by Carey Gillam
What Forastiere and the other IARC scientists did not know was that Monsanto was tipped off to their decision on glyphosate before it was made public. Documents turned over in the court case show that the EPA gave Monsanto advance warning of the decision. So when IARC announced the results of its classification on March 20, 2015, Monsanto was ready with a counterassault. Monsanto’s chairman, Hugh Grant, and other company officials asserted to reporters and investors that the classification by the elite group of scientists was “mischief” based on “junk science” and politically motivated. The company issued a statement reaffirming that “glyphosate and glyphosate-based herbicides are among the most thoroughly tested and evaluated pesticide products in the world. Their 40-year history of safe use is supported by one of the most extensive worldwide human health, crop residue and environmental databases ever compiled on any pesticide.”41 The company also angrily demanded a retraction from IARC. And Monsanto wasted no time in calling on the EPA to defend glyphosate against the cancer claims. IARC’s announcement was made on a Friday, and by the following Monday morning, Monsanto’s Dan Jenkins, who led the company’s U.S. regulatory affairs work at that time, was e-mailing and calling contacts at the EPA, providing the agency with “talking points” and urging the agency to “correct mistakes or absences of fact with respect to its record on glyphosate … as it relates to carcinogenicity.”42
Monsanto’s Philip Miller, vice president for global regulatory affairs, penned a letter to Margaret Chan, director-general of the World Health Organization (WHO), complaining that IARC “purposefully chose to disregard dozens of studies” supporting the safety of glyphosate. Miller said the company was “anxious” to address the issue. “Safety is our number one priority, and we know that IARC’s conclusions will likely cause a great deal of concern with growers and consumers alike,” Miller wrote.43
IARC’s director, Christopher Wild, wrote back affirming the agency’s support for the team’s classification of glyphosate as a probable human carcinogen, calling the finding the result of a “comprehensive review of the latest available scientific evidence.”44
CropLife International, an agrochemical industry association, also stepped into the fray, sending a series of letters to IARC and WHO expressing concerns and asking for a “clarification,” saying IARC’s findings “have undermined our work with regulators.”45
The decision by IARC could not have come at a worse time for Monsanto. In the spring of 2015, the EPA was wrapping up a years-long reregistration assessment of glyphosate that was supposed to look at potential evolving risks and see if there was any reason to limit the use of glyphosate. Before IARC’s announcement, glyphosate was slated for a green light; the new registration report was nearly completed and was planned for release to the public later in 2015. Monsanto was also working to roll out a new herbicide that combined glyphosate with another weed-killing chemical called dicamba, along with new herbicide-tolerant crops to go with it. As well, the company was undergoing a similar reregistration assessment of glyphosate in Europe. With all that at stake, the IARC report was so potentially damning that Monsanto simply could not let it stand.
Internal company documents show that within two months of IARC’s classification, Monsanto was laying out a plan to spend potentially upward of $200,000 to provide a powerful counterpunch aimed at discrediting the IARC scientists and their work. The IARC classification was a “severe stigma” that had to be addressed, according to an internal report that laid out a series of proposals for “scientific projects” to show glyphosate’s safety. For one project looking at animal test data, the “majority of the writing can be done by Monsanto” to keep costs down, even though the project would have “external authors.” Another, broader project called for assembling a panel of “credible scientists” to publish a “comprehensive evaluation” of glyphosate’s cancer-causing potential. Again, Monsanto hoped to do much of the writing to keep costs down but pegged the costs at $200,000 to $250,000.46 Monsanto tried to keep the document laying out those details confidential, but it became public as part of the Roundup litigation.
Monsanto’s panel of scientists was formed in July 2015, and in December the researchers reported—perhaps not surprisingly—that IARC was flat out wrong in classifying glyphosate the way it had. The panel said the IARC scientists had incorrectly weighted or ignored data and that there was no evidence of “human carcinogenesis.” Ten of the sixteen scientists on that panel had worked as consultants for Monsanto in the past, and two more were former Monsanto employees. But Monsanto insisted publicly that the report was “independent” and maintained that it was more valid than the work of the IARC scientists.47 The team of sixteen scientists then went on to publish their findings of glyphosate safety in a scientific journal called Critical Reviews in Toxicology. Some unsuspecting journalists reported on the panel’s findings as though they were in fact independent and equal in weight to the IARC findings that they contradicted.
Despite Monsanto’s efforts, concerns over the IARC classification were not quelled. Lawmakers and regulators in many countries had already taken notice of the red flags being waved around glyphosate before IARC’s news and were moving to limit use of the chemical. After the cancer classification, those moves intensified. Consumer protection officials in Germany called for a European Union–wide ban on glyphosate use by individuals; France restricted glyphosate sales to the public; Italy banned the use of glyphosate in public places and those frequented by children and the elderly; Colombia temporarily suspended the use of glyphosate to spray coca plants; Sri Lanka banned the importation of glyphosate; and—in an action that specifically rankled Monsanto—California said it would add glyphosate to a list of chemicals known to cause cancer.
Monsanto fired back against California’s action, suing state environmental regulators to try to block them from putting glyphosate on the list.48 Monsanto argued the move would cost the company sales and force it to provide a warning on its products—something Monsanto said would violate its right to free speech. A judge in the case ruled against Monsanto, allowing the state to require warnings about Roundup. In its lawsuit, Monsanto took the opportunity to assail the IARC scientists again, characterizing the group as an “unelected, undemocratic, unaccountable, and foreign body.”
The uproar over their classification and the attacks on their credibility caught the IARC scientists off guard. “We were not expecting this strong reaction and what happened,” Forastiere recalled. “We were doing our job. I understood there were other issues … economic consequences. But none of us had a political agenda. We are scientists.”49 Forastiere retreated and shunned hundreds of interview requests from media around the world. He and the other scientists who were not based in the United States were able to insulate themselves from the criticism a bit more easily than was Blair, who had to return home to U.S. soil, Monsanto’s home base. Monsanto soon subpoenaed Blair’s e-mails and other documents to try to discredit the IARC working group’s findings.
Throughout the uproar, the EPA provided much-needed aid to Monsanto, intentionally or not. Two months after the IARC bombshell, the EPA said it had reviewed thirty-two studies that specifically analyzed whether or not glyphosate might be an endocrine disruptor, which if true would mean glyphosate indeed could cause cancer, along with infertility, diabetes, or other problems. But the EPA said there was nothing to fear, for the studies proved glyphosate’s safety. What the EPA did not say was that twenty-seven of the thirty-two studies were either conducted by or funded by Monsanto or its industry allies. Only five of the studies considered by the EPA were independent, and three of those five did in fact find that the chemical could pose a threat. Even many of the industry’s own studies had findings that could suggest exposure to glyphosate was dangerous, but when the animals exposed to glyphosate suffered health problems or died, the scientists for these industry-backed studies dismissed the results as not valid.50
And, in what would become a highly controversial move, the E
PA’s own cancer experts, the Cancer Assessment Review Committee (CARC), responded to IARC’s classification with a report that purported to reevaluate the issue. And again, the agency found no cause for alarm, determining that the best literature showed glyphosate was “not likely” to cause cancer. The group did hedge its bets with respect to non-Hodgkin lymphoma, however, citing “conflicting evidence for the association between glyphosate exposure and NHL.” Because of that lack of clarity surrounding NHL, the group said this: “While epidemiologic literature to date does not support a direct causal association, the CARC recommends that the literature should continue to be monitored for studies related to glyphosate and risk of NHL.”51
The EPA’s Office of Research and Development (ORD), the scientific research arm of the EPA, reviewed the agency’s glyphosate cancer analysis internally and found it flawed in many ways, lacking support for the finding of “not likely” to cause cancer. The ORD said the agency had not followed its own guidelines in coming to its conclusion. The EPA did not budge, however, sticking with its defense of glyphosate’s safety.52
What observers did not know at the time, but learned later as the company’s internal documents were unsealed in the Roundup litigation, is that Monsanto had an especially helpful and well-placed ally within the EPA. A longtime agency scientist named Jesudoss “Jess” Rowland was in close communication with Monsanto regarding glyphosate’s review and was seen by the company as someone who could be especially “useful” in defending glyphosate. Rowland served at the time as the 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), which issued the report that contradicted IARC’s findings.
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 recommended that the EPA drop the extra safety margin designed to protect children in the agency’s reevaluation of what constituted a safe dose of glyphosate.53 So it is not surprising that Monsanto turned to him after the IARC decision.
E-mails obtained from the EPA through the Freedom of Information Act (FOIA) show that there were telephone communications between a Monsanto executive and Rowland about Monsanto’s desire for the EPA to help counter IARC. Details of what the two may have said to each other are unknown. But an internal Monsanto document says that Rowland told Monsanto at one point that he would try to kill an additional review of glyphosate planned by the Agency for Toxic Substances and Disease Registry, a unit of the U.S. Department of Health and Human Services. And indeed, as of this writing, no such review has occurred.54
More help from inside the EPA was seen in an odd event in the spring of 2016. Rowland’s CARC report, which was so favorable to Monsanto, was not supposed to be made public for many more months, as it was intended to inform a broader EPA report still under way. But on Friday, April 29, the CARC report mysteriously appeared on the EPA’s website. Monsanto immediately copied the report and then touted it on the company website. The report remained on the EPA’s website for three days before the EPA pulled it down and issued a public statement saying it was “inadvertently” posted. It may have been only three days, but the documents still got wide play in global news outlets as Monsanto pointed to helpful EPA language in the report such as 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.”55
The report gave Monsanto fresh ammunition as it battled to quell the mounting number of lawsuits brought by people who said Roundup gave them or family members cancer. The company even took a copy of the report to a key May 3 court hearing to help defend itself against the lawsuits.
The temporary publication of the helpful report also came, coincidentally or not, shortly before a key European vote on whether or not to reauthorize glyphosate in the European Union, which was scheduled for May 2016. The vote ultimately was postponed.
Skeptics smelled a rat, but the EPA refused to answer questions about the CARC report and refused to comply with FOIA requests seeking agency documents that might explain the fiasco. Rowland left his twenty-six-year career at the EPA shortly after the leak and sequestered himself, ducking questions from me and other reporters. Interestingly enough, Monsanto knew in advance Rowland was ready to leave the agency. Jenkins, the company’s regulatory affairs leader, told his colleagues as much in a September 2015 e-mail, saying, “Jess will be retiring from EPA in ~5–6 mos and could be useful as we move forward with ongoing glyphosate defense.”56
The conversations revealed in the documents show nothing less than “a concerted effort by Monsanto and the OPP, Jess Rowland, and his CARC committee, to ‘kill’ the glyphosate/lymphoma issue for the company,” the plaintiffs’ attorneys stated in a court filing. “The documentary evidence strongly suggests that Mr. Rowland’s primary goal was to serve the interests of Monsanto.”57
Rowland was later forced by the federal judge overseeing the Roundup cancer litigation to sit for a deposition and acknowledged, only after a specific order from the judge, that after he left the EPA he started doing some consulting work for chemical industry interests, including two that “are among Monsanto’s closest associates,” court filings submitted by plaintiffs’ attorneys stated.58 Rowland refused to provide details about how much he was being paid or the details of how and when he got the jobs, and the judge in the case declined to allow Rowland to be pressed further.
The CARC report authored by Rowland was certainly key for Monsanto, but the EPA’s defense of glyphosate didn’t stop there. In September 2016, the agency published a 227-page report stating definitively that its best experts had determined glyphosate was “not likely” to cause cancer in humans.59 Agency officials said their findings were based in part on unpublished studies submitted by Monsanto and other industry players. That differed from the work of the IARC group, which had focused on peer-reviewed, published studies.
Notably, Martin, the EPA research biologist who was part of the IARC working group that declared glyphosate probably cancer-causing, was not included on the EPA’s own team that evaluated glyphosate for cancer links.
To strengthen its glyphosate safety determination, the agency announced it would seek input from independent experts on the matter. When dealing with tricky scientific issues involving chemical research, the EPA often sets up what it calls a Scientific Advisory Panel (SAP), which it stacks with the best and brightest minds it can find in toxicology, epidemiology, microbiology, and other relevant disciplines. The meetings are open to the public, offering a glimpse into the often dry—but important—discourse that goes into classifying chemical risk. For glyphosate, the EPA did the same, signing up leading research specialists from around the United States to come together and advise the agency on its view that glyphosate was unlikely to be carcinogenic to people. The EPA specifically said it would be good to have a careful review of existing epidemiologic data, given the IARC determination.
Monsanto did not want the outside scientists brought in, did not want the SAP on glyphosate to be held. Such a panel of independent experts could “create legal vulnerabilities,” an internal Monsanto document stated.60 Publicly, Monsanto called the SAP “an unnecessary use of resources.”61 But, to its credit, the EPA refused to back away from the plan, setting the four-day meetings for mid-October 2016.
Still, even this seemingly public-minded move by the EPA would become an example of the power of industry influence. When it became clear that the EPA would go ahead wi
th the gathering of scientific experts, industry executives made their ire known. The U.S. trade group CropLife America, which is funded by Monsanto and other makers of agrochemicals, complained in writing to the EPA that the meetings were a waste of taxpayers’ time and said it had “significant concerns” about the prospects of a public meeting on the issue.62
CropLife argued that if the meetings were to be held, at least one of the independent scientists chosen to help advise the EPA was not suitable.63 CropLife specifically called for the EPA to remove Peter Infante, an expert in epidemiology, from the panel.
The demand was a bold one: Infante was world-renowned after spending twenty-four years with the U.S. Department of Labor’s Occupational Safety and Health Administration, helping to determine cancer risks to workers during the development of standards for toxic substances including asbestos, arsenic, benzene, and formaldehyde. His résumé also included a stint at the National Institute for Occupational Safety and Health, where he conducted epidemiological studies related to carcinogens, and he had served as an expert consultant in epidemiology for several world bodies, including IARC and the World Trade Organization (WTO). In 1999, Infante was chosen as one of four epidemiologists to advise the WTO during its deliberations on the European Union’s ban of chrysotile asbestos. But CropLife told the EPA that the chemical industry players it represented feared Infante would disregard industry-funded studies in favor of independent research. They said he had showed bias in the past against the industry and had testified in a past court case against Monsanto. He had to go, CropLife said.
The EPA caved. Two days after the agency received the October 12, 2016, CropLife letter asking for Infante’s ouster, the EPA said it was halting the meetings that were to have run from October 18 to October 21. The EPA refused to acknowledge that the move was due to industry arm-twisting and said the change was due to scheduling conflicts. It also said it needed to find additional epidemiology expertise.64 Oddly, no one told Infante he was off the panel. Weeks went by in which Infante continued to receive SAP documents from the EPA and was led to believe he was still to be part of the scientific team. But when the EPA finally announced in November that it was rescheduling the meetings for December, Infante’s name was missing from the SAP roster of experts. Infante was confused; he had not been notified of his exclusion until the day before the rescheduled dates were announced. The appearance of industry influence was obvious, but the agency did its best to deflect publicity around Infante’s dismissal, hinting that he had simply become “unavailable” to serve on the panel and refusing to discuss the decision in detail with reporters.