PART II: GMOs: The Great Conspiracy
7: The Invention of GMOs
The health and safety of biotechnology products is not an issue: the food, feed and environmental safety of the products must be demonstrated before the products enter the agricultural production system and supply chain.
—Monsanto, Pledge Report, 2005
“The cow hormone drug was simply the first major application of biotechnology to food production and Monsanto is a very powerful corporation with many, many linkages to top level persons in government. I think the prevailing ethic at the federal government was ‘Biotechnology is so important that we can’t let a few little questions about cow safety or human safety get in the way.’ The drug got approved, regardless of its demerits,” Michael Taylor told me.
Indeed, by the time rBGH was approved by the Food and Drug Administration, dozens of GMOs were in development in the laboratories of biotechnology companies, chiefly Monsanto, which had just filed an application for the marketing of Roundup Ready soybeans, genetically modified to resist the spraying of Roundup. The connection between the company’s maneuvering to secure approval of the controversial hormone at any cost and its plan to position itself in the market as the “Microsoft of biotechnology” was confirmed, unexpectedly, by Taylor, who, it will be recalled, worked as counsel for Monsanto, was appointed deputy commissioner of the FDA in 1991, and a few years later became a Monsanto vice president.
“I think in terms of public acceptance, it’s been one blunder after another,” he confessed in our telephone conversation. “If you’re trying to have a strategy for having the public understand and accept a new technology, having the first application of it be related to milk, which we already have more than we need, it helped create a climate of . . .”
“Suspicion?” I suggested, completely astounded by what I was hearing.
“Suspicion, yes,” he answered. “I think that Congress should change the law. It should create a mandatory notification system that ensures that every product is looked at by FDA and the FDA makes a safety judgment about every product.”
I still find it hard to understand why Taylor made this surprising confession. Was it belated remorse, or an attempt to exculpate himself for the role he played in supervising the writing of U.S. regulations of GMOs, which influenced all governments and international organizations, including the European Community? The answer is a mystery.The Scramble for Genes
Before recounting in detail the genesis of what can be considered one of the greatest conspiracies in the history of the food industry, it is appropriate to outline in broad terms the saga of genetic engineering. And just this once I must admit that Monsanto’s tenacity and enthusiasm were impressive— it overcame all its many competitors to become the unchallenged leader in this advanced field.
It is generally accepted that the story began in 1953 when the American James Watson and the Briton Francis Crick discovered the double helix structure of DNA (deoxyribonucleic acid), the molecule that contains the genetic code for every living organism. The discovery won the two geneticists and biochemists a Nobel Prize in 1962 and signaled the birth of a new discipline: molecular biology. As Hervé Kempf has noted in La Guerre secrète des OGM, it also led to the emergence of a “doctrine” according to which “the organism is a machine” entirely dependent on genes alone, the key to the understanding of the mechanisms of life. This “doctrine”—not to call it a “dogma”—was clearly summarized by the 1958 Nobel Prize winner Edward Tatum: “(1) All biochemical processes in all organisms are under genetic control. (2) These overall biochemical processes are resolvable into a series of individual stepwise reactions. (3) Each single reaction is controlled in a primary fashion by a single gene. . . . The underlying hypothesis, which in a number of cases has been supported by direct experimental evidence, is that each gene controls the production, function, and specificity of a particular enzyme.”1
In other words, every biological reaction that characterizes the functioning of a living organism is governed by one gene that expresses a function by triggering the production of a specific protein. This exclusive idea, which some call “all gene,” is the source of one of the greatest misunderstandings underlying the development of biotechnology, one that persists today. “In reality,” as Arnaud Apotheker, holder of a doctorate in biology and spokesman on GMO issues for Greenpeace France, pointed out in 1999, “every day phenomena turn out to be more complex: a single gene may code for proteins having very different primary structures and biological properties depending on the tissues of an organism or the organism itself. The molecular machinery of living things is of a complexity that we are barely beginning to glimpse.”2 We now know, for example, that some genes interact with others and that it is not a simple matter to extract them from one organism and introduce them into another in order for them to express the protein and hence the function that has been selected. Rather, transferring genes this way may cause unexpected biological reactions in the host organism.
Beginning in the early 1960s, molecular biologists set to work to develop techniques that would enable them to manipulate genetic material to create chimerical organisms that nature never would have been able to produce on its own. To do so, they strove to divide and put together fragments of DNA, to copy and multiply genes with the aim of transferring them from one species to another. This genetic tinkering was often justified by a generous humanitarian vision, expressed, for example, in 1962 by Caroll Hochwalt, Monsanto’s vice president for research, in a commencement speech at Washington University in St. Louis: “It is entirely conceivable that, through the manipulation of the genetic information at the molecular level, a crop such as rice could be ‘taught’ to build a high protein content into itself, literally working a miracle of alleviating hunger and malnutrition.”3 It should be pointed out that at the time the secrets of DNA were of little concern to Monsanto, which was busy making its fortune in the jungles of Vietnam.
So it was at Stanford University, not in St. Louis, that the first genetic manipulations took place. In 1972, as Monsanto was preparing to launch Roundup, Paul Berg succeeded in “recombining” DNA—that is, putting together two fragments of DNA from different species into a hybrid molecule. A little later, his colleague Stanley Cohen announced that he had succeeded in transferring a frog gene into the DNA of a bacterium able to reproduce the intruder in large quantities. These discoveries, which broke a law that had been considered inviolable, the impossibility of crossing what was known as the “species barrier,” created great excitement, along with deep concern, in the international scientific community. The worries turned into an uproar when Paul Berg announced his intention to insert a carcinogenic virus, SV-40, from a monkey into an E. coli cell, a bacterium that colonizes the human digestive tract. Some scientific authorities, such as Robert Pollack, a cancer virus specialist, worried: “What will happen if the manipulated organism inadvertently escapes from the laboratory?”4 The general outcry led to a temporary moratorium on genetic manipulation and, on February 25, 1975, the first international conference on recombinant DNA. For two days at Asilomar, a Pacific seaside resort in California, leading figures in the rising discipline considered the risks of genetic engineering, focusing the debate on experimental safety and the formulation of rules, such as measures to contain manipulated organisms. But at no point did they broach ethical questions, which were excluded from the outset. It was as though the biologists had already decided to “limit the involvement of the public and the government in their affairs to the minimum.”5 The message was soon received loud and clear by the future world leader in biotechnology.
After the Asilomar conference, genetic engineering experiments proliferated in the United States—the National Institutes of Health recorded more than three hundred in 1977. While attempts to place legal restrictions on these extremely hazardous new scientific activities were buried one after the other—in 1977 and 1978, sixteen bills were proposed in Congress, but none passed—start-ups and risk capital companies were flourishing, particularly in California, where another promising technology had just given birth to Silicon Valley. Companies such as Calgene and Plant Genetics Systems were established by biologists who had previously worked in universities and who, carried away by an extraordinary burst of research activity and the prospect of huge financial rewards, plunged into the economic arena, raising millions of dollars on the New York Stock Exchange or taking shares in and joining the boards of private companies.
This veritable “race for genes” brought about an unprecedented association between science and industry, which radically transformed research practices, as the sociologist Susan Wright explains in her standard work on the history of biotechnology, published in 1994: “As genetic engineering became seen as a promising investment prospect, a turn from traditional scientific norms and practices toward a corporate standard took place. The dawn of synthetic biology coincided with the emergence of a new ethos, one radically shaped by commerce.”6 This development was very markedly stimulated by Monsanto through the patent system that controlled research and the products derived from it.The Triumph of Genetic Tinkering
While start-ups were making news on the stock market, one man in St. Louis was conducting a solitary battle. His name was Ernest Jaworski, and he had joined Monsanto in 1952. This researcher, who was an expert on glyphosate and had worked out the details of its manner of acting on plant cells, had an idea that seemed completely preposterous to his colleagues in the old chemical company: instead of trying to manufacture new herbicides, why not create selective plants by manipulating their genetic makeup precisely so they could survive the spraying of herbicides?
Encouraged by John Hanley, who became CEO of Monsanto in 1972 and was also convinced that biology represented the future of chemistry, Jaworski initiated himself into the cultivation of plant cells in a Canadian laboratory and then supervised the work of thirty researchers, including such rising stars of molecular biology as Robert Fraley, Robert Horsch, and Stephen Rogers. “These young genetic engineers did believe that their workwould be good for the planet, possibly making it easier to grow food or reducing agriculture’s dependence on chemicals,” according to Daniel Charles, author of Lords of the Harvest, who was able to interview the pioneers of biotechnology before they decided to sink into stubborn silence. “Some of them, working inside chemical companies, often saw themselves as ‘green’ revolutionaries fighting against the entrenched power of the chemists, whom they dismissed as ‘nozzleheads.’ ”7
Meeting on the fourth floor of U Building at Monsanto’s Creve Coeur location, a suburb of St. Louis to which the company had recently moved, the team was nicknamed “Uphoria” by company skeptics, who saw this group of excited young men as economically irresponsible oddballs. At the same time, the “Kremlin,” as the company management, located in D Building, was called, had broken with company habits and for the first time in its history plunged headlong into basic research without knowing what applications it would lead to. “Scientific excellence was the priority,” according to Rob Horsch. “There was no pressure to produce a product. For example, we were working on petunias. No one came and said to us: ‘Petunias? What do you think we are? A university?’ In fact, we were a kind of entrepreneurial unit protected by the management.”8
Following the lead of laboratories in California, Belgium, and Germany, the Uphoria researchers developed a three-stage research program: first, to manipulate DNA to extract genes that might be useful, known as “genes of interest”; next, to transfer those genes into plant cells; and finally, to develop tissue cultures in order to reproduce and encourage the growth of these manipulated embryonic cells. The first stage was worked out thanks to the discovery of restriction enzymes, which functioned like scissors, enabling molecular biologists to cut DNA to extract genes of interest.
But the second stage was another story. Contrary to the argument often put forth by promoters of biotechnology, the techniques of genetic manipulation have absolutely nothing to do with the genealogical selection that has been practiced by breeders since the work of Louis de Vilmorin in the midnineteenth century. Seed companies have merely rationalized and systematized the ancestral practices of farmers who, since the advent of agriculture in Mesopotamia ten thousand years ago, have endeavored to keep the best grains from their harvests to seed their fields the following year. The contribution of professional breeders is to cause the cross-breeding of two plants—the “parents” of the line—selected for complementary agronomic qualities (such as resistance to disease or crop yield), in the hope that their descendants will preserve the same characteristics because of the laws of heredity. The best examples from the second generation are then selected and forced to cross-breed, and so on over several generations. It is clear that genealogical selection is based on natural laws, in this case the sexual reproduction of plant organisms; human action is aimed only at orienting the range of possibilities within a single genetic reservoir, but in the end the “improved” plant might very well have been created by Mother Nature in the fields. I will return to the effects of genealogical selection on biodiversity in Chapter Eleven, but for now, it is important to understand that this agronomic procedure cannot be identified with the techniques of genetic manipulation, which, rather than respecting the natural laws of plant development, attempt instead to break them in any way possible.
Molecular biologists knew very well that plant organisms possess defense mechanisms designed to protect them from the intrusion of foreign bodies, including, of course, genes coming from other living species. From the very beginning, those biologists understood that genetic manipulation could not be carried out without using an intermediary, or a “mule,” able to transport the selected gene and make it enter by force into the target cell. For this purpose, they turned to a bacterium that is abundant in the soil, Agrobacterium tumefaciens, which has the capacity to insert some of its genes into plant cells to cause tumors. [x] In other words, this bacterium is a pathogen that changes the genetic inheritance of cells by infecting them.
In 1974, a Belgian research team succeeded in identifying the plasmid (a ring of DNA) constituting the vector by which the gene that induces the tumor is transferred from the bacterium to the plant. In St. Louis, as in laboratories around the world at the time, they then attempted to isolate in the plasmid the gene responsible for the tumors and replace it with the gene of interest by adding a gene “promoter,” a sequence of DNA that triggers the expression of the gene to be triggered. The gene in question is often 35S, from the cauliflower mosaic virus, which is related to the hepatitis B virus, raising the alarm of some opponents of unrestricted tinkering with genes.
But there was more: if the gene-inducing tumors had been suppressed, how could one know that the plasmid was doing its work and inserting the substitute gene in the plant cell? The only solution the sorcerer’s apprentices found was to attach to the genetic construction what they called a “selection marker,” in this case a gene resistant to antibiotics, usually kanamycin. To verify that the transfer had actually taken place, the cells were sprayed with an antibiotic solution, and the “chosen” were those that survived this shock treatment. (This gave rise to further health concerns— at a time when resistance to antibiotics was in the process of becoming a serious public health problem, some Cassandras were afraid that the selection marker would be absorbed by bacteria populating the human intestinal tract, reducing medicine’s ability to fight infectious agents.)
In the meantime, on January 18, 1983, at the symposium on molecular genetics in Miami, representatives of three laboratories—one Belgian and two Americans, one of whom was Rob Horsch of Monsanto—announced that they had succeeded in inserting a genetic construct, a kanamycin resistance gene to be exact, into cells of petunia and tobacco plants (two plants susceptible to Agrobacterium tumefaciens). The three laboratories had filed patents on their simultaneous discoveries. For Monsanto, serious work was beginning and the call to battle had sounded.The “Artificial Cassette” of Roundup Ready Soybeans
“I’ll never forget the first time I used the phrase ‘We are not in the business of the pursuit of knowledge; we are in the business of the pursuit of products.’ You could have heard a pin drop. They were furious.”9 The words are those of Richard Mahoney, who, as soon as he was appointed CEO of Monsanto in 1984—a position he held until 1995—decided to shake up the Uphoria troops. The end had come for lavishly funded research on tinkering with petunias, and the aim was now clear: to create transgenic plants that brought in money. Called by Fortune one of “America’s toughest bosses,” Mahoney was an unselfconscious businessman who bluntly declared: “Forgiveness is out of style, shoulder shrugs are out of fashion. Hit the targets on time without excuses.”10
Subjected to unprecedented stress, Ernest Jaworski’s team understood that the laboratory’s success was a question of life or death and that a failure would signal the victory of the pure chemists. From then on, all research was focused on the production of plants resistant to Roundup, which, ten years after its introduction, had become the most widely sold herbicide in the world. Furthermore, the implacable boss reminded everyone that the patent guaranteeing a monopoly on glyphosate derivatives would expire in 2000 and that GMOs soon to be known as “Roundup Ready” would be a good way of pulling the rug out from under manufacturers of generics. This was a concrete objective that delighted Jaworski, because in the end this had been his original idea: to manipulate plants so that they could survive the use of herbicides, which could therefore be sprayed at any time on crops—corn, soybeans, cotton, rapeseed, and why not wheat?—to destroy only weeds.
But they hadn’t gotten there yet. In 1985, the Monsanto researchers were obsessed by only one thing: finding the gene that would immunize plant cells against Roundup. This was especially urgent because Calgene, a California start-up, had just announced in a letter published in Nature that it had succeeded in making tobacco resistant to glyphosate.11 Discussions were already under way on an agreement with the French company Rhône- Poulenc to develop crops resistant to glyphosate. At the same time, the German company Hoechst was going all out to find the gene resistant to its herbicide Basta, not to mention DuPont (Glean) and Ciba-Geigy (atrazine). In short, all the chemical giants were pursuing the same goal, because the stakes were primarily economic: companies were already imagining the patents they could file on all the major food crops in the world.
In St. Louis, stress took up permanent residence, because the notorious gene remained elusive. Jaworski’s researchers were going around in circles. They had succeeded in identifying the gene responsible for the enzyme that, as I reported in Chapter Four, is blocked by the action of glyphosate molecules, causing tissue necrosis and plant death. The idea was to manipulate it so as to deactivate the reaction to the herbicide, and then introduce it into plant cells, but nothing worked. “It was like the Manhattan Project,” said Harry Klee, a member of the research team. “The antithesis of how a scientist usually works. A scientist does an experiment, evaluates it, makes a conclusion and goes on to the next variable. With Roundup resistance we were trying twenty variables at the same time: different mutants, different promoters, multiple plant species. We were trying everything at once.”12
The search lasted for more than two years, until the day in 1987 when engineers thought of rummaging through the garbage in Monsanto’s Luling plant, located 450 miles south of St. Louis. At this site on the banks of the Mississippi, Monsanto produced millions of tons of glyphosate annually. Decontamination pools were supposed to treat production residues, but some of the residues had contaminated nearby land and ponds. Samples were taken to collect thousands of microorganisms in order to detect the ones that had naturally survived glyphosate and identify the gene that gave them that invaluable resistance. It took a further two years for a robot analyzing the molecular structure of the bacteria collected to finally come up with the rare pearl. It was “a great Eureka moment,” said Stephen Padgette, one of the “inventors” of Roundup Ready soybeans, now a Monsanto vice president.13
But the game was far from over. They now had to find the genetic construct that would enable the gene to function once it was introduced into plant cells, specifically soybeans, the oil-producing plant the team was working with after preliminary trials with tomatoes. The stakes were huge: along with corn, soybeans dominated American agriculture at the time, annually contributing $15 billion to the national economy. Until 1993, when Roundup Ready soybeans were officially launched, Stephen Padgette and his colleagues in the Roundup resistance program divided their time between the laboratory and the greenhouses covering the roof of the Chesterfield Village biotechnology research center that Monsanto had set up in a wealthy suburb of St. Louis. It took “700,000 hours and an $80 million investment” to attain the result: a genetic construct including the gene of interest (CP4 EPSPS), the promoter 35S from the cauliflower mosaic virus, and two other fragments of DNA derived from the petunia intended to control the production of the protein.14 The “‘Roundup tolerant soybean gene cassette’ is a completely artificial one that never existed in natural life kingdom nor could have evolved naturally,” reported Japanese biologist Masaharu Kawata of Nagoya University.15
This was so much so that the Monsanto researchers encountered enormous difficulties in introducing it into soybean cells. They had to give up the “mule,” Agrobacterium tumefaciens, because they had constantly faced the same problem: whenever they inundated the cells with antibiotic, the ones that had not absorbed the cassette died, but those dead cells poisoned the genetically modified cells in a phenomenon Rob Horsch named “colloperative death,” a sinister-sounding neologism indicating death from cooperative collapse.16
In the face of this resistance from nature, the team decided to bring out the heavy artillery, a “gene gun” invented by two Cornell University scientists, developed in collaboration with Agracetus, a Wisconsin biotech company that Monsanto acquired in 1996. When John Sanford and his colleague Ted Klein came up with the idea for this last-ditch weapon, they were considered crazy, even though laboratories at the time were prepared to do anything to force the desired DNA to penetrate into the target cells: some researchers were using microscopic needles, while others employed electric charges to make little holes in cell walls to enable the DNA to enter (evidence, if any were needed, that biotechnology has nothing to do with the traditional technique of genealogical selection). But nothing was working.
The gene gun is now the insertion tool most frequently used by the “artillerymen” of genetic engineering. It works by attaching genetic constructs to microscopic gold or tungsten bullets and shooting them into a culture of embryonic cells. A clear picture of the imprecision of the technique can be found in the description Stephen Padgette provided in 2001 to Stephanie Simon of the Los Angeles Times: “Trouble was, the gene gun inserted the DNA at random. Sometimes a bundle would splinter before landing in a cell. Or two gene packets would double up. Even worse, the DNA would at times land in a spot that interfered with cellular function. The team had to fire the gun tens of thousands of times to get a few dozen plants that looked promising. After three years of field tests on these promising plants, a single line of transformed soybean shone as superior. It could resist heavy doses of glyphosate, as the greenhouse experiment proved. . . . ‘It was bulletproof,’ Padgette recalled with pride. In 1993, Monsanto declared it a winner.”17
But at what cost? As Arnaud Apotheker points out in Du poisson dans les fraises: “In their determination to subjugate nature, humans use the technologies of war to force cells to accept genes of other species. For some plants, they use a chemical or bacteriological weapon to infect cells with bacteria or viruses; for others they use only classic weapons, such as gene guns. In both cases, waste is considerable, because on average one cell out of a thousand enters the transgene, survives, and is able to generate a transgenic plant.”18 In 1994, in any event, Monsanto filed a request for authorization to market Roundup Ready soybeans, the first widely grown GMO. And once again the company had “bulletproofed” everything, as its vice president said.Maneuvers in the White House
While the team in Chesterfield Village was desperately tracking the glyphosate resistance gene, company management was demonstrating a capacity for foresight that might be surprising if one were unaware of the consequences. As the New York Times reported in a very well-informed article in 2001: “In late 1986, four executives of the Monsanto Company, the leader in agricultural biotechnology, paid a visit to Vice President George Bush at the White House to make an unusual pitch.”19
To fully understand the subtlety of the strategy managed by Leonard Guarraia, then director of regulatory affairs for the company, recall that the Reagan administration’s watchword was “deregulation,” intended to “liberate market forces” by shrinking the intrusive state. This ideology was aimed at fostering American industry by reducing to the maximum extent possible what White House hard-liners called “bureaucratic obstacles,” which is how they saw the health and environmental tests required by regulatory agencies before a new product could be marketed: the FDA for food and drugs, the EPA for pesticides, and the Agriculture Department (USDA) for crops.
The United States at the time was conducting a merciless struggle to impose its superiority in competition with Japan, and to a lesser extent with Europe, particularly in the area of new technologies, but also in agricultural products. In this extremely competitive context, the stakes involved in biotechnology were considerable. For this reason, on June 26, 1986, the White House issued a policy document entitled “Coordinated Framework for the Regulation of Biotechnology,” directed primarily at preventing Congress from getting involved in this delicate issue by introducing specific legislation for the regulation of GMOs. Addressed to the three relevant regulatory agencies (FDA, EPA, and USDA), the directive provided that products derived from biotechnology would be regulated within the framework of already existing federal laws, insofar as “recently developed methods are an extension of traditional manipulations” of plants and animals.20 In other words, GMOs did not require special treatment and would be subject to the same system of approval as non-transgenic products.
But the document did not satisfy Monsanto, which clearly had another idea in mind. “‘There were no [GMO] products at the time,’ Leonard Guarraia, a former Monsanto executive who attended the Bush meeting, recalled. . . . ‘But we bugged Bush for regulation. We told him that we have to be regulated.’ ”21 So what was behind what the New York Times called an “unusual pitch”?
“In fact,” Michael Hansen of the Consumers Union told me in July 2006, “Monsanto wanted an appearance of regulation. The company knew that after the PCB and Agent Orange scandals, when it had lied or concealed data, it would not be believed if all it did was to say that GMO products posed no danger to health or the environment. It wanted federal agencies, primarily the FDA, to be the ones to say that the products were safe. So, whenever a problem arose, it would be able to say: ‘The FDA has established that GMOs do not pose any risks.’ This was also a way of covering itself in case things turned out badly.”
According to the New York Times reporter, the Washington meeting bore fruit: “In the weeks and months that followed, the White House complied, working behind the scenes to help Monsanto . . . get the regulations that it wanted. It was an outcome that would be repeated, again and again, through three administrations. What Monsanto wished for from Washington, Monsanto—and, by extension, the biotechnology industry—got.”22
To understand just how unusual Monsanto’s approach was, one has to consider that at the time some high FDA officials were absolutely opposed to the idea of regulating GMOs, even in the form of a document that would be an “appearance of regulation.” This was so, for instance, for Henry Miller, the agency spokesman for biotechnology, who had no compunctions about calling GMO opponents “troglodytes” or “intellectual Nazis” and whom the White House would have to fight hard.23
But that wasn’t all. The New York Times was able to get its hands on a draft of a secret document, dated October 13, 1986, in which the company’s directors established a veritable battle plan to impose GMOs in the United States. Among the primary objectives were “‘creating support for biotechnology at the highest U.S. policy levels,’ and working to gain endorsements for the technology in the presidential platforms of both the Republican and Democratic Parties in the 1988 election.”24
In fact, I found evidence on film of the company’s boundless self-confidence: it was capable of expressing thinly veiled threats to George Bush when it felt the administration was resisting it. I was able to see extraordinary archive footage filmed on May 15, 1987, by the Associated Press. It shows Ronald Reagan’s vice president, who was then running for president, walking through Monsanto’s St. Louis laboratories wearing a white coat. Followed by a pack of reporters, the future president first participates in a class on genetic manipulation.
“What I’d like to do today is show you some of the steps we go through when we’re moving genes from one organism to another,” explains Stephen Rogers, one of Uphoria’s three rising stars, with a test tube in his hand. “We take DNA, cut it apart, mix different pieces together, and then rejoin them. . . . This tube contains DNA that was made from a bacterium. DNA would look the same whether it was from a plant or an animal.”
“Oh, I see,” says George Bush, his eyes fixed on the test tube. “This will lead you to do what? To have a stronger plant? Or a plant that resists . . .”
“In this case it resists the herbicide,” Rogers answers.
“We have a fabulous herbicide,” says a voice off-camera.
Then Bush walks through the greenhouses on the Chesterfield Village roof, where a Monsanto executive in suit and tie shows him transgenic tomato plants that turn out to be the real purpose of this self-serving guided tour. Next comes an absolutely astounding conversation: “And we have before USDA right now a request to test this for the first time on a farm in Illinois this year,” the executive says.
“We keep hallucinating about it . . . the expense goes up and nothing happens,” says Rogers.
“And I would say quite frankly we have no complaint about the way USDA is handling it,” the executive goes on. “They’re going through an orderly process; they’re making sure as they deal with these new things [that] they do them properly, and uh, no, if we’re waitin’ until September and we don’t have our authorization we may say somethin’ different!”
“Call me, I’m in the dereg business,” says Bush with a great burst of laughter. “I can help.”
On June 2, 1987, exactly two weeks after the amazing guided tour, the Monsanto researchers conducted their first field test of transgenic crops in Jerseyville, Illinois. There is a photograph showing Stephen Rogers, Robert Fraley, and Rob Horsch posing in front of a tractor wearing farmer’s caps. Facing them are crates containing tomato shoots manipulated through the magical power of the bacterium Agrobacterium tumefaciens.Political Regulation Made to Order
George H.W. Bush assumed the presidency in January 1989. In March, he appointed his vice president, Dan Quayle, to head the Council on Competitiveness, “with responsibility for reducing the regulatory burden on the economy.”25 On May 26, 1992, Vice President Quayle presented American policy on GMOs in front of an audience of business executives, government officials, and reporters. “We are taking this step as part of the President’s regulatory relief initiative, now in its second phase,” he declared at the outset. “The United States is already the world leader in biotechnology and we want to keep it that way. In 1991 alone, it was a $4 billion industry. It should reach at least $50 billion by the year 2000, as long as we resist the spread of unnecessary regulation.”
Three days later, on May 29, Monsanto was victorious: the FDA published in the Federal Register its regulatory policy on “foods derived from new plant varieties.”26 It should be noted that the title of this twenty-page document, considered a bible around the world, carefully avoided any reference to biotechnology, presented in the introduction as merely an extension of genealogical selection, following recommendations issued by the White House six years earlier: “Foods . . . derived from plant varieties developed by the new methods of genetic modifications are regulated within the existing framework . . . utilizing an approach identical to that applied to foods developed by traditional plant breeding.”
Anyone wanting further information was asked to contact a man named James Maryanski. I went through a long struggle to locate the man who held the key position of Biotechnology Coordinator for Food Safety and Applied Nutrition at the FDA from 1985 to 2006. In 2006, this microbiologist who had joined the agency in 1977 was enjoying an active retirement, working as an “independent consultant” on the “safety of GM foods” for various governments, as the CV he gave me states. An interesting sidelight: as I was about to give up locating him, I asked to interview an FDA representative about the 1992 regulation, explaining that I was producing a documentary on Monsanto, particularly on the approval of Roundup Ready soybeans. On July 7, 2006, I received an e-mail from Mike Herndon, one of the agency’s press officers: “I must respectfully decline your request for an on-camera interview. FDA must appear neutral in its relationship with food manufacturers. Being interviewed in a documentary about a company whose products FDA regulates is inappropriate.”
The statement is ironic in light of the fact that the 1992 policy statement was developed in close cooperation with Monsanto, which in fact wanted the agency to present an “appearance of regulation,” in the words of Michael Hansen. And this task was confided to none other than Maryanski under the supervision of Michael Taylor, who was then deputy commissioner of the FDA. (I have already described Taylor’s role in the bovine growth hormone affair; I will come back to his subsequent career as a Monsanto vice president.)
I was finally able to meet the former FDA official one day in July 2006 in New York, on his return from a consultation in Japan. I was surprised to encounter a short, shy man with light-colored eyes and a calm, quiet voice. Later, viewing this filmed three-hour conversation, I was able to recognize his controlled panic, perceptible only in the nervous blinking that seized him on several occasions.
To start with, I questioned him on the instructions transmitted by the White House regarding the drafting of the regulation of transgenic foods. “Basically, the government had taken a decision that it would not create new laws,” he explained cautiously. “For the FDA, it felt that the Food, Drug, and Cosmetic Act, which ensures the safety of all foods except meat, poultry and egg products, which are regulated by the United States Department of Agriculture (USDA), had enough authority for the agency to deal with new technologies. And actually what occurred at FDA was that the commissioner, Dr. David Kessler . . . established a group of scientists under my authority and lawyers, who were given the charge to see whether in fact we could regulate foods developed by biotechnology under the existing Food, Drug, and Cosmetic Act.”
“But this decision that GMOs should not be submitted to a specific regulatory regime wasn’t based on scientific data, it was a political decision?” I asked. The question made him a little tense.
“Yes, it was a political decision. It was a very broad decision that didn’t apply to just foods. It applied to all products of biotechnology,” he said hesitatingly.The Amazing Trick of the Principle of Substantial Equivalence
I then proceeded to read a paragraph of the regulation that lies at the heart of the dispute around GMOs: “In most cases, the substances expected to become components of food as a result of genetic modification will be the same as or substantially similar to substances commonly found in food such as proteins, fats and oils, and carbohydrates.”27
These few apparently anodyne lines pointed to a concept that has been adopted around the world as the theoretical basis for the regulation of GMOs: the “principle of substantial equivalence.” Before I dissect why it represents the nub of what I called earlier one of the greatest conspiracies in the history of the food industry, let me give the floor again to James Maryanski, who continued to defend it stubbornly: “What we do know, is that the genes that are being introduced currently, to date, using biotechnology, produce proteins that are very similar to proteins that we’ve consumed for many centuries. . . . Using Roundup Ready soybeans as an example, this is a plant which has a modified enzyme that is essentially the same enzyme that’s already in the plant: it has a very small mutation, so, in terms of safety, there’s no big difference between that introduced enzyme and the one that already occurs in the plant” (emphasis added).
In other words, GMOs are roughly identical to their natural counterparts. And it is precisely this “roughly”—rather surprising coming from a microbiologist—that makes the concept of substantial equivalence suspect in the eyes of those who denounce its emptiness, such as Jeremy Rifkin of the Foundation on Economic Trends, one of the earliest opponents of biotechnology. “Here, in Washington, if you were to have an evening and go out and get a drink at one of the local haunts where all the lobbyists hang out, everybody would laugh about this. They all know this was a joke, this ‘substantial equivalency.’ This was simply a way to paper over the need for these companies, especially Monsanto, to move their products into the environment quickly, with the least amount of government interference. And I should say they were very, very good at getting their interests expressed,” he said to me in July 2006.
Michael Hansen, the Consumers Union expert, drove the point home when I spoke to him around the same time. “The principle of substantial equivalence is an alibi with no scientific basis created out of thin air to prevent GMOs from being considered at least as food additives, and this enabled biotechnology companies to avoid the toxicological tests provided for in the Food, Drug, and Cosmetic Act and to avoid labeling their products. That’s why we say that American regulations of transgenic foods violate federal law.” To support his argument, Hansen showed me a document relating to an amendment to the Food, Drug, and Cosmetic Act, passed in 1958, entitled the Food Additive Act. As the name indicates, this amendment was aimed at regulating food additives such as coloring agents, preservatives, or “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food).”
Following this definition, many are the substances that might be considered food additives, the safety of which would then have to be rigorously assessed through an obligatory procedure, including toxicological tests that might last, depending on circumstances, from twenty-eight days to two years. Answering to the “precautionary principle,” as Congress required, the tests would have to demonstrate that there is a “a reasonable certainty that the substance in the minds of competent scientists is not harmful under its intended conditions of use.” Excluded from the category of “food additives,” and therefore not subject to toxicological tests, were substances “generally recognized as safe” (GRAS), either because they were “used in food before January 12, 1958,” or because “scientific procedures” have shown that they pose no health risk.
I asked Maryanski, “Could you give me an example of substances classified as GRAS?”
“Yeah, those are common food processing enzymes, or salt, pepper, vinegar, things that have been used for many years and that the scientific community has established as safe.”
“And how was the FDA able to decide that the gene introduced into a plant by genetic manipulation was GRAS?” I asked, looking him in the eye.
We had reached the heart of the debate between advocates and adversaries of GMOs. Indeed, even though no scientific study had yet been conducted to verify it, the FDA had decided a priori that transgenes did not fit into the category of food additives and that GMOs therefore could be marketed without prior toxicological testing. This is all the more curious because when the agency published its regulation, it had been considering a request that showed how essential it was to wait. The California biotech company Calgene (the one that had given Monsanto a chill by announcing in Nature that it had succeeded in producing Roundup-resistant tobacco) had filed a request for the approval of a tomato christened “Flavr Savr,” manipulated to slow the ripening process.
There is no need to insist on the significance of a tomato tinkered with so that it can remain firm on supermarket shelves for an extended period. But it is important to know that it contained the kanamycin resistance gene and that its inventors had rightly concluded that the gene should be considered a “food additive.” They had therefore asked a laboratory (the International Research and Development Corporation of Michigan) to conduct toxicology tests designed to measure the health effects of transgenic tomatoes on rats. But the FDA did not yet know the results of the study when it published its regulation. It was later found that seven of the forty test animals had died after two weeks for unexplained reasons and that a significant number of them had developed stomach lesions. Even so, adhering to its dogma, the agency had given Calgene the green light on May 18, 1994.
Before coming back to James Maryanski, let us look at the end of this appalling story. The cultivation of the transgenic tomato, which seemed so promising in the laboratory, turned out to be a catastrophe: yields in California were so low that the inventors decided to move production to Florida, where the crop was decimated by diseases. “There are so many things that can kill a plant, and it’s all in the details,” said a former plant breeder for Calgene.28
Flavr Savr was then shifted to Mexico, where the results were far from acceptable. As a 2001 FAO study soberly commented: “Since 1996, Flavr Savr tomatoes have been taken off the fresh produce market in the United States. The manipulation of the ripening gene appeared to have had unintended consequences such as soft skin, strange taste and compositional changes in the tomato. The product was also more expensive than non-modified tomatoes. ”29
In the interim, Calgene had fallen into the pocket of Monsanto, which had definitively buried the doomed tomato.The L-Tryptophan Affair: A Strange Fatal Epidemic
Had Maryanski understood what I was getting at? In any event, he blinked nervously when I asked him on what scientific data the FDA had based its decision to declare transgenes to be GRAS. “What FDA was saying was: if you introduce a gene into a plant, that gene is DNA . . . and we have a long history of consuming DNA and we can establish that that is GRAS,” he said, seeming to search for his words.
“If we come back to the example of Monsanto’s soybeans, that means that the agency considers that a gene from a bacterium imparting resistance to a powerful herbicide is by definition less dangerous than a coloring agent?” I insisted.
“Correct,” answered the former biotechnology coordinator, blinking even more rapidly.
The FDA’s position, supported by Maryanski, infuriated Hansen, who pinpointed the question that Monsanto and its allies had always wanted to evade: “Currently, when you want to add a microscopic amount of a preservative or a chemical agent to a food product, it is considered a food additive and you therefore have to do all kinds of tests to prove that there is a reasonable certainty that it is safe. But when you manipulate a plant genetically, which can create countless differences in the food, you’re not asked to do anything. In fact, the whole misunderstanding or confusion comes from the fact that the FDA has always refused to assess the technique of genetic manipulation and not just the final product; it made the assumption that biotechnology was intrinsically neutral, even though it had received a warning sign that should have made it much more cautious.”
Hansen then told me the dramatic story of L-tryptophan, which has been thoroughly documented by Jeffrey Smith of the Institute for Responsible Technology, based in Fairfield, Iowa, a rigorous critic of GMOs.30 L-tryptophan is an amino acid found naturally in turkey, milk, brewers’ yeast, and peanut butter, among other things. A precursor to serotonin, it was prescribed in the form of a dietary supplement as a remedy for insomnia, stress, and depression. In the late 1980s, thousands of Americans suffered from a mysterious illness that was called eosinophilia-myalgia syndrome (EMS), because muscular pain (myalgia) was a symptom experienced by all victims. They also suffered from a litany of recurrent ailments: edema, coughs, skin lesions, respiratory difficulties, puckering of the skin, mouth ulcers, nausea, visual and memory problems, hair loss, and paralysis.
The strange epidemic was first reported on November 7, 1989, by Tamar Stieber, a reporter for the Albuquerque Journal, who had learned that all the victims had taken L-tryptophan (her reporting won her a Pulitzer Prize in 1990). Four days later, 154 cases were reported to medical authorities, and the FDA requested that the public avoid taking the dietary supplement. But the number of victims grew: a preliminary survey in 1991 counted thirty-seven dead and fifteen hundred permanently disabled.31 According to later estimates by the Centers for Disease Control, EMS was fatal to one hundred patients and caused illness or paralysis in five thousand to ten thousand people.
As Jeffrey Smith reported, L-tryptophan in the United States was imported from Japan, where six producers shared the market. Investigation by the health services revealed that only the product made by Showa Denko was associated with the epidemic. Investigators then discovered that in 1984 the company had modified its production process by using biotechnology to increase yields: a gene had been introduced into the bacteria from which the substance was extracted after fermentation. The manufacturer gradually changed the genetic construct so that the final strain (Strain V), produced in December 1988, turned out to contain five different transgenes and a large number of impurities.32
Then began a strange battle about the origin of the disease, which everything indicated was directed primarily at discrediting the hypothesis that the disease could have been triggered by genetic manipulation. Some researchers argued that the problem could have come from a change in the filter used by Showa Denko to purify the product, but it was later shown that this change had not taken place until January 1989, after the outbreak of the epidemic. Others suggested that L-tryptophan itself was the problem, but as the expert Gerald Gleich pointed out, “Tryptophan itself clearly is not the cause of EMS in that individuals who consumed products from other companies than Showa Denko did not develop EMS.”33 Only Showa Denko was sued, and after settlements negotiated in 1992, it paid more than $2 billion in damages to more than two thousand victims.
Nonetheless, the FDA had decided in 1991 to permanently prohibit the sale of L-tryptophan, even if it was produced conventionally, and in subsequent official reports it does not even mention the fact that the strains involved were transgenic.34 But one man at the FDA had very seriously considered the hypothesis that EMS might have been caused by the technique of genetic manipulation: James Maryanski.
In September 1991, six months before the FDA published its regulation on GMOs, according to a declassified document of which I have kept a copy, Maryanski met GAO representatives “at their request.” They wanted “to discuss issues related to food biotechnology for the studies they are conducting on new technologies,” he wrote. “They asked about L-Tryptophan and the potential that genetic engineering was involved. I said that we . . . do not yet know the cause of EMS, nor can we rule out the engineering of the organism.”35
When I met the former FDA official in July 2006, he did not know that I was aware of this document. “The FDA had considered the use of genetic manipulation, but it had no information indicating that the technique itself could create products that would be different in terms of quality or safety,” he said with assurance.
“Do you remember what happened with L-tryptophan in 1989?”
“Yes,” he mumbled.
“It was a genetically manipulated amino acid. In theory, we know amino acids very well.”
“It caused an epidemic of an unknown illness, EMS.”
“That’s true,” he said. His eyes started blinking nervously.
“How many people died?”
“Well, but we have many—”
“At least thirty-seven. And more than one thousand disabled,” I said. [xi] “Do you remember?”
“According to a declassified FDA document, you said: ‘We do not know the cause of EMS and we cannot rule out the manipulation of the organism.’ You did say what I just read?”
But six months after his statement to the GAO representatives, Maryanski did not balk at signing the FDA document approving GMOs, which stated loud and clear: “The agency is 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.”36
Beyond what it reveals about the FDA’s blind spots, the L-tryptophan affair is exemplary in more ways than one. As Jeffrey Smith points out in Genetic Roulette, “The epidemic took years to identify. It was discovered only because the disease was rare, acute, came on quickly, and had a unique source. If one of these four attributes were not present, the epidemic might have remained undiscovered. Similarly, if common GM food ingredients are creating adverse reactions, the problems and their source may go undetected.”37
Contrary to James Maryanski’s assertions, FDA scientists were perfectly aware of the unknowns and the risks associated with biotechnology and GMOs, but the agency chose to ignore their warnings.
i. These surveys were conducted by the Department of Agriculture, Cornell University, the University of Wisconsin, Dairy Today, etc.
ii. On the site www.idfa.org
, one finds the following: “Monsanto is a supplier of agricultural products that increase farm productivity and food quality. The company manufactures and markets Posilac, a technology that has demonstrated its profitability by enabling dairy farmers to produce 8 to 12 more gallons per cow per day.”
iii. On June 5, 2006, Dairy and Food Market Analyst reported that chains such as Dean Foods, Wal- Mart, and Kroger, although not very inclined to support organic farming, were promising to sell only milk that was rBST free.
iv. It was precisely to denounce the collusion between the American Cancer Society and the pharmaceutical multinationals that Epstein established the Coalition against Cancer.
v. In 1992, the program Prime Time on ABC News had broadcast a report showing employees of the Food Lion chain, filmed on hidden camera, mixing ground beef past its expiration date with fresh meat. Following the broadcast, the price of Food Lion shares had collapsed, and almost one hundred stores had been forced to close. The company sued ABC News and at trial won $5.5 million in damages. The verdict had caused serious worries in the country’s newsrooms (the damages were reduced on appeal to $2).
vi. According to the terms of this law, a whistle-blower is an employee who is the victim of retaliatory measures for having refused to participate in an illegal activity carried out by his company or for having threatened to denounce that activity to the authorities.
vii. Steve had decided to handle his case on his own, which he did with the spirit of an experienced lawyer, but the jury thought that the principal victim was Jane.
viii. Since then, Jane Akre and Steve Wilson have won many prestigious awards: the First Amendment Award of the Society of Professional Journalists; the Joe Callaway Award for Civic Courage; a Special Award for Heroism in Journalism from the Alliance for Democracy; and the Goldman Environmental Prize for North America.
ix. On March 10, 1999, the Scientific Committee on Animal Health and Animal Welfare of the European Commission issued a ninety-one-page report recommending that “rBST not be used in dairy herds.” At no point was there any mention of risks that the hormone might pose for human health. The hormone has been officially banned in the European Union since January 1, 2000.
x. Agrobacterium tumefaciens causes crown gall disease, which attacks the roots of some plants by inducing the growth of a tumor. It was discovered by two American researchers in 1907.
xi. I did not know at the time that the preliminary estimate of the number of victims was much lower than the reality.