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.”

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)

Questions about EPA-Monsanto collusion raised in cancer lawsuits

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Now  it’s getting interesting.

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

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

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

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

Lawyers for the plaintiffs want the federal judge in the case to lift a seal on documents that detail Monsanto’s interactions with Rowland regarding the EPA’s safety assessment of glyphosate. Monsanto turned the documents over in discovery but marked them “confidential,” a designation plaintiffs’ attorneys say is improper. They also want to depose Rowland. But Monsanto and the EPA object to the requests, court documents show. Rowland could not be reached for comment, and the EPA declined to comment about the court matters.

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

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

MONSANTO WANTS DOCUMENTS KEPT SECRET

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

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

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

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

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

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

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

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By Carey Gillam

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What Is Going On With Glyphosate? EPA’s Odd Handling of Controversial Chemical

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By Carey Gillam

The Environmental Protection Agency’s ongoing risk assessment of the world’s most widely used herbicide is starting to generate more questions than answers. On Monday, it also generated a giant “oops” from the EPA.

On Friday, April 29, the EPA posted on its website a series of documents related to its long-awaited risk assessment for glyphosate, the active ingredient in Monsanto’s Roundup herbicide and other weed-killing products sold around the world. The risk assessment started in 2009 and was supposed to conclude in 2015. But questions about whether or not glyphosate may cause cancer are dogging the agency’s review, and have slowed the process.

On Monday, after the contents of the documents started to generate questions from media, EPA yanked those documents from its website:

An agency spokeswoman said this:

“Glyphosate documents were inadvertently posted to the Agency’s docket. These documents have now been taken down because our assessment is not final. EPA has not completed our cancer review. We will look at the work of other governments as well as work by HHS’s Agricultural Health Study as we move to make a decision on glyphosate. Our assessment will be peer reviewed and completed by end of 2016.”

The EPA said it was “working through some important science issues on glyphosate, including residues of the chemical in human breast milk;” an “in-depth human incidents and epidemiology evaluation;” and a preliminary analysis of glyphosate toxicity to milkweed, a critical resource for the monarch butterfly.

Inadvertent or not, one of those documents posted and then withdrawn was a doozy, a heavy hammer that seeks to knock down worries about glyphosate ties to cancer. The agency released an Oct. 1, 2015 internal EPA memorandum from its cancer assessment review committee (CARC) that contradicts the March 2015 finding by the World Health Organization’s International Agency for Research on Cancer (IARC) classifying glyphosate as a probable human carcinogen. EPA found instead that glyphosate is “Not Likely to be Carcinogenic to Humans.”

The memorandum stated that the classification was based on “weight-of-evidence considerations.”

CARC said this:

“The epidemiological evidence at this time does not support a causal relationship between glyphosate exposure and solid tumors. There is also no evidence to support a causal relationship between glyphosate exposure and the following non-solid tumors: leukemia, multiple myeloma, or Hodgkin lymphoma. The epidemiological evidence at this time is inconclusive for a causal or clear associative relationship between glyphosate and NHL. Multiple case-control studies and one prospective cohort study found no association; whereas, results from a small number of case-control studies (mostly in Sweden) did suggest an association.”

Monsanto touted and tweeted the release of the document, which follows the release by EPA of a different memorandum supporting the safety of glyphosate last June. The newest memo gives the company added evidence to defend itself against a mounting stack of lawsuits filed by agricultural workers and others alleging Monsanto’s glyphosate-based Roundup herbicide gave them cancer.

“This is the EPA’s highest ranking for product safety—they also do nice job of explaining all of IARC’s mistakes,” Monsanto Chief Technology Officer Robb Fraley said in a twitter posting.

Monsanto has been calling on EPA to defend glyphosate against the cancer claims since the IARC classification came out in March 2015. A March 23, 2015 EPA email string released as part of a Freedom of Information request details Monsanto’s efforts to get EPA to “correct” the record on glyphosate “as it relates to carcinogenicity.”

Another document newly released by EPA – which was also then withdrawn – illustrates just why EPA’s risk assessment about the safety of glyphosate matters so much. In a memorandum dated Oct. 22, 2015, EPA detailed how extensively glyphosate is being used on food items.

That memo updates estimates of glyphosate use on crops in top agricultural states, and provides annual average use estimates for the decade 2004-2013. Seventy crops are on the EPA list, ranging alphabetically from alfalfa and almonds to watermelons and wheat. Glyphosate used on soybean fields, on an annual basis, is pegged at 101.2 million pounds; with corn-related use at 63.5 million pounds. Both those crops are genetically engineered so they can be sprayed directly with glyphosate as farmers treat fields for weeds. Cotton and canola, also genetically engineered to be glyphosate tolerant, also have high use numbers. But notable glyphosate use is also seen with oranges (3.2 million lbs); sorghum (3 million lbs); almonds (2.1 million lbs); grapes, (1.5 million lbs); grapefruit and apples (400,000 lbs each); and a variety of fruits, vegetables and nuts.

Despite – or perhaps because of – the delays in issuing a final regulatory risk assessment on glyphosate, questions about the impact of the chemical on human health and the environment have been mounting. In addition to the lawsuits alleging glyphosate caused cancer in farm workers and others, private groups are scrambling to test a variety of food products for glyphosate residues.

On Friday a lawsuit with a new twist on glyphosate concerns was filed in U.S. District Court in San Francisco. That suit, which seeks class action status, alleges that glyphosate residues found in Quaker Oats invalidates claims by the Quaker Oats Co. that its product is wholly natural. “Glyphosate is a synthetic biocide and probable human carcinogen, with additional health dangers rapidly becoming known,” the lawsuit states. “When a product purports to be ‘100% Natural,’ consumers not only are willing to pay more for the product, they expect it to be pesticide-free,” the lawsuit states.

Questions about glyphosate have become so prevalent that U.S. Rep. Ted Lieu wrote a letter to EPA officials in December requesting EPA scientists meet with a group of independent scientists to go over “troubling information” related to glyphosate. Lieu cited concerns that EPA is relying on Monsanto-backed data rather than independent, peer-reviewed research in assessing glyphosate. Sources close to the situation say that meeting has been scheduled for June 14, though both EPA and Lieu’s office declined to comment.

The EPA’s diligence on digging into glyphosate questions and concerns is encouraging to those who want to see a thorough risk assessment done. But the delay and the questionable actions with releasing documents and then withdrawing them from the public eye does not inspire confidence.

Indeed, in another curious move, the EPA on May 2 also issued a newly updated “registration review schedule.“ But while three dozen other chemical draft risk assessments are listed on the EPA website for release by the end of 2016, glyphosate was not included.

Oops?

This article originally appeared in Huffington Post

Carey Gillam is a veteran former Reuters journalist, current freelance writer/editor and research director for U.S. Right to Know, a food industry research group. Follow her on Twitter @CareyGillam