Son testifies about his mother’s cancer alleged due to Roundup exposure

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A woman suffering from non-Hodgkin lymphoma was a devoted user of Roundup herbicide for decades before she became ill, her son testified Tuesday in a California trial that marks the fourth such trial pitting a cancer victim against Roundup maker Monsanto.

Under questioning by a lawyer representing plaintiff Donetta Stephens, her son David Stephens recalled his mother’s frequent use of Roundup in the yard and her tendency to wear sleeveless shirts and shorts when outside spraying the weed killer. He described recalling her use when he was a child and that use continuing when he was an adult and had his own children.

Stephens also testified about a family gathering in which his mother broke the news of her cancer to the family, the lengthy series of medical treatments that followed, his mother’s memory loss and other treatment-related problems, and a period in which his mother was hospitalized multiple times and nearly died.

Stephens is one of tens of thousands of plaintiffs who filed lawsuits against Monsanto after the World Health Organization’s cancer experts in 2015 classified glyphosate as a probable human carcinogen with an association to non-Hodgkin lymphoma. Glyphosate is the active ingredient in Roundup and other weed killing brands.

Bayer AG bought Monsanto in June 2018 just as the first trial was getting underway.

Three previous trials held to date were all found in favor of the plaintiffs. Jurors in those trials agreed with claims that Monsanto’s glyphosate-based weed killers, such as Roundup, cause non-Hodgkin lymphoma, and that Monsanto spent decades covering up the risks and failing to warn users.

The Stephens case is being tried in the Superior Court of San Bernardino County in California under the oversight of Judge Gilbert Ochoa. Though the trial started in person, Judge Ochoa ordered the proceedings shifted to a Zoom trial due to concerns about the spread of Covid-19 virus.

In testimony Tuesday, David Stephens broke down, emotionally describing a time when it appeared his mother was near death, and speaking of a photo he took of her that he thought at the time would be the last.

“I took that picture because when you think that your mother is going to die and that could be the last picture…,” Stephens said haltingly. “I wanted to take that picture so I could remember…”

Donnetta Stephens is now in remission from cancer but has been left debilitated, her son testified.

Former Monsanto scientist Donna Farmer will be called to testify next week, according to Stephens’ lawyer Fletch Trammell.

Technical trouble

The trial has been plagued by technical issues since the transition to a virtual setting through Zoom. There have been multiple times proceedings have been halted because a lawyer or juror loses an audio or video connection or experiences other difficulties. The virtual format has also proven problematic at times for the presentation of certain exhibits.

A courtroom attendant has been assigned to monitor jurors to determine if they are paying attention, and to alert the judge to lost connections or other problems.

In Tuesday’s testimony, as Monsanto lawyer Manuel Cachan was attempting to cross examine Stephens, questioning the reliability of his memory regarding his mother’s use of Roundup, the technical trouble kicked in again.

“I’m sorry for the interruption, juror number 13 is having issues, just starting to quote unquote glitch out,” the courtroom attendant interjected.

Minutes later: “Pardon me… juror number 11 has just disconnected,” the courtroom attendant interrupted again.

Some legal observers have speculated that the losing party in the trial will have an easy avenue for appeal given the persistent interruptions and difficulties.

Trial overlap

A fifth Roundup trial was starting jury selection this week in a case involving a boy with non-Hodgkin lymphoma.

The child, Ezra Clark, is the subject of a trial beginning this week in Los Angeles County Superior Court. Clark was “directly exposed” to Roundup many times as he accompanied his mother while she sprayed Roundup to kill weeds around the property where the family lived, according to court documents. Ezra sometimes played in freshly sprayed areas, according to the court filings.

Ezra was diagnosed in 2016, at the age of 4, with Burkitt’s lymphoma, a form of NHL that has a high tendency to spread to the central nervous system, and can also involve the liver, spleen and bone marrow, according to the court filings.

Ezra’s mother, Destiny Clark, is the plaintiff in the case, filing on behalf of Ezra.

Opening statements in the Clark trial are scheduled to begin Wednesday morning.

Bayer denies any cancer connection

Bayer has earmarked more than $14 billion to try to settle the litigation and has announced it will stop selling glyphosate-based herbicides to consumers by 2023. But the company still insists that the herbicides it inherited from Monsanto do not cause cancer.

Last month Bayer filed a writ of certiorari with the U.S. Supreme Court, seeking the high court’s review of the Ninth Circuit Court of Appeals’ decision in the case of Hardeman v. Monsanto. 

The move is widely seen as Bayer’s best hope for putting an end to claims that exposure to Monsanto’s glyphosate-based herbicides, such as the popular Roundup brand, cause non-Hodgkin lymphoma, and the company failed to warn users of the risks.

During the month-long trial in 2019, lawyers for plaintiff Edwin Hardeman presented jurors with a range of scientific research showing cancer connections to Monsanto’s herbicides as well as evidence of many Monsanto strategies aimed at suppressing the scientific information about the risks of its products. Internal Monsanto documents showed the company’s scientists had engaged in secretly ghost-writing scientific papers that the company then used to help convince regulators of product safety.

EPA whistleblower testifies her advocacy for stronger health protections drew agency retaliation

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Children’s health expert Ruth Etzel on Monday testified in a public hearing that the Environmental Protection Agency (EPA) worked to silence and harass her, removing her from a top-level position after she complained about agency delays in advancing a lead poisoning prevention program.

In testimony before Merit Systems Protection Board Judge Joel Alexander,  Etzel described being shocked to learn she was being placed on leave without pay in September 2018 and the “vindictive” “cat and mouse games” she alleged EPA officials used to block her from scheduled national and international speaking engagements.

She also testified that the agency issued public statements designed to discredit and intimidate her.

“They appeared to be just trying to smear my good name,” she testified.

Etzel is a pediatrician and epidemiologist who was brought into the EPA in 2015 by the Obama administration to direct the agency’s Office of Children’s Health Protection (OCHP). Etzel previously worked as a senior officer in the department of public health and environment at the World Health Organization in Switzerland and also previously worked for the U.S. Centers for Disease Control and on public health matters within the U.S. Department of Agriculture.

The agency actions against her occurred during the Trump administration and allegedly followed an aggressive push by Etzel to launch a federal action plan aimed at reducing childhood exposures to lead.

According to her whistleblower complaint, Etzel spoke out about “gross mismanagement and a substantial and specific danger to public health” from childhood lead poisoning, and tried to promote the release of a new federal strategy even after EPA leadership delayed the plan’s final review. In response, “EPA placed Dr. Etzel on administrative leave without warning,” fabricated complaints about her leadership and obstructed her ability to travel to attend and speak at professional conferences, Etzel alleges.

Separate from Etzel’s allegations, four EPA scientists have recently come forward with allegations that the agency is putting corporate interests ahead of public health protection, allowing dangerous chemicals into the marketplace. The whistleblowers allege the EPA routinely uses intimidation tactics to coerce agency scientists into ignoring data showing risks of harm with certain chemicals, and/or altering assessments to downplay such risks.

Etzel and the other EPA whistleblowers are represented by lawyers at Public Employees for Environmental Responsibility. 

“Opportunity to strike”

Multiple internal EPA emails and other records were introduced on Monday as evidence, including an email in which EPA public affairs personnel discussed “an opportunity to strike” out against Etzel in communications to the media.

In a September 28, 2018 email, former EPA deputy associate administrator in the office of public affairs John Konkus wrote to colleagues about inquiries from members of the press about Etzel’s being placed on leave.

“This is our opportunity to strike,” Konkus wrote. (Konkus is no longer with the EPA; he now works as a senior manager for “government affairs” with AECOM, a consulting firm on infrastructure engineering and construction matters.)

“I felt like this was a direct strike on me and it caused me to have fear in my heart,” Etzel testified.

In an email thread with the subject line “Push this around ASAP please,” public affairs officials discussed a “stronger updated” statement about Etzel to state that she was placed on administrative leave because of “serious reports made against her by staff … ” that were “very concerning.”

After being put on leave, Etzel went on multiple television shows to talk about the agency actions. In testimony Monday she said she felt she had no other choice.

“I had been completely silenced by being placed on administrative leave and I was not able to do the job that I was hired to do. I had no other venue,” Etzel testified. “I basically took an oath when I became a doctor to do no harm and by being silent when hazards continue in the environment unabated I do harm, and so I’m not willing to do that. I had to speak out.”

Etzel said the lead plan that was ultimately rolled out after she was placed on leave was “weaker” than the one she helped design and lacked new regulations and requirements needed for the strategy to be  effective.

Former EPA official testifies

The first witness called Monday to testify on behalf of Etzel was former EPA official Reginald Allen, who served in several positions at the agency, including as Acting Deputy Chief of Staff.

Allen testified that during the Trump administration, Millan Hupp, a political appointee close to then-EPA administrator Scott Pruitt, “absolutely” engaged – along with Pruitt – in unethical behavior, and was at least partly instrumental in working to push out certain EPA personnel. Pruitt, who was appointed by Trump to run the EPA, was pushed out in July of 2018 amid evidence of multiple ethical violations.

Allen further testified that Helena Wooden-Aguilar, who was acting deputy chief of staff at the time and who was directly involved in removing Etzel, was close to Hupp and was given that position “with an agenda and that agenda included pushing aside or getting rid of the career senior executives that the political administration did not feel comfortable with or felt did not do their bidding in a way that they wanted.”

Under questioning, Allen added: “I believe it was to remove what they felt were politically unreliable career leadership in the agency… so they wouldn’t be privy to some of the things that went on in the office of the administrator.”

Wooden-Aguilar is scheduled to testify on Tuesday or Wednesday.

Allen said that when he raised concerns about ethical matters within the EPA “it was just not appreciated” and “marked” him within the agency. Allen said at one point he was falsely accused of leaking sensitive agency information to the media.

“There was even an article planted about me from the administration in the conservative press saying that I was leaking information,” Allen said. “They later determined that it was one of their own… political folks that was doing that. But the damage was already done.”

EPA defense

One witness called Monday afternoon, “leadership consultant” Catherine Allen, appeared to bolster the EPA’s position that there was no improper retaliation against Etzel and her removal from the children’s health office was due to poor leadership and complaints about her management of that office.

The EPA asserts there were many complaints about Etzel’s management, including allegations from employees that she “failed to follow agency HR policy,” was emotional and would “bully” co-workers.

Allen testified that she determined Etzel had poor management abilities and “had lost the respect, the trust, the confidence” of those she managed.

Allen confirmed her findings in a report that stated: “It is my view that Ms. Etzel cannot effectively perform her duties… the longer she is allowed to stay in this role the more the agency is exposed to legal and operational risk. The staff deserve better.”

Bayer Roundup trial goes virtual, and it does not go well

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In fits and starts, and with a good dose of frustration over technical difficulties, a California trial pitting an elderly cancer victim against Monsanto owner Bayer AG resumed on Monday in a virtual format after in-person proceedings were suspended last week, reportedly due to concerns about the spread of Covid-19.

Due to an array of technical problems, lawyers for plaintiff Donnetta Stephens were only able to present abbreviated testimony on Monday from expert witness Charles Benbrook, a former research professor who served at one time as executive director of the National Academy of Sciences board on agriculture.

Benbrook is considered a key witness, and is being called to testify about topics that include the history of scientific submissions to the U.S. Environmental Protection Agency (EPA) by Monsanto and alleged regulatory shortcomings.

The case, which is being tried in the Superior Court of San Bernardino County in California under the oversight of Judge Gilbert Ochoa,  is the fourth Roundup cancer trial to take place in the United States and the first since 2019. Juries in all three prior trials found in favor of the plaintiffs, agreeing with claims that Monsanto’s glyphosate-based weed killers, such as Roundup, cause non-Hodgkin lymphoma and Monsanto spent decades covering up the risks, and failing to warn users.

Stephens is one of tens of thousands of plaintiffs who filed lawsuits against Monsanto after the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen with an association to non-Hodgkin lymphoma.

The three prior trials were all lengthy, in-person proceedings loaded with weeks of highly technical testimony about scientific data, regulatory matters and documents detailing internal Monsanto communications.

Monday’s proceedings indicated that both sides may face significant challenges in trying to convey and combat the evidence and testimony in a virtual format.

Among the issues on Monday, a court reporter couldn’t fully hear the exchanges between lawyer and witness; jurors had difficulty turning on their computer cameras, a requirement issued by the judge; and the judge himself had to relocate at one point in an effort to improve audio transmission.

A courtroom attendant reassured the judge that he was checking in on the jurors every ten minutes and “it appeared that they were all paying attention.”

At one point when calling a break, Judge Ochoa pleaded: “Ladies and gentleman of the jury please, whatever you do, don’t turn off your computers, don’t touch them, just leave them alone and hopefully everybody’s computer will play nice.”

The judge recessed for the day in mid-afternoon, thanking the jurors for their patience.

“We did have some major technical difficulties,” Judge Ochoa said. He noted, however, that they “did make history” by holding the court’s first “Zoom trial.”

Covid delays one Roundup cancer trial while another looms

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The California trial pitting an elderly cancer victim against Monsanto owner Bayer AG has been delayed due to concerns about the spread of Covid-19, with proceedings now expected to resume next week in a virtual format via Zoom.

Lawyers for plaintiff Donnetta Stephens say that she was a regular user of Monsanto’s glyphosate-based Roundup herbicide for more than 30 years, an extended exposure that caused her to develop non-Hodgkin lymphoma (NHL).

Before the trial interruption jury members heard expert witness testimony from former U.S. government scientist Christopher Portier, who told jurors of multiple scientific studies that support claims glyphosate herbicides cause NHL. Lawyers for Monsanto sought to discredit Portier, and discount his testimony, arguing he had a vested financial interest in helping plaintiffs’ attorneys.

Additional experts were due to testify this week before in-person proceedings were scuttled due to positive cases of the Covid-19 virus showing up among people in the courtroom.

Stephens was diagnosed with NHL in 2017 and has suffered from numerous health complications amid multiple rounds of chemotherapy since then. Because of her poor health,  a judge in December granted Stephens a trial “preference,” meaning her case was expedited, after her lawyers informed the court that Stephens is “in a perpetual state of pain,” and losing cognition and memory.

She is one of tens of thousands of plaintiffs who filed lawsuits against Monsanto after the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen with an association to non-Hodgkin lymphoma.

She and the others who have sued allege that Monsanto has known for decades of scientific research showing its glyphosate herbicides could cause cancer, but has failed to warn users of the risks, working instead to suppress information about potential dangers.

The company lost the three trials held to date.

Trial with child plaintiff is next

Though Bayer last year said it was moving to settle outstanding Roundup lawsuits, many remain active and headed toward trial.

A boy with non-Hodgkin lymphoma is the subject of a trial scheduled for Sept. 13 in Los Angeles County Superior Court. Ezra Clark was “directly exposed” to Roundup many times as he accompanied his mother while she sprayed Roundup to kill weeds around the property where the family lived, according to court documents. Ezra sometimes played in freshly sprayed areas, according to the court filings.

Ezra was diagnosed in 2016, at the age of 4, with Burkitt’s lymphoma, a form of NHL that has a high tendency to spread to the central nervous system, and can also involve the liver, spleen and bone marrow, according to the court filings.

Ezra’s mother, Destiny Clark, is the plaintiff in the case, filing on behalf of Ezra.

Expedited trial sought for dying man

U.S. District Judge Vince Chhabria, who has been overseeing thousands of Roundup cases through multidistrict litigation proceedings set up in 2016 in federal court in the Northern District of California, has set several upcoming deadlines for moving cases forward that are under his purview. According to a court document filed Monday,  close to 4,000 cases have come under Chhabria’s oversight since the inception of the litigation.

Chhabria has ordered lawyers in the litigation to submit to him by Wednesday a list of certain cases that have not yet settled, and proposed schedules for advancing those cases. He also set a case management conference for Sept. 8.

At least one plaintiff is seeking an expedited trial, asking Chhabria to approve trial preference already granted him by a state court judge. Plaintiff Donald Miller was diagnosed with Stage IV non-Hodgkin lymphoma after using Roundup product for over four decades, according to the court filings.

Miller’s doctor estimated he had a five-year overall survival expectancy of only thirty-seven percent as of
February, 2020, according to court filings. A hearing on the matter is set for Sept. 23.

Many more cases remain pending in state courts, with plaintiffs’ lawyers jockeying for trial dates.

Bayer last week petitioned the U.S. Supreme Court to review one of its trial losses. The company claims federal law preempts key claims made in the litigation.

Bayer, which bought Monsanto in 2018, insists that when used as directed, its glyphosate herbicides are safe and do not cause cancer. It says regulatory approvals support its position.

EPA’s assessments of chemicals draws criticism from its own scientists

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Many U.S. scientists working for the Environmental Protection Agency (EPA) say they don’t trust the agency’s senior leaders to be honest and they fear retaliation if they were to report a violation of the law, according to a survey of employees conducted in 2020.

According to the Federal Employee Viewpoint Survey for 2020, which was conducted by the U.S. Office of Personnel Management, 75 percent of EPA workers in the National Program Chemicals Division who responded to the survey indicated that they did not think the agency’s senior leadership maintained “high standards of honesty and integrity.” Sixty-five percent of the workers responding from the Risk Assessment Division answered the same way.

Also alarming, 53 percent of respondents in the EPA’s Risk Assessment Division said they could not disclose a suspected violation of the law or regulation without fear of reprisal. Forty-three percent of responding EPA workers in the Office of Pollution Prevention and Toxics (OPPT) answered the same way.

The negative sentiments reflected in the survey results coincide with mounting reports of malfeasance inside EPA’s chemical assessment programs, according to the Public Employees for Environmental Responsibility (PEER).

“It should be of grave concern that more than half the EPA chemists and other specialists working on crucial public health concerns do not feel free to report problems or flag violations,” PEER Executive Director Tim Whitehouse, a former EPA enforcement attorney, said in a statement.

Earlier this month, the National Academies of Sciences, Engineering, and Medicine said the EPA’s hazard assessment practices within the framework of the Toxic Substances Control Act were of “critically low quality.”

“EPA’s new leadership will have its hands full righting this sinking ship,” Whitehouse said.

After taking office in January, President Joe Biden issued an executive order noting that the EPA under Biden may diverge in its position on several chemicals from decisions made by the agency under previous president Donald Trump.

In correspondence dated Jan. 21, the EPA Office of General Counsel said the following:

“In conformance with President Biden’s Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis issued January 20, 2021, (Health and Environment EO), this will confirm my request on behalf of the U.S. Environmental Protection Agency (EPA) that the U.S. Department of Justice (DOJ) seek and obtain abeyances or stays of proceedings in pending litigation seeking judicial review of any EPA regulation promulgated between January 20, 2017, and January 20, 2021, or seeking to establish a deadline for EPA to promulgate a regulation in connection with the subject of any such

Thailand’s reversal on glyphosate ban came after Bayer scripted U.S. intervention, documents show

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A year ago Thailand was set to ban the widely used weed killing chemical glyphosate, a move applauded by public health advocates because of evidence the chemical causes cancer, along with other harms to people and the environment.

But under heavy pressure from U.S. officials, Thailand’s government reversed the planned ban on glyphosate last November and delayed imposing bans on two other agricultural pesticides despite the fact that the country’s National Hazardous Substances Committee said a ban was necessary to protect consumers.

A ban, particularly on glyphosate, would “severely impact” Thai imports of soybeans, wheat and other agricultural commodities, U.S. Department of Agriculture Undersecretary Ted McKinney warned Thailand Prime Minister Prayuth Chan-Ocha in pushing for the reversal. Imports could be impacted because those commodities, and many others, typically are laced with residues of glyphosate.

Now, newly revealed emails between government officials and Monsanto parent Bayer AG show that McKinney’s actions, and those taken by other U.S. government officials to convince Thailand not to ban glyphosate, were largely scripted and pushed by Bayer.

The emails were obtained through a Freedom of Information Act request by the Center for Biological Diversity, a nonprofit conservation organization. The group sued the U.S. Department of Agriculture (USDA) and the U.S. Department of Commerce on Wednesday seeking additional public records regarding the actions of the departments of trade and agriculture in pressuring Thailand on the glyphosate issue. There are several documents the government has thus far refused to release regarding communications with Bayer and other companies, the organization said.

“It’s bad enough that this administration has ignored independent science to blindly support Bayer’s self-serving assertions of glyphosate’s safety,” said Nathan Donley, a senior scientist at the Center for Biological Diversity. “But to then act as Bayer’s agent to pressure other countries to adopt that position is outrageous.”

Glyphosate is the active ingredient in Roundup herbicides and other brands developed by Monsanto, which are worth billions of dollars in annual sales. Bayer bought Monsanto in 2018 and has been struggling ever since to suppress mounting global concerns about scientific research showing that glyphosate herbicides can cause a blood cancer called non-Hodgkin lymphoma. The company is also fighting off lawsuits involving more than 100,000 plaintiffs who claim their development of non-Hodgkin lymphoma was caused by exposure to Roundup and other Monsanto glyphosate-based herbicides.

Glyphosate weed killers are the most widely used herbicides in the world, in large part because Monsanto developed genetically engineered crops that tolerate being sprayed directly with the chemical. Though useful to farmers in keeping fields free of weeds, the practice of spraying herbicide over the tops of growing crops leaves varying levels of the pesticide in both raw grain and finished foods. Monsanto and U.S. regulators maintain pesticide levels in food and livestock feed are not harmful to humans or livestock, but many scientists disagree and say even trace amounts can be dangerous.

Different countries set different legal levels for what they determine to be safe amounts of the weed killer in food and raw commodities. Those “maximum residue levels” are referred to as MRLs. The U.S. allows the highest MRLs of glyphosate in food when compared to other countries.

If Thailand banned glyphosate, the allowed level of glyphosate in food likely would be zero, Bayer warned U.S. officials.

High-level help

The emails show that in September 2019 and again in early October of 2019 James Travis, senior director for Bayer international government affairs and trade, sought assistance in reversing the glyphosate ban from multiple high-level officials from the USDA and the Office of the United States Trade Representative (USTR).

Among those Bayer sought aid from was Zhulieta Willbrand, who at that time was chief of staff of trade and foreign agricultural affairs at the U.S. Department of Agriculture.  After Thailand’s decision to reverse the ban on glyphosate, Willbrand was hired to work directly for Bayer on international trade matters.

When asked if the assistance from Willbrand while she was a government official helped her get a job at Bayer, the company said that it “ethically strives” to hire people from “all backgrounds” and any inference that she was hired for any reason other than the immense talent she brings to Bayer is false.”

In an email to Willbrand dated Sept. 18, 2019, Travis told her Bayer thought there was “real value” for U.S. government engagement on the glyphosate ban, and he noted that Bayer was organizing other groups to protest the ban as well.

“On our end, we are educating farmer groups, plantations and business partners so that they too can articulate concerns and the need for a rigorous, science based process,” Travis wrote to Willbrand. Willbrand then forwarded the email to McKinney, the USDA’s Under Secretary for Trade and Foreign Agricultural Affairs.

In an Oct. 8, 2019, email string with the subject line “Summary of Thailand Ban – Developments Moving Quickly,” Travis wrote to Marta Prado, deputy assistant U.S. Trade Representative for Southeast Asia and the Pacific, copying Willbrand and others, to update them on the situation.

Travis wrote that Thailand looked poised to ban glyphosate at a “dramatically” accelerated pace, by December 1, 2019. Along with glyphosate, the country was planning to also ban chlorpyrifos, an insecticide made popular by Dow Chemical that is known to damage babies’ brains; and paraquat, a herbicide scientists say causes the nervous system disease known as Parkinson’s.

Travis pointed out the risk a glyphosate ban would pose to sales of U.S. commodities because of the MRL issue and provided other background material the officials could use to engage with Thailand.

“In light of recent developments, we are growing more concerned that some policymakers and lawmakers are rushing the process and will not thoroughly consult all farming stakeholders nor fully consider the economic and environmental impact of banning glyphosate,” Travis wrote to the U.S. officials.

The email exchanges show that Bayer and U.S. officials discussed potential personal motivations of Thai officials and how such intelligence could be useful. “Knowing what motivates her may help with USG counter arguments,” one U.S. official wrote to Bayer about one Thai leader.

Travis suggested that U.S. officials engage much as they had with Vietnam when that country moved in April 2019 to ban glyphosate.

Shortly after the appeal from Bayer, McKinney wrote to the Thailand Prime Minister about the matter. In an Oct. 17, 2019 letter McKinney, who previously worked for Dow Agrosciences, invited Thailand officials to Washington for an in-person discussion about glyphosate safety and the Environmental Protection Agency’s determination that glyphosate “poses no meaningful risk to human health when used as authorized.”

“Should a ban be implemented it would severely impact Thailand’s imports of agricultural commodities such as soybean and wheat,” McKinney wrote. “I urge you to delay a decision on glyphosate until we can arrange an opportunity for U.S. technical experts to share the most relevant information to address Thailand’s concerns.”

A little more than a month later, on Nov. 27, Thailand reversed the planned glyphosate ban. It also said it would delay bans on paraquat and chlorpyrifos for several months.

Thailand did finalize bans of paraquat and chlorpyrifos on June 1, of this year. But glyphosate remains in use. 

When asked about its engagement with U.S. officials on the issue, Bayer issued the following statement:

Like many companies and organizations operating in highly regulated industries, we provide information and contribute to science-based policymaking and regulatory processes. Our engagements with all those in the public sector are routine, professional, and consistent with all laws and regulations.

The Thai authorities’ reversal of the ban on glyphosate is consistent with the science-based determinations by regulatory bodies around the world, including in the United StatesEuropeGermanyAustraliaKoreaCanadaNew ZealandJapan and elsewhere that have repeatedly concluded that our glyphosate-based products can be used safely as directed.

 Thai farmers have used glyphosate safely and successfully for decades to produce essential crops including cassava, corn, sugar cane, fruits, oil palm, and rubber. Glyphosate has helped farmers to improve their livelihoods and meet community expectations of safe, affordable food that is produced sustainably.”

 

U.S. regulators relied for years on flawed pesticide data provided by Dow Chemical

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For years, U.S. regulators relied on falsified data provided by Dow Chemical to allow unsafe levels of the chemical chlorpyrifos into American homes, according to a new analysis from University of Washington researchers.

The analysis reexamines work from the 1970s sponsored by Dow and submitted to the Environmental Protection Agency (EPA) to guide the agency in establishing what scientists refer to as a “no-observed-adverse-effect-level” or NOAEL. Such thresholds are used to determine what types of use and at what level a chemical exposure can be allowed and still be considered “safe.”

According to the new analysis, published online July 3 in the journal Environmental International, the inaccurate findings were the result of a chlorpyrifos dosing study conducted by researcher Frederick Coulston and colleagues from the Albany Medical College in the early 1970s for Dow.

The authors of the new paper reexamining that prior work are Lianne Sheppard, Seth McGrew and Richard Fenske of the Department of Environmental and Occupational Health Sciences, School of Public Health at the University of Washington.

While the study was authored by the Coulston group, the analysis was completed by a Dow statistician and concluded that 0.03 mg/kg-day was the chronic NOAEL level for chlorpyrifos in humans. But the new analysis by the University of Washington researchers found that wildly overstated the margin of safety. Had the data been properly analyzed a lower NOAEL of 0.014 mg/kg-day would have been found, they said.

The Coulston study did not undergo peer review but still was used by the EPA for risk assessments throughout much of the 1980′s and 1990′s, the University of Washington researchers reported.

The researchers concluded: “During that period, EPA allowed chlorpyrifos to be registered for multiple residential uses that were later cancelled to reduce potential health impacts to children and infants. Had appropriate analyses been employed in the evaluation of this study, it is likely that many of those registered uses of chlorpyrifos would not have been authorized by EPA. This work demonstrates that reliance by pesticide regulators on research results that have not been properly peer-reviewed may needlessly endanger the public.”

Widely used

Commonly known as the active ingredient in the brand name Lorsban, chlorpyrifos insecticides were introduced by Dow Chemical in 1965 and have been used widely in agricultural settings. The largest agricultural market for chlorpyrifos is corn but the pesticide is also used by farmers growing soybeans, fruit and nut trees, Brussels sprouts, cranberries, and cauliflower, as well as other row crops. Residues of the chemical are commonly found in food. Non-agricultural uses include golf courses, turf, green houses, and utilities.

Despite the science promoted by Dow, independent scientific research has shown mounting evidence of the dangers of chlorpyrifos, particularly to young children. Scientists have found that prenatal exposures to chlorpyrifos are associated with lower birth weight, reduced IQ, the loss of working memory, attention disorders, and delayed motor development.

The American Academy for Pediatrics, which represents more than 66,000 pediatricians and pediatric surgeons, has warned that continued use of the chemical puts developing fetuses, infants, children and pregnant women at great risk.

Chlorpyrifos is so dangerous that the European Food Safety Authority has stated that there is no safe exposure level.

The EPA reached an agreement with Dow in 2000 to phase out all residential uses of the chemical because of research showing the chemical is dangerous to the developing brains of babies and young children. In 2012, chlorpyrifos was banned from use around schools.

In February 2020, after pressure from consumer, medical, scientific groups and in face of growing calls for bans around the world, Corteva AgriScience, a successor corporation to a merger of Dow and DuPont, said it would phase out production of chlorpyrifos. The chemical, however, remains legal for other companies to make and sell.

Human subjects

The study that is the subject of the new paper by the University of Washington researchers was overseen in 1971 by the Albany Medical College’s Institute of Experimental Pathology and Toxicology. The study included 16 healthy adult male inmates from a pool of volunteers at Clinton Correctional Facility, a maximum-security prison in Dannemora, New York.

The volunteers were randomized into four experimental groups, including one control group, whose members received a daily placebo. The members of the three other groups received daily chlorpyrifos treatments at three different doses.  The study took place over 63 days.

The new analysis found several problems with the study, including the omission of eight valid baseline measurements for one of the three treatment groups.

“Such an omission of valid data without justification is a form of data falsification that violates all standard codes of ethical research practice and is classified as outright research misconduct,” the University of Washington researchers concluded.

The researchers said that chlorpyrifos “passed through the regulatory process without much debate,” even though there was “growing evidence that it might pose a health hazard in residential environments.”

“The Coulston Study misled regulators by omitting valid data,” and “may have adversely impacted public health” for several years, the University of Washington paper concludes.

Organic Trade Meets in D.C. as Battle Brews Over Standards

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This article originally appeared in Huffington Post

It’s “Organic Week” again in Washington, D.C., and attendees of the “signature policymaking event” for the Organic Trade Association (OTA) have much to celebrate. Last week, the OTA, the leading voice for the organic industry, announced that the sector posted its largest-ever annual dollar gain in 2015, with total organic retail sales growing by $4.2 billion, or 11 percent, to a record of $43.3 billion.

“Fueled by consumer choice, organic is the future of farming,” the OTA said in a statement touting the conference, which runs May 23-May 27.

Still, the industry acknowledges that future is clouded by persistent supply shortages in the face of what OTA calls the “seemingly unquenchable consumer demand for organic.”

Agriculture Secretary Tom Vilsack is slated to address the OTA Wednesday, to tell organic leaders that the U.S. Department of Agriculture wants to make it easier for new farmers to become certified organic and to help the organic sector with its demand problem.

But across the country, in a federal courtroom in California, a group of consumer and environmental lawyers and nonprofit groups are raising a red flag in the face of the USDA push to grow the organic sector. Corners are being cut, they allege. Standards are being shirked, and consumers are being short-changed by USDA National Organic Program standard changes.

A hearing is scheduled Thursday in one key case involving synthetic chemicals in compost in organic production. The Center for Environmental Health, the Center for Food Safety and Beyond Pesticides sued Vilsack and other USDA officials last year for issuing a guidance document in 2010 that “radically changed organic requirements.” Under the new provision, organic producers can use compost materials that have been treated with synthetic pesticides that otherwise are banned from organic use.

Under the changes introduced by USDA, organic producers can use materials such as lawn trimmings that have been contaminated with synthetic pesticides as compost feedstocks for their crops. Compost contaminated with an insecticide known as bifenthrin and other pesticides are now allowed, the lawsuit alleges.

This flouts a key appeal of organics – the idea that synthetic pesticides have little to no place in production, the groups argue. And the agency violated the law by failing to give public notice or allow for public comment as they created this “loophole,” the groups allege.

“Organic consumers are being misled, and can no longer rely on the organic label to ensure the food they purchase is produced without synthetic pesticides in agricultural inputs,” the lawsuit states.

The Center for Food Safety and other plaintiffs describe themselves in court pleadings as working to protect the environment and public health and to act as a watchdog on the integrity of organic production. They expected the OTA to back up their bid for organic integrity, or at least not to try to get in their way. But on May 2, OTA asked to participate in the case not on the side of the consumer advocates but against them.

In its filing, OTA, along with California Certified Organic Farmers (CCOF) have joined with Western Growers Association (WG), which represents farmers responsible for roughly a third of fresh U.S. organic produce, to oppose the consumer protection groups over the compost issue. The OTA and other industry groups are arguing that if the USDA provision allowing for synthetic pesticides in compost is thrown out by the court, organic practices would be “severely unsettled.”

The groups say in court filings that it would be analytically and economically impossible to demonstrate all compost is free of each synthetic chemical substance prohibited in organic crop production. They say a sudden elimination of the compost provision could lead to costly civil litigation and many growers’ organic certifications would be directly at risk. Unwinding the USDA’s “professional and responsible approach to a complex subject” would be “extremely disruptive,” the organic groups say.

The plaintiffs counter that such claims of disruptive consequences are a “red herring.” An erosion of organic standards may help expand production and meet consumer demands, but such a path could make for a slippery slope and an ultimate demise of the draw organics hold. “These environmental values, and specifically not supporting pesticide-dependent agriculture, are a major driver to why consumers pay the premium to buy organic foods,” their filing states.

Thursday’s hearing in San Francisco will take up pending cross motions for summary judgment in the case. Meanwhile back in Washington, the OTA will be marking “advocacy day,” fanning out through Capitol Hill to meet with lawmakers and push for policies that support continued organic industry growth.

Consumers would do well to keep an eye on both.

Carey Gillam is a veteran former Reuters journalist and now research director for U.S. Right to Know, a food industry research group.  Follow Carey Gillam on Twitter: www.twitter.com/careygillam 

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Conflict of Interest Concerns Cloud Glyphosate Review

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By Carey Gillam

It’s been a little more than a year since the World Health Organization’s (WHO) cancer research experts upended the agrichemical industry’s favorite child. The group, the International Agency for Research on Cancer (IARC) declared the globe’s most widely used herbicide – glyphosate – to be a probable human carcinogen.

Since then, Monsanto Co., which draws roughly a third of its $15 billion in annual revenues from its Roundup branded glyphosate-based herbicide products, (and much of the rest from glyphosate-tolerant crop technology) has been on a mission to invalidate the IARC finding. Through an army of foot soldiers that include industry executives, public relation professionals and public university scientists, the company has called for a rebuke of IARC’s work on glyphosate.

How successful those efforts will or will not be is still an open question. But some answers are expected following a meeting being held this week in Geneva, Switzerland. An “international expert scientific group” known as JMPR is reviewing IARC’s work on glyphosate, and the results are expected to offer regulators around the world a guide for how to view glyphosate.

The group, officially known as the Joint FAO-WHO Meeting on Pesticide Residues (JMPR), is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and WHO. JMPR meets regularly to review residues and analytical aspects of pesticides, to estimate maximum residue levels, and to review toxicological data and estimate acceptable daily intakes (ADIs) for humans.

After this week’s meeting, set to run from May 9-13, JMPR is expected to issue a series of recommendations that will then go to the FAO/WHO Codex Alimentarius Commission. The Codex Alimentarius was established by FAO and the World Health Organization develops harmonized international food standards as a means to protect consumer health and promote fair practices in food trade.

The meeting comes as both European and U.S. regulators are wrestling with their own assessments and how to react to the IARC classification. It also comes as Monsanto looks for backing for its claims of glyphosate safety.

Glyphosate is not just a lynchpin for sales of the company’s herbicides but also for its genetically modified seeds designed to tolerate being sprayed with glyphosate. The company also is currently defending itself against several lawsuits in which farmworkers and others allege they contracted cancer linked to glyphosate and that Monsanto knew of, but hid, the risks. And, a rebuke of IARC’s glyphosate classification could help the company in its lawsuit against the state of California, which aims to stop the state from following the IARC classification with a similar designation.

Depending on the result of the JMPR, the Codex will decide on any actions necessary regarding glyphosate, said WHO spokesperson Tarik Jasarevic.

“It is the JMPR’s function to conduct risk assessment for agricultural use and assessing the health risks to consumers from residues found in food,” said Jasarevic

The outcome of the JMPR meeting is being watched closely by a number of environmental and consumer groups that want to see new safety standards for glyphosate. And not without some worry. The coalition, which includes the Natural Resources Defense Council and Friends of the Earth, has expressed concern about apparent conflicts of interest on the expert advisory panel. Some individuals appear to have financial and professional ties to Monsanto and the chemical industry, according to the coalition.

The coalition specifically cited concerns with member ties to the nonprofit International Life Sciences Institute (ILSI), which is funded by Monsanto and other chemical, food and drug companies. The Institute’s board of trustees includes executives from Monsanto, Syngenta, DuPont, Nestle and others, while its list of member and supporting companies includes those and many more global food and chemical concerns.

Internal ILSI documents, obtained by a state public records request, suggest that ILSI has been generously funded by the agrichemical industry. One document that appears to be ILSI’s 2012 major donor list shows total contributions of $2.4 million, with more than $500,000 each from CropLife International and from Monsanto.

“We have significant concerns that the committee will be unduly influenced by the overall pesticide industry and particularly Monsanto- the largest producer of glyphosate in the world,” the coalition told WHO in a letter last year.

One such JMPR expert is Alan Boobis, professor of biochemical pharmacology and director of the toxicology unit in the faculty of medicine at Imperial College London. He is a member and a past chairman of the board of trustees of ILSI, vice-president of ILSI Europe and chair of ILSI.

Another member is Angelo Moretto, Director of the International Centre for Pesticides and Health Risks Prevention at “Luigi Sacco” Hospital of the ASST Fatebenefratelli Sacco, in Milan, Italy. The coalition said that Moretto has been involved in various projects with ILSI and has served as a member of the steering team for an ILSI project on risks of chemical exposures financed by agrichemical companies that included Monsanto.

Another is Aldert Piersma, a senior scientist at the National Institute for Public Health and the Environment in the Netherlands and an advisor to projects of ILSI’s Health and Environmental Sciences Institute.

In all the JMPR list of experts totals 18. Jasarevic said that the roster of experts are chosen from a group of individuals who expressed interest in being involved, and all are “independent and are selected based on their scientific excellence, as well as on their experience in the field of pesticide risk assessment.”

Aaron Blair, a scientist emeritus at the National Cancer Institute and the chairman of the IARC group that made the glyphosate classification, has defended IARC’s work as based on a thorough scientific review. He said he had no concerns to discuss regarding the  JMPR review of IARC’s work.

“I am sure the evaluation by the joint FAO/WHO group will make the reasons for their evaluation clear, which is what is critical for the press and public,” he said.

The world is waiting.

Not Just For Corn and Soy: A Look at Glyphosate Use in Food Crops

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By Carey Gillam

As the active ingredient in Monsanto’s branded Roundup weed killer, along with hundreds of other weed-killing products, the chemical called glyphosate spells billions of dollars in sales for Monsanto and other companies each year as farmers around the world use it in their fields and orchards.  Ubiquitous in food production, glyphosate is used not just with row crops like corn, soybeans and wheat but also a range of fruits, nuts and veggies. Even spinach growers use glyphosate.

Though considered for years as among the safest of agrichemicals, concerns about glyphosate have been growing after the World Health Organization’s cancer experts last year classified it as a probable human carcinogen, based on a series of scientific studies.  There are other concerns as well – mounting weed resistance to glyphosate; negative impacts on soil health; and a demise in the monarch butterfly population tied to glyphosate use on forage that young monarchs feed on. The EPA is currently finishing a risk assessment for glyphosate that examines the range of issues.

The EPA is still trying to determine just how worrisome glyphosate is, or isn’t. In the meantime it’s worth a look at how widespread the use of glyphosate is in our food supply. A document released by EPA on April 29 gives us a peek.

In a memorandum dated Oct. 22, 2015, EPA analysts reported an “updated Screening Level Usage Analysis”for glyphosate use 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. And, when compared to a prior analysis that ran through 2011, it shows that glyphosate use has been growing in production of most of the key food crops on the list. Here’s a snapshot:

Glyphosate used on U.S. soybean fields, on an average annual basis, was pegged at 101.2 million pounds; with corn-related use at 63.5 million pounds. Both estimates are up from a prior analysis that ran through 2011, which pegged average annual soybean use at 86.4 million pounds and corn at 54.6 million pounds. Both those crops are genetically engineered so they can be sprayed directly with glyphosate as farmers treat fields for weeds. Use with sugar beets, also genetically engineered as glyphosate-tolerant, was estimated at 1.3 million pounds, compared to 1 million pounds.

Notably, glyphosate use is also seen with a variety of crops not engineered to be sprayed directly. Looking at the period ending in 2013 compared to 2011, glyphosate use in wheat production was pegged at 8.6 million pounds, up from 8.1 million pounds; use in almonds was pegged at 2.1 million pounds, unchanged from the prior analysis;  grape use was pegged at 1.5 million pounds, up from 1.4 million pounds; and rice use was estimated at 800,000 pounds, compared to 700,000 pounds in the prior analysis.

You can check out your own favorite food here, and compare it to the prior analysis here. Some on the list may surprise you, including cherries, avocados, apples, lemons, grapefruit, peanuts, pecans and walnuts.

The growing use of glyphosate on food crops has prompted calls for regulators to start testing levels of such residues on food to determine if they are within levels regulators deem safe. They’ve been doing such testing for years for residues of other agrichemicals. The Food and Drug Administration said in February it would start doing that type of testing for glyphosate residues this year on a limited basis.

In the meantime, the EPA, which sets the “tolerance” levels that deem what is safe regarding pesticide residue,  announced May 3 that it was finalizing a new rule that will expand the numbers of crops that can have tolerances established. The EPA said this will “allow minor use growers a wider choice of pest control tools including lower-risk pesticides, to be used on minor crops, both domestically and in countries that import food to the United States.”

 Yummy.