Bayer Makes Bid for “Trust” Amid Third Monsanto Cancer Trial

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Bayer AG, which bought Monsanto last summer, said Monday that it was making scientific studies available for public scrutiny in an effort to counter growing concerns about the safety of Monsanto’s flagship glyphosate-based herbicide products.

“Transparency is a catalyst for trust, so more transparency is a good thing for consumers, policymakers and businesses, Liam Condon, president of Bayer’s crop science division, said in a statement. Safety, he said, is the company’s top priority.

The comments come as pressure is mounting on Bayer management as roughly 11,000 people are suing Monsanto alleging glyphosate-based herbicides such as Roundup cause non-Hodgkin lymphoma, and Monsanto has hidden the risks and manipulated the scientific record. The first Roundup cancer trial resulted in a jury verdict of $289 million in damages against Monsanto, though a judge later lowered that to $78 million. The second such trial ended last month with a jury verdict of $80.2 million against Monsanto. The third trial is now underway.

Last week U.S. District Judge Vince Chhabria told Bayer attorneys and plaintiffs’ attorneys that he would like the parties to enter into mediation to discuss a possible settlement. He vacated a fourth trial set to begin in May.

Monsanto and Bayer deny the allegations and say the weight of science supports the safety of glyphosate herbicides. They also deny claims that company scientists ghost-wrote seemingly independent scientific papers and otherwise manipulated the scientific record.

“By making our detailed scientific safety data available, we encourage anyone interested to see for themselves how comprehensive our approach to safety is. We embrace the opportunity to engage in dialogue so we can build more trust in sound science,” said Condon.

The company said it was providing access to 107 Bayer-owned glyphosate safety study reports that were submitted to the European Food Safety Authority as part of the substance authorization process in the European Union. The studies are accessible on Bayer’s transparency platform.

The news from Bayer comes ahead of an April 26 shareholders meeting in which some investors are calling for the head of Bayer CEO Werner Baumann for leading the company into the Monsanto acquisition. Monsanto’s top management walked away with millions of dollars in exit packages just before the first Roundup cancer trial, leaving Bayer holding the bag for the litigation losses and the bad publicity. Since last summer, the company has seen an exodus of customers as retailers, cities, school districts and others say they are backing away from the Monsanto herbicides.

As Bayer focuses on its messaging outside the court room, epidemiologist Beate Ritz, professor at the University of California Los Angeles School of Public Health, is due to take the stand today in Pilliod v. Monsanto,  the third Roundup cancer trial. Ritz has testified in the two prior trials that her analysis of several scientific studies shows that  there is a “credible link” between glyphosate-based herbicides such as Monsanto’s Roundup and non-Hodgkin’s lymphoma.

The current case was brought by Alva and Alberta Pilliod, a married couple who both have non-Hodgkin lymphoma they allege is due to years of Roundup use.

Following Ritz will be testimony from Dennis Weisenburger, a pathologist specializing in studying the causes of non-Hodgkin lymphoma. Weisenburger testified in the Edwin Hardeman v. Monsanto trial that Roundup is a “substantial cause” of cancer in people who are exposed.

Meanwhile, plaintiffs’ attorneys continue to worry about what they believe to be “geofencing” by Monsanto.   Geofencing is a popular advertising technique that delivers specific messaging/content to anyone within a specific geographic area designated by the company or group paying for the ad. The area can be very small, a mile radius around a specific address, for instance.  Anyone within that designated area using an app on a smart phone – such as a weather app or a game – would then be delivered the ad. Targeted individuals don’t have to be searching for information; it just appears on their smart phone.

Plaintiffs’ attorneys raised the issue in the Hardeman case, and had concerns that Monsanto was pushing messaging to jurors through geofencing in the first Roundup cancer trial, which was brought by groundskeeper Dewayne “Lee” Johnson.

In the Pilliod case, the issue was discussed Thursday in court as the plaintiffs attorneys sought a judicial order to prohibit Monsanto from the tactic, but the judge was skeptical and declined to issue such an order.

Here is part of the exchange. All can be seen in the trial transcript. 

PLAINTIFFS’ ATTORNEY BRENT WISNER:  Your Honor, I think there’s one — and I get your point. I think just to clarify one procedural factual thing. Right? If I were to walk over to a juror personally and say to you, “Hey, Juror Number 3, Monsanto’s stuff causes cancer and all these studies show it,” I mean, that would be a mistrial. Instantaneously. That’s jury tampering. Right? Now if they do that same thing — if I did the same thing by targeting every person’s phone in this courtroom or every single person’s phone in this courthouse and pushing that information, that same message to them on their phone — and what happens is -­  I don’t know if you use your phone for this kind of purposes, but, for example, when I look at my ESPN app and I’m looking at the scores for the UCLA water polo team, or whatever, you know, there’s little ads that pop up.

THE COURT: Sure.

MR. WISNER: And those ads are saying “Federal judge says Roundup is safe.” That’s the kind of stuff
we’re seeing. We saw this happening with quite intensity in the Johnson trial. Numerous jurors during voir dire mentioned that they were having these things pushed on them as soon as they walked in the building. And so whether or not Monsanto is or is not doing that, I think that if they are, that should be
prohibited. That’s not really a point of First Amendment. That is now clearly targeting people that
they know they can’t speak to.

THE COURT: And you’re asking me to assign a subjective intent that I don’t know exists and it’s
still prior restraint. I mean, technology has taken us places probably we never thought it would go… I guess if I were picking sides, I might believe that. But I can’t pick sides.

Who Is Paying for Monsanto’s Crimes? We Are

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This article was originally published in The Guardian.

By Carey Gillam

The chickens are coming home to roost, as they say in farm country.

For the second time in less than eight months a US jury has found that decades of scientific evidence demonstrates a clear cancer connection to Monsanto’s line of top-selling Roundup herbicides, which are used widely by consumers and farmers. Twice now jurors have additionally determined that the company’s own internal records show Monsanto has intentionally manipulated the public record to hide the cancer risks. Both juries found punitive damages were warranted because the company’s cover-up of cancer risks was so egregious.

The juries saw evidence that Monsanto has ghost-written scientific papers, tried to silence scientists, scuttled independent government testing and cozied up to regulators for favorable safety reviews of glyphosate, the active ingredient in Roundup.

Even the US district judge Vince Chhabria, who oversaw the San Francisco trial that concluded Wednesday with an $80.2m damage award, had harsh words for Monsanto. Chhabria said there were “large swaths of evidence” showing that the company’s herbicides could cause cancer. He also said there was “a great deal of evidence that Monsanto has not taken a responsible, objective approach to the safety of its product … and does not particularly care whether its product is in fact giving people cancer, focusing instead on manipulating public opinion and undermining anyone who raises genuine and legitimate concerns about the issue.”

Monsanto’s new owner, the German pharmaceutical company Bayer, asserts that the juries and judges are wrong; the evidence of a cancer risk is invalid; the evidence of bad corporate conduct is misunderstood and out of context; and that the company will ultimately prevail.

Meanwhile, Monsanto critics are celebrating the wins and counting on more as a third trial got underway this week and 11,000 additional plaintiffs await their turn. As well, a growing number of communities and businesses are backing away from use of Monsanto’s herbicides. And investors are punishing Bayer, pushing share prices to a seven-year low on Thursday.

Susquehanna Financial Group analyst Tom Claps has warned shareholders to brace for a global settlement of between $2.5bn and $4.5bn.

“We don’t believe [Monsanto] will lose every single trial, but we do believe that they could lose a significant majority,” he told the Guardian.

Following the recent courtroom victories, some have cheered the notion that Monsanto is finally being made to pay for alleged wrongdoing. But by selling to Bayer last summer for $63bn just before the Roundup cancer lawsuits started going to trial, Monsanto executives were able to walk away from the legal mess with riches. The Monsanto chairman Hugh Grant’s exit package allowed him to pocket $32m, for instance.

Amid the uproar of the courtroom scuffles, a larger issue looms: Monsanto’s push to make use of glyphosate herbicides so pervasive that traces are commonly found in our food and even our bodily fluids, is just one example of how several corporate giants are creating lasting human health and environmental woes around the world. Monsanto and its brethren have targeted farmers in particular as a critical market for their herbicides, fungicides and insecticides, and now many farmers around the world believe they cannot farm without them.

Studies show that along with promoting illness and disease in people, these pesticides pushed by Bayer and Monsanto, DowDuPont and other corporate players, are endangering wildlife, soil health, water quality and the long-term sustainability of food production. Yet regulators have allowed these corporations to combine forces, making them ever more powerful and more able to direct public policies that favor their interests.

The Massachusetts senator Elizabeth Warren this week called for taking back some of that power. She announced on Wednesday a plan to break up big agribusinesses and work against the type of corporate capture of Washington we have seen in recent years.

It’s a solid step in the right direction. But it cannot undo the suffering of cancer victims, nor easily transform a deeply contaminated landscape to create a healthier future and unleash us from the chains of a pesticide-dependent agricultural system.

And while Bayer may dole out a few billion dollars in damages, who is really being made to pay?

We all are.

Geoffrey Kabat’s Ties to Tobacco and Chemical Industry Groups

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Geoffrey Kabat, PhD, is a cancer epidemiologist and author of two books arguing that that health hazards of pesticides, electromagnetic fields, secondhand tobacco smoke and other environmental exposures are “greatly overblown.” He is often quoted in the press as an independent expert on cancer risk. Reporters who use Dr. Kabat as a source should be aware of (and disclose) his longstanding ties to the tobacco industry and involvement with groups that partner with the chemical industry on PR and lobbying campaigns.

Front group leader and advisor

Dr. Kabat is a member of the board of directors of the Science Literacy Project, the parent group of Genetic Literacy Project, which works behind the scenes with Monsanto to promote and defend agrichemical products. Dr. Kabat is also a member of the board of scientific advisors of the American Council on Science and Health (ACSH), a group that receives funding from chemical, tobacco and pharmaceutical companies.

Both Genetic Literacy Project and ACSH partnered with Monsanto on a public relations campaign to attempt to discredit the International Agency for Research on Cancer (IARC) for its report that glyphosate, the main ingredient in Monsanto’s Roundup herbicide, is a probable human carcinogen. According to documents released via litigation:

  • A Monsanto PR plan (February 2015) named Genetic Literacy Project among the “industry partners” Monsanto planned to engage in its efforts to “neutralize [the] impact” of the IARC report. The goals of Monsanto’s plan were to “protect the reputation and FTO of Roundup” and “provide cover for regulatory agencies…” GLP has since posted more than 200 articles critical of the cancer agency.
  • Emails from February 2015 show that Monsanto funded ACSH on an ongoing basis and reached out to give ACSH the “full array” of Monsanto information about the IARC report on glyphosate. In the emails, Monsanto staffers discussed the usefulness of ACSH’s materials on pesticides, and one wrote, “You WILL NOT GET A BETTER VALUE FOR YOUR DOLLAR than ACSH.” (emphasis in original)
  • ACSH staffers told Monsanto the IARC glyphosate report was on their radar, and noted, “We are involved in a full-court press re: IARC, regarding ag-chemicals, DINP [phthalate] and diesel exhaust.”

These groups used similar messaging to attack the IARC cancer researchers as “scientific frauds” and “anti-chemical enviros” who “lied” and “conspired to misrepresent” the science on glyphosate. They cited Dr. Kabat as a key source for claims that IARC is “discredited” and “only enviro-fanatics” pay attention to reports on cancer hazard. Dr. Kabat has written that “there are literally no more studies we can do to show glyphosate is safe,” based on an interview with an anonymous expert.

Attacking scientists who raise cancer concerns

Another example of how Dr. Kabat aids the Monsanto-connected groups can be found in his efforts to discredit a different group of scientists who raised cancer concerns about glyphosate in a February 2019 meta-analysis. The meta-analysis, co-authored by three scientists who were tapped by EPA to serve on an expert scientific advisory committee on glyphosate, reported “compelling links” between exposures to glyphosate-based herbicides and increased risk of non-Hodgkin lymphoma.

Dr. Kabat skewered the analysis in an article that was first published on Forbes but was later removed after Forbes editors received complaints about Kabat’s lack of disclosure about his ties to ACSH. When questioned about the issue, Forbes said the article was pulled because it violated Forbes standards and Kabat would no longer be a contributor to Forbes.

Dr. Kabat’s deleted Forbes article can still be read on Science 2.0, a website run by the former director of ACSH, and a version appears on Genetic Literacy Project. GLP Executive Director Jon Entine promoted Dr. Kabat’s article along with suggestions that the scientists may have committed “deliberate fraud.”

Jon Entine is also tied in with the American Council on Science and Health. ACSH published Entine’s 2011 book that defends atrazine, a pesticide manufactured by Syngenta, which was funding ACSH.

For more information about industry-orchestrated attacks on IARC, see:

Dr. Kabat’s longstanding tobacco ties

Dr. Kabat has published several papers favorable to the tobacco industry that were funded by the tobacco industry. He and his co-author on some of those papers, James Enstrom (a trustee of the American Council on Science and Health), have longstanding ties to the tobacco industry, according to a 2005 paper in BMJ Tobacco Control.

In a widely cited 2003 paper in BMJ, Kabat and Enstrom concluded that secondhand smoke does not increase the risk of lung cancer and heart disease. The study was sponsored in part by the Center for Indoor Air Research (CIAR), a tobacco industry group. Although that funding was disclosed, a follow-up analysis in BMJ Tobacco Control found that the disclosures provided by Kabat and Enstrom, although they met the journal’s standards, “did not provide the reader with a full picture of the tobacco industry’s involvement with the study authors. The tobacco industry documents reveal that the authors had long standing financial and other working relationships with the tobacco industry.” (emphasis added)

This table in the BMJ Tobacco Control paper reports the early ties:

Source: https://tobaccocontrol.bmj.com/content/14/2/118

In 2019, a search for Geoffrey Kabat in the UCSF Tobacco Industry Documents brings up over 800 documents, including a 2007 invoice to Phillip Morris for over $20,000 for “consulting on the health effects of low-yield cigarettes” billed at $350 an hour.

In 2008, Kabat and Enstrom published a paper partly funded by Phillip Morris reporting that previous assessments appeared to have overestimated the strength of the association between environmental tobacco smoke and coronary heart disease.

In 2012, Dr. Kabat co-authored a paper finding that mentholated cigarettes were not an important contributor to esophageal cancer. For that paper, Dr. Kabat declared he had “served as a consultant to a law firm and to a consulting firm on the health effects of menthol cigarettes.”

For more information from U.S. Right to Know about front groups and academics with undisclosed ties to food and chemical companies, see our Agrichemical Industry Propaganda Tracker.

Weedkiller ‘Raises Risk of Non-Hodgkin Lymphoma by 41%’

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Study says evidence ‘supports link’ between exposure to glyphosate and increased risk

This article was originally published in the Guardian.

By Carey Gillam

A broad new scientific analysis of the cancer-causing potential of glyphosate herbicides, the most widely used weedkilling products in the world, has found that people with high exposures to the popular pesticides have a 41% increased risk of developing a type of cancer called non-Hodgkin lymphoma.

The evidence “supports a compelling link” between exposures to glyphosate-based herbicides and increased risk for non-Hodgkin lymphoma (NHL), the authors concluded, though they said the specific numerical risk estimates should be interpreted with caution.

The findings by five US scientists contradict the US Environmental Protection Agency’s (EPA) assurances of safety over the weed killer and come as regulators in several countries consider limiting the use of glyphosate-based products in farming.

Monsanto and its German owner Bayer AG face more than 9,000 lawsuits in the US brought by people suffering from NHL who blame Monsanto’s glyphosate-based herbicides for their diseases. The first plaintiff to go to trial won a unanimous jury verdict against Monsanto in August, a verdict the company is appealing. The next trial, involving a separate plaintiff, is set to begin on 25 February, and several more trials are set for this year and into 2020.

Monsanto maintains there is no legitimate scientific research showing a definitive association between glyphosate and NHL or any type of cancer. Company officials say the EPA’s finding that glyphosate is “not likely” to cause cancer is backed by hundreds of studies finding no such connection.

The company claims the scientists with the International Agency for Research on Cancer (IARC) who classified glyphosate as a probable human carcinogen in 2015 engaged in improper conduct and failed to give adequate weight to several important studies.

But the new analysis could potentially complicate Monsanto’s defense of its top-selling herbicide. Three of the study authors were tapped by the EPA as board members for a 2016 scientific advisory panel on glyphosate. The new paper was published by the journal Mutation Research /Reviews in Mutation Research, whose editor in chief is EPA scientist David DeMarini.

The study’s authors say their meta-analysis is distinctive from previous assessments. “This paper makes a stronger case than previous meta-analyses that there is evidence of an increased risk of NHL due to glyphosate exposure,” said co-author Lianne Sheppard, a professor in the Environmental and Occupational Health Sciences department at the University of Washington. “From a population health point of view there are some real concerns.”

Sheppard was one of the scientific advisers to the EPA on glyphosate and was among a group of those advisers who told the EPA that it failed to follow proper scientific protocols in determining that glyphosate was not likely to cause cancer. “It was wrong,” Sheppard said of the EPA glyphosate assessment. “It was pretty obvious they didn’t follow their own rules. “Is there evidence that it is carcinogenic? The answer is yes.”

An EPA spokesperson said: “We are reviewing the study.” Bayer, which bought Monsanto in the summer of 2018, did not respond to a request for comment about the study.

A Bayer statement on glyphosate cites the EPA assessment and says that glyphosate herbicides have been “extensively evaluated” and are proven to be a “safe and efficient weed control tool”.

The study authors said their new meta-analysis evaluated all published human studies, including a 2018 updated government-funded study known as the Agricultural Health Study (AHS). Monsanto has cited the updated AHS study as proving that there is no tie between glyphosate and NHL. In conducting the new meta-analysis, the researchers said they focused on the highest exposed group in each study because those individuals would be most likely to have an elevated risk if in fact glyphosate herbicides cause NHL.

Looking only at individuals with real-world high exposures to the pesticide makes it is less likely that confounding factors may skew results, the authors said. In essence – if there is no true connection between the chemical and cancer then even highly exposed individuals should not develop cancer at significant rates.

In addition to looking at the human studies, the researchers also looked at other types of glyphosate studies, including many conducted on animals.

“Together, all of the meta-analyses conducted to date, including our own, consistently report the same key finding: exposure to GBHs are associated with an increased risk of NHL,” the scientists concluded.

David Savitz, professor of epidemiology in the Brown University School of Public Health, said the work was “well conducted” but lacking “fundamentally new information”.

“I would suggest it sustains the concern and need for assessment but doesn’t put the question to rest in any definitive sense,” Savitz said.

In a statement Bayer later said, “[The study] does not provide new epidemiology data; instead, it is a statistical manipulation that is at odds with the extensive body of science, 40 years of real world experience and the conclusions of regulators.”

It added: “[The study] provides no scientifically valid evidence that contradicts the conclusions of the extensive body of science demonstrating that glyphosate-based herbicides are not carcinogenic.”

Glyphosate: Cancer and Other Health Concerns

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Glyphosate, a synthetic herbicide patented in 1974 by the Monsanto Company and now manufactured and sold by many companies in hundreds of products, has been associated with cancer and other health concerns. Glyphosate is best known as the active ingredient in Roundup-branded herbicides, and the herbicide used with “Roundup Ready” genetically modified organisms (GMOs).

Herbicide tolerance is the most prevalent GMO trait engineered into food crops, with some 90% of corn and 94% of soybeans in the U.S. engineered to tolerate herbicides, according to USDA data. A 2017 study found that Americans’ exposure to glyphosate increased approximately 500 percent since Roundup Ready GMO crops were introduced in the U.S in 1996. Here are some key facts about glyphosate:

Most Widely Used Pesticide

According to a February 2016 study, glyphosate is the most widely used pesticide: “In the U.S., no pesticide has come remotely close to such intensive and widespread use.” Findings include:

  • Americans have applied 1.8 million tons of glyphosate since its introduction in 1974.
  • Worldwide 9.4 million tons of the chemical has been sprayed on fields – enough to spray nearly half a pound of Roundup on every cultivated acre of land in the world.
  • Globally, glyphosate use has risen almost 15-fold since Roundup Ready GMO crops were introduced.

Cancer Concerns

The scientific literature and regulatory conclusions regarding glyphosate and glyphosate-based herbicides show a mix of findings, making the safety of the herbicide a hotly debated subject:

In 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans” after reviewing years of published and peer-reviewed scientific studies. The team of international scientists found there was a particular association between glyphosate and non-Hodgkin lymphoma.

At the time of the IARC classification, the Environmental Protection Agency (EPA) was conducting a registration review. The EPA’s Cancer Assessment Review Committee (CARC) issued a report in September 2016 concluding that glyphosate was “not likely to be carcinogenic to humans” at doses relevant to human health. In publishing the CARC report, the EPA said that it was beginning work with the National Toxicology Program to investigate the mechanisms and toxic effects of glyphosate formulations.

The agency then convened a Scientific Advisory Panel (SAP) in December 2016 to review the CARC report conclusion that glyphosate was not likely to be carcinogenic. The scientific advisory panel members were divided in their assessment of EPA’s work, with some finding the EPA erred in how it evaluated certain research. Additionally, the EPA’s Office of Research and Development determined that the agency’s Office of Pesticide Programs had not followed proper protocols in its evaluation of glyphosate. An ORD memo stated that the government scientists agreed in part with IARC and believed EPA was not properly following guidelines in coming to the conclusion that glyphosate was not likely to be carcinogenic. ORD said the evidence could be deemed to support a “likely” carcinogenic or “suggestive” evidence of carcinogenicity classification. Nevertheless the EPA issued a draft report on glyphosate in December 2017 continuing to hold that the chemical is not likely to be carcinogenic.

The European Food Safety Authority and the European Chemicals Agency have said glyphosate is not likely to be carcinogenic to humans. But a March 2017 report by environmental and consumer groups argued that regulators relied improperly on research that was directed and manipulated by the chemical industry.

The WHO/FAO Joint Meeting on Pesticide Residues determined that glyphosate was unlikely to pose a carcinogenic risk to humans from exposure through the diet, though the finding was tarnished by conflict of interest concerns after it was revealed that certain members of the group, including its chair, worked for the International Life Sciences Institute, a group funded in part by Monsanto and one of its lobbying organizations.

On March 28, 2017, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment confirmed that it would add glyphosate to California’s Proposition 65 list of chemicals known to cause cancer. Monsanto sued to block the action but the case was dismissed. In a separate case, the court found that California could not require cancer warnings for products containing glyphosate. On June 12, 2018, the United States District Court for the Eastern District of California denied the California Attorney General’s request for the court to reconsider the decision. The court found that California could only require commercial speech that disclosed “purely factual and uncontroversial information,” and the science surrounding glyphosate carcinogenicity was not proven.

A long-running U.S. government-backed prospective cohort study of farm families in Iowa and North Carolina has not found any connections between glyphosate use and non-Hodgkin lymphoma, though researchers found that “among applicators in the highest exposure quartile, there was an increased risk of acute myeloid leukemia (AML) compared with never users…” The most recent published update to the study was made public in late 2017.

New studies in 2019 report cancer links and concerns about the validity of the EPA classification:  

  • An analysis published January 2019 argues that the U.S. EPA’s classification of glyphosate disregarded substantial scientific evidence of genotoxicity (the negative impact on a cell’s genetic material) associated with weed killing products such as Roundup.
  • A February 2019 meta-analysis of scientific studies reported a “compelling link” between glyphosate-based herbicides and non-Hodgkin lymphoma. Three of the study authors were members of the EPA’s scientific advisory panel on glyphosate who have stated publicly that the EPA failed to follow proper scientific practices in its glyphosate assessment.
  • A March 2019 study analyzed data from more than 30,000 farmers and agricultural workers from studies done in France, Norway and the U.S., and reported links between glyphosate and diffuse large B-cell lymphoma.

Cancer Lawsuits

More than 650 lawsuits against Monsanto Co. are part of multi district litigation (MDL) being overseen by Judge Vince Chhabria in U.S. District Court in San Francisco, filed by people alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma, and that Monsanto covered up the risks. An estimated 9,000 similar actions are pending in state courts. U.S. Right to Know is posting key documents from the litigation on our Monsanto Papers pages. See Carey Gillam’s Roundup Trial Tracker for news and tips about the ongoing legislation. 

In March 2017, the federal court judge unsealed some internal Monsanto documents that raised new questions about Monsanto’s influence on the EPA process and about the research regulators rely on. The documents suggest that Monsanto’s long-standing claims about the safety of glyphosate and Roundup do not necessarily rely on sound science as the company asserts, but on efforts to manipulate the science.

A study for the European Parliament published January 15, 2019 asserts that the EU approval of glyphosate was based on plagiarized text from Monsanto. The study found plagiarism in 50.1 percent of chapters dealing with the assessment of published studies on health risks related to glyphosate in Germany’s Federal Institute for Risk Assessment, including whole paragraphs and entire pages of plagiarized text.

See also 2018 journal articles about scientific interference:

The first trial concluded in August 2018 with the jury ruling that Monsanto’s weed killer was a substantial contributing factor in causing DeWayne “Lee” Johnson’s cancer, and ordering Monsanto to pay $289.25 million in damages, including $250 million in punitive damages. The judge in the case reduced the punitive damages to $39 million, bringing the total award to $78 million. Monsanto declared it would appeal and Johnson has cross-appealed, seeking to reinstate the jury award.

March 19, 2019 update: In a blow to Bayer, a federal journey handed a first-round victory to plaintiff Edwin Hardeman, as the six jury members found that Hardeman’s exposure to Roundup was a “substantial factor” in causing his non-Hodgkin lymphoma. The jury decision means the trial now moves into a second phase in which jurors will take up the issue of liability and damages.

Endocrine Disruption and Other Health Concerns

Some research suggests that glyphosate may be an endocrine disruptor. It has also been linked to liver disease, birth defects and reproductive problems in laboratory animals; and may kill beneficial gut bacteria and damage the DNA in human embryonic, placental and umbilical cord cells. Many scientists have raised concerns about the health risks of glyphosate. See:

Recent studies have shown adverse biological effects from low-dose exposures to glyphosate at levels to which people are routinely exposed.

  • A birth cohort study in Indiana published in 2017 – the first study of glyphosate exposure in US pregnant women using urine specimens as a direct measure of exposure – found detectable levels of glyphosate in more than 90% of the pregnant women tested and found the levels were significantly correlated with shortened pregnancy lengths.
  • A 2018 ecological and population study conducted in Argentina found high concentrations of glyphosate in the soil and dust in agricultural areas that also reported higher rates of spontaneous abortion and congenital abnormalities in children, suggesting a link between environmental exposure to glyphosate and reproductive problems. No other relevant sources of pollution were identified.
  • A 2017 study associated chronic, very low-level glyphosate exposures to non-alcoholic fatty liver disease in rats. According to the researchers, the results “imply that chronic consumption of extremely low levels of a GBH formulation (Roundup), at admissible glyphosate-equivalent concentrations, are associated with marked alterations of the liver proteome and metabolome,” the biomarkers for NAFLD.
  • A 2018 rat study conducted by the Ramazzini Institute reported that low-dose exposures to Roundup at levels considered safe significantly altered the gut microbiota in some of the rat pups. Another 2018 study reported that higher levels of glyphosate administered to mice disrupted the gut microbiota and caused anxiety and depression-like behaviors.
  • A 2018 rat study by Argentinian researchers linked low-level perinatal glyphosate exposures to impaired female reproductive performance and congenital anomalies in the next generation of offspring.

Glyphosate has also been linked by recent studies to harmful impacts on bees and monarch butterflies.

Desiccation

Some farmers use glyphosate on non-GMO crops such as wheat, barley, oats, and lentils to dry down the crop ahead of harvest in order to accelerate the harvest. This practice, known as desiccation, may be a significant source of dietary exposure to glyphosate.

Glyphosate Found in Food: U.S. Drags Its Feet on Testing

The USDA quietly dropped a plan to start testing food for residues of glyphosate in 2017. Internal agency documents obtained by U.S. Right to Know show the agency had planned to start testing over 300 samples of corn syrup for glyphosate in April 2017. But the agency killed the project before it started. The U.S. Food and Drug Administration began a limited testing program in 2016, but the effort was fraught with controversy and internal difficulties and the program was suspended in September 2016. Both agencies have programs that annually test foods for pesticide residues but both have routinely skipped testing for glyphosate.

Before the suspension, one FDA chemist found alarming levels of glyphosate in many samples of U.S. honey, levels that were technically illegal because there have been no allowable levels established for honey by the EPA. Here is a recap of news about glyphosate found in food:

Pesticides in Our Food: Where’s the Safety Data?

USDA data from 2016 shows detectable pesticide levels in 85% of more than 10,000 foods sampled, everything from mushrooms to grapes to green beans. The government says there are little to no health risks, but some scientists say there is little to no data to back up that claim. See “Chemicals on our food: When “safe” may not really be safe: Scientific scrutiny of pesticide residue in food grows; regulatory protections questioned,” by Carey Gillam (11/2018).

New Analysis Raises Questions About EPA’s Glyphosate Classification

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Researcher says the EPA has disregarded substantial evidence that the popular herbicide is linked to cancer

This article was originally published in Environmental Health News.

By Carey Gillam

A little more than a month ahead of a first-ever federal trial over the issue of whether or not Monsanto’s popular weed killers can cause cancer, a new analysis raises troubling questions about the U.S. Environmental Protection Agency’s (EPA) handling of pertinent science on glyphosate safety.

According to the report, which examines the opposing positions taken by the EPA and an international cancer research agency on glyphosate-based herbicides, the EPA has disregarded substantial scientific evidence of genotoxicity associated with weed killing products such as Roundup and other Monsanto brands. Genotoxicity refers to a substance’s destructive effect on a cell’s genetic material. Genotoxins can cause mutations in cells that can lead to cancer.

The EPA classifies glyphosate as not likely to be carcinogenic while the International Agency for Research on Cancer (IARC), which is part of the World Health Organization, classifies it as “probably carcinogenic.”

The paper was authored by Charles Benbrook, a former research professor who served at one time as executive director of the National Academy of Sciences board on agriculture, and was published in the journal Environmental Sciences Europe on Monday. It is based on Benbrook’s review of EPA and IARC records regarding the types and numbers of glyphosate studies each organization evaluated.

“Clearly, compared to EPA’s genotoxicity review, the IARC review is grounded on more recent, more sensitive, and more sophisticated genotoxic studies, and more accurately reflects real-world exposures,” Benbrook told EHN.

Benbrook testified as an expert witness in the first lawsuit to go to trial against Monsanto over claims its glyphosate herbicides cause cancer. The plaintiff in that case, Dewayne “Lee” Johnson, won a unanimous jury award of $289 million last year that the judge in the case cut to $78 million. Thousands of additional cancer victims have sued Monsanto and the second trial begins Feb. 25 in federal court in San Francisco. Benbrook is also expected to testify for the plaintiff in that case.

Monsanto is seeking to exclude Benbrook’s testimony at trial, saying he has no expertise in any physical science or field of medicine and no training or degree in toxicology and has never worked at the EPA or other regulatory body.

The EPA did not respond to a request for comment. The agency has maintained, however, that its review of glyphosate has been robust and thorough. Glyphosate has low toxicity for humans, and glyphosate products can be safely used by following directions on labeled products, according to the EPA.

In the new analysis, Benbrook is critical of the EPA’s scrutiny of glyphosate herbicides, noting that little weight was given to research regarding the actual formulations sold into the marketplace and used by millions of people around the world. Instead, the EPA and other regulators have mostly pointed to dozens of studies paid for by Monsanto and other companies selling glyphosate herbicides that found no cancer concerns. The EPA has given little attention to several independent research projects that have indicated the formulations can be more toxic than glyphosate alone, according to Benbrook.

Indeed, the EPA only started working in 2016—some 42 years after the first glyphosate herbicides came to market – with the U.S. National Toxicology Program to evaluate the comparative toxicity of the formulations. Early results disclosed in 2018 supported concerns about enhanced toxicity in formulations.

Several scientists, including from within the EPA’s Office of Research and Development (ORD), and from a panel of scientific experts convened by the EPA, have cited deficiencies and problems with the EPA’s decision to classify glyphosate as not likely to be carcinogenic to humans. But Benbrook’s analysis is the first to look deeply at how and why the EPA and IARC drew such divergent conclusions.

Benbrook looked at the citations for genotoxicity tests discussed in the EPA and IARC reports, both those that were published in peer-reviewed journals and the unpublished ones that were presented to the EPA by Monsanto and other companies.

Some studies looked at glyphosate alone, and/or glyphosate-based herbicide formulations and some included findings about a substance called aminomethylphosphonic acid (AMPA), which is glyphosate’s primary metabolite.

Benbrook’s analysis found that within the body of available evidence, the EPA relied on 151 studies, 115 of which showed negative results, meaning no evidence of genotoxicity, and only 36 that had positive results. IARC cited 191 studies, only 45 of which showed negative results and 146 of which showed evidence of genotoxicity.

IARC said within these studies it found “strong evidence that exposure to glyphosate or glyphosate-based formulations is genotoxic…”

Benbrook’s analysis reports that over the last three years at least 27 additional studies have been published addressing possible mechanisms of genotoxic action for glyphosate and/or formulated glyphosate-based herbicides and all but one of the 27 studies reported one or more positive result. There were 18 positives arising from DNA damage, six associated with oxidative stress, and two with other genotoxicity mechanisms, his paper states.

According to Benbrook, the EPA’s failure to focus on formulated glyphosate-based herbicides is dangerous because these formulations “account for all commercial uses and human exposures (no herbicide products contain just glyphosate).”

More research is needed on real-world exposures, Benbrook concludes.

Update: See also the editorial by the editors of Environmental Sciences Europe about the implications of Benbrook’s analysis, “Some food for thought: a short comment on Charles Benbrook’s paper“.

Carey Gillam is a journalist and author, and a public interest researcher for US Right to Know, a not-for-profit food industry research group. Follow her on Twitter at @careygillam.

ILSI Wields Stealthy Influence for Food, Agrichemical Industries

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The International Life Sciences Institute (ILSI) is a corporate-funded nonprofit organization founded in 1978 by Alex Malaspina, a former senior vice president at Coca-Cola who worked for the company from 1969 until 2001. ILSI claims on its website to bring together scientists from industry, government and academia to “provide science that improves public health.” However, evidence suggests that ILSI Global and its branches operate as fronts to influence science and policies in ways that benefit corporate interests over public health.

ILSI is funded by the food and agrichemical industries, according to internal documents obtained by U.S. Right to Know.

U.S. Right to Know has also reported just how far the influence of ILSI and its top operatives extends. In 2016, Carey Gillam reported that ILSI’s founder, Alex Malaspina, was able to ask for and receive input and guidance from a top official at the U.S. Centers for Disease Control and Prevention (CDC) on how to address actions by the World Health Organization that were hurting the food and beverage industry.

The emails, obtained via state freedom of information requests, reveal that Dr. Barbara Bowman, director of a CDC division charged with preventing heart disease and stroke, tried to help Malaspina find inroads to influence WHO officials to back off anti-sugar talk. Bowman suggested people and groups for Malaspina to talk to, and solicited his comments on some CDC summaries of reports, the emails show. (Bowman stepped down after articles were published reporting on these ties.)

Coca-Cola has kept close ties with ILSI ever since Malaspina founded the group. In 2015, ILSI’s president was Rhona Applebaum, Coke’s chief health and science officer. Applebaum retired from Coke in November 2015 after revelations that the company funded a group called the Global Energy Balance Network to spin the obesity story. Coca-Cola has gone to great lengths to try to shift blame for obesity away from sugary drinks. For more on Coke’s obesity spin campaign, see articles from the New York Times and Associated Press.

ILSI soda controversy in China

Two papers published in January 2019 document how Coca-Cola and other corporations used ILSI to influence decades of Chinese science and public policy on obesity and diet-related illnesses such as Type 2 diabetes and hypertension.

On Jan. 9, 2019, The New York Times reported on the two new studies showing how Coca-Cola and other Western food and beverage giants “helped shape decades of Chinese science and public policy on obesity and diet-related diseases” by operating through ILSI to cultivate key Chinese officials “in an effort to stave off the growing movement for food regulation and soda taxes that has been sweeping the west.”

ILSI is so well-placed in China that it operates from inside the government’s Centre for Disease Control and Prevention in Beijing, the researchers reported. See:

ILSI glyphosate controversy

In May 2016, ILSI came under scrutiny after revelations that the chair of ILSI’s board of trustees, Alan Boobis, was at the same time the chairman of a UN panel that found Monsanto’s herbicide glyphosate unlikely to pose a cancer risk through diet.

ILSI has received at least $500,000 in donations from Monsanto, in addition to significant contributions from other chemical industry sources. Monsanto draws roughly a third of its $15 billion annual revenues from its Roundup branded glyphosate-based herbicide products.

The story and corporate funding of ILSI was first reported by Carey Gillam for U.S. Right to Know. The Guardian, Die Zeit, ARD and Horticulture Week have also covered the conflict of interest involving ILSI and the glyphosate review by the UN’s Joint Meeting on Pesticide Residues.

More on ILSI:

International Life Sciences Institute (ILSI) 2012 major donor list

UCSD Hires Coke-Funded Researcher,” by Morgan Cook, San Diego Union-Tribune (9.29.2016)

What is Going on at the CDC? Health Agency Ethics Need Scrutiny,” by Carey Gillam, The Hill (8.27.2016)

More Coca-Cola Ties Seen Inside U.S. Centers for Disease Control,” by Carey Gillam, Huffington Post (8.1.2016)

“CDC Official Exits Agency After Coca-Cola Connections Come to Light,” by Carey Gillam, Huffington Post (12.6.2017)

Beverage Industry Finds Friend Inside U.S. Health Agency,” by Carey Gillam, Huffington Post (6.28.2016)

Conflict of Interest Concerns Cloud Glyphosate Review,” by Carey Gillam, U.S. Right to Know (5.12.2016)

UN/WHO Panel in Conflict of Interest Row over Glyphosate Cancer Risk,” by Arthur Neslen, The Guardian (5.17.2016)

Hank Campbell’s Maze of Monsanto-Loving Science Blogs

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Update: As this article was about to publish, Hank Campbell was removed from the staff roster of the American Council on Science and Health, the organization he has led as president since July 2015, for unknown reasons. A few days later, he delinked his ring of science blogs (Science 2.0, Science Codex, ScienceBlogs) from ACSH.org.

Hank Campbell was until this week president of the American Council on Science and Health (ACSH), a group that claims to be a “pro-science consumer advocacy organization,” but according to leaked internal documents and emails released via litigation, ACSH offers its advocacy not to consumers but to chemical, tobacco and pharmaceutical corporate interests (and others) that provide financial backing. For more about ACSH’s work as a corporate front group, see our fact sheet.

Campbell took over the leadership of ACSH in July 2015 from acting president Gil Ross, MD, a convicted felon who was jailed for Medicaid fraud. Tax records show that Dr. Ross was still on the ACSH payroll as of 2017 with $111,618 in compensation as “former senior director of medicine and public health,” while Campbell received $224,358. Prior to leading ACSH, Campbell worked in software development, created what he calls the “world famous Science 2.0 movement,” and wrote a book about the “anti-science” left.

He runs a ring of questionable science websites, including one that posted anti-Semitic materials that Campbell tried to defend.

Campbell’s network of for-profit, non-profit science blogs

NYU Professor Charles Seife posted documents in November that shed light on Campbell’s network of science blogs that help promote the American Council on Science and Health. In a Twitter thread he called “Mapping a Monsanto-loving octopus,” Seife reported:

  • Campbell’s corporation ION Publications LLC (founded in 2008) owns several science blogging websites, including Science 2.0, Science Codex and others. According to its most recent tax records, ACSH paid ION $60,000 as a “website development service that promotes ACSH.org and increases traffic to the website.”
  • In 2018, Campbell converted Science 2.0 into a nonprofit and then acquired ScienceBlogs.com. The nonprofit’s officers are Campbell and David Zaruk, a former chemical industry lobbyist who once worked for the public relations firm Burson-Marsteller. The science blogging websites under these umbrellas cross-promote each other and the ACSH.org website.

Seife summed up his Twitter thread: “this is how a once-admired science blogging site, @scienceblogs, was acquired by a complex and, IMO, shady network of for-profits and non-profits helping Monsanto.”

Helping Monsanto

According to documents released via litigation, Monsanto paid the American Council on Science and Health in 2015 to defend glyphosate and help discredit the scientists of the World Health Organization’s cancer research panel for their report raising cancer concerns about the herbicide.

The documents indicate that Monsanto executives were uncomfortable about working with ACSH but did so anyway because “we don’t have a lot of supporters and can’t afford to lose the few we have,” Daniel Goldstein, Monsanto’s senior science lead, wrote in an email to colleagues. Goldstein provided links to two books, a pamphlet, a pesticide review and 53 articles on the ACSH.org website that he described as “EXTREMELY USEFUL” (emphasis Goldstein’s).

Anti-Semitic material on Science 2.0

Some former writers for ScienceBlogs.com refused to grant rights for their work to remain on the site due to its association with Campbell and Science 2.0, and other observers called on writers to do the same. At issue was Science 2.0’s publishing of anti-Semitic material, which Campbell tried to explain and defend.

In response to the criticism, Campbell removed some posts by the physicist Sascha Vongehr, including one titled, “One Thing Hitler Did Wrong.” The removal notice describes Vongehr’s work as “satire” that came off as offensive due to the “the author’s imperfect grasp of the English language.” Science 2.0 continues to display dozens of articles by Vongehr, including some that contain various anti-Semitic sentiments, such as a post in which Vongehr describes himself as “a Germanic racist” and another titled “Advanced Racism For Dr Duke And Prof Slattery: Why Hate Jews?”

Related:
Science 2.0 refuses to remove Nazi eugenics blog posts, by Keira Havens, Medium (7.9.2018)

Using USA Today as an outlet

In February 2017, two dozen health, environmental, labor and public interest groups wrote to the editors of USA Today with concerns that the paper regularly publishes science columns authored by ACSH staff, including Campbell, without disclosing ACSH’s funding from multiple corporate interests. ACSH Vice President of Scientific Affairs Alex Berezow, who co-authored Campbell’s 2012 book, remains on the USA Today Board of Contributors but his bio there does not disclose his leadership staff position at ACSH.

Related:

Chemicals on Our Food: When “Safe” May Not Really Be Safe

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Scientific scrutiny of pesticide residue in food grows; regulatory protections questioned

This article was originally published in Environmental Health News.

By Carey Gillam

Weed killers in wheat crackers and cereals, insecticides in apple juice and a mix of multiple pesticides in spinach, string beans and other veggies – all are part of the daily diets of many Americans. For decades, federal officials have declared tiny traces of these contaminants to be safe. But a new wave of scientific scrutiny is challenging those assertions.

Though many consumers might not be aware of it, every year, government scientists document how hundreds of chemicals used by farmers on their fields and crops leave residues in widely consumed foods. More than 75 percent of fruits and more than 50 percent of vegetables sampled carried pesticides residues in the latest sampling reported by the Food and Drug Administration. Even residues of the tightly restricted bug-killing chemical DDT are found in food, along with a range of other pesticides known by scientists to be linked to a range of illnesses and disease. The pesticide endosulfan, banned worldwide because of evidence that it can cause neurological and reproductive problems, was also found in food samples, the FDA report said.

U.S. regulators and the companies that sell the chemicals to farmers insist that the pesticide residues pose no threat to human health. Most residue levels found in food fall within legal “tolerance” levels set by the Environmental Protection Agency (EPA), regulators say.

“Americans depend on the FDA to ensure the safety of their families and the foods they eat,” FDA Commissioner Scott Gottlieb said in a press release accompanying the agency’s Oct. 1 release of its residue report. “Like other recent reports, the results show that overall levels of pesticide chemical residues are below the Environmental Protection Agency’s tolerances, and therefore don’t pose a risk to consumers.”

The EPA is so confident that traces of pesticides in food are safe that the agency has granted multiple chemical company requests for increases in the allowed tolerances, effectively providing a legal basis for higher levels of pesticide residues to be allowed in American food.

But recent scientific studies have prompted many scientists to warn that years of promises of safety may be wrong. While no one is expected to drop dead from eating a bowl of cereal containing pesticide residues, repeated low level exposures to trace amounts of pesticides in the diet could be contributing to a range of health problems, particularly for children, scientists say.

“There are probably many other health effects; we just haven’t studied them”

A team of Harvard scientists published a commentary in October stating that more research about potential links between disease and consumption of pesticide residues is “urgently needed” as more than 90 percent of the U.S. population has pesticide residues in their urine and blood. The primary route of exposure to these pesticides is through the food people eat, the Harvard research team said.

Several additional Harvard-affiliated scientists published a study earlier this year of women who were trying to get pregnant. The findings suggested that dietary pesticide exposure within a “typical” range was associated both with problems women had getting pregnant and delivering live babies, the scientists said.

“Clearly the current tolerance levels protect us from acute toxicity. The problem is that it is not clear to what extent long-term low-level exposure to pesticide residues through food may or may not be health hazards,” said Dr. Jorge Chavarro, associate professor of the Departments of Nutrition and Epidemiology at the Harvard T.H. Chan School of Public Health, and one of the study authors.

“Exposure to pesticide residues through diet is associated [with] some reproductive outcomes including semen quality and greater risk of pregnancy loss among women undergoing infertility treatments. There are probably many other health effects; we just haven’t studied them sufficiently to make an adequate risk assessment,” Chavarro said.

Toxicologist Linda Birnbaum, who directs the U.S. National Institute of Environmental Health Sciences (NIEHS), has also raised concerns about pesticide dangers through exposures once assumed to be safe. Last year she called for “an overall reduction in the use of agricultural pesticides” due to multiple concerns for human health, stating that “existing US regulations have not kept pace with scientific advances showing that widely used chemicals cause serious health problems at levels previously assumed to be safe.”

In an interview Birnbaum said that pesticide residues in food and water are among the types of exposures that need greater regulatory scrutiny.

“Do I think that levels that are currently set are safe? Probably not,” said Birnbaum. “We have people of different susceptibility, whether because of their own genetics, or their age, whatever may make them more susceptible to these things,” she said.

“While we look at chemicals one at a time, there is a lot of evidence for things acting in a synergistic fashion. A lot of our standard testing protocols, many that were developed 40 to 50 years ago, are not asking the questions we should be asking,” she added.

Legal doesn’t mean safe

Other recent scientific papers also point to troubling findings. One by a group of international scientists published in May found glyphosate herbicide at doses currently considered “safe” are capable of causing health problems before the onset of puberty. More research is needed to understand potential risks to children, the study authors said.

And in a paper published Oct. 22 in JAMA Internal Medicine, French researchers said that when looking at pesticide residue links to cancer in a study of the diets of more than 68,000 people, they found indications that consumption of organic foods, which are less likely to carry synthetic pesticide residues than foods made with conventionally grown crops, was associated with a reduced risk of cancer.

A 2009 paper published by a Harvard researcher and two FDA scientists found 19 out of 100 food samples that children commonly consumed contained at least one insecticide known to be a neurotoxin. The foods the researchers looked at were fresh vegetables, fruits and juices. Since then, evidence has grown about the harmful human health impacts of insecticides, in particular.

Unacceptable levels

“A number of current legal standards for pesticides in food and water do not fully protect public health, and do not reflect the latest science,” said Olga Naidenko, senior science advisor to the non-profit Environmental Working Group, which has issued several reports looking at potential dangers of pesticides in food and water. “Legal does not necessarily reflect ‘safe,'” she said.

One example of how regulatory assurances of safety have been found lacking when it comes to pesticide residues is the case of an insecticide known as chlorpyrifos. Marketed by Dow Chemical, which became the DowDuPont company in 2017, chlorpyrifos is applied to more than 30 percent of apples, asparagus, walnuts, onions, grapes, broccoli, cherries and cauliflower grown in the U.S. and is commonly found on foods consumed by children. The EPA has said for years that exposures below the legal tolerances it set were nothing to worry about.

Yet scientific research in recent years has demonstrated an association between chlorpyrifos exposure and cognitive deficits in children. The evidence of harm to young developing brains is so strong that the EPA in 2015 said that it “cannot find that any current tolerances are safe.”

The EPA said that because of unacceptable levels of the insecticide in food and drinking water it planned to ban the pesticide from agricultural use. But pressure from Dow and chemical industry lobbyists have kept the chemical in wide use on American farms. The FDA’s recent report found it the 11th most prevalent pesticides in U.S. foods out of hundreds included in the testing.

A federal court in August said that the Trump Administration was endangering public health by keeping chlorpyrifos in use for agricultural food production. The court cited “scientific evidence that its residue on food causes neurodevelopmental damage to children” and ordered the EPA to revoke all tolerances and ban the chemical from the market. The EPA has yet to act on that order, and is seeking a rehearing before the full 9th Circuit Court of Appeals.

When asked how to explain its changing positions on chlorpyrifos, an agency spokesman said that the EPA “plans to continue to review the science addressing neurodevelopmental effects” of the chemical.

The fact that it is still in wide use frustrates and angers physicians who specialize in child health and leaves them wondering what other pesticide exposures in food might be doing to people.

“The bottom line is that the biggest public health concerns for chlorpyrifos are from its presence in foods,” said Dr. Bradley Peterson director of the Institute for the Developing Mind at the Children’s Hospital of Los Angeles. “Even small exposures can potentially have harmful effects.”

The EPA decision to continue to allow chlorpyrifos into American diets is “emblematic of a broader dismissal of scientific evidence” that challenges human health as well as scientific integrity, according to Dr. Leonardo Trasande, who directs the Division of Environmental Pediatrics within the Department of Pediatrics at New York University’s Langone Health.

Epidemiologist Philip Landrigan, director of Boston College’s Global Public Health initiative, and a former scientist with the U.S. Centers for Disease Control, is advocating for a ban on all organophosphates, a class of insecticides that includes chlorpyrifos, because of the danger they pose to children.

“Children are exquisitely vulnerable to these chemicals,” said Landrigan. “This is about protecting kids.”

Increased tolerances at industry request

The Federal Food, Drug, and Cosmetic Act authorizes the EPA to regulate the use of pesticides on foods according to specific statutory standards and grants the EPA a limited authority to establish tolerances for pesticides meeting statutory qualifications.

Tolerances vary from food to food and pesticide to pesticide, so an apple might legally carry more of a certain type of insecticide residue than a plum, for instance. The tolerances also vary from country to country, so what the U.S. sets as a legal tolerance for residues of a pesticide on a particular food can – and often is – much different than limits set in other countries. As part of the setting of those tolerances, regulators examine data showing how much residue persists after a pesticide is used as intended on a crop, and they undertake the dietary risk assessments to confirm that the levels of pesticide residues don’t pose human health concerns.

The agency says that it accounts for the fact that the diets of infants and children may be quite different from those of adults and that they consume more food for their size than adults. The EPA also says it combines information about routes of pesticide exposure – food, drinking water residential uses – with information about the toxicity of each pesticide to determine the potential risks posed by the pesticide residues. The agency says if the risks are “unacceptable,” it will not approve the tolerances.

The EPA also says that when it makes tolerance decisions, it “seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices.”

Monsanto, which became of unit of Bayer AG earlier this year, has successfully asked the EPA to expand the levels of glyphosate residues allowed in several foods, including in wheat and oats.

In 1993, for example, the EPA had a tolerance for glyphosate in oats at 0.1 parts per million (ppm) but in 1996 Monsanto asked EPA to raise the tolerance to 20 ppm and the EPA did as asked. In 2008, at Monsanto’s suggestion, the EPA again looked to raise the tolerance for glyphosate in oats, this time to 30 ppm.

At that time, it also said it would raise the tolerance for glyphosate in barley from 20 ppm to 30 ppm, raise the tolerance in field corn from 1 to 5 ppm and raise the tolerance of glyphosate residue in wheat from 5 ppm to 30 ppm, a 500 percent increase. The 30 ppm for wheat is matched by more than 60 other countries, but is well above the tolerances allowed in more than 50 countries, according to an international tolerance database established with EPA funding and maintained now by a private government affairs consulting group.

“The Agency has determined that the increased tolerances are safe, i.e, there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue,” the EPA stated in the May 21, 2008 Federal Register.

“All these statements from EPA – trust us it’s safe. But the truth is we have no idea if it actually is safe,” said Dr. Bruce Lanphear, a clinician scientist at the Child & Family Research Institute, BC Children’s Hospital, and a professor in the faculty of health sciences at Simon Fraser University in Vancouver, British Columbia. Lanphear said that while regulators assume toxic effects increase with dose, scientific evidence shows that some chemicals are most toxic at the lowest levels of exposure. Protecting public health will require rethinking basic assumptions about how agencies regulate chemicals, he argued in a paper published last year.

In recent years both Monsanto and Dow have received new tolerance levels for the pesticides dicamba and 2,4-D on food as well.

Raising tolerances allows farmers to use pesticides in various ways that may leave more residues, but that doesn’t threaten human health, according to Monsanto. In a blog posted last year, Monsanto scientist Dan Goldstein asserted the safety of pesticide residues in food generally and of glyphosate in particular. Even when they exceed the regulatory legal limits, pesticide residues are so minuscule they pose no danger, according to Goldstein, who posted the blog before he retired from Monsanto this year.

About half of foods sampled contained traces of pesticides

Amid the scientific concerns, the most recent FDA data on pesticide residues in food found that roughly half of the foods the agency sampled contained traces of insecticides, herbicides, fungicides and other toxic chemicals used by farmers in growing hundreds of different foods.

More than 90 percent of apple juices sampled were found to contain pesticides. The FDA also reported that more than 60 percent of cantaloupe carried residues. Overall, 79 percent of American fruits and 52 percent of vegetables contained residues of various pesticides – many known by scientists to be linked to a range of illnesses and disease. Pesticides were also found in soy, corn, oat and wheat products, and finished foods like cereals, crackers and macaroni.

The FDA analysis “almost exclusively” is focused on products that are not labeled as organic, according to FDA spokesman Peter Cassell.

The FDA downplays the percentage of foods containing pesticide residues and focuses on the percentage of samples for which there is no violation of the tolerance levels. In its most recent report, the FDA said that more than “99% of domestic and 90% of import human foods were compliant with federal standards.”

The report marked the agency’s launch of testing for the weed killer glyphosate in foods. The Government Accountability Office said in 2014 that both the FDA and the U.S. Department of Agriculture should start regularly testing foods for glyphosate. The FDA did only limited tests looking for glyphosate residues, however, sampling corn and soy and milk and eggs for the weed killer, the agency said. No residues of glyphosate were found in milk or eggs, but residues were found in 63.1 percent of the corn samples and 67 percent of the soybean samples, according to FDA data.

The agency did not disclose findings by one of its chemists of glyphosate in oatmeal and honey products, even though the FDA chemist made his findings known to supervisors and other scientists outside the agency.

Cassell said the honey and oatmeal findings were not part of the agency’s assignment.

Overall, the new FDA report covered sampling done from Oct. 1, 2015, through Sept. 30, 2016, and included analysis of 7,413 samples of food examined as part of the FDA’s “pesticide monitoring program.” Most of the samples were of food to be eaten by people, but 467 samples were of animal food. The agency said that pesticide residues were found in 47.1 percent of the samples of food for people produced domestically and 49.3 percent of food imported from other countries destined for consumer meals. Animal food products were similar, with pesticide residues found in 57 percent of the domestic samples and 45.3 percent of imported foods for animals.

Many imported food samples showed residues of pesticides high enough to break the legal limits, the FDA said. Nearly 20 percent of imported grain and grain product samples showed illegally high levels of pesticides, for example.