The genie was released in the 1980s and 1990s by the Reagan and Bush administrations, which had long made industrial deregulation a national priority. To their eyes, the burgeoning biotech industry was a perfect merging of business and science that—if left alone—would generate colossal corporate profits for American agricultural conglomerates.
“As genetic engineering became seen as a promising investment prospect, a turn from traditional scientific norms and practices toward a corporate standard took place,” sociologist Susan Wright observes. “The dawn of synthetic biology coincided with the emergence of a new ethos, one radically shaped by commerce.”
If nothing else, all this grain would supercharge the meat industry: Reagan’s first secretary of agriculture was in the hog business; his second was president of the American Meat Institute. George H. W. Bush later appointed the president of the National Cattlemen’s Association to a senior USDA position.
The trick was to come up with federal policy that would allow this new technology, and the products it generated, to enter the marketplace without regulatory hassles—and without worrying the public that the foods they made were somehow different from traditional foods.
Creating these rules required some fancy bureaucratic footwork. Since 1958, Congress (through the Federal Food, Drug, and Cosmetic Act) had mandated that “food additives”—typically chemical ingredients added to processed foods—should undergo extensive premarket safety testing, including long-term animal studies. Commonly used ingredients, like salt and pepper, were considered GRAS (for “generally regarded as safe”) and were exempted from further testing.
The billion-dollar question was: Should genetically altered foods be considered a “new” food additive—and thus be forced to undergo extensive testing—or “safe,” like salt and pepper?
In the early 1990s, the FDA put together a scientific task force to study this question. A consensus quickly emerged that these new products should be developed cautiously, and should be tested to see just what impact they might have on the health of people and animals who eat them.
“The unintended effects cannot be written off so easily by just implying that they too occur in traditional breeding,” wrote microbiologist Dr. Louis Pribyl. “There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering.”
Pribyl said applying the GRAS label to GMOs was not scientifically sound. It was, instead, “industry’s pet idea”—a way to apply a formal stamp of government approval on foods that were, in fact, a completely new thing under the sun.
The director of the FDA’s Center for Veterinary Medicine went further, warning that using GMOs in animal feed could introduce unexpected toxins into meat and milk products. The head of the FDA’s Biological and Organic Chemistry Section emphasized that just because GMOs had not been proven to be dangerous did not confirm their safety. Saying that GMOs were as safe as traditional foods “conveys the impression that the public need not know when it is being exposed to new food additives.”
Likewise, deep inside the labs of government and university laboratories, enthusiasm for genetically engineered food was not nearly as uniform as its promoters in government or industry claimed. “This technology is being promoted, in the face of concerns by respectable scientists and in the face of data to the contrary, by the very agencies which are supposed to be protecting human health and the environment,” said Suzanne Wuerthele, a toxicologist at the EPA. “The bottom line in my view is that we are confronted with the most powerful technology the world has ever known, and it is being rapidly deployed with almost no thought whatsoever to its consequences.”
But given the revving engines of industry, it was tough for GMO skeptics in the scientific community to have their voices heard. University scientists applying for grants to look more closely at potential dangers of GMOs were routinely underfunded, squashed, or simply shouted down. Government scientists were stymied by the influence of the food and chemical industries, whose former executives were routinely placed at the top of the very agencies charged with regulating products made by the companies they used to work for.
It was no secret that the Reagan and Bush administrations had made subsidizing (and deregulating) these companies, and this technology, a national priority. There was no way a regulatory agency could fairly scrutinize an industry it was also funding with so much money, said Philip Regal, a professor at the University of Minnesota’s College of Biological Sciences.
“The more I interacted with biotech developers over the years, the more evident it became that they were not creating a science-based system for assessing and managing risks,” Regal said. “And as momentum built and pressures to be on the bandwagon mounted, people in industry and government who were alerted to potential problems were increasingly reluctant to pass the information on to superiors or to deal with it themselves. Virtually no one wanted to appear as a spoiler or an obstruction to the development of biotechnology.”
From biotechnology’s earliest days, “it was clearer than ever that the careers of too many thousands of bright, respected, and well-connected people were at stake—and that too much investment needed to be recovered—for industry or government to turn back,” Regal said. “The commercialization of GE foods would be allowed to advance without regard to the demands of science; and the supporting rhetoric would stay stretched well beyond the limits of fact.”
Despite this backbeat of scientific concern, the administration of George H. W. Bush—with considerable input from policy executives at companies like Monsanto—ruled that GMOs would not be subjected to any more testing than traditional foods. The GRAS policy would be explicitly designed not to test new food science but to assure “the safe, speedy development of the U.S. biotechnology industry,” Bush’s FDA Commissioner David Kessler wrote.
The FDA policy made it official: the agency was “not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.”
Genetic manipulation was no different from breeding techniques farmers had been using for centuries, Kessler argued. Properly monitored, GM foods posed no special risk and should not require advance federal approval before being sold. “New products come to our kitchens and tables every day,” Kessler said. “I see no reason right now to do anything special because of these foods.”
Beyond giving a green light to the technology itself, the FDA even left the decision about whether new GM foods were GRAS to the companies themselves.
The victory of agribusiness over the FDA’s own scientists furthered a decades-long tradition, in which government agencies “have done exactly what big agribusiness has asked them to do and told them to do,” a fifteen-year veteran of the FDA told The New York Times. “What Monsanto wished for from Washington, Monsanto—and by extension, the biotechnology industry—got.”
Genetic engineering now had the full-throated support of the U.S. government. Administration officials and food industry groups of all kinds lined up to tout the benefits of biotechnology and celebrate the wall that had been erected to protect companies from federal oversight. The hands-off approach was framed as a fine example of what Bush administration officials called “regulatory relief.”
Such policy “will speed up and simplify the process of bringing better agricultural products, developed through biotech, to consumers, food processors, and farmers,” Vice President Dan Quayle announced. “We will ensure that biotech products will receive the same oversight as other products, instead of being hampered by unnecessary regulation.”
Quayle’s declaration put the full weight of the federal government behind a policy that had largely been dictated by agribusiness—especially Monsanto, which by this time had become the world’s l
argest developer of GM seeds.
“What Monsanto wanted (and demanded) from the FDA was a policy that projected the illusion that its foods were being responsibly regulated but that in reality imposed no regulatory requirement at all,” writes Steven Druker, an environmental attorney and author of the book Altered Genes, Twisted Truth. The FDA “ushered these controversial products onto the market by evading the standards of science, deliberately breaking the law, and seriously misrepresenting the facts—and that the American people were being regularly (and unknowingly) subjected to novel foods that were abnormally risky in the eyes of the agency’s own scientists.”
In the twenty-five years since the GRAS decision, the FDA has never overturned a company’s safety determination and, thus, has never required food-additive testing of any transgenic crop.
The Perils of Self-Regulation
Allowing industry to regulate itself has led to a great deal of criticism, of course, since it’s rarely in industry’s best interest to reveal problems with its products, even when they are well known. This is not a new game, as users of countless other products—from Agent Orange to cigarettes to opioid pain relievers—have learned. In those cases, industry scientists knew their products were harmful, but companies continued to promote them and withhold conflicting data for years.
In 2002, a committee of the National Academy of Sciences, the country’s premier scientific advisory body, declared that the USDA’s regulation of GMOs was “generally superficial”: it lacked transparency, used too little external scientific and public review, and freely allowed companies to claim that their own science was “confidential business information.” The committee itself complained that it was denied access to the very information it needed to conduct its review—and not just by the companies. The amount of information kept secret by the USDA itself “hampers external review and transparency of the decision-making process.”
The EPA has also come under intense criticism for—among other things—the way it has handled the staggering population declines of bees and monarch butterflies, both of which have been linked to chemicals sprayed on hundreds of millions of acres of GM crops. The monarch is now as much a symbol for the anti-GMO movement as the polar bear is for climate change activists.
And the FDA? The agency’s own policy states that “it is the responsibility of the producer of a new food to evaluate the safety of the food.” Denied essential proprietary data by companies they are supposed to oversee, the FDA “is unable to identify unintentional mistakes, errors in data interpretation or intentional deception, making it impossible to conduct a thorough and critical review,” a study by William Freese and David Schubert at the Center for Food Safety found.
Such voluntary self-regulation means “government approval” amounts to little more than a rubber stamp, Michael Hansen of the Consumers Union told me. Even though companies test their products, they have a way of doing tests over and over until they get the results they like, Hansen said, and show only favorable results to the agencies overseeing them. Companies are not always forthcoming with the data they do accumulate, and sometimes actively refuse to turn over research even when federal regulators ask for it.
For four decades, the American legal system has repeatedly upheld the industry’s right to control the seeds underpinning our food. Monsanto alone filed 147 seed patent infringement lawsuits in the United States between 1997 and April 2010, settling all but nine out of court. The cases that went to court were all decided in favor of the company.
North of the border, where GMOs are considerably less popular, it has been a bit more complicated.
Patenting Our Food: The Schmeiser Case
Wandering around his canola farm in Saskatchewan in the late 1990s, Percy Schmeiser noticed plants growing not just in the fields, but in a nearby drainage ditch. He did what many farmers would have done to get rid of an unwanted infestation: he sprayed the plants with glyphosate.
Nothing happened.
The canola plants, it turned out, had sprouted from genetically modified Roundup Ready seeds that had floated in from nearby farms. Schmeiser’s neighbors—and 30,000 other Canadian farmers—had paid Monsanto $15 an acre for the right to use these GM seeds; their harvests constituted more than 40 percent of Canada’s canola crop. Monsanto was keen to protect its product: they had farmers sign contracts agreeing not to save or replant the seeds, and they sent out inspectors to make sure the farmers were complying with seed contracts.
Schmeiser had not been part of this deal. For several years, he had planted his own (non-GM) canola fields with seeds he had saved from his own plants. After discovering Roundup-resistant plants in his ditch, he wondered just how much of his farm had been contaminated by Monsanto’s seeds. He sprayed three acres with glyphosate; 60 percent survived.
When word got out that Schmeiser had acres of Monsanto-patented seeds growing in his fields, someone called the company, using an anonymous-tip line the company had set up for farmers to turn in their neighbors. Monsanto sent private investigators to patrol the roads near Schmeiser’s farm. They took crop samples from his fields, and in 1998, Monsanto notified Schmeiser that he was using the company’s seeds without a license.
Undaunted, Schmeiser saved seeds he had harvested from plants that had survived spraying, and planted them on about 1,000 acres. Later tests would confirm that nearly 98 percent of these plants were Roundup resistant.
Monsanto sued Schmeiser for patent infringement. “We’ve put years, years, and years of research and time into developing this technology,” said Randy Christenson, Monsanto’s regional director in Western Canada. “So for us to be able to recoup our investment, we have to be able to pay for that.”
Schmeiser had a different take. “I’ve been farming for fifty years, and all of a sudden I have this,” he said. “It’s very upsetting and nerve-racking to have a multi-giant corporation come after you. I don’t have the resources to fight this.”
In court, Schmeiser argued that the GM seeds on his field had arrived the same way seeds have always arrived—they were blown in on the wind. “You can’t control it,” he said. “You can’t put a fence around it and say that’s where it stops. It might end up 10 miles, 20 miles away.” Furthermore, he argued, a company should not be allowed to patent a higher life form, like a canola plant. Plants were part of the natural order of things, not widgets that came off a company’s factory floor.
This was not the first time Canada’s courts had to wrestle with whether a company could own a life form. The country’s supreme court had previously ruled that Harvard University did not have the right to patent a genetically altered “OncoMouse” (a rodent genetically designed to rapidly develop cancer) even though it had taken university scientists seventeen years to develop it. Courts in Europe and the United States had sided with Harvard, but Schmeiser argued that the Canadian ruling—that an advanced life form could not be patented—ought to apply in his case too.
In 2001, a trial judge rejected Schmeiser’s argument and fined him $20,000 for infringing on Monsanto’s patent. On appeal—and in a show of just how complex biology and patent law can be—the Supreme Court agreed, but its 5–4 decision was split. The court’s minority argued that Monsanto had claimed patent protection over the gene and the genetic process, not the life form (that is, the plant itself), and that Schmeiser should not be held liable for using an (unpatentable) plant. The majority, interestingly, agreed: plants could not be patented in Canada. But the five justices also ruled that a plant’s genes could be patented: by “using” the plant, Schmeiser had in effect “used” the patented gene.
The ruling forced Schmeiser to turn over any Roundup Ready seeds or crops on his property. In a small consolation, the court ruled that Schmeiser did not have to pay Monsanto for the profits he had made from his crop. Monsanto, for its part, made sure the world knew its point of view. “The truth is Percy Schmeiser is not a hero,” the company says.
“He’s simply a patent infringer who knows how to tell a good story.”
In effect, the Canadian court gave Monsanto legal control over something it could not patent—Roundup Ready canola plants—by giving it legal control over something it could control—the plant’s genes. In Canada at least, plants themselves are still not patentable, and farmers are allowed some protection if they don’t intentionally use patented seeds. Canadian growers also (for the moment, at least) still enjoy a “farmer’s privilege”—protected by the national Plant Breeders Rights Act—that allows them to save and replant traditionally bred seeds.
This is in direct contrast to laws in the United States, where the Supreme Court has ruled that plants can be patented in spite of laws protecting a farmer’s right to save seeds. This position—promoting the rights of large companies over the rights of small farmers—is very much in keeping with the American government’s longstanding and unwavering support of the biotech industry.
In the end, the early (and ongoing) rush to develop, plant, and profit from GM seeds has simply outpaced and overwhelmed our ability to understand their impact on our lives, John Vandermeer, the agroecologist at the University of Michigan, told me.
“I would be far less negative about GMOs had the people developing [them] taken the same approach as they did at Asilomar,” Vandermeer told me. “They could have said, ‘Let’s have a moratorium on selling them until we can be sure that they are safe.’ But partly because of the profits involved, that was never done. Had we done this, it’s my guess that Bt and Roundup transgenic crops never would have been developed and spread throughout the landscape. What we are discovering is that they should probably never have been used.”
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