Pursuing Truth and Transparency in America's Food System

Carey Gillam Launches Book on Pesticide Problems & Monsanto Influence; Called to Appear Before EU Parliament

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News Release
For Immediate Release: Tuesday, October 10, 2017
For More Information Contact: Stacy Malkan (510) 542-9224                       

Today, Carey Gillam, a former Reuters reporter and current research director for U.S. Right to Know, launched her new book, Whitewash: The Story of a Weed Killer, Cancer and the Corruption of Science (Island Press), a hard-hitting investigation into the pesticide at the center of a regulatory and legal maelstrom on both sides of the Atlantic.

Tomorrow, Gillam will appear as an invited expert before members of the European Parliament at a joint committee hearing to discuss Monsanto’s efforts to manipulate science and regulatory assessments on glyphosate.

Gillam’s book and testimony are based on 20 years of research and scores of industry documents that describe the patterns of deception surrounding Monsanto’s flagship weed killer Roundup and its active ingredient glyphosate, and the impacts on people and the environment.

According to Publishers Weekly, “Gillam expertly covers a contentious front where corporate malfeasance intersects with issues of public health and ecology.” Kirkus Reviews calls Whitewash “a hard-hitting, eye-opening narrative,” and a “forceful argument for an agricultural regulatory environment that puts public interest above corporate profits.”

As Whitewash details, glyphosate is the most widely used agrichemical in history—a pesticide so pervasive it’s in our air, our water, our food, and even our own bodies. For decades it’s been lauded as the chemical that’s “safe enough to drink,” but a growing body of scientific research ties glyphosate to cancers and a host of other health and environmental threats.

Whitewash explores the legal claims of thousands of Americans who allege Roundup caused their cancers, and exposes the powerful influence of a multi-billion-dollar industry that has worked for decades to keep consumers in the dark and regulators in check. The book reveals how political influence has been at work for years in regulatory agencies while also laying bare unappetizing truths about the levels of glyphosate and other pesticides commonly found in our food products.

Whitewash makes clear that 55 years after Rachel Carson and Silent Spring awakened the world to the dangers of unchecked pesticide use, we have failed to heed her warnings.

Recent news about Monsanto’s actions on glyphosate:

New York Times:Monsanto’s Roundup Faces European Politics and US Lawsuits,” by Danny Hakim, Oct. 4, 2017

Le Monde Series:

The Guardian:Monsanto Banned from EU Parliament,” by Arthur Neslen, Sept. 28, 2017

USRTK: How Monsanto Manufactured ‘Outrage’ Over IARC Cancer Classification of Glyphosate,” by Carey Gillam, Sept. 19, 2017

Carey Gillam is a veteran journalist, researcher, and writer with more than 25 years of experience covering corporate America. A former senior correspondent for Reuters’ international news service, Gillam digs deep into the big business of food and agriculture.

U.S. Right to Know is a nonprofit organization that investigates the risks associated with the corporate food system, and the food industry’s practices and influence on public policy.

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Collusion or Coincidence? Records Show EPA Efforts to Slow Herbicide Review Came in Coordination with Monsanto

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Newly released government email communications show a persistent effort by multiple officials within the Environmental Protection Agency (EPA) to slow a separate federal agency’s safety review of Monsanto’s top-selling herbicide. Notably, the records demonstrate that the EPA efforts came at the behest of Monsanto, and that EPA officials were helpful enough to keep the chemical giant updated on their progress.

The communications, most of which were obtained through Freedom of Information Act (FOIA) requests, show that it was early 2015 when the EPA and Monsanto began working in concert to stall a toxicology review that a unit tied to the Centers for Disease Control and Prevention (CDC) was conducting on glyphosate, the key ingredient in Monsanto’s branded Roundup herbicide products. The details revealed in the documents come as Monsanto is defending itself against lawsuits alleging that it has tried to cover up evidence of harm with its herbicides.

The Agency for Toxic Substances and Disease Registry (ATSDR), a federal public health agency that along with the CDC is part of the U.S. Department of Health and Human Services (HHS), is charged with evaluating the potential adverse human health effects from exposures to hazardous substances in the environment. So it made sense for the ATSDR to take a look at glyphosate, which is widely used on U.S. farms, residential lawns and gardens, school playgrounds and golf courses. Glyphosate is widely used in food production and glyphosate residues have been found in testing of human urine.

The ATSDR announced in February 2015 that it planned to publish a toxicological profile of glyphosate by October of that year. But by October, that review was on hold, and to this date no such review has yet been published.

The documents reveal this was no accident, no bureaucratic delay, but rather was the result of a collaborative effort between Monsanto and a group of high-ranking EPA officials.

For Monsanto, the timing of the ATSDR review was worrisome. In March 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) had declared glyphosate to be a probable human carcinogen, and Monsanto feared ATSDR might have similar concerns about the chemical. Previous reports have described how one EPA official, Jess Rowland, communicated to Monsanto in April 2015 his willingness to try to kill the ATSDR review. Rowland, who retired in 2016, was the deputy division director within the health effects division of the EPA’s Office of Pesticide Programs (OPP). Allegations of collusion between Rowland and Monsanto have prompted a probe by the EPA’s Office of Inspector General.

But the trove of documents newly obtained from within EPA and HHS demonstrate that the assistance to Monsanto came not only from Rowland but also from even higher-level EPA officials. Rather than encourage and assist the toxicology review of glyphosate, Monsanto and EPA officials repeatedly complained to ATSDR and HHS that such a review was unnecessarily “duplicative” and should take a back seat to an EPA review also underway.

The following timeline shows how the events unfolded:

May 19, 2015 – Michael Dykes, who at that time was Monsanto’s long-time vice president of government affairs, wrote directly to the EPA’s Jim Jones, the Assistant Administrator for the Office of Chemical Safety & Pollution Prevention. Jones had oversight of the EPA’s Office of Pesticide Programs (OPP) and was a presidential appointee who carried significant clout. The afternoon was waning when the email came in at 3:28 p.m. Dykes reminded Jones that they had recently discussed the HHS’ ATSDR glyphosate review at a meeting. “You were not aware of their review. Did you learn anything more about their efforts?” Dykes asked.

Jones did not waste time. Roughly an hour later he forwarded the message to OPP Director Jack Housenger, writing “Monsanto thinks atsdr is doing a glyphosate Assessment. Could you guys run that down?” Housenger responds quickly: “Yes. Jess checked with them…. It has been difficult to get information.”

Within an hour Jones instructed a member of his staff to get him contact information for the head person responsible for ATSDR. She replied the next morning that Dr. Patrick Breysse was the point person. Breysse joined the CDC in 2014 as director of its National Center for Environmental Health, overseeing the NCEH’s ATSDR.

May 20, 2015 It was only a little after 8:30 a.m. but Jones told the staff member to instruct Housenger to get in touch with Breysse, and within two hours Housenger had penned an email to Breysse explaining that an EPA’s own re-evaluation/risk assessment of glyphosate was nearing completion, and asking Breysse if “you would still feel the need to do your assessment.” Housenger told Breysse that he already had reached the individual assigned to the ATSDR assessment and she had indicated she would “coordinate” with EPA, but that was not sufficient. Housenger did not mention Monsanto’s outreach to EPA on the issue, but instead questioned “whether this is a good use of government resources” for ATSDR to continue with its review. Breysse responded that he would “look into this” and Housenger thanked him for his quick response. Breysse then reached out to an ATSDR division director named James Stephens to arrange a discussion about the EPA request.

May 21, 2015 James Stephens wrote back to Patrick Breysse that the ATSDR team thought the EPA work “overlaps but isn’t totally duplicative…” and stated that the ASTDR team has not been able to see draft copies of the EPA’s work. “I think we would all welcome further discussion with EPA but would hope to use it to help us find out more about what they are doing, ” he told Breysse. After hearing from Stephens, Breysse wrote back to Housenger saying ATSDR staff would be in touch to discuss. Housenger replied with his reiteration that the ATSDR review would be a “duplicative government effort” and that the EPA draft would be out in July of 2015. (As of this writing, that EPA preliminary risk assessment still has not been released, though in 2016 the EPA did release a cancer assessment report that declared glyphosate was not likely to cause cancer.)

June 4, 2015 Pressing the issue, EPA’s Housenger wrote again to Breysee to say he had not heard from anyone yetThe ATSDR’s Stephens wrote back promising to make sure “someone gives you a ring.” Internal Monsanto emails show that at the same time, Monsanto was also pushing the “duplicative” narrative with HHS, meeting on June 4 with HHS Deputy Assistant Secretary for Global Health Mitchel Wolfe to ask him to help repudiate the IARC classification and to recognize that a review of glyphosate was “not the primary role” for his agency. “Dr. Wolfe said he would follow up on what was going on with ATSDR and he was encouraged to have discussions with EPA staff, as well,” a Monsanto memo detailing the meeting states.

June 9, 2015 Henry Abadin, an ATSDR supervisory scientist, reported to Stephens that he had talked with Housenger and explained that the agency did not believe it was “duplicating efforts.” Nevertheless, he said he told EPA, “we did not have a problem with putting the glyphosate profile on hold, pending the OPP final report.”

June 19, 2015 To further ensure the ATSDR review didn’t move forward, Monsanto’s Dykes talked again with HHS’s Wolfe, asking for an update on ATSDR. “I explained… our question was about the purpose and scope of such a duplicative review by ATSDR. I also told him that we were concerned that ATSDR may come out any day with a report. I again stressed that we were concerned that they were even reviewing glyphosate as were the people we talked with at EPA,” Dykes wrote to colleagues.

June 21, 2015 It was a Sunday, but Monsanto’s Dykes was still concerned enough about the ATSDR review to copy multiple colleagues on a late night email to report that he had continued to press the “duplicative” point with ATSDR but was concerned about a “glyphosate review coming any day.” In a text message sent that same day, Monsanto scientist Eric Sachs reached out to a former EPA toxicologist named Mary Manibusan asking for contacts at ATSDR. “We’re trying to do everything we can to keep from having a domestic IARC occur w this group. may need your help,” Sachs wrote. The text messages were among certain internal Monsanto records obtained by cancer victims who are suing Monsanto alleging Roundup caused their diseases.

June 23, 2015 By Tuesday, Monsanto’s Jenkins had good news: He had heard from Housenger that the EPA official had been successful in garnering a promise from ATSDR to put its report “on hold.” The review was not dead, however, he wrote: ATSDR argues “that their process is distinguishable and not duplicative. They look at different endpoints and told EPA they don’t “make a call on cancer”, but I think we should continue to be cautious.”

On June 24, 2015 Monsanto’s chief scientist William Heydens responded:“’Distinguishable and not duplicative’? Seriously? And I will believe the not ‘making a call on cancer’ part when I see it. Anyway, at least they know they are being watched, and hopefully that keeps them from doing anything too stupid…” Jenkins wrote back, acknowledging that Monsanto had much more to fear from ATSDR than EPA as the two agencies had arrived at “different conclusions” on other issues. He reported he had been told ATSDR was “VERY conservative and IARC like…”

By October 23, 2015 EPA and Monsanto had the ATSDR review fully on hold. EPA’s Housenger wrote to update Monsanto’s Jenkins: “They are waiting for our glyphosate RA. And they agreed to share what they do.”

That same month, the EPA’s Cancer Assessment Review Committee (CARC), which was chaired by Rowland, issued an internal report stating that contrary to IARC, the EPA’s review of glyphosate found it “not likely to be carcinogenic to humans.”

The EPA still has yet to issue the overall new risk assessment it said would be out in 2015. The agency has offered ever-changing timelines for the assessment, but now says its intends to release a draft risk assessment sometime this year. That will be followed by a 60-day public comment period. After the public comment period the EPA will determine whether any risk management is needed. In the meantime, Monsanto has cited the EPA’s backing of glyphosate safety as repudiation of the IARC finding both in court and with regulators in Europe who are also looking at glyphosate safety issues.

The EPA did not respond to a request for comment about its efforts to delay the ATSDR report or communications with Monsanto regarding that effort.

But Brent Wisner, a lawyer representing many of the cancer victims who are suing Monsanto, said the documents offer damning evidence of improperly close ties between the EPA and the chemical company.

“I think it’s very clear… that EPA officials and Monsanto employees worked together to accomplish a goal of stopping that analysis at ATSDR. That is collusion. I don’t know what else you’d call that,” said Wisner.

For its part, the ATSDR said this week that the review it started in 2015 “is not complete” but that it anticipates a draft glyphosate toxicological profile to be issued for public comment by the end of this year. A spokesperson for the agency declined to discuss the circumstances surrounding the delay in the review.

And Jones, whose EPA job ended when the Trump administration took over, defended his responsiveness to Monsanto’s concern about the ATSDR review, saying it had only to do with the “efficient use of government resources.”

“Had any party contacted me and informed me that another agency within the Administration was simultaneously assessing a chemical as my organization, I would have intervened,” Jones said. “There is no value to the same government investing limited resources to work on the same issue. As you know resources at the federal level were and are scarce which made duplication even more problematic.” Jones said additionally that “when two organizations assess the same chemical, it is very likely there will be differences in their assessments. Even when these differences don’t matter from a public health perspective, an enormous amount of energy is spent attempting to resolve these differences” and that is not ultimately in the “public interest.”

What’s in Roundup? Internal EPA Documents Show Scramble for Data

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By Carey Gillam

As agrochemical giant Monsanto Co. faces a growing wave of U.S. lawsuits over its top-selling Roundup herbicide line, among its key defense arguments is that the U.S. Environmental Protection Agency (EPA) has long backed the safety of the weed-killing products.

And indeed, the EPA has been a stalwart supporter of Monsanto Co.’s claims of safety, assuring the public that there is nothing to fear from the company’s cocktail of chemicals. But internal agency documents, released in response to a Freedom of Information Act (FOIA) lawsuit, indicate that as recently as last year, the agency had holes in its data files when it comes to the actual Roundup formulations used by consumers, farmers and others around the world. The documents also raise questions about how and why regulators for years have failed to require robust testing on what is the world’s most widely used weed killer.

The EPA documents show that only a little more than a year ago, in March and April of 2016, EPA officials were scrambling to gather data on ingredients Monsanto has commonly used to formulate its herbicide products. Glyphosate is the active ingredient in Roundup brands as well as hundreds of other herbicides, and the agency has a deep database of studies submitted by Monsanto regarding that specific chemical. But in the EPA records from 2016, the agency is seen urgently asking Monsanto for any studies it could provide analyzing the safety of its fully formulated products and seeking to understand the make-up of formulations used for decades. Even though Monsanto has been selling Roundup herbicides for more than 40 years, the internal agency documents indicate the agency had only sparse information about those formulations.

The EPA’s interest in scrutinizing formulations came after the agency was poised to issue an updated favorable risk assessment of glyphosate in 2015. The agency only delayed finalizing that assessment after the International Agency for Research on Cancer (IARC) reported in 2015 that there was enough peer-reviewed, published research to classify glyphosate as a probable human carcinogen. IARC also noted in its report that there was research showing risks with formulations.

The EPA appeared to be playing catch-up in March of last year when agency officials requested information from Monsanto on the inert ingredients in popular U.S. and European formulations of glyphosate used in “the present day and also dating back to the 80s.” EPA was particularly interested in “information on how glyphosate formulations have changed over time in the last 20-30 years.”

“EPA suggested that Monsanto provide in writing any information that documents the changes of glyphosate formulations over time and across the globe.” 4/5/16

The EPA records also show a certain level of double-talk about that lack of data. Even as the agency was working to gather details on the Roundup formulations, the agency was at the same time assuring the public that there was no reason for concern because the EPA had the information needed to gauge the safety of those formulations.

Consider this statement from the agency:

“Often, glyphosate products contain water, dyes, and/or surfactants that help facilitate movement of glyphosate into the plant…” EPA Chemical Review Manager Khue Nguyen wrote in January 2016 to an 83-year-old homeowner who had read about Roundup concerns and written to the agency seeking answers. “While manufacturers of pesticide products do not always disclose all ‘other ingredients’ on their labels … they are required to disclose those ingredients to EPA. Inert ingredients in a product such as Roundup are not of concern for the consumer when pesticide products are used according to the label.”

Contrast those public assurances about the EPA’s knowledge of Roundup ingredients with an internal discussion documented by Nguyen three months later. In an email dated April 6, 2016, Nguyen reminded five Monsanto executives that the EPA had a “time sensitive” information request—it needed data, and the notes attached to the email show a particular need for data on glyphosate formulations:

“In an effort to resolve questions about the potential toxicity of glyphosate, glyphosate formulations, and any co-formulants (inert ingredients and surfactants), EPA was interested in any data or information Monsanto may have on how the formulations may differ from data on the active ingredient and surfactants independently of one another,” the notes attached to Nguyen’s email state. The notes go on to ask for information about changes in Monsanto’s Roundup formulation “over the years.”

The notes state “Monsanto indicated that up until 2000, nearly all glyphosate products on the market were its Roundup formulation which used some form of tallow amine as a surfactant. Afterwards, the properties of surfactants used and the ratio of surfactant to active ingredient were changed in most formulations… EPA suggested that Monsanto provide in writing any information that documents the changes of glyphosate formulations over time and across the globe.”

Subsequent to that meeting, Monsanto did send over some data, and in a follow-up email dated April 18, 2016, an EPA scientist sought clarification about what to look for. “Just to be clear on our strategy here, we want to see which of these we have or don’t have, and we also want to see if there are any formulation studies that will help our analysis. Does that sound right?”

It is heartening that EPA is starting to pay attention to questions about the safety of Roundup formulations, but such evaluations are long overdue and the agency’s public assurances of safety despite the lack of data is “such hypocrisy,” said Michael Hansen, senior staff scientist with the Consumers Union. “And it’s an admission that this is a big problem.”

These mixtures, or formulations, have raised concerns with certain independent scientists who say laboratory studies show the combinations of glyphosate with other substances used in Roundup are more toxic that glyphosate alone, and can possibly cause cancer or other health problems. Some research has indicated the formulations can be endocrine disruptors, meaning they have the potential to trigger serious diseases such as cancers, reproductive and developmental problems, and birth defects.

The EPA’s knowledge—or lack thereof—about formulated Roundup products is also potentially important to litigation pending against Monsanto. Thousands of people around the United States are suing the chemical company, alleging that not only did Roundup exposure cause them or their loved ones to get cancer, but that Monsanto knew the Roundup formulations could be harmful but covered up the evidence. They also allege that certain EPA officials colluded with Monsanto in the handling of safety assessments, and the EPA’s Office of Inspector General (OIG) has confirmed it is probing those concerns.

One ingredient traditionally used in Roundup has been the focus of particular scrutiny as some research has shown that this added ingredient, polyethoxylated tallow amine (POEA), can be extremely damaging to human cells. POEA is a surfactant that helps glyphosate adhere to the leaves of plants. European regulators became so concerned with POEA that in 2016 they agreed to ban it from use as a co-formulant in glyphosate-based herbicides after the European Food Safety Authority (EFSA), in a 2015 report, said there was insufficient data available to perform a risk assessment on POEA. EFSA stated: “Its genotoxicity, long term toxicity/carcinogenicity, reproductive/developmental toxicity and endocrine disrupting potential should be further clarified.”

In part of the April 18, 2016 email string with the EPA, a Monsanto executive confirmed the widespread use of POEA in its products, telling the EPA “the surfactant system used almost exclusively in Roundup agricultural herbicide formulations globally throughout these two decades (the 1980s and 1990s) contained a polyethoxylated tallow amine surfactant…”

Monsanto says on its website that tallowamine-based products “do not pose an imminent risk for human health when used according to instructions” and points out that in 2009 the EPA exempted the surfactant from legal limitations on residues in food, because there “is a reasonable certainty that no harm will result to the general population…”

Still, the company itself has admitted a lack of extensive safety tests on its formulated products. In an internal Monsanto email from December 2010, a Monsanto chemistry regulatory affairs manager noted that “with regards to the carcinogenicity of our formulations we don’t have such testing on them directly…” The manager went on to explain that the company has “extensive testing” on glyphosate and “some extensive tox testing” on the surfactant and should be able to address questions about the safety of its formulations “in a confident manner.” That email and hundreds of others were obtained by plaintiffs as part of discovery in the lawsuits against Monsanto.

In a 2002 email also obtained as part of discovery in the court case, a Monsanto scientist writes to a colleague, “we are in pretty good shape with glyphosate but vulnerable with surfactants. What I’ve been hearing from you is that this continues to be the case with these studies – Glyphosate is OK but the formulated product (and thus the surfactant) does the damage.” In another 2002 email between the same Monsanto colleagues, the scientist writes, “Even though no testing requirements have been implemented for several years now, this damn endocrine crap just doesn’t go away, does it.”

And in a 2003 email, a Monsanto toxicologist writes, “you cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement. The testing on the formulations are not anywhere near the level of the active ingredient. We can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

An EPA spokesman confirmed that the agency does not “routinely require long-term toxicity studies for pesticide product formulations” as it does for active ingredients like glyphosate. He added, however, that all inert ingredients in pesticide products, must be approved for use by EPA and “each component of an inert mixture must be supported by a battery of toxicity data and must be approved for use by EPA.”

Further, the EPA spokesman said, “If there are data to indicate risk for a formulated mixture, EPA evaluates the potential effects in our risk assessments. The human health risk assessment process is conservative… thus ensuring that when a pesticide is used according to the label, people are well protected.”

The EPA’s recent interest in pursuing questions about formulated glyphosate products was also seen in September 2016, when the agency stated that it was collaborating with the National Toxicology Program (NTP) Division of the National Institute of Environmental Health Sciences to develop a research plan that would evaluate “the role of glyphosate in product formulations and the differences in formulation toxicity.” The agency acknowledged that “currently, the publicly available information regarding non-cancer endpoints for glyphosate and glyphosate formulations is limited.”

The status of EPA’s involvement in that collaboration is unknown but the NTP confirms on its website that it is “undertaking additional research to investigate the potential genetic and mechanistic toxicity of glyphosate and glyphosate formulations.”

Still, CropLife America, the lobbying group for Monsanto and other agrochemical industry players, have made it clear such an inquiry is not welcomed. In a letter dated October 2016, CropLife questioned “why EPA would collaborate and develop a research program with the National Toxicology Program (NTP) without input from the registrant.” That registrant, Monsanto, “would be the appropriate source” for data EPA might need, CropLife wrote.

This story was originally published by EcoWatch.

Monsanto Spin Doctors Target Cancer Scientist In Flawed Reuters Story

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In a well-orchestrated and highly coordinated media coup, Monsanto Co. and friends this week dropped a bombshell on opponents who are seeking to prove that the company’s beloved Roundup herbicide causes cancer.

A widely circulated story published June 14 in the global news outlet Reuters (for which I formerly worked) laid out what appeared to be a scandalous story of hidden information and a secretive scientist, “exclusive” revelations that the story said could have altered a critical 2015 classification that associated Monsanto’s Roundup to cancer and triggered waves of lawsuits against Monsanto.

It was a blockbuster of a story, and was repeated by news organizations around the globe, pushed by press releases from Monsanto-backed organizations and trumpeted by industry allies like the American Chemistry Council.

It was also flawed and misleading in a number of critical respects.

Authored by Reuters’ reporter Kate Kelland, who has a history of cozy relations with a group partly funded by agrichemical company interests, the piece accused a top epidemiologist from the U.S. National Cancer Institute of failing to share “important” scientific data with other scientists as they all worked together assessing the herbicide glyphosate for the International Agency for Research on Cancer (IARC). That group reviewed a wide body of research on glyphosate and determined in March of 2015 that the pesticide should be classified as a probable human carcinogen. Had the group known of this missing data, it’s conclusion could have been different, according to Reuters.

The story was particularly timely given glyphosate and Roundup are at the center of mass litigation in the United States and under scrutiny by U.S. and European regulators. After the IARC classification, Monsanto was sued by more than 1,000 people in the United States who claim they or their loved ones got non-Hodgkin lymphoma (NHL) from exposure to Monsanto’s glyphosate-based Roundup and the company and the cases could start going to trial next year. Roundup is the most widely used herbicide in the world and brings in billions of dollars a year for Monsanto. The company insists the IARC classification is meritless and the chemical is proven safe by decades of research.

So yes, it was a big story that scored big points for Monsanto in the debate over glyphosate safety. But drilling deeply into the sourcing and selective nature of the Reuters piece makes it clear the story is not only seriously flawed, but that it is part of an ongoing and carefully crafted effort by Monsanto and the pesticide industry to discredit IARC’s work.

The story contains at least two apparent factual errors that go to the credibility of its theme. First the story cites “court documents” as primary sources when in fact the documents referred to have not been filed in court and thus are not publicly available for reporters or members of the public to access. Kelland does not share links to the documents she references but makes it clear her information is largely based on a deposition from Aaron Blair, the National Cancer Institute epidemiologist who chaired the IARC working group on glyphosate, as well as related emails and other records. All were obtained by Monsanto as part of the discovery process for the Roundup litigation that is pending in federal court in San Francisco. By citing court documents, Kelland avoided addressing whether or not Monsanto or its allies spoon-fed the records to her. And because the article did not provide a link to the Blair deposition, readers are unable to see the full discussion of the unpublished study or the multiple comments by Blair of many other studies that do show evidence of links between glyphosate and cancer. I’m providing the deposition here, and disclosing that I requested and obtained it from attorneys involved in the Roundup litigation after Kelland’s story was published.

Second, the story relies in part on an anti-IARC view of a scientist named Bob Tarone and refers to him as an “independent” expert, someone “independent of Monsanto.” Kelland quotes Tarone as saying that IARC’s evaluation of glyphosate is “flawed and incomplete.” Except, according to information provided by IARC, Tarone is far from independent of Monsanto; Tarone in fact has acknowledged that he is a paid consultant to Monsanto, and a piece cited by Reuters and authored by Tarone last year in a European scientific journal is being recorrected to reflect Tarone’s conflict of interest, according to IARC, which said it has been in communication with that journal.

But much more noteworthy than the errors is how selective the story is in pulling from the Blair deposition. The story ignored Blair’s many affirmations of research showing glyphosate connections to cancer, and focused instead on Blair’s knowledge of one unpublished research study that was still in progress. The story hones in on speculation that the data perhaps could have been finished and published in time to be reviewed by IARC and further speculation by Blair, prodded by a Monsanto attorney, that had it been finished and had it been published it could have helped counter the other studies IARC viewed that showed positive cancer connections.

That research, part of a massive ongoing project by U.S. government researchers called the Agricultural Health Study, includes hundreds of studies and years of data analyzing pesticide impacts on farmers. Blair, who retired from the National Cancer Institute in 2007, was not leading that research but was part of a team of scientists who in 2013 were analyzing data about pesticide use and the risk of non-Hodgkin lymphoma. The data specific to glyphosate did not show a connection to NHL but in working to publish a paper about all the data the group had gathered, they decided to narrow the focus to insecticides and in 2014 did publish a paper on that work. The data on glyphosate and NHL has yet to be published, and some scientists who are familiar with the work say it has not tracked people long enough yet to be definitive given NHL generally takes 20 or more years to develop. A prior compilation of data by AHS researchers that also showed no connection between glyphosate and NHL was published in 2005 and was considered by IARC. But because the newer data was not published it was not considered by IARC.

Blair said the decision to limit the published work to insecticides was to make the data more manageable and was made well before IARC announced it would be looking at glyphosate in 2015.

“The rule is you only look at things that are published,” Blair told me this week after the Reuters story was published. “What would it be like if everyone on the working group whispered things they knew but weren’t published and made decisions on that?” IARC confirmed it does not consider unpublished research. In his deposition, Blair states that nothing has changed his opinion about glyphosate and NHL.

Epidemiologist and University of Toronto scientist John McLaughlin, who sat on the glyphosate working group for IARC with Blair, said to me in a note this week that the information about the unpublished work written about by Reuters did not alter his view of the validity of IARC conclusion on glyphosate either.

Also left out of the Reuters story – the deposition and a draft copy of the study in question shows that there were concerns about the AHS results due to “relatively small” subgroups of exposed cases. And notably, the Reuters report leaves out Blair’s discussion of the North American Pooled Project, in which he participated, which also contains data related to glyphosate and NHL but is not favorable to Monsanto. A synopsis of that project presented to the International Society for Environmental Epidemiology in 2015 showed that people who used glyphosate for more than five years had significantly increased odds of having NHL, and the risk was also significantly higher for people who handled glyphosate for more than two days per year. That information, like the new AHS data, was not given to IARC because it wasn’t yet published.

“When Dr. Blair’s deposition transcript is read in total, it shows that nothing was wrongfully withheld from IARC,” said Plaintiffs’ attorney Aimee Wagstaff. She said Monsanto was using pieces of the deposition to “further its agenda in the media.”

To epidemiologist Peter Infante, who spent more than 20 years leading a cancer identification unit at the Occupational Safety and Health Administration and analyzed a body of epidemiology research on glyphosate in testimony to an Environmental Protection Agency (EPA) Scientific Advisory Committee in December, the attention drawn to unpublished data that supports Monsanto’s position is much ado about nothing.

“You still have other studies that show dose response,” he told me. “This Agricultural Health Study is not the gold standard. For glyphosate and NHL they haven’t been following people long enough. Even if the data had been published and had been considered by IARC it would be in the context of all the other study results.”

And finally, in an odd exclusion, the story fails to disclose that Kelland herself has at least tangential ties to Monsanto and friends. Kelland has helped promote an organization called the Science Media Centre, a group whose aim is to connect certain scientists such as Tarone with journalists like Kelland, and which gets its largest block of funding from corporations that include the agrichemical industry. Current and past funders include Monsanto, Monsanto’s proposed merger partner Bayer AG, DuPont and agrichemical industry lobbyist CropLife International. Kelland appears in a promotional video for SMC touting the group and authored an essay applauding the SMC that appeared in a SMC promotional report.

As a Reuters reporter for 17 years (1998-2015) I know the value of an “exclusive.” The more such scoops a reporter garners, the more bonus points and high praise from editors. It’s a system seen in many news agencies and it works great when it encourages dogged, investigative journalism. But powerful corporations like Monsanto also know how eager reporters are to land exclusives and know that handing favored journalists cherry-picked information with the promise of exclusivity can serve their public relations needs quite well. Follow up the hand-fed story with a press release from an industry-funded outlet and calls for an investigation from the industry group American Chemistry Council and you have propaganda gold.

What you don’t have is the truth.

Of Mice, Monsanto and a Mysterious Tumor

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Call it the case of the mysterious mouse tumor.

It’s been 34 years since Monsanto Co. presented U.S. regulators with a seemingly routine study analyzing the effects the company’s best-selling herbicide might have on rodents. Now, that study is once again under the microscope, emerging as a potentially pivotal piece of evidence in litigation brought by hundreds of people who claim Monsanto’s weed killer gave them cancer.

This week tissue slides from long-dead mice in that long-ago research study are being scrutinized by fresh eyes as an expert pathologist employed by lawyers for cancer victims looks for evidence the lawyers hope will help prove a cover-up of the dangers of the weed killer called glyphosate.

Glyphosate, which is the active ingredient in Monsanto’s branded Roundup products, is the most widely used herbicide in the world, and is applied broadly in the production of more than 100 food crops, including wheat, corn and soy, as well as on residential lawns, golf courses and school yards.

Residues have been detected in food and human urine, and many scientists around the world have warned that exposure through diet as well as through application can potentially lead to health problems. The World Health Organization’s International Agency for Research on Cancer (IARC) declared glyphosate a probable human carcinogen in 2015 based on a review of scientific literature, triggering the wave of lawsuits against Monsanto, and pushing California regulators to announce they would add glyphosate to a list of known carcinogens.

What the expert finds, or doesn’t find, is expected to be key evidence in hearings slated for the week of Dec. 11 in dozens of consolidated cases being overseen by a federal judge in San Francisco.

Rewind to 1983

Monsanto, as well as many other scientists and regulatory bodies, have defended glyphosate’s safety. They say research showing a cancer connection is flawed and hundreds of studies support its safety.

And yet—rewind to July 1983 and a study titled “A Chronic Feeding Study of Glyphosate (Roundup Technical) in Mice.” Following the document trail that surrounds the study offers an illuminating look into how science is not always clear-cut, and the lengths Monsanto has had to go to in order to convince regulators to accept scientific interpretations that support the company’s products.

The two-year study ran from 1980-1982 and involved 400 mice divided into groups of 50 males and 50 females that were administered three different doses of the weed killer or received no glyphosate at all for observation as a control group. The study was conducted for Monsanto to submit to regulators. But unfortunately for Monsanto, some mice exposed to glyphosate developed tumors at statistically significant rates, with no tumors at all in non-dosed mice.

A February 1984 memo from Environmental Protection Agency toxicologist William Dykstra stated the findings definitively: “Review of the mouse oncogenicity study indicates that glyphosate is oncogenic, producing renal tubule adenomas, a rare tumor, in a dose-related manner.” Researchers found these increased incidences of the kidney tumors in mice exposed to glyphosate worrisome because while adenomas are generally benign, they have the potential to become malignant, and even in noncancerous stages they have the potential to be harmful to other organs. Monsanto discounted the findings, arguing that the tumors were “unrelated to treatment” and showing false positives, and the company provided additional data to try to convince the EPA to discount the tumors.

But EPA toxicology experts were unconvinced. EPA statistician and toxicology branch member Herbert Lacayo authored a February 1985 memo outlining disagreement with Monsanto’s position. A “prudent person would reject the Monsanto assumption that Glyphosate dosing has no effect on kidney tumor production,” Lacayo wrote. ”Glyphosate is suspect. Monsanto’s argument is unacceptable.”

Eight members of the EPA’s toxicology branch, including Lacayo and Dykstra, were worried enough by the kidney tumors in mice that they signed a consensus review of glyphosate in March 1985 stating they were classifying glyphosate as a Category C oncogen, a substance “possibly carcinogenic to humans.”

Research rebuttal

That finding did not sit well with Monsanto, and the company worked to reverse the kidney tumor concerns. On April 3, 1985, George Levinskas, Monsanto’s manager for environmental assessment and toxicology, noted in an internal memorandum to another company scientist that the company had arranged for Dr. Marvin Kuschner, a noted pathologist and founding dean of the medical school at the State University of New York at Stony Brook, to review the kidney tissue slides.

Kushner had not yet even accessed the slides but Levinskas implied in his memo that a favorable outcome was assured: “Kuschner will review kidney sections and present his evaluation of them to EPA in an effort to persuade the agency that the observed tumors are not related to glyphosate,” Levinskas wrote. Notably, Levinskas, who died in 2005, was also involved in efforts in the 1970s to downplay damaging findings from a study that found rats exposed to Monsanto’s PCBs developed tumors, documents filed in PCB litigation revealed.

Kuschner’s subsequent re-examination did —as Monsanto stated it would—determine the tumors were not due to glyphosate. Looking over slides of the mouse tissue from the 1983 study, Kuschner identified a small kidney tumor in the control group of the mice – those that had not received glyphosate. No one had noted such a tumor in the original report. The finding was highly significant because it provided a scientific basis for a conclusion that the tumors seen in the mice exposed to glyphosate were not noteworthy after all.

Additionally, Monsanto provided the EPA with an October 1985 report from a “pathology working group” that also rebutted the finding of the connection between glyphosate and the kidney tumors seen in the 1983 study. The pathology working group said “spontaneous chronic renal disease” was “commonly seen in aged mice.” Monsanto provided the report to the EPA stamped as a “trade secret” to be kept from the prying eyes of the public.

The EPA’s own scientists still did not agree, however. An EPA pathologist wrote in a December 1985 memo that additional examination of the tissue slides did not “definitively” reveal a tumor in the control group. Still, the reports by the outside pathologists brought into the debate by Monsanto helped push the EPA to launch a reexamination of the research.

And by February 1986 an EPA scientific advisory panel had dubbed the tumor findings equivocal; saying that given the tumor identified in the control group by some pathologists, the overall incidences of tumors in the animals given glyphosate were not statistically significant enough to warrant the cancer linkage.

The panel did say there may be reason for concern and noted that the tumor incidences seen in the mice given glyphosate were “unusual.”

The advisory panel told the EPA the studies should be repeated in hopes of more definitive findings, and that glyphosate be classified into what the agency at that time called Group D—“not classifiable as to human carcinogenicity.” The EPA asked Monsanto for a repeat of the mouse oncogenicity study but Monsanto refused to do so.

The company argued “there is no relevant scientific or regulatory justification for repeating the glyphosate mouse oncogenicity study.” Instead, the company provided EPA officials with historical control data that it argued supported its attempt to  downplay the tumor incidences seen in the worrisome 1983 study.

The company said the tumors in mice appear “with some regularity” and were probably attributable to “genetic or environmental” factors. “It is the judgement of Monsanto scientists that the weight-of-evidence strongly supports a conclusion that glyphosate is not oncogenic in the mouse.” Monsanto said repeating the mouse study would “require the expenditure of significant resources… and tie-up valuable laboratory space.”

Feds fold

The discussions between Monsanto and the EPA dragged on until the two sides met in November 1988 to discuss the agency’s request for a second mouse study and Monsanto’s reluctance to do so. Members of the EPA’s toxicology branch continued to express doubts about the validity of Monsanto’s data, but by June of 1989, EPA officials conceded, stating that they would drop the requirement for a repeated mouse study.

By the time an EPA review committee met on June 26, 1991, to again discuss and evaluate glyphosate research, the mouse study was so discounted that the group decided that there was a “lack of convincing carcinogenicity evidence” in relevant animal studies. The group concluded that the herbicide should be classified far more lightly than the initial 1985 classification or even the 1986 classification proposed by the advisory panel. This time, the EPA scientists dubbed the herbicide a Group E chemical, a classification that meant “evidence of non-carcinogenicity for humans.” At least two members of the EPA committee refused to sign the report, stating that they did not concur with the findings. In a memo explaining the decision, agency officials offered a caveat. They wrote that the classification “should not be interpreted as a definitive conclusion that the agent will not be a carcinogen under any circumstances.”

Despite the EPA’s ultimate conclusion, the mouse study was among those cited by IARC for classifying glyphosate as a probable human carcinogen. Indeed, many other animal studies have similarly had questionable results, including a 1981 rat study that showed an increase in incidences of tumors in the testes of male rats and possible thyroid carcinomas in female rats exposed to glyphosate and a 1990 study that showed pancreatic tumors in exposed rats. But none have swayed the EPA from its backing of glyphosate safety.

Christopher Portier, who was an invited specialist to the IARC review of glyphosate and is former director of the National Center for Environmental Health and Agency for Toxic Substances and Disease Registry at the U.S. Centers for Disease Control and Prevention, believes the evaluations applied to glyphosate data by regulators are “scientifically flawed” and putting public health at risk.

“The data in these studies strongly supports the ability of glyphosate to cause cancer in humans and animals; there is no reason to believe that all of these positive studies arose simply by chance,” Portier said.

Monsanto fought the plaintiffs’ request to view the mouse tissue slides, calling it a “fishing expedition,” but was overruled by U.S. District Judge Vince Chhabria who is overseeing the roughly 60 combined lawsuits under his purvey. Monsanto has confirmed that roughly 900 additional plaintiffs have cases pending in other jurisdictions. All make similar claims – that Monsanto manipulated the science, regulators and the public in ways that hid or minimized the danger posed by its herbicide.

“The importance of the original kidney slides and the re-cut kidney slides is immense to the question of general causation and played a critical role in the EPA’s decision to re-categorize glyphosate…” the plaintiffs’ attorneys stated in a court filing.

Plaintiffs’ attorney Aimee Wagstaff reiterated that in a recent court hearing, telling Judge Chhabria that the events surrounding the 1983 mouse study “sort of dominoed,” and potentially are “extremely relevant” to the cancer litigation.

(First published in Environmental Health News)

(Coming in October 2017 – Whitewash- The Story of a Weed Killer, Cancer, and the Corruption of Science, Island Press)

Canadians Report Weed Killer Detected in 30 Percent of Food Tested

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The Canadian Food Inspection Agency has gone where the U.S. government dares not tread – testing thousands of foods commonly consumed by its citizens for residues of a controversial herbicide linked to cancer. And the findings are less than appetizing.

The agency said it found the pesticide known as glyphosate, the key ingredient in Monsanto Co.’s Roundup branded herbicides and other products, in 29.7 percent of 3,188 foods tested in 2015 and 2016. Glyphosate was found in 47.4 percent of beans, peas and lentil products; 36.6 percent of grain products; and 31 percent of baby cereals, the agency report states.

Only 1.3 percent of the total samples were found with glyphosate residue levels above what Canadian regulators allow, though 3.9 percent of grain products contained more of the weed killer than is permissible. These legally allowable levels are referred to as Maximum Residue Limits (MRLs), and they vary from food to food and pesticide to pesticide, as well as from country to country. Regulators and agrichemical industry interests say as long as residue levels are lower than the established MRLs, consuming the pesticide residues is not harmful to humans. But a growing number of scientists and medical professionals say such claims are false, particularly with pesticides like glyphosate, which is the most widely used agrichemical on the planet, commonly used in the production of dozens of food crops. Glyphosate is sprayed directly onto crops like corn, soybeans, sugar beets and canola, all of which are genetically engineered to tolerate the pesticide. Monsanto has also encouraged farmers to spray the chemical directly on oats, wheat, peas and lentils shortly before harvest to help dry them out.

“It’s all guesswork, and not based on a lot,” Dr. Bruce Blumberg, Professor of Developmental and Cell Biology in the University of California, Irvine’s School of Biological Sciences said of the MRLs. “Nobody is actually measuring levels of this pesticide in humans. They don’t do that but they should.”

The World Health Organization’s International Agency for Research on Cancer classified glyphosate as a probable human carcinogen in 2015 and said years of research on the chemical shows strong evidence of genotoxicity and oxidative stress from glyphosate, including findings of DNA damage in the peripheral blood of exposed humans. Many regulatory bodies, including the U.S. Environmental Protection Agency, have determined glyphosate is not carcinogenic, but the issue is the subject of much controversy. Internal Monsanto documents revealed through litigation in California indicate that the company may have ghost-written studies attesting to the safety of the chemical that were relied on by regulators. They also show the company discussing an EPA official that may help “kill” a cancer study of glyphosate.

Oddly, the USDA did intend to start testing some food samples for glyphosate this year, with a start date of April 1, agency documents obtained through Freedom of Information Act requests show. But the agency decided to abandon that plan earlier this year. As well, the FDA started its first-ever glyphosate testing program last year but suspended that “special assignment” in September. Even the CFIA has handled the glyphosate testing in a curious manner: The agency said it would not release detailed data on glyphosate residues found in food because it is considered “confidential business information.”

A source within the FDA said there has been political pressure not to delve too deeply into the issue of glyphosate residues. But both the USDA and FDA have said their reasons for not testing have nothing to do with outside influence and are purely based on the fact that glyphosate is more difficult and expensive to test for than other pesticides, and the fact that it is considered safe. The FDA has said it is working on resuming its limited testing of corn, soy, eggs and milk for glyphosate residues.

“I’m not sure what is going on, but it doesn’t smell good,” said Blumberg, who has been active in lobbying Irvine school districts and city leaders to reduce their use of glyphosate and other pesticides in public areas.

Moms Exposed to Monsanto Weed Killer Means Bad Outcomes for Babies

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Concerns about the world’s most widely used herbicide are taking a new twist as researchers unveil data that indicates pervasive use of Monsanto Co.’s weed killer could be linked to pregnancy problems.

Researchers looking at exposure to the herbicide known as glyphosate, the key ingredient in Monsanto’s Roundup branded herbicides, said they tested and tracked 69 expectant mothers and found that the presence of glyphosate levels in their bodily fluids correlated with unfavorable birth outcomes. The research is still in preliminary stages and the sample size is small, but the team is scheduled to present their findings on Thursday at a conference put on by the Children’s Environmental Health Network (CEHN) in Washington, D.C.

“This is a huge issue,” said Paul Winchester, medical director of the neonatal intensive care unit at the Franciscan St. Francis Health system and professor of clinical pediatrics at Riley Hospital for Children in Indianapolis, Indiana. He said this is the first U.S. study to demonstrate glyphosate is present in pregnant women. “Everyone should be concerned about this.”

Glyphosate is a popular agricultural pesticide, used widely in farming operations around the world. It’s commonly sprayed directly on many food crops and those used for livestock feed. But it has become the subject of hot debate over the last few years because of research that links the herbicide to types of cancer and other health ailments. Monsanto is being sued by hundreds of people who claim they or their loved ones developed non-Hodgkin lymphoma because of exposure to glyphosate-based Roundup. Monsanto, the EPA and other regulatory bodies, say evidence of carcinogenicity is lacking and the chemical is among the safest of all pesticides used in food production. But documents discovered in the course of the litigation indicate the company may have manipulated scientific research to hide evidence of harm.

The team that presented their report Wednesday included scientists who have long been skeptical of Monsanto’s products as well as medical researchers who have come to have concerns about glyphosate and other pesticides through their study of pediatric health problems.

Winchester, who led the urine sampling study, said his look at glyphosate and pregnant women is in very early stages and he and co-researchers are hoping to launch a much larger project later this year. The preliminary work detected glyphosate in the urine of 63 of 69 (91%) pregnant women receiving prenatal care through an Indiana obstetric practice. Researchers collected the data over two years, from 2015-2016, and found that higher glyphosate levels in women correlated with significantly shorter pregnancies and with lower adjusted birth weights.

Correlation does not prove causation. Still, the findings are worrisome because low birth weights and shortened gestation are seen as risk factors for many health and/or neurodevelopmental problems over the course of an individual’s life. Low birth-weight babies are more likely to have diabetes, heart disease, high blood pressure, and to be obese, research shows.

People can be exposed to glyphosate through food and through association with farming operations that spray glyphosate on corn and soybean production fields. Both soy and corn, along with several other crops, have been genetically engineered to tolerate direct application of glyphosate. Farmers often also use glyphosate directly on wheat, oats and other non-genetically engineered crops shortly before harvest, leading to residues in grain-based food products.

Glyphosate use has climbed sharply over the last two decades with the rise of genetically engineered crops and in connection with the subsequent spread of glyphosate-resistant weeds. Dr. Charles Benbrook, one of the scheduled presenters at the CEHN conference, projects that by 2020, “more acres of cropland in the Midwest will harbor three or more glyphosate-resistant weeds than one or none.” Farmers have been trying to fight the resistant weeds with more glyphosate and other chemicals. New crops engineered to tolerate 2,4-D and dicamba herbicides mixed with glyphosate are being rolled out now. Industry data indicates herbicide use is expected to continue to climb, making it ever more critical for scientists and medical professional to get a handle on exposure levels and impacts on reproductive health, the team said in their presentation.

Winchester has been conducting research into pesticide exposures and impacts on pregnant women for many years, including in-depth work on atrazine, another herbicide popular with farmers. He said he was surprised to see such a high percentage of women tested showing glyphosate in their urine. He said much more research on glyphosate impacts is needed, and more data is needed on levels of exposure through food. He was sharply critical of the U.S. government, which routinely skips testing for glyphosate residues in food even though regulatory agencies test thousands of food products each year for residues of other types of pesticides, including atrazine.

He and the other researchers are calling on the Centers for Disease Control to include glyphosate and its primary metabolite, aminomethylphosphonic acid (AMPA) in biomonitoring work it does to track levels of pesticides and other chemicals in urine and blood.

“Is this level of exposure safe or not? We’ve been told it is, but exposures haven’t been measured,” Winchester said. “It’s mind-boggling.”

(First posted in The Huffington Post)

USDA Drops Plan to Test for Monsanto Weed Killer in Food

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By Carey Gillam

The U.S. Department of Agriculture has quietly dropped a plan to start testing food for residues of glyphosate, the world’s most widely used weed killer and the key ingredient in Monsanto Co.’s branded Roundup herbicides.

The agency spent the last year coordinating with the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) in preparation to start testing samples of corn syrup for glyphosate residues on April 1, according to internal agency documents obtained through Freedom of Information Act requests. Documents show that at least since January 2016 into January of this year, the glyphosate testing plan was moving forward. But when asked about the plan this week, a USDA spokesman said no glyphosate residue testing would be done at all by USDA this year.

The USDA’s plan called for the collection and testing of 315 samples of corn syrup from around the United States from April through August, according to the documents. Researchers were also supposed to test for the AMPA metabolite, the documents state. AMPA (aminomethylphosphonic acid) is created as glyphosate breaks down. Measuring residues that include those from AMPA is important because AMPA is not a benign byproduct but carries its own set of safety concerns, scientists believe.

On Jan. 11, USDA’s Diana Haynes wrote to colleagues within USDA: “Based on recent conversations with EPA, we will begin testing corn syrup for glyphosate and its AMPA metabolite April 1, 2017 with collection ending August 31, 2017. This program change will need to be announced at the February PDP Conference Call.” Haynes is director of a USDA Agricultural Marketing Service division that annually conducts the Pesticide Data Program (PDP), which tests thousands of foods for hundreds of different pesticide residues.

The USDA spokesman, who did not want to be named, acknowledged there had been a glyphosate test plan but said that had recently changed: “The final decision for this year’s program plan, as a more efficient use of resources, is to sample and test honey which covers over 100 different pesticides.” Glyphosate residue testing requires a different methodology and will not be part of that screening in honey, he said.

The USDA does not routinely test for glyphosate as it does for other pesticides used in food production. But that stance has made the USDA the subject of criticism as controversy over glyphosate safety has mounted in recent years. The discussions of testing this year come as U.S. and European regulators are wrestling with cancer concerns about the chemical, and as Monsanto, which has made billions of dollars from its glyphosate-based herbicides, is being sued by hundreds of people who claim exposures to Roundup caused them or their loved ones to suffer from non-Hodgkin lymphoma. Internal Monsanto documents obtained by plaintiffs’ attorneys in those cases indicate that Monsanto may have manipulated research regulators relied on to garner favorable safety assessments, and last week, Congressman Ted Lieu called for a probe by the Department of Justice into Monsanto’s actions.

Along with the USDA, the Food and Drug Administration also annually tests thousands of food samples for pesticide residues. Both agencies have done so for decades as a means to ensure that traces of weed killers, insecticides, fungicides and other chemicals used in farming do not persist at unsafe levels in food products commonly eaten by American families. If they find residues above the “maximum residue level” (MRL) allowed for that pesticide and that food, the agencies are supposed to inform the EPA, and actions can be taken against the supplier. The EPA is the regulator charged with establishing MRLs, also called “tolerances,” for different types of pesticides in foods, and the agency coordinates with USDA and FDA on the pesticide testing programs.

But despite the fact that glyphosate use has surged in the last 20 years alongside the marketing of glyphosate-tolerant crops, both USDA and FDA have declined to test for glyphosate residues aside from one time in 2011 when the USDA tested 300 soybean samples for glyphosate and AMPA residues. At that time the agency found 271 samples contained glyphosate, but said the levels were under the MRL – low enough not to be worrisome. The Government Accountability Office took both agencies to task in 2014 for the failure to test regularly for glyphosate.

Europe and Canada are well ahead of the United States when it comes to glyphosate testing in food. In fact, the Canadian Food Inspection Agency (CFIA) is preparing to release its own findings from recent glyphosate testing. The CFIA also routinely skipped glyphosate in annual pesticide residue screening for years. But it began collecting data in 2015, moving to address concerns about the chemical that were highlighted when the World Health Organization’s International Agency for Research on Cancer (IARC) classified glyphosate as a probable human carcinogen in March 2015.

Canadian food activist and researcher Tony Mitra obtained more than 7,000 records from CFIA about its glyphosate testing last year, and claims that results are alarming, showing glyphosate pervasive in many foods. CFIA would not respond to requests for comment about its glyphosate testing.

One of the USDA’s explanation’s for not testing for glyphosate over the years has been cost – the agency has said that it is too expensive and inefficient to look for glyphosate residues in food headed for American dinner tables. And because glyphosate is considered so safe, testing would be a waste of time, the USDA has stated. That argument mimics Monsanto’s own – the company, which patented glyphosate in 1974 and has been a dominant provider of glyphosate ever since, says if the USDA did seek to test for glyphosate residues in food it would be a “misuse of valuable resources.”

FDA TESTS REMAIN IN LIMBO

The FDA began its own limited testing program for glyphosate residues – what it called a “special assignment” – last year. But the effort was fraught with controversy and internal difficulties and the program was suspended last fall. Before the suspension, one agency 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. That revelation caused angst in the beekeeping industry and at least one large honey company was sued by consumer organizations over the glyphosate contamination. The same chemist also found glyphosate levels in many samples of oatmeal, including infant oat cereal. The FDA did not publicize those findings, but they were revealed in internal records obtained through a FOIA request.

Officially, the FDA was only looking for glyphosate residues in corn, soy, eggs and milk in last year’s testing assignment, though internal records discussed tests on sugar beets, popcorn, wheat and other foods or grains. Newly obtained FDA documents show the agency is engaged now in a “glyphosate collaboration” designed to validate the testing methodology to be used by multiple FDA laboratories.

“Once the first phase of this collaboration is completed and approved by quality control reviewers, the special assignment can be restarted,” said FDA spokeswoman Megan McSeveney.

CropLife America, an industry organization that represents the interests of Monsanto and other agrichemical companies, keeps a close eye on the government’s pesticide residue testing. Last year the organization sought to diffuse potential legal problems related to glyphosate and other pesticides in honey by asking EPA to set a blanket tolerance that would cover inadvertent contamination of honey by pesticides. Records show regulators have found 26 different pesticides in honey samples in past tests.

CropLife also has complained to USDA that data from its testing program is used by proponents of organic agriculture to promote organics over conventional foods. The group last year sent USDA a series of questions about its testing, and asked USDA: “What can we do to assist you in fighting these scaremongering tactics?”

The USDA’s most recent published report on pesticide residues in food found that for 2015 testing, 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. But the agency said the important point was that most of the samples, over 99 percent, had residues below the EPA’s established tolerances and are at levels that “do not pose risk to consumers’ health and are safe.”

Many scientists take issue with using MRLs as a standard associated with safety, arguing they are based on pesticide industry data and rely on flawed analyses. Much more research is needed to understand the impact on human health of chronic dietary exposures to pesticides, many say.

(First appeared in The Huffington Post.)

Questions about EPA-Monsanto collusion raised in cancer lawsuits

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Now  it’s getting interesting.

A new court filing made on behalf of dozens of people claiming Monsanto Co.’s Roundup herbicide gave them cancer includes information about alleged efforts within the Environmental Protection Agency to protect Monsanto’s interests and unfairly aid the agrichemical industry.

The filing, made late Friday by plaintiff’s attorneys, includes what the attorneys represent to be correspondence from a 30-year career EPA scientist accusing top-ranking EPA official Jess Rowland of playing “your political conniving games with the science” to favor pesticide manufacturers such as Monsanto. Rowland oversaw the EPA’s cancer assessment for glyphosate, the key ingredient in Monsanto’s weed-killing products, and was a key author of a report finding glyphosate was not likely to be carcinogenic. But in the correspondence, longtime EPA toxicologist Marion Copley cites evidence from animal studies and writes: “It is essentially certain that glyphosate causes cancer.”

Attorneys for the plaintiffs declined to say how they obtained the correspondence, which is dated March 4, 2013. The date of the letter comes after Copley left the EPA in 2012 and shortly before she died from breast cancer at the age of 66 in January 2014. She accuses Rowland of having “intimidated staff” to change reports to favor industry, and writes that research on glyphosate, the key ingredient in Monsanto’s Roundup, shows the pesticide should be categorized as a “probable human carcinogen.” The International Agency for Research on Cancer, an arm of the World Health Organization, declared as much – that glyphosate was a probable human carcinogen – in March 2015 after reviewing multiple scientific studies. Monsanto has rejected that classification and has mounted a campaign to discredit IARC scientists.

The communication, if authentic, could be an explosive development in the snowballing multi-district litigation that now comprises more than 60 plaintiffs from around the United States accusing Monsanto of covering up evidence that Roundup herbicide could cause cancer. The plaintiffs, all of whom are suffering from non-Hodgkin lymphoma (NHL) or lost a loved one to NHL, have asserted in recent court filings that Monsanto wielded significant influence within the EPA’s Office of Pesticide Programs (OPP), and had close ties specifically to Rowland, who until last year was deputy division director within the health effects division of the OPP. Rowland managed the work of scientists who assessed human health effects of exposures to pesticides like glyphosate and he chaired the EPA’s Cancer Assessment Review Committee (CARC) that determined glyphosate was “not likely to be carcinogenic to humans.” Rowland left the EPA in 2016 shortly after a copy of the CARC report was leaked and cited by Monsanto as evidence that the IARC classification was flawed.

Lawyers for the plaintiffs want the federal judge in the case to lift a seal on documents that detail Monsanto’s interactions with Rowland regarding the EPA’s safety assessment of glyphosate. 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. Rowland could not be reached for comment, and the EPA declined to comment about the court matters.

“The Plaintiffs have a pressing need for Mr. Rowland’s testimony to confirm his relationship with Monsanto and EPA’s substantial role in protecting the Defendant’s business…” plaintiff’s attorneys wrote in the Feb. 10 filing in the multi-district litigation, which has been consolidated in the U.S. District Court for the Northern District of California. “Mr. Rowland operated under Monsanto’s influence to cause EPA’s position and publications to support Monsanto’s business.”

The EPA has spent the last few years assessing the health and environmental safety profile of glyphosate as global controversy over the chemical has mounted. The agency had planned to finish its risk assessment on glyphosate in 2015; then said it would be completed in 2016; then said it would be finished by the first quarter of 2017. Now the agency says it hopes to have it completed by the end of the third quarter of 2017.

MONSANTO WANTS DOCUMENTS KEPT SECRET

In a bid to stop the release of further damning documents, attorneys for Monsanto on Monday asked the federal judge in the Roundup litigation to block plaintiffs’ attorneys from including copies of documents they’ve obtained through discovery as exhibits in the court filings because members of the public and the media can see them. They argued that plaintiffs’ attorneys were unfairly attempting to “try this case in the court of public opinion.” Monsanto specifically complained that the organization I work for, U.S. Right to Know, was monitoring the court docket looking for confidential materials to report to the public. The company said reporting on “cherry-picked documents” could be “potentially prejudicial” to its business and to the fairness of the litigation, potentially tainting a jury pool. “Litigation in the press is not in the public interest,” Monsanto’s filing states.

The company asked Judge Vince Chhabria to order that discovery materials not be filed as exhibits or other types of filings that could be visible to the public.

Monsanto also made a new filing in the litigation on Friday, laying out its assertion that there is no evidence Roundup and glyphosate products are “defective or unreasonably dangerous” and said the products complied with “all applicable government safety standards.” There is no evidence of carcinogenicity in glyphosate or Roundup, Monsanto said in its filing.

In a separate filing made on Feb. 8, Monsanto submitted a court brief arguing that the IARC classification of glyphosate as a probable human carcinogen is not relevant to the question of whether or not Roundup caused the plaintiffs’ cancers. IARC’s approach is “less rigorous” than EPA’s in evaluating scientific evidence, and IARC’s conclusions are “scientifically unreliable,” according to the brief. Monsanto told the court that neither the views of IARC or EPA are necessarily relevant to the general causation issue of the litigation because plaintiffs will need to present admissible expert testimony showing the company’s products in fact caused their cancers.

As the litigation drags on, legislation that could potentially benefit Monsanto and numerous other companies facing consumer class action lawsuits was proposed on Feb. 9. The “Fairness in Class Action Litigation Act of 2017” (H.R. 985) was introduced in the U.S. House of Representatives by House Judiciary Chairman Bob Goodlatte (R-VA.) Business interests backing the law say it would reduce frivolous suits and ensure that plaintiffs receive the bulk of any damage awards rather than enriching the attorneys who bring such lawsuits. But opponents say it would make it nearly impossible for individuals with limited financial resources to challenge powerful corporations in court. The bill would apply both to pending and future class action and multi-district litigation.

“The bill is designed to ensure that no class action could ever be brought or litigated for anyone,” said Joanne Doroshow, executive director of the Center for Justice & Democracy. “It would obliterate civil rights, antitrust, consumer, essentially every class action in America.”

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)