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Monsanto Co. pressed the EPA in 2015 to publicize a report that would show its Roundup herbicide doesn’t cause cancer, but the agency appeared reluctant to do so on the company’s timeline, newly released documents show.
The correspondence, part of a cache of documents posted Aug. 1 by attorneys representing cancer patients in multidistrict litigation against Monsanto, is an attempt to showcase what the attorneys claim is an inappropriately close relationship between the Environmental Protection Agency and Monsanto. But it also shows an agency whose leaders under President Barack Obama were in no hurry to put out a key report that would have helped the company’s reputation.
As part of their case, the attorneys have portrayed the EPA as improperly friendly to industry, meeting frequently with officials and seeking to silence other federal agencies whose studies on glyphosate could cripple the chemical’s clean bill of health ( In re Roundup Products Liability Litigation, N.D. Cal., No. 3:16-md-02741, motion filed 8/1/17 ).
The documents are “a brief but elaborate snapshot” into the way that public health is hurt by Monsanto’s conduct, Pedram Esfandiary, an attorney with Baum, Hedlund, Aristei & Goldman PC in Los Angeles, the firm that is representing the plaintiffs, told Bloomberg BNA.
The company sought, starting in September 2015 and continuing for seven months, release of a preliminary EPA risk assessment that would conclude that glyphosate was not carcinogenic, according to the documents.
The International Agency for Research on Cancer (IARC), an agency under the World Health Organization, in March 2015 found glyphosate, the main ingredient in Roundup, to be a “probable” carcinogen.
Scott Partridge, Monsanto’s vice president of global strategy, told Bloomberg BNA that pesticide manufacturers regularly meet with the Office of Pesticide Programs to provide information to allow the EPA to assess a product’s risk to health and the environment.
“We have a responsibility to be in routine contact with the EPA,” he said. “There is nothing improper about this.”
The company was battling a tide of questions over the safety of its signature weedkiller in 2015 when the IARC classification came as the EPA was reviewing glyphosate.
A solution was coming soon, company officials hoped: The EPA was set to publish a preliminary risk assessment that would conclude that glyphosate was not carcinogenic, countering IARC’s finding and concurring with results from regulatory agencies around the world. This would smooth the path to re-registering the chemical, a process that began in 2009 as part of the agency’s periodic review of the herbicide.
Getting the EPA to release that report was easier said than done, according to the correspondence. The risk assessment was expected to come out “in the first or second week of October” 2015, Monsanto regulatory lead Dan Jenkins told his colleagues via text message on Sept. 23, 2015.
“Spoke to EPA: is going to conclude that IARC is wrong. So is [the European Food Safety Authority],” Jenkins typed. But the EPA didn’t publish the assessment right away, and Monsanto began intensifying its push for a report. The company set up a meeting between CEO Hugh Grant and then-Administrator Gina McCarthy.
By December 2015, top lobbyists and communications executives at the company appeared angry that the agency was lagging on releasing the assessment.
“We need to share with EPA political and career staff they need to get glyphosate PRA [preliminary risk assessment] out now they are losing credibility,” Philip Miller, at the time vice president of global regulatory and government affairs, told colleagues in a text message. "[CBS News] asked Hugh today if glyphosate causes cancer. Let them know they are failing their duty to the public.”
Two months later, optimism within the company seemed to wane. The EPA was going to invite academic scientists and industry consultants to partake in a scientific advisory panel (SAP), a move that would slow down the release of a report. The panel of independent scientists assesses the EPA’s more contentious decisions.
“If their current thought process holds, then it is unlikely that the [preliminary risk assessment] will come out in 2016,” Jeremy Stump, vice president of North America government affairs for the company, told colleagues in a Feb. 12, 2016, email.
A tête-a-tête between the Monsanto and EPA chiefs on March 3, 2016, didn’t move the needle, according to an email from David Heering, the lead for strategy and compliance for the company’s technology division.
EPA’s McCarthy “did not understand why glyphosate reregistration/classification was such a big issue,” according to the talking points prepared for another meeting between Grant and McCarthy that Heering sent to colleagues. “Hugh needs to question her as to why they then considered IARC’s flawed classification and again, why are you convening an SAP when your own internal scientists have confirmed the safety of glyphosate.” A spokesman for Monsanto confirmed that the meeting took place.
The Cancer Assessment Review Committee (CARC) report was completed in October 2015, but wasn’t made public until six months later. The publication of the risk assessment was an accident, according to the EPA. The agency posted the report in April 2016, then quickly took it offline, claiming it was only a draft and not intended to be final. Nevertheless, Monsanto cited it in a legal case in federal court.
The EPA eventually rewrote the cancer review under a new committee, which reached the same conclusion of the CARC report: glyphosate is non-carcinogenic. The agency also convened a scientific advisory panel in December 2016 that was split on the EPA’s conclusion, with some scientists unable to support the “not likely to be carcinogenic to humans” finding.
Even in the months before IARC released its glyphosate finding, Monsanto was already gearing up to fight against anti-glyphosate sentiment, and hoping to enlist growers in a scientific and ideological battle. Glyphosate is the most popular herbicide in the world, and is an essential crop management tool for many farmers.
“We’II need their strong voices to combat the activists that are already well organized for this and have been meeting with EPA,” Jenkins wrote in a Nov. 6, 2014, text message. “They smell blood and their [sic] circling.”
The attorneys also sought to highlight the extent to which Monsanto tried to delay a study on glyphosate from the Agency for Toxic Substances and Disease Registry, a division of the Centers for Disease Control. The company feared that agency’s findings would draw a link between carcinogenicity and glyphosate.
"[Former EPA scientist] Mary Manibusan told me yesterday that EPA has had several issues in the past with ATSDR coming to different conclusions. She said they tried to execute several [memoranda of understanding] but were unsuccessful. She describes ATSDR as being VERY conservative and IARC like in this regard,” Jenkins wrote in a June 24, 2015, email.
Jack Housenger, then-director of the Office of Pesticide Programs, sent Jenkins an email in October 2015 to say that the ATSDR director agreed to postpone its review until the EPA released the CARC report.
Housenger said this was not done to placate Monsanto, but rather to coordinate federal work and save money.
“We didn’t want conflicting U.S. reviews,” he told Bloomberg BNA.
Jess Rowland, the author of the CARC report and a former deputy division director in the EPA’s Office of Pesticide Programs, was mentioned several times in the correspondence, although the attorneys did not unveil any emails or text messages from Rowland himself. Plaintiffs’ attorneys have painted Rowland as Monsanto’s “friend” within the agency who tried to stop the ATSDR review. His attorneys declined to comment.
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The correspondence between Monsanto and EPA is available at http://src.bna.com/rkU.
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