tumors: leukemia, multiple myeloma, or Hodgkin lymphoma. The epidemiological evidence at this time is inconclusive for a causal or clear associative relationship between glyphosate and NHL. Multiple case-control studies and one prospective cohort study found no association; whereas, results from a small number of case-control studies (mostly in Sweden) did suggest an association.”

Monsanto touted and tweeted the release of the document, which follows the release by EPA of a different memorandum supporting the safety of glyphosate last June. The newest memo gives the company added evidence to defend itself against a mounting stack of lawsuits filed by agricultural workers and others alleging Monsanto’s glyphosate-based Roundup herbicide gave them cancer.

“This is the EPA’s highest ranking for product safety—they also do nice job of explaining all of IARC’s mistakes,” Monsanto Chief Technology Officer Robb Fraley said in a twitter posting.

Monsanto has been calling on EPA to defend glyphosate against the cancer claims since the IARC classification came out in March 2015. A March 23, 2015 EPA email string released as part of a Freedom of Information request details Monsanto’s efforts to get EPA to “correct” the record on glyphosate “as it relates to carcinogenicity.”

Another document newly released by EPA – which was also then withdrawn – illustrates just why EPA’s risk assessment about the safety of glyphosate matters so much. In a memorandum dated Oct. 22, 2015, EPA detailed how extensively glyphosate is being used on food items.

That memo updates estimates of glyphosate use on crops in top agricultural states, and provides annual average use estimates for the decade 2004-2013. Seventy crops are on the EPA list, ranging alphabetically from alfalfa and almonds to watermelons and wheat. Glyphosate used on soybean fields, on an annual basis, is pegged at 101.2 million pounds; with corn-related use at 63.5 million pounds. Both those crops are genetically engineered so they can be sprayed directly with glyphosate as farmers treat fields for weeds. Cotton and canola, also genetically engineered to be glyphosate tolerant, also have high use numbers. But notable glyphosate use is also seen with oranges (3.2 million lbs); sorghum (3 million lbs); almonds (2.1 million lbs); grapes, (1.5 million lbs); grapefruit and apples (400,000 lbs each); and a variety of fruits, vegetables and nuts.

Despite – or perhaps because of – the delays in issuing a final regulatory risk assessment on glyphosate, questions about the impact of the chemical on human health and the environment have been mounting. In addition to the lawsuits alleging glyphosate caused cancer in farm workers and others, private groups are scrambling to test a variety of food products for glyphosate residues.

On Friday a lawsuit with a new twist on glyphosate concerns was filed in U.S. District Court in San Francisco. That suit, which seeks class action status, alleges that glyphosate residues found in Quaker Oats invalidates claims by the Quaker Oats Co. that its product is wholly natural. “Glyphosate is a synthetic biocide and probable human carcinogen, with additional health dangers rapidly becoming known,” the lawsuit states. “When a product purports to be ‘100% Natural,’ consumers not only are willing to pay more for the product, they expect it to be pesticide-free,” the lawsuit states.

Questions about glyphosate have become so prevalent that U.S. Rep. Ted Lieu wrote a letter to EPA officials in December requesting EPA scientists meet with a group of independent scientists to go over “troubling information” related to glyphosate. Lieu cited concerns that EPA is relying on Monsanto-backed data rather than independent, peer-reviewed research in assessing glyphosate. Sources close to the situation say that meeting has been scheduled for June 14, though both EPA and Lieu’s office declined to comment.

The EPA’s diligence on digging into glyphosate questions and concerns is encouraging to those who want to see a thorough risk assessment done. But the delay and the questionable actions with releasing documents and then withdrawing them from the public eye does not inspire confidence.

Indeed, in another curious move, the EPA on May 2 also issued a newly updated “registration review schedule.“ But while three dozen other chemical draft risk assessments are listed on the EPA website for release by the end of 2016, glyphosate was not included.

Oops?

This article originally appeared in Huffington Post

Carey Gillam is a veteran former Reuters journalist, current freelance writer/editor and research director for U.S. Right to Know, a food industry research group. Follow her on Twitter @CareyGillam

What Killed Jack McCall? A Farmer Dies; A Case Against Monsanto Takes Root

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By Carey Gillam

CAMBRIA, Calif.- Standing on the ridge overlooking her central California farm, new widow Teri McCall sees her husband Jack nearly everywhere. There, atop the highest hill, is where the couple married in 1975- two self-described “hippies’ who knew more about how to surf than farm. And over there, surrounded by the lemon, avocado and orange trees Jjack mccall copyack planted, sits the 800-square-foot house the young Vietnam veteran built for his bride and a family that grew to include two sons and a daughter. Solar panels Jack set up in a sun-drenched stretch of grass power the farm’s irrigation system.

And down there, clasped in the cusp of the velvet green valley sits the century-old farmhouse Jack and Teri eventually made their permanent home. Jack installed a stained glass window featuring a heart and flowers over the front door.

“Literally hundreds of times a day, something reminds me of him,” McCall says, as she and a visitor strolled through the orchards on a recent sunny spring morning. “That’s part of why it’s so hard to believe… I can never see him again.”

Anthony ‘Jack’ McCall, 69, died Dec. 26 after a painful and perplexing battle with non-Hodgkin lymphoma. The loss is certain, fixed forever into his family’s heartbreak. But questions about why and how he was stricken – a man who never smoked, stayed fit and had no history of cancer in his family – are part of what some legal experts see as a potential landmark legal claim against one of the world’s largest agrichemical companies, Monsanto Co.

McCall shunned pesticide use on his farm, except for the herbicide called Roundup – marketed by Monsanto as having extremely low toxicity. He used Roundup regularly, spraying it himself around the farm to drive back worrisome weeds. He even recommended Roundup to friends, telling them it was supposed to be much safer than alternatives on the market, and touting its effectiveness.

But now in his death, McCall is one of several plaintiffs in more than a dozen lawsuits that claim the active ingredient in Roundup – a chemical called glyphosate – gave them cancer, and that Monsanto has long known glyphosate poses “significant risks to human health, including a risk of causing cancer.”

The lawsuits, brought by plaintiffs in California, Florida, MissouriDelaware, Hawaii,and elsewhere over the last several months, claim Monsanto has hidden evidence, and manipulated regulators and the public into believing in the safety of glyphosate, which annually brings in about $5 billion, or a third of total sales, for the agribusiness giant. Like McCall, many farmed, or worked in agricultural jobs in which they regularly were using or exposed to glyphosate.

The claims come at a critical time for Monsanto and its signature product as regulators in the United States and other countries evaluate whether or not to continue to allow glyphosate herbicides. Last year the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen. That team, the International Agency for Research on Cancer (IARC), said glyphosate shows a “positive association” for non-Hodgkin lymphoma. 

The outcomes of the legal battle and the regulatory reviews could have broad implications. Glyphosate is the most widely used herbicide on the planet, sprayed on fields for row crops like corn, soybeans and wheat, as well as a variety of fruits, nuts and vegetable crops such as almonds, apples, cherries and oranges.

That ubiquitous role played by glyphosate means the litigation, plaintiffs’ lawyers say, marks the beginning of a potential wave of legal actions against Monsanto. Teams of attorneys have been criss-crossing the country lining up potential plaintiffs who they say will likely number in the hundreds and possibly thousands. It’s a time-tested practice by plaintiffs’ attorneys who have brought similar mass actions in the past against tobacco, pharmaceutical and chemical industries.

“Monsanto has deliberately concealed or suppressed information about the dangers of its product,” said environmental and chemical pollution attorney Robert F. Kennedy Jr., who is assisting in litigating glyphosate cases. “This is big. It’s on every farm in the world.”

Kennedy predicts glyphosate liability litigation will become as widespread as has been decades of litigation over asbestos, which is seen in legal circles as the longest-running mass tort action in U.S. history. Asbestos was used for years as a safe and effective flame retardant in the construction industry but has been tied to lung diseases and cancers, and spawned hundreds of millions of dollars in legal claims.

The glyphosate litigation partly mirrors courtroom battles Monsanto has been fighting for years involving the polychlorinated biphenyls, or PCBs it once manufactured. Plaintiffs in those cases also claim PCBs caused them to fall ill while Monsanto hid the risks. Monsanto claims plaintiffs cannot definitively link illnesses to PCB exposure.

AMONG THE SAFEST OPTIONS
Patented by Monsanto and commercialized in 1974, glyphosate herbicide has long been considered among the safest pesticide options on the market. The weed-killer came off patent in 2000 and is now used in more than 700 products around the world, beloved by farmers, homeowners, and groundskeepers. The chemical is the world’s most widely used herbicide with an estimated 1.8 billion pounds applied in 2014, up 12-fold from 1994, according to recently published research.

But as use has grown, concerns about safety have also mounted. Residues have been documented by public and private researchers in waterways, air, food and in human bodily fluids. Several scientific studies tied the chemical to cancers and other health problems before the March 2015 classification by IARC.

Lawyers for plaintiffs in the glyphosate cases say that among the evidence that glyphosate’s toxicity has long been known is an EPA memo detailing how glyphosate was classified by agency scientists as a possible human carcinogen in 1985 before classified in 1991 as a having “evidence of non-carcinogenicity” for humans. The classification was changed despite the fact that some peer review members did not concur. The lawsuits also cite evidence of fraud at laboratories used by Monsanto to perform toxicology studies of glyphosate, and point to fraud convictions of executives at those labs.

St. Louis-based Monsanto, a global agrichemical and seed powerhouse, cites its own evidence to counter both the validity of the allegations in the lawsuits, as well as the IARC findings. Last year, the company hired a team of experts to review the safety of glyphosate, and said that team found no cancer links. 

“Comprehensive long-term toxicological studies repeated over the last 30 years have time and again demonstrated that glyphosate is unlikely to pose a cancer risk in humans,” Monsanto states on its website. ‘Regulatory authorities and independent experts around the world have reviewed numerous long-term/carcinogenicity and genotoxicity studies and agree that there is no evidence that glyphosate… causes cancer, even at very high doses.”

Monsanto attorneys have been seeking to dismiss and/or delay several cases thus far filed, asserting that federal law and approvals by the Environmental Protection Agency for labels on Roundup herbicide products protect Monsanto from the claims in the lawsuits. In recent arguments in U.S. District Court in Northern California, for example, lawyers for Monsanto argued that “EPA repeatedly has concluded that glyphosate is not a carcinogen.” But in April a federal judge in California ruled that Monsanto was not protected from liability by the EPA registration and approved labels.

In a Missouri case that Monsanto also was unable to get dismissed, discovery is starting, and plaintiffs’ lawyers are eagerly awaiting what they hope will be a treasure trove of evidence for their clients.

The legal claims come at the same time that European and U.S. regulators are conducting their own assessments of the safety of glyphosate and considering restrictions, processes that have become fraught with infighting and accusations of bias from both fans and foes of glyphosate. The European Food Safety Authority (EFSA) said in November that evidence shows glyphosate is unlikely to be carcinogenic. But the European Parliament has said the herbicide use should be reined in with a ban on non-professional use and around parks and playgrounds because of the health worries.

The EPA was due to release a fresh risk assessment on glyphosate nearly a year ago, but has stalled the process amid the uproar. And in an odd twist to the saga, on April 29, the agency posted an internal document to its website, showing that the EPA’s cancer assessment experts have determined that glyphosate is “Not Likely to be Carcinogenic to Humans.”

On May 2, EPA withdrew the memo from its website and said it was not supposed to have been released because the cancer assessment is ongoing. But Monsanto heralded the release of the document as proof of what it has been saying about glyphosate’s safety.

Wall Street is keeping a wary eye on the litigation. But generally market watchers care less about Monsanto’s risk from potential liability payouts and more about any potential long-term revenue hit if regulators were to restrict or ban glyphosate, said Piper Jaffray analyst Brett Wong, who tracks Monsanto’s business strategies and financial health. The courtroom battles could influence regulators, he said.

“There are obviously a lot of lawsuits,” Wong said. “They aren’t intrinsic to impacting their business but there is always some sentiment pressure on investors. If it were to impact the regulatory structure and glyphosate was banned… that could obviously have an impact.”

Legal experts with experience defending the chemical industry are watching the cases with interest, and many say given a lack of regulatory support for the cancer linkage, plaintiffs’ attorneys have an uphill climb to make such claims stick.

“The evidence to support the claims isn’t there, said one prominent lawyer, declining to be quoted by name. “It’s not mothers’ milk by any means. I wouldn’t mix it in my drink, but it’s one of the safest chemicals out there,” he said.

Attorney Brent Wisner, who is representing the McCall family, said he is confident in the strength of the evidence against Monsanto. “It’s going to be a fairly large litigation when it’s all said and done. We’re confident we’ll be able to show that Monsanto controlled research and suppressed science,” he said.

Back in Cambria, Jack McCall’s son Paul McCall is running the farm in his father’s place. His eyes tear quickly when asked about his father’s diagnosis in September 2015 and death only three months later, the day after Christmas. He doesn’t want to talk about the lawsuit, other than to say he has no use for glyphosate now, and wants to warn others away from it.

“This is a battle that has to be fought,” he said.

How big and how bloody the litigation becomes is still an open question. The shouting from both sides of the issues is getting louder with each passing day. But the deep questions about the safety of this herbicide deserve serious and scientific review as the answers hold implications for our food production, our environment and the health of our families well into the future.

This article originally appeared in Huffington Post

Carey Gillam is a veteran former Reuters journalist, current freelance writer/editor and research director for U.S. Right to Know, a food industry research group

Not Just For Corn and Soy: A Look at Glyphosate Use in Food Crops

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By Carey Gillam

As the active ingredient in Monsanto’s branded Roundup weed killer, along with hundreds of other weed-killing products, the chemical called glyphosate spells billions of dollars in sales for Monsanto and other companies each year as farmers around the world use it in their fields and orchards.  Ubiquitous in food production, glyphosate is used not just with row crops like corn, soybeans and wheat but also a range of fruits, nuts and veggies. Even spinach growers use glyphosate.

Though considered for years as among the safest of agrichemicals, concerns about glyphosate have been growing after the World Health Organization’s cancer experts last year classified it as a probable human carcinogen, based on a series of scientific studies.  There are other concerns as well – mounting weed resistance to glyphosate; negative impacts on soil health; and a demise in the monarch butterfly population tied to glyphosate use on forage that young monarchs feed on. The EPA is currently finishing a risk assessment for glyphosate that examines the range of issues.

The EPA is still trying to determine just how worrisome glyphosate is, or isn’t. In the meantime it’s worth a look at how widespread the use of glyphosate is in our food supply. A document released by EPA on April 29 gives us a peek.

In a memorandum dated Oct. 22, 2015, EPA analysts reported an “updated Screening Level Usage Analysis”for glyphosate use on food items. That memo updates estimates of glyphosate use on crops in top agricultural states, and provides annual average use estimates for the decade 2004-2013. Seventy crops are on the EPA list, ranging alphabetically from alfalfa and almonds to watermelons and wheat. And, when compared to a prior analysis that ran through 2011, it shows that glyphosate use has been growing in production of most of the key food crops on the list. Here’s a snapshot:

Glyphosate used on U.S. soybean fields, on an average annual basis, was pegged at 101.2 million pounds; with corn-related use at 63.5 million pounds. Both estimates are up from a prior analysis that ran through 2011, which pegged average annual soybean use at 86.4 million pounds and corn at 54.6 million pounds. Both those crops are genetically engineered so they can be sprayed directly with glyphosate as farmers treat fields for weeds. Use with sugar beets, also genetically engineered as glyphosate-tolerant, was estimated at 1.3 million pounds, compared to 1 million pounds.

Notably, glyphosate use is also seen with a variety of crops not engineered to be sprayed directly. Looking at the period ending in 2013 compared to 2011, glyphosate use in wheat production was pegged at 8.6 million pounds, up from 8.1 million pounds; use in almonds was pegged at 2.1 million pounds, unchanged from the prior analysis;  grape use was pegged at 1.5 million pounds, up from 1.4 million pounds; and rice use was estimated at 800,000 pounds, compared to 700,000 pounds in the prior analysis.

You can check out your own favorite food here, and compare it to the prior analysis here. Some on the list may surprise you, including cherries, avocados, apples, lemons, grapefruit, peanuts, pecans and walnuts.

The growing use of glyphosate on food crops has prompted calls for regulators to start testing levels of such residues on food to determine if they are within levels regulators deem safe. They’ve been doing such testing for years for residues of other agrichemicals. The Food and Drug Administration said in February it would start doing that type of testing for glyphosate residues this year on a limited basis.

In the meantime, the EPA, which sets the “tolerance” levels that deem what is safe regarding pesticide residue,  announced May 3 that it was finalizing a new rule that will expand the numbers of crops that can have tolerances established. The EPA said this will “allow minor use growers a wider choice of pest control tools including lower-risk pesticides, to be used on minor crops, both domestically and in countries that import food to the United States.”

 Yummy.

Big Week for Big Ag Players Monsanto and Dow

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Monsanto Shareholders Meeting Draws Fire 

An array of GMO and pesticide critics spoke out at Monsanto Co.’s annual meeting of shareholders on Friday, Jan. 29  in the company’s hometown of Creve Coeur, Missouri, calling on the company to address concerns about the company’s genetically engineered crop products and the glyphosate-based Roundup herbicide used on those crops.

Shareholder representatives, as well as others from outside organizations, told Monsanto Chairman and CEO Hugh Grant that the company should take several steps, including reporting on any plans to  mitigate risks to human health and the environment tied to Roundup and its main ingredient, glyphosate.  In March 2015, the World Health Organization’s cancer experts classified glyphosate as “probably carcinogenic to humans.” And Monsanto is facing numerous lawsuits filed by farmworkers and others who say Roundup caused their cancers.

“Given that about half of Monsanto’s revenue comes from Roundup and other glyphosate-based herbicides, the labeling of the company’s core product as ‘probably carcinogenic’ is not a healthy boost for the company’s prospects,” John Harrington, CEO of Harrington Investments, said in a statement.  Harrington Investments provide investment advisory services with a focus on environmental and social objectives, and has an active shareholder advocacy program.

Along with Harrington Investments,  representatives from the Organic Consumers Association, Moms Across America, SumofUs, Women’s International League for Peace and Freedom, and GMO Free Midwest attended the meeting to protest the company’s promotion of Roundup, which the protesters say is tied to a range of diseases.

The group told Monsanto’s Grant that there are an increasing number of independent studies associating glyphosate with cancer, birth defects, kidney disease, and hormone disruption.

Grant deflected the criticisms and said that both glyphosate and GMOs are proven safe: “This is the 20th year of planting GMOs,” said Grant. “Four billion acres have been planted on the planet… without a single health issue. These are the most widely tested products that the food industry has ever seen.”

Monsanto brings in roughly $5 billion a year in revenues from sales of Roundup and related products.

Doctors and scientists have raised concerns about health trends in areas where farm workers and communities, such as Hawaii and Argentina, have high exposures to the chemicals used on Roundup Ready crops, which have been genetically engineered to tolerate being sprayed with glyphosate.

An audio replay of the meeting is available on Monsanto’s website at www.monsanto.com/investors.

Dow Gets Court Go-Ahead on Controversial New Herbicide

A federal appellate court has awarded a victory to Dow AgroSciences in the company’s controversial bid to bring a new weedkiller to U.S. farmlands. The new herbicide, branded Enlist Duo, combines glyphosate and 2,4-D, both of which have been linked to cancer and other health problems.

The Chicago Tribune reported that the 9th U.S. Circuit Court of Appeals rejected the U.S. Environmental Protection Agency’s request to vacate its own scientists’ 2014 approval  of the Dow weedkiller without detailing the reason behind the order.

Dow’s new herbicide is designed to address widespread herbicide resistance that has taken hold on roughly 60 million acres of U.S. farmland after widespread use of glyphosate. Glyphosate, the primary ingredient in Monsanto Co.’s Roundup, became pervasive in production of corn, soybeans, cotton and other crops after Monsanto genetically engineered crops to withstand direct dousing of the chemical.

Enlist Duo is designed to be used on genetically engineered corn, cotton and soybeans developed by Dow to be immune to the glyphosate-2,4D  mix.  In December, the Chicago Tribune revealed that the EPA approved Enlist Duo after the agency discounted evidence of kidney problems that Dow’s own researchers said were caused by 2,4-D.

Dow has said it sees the Enlist line of crops and chemicals as a $1 billion market opportunity.

Read more here http://www.chicagotribune.com/news/watchdog/ct-dow-enlist-duo-court-ruling-20160127-story.html

Following an Email Trail: How a Public University Professor Collaborated on a Corporate PR Campaign

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By Carey Gillam

Former University of Illinois food science professor Bruce Chassy is known for his academic gravitas. Now retired nearly four years, Chassy still writes and speaks often about food safety issues, identifying himself with the full weight of the decades of experience earned at the public university and as a researcher at the National Institutes of Health. Chassy tells audiences that before he retired in 2012, he worked “full time” doing research and teaching.

What Chassy doesn’t talk much about is the other work he did while at the University of Illinois – promoting the interests of Monsanto Co., which has been trying to overcome mounting public concerns about the genetically engineered crops and chemicals the company sells. He also doesn’t talk much about the hundreds of thousands of dollars Monsanto donated to the university as Chassy was helping promote GMOs, or Monsanto’s secretive role in helping Chassy set up a nonprofit group and website to criticize individuals and organizations who raise questions about GMOs.

But emails released through Freedom of Information Act requests show that Chassy was an active member of a group of U.S. academics who have been quietly collaborating with Monsanto on strategies aimed at not just promoting biotech crop products, but also rolling back regulation of these products and fending off industry critics. The emails show money flowing into the university from Monsanto as Chassy collaborated on multiple projects with Monsanto to counter public concerns about genetically modified crops (GMOs) – all while representing himself as an independent academic for a public institution.

A New York Times article by Eric Lipton published last September laid bare the campaign crafted by Monsanto and other industry players to use the credibility of prominent academics to push the industry’s political agenda. That Times article focused primarily on University of Florida academic Kevin Folta, chairman of the university’s Horticultural Sciences Department, and Folta’s work on behalf of Monsanto. But an examination of recently released email exchanges between Monsanto and Chassy show new depths to the industry efforts.

The collaborations come at a critical juncture in the United States regarding GMO public policy. Mandatory GMO labeling is set to take effect in Vermont on July 1; Congress is wrestling over a federal labeling law for GMOs; and several other states are seeking their own answers to rising consumer demand for transparency about this topic.

Many consumer and environmental groups want to see more restrictions and regulation on GMO crops and the glyphosate herbicide many know as Roundup, which is used on GMOs. But the companies that market the crops and chemicals argue their products are safe and there should be less regulation, not more. Monsanto’s roughly $15 billion in annual revenue comes almost exclusively from GMO crop technology and related chemicals.

Amid the furor, the revelations about corporate collaboration with public university scientists to promote GMOs have sparked a new debate about a lack of transparency in the relationships between academics and industry.

Chassy has said he did nothing unethical or improper in his work supporting Monsanto and the biotech crop industry. “As a public-sector research scientist, it was expected… that I collaborate with and solicit the engagement of those working in my field of expertise,” Chassy has stated.

Still, what you find when reading through the email chains is an arrangement that allowed industry players to cloak pro-GMO messaging within a veil of independent expertise, and little, if any, public disclosure of the behind-the-scenes connections.

CRITICAL COLLABORATIONS

  • In a November 2010 email, Monsanto chief of global scientific affairs Eric Sachs tells Chassy that Monsanto has just sent a “gift of $10,000” to the university “so the funds should be there.”  He then tells Chassy he is working on a plan for Monsanto and others in the agribusiness industry to support an “academics review” website that Chassy can use to counter concerns and allegations raised by critics of GMOs.  “From my perspective the problem is one of expert engagement and that could be solved by paying experts to provide responses,” Sachs wrote. “The key will be keeping Monsanto in the background so as not to harm the credibility of the information.”
  • In a separate 2010 exchange, Jay Byrne, president of the v-Fluence public relations firm and former head of corporate communications for Monsanto, tells Chassy he is trying to move the Academics Review project forward. He suggests “we work on the money (for all of us).” Byrne says that he has a list of GMO critics for Academics Review to target. He tells Chassy that the topic areas “mean money for a range of well-heeled corporations.”
  • In one email exchange from September 2011, Chassy suggests how the biotech crop industry might “spin” a government study that found significant levels of the chemical glyphosate, the key ingredient in Monsanto’s Roundup herbicide, in air and water samples.
  • In emails from 2012, Chassy and Monsanto’s Sachs and Monsanto’s John Swarthout, who leads the company’s “scientific outreach and issues management,” discuss an upcoming presentation Chassy is preparing to make in China. They discuss Monsanto’s review of, and changes to, the presentation.  Monsanto’s Sachs instructs Swarthout to send slide decks to Chassy as material for his presentation.
  • In April 2012, Monsanto toxicologist Bruce Hammond asks in an email if short videos can be created about the “safety of GM crops.” Chassy says that he is applying for funding from the State Department and “also seeking other sources of support” and can use university equipment to make the videos. Chassy asks Monsanto’s Hammond for a list of videos that “you think would be helpful.” Chassy tells Hammond that Byrne’s group V-fluence has helped create and edit the video scenarios.

EMAILS ABOUT MONEY 

The emails also discuss money.

  • In an October 2010 email, Chassy tells colleagues at the university that Monsanto has told him it is going to make a “substantial contribution” to his biotech account at the university.
  • In an October 2011 exchange, Chassy asked Sachs about a contribution for the university foundation biotech fund. The Monsanto executive responded that he would “make a gift to the foundation right away” if it had not already been made. Chassy instructs Monsanto to mail the check to the head of the university’s department of food science and to enclose a letter saying the check is “an unrestricted grant… in support of the biotechnology outreach and education activities of Professor Bruce M. Chassy.”
  • Also in May 2012, Monsanto made a $250,000 grant to the university to help set up an agricultural communications endowed chair. That donation was just a drop in the bucket of the donations from Monsanto – at least $1.9 million in the last five years, according to the university, – for agriculture-related projects.

CONTINUED CLOSE TIES

The close ties between Monsanto and Chassy continued past Chassy’s retirement in June 2012 from the university. Through 2013 and 2014 Chassy frequently appeared as an “independent expert” on the GMO Answers website, a pro-GMO site funded by Monsanto and other agribusiness giants. In that role, he answered questions and concerns about GMOs.

Chassy also has continued to operate Academics Review, publishing critical articles about individuals and organizations, including the World Health Organization’s cancer experts, that report information unfavorable for the GMO crop industry.  (I was the subject of at least two such attacks in 2014. Chassy objected to my presentation of both sides of the GMO safety debate in one Reuters article and objected to a second Reuters article that detailed the findings of a USDA report that found both benefits but also concerns associated with GMOs.)

When asked about its interactions with Chassy, Monsanto has said that there is nothing improper with its “engagements” with “public sector experts,” and that such collaborations help educate the public on important topics.  The university also has said it sees nothing wrong with the relations. A university spokeswoman said Chassy has “strong scientific credibility.”  She also said that Monsanto has given the university at least $1.9 million in the last five years.

But others familiar with the issues say the lack of transparency is a problem.

“These revelations regarding the connections are very important,” said George Kimbrell, senior attorney with the Center for Food Safety, a nonprofit consumer advocacy group. “The basic disclosure that some academics and other ‘neutral’ commentators in the public sphere are actually paid operatives/working directly with the chemical industry rightly alarms the public, as they are being misled.”

Revelations similar to these involving University of Florida Professor Kevin Folta’s connections to Monsanto did spark a public backlash after emails showed Folta received an unrestricted $25,000 grant and told Monsanto he would “write whatever you like.”  Folta said in a Jan. 18 blog that he no longer works with Monsanto because of the heated backlash.

Both Chassy and Folta have repeatedly written or been quoted in news articles that failed to disclose their connections to Monsanto and the GMO industry. In a recent example, Chassy has co-authored a series of articles that argue GMO labeling is a “disaster in waiting,” again with no disclosure of his collaboration with GMO developer Monsanto. His co-author is Jon Entine, founder of the PR firm ESG MediaMetrics, whose clients have included Monsanto, a connection Entine does not include in the article.

The revelations in the emails about Chassy, Folta and other assorted academics, leave many questions about who to trust, and how to trust, information critical to understanding our evolving food system. With food labeling issues at the forefront of debate, it’s time for more transparency.

Carey Gillam has worked as a journalist, researcher and writer specializing in the food and agriculture industry for nearly 20 years and has been recognized as one of the top food and agriculture journalists in the United States, winning several awards for her coverage of the industry. She recently left a career as senior correspondent for the Reuters international news service to become  Research Director at U.S. Right to Know, a nonprofit public interest group that works to inform the public about the U.S.  food industry and its often-hidden role in public policy.