June 3, 2019 – Los Angeles, California – – At the end of April, the third Roundup cancer trial of Pilliod et al. v. Monsanto Company was nearing its end. The first two trials resulted in landmark defeats for Monsanto (now Bayer). Jury verdicts worth a combined $369 million led to monumental drops in Bayer’s stock price and concerns that a shuffling of personnel within the boardroom might be imminent.
But on April 30, as Baum, Hedlund, Aristei & Goldman attorney Brent Wisner and the legal team representing Alva and Alberta Pilliod were preparing for closing arguments, the U.S. Environmental Protection Agency (EPA) threw Monsanto a well-timed lifeline by releasing its 2019 evaluation for glyphosate, a key ingredient in Roundup.
No one on the Pilliod legal team was entirely surprised that the EPA report found glyphosate is not carcinogenic, but the timing and the details of the report itself were suspect.
“If you read the document, it literally reads like the opening statement from Monsanto during our trial,” said Wisner. “It was—Monsanto wants a report; EPA brings it.”
Attorneys for Monsanto sprang into action and immediately filed a request with the court to allow the jury in the Pilliod trial to see the newly released EPA report. In response, attorneys for the Pilliods filed an opposition to Monsanto’s request, which included a 2018 report from Hakluyt, a strategic intelligence and advisory firm hired by Monsanto to gauge regulatory attitudes for glyphosate.
Monsanto hired Hakluyt & Company to “take the temperature on current regulatory attitudes for glyphosate.” Among other things, the Hakluyt report noted that a White House official said Monsanto could count on the Trump administration to be an ally on pesticides regulation:
“A domestic policy adviser at the White House said, for instance: ‘We have Monsanto’s back on pesticides regulation. We are prepared to go toe-to-toe on any disputes they may have with, for example, the EU. Monsanto need not fear any additional regulation from this administration.”
According to the Pilliods’ attorneys, the Hakluyt report speaks “directly to the credibility of the 2019 EPA glyphosate evaluation, issued by an administration which holds itself out as favoring Monsanto’s business interests.”
On May 13, the Pilliod trial culminated in a historic verdict worth $2.055 billion, likely one of the largest jury verdicts in the country this year. Following the defeat, officials at Bayer said more or less the same thing they said after previous losses; EPA says glyphosate is safe.
While that may be true, the Hakluyt report serves as another example demonstrating that EPA is more interested in having Monsanto’s back than it is in protecting the public from harmful chemicals.
EPA Has Buried its Head in the Sand on Roundup Since Inception
In his closing argument in Pilliod v. Monsanto Company, Brent Wisner told the jury that Roundup was “born in fraud.” EPA approved glyphosate in 1974 based (in part) on studies conducted at Industrial Bio-Test Laboratories (IBT). A subsequent EPA review of the data, however, found that the glyphosate studies contained inaccuracies and that IBT routinely falsified data.
One EPA reviewer noted at the time that it was “hard to believe the scientific integrity of the studies when they said they took specimens of the uterus from male rabbits.”
Following EPA’s review, a federal jury found three IBT officials guilty of attempting to defraud the government by covering up inaccurate research data. Nevertheless, the agency permitted Monsanto to continue selling its herbicide despite the fraudulent testing.
When Monsanto finally agreed to EPA’s requests to retest glyphosate after the IBT scandal, a 1983 study found a statistically significant number of benign and malignant kidney tumors in a group of male mice exposed to glyphosate. In 1985, eight members of the EPA’s toxicology branch signed a consensus review of glyphosate stating they were classifying glyphosate as a Category C oncogen, a substance “possibly carcinogenic to humans.”
Monsanto fought the classification for years, balking at the agency’s reasonable request to repeat the mouse study that found kidney tumors. The stonewalling worked as EPA eventually relented and classified glyphosate as Category E, “evidence of non-carcinogenicity in humans.”
Interestingly, that 1983 mouse study that reported kidney tumors was among those cited by the International Agency for Research on Cancer (IARC) in its classification for glyphosate as a “probable human carcinogen.”
In 1991, another laboratory conducting studies for Monsanto was embroiled in scandal. Craven Laboratories performed analytical chemistry studies for Monsanto for a decade, conducting 9 of the 15 residue studies (analysis of foods for trace amounts of chemicals) needed to register Roundup. According to a New York Times report, Craven fabricated Roundup residue studies relied upon by EPA.
Remarkably, EPA was unmoved by the fraudulent testing. “Based on what we know, we don’t think there is an environmental or health problem,” said Linda Fisher, who was then assistant administrator for pesticides and toxic substances at EPA. “First of all, we’re dealing with allegations. Right now we’re moving out to take preventive measures.”
A federal grand jury indicted Don Craven, owner of Craven Laboratories, with felony counts of conspiracy, mail fraud, making false statements, concealment of material facts, and obstructing EPA proceedings. Other employees were implicated. Craven Laboratories was heavily fined.
Monsanto, the beneficiary of the fraudulent data from both IBT and Craven, was largely unaffected by either scandal. Glyphosate-based herbicides remained on the shelves and continued to bring in massive profits for the agrochemical giant.
Linda Fisher spent another four years working at EPA before she was hired by Monsanto in 1995 to head the company’s Washington D.C. office. She later returned to EPA in 2001.
In 2015, not long after IARC concluded that glyphosate is a probable human carcinogen, Monsanto got wind that the U.S. Department of Health and Human Services Agency for Toxic Substances and Disease Registry (ATSDR) intended to evaluate glyphosate.
According to court documents, a senior EPA official named Jess Rowland from the Office of Pesticide Programs told Monsanto executive, Daniel Jenkins, that he would be game to try and kill the ATSDR review.
“If I can kill this I should get a medal,” Rowland said to Jenkins.
A couple months later, Monsanto scientist Eric Sachs reached out to former EPA official Mary Manibusan, who worked with Rowland at EPA, to ask if she knew anyone 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,” wrote Sachs via text message.
“Sweetheart I know lots of people. You can count of me,” Manibusan responded.
Monsanto’s efforts paid off—ATSDR’s glyphosate review was placed on hold.
ATSDR ultimately did conduct its glyphosate review and released it in April 2019, just a couple weeks before EPA released its evaluation. Contrary to EPA, however, ATSDR confirmed the glyphosate cancer risk.
As for Rowland and Manibusan, after they left EPA, both went to work as consultants for the chemical industry.
What Else Does the Hakluyt Report Say?
The Hakluyt report is noteworthy not just because of the Trump White House’s purported backing of Monsanto on pesticide regulation; it details a rift at most government agencies between “political” staff and “professional” staff on issues such as pesticide regulation, climate science and other issues.
“While this appears to be true of various agencies – Health and Human Services, Commerce, Education, Interior, the Food and Drug Administration, and so on – the EPA may be the leading example of this phenomenon,” the report says.
Generally speaking, professional staff are scientists who have worked at an agency for many years, in some cases. Political staff are appointees. Per the Hakluyt report, the glyphosate issue is one flashpoint for this rift. A prominent Washington D.C. law firm partner who has “extensive contacts at the EPA” is quoted as saying:
“In essence, the political leadership favors deregulation and dismisses the expert risk analysis. It is especially averse to theoretical risk analysis, for example, on the risks of glyphosate, about which a scientific consensus is yet to form … With regard to glyphosate, in particular, the differences between political and professional staff are sharp.”
Within EPA, professional staffers reportedly have “doubts about glyphosate,” but those doubts “are not shared by the EPA’s leadership,” and thus, not likely to get in the way, the Hakluyt report says.
“We heard a unanimous view from senior levels of the EPA (and USDA) that glyphosate is not seen as carcinogenic, and that this is highly unlikely to change under this administration—whatever the level of disconnect between political and professional staffers.”
Hakluyt Report is More Evidence Confirming EPA is a Captured Agency
The documented history of close ties between Monsanto and EPA, the Trump White House’s backing of industry, the rift between political and professional staff at EPA, and the ascendancy of the political points of view within the agency—it is all enough to make you wonder whether we can trust EPA on glyphosate. It is deeply troubling that non-industry experts and health agencies like IARC and ATSDR are finding a link between glyphosate and cancer when EPA is towing the corporate line for Monsanto and Bayer, finding that glyphosate does not cause cancer.
“EPA has got it wrong on glyphosate,” says Brent Wisner. “Currently, this administration and this EPA will not take action against Monsanto. We’ve seen the internal documents, the text messages, the emails between senior EPA officials and Monsanto employees, and the simple fact is they know that this EPA will not take adverse action against them. It is a travesty that this truth about it causing cancer and this awareness that we’re trying to raise has to be done in the context of litigation … these lawsuits only exist because the EPA has failed the American public for 45 years.”
“The Hakluyt report shows us just how deep it runs. And it’s not just a political thing, but it’s actually in the staffers themselves. The fact that the White House is telling Monsanto, ‘We have your back,’ it just tells us that we’re going to have to keep fighting this fight and that we are not going to get any support or help from the public agencies that ironically are supposed to be protecting the public health.”