by Carey Gillam
And even though other research acknowledged by the EPA showed apparent ties between glyphosate and blood and pancreatic problems in rats, decreased enzyme production in rabbits, sickness and death in pregnant rats and rabbits, and more, the agency held to a position that there was no significant evidence of danger.
That narrative became so entrenched in the EPA that when a review committee met on June 26, 1991, to again discuss and evaluate glyphosate research, the group decided that there was a “lack of convincing carcinogenicity evidence” in relevant animal studies. The group concluded that the herbicide should be classified far more lightly than the initial 1985 classification or even the 1986 classification proposed by the advisory panel. This time, the EPA scientists dubbed the herbicide a Group E chemical, a classification that meant “evidence of noncarcinogenicity for humans.” In a memo explaining the decision, authored by William Dykstra and George Z. Ghali, both scientists within the Health Effects Division of the EPA’s Office of Pesticides and Toxic Substances, the agency officials offered a caveat. They wrote that the classification “should not be interpreted as a definitive conclusion that the agent will not be a carcinogen under any circumstances.”25
Not all the review members agreed with the conclusion in 1991. Of the seventeen peer review members involved, at least two did not concur, writing their objection next to their name. A third simply did not sign the document, which stated “signature indicates concurrence.”
Another study examined by the EPA over the course of its glyphosate analysis was one called “A Lifetime Feeding Study of Glyphosate (Roundup Technical) in Rats,” prepared by Biodynamics Inc. for Monsanto in 1981. Even though that study showed some tumors in the testes of male rats as well as possible thyroid carcinomas in females who received high doses of the pesticide, it was determined that the data did not demonstrate noteworthy links between glyphosate and cancer. The study was marked by Monsanto as a trade secret and kept from public scrutiny. The 1983 study that showed kidney tumors in mice was also considered a trade secret. In fact, many of the roughly 290 studies, reports, memos, and letters that the EPA said were relevant to its decision making on glyphosate at that time were generated or submitted by Monsanto and were unpublished, meaning they were not peer-reviewed and not available for review or analysis by the public and independent scientists.
The questions about those kidney tumor conclusions have never been fully resolved, at least in the minds of those who believe Monsanto’s influence was ultimately what led the EPA to drop its view of glyphosate as a possible carcinogen. The plaintiffs suing Monsanto over cancer claims allege that only scientists with financial ties to Monsanto have ever affirmed the presence of a tumor in the control group for that mouse study. But Monsanto says the evidence overwhelmingly disproves cancer connections.
Some of the research Monsanto provided to the EPA raised red flags in part because fraud had been discovered at two of the laboratories the company used regularly. The deceptions the FDA discovered at Industrial Bio-Test Laboratories (IBT) in 1976 were particularly egregious, leading to the repeat of some toxicology studies of many products, including Roundup. In 1983, three IBT officials were convicted of trying to defraud the government by covering up inaccurate research data. During court proceedings, testimony revealed that IBT laboratory workers sometimes substituted new animals for test animals that had died, without noting the deaths or substitutions in lab reports. Plus, entire test data and lab reports for one product were copied into reports for other products. Then there were the so-called magic pencil studies, in which false data were submitted if test results indicated a product’s adverse or fatal effects.
One of those convicted was a Monsanto insider named Paul L. Wright. Wright was a Monsanto toxicologist before he went to work at IBT as a section head for rat toxicology, and he went back to work for Monsanto after the IBT fraud was exposed. He was actually employed by Monsanto at the time he was convicted.26 Wright also was involved in IBT’s testing of PCBs, and memos that came to light during the government’s investigation included discussions of efforts by Monsanto to get test results on PCBs altered to cast its product in a more favorable light.27
Fraud was also uncovered in 1990 in Craven Laboratories, another lab used by Monsanto to test glyphosate. State and federal investigators found that lab researchers had falsified pesticide residue testing data for at least a decade. Monsanto said that it had all the affected studies done by both Craven and IBT repeated. But critics have little trust in the company-funded reports.
Despite the findings of fraud in the laboratories, it was not easy for the EPA’s own experts to challenge companies such as Monsanto. EPA scientist Cate Jenkins, who holds a doctorate in chemistry, found that out firsthand in 1990 when she suspected Monsanto’s studies on dioxins were fraudulent and had led the EPA to erroneously conclude that dioxins did not cause cancer. Jenkins alerted top officials within the agency to her suspicions, pointing out “numerous” “misrepresentations and falsifications” in Monsanto’s health studies on dioxin submitted to the agency, which made the chemical seem much safer than it was. She accused the company of covering up dioxin contamination problems and engaging in “obvious fraud.”28 Her allegations were shared with Monsanto, which deemed them baseless. In 1991, she pressed the issue again, telling EPA investigators that Monsanto’s influence was weakening the EPA’s regulation of dioxins. Jenkins was subsequently demoted, an action she responded to by filing a complaint with the U.S. Department of Labor. It took two years of battling for her job before she was reinstated.29
Indeed, safety data for pesticides during the era of glyphosate’s introduction were so unsound, so suspect, that in a 1982 article in Mother Jones magazine, Marcia Williams, former director of the EPA’s Special Pesticide Review Division, was quoted as saying that “none of the 600 chemicals which have been registered have adequate data to support them.”30
Despite the concerns, by September 1993 the EPA had given a green light to Monsanto and glyphosate for a wide range of uses, citing the chemical’s safety for humans, animals, birds, bees, and aquatic animals alike. The agency’s only noted concern? The “potential hazard to … the Houston toad,” as the agency stated in a 259-page description of its stance on glyphosate.31 (The endangered species was facing a host of modern-day development threats, including pesticide use, officials found.)
And in a move that would later fuel criticism, the EPA’s safety declarations were largely based on glyphosate alone, not on how it affects people, animals, and the environment when it is mixed with other ingredients, as it is in branded herbicide formulas such as Roundup. Research has shown that these combinations of glyphosate with other chemicals might be more dangerous than glyphosate alone. By 2016, European and U.S. regulatory authorities would be talking about the need to more thoroughly examine these “formulated” products.
“The whole pesticide approval process is so narrowly focused on individual ingredients that no one at the EPA has taken a step back to look at the bigger picture; and when you look at the bigger picture, it’s clear that the agency has created a monster,” said Nathan Donley, who holds a doctoral degree in cell and developmental biology. “Pesticide labels are so permissive regarding what a pesticide can be mixed with that no one really has any clue about what is being mixed with what and where. The EPA treats pesticide mixtures as something to be swept under the rug. They pay lip service to it every once in a while, but when it comes to actually doing something about it, they revert back to the decades-old practice of pretending that it doesn’t exist. With the EPA, lack of evidence of harm equals no harm when it comes to mixture toxicity. It’s just indefensible.”32
One reason for the EPA’s apparent eagerness to green-light new pesticides is a little-known provision in the agency’s statute that calls for the EPA to examine not only how a pesticide affects human and environmental well-being but also how it affects the financial well-being of agricultural players. As startling as that may be to consumers
, it’s a fact that protecting public health and the environment is only part of the equation when the EPA decides whether or not to allow pesticides to market. Many people assume the EPA’s sole role is to look at potential hazards, health or otherwise, when evaluating pesticides such as glyphosate. But under the law, the EPA must balance risks against benefits, weighing whether or not a pesticide creates an “unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.” The EPA does a risk-benefit analysis, taking into account that “even though pesticide use entails some risk, pesticides provide substantial benefits to society.”33
As the agency wrestled over safety concerns with glyphosate, it also was busy figuring out how much of the pesticide would legally be allowed into the food supply. Not coincidentally, many of the studies and reports Monsanto provided to the EPA concerned the fact that using glyphosate in farming was bound to leave glyphosate residues in food. The fact that the agency reversed its earlier view that glyphosate could be a possible carcinogen was key because food safety laws frowned on allowing residues of cancer-causing chemicals in food. By 1991, the company had submitted specific reports aimed at establishing or raising government allowances for glyphosate residues in numerous crops, including corn, soybeans, wheat, potatoes, sorghum, grapes, and dozens of others.34 Because Roundup was used on tea plantations in Argentina, India, Sri Lanka, Taiwan, and elsewhere, Monsanto even requested allowances for the weed killer in instant tea.35
Using Monsanto’s work as a guide, the EPA set what the agency calls “tolerances,” essentially benchmarks for levels of glyphosate residues that would be permitted on a range of food crops. Those tolerance levels were tied to how much of the chemical was expected to be used on different crops and how much residue was expected to remain. Over the years, Monsanto requested and received approvals for greater and greater tolerances to dovetail with the increasing amounts of its weed killer being used on food and livestock feed crops, setting up the potential for people and animals to consume higher and higher levels of weed killer in their daily diets.
The EPA has made clear that it does not believe these residues pose a threat. The agency states that “the chronic dietary risk posed by glyphosate food uses is minimal.”36 And that belief—the EPA’s assurance of safety—was cited for years by other federal agencies as a reason why they skipped over glyphosate when conducting annual testing programs specifically designed to make sure pesticide residues on food were within legal limits. Glyphosate got a pass while other, less widely used pesticides did not. Without such tests, there was no way of knowing if the ever-higher legal levels for glyphosate were being adhered to—or if the food supply was being contaminated with a flood of the weed-killing chemical.
The EPA’s flexible allowances for levels of glyphosate residues in food would prove to be critical to Monsanto’s future as an agricultural powerhouse. By 1993, Monsanto’s patent protection on glyphosate was approaching its sunset—it would expire in 2000 in the United States. After that, rivals would be free to offer cheaper generic glyphosate herbicides to compete with Monsanto’s Roundup. But Monsanto had a strategy to keep its Roundup sales strong. The company’s scientists had figured out how to alter the genetic makeup of soybeans and other widely grown crops so that they could withstand being sprayed directly with glyphosate. These “Roundup Ready” crops marked the dawning of a new era for agriculture that would quickly and drastically change the face of food production. The EPA’s stamp of approval for the safety of Monsanto’s Roundup was an essential first step. Monsanto would later cite the EPA’s determination that glyphosate did not cause cancer when asking the USDA to approve its new glyphosate-tolerant crops. And by 2001, only five years after the introduction of those Roundup Ready crops, glyphosate would be established as the most widely used agrochemical in America.37
CHAPTER 3
The “Roundup Ready” Rollout
Mark Nelson was still a young farmer in the mid-1990s, figuring out the best tools and tactics for coaxing corn, soybeans, and wheat from the farm fields of northeastern Kansas, when he started hearing about a new type of high-tech seed that would soon be for sale. Other farmers Nelson knew were talking about it. So were university extension agents and seed dealers. It seemed everyone was talking about, and waiting for, these special seeds that had been transformed by alterations to their DNA. Through the magic of technology, scientists at Monsanto Company had found they could insert genetic material from a strain of Agrobacterium into the chromosome of the soybean, transforming the bean into a crop that could withstand being sprayed with Monsanto’s Roundup and still continue to grow and flourish. The company then planted and studied the altered soybean seeds in locations around the United States and in Puerto Rico, Argentina, and Costa Rica through 1991 and 1992, developing a wide range of soybean varieties to commercialize.1
This was different from the seed breeding of the past, in which scientists crossbred crop species to obtain desired traits, such as hardier and higher-yielding plants. These new crops contained genetic material that had never naturally made its way into a corn or wheat or soy plant. They were the product of high-dollar laboratories where scientists in lab coats pored over petri dishes, and they were patented by Monsanto. Farmers planting these special seeds would no longer be able to save some of the finished crop and replant the seeds, as farmers had for generations. The seeds for these genetically modified organisms (GMOs) had to be purchased new every year, or Monsanto’s patent would be infringed.
With a wife and three young daughters to provide for, Nelson was wary of the hefty price tag attached to the new specialty seeds and the fact that those costs would repeat each season. But as the agricultural community around him quickly embraced them, so did he. The benefits were obvious: while farmers previously had needed to till the soil to disrupt weed growth, rotate the types of crops they planted year after year, and often treat their entire barren fields with various chemicals to kill weeds before planting, the combination of Roundup herbicide and Roundup Ready crops made farming much easier. By itself, Roundup was a godsend to farmers like Nelson, but it couldn’t be used once crops emerged from the ground because even a light drizzle of the potent pesticide adrift on a breeze could do great damage to a corn or wheat stalk. With the new types of seeds, the herbicide could be used at will.
“We said yes. The sticker shock was big,” Nelson said. “But the weed control was great.” Nelson was already a big fan of Roundup herbicide. It knocked out more weed types more effectively than the other types of herbicides Nelson had tried, and he was reassured by the company’s assertions that it was better for the environment than rival products. Nelson, who grew up helping his grandfather farm, especially liked that Roundup reduced the need for tilling, a practice known to erode soil and deplete moisture and essential nutrients from the ground. “When it came out, that was all we used,” Nelson said of Roundup. “We just used it and used it and used it. We didn’t even know what was in it; we never heard the word ‘glyphosate.’ It was just all Roundup.”2
It was 1996 when Monsanto unveiled its Roundup Ready soybean. Soybeans were, and are, one of the world’s largest sources of plant-based protein, ranking as a top crop for farmers and serving as a key ingredient in many types of food for people, pets, and livestock. Soy is commonly found in infant formula, cereals and crackers, rolls and pastries, and even fruit drink mixes and canned soups. It’s often used as a meat extender and found in pork link sausages and luncheon meats. And it’s used to make an array of products consumed by vegetarians, such as tofu and soy milk. To put it mildly, Monsanto’s introduction of the new soybean spelled a very large market opportunity. And because the soybean was designed to be used in conjunction with Monsanto’s branded glyphosate-based Roundup, the profit prospects for the company were enormous.
In seeking government approval for Roundup Ready soybeans, Monsanto again touted the safety of its glyphosate pesticide and m
ade clear that selling the new beans was also about selling Roundup. Farmers buying and planting the new beans could “take advantage of this herbicide’s well-known, very favorable environmental and safety characteristics,” Monsanto told the U.S. Department of Agriculture (USDA).3
The company reminded regulators that “glyphosate is only toxic to plants but not to other living species, including mammals.”4 But because of their tweaked DNA, these new crops would not die even if sprayed repeatedly with glyphosate. The company had discovered organisms that conferred resistance to glyphosate in the sludge-filled waste ponds surrounding its Roundup production plant in Luling, Louisiana.
Monsanto told regulators that its new Roundup Ready system—the herbicide combined with the herbicide-tolerant crops—should save farmers money on fuel, for there would be little need to power up tractors and plow weedy fields. The company also said that the Roundup Ready crop system “may” reduce overall herbicide use,5 a statement that would prove to be not just wrong but colossally so. Herbicide use actually skyrocketed over the twenty years that followed the introduction of Monsanto’s Roundup Ready crops, helping Monsanto reap billions of dollars in herbicide sales, on top of the billions of dollars it made from the specialty seed sales. It was a brilliant move for Monsanto, but it was one that environmentalists, scientists, consumers, and regulators would eventually realize came with devastating costs.