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 mergerwith 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 American 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)

Tests Show Monsanto Weed Killer in Cheerios, Other Popular Foods

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Independent testing on an array of popular American food products found many samples contained residue levels of the weed killer called glyphosate, leading the nonprofit organization behind the testing to call for corporate and regulatory action to address consumer safety concerns.

The herbicide residues were found in cookies, crackers, popular cold cereals and chips commonly consumed by children and adults, according to Food Democracy Now and the group’s “Detox Project,” which arranged for the testing at the San Francisco-based Anresco lab. Anresco uses liquid chromatography tandem mass spectrometry (LC-MS/MS), a method widely considered by the scientific community and regulators as the most reliable for analyzing glyphosate residues. The groups issued a report Monday that details the findings.

The announcement of the private tests comes as the Food and Drug Administration (FDA) is struggling with its own efforts to analyze how much of the herbicide residues might be present in certain foods. Though the FDA routinely tests foods for other pesticide residues, it never tested for glyphosate until this year. The testing for glyphosate residues was recently suspended, however. Glyphosate is under particular scrutiny now because last year the World Health Organization’s International Agency for Research on Cancer (IARC) classified it as a probable human carcinogen. Glyphosate is the world’s most widely used herbicide and is the key ingredient in Monsanto Co.’s branded Roundup, as well as in hundreds of other products. The Environmental Protection Agency is now finalizing a risk assessment for glyphosate to determine if future use should be limited.

The tests conducted by Anresco were done on 29 foods commonly found on grocery store shelves. Glyphosate residues were found in General Mills’ Cheerios at 1,125.3 parts per billion (ppb), in Kashi soft-baked oatmeal dark chocolate cookies at 275.57 ppb, and in Ritz Crackers at 270.24 ppb, according to the report. Different levels were found in Kellogg’s Special K cereal, Triscuit Crackers and several other products. The report noted that for some of the findings, the amounts were “rough estimates at best and may not represent an accurate representation of the sample.” The food companies did not respond to a request for comment.

The EPA sets a “maximum residue limit” (MRL), also known as a tolerance, for pesticide residues on food commodities, like corn and soybeans. MRLs for glyphosate vary depending upon the commodity. Finished food products like those tested at Anresco might contain ingredients from many different commodities.

The nonprofit behind the report said that concerns about glyphosate comes as research shows that Roundup can cause liver and kidney damage in rats at only 0.05 ppb, and additional studies have found that levels as low as 10 ppb can have toxic effects on the livers of fish. The groups criticized U.S. regulators for setting an acceptable daily intake (ADI) at for glyphosate at much higher levels than other countries consider safe. The United States has set the ADI for glyphosate at 1.75 milligrams per kilogram of bodyweight per day (mg/kg/bw/day) while the European Union has set it at 0.3, for instance. The EPA is supposed to set an ADI from all food and water sources that is at least 100 times lower than levels that have been demonstrated to cause no effect in animal testing. But critics assert that the EPA’s analyses have been unduly influenced by the agrichemical industry.

The groups said that the federal government should conduct an investigation into the “harmful effects of glyphosate on human health and the environment,” and the relationships between regulators and the agrichemical industry that has long touted the safety of glyphosate.

Monsanto has said repeatedly that there are no legitimate safety concerns regarding glyphosate when it is used as intended, and that toxicological studies in animals have demonstrated that glyphosate does not cause cancer, birth defects, DNA damage, nervous system effects, immune system effects, endocrine disruption or reproductive problems. The company, which has been reaping roughly $5 billion a year from glyphosate-based products, says any glyphosate residues in food are too minimal to be harmful.

Both the U.S. Department of Agriculture and the FDA have echoed Monsanto’s reassurances in the past, citing the chemical’s proven safety as justification for not including glyphosate residue testing in annual programs that test thousands of food products each year for hundreds of different types of pesticides. But the lack of routine government monitoring has made it impossible for consumers or regulators to determine what levels of glyphosate are present in foods, and questions about the chemical’s safety persist.

A key reason glyphosate residues persist in so many food products has to do with its widespread use in food production. Glyphosate is sprayed directly on several crops genetically engineered to tolerate the herbicide, such as corn, soybeans, sugar beets, and canola. Glyphosate is also sprayed directly on many types of conventional crops ahead of harvest, including wheat, oats and barley. In all, glyphosate is used in some fashion in the production of at least 70 food crops, according to the EPA, including a range of fruits, nuts and veggies. Even spinach growers use glyphosate. In the report issued Monday, the groups call for a permanent ban on the use of glyphosate as a pre-harvest drying agent because of the residue levels.

A recent analysis done by a senior FDA chemist found glyphosate residues in several types of oatmeal products, including baby food, and in several honey samples. The glyphosate residues found in honey were higher than allowed in the European Union.

(This article first appeared in The Huffington Post)

More Bad News for Honey as U.S. Seeks to Get Handle on Glyphosate Residues in Foods

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Testing for residues of an herbicide developed by Monsanto Co. that has been linked to cancer has turned up high levels in honey from the key farm state of Iowa, adding to concerns about herbicide contamination that have triggered at least two lawsuits against honey industry players and prompted scrutiny by regulators.

The Food and Drug Administration began glyphosate residue testing in a small number of foods earlier this year after the International Agency for Research on Cancer classified glyphosate as a probable human carcinogen in March 2015. The “special assignment,” as the FDA refers to the testing project, is the first time the FDA has ever looked for glyphosate residues in food, though it annually tests foods for numerous other pesticides.

Research by FDA chemist Narong Chamkasem and John Vargo, a chemist at the University of Iowa, shows that residues of glyphosate – the chief ingredient in Monsanto’s branded Roundup herbicide – have been detected at 653 parts per billion, more than 10 times the limit of 50 ppb allowed in the European Union. Other samples tested detected glyphosate residues in honey samples at levels from the low 20s ppb to over 123 parts per billion ppb. Some samples had none or only trace amounts below levels of quantification. Previous reports had disclosed glyphosate residues in honey detected as high as 107 ppb. The collaborative work was part of an effort within FDA to establish and validate testing methodology for glyphosate residues.

“According to recent reports, there has been a dramatic increase in the usage of these herbicides, which are of risk to both human health and the environment,” Chamkasem and Vargo stated in their laboratory bulletin.

Because there is no legal tolerance level for glyphosate in honey in the United States, any amount could technically be considered a violation, according to statements made in FDA internal emails, obtained through Freedom of Information Act (FOIA) requests.

The Environmental Protection Agency may soon move to set a tolerance, however. The agency has set tolerance levels for glyphosate residues in many foods the EPA expects might contain residues of the weed killer. When residue levels are detected above the tolerance levels, enforcement action can be taken against the food producer.

“EPA is evaluating the necessity of establishing tolerances for inadvertent residues of pesticides in honey,” the agency said in a statement. The EPA also said there was no reason for consumers to be concerned about the residue in honey.  “EPA has examined the glyphosate residue levels found in honey and has determined that glyphosate residues at those levels do not raise a concern for consumers,” the agency said.

Despite the reassurances, at least two lawsuits have been filed over the issue. The Organic Consumers Association and the Beyond Pesticides nonprofit group filed suit Nov. 1 against the Sioux Honey Association Cooperative, a large Iowa-based group of bee keepers who produce the nationally known brand Sue Bee Honey. Sue Bee bills itself as “America’s Honey,” but the lawsuit alleges that the labeling and advertising of Sue Bee Products as “Pure,” “100% Pure,” “Natural,” and “All-natural” is “false, misleading, and deceptive.” Some of the glyphosate residues detected in the FDA tests were found in the Sue Bee brand, according to the FDA documents obtained through FOIA requests

The claims are similar to another lawsuit, which seeks class action status, that was filed against Sioux Honey Association in late September in U.S. District Court for the Eastern District of New York.

Quaker Oats was sued earlier this year on a similar claim regarding glyphosate residues. The FDA has also found glyphosate residues in oatmeal, including several types of infant oat cereal.

Considering corn is the key crop grown in Iowa, and most of the U.S. corn crop is genetically modified to tolerate being sprayed directly with glyphosate, it is not necessarily surprising that glyphosate residues are showing up in honey in Iowa and other farm states. Honey bees naturally migrate from field to field and plant to plant, so can become contaminated by the pesticide easily and then transfer pesticide residues to their honey, according to bee industry leaders.

“It’s a chemical intrusion, a chemical trespass into our product,” said Darren Cox, president of the American Honey Producers Association. “We have really no way of controlling it. I don’t see an area for us to put our bees. We can’t put them in the middle of the desert. They need to be able to forage in ag areas. There are no ag areas free of this product.”

Sioux Honey Association President David Allibone said no one from the FDA has communicated with his group about the chemical residues found in honey, and he said he could not discuss the issue further because of the litigation.

The lawsuit filed Tuesday acknowledges the difficulties beekeepers face. They “are often the victims of, and have little recourse against, contamination of their hives caused by pesticide applications in the fields where bees forage,” the lawsuit states.

The glyphosate residues showing up in food are surprising and worrisome, according to dietitian Mitzi Dulan, a nationally known nutrition and wellness expert.

“I think more testing should be done so that we are armed with the knowledge and then we can decide what we want to put into our bodies,” Dulan said. “I do believe in minimizing pesticide exposures whenever possible.”

Jay Feldman, executive director of Beyond Pesticides, a plaintiff in the lawsuit filed Tuesday, said regulators need to do more to address the issue.

“Until U.S. regulatory agencies prohibit Monsanto and other manufacturers of glyphosate from selling pesticides that end up in the food supply, we need to protect consumers by demanding truth and transparency in labeling,” Feldman said.

(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 aprobable 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.

FDA Tests Confirm Oatmeal, Baby Foods Contain Residues of Monsanto Weed Killer

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The U.S. Food and Drug Administration, which is quietly starting to test certain foods for residues of a weed killing chemical linked to cancer, has found the residues in a variety of oat products, including plain and flavored oat cereals for babies.

Data compiled by an FDA chemist and presented to other chemists at a meeting in Florida showed residues of the pesticide known as glyphosate in several types of infant oat cereal, including banana strawberry- and banana-flavored varieties. Glyphosate was also detected in “cinnamon spice” instant oatmeal; “maple brown sugar” instant oatmeal and “peach and cream” instant oatmeal products, as well as others. In the sample results shared, the levels ranged from nothing detected in several different organic oat products to 1.67 parts per million, according to the presentation.

Glyphosate, which is the key ingredient in Monsanto Co.’s Roundup herbicide, is the most widely used weed killer in the world, and concerns about glyphosate residues in food spiked after the World Health Organization in 2015 said a team of international cancer experts determined glyphosate is a probable human carcinogen. Other scientists have raised concerns about how heavy use of glyphosate is impacting human health and the environment.

The EPA maintains that the chemical is “not likely” to cause cancer, and has established tolerance levels for glyphosate residues in oats and many other foods. The levels found by the FDA in oats fall within those allowed tolerances, which for oats is set by the EPA at 30 ppm. The United States typically allows far more glyphosate residue in food than other countries allow. In the European Union, the tolerance for glyphosate in oats is 20 ppm.

Monsanto, which derives close to a third of its $15 billion in annual revenues from glyphosate-based products, has helped guide the EPA in setting tolerance levels for glyphosate in food, and in 2013 requested and received higher tolerances for many foods. The company has developed genetically engineered crops designed to be sprayed directly with glyphosate. Corn, soybeans, canola and sugar beets are all genetically engineered to withstand being sprayed with glyphosate.

Oats are not genetically engineered. But Monsanto has encouraged farmers to spray oats and other non-genetically modified crops with its glyphosate-based Roundup herbicides shortly before harvest. The practice can help dry down and even out the maturity of the crop. “A preharvest weed control application is an excellent management strategy to not only control perennial weeds, but to facilitate harvest management and get a head start on next year’s crop,” according to a Monsanto “pre-harvest staging guide.”

In Canada, which is among the world’s largest oat producers and is a major supplier of oats to the United States, the Monsanto marketing materials tout the benefits of glyphosate on oat fields: “Pre-harvest application of Roundup WeatherMAX and Roundup Transorb HC are registered for application on all oat varieties – including milling oats destined for human consumption.” Glyphosate is also used by U.S. oat farmers. The EPA estimates that about 100,000 pounds of glyphosate are used annually in production of U.S. oats.

Glyphosate is also used on wheat shortly before harvest in this way, as well as on other crops. A division of the U.S. Department of Agriculture known as the Grain Inspection, Packers & Stockyards Administration (GIPSA) has been testing wheat for glyphosate residues for years for export purposes and have detected the residues in more than 40 percent of hundreds of wheat samples examined in fiscal 2009, 2010, 2011 and 2012.

Even though the FDA annually examines foods for residues of many other types of pesticides, it has skipped testing for glyphosate residues for decades. It was only in February of this year that the agency said it would start some glyphosate residue analysis. That came after many independent researchers started conducting their own testing and found glyphosate in an array of food products, including flour, cereal, and oatmeal.

Monsanto and U.S. regulators have said glyphosate levels in food are too low to translate to any health problems in humans. But critics say such assurances are meaningless unless the government actually routinely measures those levels as it does with other pesticides.

And some do not believe any level of glyphosate is safe in food. Earlier this year, Taiwan recalled more than 130,000 pounds of oat supplies after detecting glyphosate residues. And San Francisco resident Danielle Cooper filed a lawsuit in May 2016 seeking class action status against the Quaker Oats Co. after glyphosate residues were found in that company’s oat products, which are used by millions of consumers as cereal and for baking cookies and other treats. Cooper said she expected the oat products, which have been labeled as “100% Natural,” to be pesticide free.

“Glyphosate is a dangerous substance, the presence and dangers of which should be disclosed, the lawsuit states.

Quaker Oats has said any trace amounts of glyphosate found in its products are safe, and it stands by the quality of its products.

HERBICIDE IN HONEY

In addition to oats, the FDA also earlier this year tested samples of U.S. honey for glyphosate residues and found all of the samples contained glyphosate residues, including some with residue levels double the limit allowed in the European Union, according to documents obtained through a Freedom of Information Act request. The EPA has not set a tolerance level for glyphosate in honey, so any amount is problematic legally.

Despite internal discussions about a need to pursue action after the honey findings in January, the FDA did not notify the honey companies involved that their products were found to be contaminated with glyphosate residues, nor did it notify the public.

The FDA has also tested corn, soy, eggs and milk in recent months, and has not found any levels that exceed legal tolerance, though analysis is ongoing.

“These preliminary results showed no pesticide residue violations for glyphosate in all four commodities tested. However, the special assignment is ongoing and all results must go through the FDA’s quality control process to be verified,” said FDA spokeswoman Megan McSeveney. The tests on honey were not considered part of the official special assignment, said McSeveney.

“Dr. Narong Chamkasem, an FDA research chemist based in Atlanta, tested 19 samples of honey as part of a research project that he individually conducted,” she said.

The glyphosate residue testing by FDA may be headed for a slow-down. Sources say there it talk of closing the FDA’s Atlanta laboratory that has done glyphosate residue tests. The work would then reportedly be shifted to other facilities around the country.

The revelations about glyphosate residues in certain foods come as both European and U.S. regulators are evaluating glyphosate impacts for risks to humans and the environment. The EPA is holding four days of meetings in mid-October with an advisory panel to discuss cancer research pertaining to glyphosate, and debate is ongoing over whether or not the team of international scientists who last year declared it a probable human carcinogen were right nor not.

Aaron Blair, the chairman of the International Agency for Research on Cancer (IARC) working group that classified glyphosate as probably carcinogenic to humans, said that the science on glyphosate is still evolving. He said that it is common for it to take years, sometimes decades, for industry and regulators to accept certain research findings and for scientists to reach consensus. He likened glyphosate to formaldehyde, which many years ago was also classified by IARC as “probably carcinogenic” to humans before it later was accepted to be carcinogenic.

“There is not a single example of IARC being wrong, showing something is a probable carcinogen and then later it is proven not to be,” Blair said.

(This story first appeared in The 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 human’ 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 adetailed 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 Decemberthat 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)

FDA Finds Monsanto’s Weed Killer In U.S. Honey

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By Carey Gillam

The Food and Drug Administration, under public pressure to start testing samples of U.S. food for the presence of a pesticide that has been linked to cancer, has some early findings that are not so sweet.

In examining honey samples from various locations in the United States, the FDA has found fresh evidence that residues of the weed killer called glyphosate can be pervasive – found even in a food that is not produced with the use of glyphosate. All of the samples the FDA tested in a recent examination contained glyphosate residues, and some of the honey showed residue levels double the limit allowed in the European Union, according to documents obtained through a Freedom of Information Act request. There is no legal tolerance level for glyphosate in honey in the United States.

Glyphosate, which is the key ingredient in Monsanto Co.’s Roundup herbicide, is the most widely used weed killer in the world, and concerns about glyphosate residues in food spiked after the World Health Organization in 2015 said its cancer experts determined glyphosate is a probable human carcinogen. Other international scientists have raised concerns about how heavy use of glyphosate is impacting human health and the environment.

Records obtained from the FDA, as well as the Environmental Protection Agency and the U.S. Department of Agriculture, detail a range of revelations about the federal government’s efforts to get a handle on these rising concerns. In addition to honey, the records show government residue experts discussing glyphosate found in soybean and wheat samples, “glyphosate controversies,” and the belief that there could be “a lot of violation for glyphosate” residues in U.S. crops.

Even though the FDA annually examines foods for residues of many pesticides, it has skipped testing for glyphosate residues for decades. It was only in February of this year that the agency said it would start some glyphosate residues analysis. That came after many independent researchers started conducting their own testing and found glyphosate in an array of food products, including flour, cereal, and oatmeal. The government and Monsanto have maintained that any glyphosate residues in food would be minimal enough to be safe. But critics say without robust testing, glyphosate levels in food are not known. And they say that even trace amounts may be harmful because they are likely consumed so regularly in many foods.

The residue issues are coming into the spotlight at the same time that the EPA is completing a risk assessment to determine if use of this top-selling herbicide should be limited. The agency has scheduledpublic meetings on the matter Oct. 18-21 in Washington. The EPA’s risk assessment report was initially due out in 2015, but still has not been finalized. The agency now says it will be completed in “spring 2017.”

In the records released by the FDA, one internal email describes trouble locating honey that doesn’t contain glyphosate: “It is difficult to find blank honey that does not contain residue. I collect about 10 samples of honey in the market and they all contain glyphosate,” states an FDA researcher. Even “organic mountain honey” contained low concentrations of glyphosate, the FDA documents show.

According to the FDA records, samples tested by FDA chemist Narong Chamkasem showed residue levels at 107 ppb in samples the FDA associated with Louisiana-based Carmichael’s Honey; 22 ppb in honey the FDA linked to Leighton’s Orange Blossom Honey in Florida and residues at 41 ppb in samples the FDA associated with Iowa-based Sue Bee Honey, which is marketed by a cooperative of American beekeepers as “pure, all-natural” and “America’s Honey.” Customers “can be assured that Sue Bee Honey is 100% pure, 100% all-natural and 100% American,” the Sioux Honey Association states.

In a Jan. 8, 2016 email Chamkasem pointed out to fellow FDA scientists that the EU tolerance level is 50 ppb and there is no amount of glyphosate allowed at all in honey in the United States. But Chris Sack, an FDA chemist who oversees the agency’s pesticide residue testing, responded by reassuring Chamkasem and the others that the glyphosate residues discovered are only “technically a violation.”

“The bee farmers are not breaking any laws; rather glyphosate is being introduced by the bees,” Sack wrote in response. “While the presence of glyphosate in honey is technically a violation, it is not a safety issue.”

Sack said the EPA had been “made aware of the problem” and was expected to set tolerance levels for honey. Once tolerance levels are set by EPA – if they are set high enough – the residues would no longer be a violation. When contacted this week, the EPA said there are currently no pending requests to set tolerance levels for glyphosate in honey. But, the agency also said: “there is no dietary risk concern from exposure to glyphosate residues in honey at this time.”

Sioux Honey Vice President Bill Huser said glyphosate is commonly used on farm fields frequented by bees, and the pesticide travels back with the bees to the hives where the honey is produced.

“The industry doesn’t have any control over environmental impacts like this,” Huser said. Most of Sue Bee’s honey comes from bees located near clover and alfalfa in the upper Midwest, he said. Beekeepers located in the South would have honeybees close to cotton and soybean fields. Alfalfa, soybeans and cotton are all genetically engineered to be sprayed directly with glyphosate.

The FDA results are not the first to find glyphosate in honey. Sampling done in early 2015 by the scientific research company Abraxis found glyphosate residues in 41 of 69 honey samples with glyphosate levels between 17 and 163 ppb, with the mean average being 64 ppb.

Bee keepers say they are innocent victims who see their honey products contaminated simply because they might be located within a few miles of farms where glyphosate is used.

“I don’t understand how I’m supposed to control the level of glyphosate in my honey when I’m not the one using Roundup,” one honey company operator said. “It’s all around me. It’s unfair.”

The FDA did not respond to a question about the extent of its communications with Monsanto regarding residue testing, but the records released show that Monsanto has had at least some interaction with the FDA on this issue. In April of this year, Monsanto’s international regulatory affairs manager Amelia Jackson-Gheissariemailed FDA asking to set up a time to talk about “enforcement of residue levels in the USA, particularly glyphosate.”

The FDA routinely looks for residues of a number of commonly used pesticides but not glyphosate. The look for glyphosate this year is considered a “special assignment” and came after the agency was criticized by the U.S. Government Accountability Office in 2014 for failing to test for glyphosate.

The FDA has not released formal results of its testing plans or the findings, but Sack made a presentation in June to the California Specialty Crops Council that said the agency was analyzing 300 samples of corn; 300 samples of soy; and 120 samples each of milk and eggs. He described some partial results achieved through April that showed glyphosate levels found in 52 samples of corn and 44 samples of soybeans but not above legally allowed levels. The presentation did not mention honey. The presentation also stated that glyphosate testing at the FDA will be expanded to “routine screening.”

The USDA also will start testing for glyphosate, but not until next year, according to information the agency gave to the nonprofit group Beyond Pesticides in a meeting in Washington in January. Documents obtained through FOIA show a plan to test in syrups and oils in 2017.

Soybeans and Wheat

Like the FDA, the USDA has dragged its feet on testing. Only one time, in 2011, has the USDA tested for glyphosate residues despite the fact that the agency does widespread testing for residues of other less-used pesticides. In what the USDA called a “special project” the agency tested 300 soybean samples for glyphosate and found more than 90 percent – 271 of the samples – carried the weed killer residues. The agency said then that further testing for glyphosate was “not a high priority” because glyphosate is considered so safe. It also said that while residues levels in some samples came close to the very high levels of glyphosate “tolerance” established by EPA, they did not exceed those levels.

Both the USDA and the FDA have long said it is too expensive and is unnecessary to test for glyphosate residues. Yet the division within the USDA known as the Grain Inspection, Packers & Stockyards Administration (GIPSA) has been testing wheat for glyphosate residues for years because many foreign buyers have strong concerns about glyphosate residues. GIPSA’s testing is part of an “export cargo sampling program,” documents obtained from GIPSAshow. Those tests showed glyphosate residues detected in more than 40 percent of hundreds of wheat samples examined in fiscal 2009, 2010, 2011 and 2012. The levels vary, the data shows. GIPSA has also been helping FDA access soybeans to test. In a May 2015 email, GIPSA chemist Gary Hinshaw told an FDA food safety official that “it isn’t difficult to find soybeans containing glyphosate.” In a December 7, 2015 email from FDA chemist Terry Councell to Lauren Robin, also a chemist and an FDA consumer safety officer, Councell said that glyphosate was present even in processed commodities, though “way below tolerance.”

The fact that the government is aware of glyphosate residues in food, but has dragged its feet on testing for so long, frustrates many who are concerned about the pesticide.

“There is no sense of urgency around these exposures that we live with day in and day out,” said Jay Feldman, executive director of Beyond Pesticides.

(First appeared in The Huffington Post)

Monsanto Fingerprints Found All Over Attack On Organic Food

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This article first appeared in the Huffington Post.

By Stacy Malkan

When a reputable-sounding nonprofit organization released a report attacking the organic food industry in April 2014, the group went to great lengths to tout its independence.

The 30-page report by Academics Review, described as “a non-profit led by independent academic experts in agriculture and food sciences,” found that consumers were being duped into spending more money for organic food because of deceptive marketing practices by the organic industry.

Trade press headlines blared: “Organics exposed!” (Brownfield News) and “Organic Industry Booming by Deceiving Consumers” (Food Safety Tech News), touting the findings by supposedly independent experts.

The findings were “endorsed by an international panel of independent agricultural science, food science, economic and legal experts from respected international institutions,” according to the group’s press release.

In case the point about independence wasn’t clear, the press release ends on this note: “Academics Review has no conflicts-of-interest associated with this publication, and all associated costs for which were paid for using our general funds without any specific donor’ influence or direction.”

What was not mentioned in the report, the news release or on the website: Executives for Monsanto Co., the world’s leading purveyor of agrichemicals and genetically engineered seeds, along with key Monsanto allies, engaged in fund raising for Academics Review, collaborated on strategy and even discussed plans to hide industry funding, according to emails obtained by U.S. Right to Know via state Freedom of Information Act (FOIA) requests.

Monsanto’s motives in attacking the organic industry are obvious: Monsanto’s seeds and chemicals are banned from use in organic farming, and a large part of Monsanto’s messaging is that its products are superior to organics as tools to boost global food production.

Academics Carry Monsanto’s Message 

Academics Review was co-founded by “two independent professors … on opposite ends of the planet,” Bruce Chassy, Ph.D., professor emeritus at University of Illinois, and David Tribe, Ph.D., senior lecturer at University of Melbourne. They claim the group “only accepts unrestricted donations from non-corporate sources.”

Yet two email exchanges in 2010 reveal plans to find corporate funding for Academics Review while keeping corporate fingerprints hidden.

In a March 11, 2010 email exchange with Chassy, Jay Byrne, former head of communications at Monsanto who now runs a PR and market research firm, offered to act as a “commercial vehicle” to help find corporate funding for Academics Review.

Chassy discussed his interest in attacking the organic industry in the emails. “I would love to have a prime name in the middle of the organic aura from which to launch ballistic missiles…” he wrote, “I sure don’t have the money.”

Byrne replied,

“Well, I suggest we work on the money (for all of us) first and quickly! I’ve proposed to Val [Giddings, former vice president of BIO, the biotech industry trade association] that he and I meet while I’m in DC next week so we can (not via e-mail) get a clear picture of options for taking the Academic Review project and other opportunities forward. The “Center for Consumer Freedom” (ActivistCash.com) has cashed in on this to the extreme.”

The Center for Consumer Freedom is directed by Rick Berman, a lobbyist who has been called “Dr. Evil“ and the “king of corporate front groups and propaganda“ for his work to promote the tobacco industry and other corporate interests under the cover of neutral-sounding groups.

“I think we have a much better concept,” Byrne told Chassy.

Byrne shared an “opportunities” list of targets comprised of people, groups and content critical of GMOs and Monsanto: Vandana Shiva, Andrew Kimbrell, Ronnie Cummins, Sierra Club, Greenpeace, Institute for Agriculture and Trade Policy, Michael Pollan’s book “In Defense of Food,” the movies “Food, Inc” and “The World According to Monsanto,” and “topic cross-over on all the risk areas of ag-biotech (out crossing/ contamination, bees, butterflies, human safety, etc…).”

“All of these individuals, organizations, content items and topic areas mean money for a range of well heeled corporations, Byrne wrote, adding:

All of these individuals, organizations, content items and topic areas mean money for a range of well heeled corporations.

“I believe Val and I can identify and serve as the appropriate (non-academic) commercial vehicles by which we can connect these entities with the project in a manner which helps to ensure the credibility and independence (and thus value) of the primary contributors/owners… I believe our kitchen cabinet here can serve as gatekeepers (in some cases toll takers) for effective, credible responses, inoculation and proactive activities using this project platform…”

“Sounds good to me,” Chassy replied. “I’m sure that you will let me know what you discuss.”

In an email exchange with Chassy dated November 30, 2010, Eric Sachs, a senior public relations operative for Monsanto, discussed finding corporate support for Academics Review while “keeping Monsanto in the background.”

Sachs wrote to Chassy:

“You and I need to talk more about the “academics review” site and concept. I believe that there is a path to a process that would better respond to scientific concerns and allegations. I shared with Val yesterday. From my perspective the problem is one of expert engagement and that could be solved by paying experts to provide responses. You and I have discussed this in the past. Val explained that step one is establishing 501(c)3 not-for-profit status to facilitate fund raising. That makes sense but there is more. I discussed with Jerry Steiner today (Monsanto Executive Team) and can help motivate CLI/BIO/CBI and other organizations to support. The key will be keeping Monsanto in the background so as not to harm the credibility of the information.”

The key will be keeping Monsanto in the background so as not to harm the credibility of the information.

CLI/BIO/CBI refers to three industry trade groups — Crop Life International, the Biotechnology Innovation Organization and the Council for Biotechnology Information — that represent agrichemical corporations.

Chassy responded to Sachs, “Yes we should talk about Academics Review. I think we are on the same page.”

When asked directly about funding, Chassy replied via email: “Academics Review does not solicit or accept funds from any source for specific research or any other activities associated with any products, services or industry. Academics Review only accepts unrestricted donations from non-corporate sources to support our work.”

He said that Academics Review incorporated and reported no income in 2012 and he provided the IRS form 990s for 2013 and 2014 (now also posted on the website). Those documents report $419,830 in revenues but include no information about contributors. Chassy did not respond to requests to provide that information.

Press Covers “Independent” Attack on Organic

Academics Review released its organic marketing study in April 2014 to a robust round of trade press coverage describing the findings of “independent researchers”:

• “The Organic Food Industry Has Been Engaged in ‘Multi-Decade Public Disinformation Campaign’ claims report” (Food Navigator)

• “Report: Organic Industry Achieved 25 Years of Fast Growth Through Fear and Deception” (Food Safety News)

• “A Scathing Indictment of Organic Food Marketing” (Hoard’s Dairyman)

• “Using Fear as a Sales Tactic” (Food Business News)

In the New York Post, Naomi Schaffer Riley built a case against “tyranny of the organic mommy mafia” who are duped by disingenuous marketing tactics of the organic industry. Her sources included the Academics Review report and Julie Gunlock, author of a book about the “culture of alarmism.”

Riley didn’t mention that Gunlock, and also Riley herself, are both senior fellows at the Independent Women’s Forum, a group heavily funded by Donors Trust, which has bankrolled corporate attacks on unions, public schools and climate scientists.

In the Des Moines Register, John R. Block, a former U.S. secretary of agriculture who now works for a law firm that lobbies for agribusiness interests, reported on the “blockbuster report” by Academics Review and its findings that the organic industry’s secret to success is “black marketing.”

The corporate front group American Council on Science and Health, which receives funding from the agrichemical industry and where Chassy serves as a scientific advisor, pushed the “black marketing” theme in articles by ACSH president Hank Campbell and Henry I. Miller, MD, a Hoover Institute fellow who served as the spokesmodel in commercials for the effort to kill GMO labeling in California, for which Monsanto was the lead funder.

Miller, who has a long history of making inaccurate scientific claims in support of corporate interests, also used the Academics Review report as a source for organic attacks in Newsweek and the National Review, and claimed in the Wall Street Journal that organic farming is not sustainable.

Similar anti-organic themes run through other agrichemical industry PR channels.

GMO Answers, a marketing website funded by the Big Six agrichemical companies (and where Chassy and Tribe serve as “independent experts”), promotes the ideas that organics are no healthierno better for the environmentand just a marketing program — although, ironically, the PR firm that runs GMO Answers has launched a specialty group in San Francisco to try to cash in on the organic market.

Monsanto’s top spokesperson, Robb Fraleyalso repeatedly trashes the organicindustry on his Twitter feed.

Money Flow Goes Public; Academics Review Goes Silent 

In March 2016, Monica Eng reported for WBEZ on documents showing that Monsanto paid Professor Bruce Chassy more than $57,000 over a 23-month period to travel, write and speak about GMOs — money that was not disclosed to the public.

According to Eng’s investigation, the money was part of at least $5.1 million in undisclosed money Monsanto sent through the University of Illinois Foundation to university employees and programs between 2005 and 2015.

“Chassy did not disclose his financial relationship with Monsanto on state or university forms aimed at detecting potential conflicts of interest,” Eng reported.

“Documents further show that Chassy and the university directed Monsanto to deposit the payments through the University of Illinois Foundation, a body whose records are shielded from public scrutiny. The foundation also has the ability to take in private money and disburse it to an individual as a ‘university payment’ — exempt from disclosure.”

In January 2016, Carey Gillam, research director of U.S. Right to Know, reported on emails showing that hundreds of thousands of dollars had flowed from Monsanto to the University of Illinois “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.”

“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,” Gillam wrote.

The last post on the Academics Review site, dated Sept. 2, 2015, is a blog by Chassy explaining that some of his emails would be made public due to the FOIA requests of U.S. Right to Know, which he characterized as an assault on his 40 years of public science, research and teaching.

Financial support from the private sector for public sector research and outreach is “appropriate, commonplace and needed to further the public interest,” Chassy wrote. “Such support should be, and in all my experiences has been, transparent and done under the strict ethical guidelines of the public institutions that are benefiting from private sector or individual financial contributions.”

Three days later, some of Chassy’s emails were first made public in a front-page New York Times article by two-time Pulitzer Prize winning journalist Eric Lipton. Lipton reported that Monsanto gave Chassy a grant for an undisclosed sum in 2011 for “biotechnology outreach and education activities.”

Chassy told Lipton that the money he received from Monsanto “helped to elevate his voice through travel, a website he created and other means.”

Still Getting Press as an Independent Source 

Despite the revelations in the emails and the disclosure of Chassy’s financial ties to Monsanto, the Academics Review website and its report attacking the organic industry are still posted online with all the descriptions claiming independence.

And Chassy still enjoys press coverage as an “independent” expert on GMOs. In May 2016, two separate Associated Press stories quoted Chassy on that topic. Neither story mentioned Chassy’s now-public financial ties to Monsanto.

Stacy Malkan is co-director of the consumer group U.S. Right to Know. She is author of the award-winning book, “Not Just a Pretty Face: The Ugly Side of the Beauty Industry” (New Society 2007).