Monsanto, EPA Seek to Keep Talks Secret On Glyphosate Cancer Review

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By Carey Gillam

Monsanto Co. and officials within the Environmental Protection Agency are fighting legal efforts aimed at exploring Monsanto’s influence over regulatory assessments of the key chemical in the company’s Roundup herbicide, new federal court filings show.

The revelations are contained in a series of filings made within the last few days in the U.S. District Court for the Northern District of California as part of litigation brought by more than 50 people suing Monsanto. The plaintiffs claim they or their loved ones developed non-Hodgkin lymphoma (NHL) after exposure to Roundup herbicide, and that Monsanto has spent decades covering up cancer risks linked to the chemical.

Lawyers for the plaintiffs want the court to lift a seal on documents that detail Monsanto’s interactions with former top EPA brass Jess Rowland regarding the EPA’s safety assessment of glyphosate, which is the key ingredient in Roundup. Monsanto turned the documents over in discovery but marked them “confidential,” a designation plaintiffs’ attorneys say is improper. They also want to depose Rowland. But Monsanto and the EPA object to the requests, court documents show.

The EPA has spent the last few years assessing the health and environmental safety aspects of glyphosate as global controversy over the chemical has mounted. The World Health Organization’s International Agency for Research on Cancer (IARC) declared in March 2015 that glyphosate is a probable human carcinogen, with a positive association found between glyphosate and NHL. Monsanto has been fighting to refute that classification.

Rowland has been key in Monsanto’s efforts to rebut the IARC finding because until last year he was a deputy division director within the health effects division of the EPA’s Office of Pesticide Programs, managing the work of scientists who assessed human health effects of exposures to pesticides like glyphosate. And, importantly, he chaired the EPA’s Cancer Assessment Review Committee (CARC) that issued an internal report in October 2015 contracting IARC’s findings. That 87-page report, signed by Rowland, determined that glyphosate was “not likely to be carcinogenic to humans.”

The EPA finding has been highly valued by Monsanto, helping bolster the company’s defense against the Roundup liability lawsuits, and helping shore up market support for a product that brings in billions of dollars in revenues to the company annually. The EPA’s stamp of approval for the safety of glyphosate over the last few decades has also been key to the success of Monsanto’s genetically engineered, glyphosate-tolerant crops, which have been popular with farmers.

But the handling of the CARC report raised questions when it was posted to a public EPA website on April 29, 2016 and kept on the site for only three days before being pulled down. The agency said the report was not final and that it should not have been posted, but Monsanto touted the report as a public affirmation of its safety claims for glyphosate. The company also brought a copy of the report to a May court hearing in the Roundup litigation as a counter point to the IARC cancer classification. Shortly after the CARC report was removed from the EPA website, Rowland left his 26-year career at the EPA.

Plaintiffs’ attorneys have asked to depose Rowland to learn about that situation and other dealings with Monsanto. But, along with Monsanto’s objection to releasing the documents that relate to its conversations with Rowland, the EPA has specifically refused the deposition request, saying it would “not clearly be in the interests of EPA” to allow attorneys to question Rowland about the cancer review and interactions with Monsanto.

Monsanto has so far turned over six million pages of documents through the court-ordered discovery process, but has designated roughly 85 percent of the information as “confidential,” meaning plaintiffs’ attorneys must black out information from those documents in any court filings that could be accessed by reporters or other members of the public. That designation is improper for many of the documents, especially ones dealing with the company’s interactions with, and influence attempts over, EPA officials, plaintiffs’ lawyers argue. 

The lawyers say that the documents obtained through discovery show that “Monsanto has been confident all along that EPA would continue to support glyphosate, whatever happened and no matter who held otherwise.” According to the court filings by plaintiffs’ attorneys, the documents show “it is clear that Monsanto enjoyed considerable influence within the EPA’s OPP, and was close with Mr. Rowland… The documentary evidence strongly suggests that Mr. Rowland’s primary goal was to serve the interests of Monsanto.”

The EPA is a taxpayer-funded, public agency and its dealings with Monsanto should be subject to public scrutiny, particularly given the widespread use of glyphosate herbicide products and the ongoing international debate over the safety of the chemical, they claim.

“The health and safety of millions of U.S. citizens is at stake,” states a Jan. 16 plaintiffs’ filing. “Decisions affecting the public health should not be based on secret conversations between Monsanto and EPA officials. If Monsanto wants to advocate on behalf of glyphosate to EPA employees, they should have to do it publicly, so that concerned citizens have equal opportunity to advocate for their health and the health of their families. This issue is too important to allow Monsanto to improperly influence the EPA, and then hide such communication behind an improper ‘confidential’ designation.”

“The health and safety of millions of U.S. citizens is at stake. Decisions affecting the public health should not be based on secret conversations between Monsanto and EPA officials.”

Monsanto is adamant that its documents not be made public, arguing that releasing them would be “premature and improper.” Allowing public dissemination “of a few select internal corporate documents taken out of context… would be prejudicial to Monsanto and could cause reputational harm,” the company’s attorneys wrote in their response.

The plaintiffs’ attorneys say at least four specific documents they have obtained are clearly in the public interest and “illuminate that one of Monsanto’s chief business strategies is its secret and untoward influence on EPA.” The documents include both internal memos and email chains, according to descriptions of the documents.

“Since Monsanto’s communications with the EPA remain secret, these known lobbying efforts are only the tip of the iceberg of Monsanto’s collusion with the EPA. Monsanto’s bad acts in violating U.S. regulations through secret communications with the EPA should not by rewarded by allowing them to keep these communications secret by merely stamping them ‘Confidential,’” the plaintiffs’ attorney state in the filings. “These documents summarize communications with EPA which are not elsewhere memorialized; they are not trade secrets and the public has a compelling interest in disclosure.”

Monsanto argues otherwise, saying the four documents at issue “contain sensitive, non-public commercial information, relate to a motion seeking to obtain discovery from a non-party, and bear only a tangential, at best, connection to the questions at issue in this litigation; hence, any public interest “is minimal.’”

U.S. District Judge Vince Chhabria, who is overseeing the Roundup litigation, is expected to rule on the matters within the next few days.

In a separate case, Monsanto and California environmental regulators face off Jan. 27 over plans by state regulators to list glyphosate as a carcinogen. The state Office of Environmental Health Hazard Assessment (OEHHA) said it would add glyphosate to its list of known carcinogens after the IARC classification. Monsanto has sued to prevent the listing. The upcoming hearing takes up OEHHA’s motion to dismiss Monsanto’s lawsuit.

Carey Gillam is a veteran journalist and research director for U.S. Right to Know, a non-profit consumer education group. This article first appeared in the Huffington Post. 

New Research: GMO Insect Resistance Failing; Corn Crop in Jeopardy

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By Carey Gillam 

New research adds to evidence that the effectiveness of popular genetically engineered traits used to protect corn and cotton from insects is failing, putting U.S. corn production potential in jeopardy, and spurring a need for increased insecticide use.

The study, authored by a trio of independent researchers, documents resistance in a major crop pest called corn earworm, and adds to warnings that the popular GMO insect-resistant technology known as Bt, after the soil-dwelling bacteria Bacillus thuringiensis, has lost its luster. It is noteworthy as the first long-term, in-field assessment of transgenic Bt corn’s effectiveness against one of the most damaging pests of sweet corn, field corn, cotton and many other high-value crops. Before publishing their findings, which cover 20 years of observations, the researchers presented them to the Environmental Protection Agency (EPA) as well as to the corporations that developed and market the traits, said Galen Dively, a University of Maryland entomologist and lead researcher on the study.

Crops engineered with Bt genes express specific proteins known as (Cry proteins) that make the crops toxic to specific insects – the plants effectively provide their own insecticide – reducing the need for chemical applications. In 2015, more than 80 percent of the U.S. corn crop carried at least one Bt trait. Much of the corn now planted is engineered with multiple Bt Cry proteins, but the new research indicates that the insect (called earworm in corn but bollworm in cotton) is now able to survive multiple genetically engineered traits in a pyramided variety. Other research has shown wide failure of traits supposed to protect against the western corn rootworm as well, leaving farmers facing big and potentially costly problems as resistance builds, according to the researchers.

“With widespread use of genetically engineered crops, the targeted insects developing resistance to these protein is a major threat to the sustainability of the Bt technology,” researcher Dilip Venugopal wrote in a summary of the group’s findings. “Increasing damages by corn earworm to Bt field corn are reported already in North Carolina and Georgia, and corn earworm could become a major pest. We predict that corn earworm resistance to the Cry toxins is likely to increase, and spread. Therefore, the risk of damage to corn production across a large portion of U.S. is high.” Venugopal is a science and technology policy fellow working with a division of the EPA.

The research adds to evidence that after 20 years of use of crops engineered to tolerate herbicides and resist certain harmful insects, both technologies are losing effectiveness. The two most widely used types of GMO traits are glyphosate-tolerance, developed in soybeans, corn, cotton, canola and other crops; and the Bt insect-resistant trait. But at least 70 million acres of U.S. farmland have become infested with glyphosate-resistant weeds since the GMO crops were introduced. As well, signs of mounting insect resistance to the Bt technology have been raising concerns across the farm belt for the last several years. Last summer, scientists published research documenting increasing western corn rootworm resistance to the Bt proteins, and widespread corn damage was reported by farmers. Farmers are using more herbicides to try to control resistant weeds, and returning to insecticide use to combat the resistant pests, agricultural experts say.

Fred Gould, an entomologist at North Carolina State University, said the Dively work is a “very important study,” that does not bode well for future crop health. And University of Minnesota Extension Entomologist William Hutchinson said the study demonstrates a need for better monitoring of resistance in traits that still work. As the study showed, there is still very good effectiveness with varieties that contain both Vip3A+Cry1Ab, he pointed out.

One key misstep has been reliance on the “refuge-in-a-bag” (RIB) system that allowed farmers to avoid setting aside part of their fields as areas free of the Bt trait, a practice proven to discourage resistance. With the RIB system, however, researchers have found that farmers actually encouraged resistance by spreading uneven low doses of the Bt toxin to feeding insects throughout their fields, which helped build up resistance in the insects over time. The companies behind the Bt traits have encouraged refuge-in-a-bag. Seed giant Monsanto Co., which made $5.8 billion in sales of corn seeds and traits last year, has touted refuge-in-a-bag as fast and convenient for farmers, allowing them to plant the specialized seed “fence row to fence row.

The EPA shoulders a good deal of the blame for the problem, according to the agency’s Office of Inspector General (OIG), which criticized the agency last year for its handling of the resistance issues. Among other missteps, the agency has been too reliant on the seed and chemical industry to self-report the resistance issues, and has not provided farmers or researchers with a direct means to report resistance incidents to the regulators, according to the OIG.

The EPA also is too secretive with the information it does get from the seed companies, keeping compliance reports and monitoring data from the public. “Transparency is an EPA core value,” the OIG wrote. “The EPA has both information and the means to enhance transparency regarding its regulatory oversight of genetically engineered crops such as Bt corn.”

Trusting the industry to self-report is a particular problem because there is evidence the industry would rather not do so. An Iowa case of insect resistance found in 2009 was not reported as it should have been, for instance, the OIG said. The EPA has been working to correct the deficiencies laid out by the OIG by mid-2017.

The EPA said it is “conducting an analysis of this study and other information related to corn earworm resistance and will determine if improvements to the current resistance management strategies are warranted.” The EPA said as part of that process, it will hold a public meeting with a panel of scientific advisers later this year.

But it may well be too little too late. Time-tested agricultural practices such as crop rotation and a mix of other strategies are essential to combating resistance issues. Relying on one type of genetically engineered technology season after season is bound to fail eventually, according to agricultural experts.

“There’s nothing they can do about it,” said Dively. “There is pretty strong evidence it’s going to get worse,” said Dively.

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)

Trump Talk Of Pompeo For Cabinet Could Spell Setback For Consumers

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News that President-elect Donald Trump is considering U.S. Rep. Mike Pompeo for a cabinet slot illustrates just how dark the days ahead might be for America’s burgeoning “food movement,” which has been advocating for more transparency and fewer pesticides in food production.

Pompeo, a Republican from the farm state of Kansas, was the designated hitter for Monsanto Co. and the other Big Ag chemical and seed players in 2014 when the industry rolled out a federal effort to block states from mandating the labeling of genetically modified foods. Pompeo introduced the “Safe and Accurate Food Labeling Act” in April of that year with the intention of overriding bills in roughly two dozen states.

In bringing the bill forward, Pompeo was acting on behalf the Grocery Manufacturers Association (GMA), which represents the interests of the nation’s largest food and beverage companies. The bill, which critics called the “Deny Americans the Right to Know” Act, or the “DARK Act,” went through two years of controversy and compromise before a version passed and was signed into law by President Barack Obama this summer. The law nullified a mandatory labeling bill set to take effect in Vermont in July of this year, and it offered companies options to avoid stating on their packaging whether or not a product contained GMO ingredients.

Pompeo has shown himself to be a “puppet” for special interests, and if he is named to a top position in the new administration, it could spell a significant setback for consumers, according to Andrew Kimbrell, executive director of the Center for Food Safety.

“The worst choice I can think of,” Kimbrell said of Pompeo. “Far from draining the swamp, Pompeo is the ultimate “swamp” creature. He is little more than a puppet for the big chemical and biotech companies.”

Consumer groups have pushed for mandatory labeling for years because of concerns that genetically engineered crops on the market now carry potential and actual risks for human health and the environment. A chief concern has to do with the fact that most GMO crops are sprayed with glyphosate herbicide, the active ingredient in Monsanto’s Roundup brand. The World Health Organization has declared glyphosate a probable human carcinogen, and residues of glyphosate are increasingly being detected in commonly consumed foods.

The Trump transition team answer for those consumer concerns about pesticides doesn’t look reassuring either. Trump has named Myron Ebell, director of the Center for Energy and Environment at the Competitive Enterprise Institute, to lead transition efforts at the Environmental Protection Agency (EPA). That’s happy news for the agrichemical industry because Ebell appears to be a big fan of pesticides.His group’s SAFEChemicalPolicy.org website champions the safety and benefits of chemicals used in agriculture and elsewhere, and discounts research that indicates harm.

“The EPA is supposed to protect us from dangerous chemicals, not defend them, as Ebell would almost certainly do if he ran the agency,” the Environmental Defense Fund said in a statement.

(This 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)

FDA Suspends Testing for Glyphosate Residues in Food

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By Carey Gillam

Government testing for residues of an herbicide that has been linked to cancer has been put on hold, slowing the Food and Drug Administration’s first-ever endeavor to get a handle on just how much of the controversial chemical is making its way into U.S. foods.

The FDA, the nation’s chief food safety regulator, launched what it calls a “special assignment” earlier this year to analyze certain foods for residues of the weed killer called glyphosate after the agency was criticized  by the U.S. Government Accountability Office for failing to include glyphosate in annual testing programs that look for many less-used pesticides. Glyphosate is the most widely used herbicide in the world, and is the key ingredient in Monsanto Co.’s branded Roundup herbicide line.

Glyphosate is under particular scrutiny now after the World Health Organization’s cancer experts last year declared the chemical a probable human carcinogen. Several private groups and nonprofits have been doing their own testing, and have been finding glyphosate residues in varying levels in a range of foods, raising consumer concerns about the pesticide’s presence in the American diet.

The FDA’s residue testing for glyphosate was combined with a broader herbicides analysis program the FDA set in motion in February of this year. But the glyphosate testing has been particularly challenging for the FDA. The agency was finally forced to put the glyphosate residue testing part of the work plan on hold amid confusion, disagreement and difficulties with establishing a standard methodology to use across the agency’s multiple U.S. laboratories, according to FDA sources. Equipment issues have also been a problem, with some labs citing a need for more sensitive instruments, sources within FDA said.

FDA spokeswoman Megan McSeveney confirmed the testing suspension and said the agency is not sure when it will resume.

“As testing for glyphosate will expand to several locations, we are currently working to ensure that the methods are validated for use in these labs. As soon as the validation is completed, testing for glyphosate will resume,” she said. “We cannot speculate on timing at this point.”

Alongside the testing for glyphosate, the FDA laboratories have also been analyzing foods for 2,4-D and other “acid herbicides,” documents obtained from the FDA show. The category of acid herbicides includes five of the top 10 active ingredients used in homes and gardens. Usage of 2,4-D is expected to triple in the coming year, according to the FDA.

The FDA work detail calls for the examination of roughly 1,340 food samples, 82 percent of which are to be domestic and 18 percent imported. The foods are to be collected from warehouse and retail stores only, and are to include a variety of cereal grains, vegetables and non-flavored, whole milk and eggs. Documents obtained from the agency through Freedom of Information requests show the agency has been testing corn and soybeanswheat, barley, sugar beets, rice, and even samples of yellow popcorn and “organic white popcorn.” 

McSeveney said glyphosate residues were only being analyzed in soy, corn, milk and eggs and the popcorn samples, while the other foods are being tested for residues of other herbicides.

Earlier this year, one of the agency’s senior chemists also analyzed glyphosate residues in honey and oatmeal and reported his results to the agency. Some honey samples contained residue levels well over the limit allowed in the European Union. The United States has no legal tolerance for glyphosate in honey, though the Environmental Protection Agency (EPA) said recently it may set one because of the FDA findings. The results for honey and oatmeal are not considered to be part of the official assignment, however, according to McSeveney.

With the testing on hold, it is not clear when the agency might have final results on the glyphosate residue analysis. McSeveney said preliminary results showed no violations of legal tolerance levels allowed for glyphosate in the foods tested. She did not provide details on what, if any, levels of residue were found. Tolerance levels are set by the EPA for a variety of pesticides expected to be found in foods. When residue levels are detected above the tolerance levels, enforcement action can be taken against the food producer.

Monsanto said earlier this year that no data has ever indicated residue levels of more than a fraction of allowable levels, and it is confident FDA testing will reaffirm the safety of its herbicide.

Though FDA annually tests domestic and imported foods for residues of other pesticides, it never tested for glyphosate before. It has not routinely tested for 2,4-D either, a fact also criticized by the GAO. The FDA testing for 2,4-D residues comes as the use of 2,4-D with food crops is expected to start rising due to the commercialization of new formulated herbicide products that combine glyphosate and 2,4-D. Safety questions have been raised about the combination. But the EPA gave a green light on Nov. 1 to a Dow AgroSciences’ herbicide combination of glyphosate and 2,4-D. The new products are intended to counter widespread weed resistance to glyphosate, and be used with new types of genetically engineered herbicide-tolerant crops.

The agrichemical industry asserts that residues of glyphosate, 2,4-D and the array of other chemicals used in modern-day agriculture do not pose a danger to human health, but the lack of testing to determine actual residue levels of some of the most-used chemicals, like glyphosate and 2,4-D, has been troubling to many consumer groups.

Getting solid data on glyphosate’s presence in the American food supply is more important than ever now as the EPA finalizes a risk assessment for glyphosate and tries to determine if any limits should be put on future use of the herbicide. The FDA work covers only a few foods, but is a long-needed, good first step. Consumers can only hope the testing resumes soon.

The article was first published 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 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.