Office of Pesticide Programs

Glyphosate: Cancer and Other Health Concerns

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Posted on by Stacy Malkan

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

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

Most Widely Used Pesticide

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

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

Statements from scientists and health care providers 

Cancer concerns

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

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

U.S. agencies: At the time of the IARC classification, the Environmental Protection Agency (EPA) was conducting a registration review. The EPA’s Cancer Assessment Review Committee (CARC) issued a report in September 2016 concluding that glyphosate was “not likely to be carcinogenic to humans” at doses relevant to human health. In December 2016, the EPA convened a Scientific Advisory Panel to review the report; members were divided in their assessment of EPA’s work, with some finding the EPA erred in how it evaluated certain research. Additionally, the EPA’s Office of Research and Development determined that EPA’s Office of Pesticide Programs had not followed proper protocols in its evaluation of glyphosate, and said the evidence could be deemed to support a “likely” carcinogenic or “suggestive” evidence of carcinogenicity classification. Nevertheless the EPA issued a draft report on glyphosate in December 2017 continuing to hold that the chemical is not likely to be carcinogenic. In April 2019, the EPA reaffirmed its position that glyphosate poses no risk to public health. But earlier that same month, the U.S. Agency for Toxic Substances and Disease Registry (ATSDR) reported that there are links between glyphosate and cancer. According to the draft report from ATSDR, “numerous studies reported risk ratios greater than one for associations between glyphosate exposure and risk of non-Hodgkin’s lymphoma or multiple myeloma.” 

E.U. and WHO/FAO: The European Food Safety Authority and the European Chemicals Agency have said glyphosate is not likely to be carcinogenic to humans. A March 2017 report by environmental and consumer groups argued that regulators relied improperly on research that was directed and manipulated by the chemical industry. A 2019 study found that Germany’s Federal Institute for Risk Assessment for glyphosate, which found no cancer risk played a key role in influencing the EFSA report, included sections of text that had been plagiarized from Monsanto studies. text. In 2016, the WHO/FAO Joint Meeting on Pesticide Residues determined that glyphosate was unlikely to pose a carcinogenic risk to humans from exposure through the diet, though the finding was tarnished by conflict of interest concerns after it was revealed that certain members of the group, including its chair, worked for the International Life Sciences Institute, a group funded in part by Monsanto and one of its lobbying organizations.

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

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

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

Cancer lawsuits

More than 42,000 people have filed suit against Monsanto Company (now Bayer) alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma (NHL), and that Monsanto covered up the risks. As part of the discovery process, Monsanto has had to turn over millions of pages of internal records. We are posting these Monsanto Papers as they become available. For news and tips about the ongoing legislation, see Carey Gillam’s Roundup Trial Tracker. The first three trials ended in large awards to plaintiffs for liability and damages, with juries ruling that Monsanto’s weed killer was a substantial contributing factor in causing them to develop NHL. Bayer is appealing the rulings. 

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

More information about scientific interference:

Endocrine disruption and other health concerns

Some research suggests that glyphosate may be an endocrine disruptor. It has also been linked to liver disease, birth defects and reproductive problems in laboratory animals; and may kill beneficial gut bacteria and damage the DNA in human embryonic, placental and umbilical cord cells. A 2019 study in a Nature journal reported increases in obesity, reproductive and kidney diseases, and other problems in the second- and third-generation offspring of rats exposed to glyphosate. See the study and Washington State University press release.

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

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

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

Sri Lankan scientists awarded AAAS freedom award for kidney disease research

The AAAS has awarded two Sri Lankan scientists, Drs. Channa Jayasumana and Sarath Gunatilake, the 2019 Award for Scientific Freedom and Responsibility for their work to “investigate a possible connection between glyphosate and chronic kidney disease under challenging circumstances.” The scientists have reported that glyphosate plays a key role in transporting heavy metals to the kidneys of those drinking contaminated water, leading to high rates of chronic kidney disease in farming communities. See papers in  SpringerPlus (2015), BMC Nephrology (2015), Environmental Health (2015), International Journal of Environmental Research and Public Health (2014). The AAAS award had been under review since February amidst a fierce opposition campaign by pesticide industry allies to undermine the work of the scientists. 

Desiccation: another source of dietary exposures 

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

Glyphosate in food: U.S. drags its feet on testing

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

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

Pesticides in our food: Where’s the safety data?

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

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

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Posted on by Carey Gillam

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 yet. The 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.”

Questions about EPA-Monsanto collusion raised in cancer lawsuits

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Posted on by Carey Gillam

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.”

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

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Posted on by Stacy Malkan

By Carey Gillam

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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