Pursuing Truth and Transparency in America's Food System

Email of intrigue: “IARC is killing us!”

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As researchers we often look to documents to shed new light on issues important to food policy. Sometimes, they simply reflect what we already know.

That’s the case with one new communication string that adds to evidence of a far-reaching strategy by food industry players to discredit and diminish the world’s leading cancer research agency. We’ve already seen documents from Monsanto and other chemical industry interests laying out plans to tear apart the credibility of the International Agency for Research on Cancer (IARC) because of its classification of Monsanto’s weed killer glyphosate as a probable human carcinogen.

Now we see evidence that other food industry players are part of the scheme; working to head off potentially damaging IARC scrutiny of food additives such as aspartame, sucralose, and more.

The email of intrigue was obtained through a state open records request.  It shows communication between James Coughlin, a one-time scientist for Kraft General Foods Inc. who operates a food and “nutritional” consulting business, and Timothy Pastoor, a retired toxicologist with the agrochemical giant Syngenta AG who now runs his own “science communications” business. Also included on a portion of the email string is Monsanto PR man Jay Byrne, who runs a “reputation management” and public relations business, and Douglas Wolf, a former Environmental Protection Agency scientist now with Syngenta.

In the October 2016 email, Coughlin tells Pastoor how he’s been “fighting IARC forever!!” dating back to his time at Kraft. He relates the time he spent criticizing the international cancer agency to a U.S. House of Representatives staffer who was coordinating an effort to strip U.S. funding from IARC.

And then, articulating the deep fear the food industry holds for the cancer agency, he gets to the meat of the matter: “IARC is killing us!” he writes. The 2-page string can be found here. An excerpt is below:

EPA Glyphosate Registration Review Public Comments Now Due

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For anyone interested in commenting on the EPA’s latest safety review of the weed killing chemical glyphosate:

  • Docket ID:EPA-HQ-OPP-2009-0361
  • Abstract:Federal Register for Tuesday, February 27, 2018 (83 FR 8476) (FRL–9973–07) EPA–HQ–OPP–2017–0720; Registration Review; Draft Human Health and/or Ecological Risk Assessments for Several Pesticides; Notice of Availability
  • Document Type:Notice
  • Status:Posted
  • Received Date:Feb 27, 2018
  • FR Citation:83
  • Start-End Page:8476 – 8478
  • Comment Start Date:Feb 27, 2018
  • Comment Due Date:Apr 30, 2018
  • Glyphosate Case 0178 EPA-HQ-OPP-2009-0361 glyphosateRegReview@epa.gov (703) 347-0292.

See all details here: https://www.regulations.gov/docket?D=EPA-HQ-OPP-2009-0361

Hold the Plum Pudding: US Food Sampling Shows Troubling Pesticide Residues

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By Carey Gillam

Sometimes the truth about our food is not very appetizing.

As many gather this holiday season for shared family meals, it is likely that they’ll be serving up small doses of pesticides with each plate passed, including a prevalent type shown to be harmful to children and reproductive health.

New data released recently by the Food and Drug Administration (FDA) shows a rise in the occurrence of pesticide residues detected in thousands of samples of commonly consumed foods. Documents obtained from the agency through Freedom of Information Act (FOIA) requests also show the government is bracing for more, with the use of at least one controversial weed killing chemical – the herbicide known as 2,4-D – expected to triple in the next year.

And buried deep within the FDA’s latest annual pesticide residue report is data showing that a controversial insecticide called chlorpyrifos, which is marketed by Dow Chemical and is banned from household use due to known dangers, was the fourth-most prevalent pesticide found in foods out of 207 pesticides detected.

Overall, about 50 percent of domestic food and 43 percent of imported foods sampled showed pesticide residues in the FDA’s testing for fiscal year 2015, which is the period covered in the new report. That is up from about 37 percent of domestic and 28 percent of imported foods found with residues in 2010, and up from 38.5 percent and 39 percent, respectively, found by FDA a decade earlier in 2005.

FDA sampling has been shrinking over the years, dropping about 25 percent from a decade ago from more than 7,900 samples to 5,989 samples tested in its latest report. The U.S. Department of Agriculture also does annual pesticide residue testing, but looks at more than 10,000 samples. The latest USDA residue report, which also was for the 2015 time period, found about 85 percent of samples contained pesticide residues.

Notably, samples of fruits and vegetables – considered healthy food choices – showed the highest frequency of pesticide residues in the new FDA report. Roughly 82 percent of domestic American fruits and 62 percent of domestic vegetables carried residues of weed killers, insecticides and other pesticides commonly used by farmers.

Among the domestic food samples, FDA said 97 percent of apples, 83 percent of grapes, 60 percent of tomatoes, 57 percent of mushrooms and 53 percent of plums carried residues. Exactly half of the fruit jams and jellies and similar spreads examined were tainted with pesticides, according to the FDA data.

Looking at imported fruits and vegetables, the FDA found that roughly 51 percent of imported fruits and 47 percent of imported vegetables carried residues. Overall, the imported foods had more illegally high levels of pesticide residues than did domestic foods sampled. More than 9 percent of both imported fruits and vegetables were considered in violation of legal pesticide residue limits compared to only 2.2 percent of American-grown fruits and 3.8 percent of domestic vegetables.

The FDA said some specific commodities brought into the country may warrant special attention due to illegally high levels of pesticides, including cabbage, mushrooms, oranges and orange juice and rice.

Outdated “safe” levels

The Environmental Protection Agency sets legal limits, referred to as “maximum residue limits” (MRLs) for pesticide residues on foods. The FDA and USDA routinely assure consumers that if residues are below the established MRLs, they are both legal and safe. But many scientists and medical professionals disagree, saying regulatory methods are outdated and too dependent on input from the chemical industry players selling the pesticides.

“Risk assessment practices at federal agencies have not been updated for modern scientific principles, including accounting for the fact that people are exposed to multiple chemicals and that certain groups, such as genetically susceptible, the very young and old can be at greater risk of exposure,” said Tracey Woodruff, a former EPA senior scientist who directs the Program on Reproductive Health and the Environment at the University of California San Francisco School of Medicine.

The controversy around chlorpyrifos underscores those concerns. Farmers have been using chlorpyrifos since 1965 and the government has long maintained that as long as residues are below established MRLs, they are safe.

But in recent years, that regulatory view has shifted as studies show that this pesticide, which is used on corn and fruits and vegetables such as cranberries, Brussels sprouts, and broccoli, can have harmful neurodevelopmental effects on fetuses whose mothers are exposed and on young children. Research ties the chemical to attention deficit problems, tremors, and autism.

On December 15, California’s Office of Environmental Health Hazard Assessment listed chlorpyrifos as known to “cause reproductive toxicity.” And the EPA has said that it can no longer vouch for the safety of the residues found in food. The EPA had planned to outlaw chlorpyrifos use in agriculture. But the Trump administration reversed that plan earlier this year after heavy lobbying from Dow and other agrochemical industry representatives.

The FDA declined to comment about its report and declined to address questions about the safety of chlorpyrifos residues found in food.

Surge in 2,4-D expected

Separate from the FDA’s published residue report, internal FDA documents show the agency working to get a handle on the residues of two widely used herbicides – glyphosate and 2,4-Dichlorophenoxyacetic acid (2,4-D). An internal memo dated in May of this year obtained through FOIA states that 2,4-D use is “expected to triple in the coming year” because of new genetically engineered crops designed to tolerate direct application of the herbicide.

Neither FDA nor USDA has routinely tested for glyphosate despite the fact it is the world’s most widely used herbicide, and testing by academics, consumer groups and other countries has shown residues of the weed killer in food. The FDA said in early 2016 that it planned to start testing for the weed killer, and documents show that one FDA chemist reported finding residues in honey and in oatmeal products, but overall results of the program testing have not been released publicly.

Details of the testing program are being kept secret, and in the documents released by FDA through the FOIA, large blocks of information are blacked out. FDA declined to comment about the status of the glyphosate and 2,4-D testing, including when it might publish some results.

Pesticides that the FDA did test for, and find, in the latest food sampling report, included endosulfan, an insecticide that has been banned in more than 80 countries and is being phased out due to established dangers to human health; the insecticide DDT, which was banned in the 1970s in the United States, and malathion, an insecticide classified by the International Agency for Research on Cancer as probably carcinogenic.

This article first appeared in Environmental Health News.

Decades of Deceit: Carey Gillam’s presentation to the European Parliament glyphosate hearing

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Carey Gillam is an investigative journalist and award-winning author who spent 17 years on the food and agriculture beat for Reuters. Gillam is now research director of the public interest research group U.S. Right to Know. These remarks were delivered Oct. 11, 2017 before a joint public hearing on “The Monsanto Papers and Glyphosate” before the European Parliament committees on the Environment, Public Health and Food Safety; and Agriculture and Rural Development.

Links: slides via SlideShare; Carey’s remarks; video of Carey’s presentation and full hearing

Decades of Deceit: How Corporate Influence Has Manipulated Science and Safety Assessments on Glyphosate 

Revelations from the Monsanto Papers and Other Research

Good morning – I am an investigative journalist, someone who has spent 30 years focusing on facts, pursuing truth. And having spent roughly 20 of those 30 years delving into the dealings of Monsanto I can confidently tell you that the story of the company’s top selling chemical, glyphosate, is not one of truth, but one of deceit – carefully calculated and choreographed deceit. There is overwhelming evidence of attempts to deceive, and to do so in ways that manipulate the press and manipulate policy makers like you.

In my reporting role I – along with colleagues at U.S. Right to Know – have obtained thousands of documents from our US regulators as well as from US scientists who work at public universities, and these documents show clearly the long history of deception when it comes to presentation of glyphosate matters. In addition to those documents, we have now the thousands of pages of internal Monsanto emails, memos and other documents that make it clear beyond any doubt the efforts by this company to manipulate policy makers and members of the public.

You just heard panelists talk about the science. I’m here to share with you what the documents show about deception. We know from the documents that Monsanto has:

  • Ghostwritten research papers that assert glyphosate safety for publication & regulatory review
  • Provided alternative assessments for studies that Indicate harm; convinced regulators to discount evidence of safety problems
  • Developed a network of European & U.S. scientists to push glyphosate safety message to regulators and lawmakers while appearing to be independent of industry
  • Utilized public relations teams to ghostwrite articles and blogs that are posted using names of scientists who appear to be independent
  • Formed front groups that work to discredit journalists and scientists who publicize safety concerns
  • Provided EPA “talking points” to use if questioned by press about IARC classification
  • Successfully pushed EPA to remove top independent epidemiologist from EPA Scientific Advisory Panel
  • Enlisted 3 EPA officials to block a 2015 Glyphosate Review by the U.S. Agency for Toxic Substances and Disease Registry that Monsanto said would likely agree with IARC

Full text of remarks posted here (PDF). For many examples of Monsanto’s manipulations revealed in the documents, see Carey’s slides posted below – slides also available via PDF or SlideShare.  

[slideshare id=80870216&doc=careygillamslidestoeuropeanparliamenthearingonmonsantopapers-171016190325]

Link to video of Carey Gillam’s presentation and video of full hearing

Carey Gillam is a veteran journalist, researcher, and writer with more than 25 years of experience covering corporate America, and a former senior correspondent for Reuters’ international news service. Her new book “Whitewash: The Story of a Weed Killer, Cancer and the Corruption of Science” was just released by Island Press. Carey is also the research director of U.S. Right to Know, a nonprofit organization that investigates the risks associated with the corporate food system, and the food industry’s practices and influence on public policy.

How Monsanto Manufactured ‘Outrage’ at IARC over Cancer Classification

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By Carey Gillam

Three years ago this month Monsanto executives realized they had a big problem on their hands.

It was September 2014 and the company’s top-selling chemical, the weed killer called glyphosate that is the foundation for Monsanto’s branded Roundup products, had been selected as one among a handful of pesticides to undergo scrutiny by the World Health Organization’s International Agency for Research on Cancer (IARC). Monsanto had spent decades fending off concerns about the safety of glyphosate and decrying scientific research indicating the chemical might cause cancer or other diseases. And even though the IARC review was still months away, Monsanto’s own scientists knew what the outcome would likely be—and they knew it wouldn’t be good.

Internal company records show not just the level of fear Monsanto had over the impending review, but notably that company officials fully expected IARC scientists would find at least some cancer connections to glyphosate. Company scientists discussed the “vulnerability” that surrounded their efforts to defend glyphosate amid multiple unfavorable research findings in studies of people and animals exposed to the weed killer. In addition to epidemiology studies, “we also have potential vulnerabilities in the other areas that IARC will consider, namely, exposure, genetox and mode of action…” a Monsanto scientist wrote in October 2014. That same email discussed a need to find allies and arrange funding for a “fight”—all months before the IARC meeting in March 2015.

And Monsanto predicted internally before IARC even met that the review of the scientific evidence would result in a decision that glyphosate “possibly” was carcinogenic or “probably” was. Monsanto officials had forecast the IARC decision in an internal “preparedness” plan that warned colleagues to “assume and prepare for the outcome…” The document shows Monsanto thought it most likely that IARC would peg glyphosate as a “possible human carcinogen.” The rating of probable carcinogen was “possible but less likely,” the Monsanto memo stated. IARC ultimately did classify glyphosate as “probably carcinogenic to humans.”

As the IARC meeting loomed, the internal documents show that Monsanto did not wait for the actual IARC decision before acting. It enlisted teams of PR and lobbying experts, scientists and others in a plan aimed at creating what was designed to appear as a storm of “outcry” and “outrage” to follow the IARC classification. IARC had a history of “questionable and politically charged rulings,” the Monsanto memo said.

The plan was to create enough controversy to thoroughly discredit IARC’s evaluation because Monsanto officials knew that regulators would be influenced by IARC, and continued widespread use of the top-selling chemical could be at risk.

“It is possible that IARC’s decision will impact future regulatory decision making,” Monsanto stated in its internal correspondence.

The timing was critical because in 2015 both the U.S. Environmental Protection Agency (EPA) and the European Commission were evaluating re-authorizations of Monsanto’s weed killer. Following IARC’s classification, both the European Union and the EPA delayed final decisions on glyphosate amid the still-brewing debate over the chemical’s safety.

“What this indicates to me is that it was obvious to Monsanto that there was evidence of carcinogenicity,” said Peter Infante, an epidemiologist who worked for more than 24 years for the U.S. government studying cancer risks to workers from exposure to toxic substances. “It would seem to me that Monsanto does not like the public to be informed of the cancer hazard.”

“What this indicates to me is that it was obvious to Monsanto that there was evidence of carcinogenicity.”

After the IARC ruling, a storm of protest did erupt from various individuals and organizations alongside Monsanto’s howls of indignant outrage. Some have questioned the wisdom of U.S. funding for IARC and Monsanto has perpetuated a false narrative that the chairman of the IARC working group withheld critical information from the team.

The document trail, which includes internal emails, memos and other communications obtained from Monsanto by plaintiffs’ attorneys through litigation pending in the U.S., makes clear that the debate over, and challenge to, IARC’s classification did not sprout authentically from a variety of voices, but rather was manufactured by Monsanto in advance of IARC’s decision and continued afterward. The goal was—and is—to convince regulators to discount the findings of the team of independent scientific experts who made up the IARC team that examined glyphosate.

The internal records obtained through litigation, combined with documents obtained through Freedom of Information Act (FOIA) and state records requests also show that the actions employed to discredit IARC were part of a decades-long pattern of deceptive tactics by Monsanto to persuade regulators, lawmakers and members of the press and public that glyphosate and Roundup are safe. The company has used these tactics multiple times over the years to try to discredit several scientists whose research has found harmful effects associated with glyphosate.

Orchestrate Outcry”

The IARC attack plan, which was laid out in a February 2015 memo, involved not only Monsanto’s internal PR people, scientists and marketing experts, but a range of outside industry players. Various individuals were assigned tasks. The “strategies and tactics” included:

  • “Orchestrate Outcry” with IARC Decision—Industry conducts robust media/social media outreach on process and outcome.
  • “Identify/request third-party experts to blog, op/ed, tweet and/or link, repost, retweet, etc.” The documents show one such “expert,” academic Henry Miller, was provided a draft article to submit to Forbes for publication under his name with no mention of Monsanto’s involvement. Forbes learned of the deceit last month and severed relations with Miller.
  • “Inform/Inoculate/Engage Industry Partners”—Notably the industry partners listed included three organizations that purport to be independent of Monsanto but have long been seen by critics as front groups for the company—Monsanto named Academics Review and the Genetic Literacy Project, both based in the U.S. and Sense About Science, which has run operations in the United Kingdom and the U.S., as groups to help with its mission. In fact, Sense About Science was the group identified by Monsanto to lead the industry response and “provide a platform for IARC observers.” The groups did as Monsanto planned, posting scathing attacks on IARC on their websites.
  • Engagement with Regulatory Agencies—Monsanto planned for grower associations/ growers to “write regulators with an appeal that they remain focused on the science, not the politically charged decision by IARC.”
  • “Push opinion leader letter to key daily newspaper on day of IARC ruling” with assistance of the Potomac Group marketing firm.

The preparedness plan also called for supporting “the development of three new papers on glyphosate focused on epidemiology and toxicology.” As planned, shortly after the IARC decision Monsanto arranged for several scientists—many of them former employees or paid consultants—to author and publish research papers supporting glyphosate safety. It was revealed through discovery documents that Monsanto discussed ghostwriting the papers. In one email, company scientist William Heydens told colleagues the company could “ghost-write” certain reports that would carry the names of outside scientists—”they would just edit & sign their names so to speak,” he wrote. He cited as an example a 2000 study that has been regarded as influential by regulators. Documents show Monsanto’s heavy writing and editing involvement in the resulting purportedly “independent” review.

Monsanto has adamantly denied ghostwriting, but one memo from August 2015 from the files of Monsanto scientist David Saltmiras actually uses that term, stating that he “ghostwrote cancer review paper Greim et al (2015)…” referring to a paper that showed authorship by German scientist Helmut Greim along with Saltmiras. (Monsanto has acknowledged that Greim worked as a consultant to the company with part of his job being to publish peer-reviewed data on glyphosate).

Another internal email illustrates the writing by a Monsanto scientist of a research paper titled “Developmental and Reproductive Outcomes… after Glyphosate Exposure.” The scientist, Donna Farmer, did extensive work, including what she called a “cut and paste” of certain information. But her name was not included as an author before the paper was submitted to a journal. The published version concluded there was “no solid evidence linking glyphosate exposure to adverse developmental or reproductive effects.”

The paper trail of documents also show that Monsanto feared that a U.S. health agency planning to review glyphosate in 2015 might agree with IARC and collaborated with the EPA to successfully block that agency—the Agency for Toxic Substances & Disease Registry (ATSDR)—from doing its review. “We’re trying to do everything we can to keep from having a domestic IARC occur,” a company official wrote. 

The record also shows that well before IARC, Monsanto recruited networks of academic scientists in the U.S and Europe who have defended Monsanto’s products, including its weed killer, without declaring their collaborations with Monsanto. And that these silent soldiers helped Monsanto discredit scientists who reported research showing harm associated with glyphosate and Roundup, including working at Monsanto’s bidding to get one damaging study by French scientist Gilles-Éric Séralini retracted from a scientific journal where it was published in September 2012. The company even discounted concerns by one of its own paid consultants who found evidence of glyphosate’s genotoxicity and refused to do the additional tests he recommended.

If what Monsanto says is true, that glyphosate is so very safe, and that there is no evidence it causes cancer or other health problems, then why all the smoke and mirrors? Why would the company need to ghostwrite research papers to present to regulators? Why would Monsanto need to establish networks of scientists to promote glyphosate safety and to tear down scientists whose research raises concerns? Why would Monsanto try to block a review of glyphosate by the U.S. ATSDR?

Two committees of the European Parliament have scheduled a hearing for Oct. 11 in Brussels to delve into these and other questions as the European Commission faces a looming deadline for making a decision on the re-authorization of glyphosate before the end of 2017.

Lawmakers should take note of evidence that their own food safety agency appears to have dropped the ball on independent assessments of glyphosate research. Records show that the European Food Safety Authority (EFSA) dismissed a study linking Monsanto’s weed killer to cancer at the advice of an EPA official who Monsanto deemed “useful” and who is part of a probe now into possible collusion between the EPA and Monsanto.

They should also pay heed to news that EFSA based its recommendation on glyphosate on a report that copied and pasted analyses from a Monsanto study.

Monsanto Chairman Hugh Grant was invited to address the Parliament meeting in October, but declined to appear or to send anyone else from Monsanto. Dr. Roland Solecki, head of chemical safety for the German Federal Institute for Risk Assessment (BfR), has also declined, according to organizers. I do plan to participate, as will a representative from IARC and several others.

Throughout this debate, it is worthwhile to remember that the concerns about glyphosate safety have deep roots that date all the way back to at least 1985 when EPA toxicologists looked at data showing rare tumors in mice dosed with glyphosate and determined that glyphosate was “possibly carcinogenic to humans.”

Monsanto protests eventually reversed that classification but in light of all of the deceptive tactics recently revealed in documents, the words of an EPA scientist more than 30 years ago are worth considering today: “Glyphosate is suspect… Monsanto’s argument is unacceptable.”

The EPA scientist in that 1985 memo also wrote: “Our viewpoint is one of protecting the public health when we see suspicious data. It is not our job to protect registrants…”

European lawmakers would be wise to recall those words.

This article was originally published in EcoWatch.

Carey Gillam is a veteran reporter and author of Whitewash – The Story of a Weed Killer, Cancer and the Corruption of Science. She is research director for U.S. Right to Know, a nonprofit consumer watchdog group working for truth and transparency in our food system.  

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.

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)

FDA Resumes Testing Foods For Weed Killer, Safety Questions Grow

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The Food and Drug Administration (FDA) has resumed its first-ever endeavor to evaluate how much of a controversial chemical is making its way into the U.S. food supply. And the tests can’t come soon enough as safety concerns about the herbicide known as glyphosate grow.

The FDA, the nation’s chief food safety regulator, launched what it calls a “special assignment” last year to analyze certain foods for glyphosate residues after the agency was criticized by the U.S. Government Accountability Office for failing to include glyphosate in annual testing programs that look for many less-used pesticides in foods. But the agency scuttled the testing after only a few months amid disagreement and difficulties with establishing a standard methodology to use across the agency’s multiple U.S. laboratories, according to FDA sources.

Many observers suspected the suspension might be politically motivated because it came after one FDA chemist found glyphosate in several samples of U.S. honey and oatmeal products, including baby food. As well, private organizations have detected glyphosate residues in an array of food products. In April the Canadian Food Inspection Agency reported that it found glyphosate residues – mostly in small amounts – in roughly 30 percent of foods it tested. The U.S. Department of Agriculture had intended to start testing some food samples for glyphosate in April of this year, agency documents obtained through Freedom of Information Act requests show. But the agency decided to abandon that plan.

Sources inside the FDA said agency glyphosate testing resumed in early June and FDA spokeswoman Megan McSeveney confirmed the news this week. Alongside the testing for glyphosate, the FDA laboratories have also said they were analyzing foods for 2,4-D and other “acid herbicides.” Chemical company players have started combining 2,4-D and the herbicide dicamba with glyphosate in new weed-killing products and use is expected to rise, so tracking residues in food is important. But the FDA has provided few details about any of the testing, and what is known has mostly been learned through internal documents obtained through Freedom of Information requests.

Glyphosate is the most widely used herbicide in the world, and is the key ingredient in Monsanto Co.’s branded Roundup herbicides. It has been classified as a probable human carcinogen by the World Health Organization’s International Agency for Research on Cancer (IARC), which said that years of research on the chemical shows evidence of genotoxicity and oxidative stress from glyphosate, including findings of DNA damage in the peripheral blood of exposed humans. But U.S. and other many other regulatory bodies have said there is not sufficient evidence to support that view.

There was also news on Wednesday that the Environmental Protection Agency’s (EPA), Office of Inspector General is initiating a probe into possible collusion between Monsanto and a former top EPA official who provided favorable assessments of the safety of glyphosate while at the EPA. That official, Jesudoss Rowland, was deputy division director within the health effects division of the Office of Pesticide Programs. Rowland managed the work of scientists who assessed human health effects of exposures to pesticides and he chaired the EPA’s Cancer Assessment Review Committee (CARC) that contradicted the IARC finding and 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.

Rowland had a long history of taking a favorable position on Monsanto’s glyphosate. In 1998, Rowland and the hazard identification assessment review committee ― where he served as executive secretary at the time ― recommended that the EPA drop the extra safety margin designed to protect children in the agency’s re-evaluation of what constituted a safe dose of glyphosate. Rowland and another EPA scientist authored the report making the recommendation. The decision to drop the extra safety margin called for in the Food Quality Protection Act was important in helping Monsanto gain approval for expanded tolerance levels for glyphosate residues in food. Pesticide residues are legal in food if they fall under the so-called “maximum residue levels” or MRLs set by the EPA.

As the FDA tests for glyphosate residues in food the agency specifically will be looking to see if residues they do find fall within those MRLs. Over the years, the legal limits for glyphosate in food have risen multiple times as glyphosate use has risen.

Glyphosate exposures in food and in the environment need much more scrutiny, according to a group of 20 doctors and scientists who put their concerns in writing last month: “Should the public be assured of the safety of glyphosate? We think not…” the group wrote. “We urge the public not to be duped by chemical company apologists who attempt to obscure independent scientific findings that threaten a highly profitable product.”

(First published in Huffington Post)

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.