The mandate of the FDA is to assure the safety of drugs, medical devices, and foods, and the agency's policy for food biotechnology focuses on consequences that might present direct risks to human human health. In approving transgenic foods, the FDA does not consider whether they might pose health. In approving transgenic foods, the FDA does not consider whether they might pose ecological ecological risks. They might, for example, displace existing plants and animals, create new plant pathogens, disrupt ecosystems, transfer genes to weeds or wild relatives, reduce crop diversity, or "contaminate" native plants or organically grown foods. Widespread planting of risks. They might, for example, displace existing plants and animals, create new plant pathogens, disrupt ecosystems, transfer genes to weeds or wild relatives, reduce crop diversity, or "contaminate" native plants or organically grown foods. Widespread planting of Bt Bt crops, for example, might encourage the proliferation of insects resistant to the crops, for example, might encourage the proliferation of insects resistant to the Bt Bt toxin. Similarly, widespread use of herbicide-resistant crops might transfer that resistance to undesirable weeds or encourage further reliance on chemicals-such as Monsanto's Roundup-as pest-management strategies. toxin. Similarly, widespread use of herbicide-resistant crops might transfer that resistance to undesirable weeds or encourage further reliance on chemicals-such as Monsanto's Roundup-as pest-management strategies.26 Despite such concerns, plantings of transgenic crops increased from negligible acreage in 1995 to hundreds of millions of acres within just a few years. Agricultural producers quickly adopted transgenic soybeans, corn, and cotton, largely because they simplify the control of weeds and insect pests by requiring fewer applications of the more toxic chemicals. Farmers, apparently, perceive significant benefits from growing transgenic crops, but how are we, as citizens and consumers, to reconcile the risks and benefits? Let's begin by looking at the risks. Despite such concerns, plantings of transgenic crops increased from negligible acreage in 1995 to hundreds of millions of acres within just a few years. Agricultural producers quickly adopted transgenic soybeans, corn, and cotton, largely because they simplify the control of weeds and insect pests by requiring fewer applications of the more toxic chemicals. Farmers, apparently, perceive significant benefits from growing transgenic crops, but how are we, as citizens and consumers, to reconcile the risks and benefits? Let's begin by looking at the risks.
Environmental Risks When researchers began to examine questions of environmental risk, their early results provided plenty of justification-albeit highly preliminary-for concern. In 1996, for example, farmers planted 2 million acres with Monsanto's Bt Bt cotton, but lost thousands of acres when the toxin failed to protect against a bollworm infestation. This event raised the uncomfortable possibility that such huge plantings might promote cotton, but lost thousands of acres when the toxin failed to protect against a bollworm infestation. This event raised the uncomfortable possibility that such huge plantings might promote Bt Bt resistance. resistance.27 According to investigative accounts, EPA officials asked Monsanto to evaluate whether the surviving bollworms were indeed According to investigative accounts, EPA officials asked Monsanto to evaluate whether the surviving bollworms were indeed Bt Bt-resistant, but the agency could not force the company to cooperate: "Further evaluation of the crop is entirely dependent on Monsanto's own reporting."28 Also in 1996, researchers reported that transgenic oilseed (canola) plants readily transmitted herbicide resistance to related weeds. Because weeds reproduce rapidly and compete for nutrients with crop plants, this finding raised fears that cross-pollination might create herbicide-resistant "superweeds" that could overrun cropland and cause an ecological catastrophe. EPA officials revealed the consequences of the regulatory gap, however, when they explained that monitoring of herbicide resistance is not a federal responsibility: "It is the developer of the product that has the interest in assuring that resistance does not build up." Also in 1996, researchers reported that transgenic oilseed (canola) plants readily transmitted herbicide resistance to related weeds. Because weeds reproduce rapidly and compete for nutrients with crop plants, this finding raised fears that cross-pollination might create herbicide-resistant "superweeds" that could overrun cropland and cause an ecological catastrophe. EPA officials revealed the consequences of the regulatory gap, however, when they explained that monitoring of herbicide resistance is not a federal responsibility: "It is the developer of the product that has the interest in assuring that resistance does not build up."29 These early reports on environmental risks were based on single studies and needed further confirmation, but others soon followed. For example, preliminary studies showed that bees and other beneficial insects die when exposed to the Bt Bt toxin, but certain harmful moths and tobacco budworms resist it. The toxin, but certain harmful moths and tobacco budworms resist it. The Bt Bt toxin remains stable in soil for many months, meaning that it exerts continuous pressure to encourage the growth of resistant insects. Herbicide-resistant plants transfer resistance to related weeds, sometimes over great distances through pollen drift. toxin remains stable in soil for many months, meaning that it exerts continuous pressure to encourage the growth of resistant insects. Herbicide-resistant plants transfer resistance to related weeds, sometimes over great distances through pollen drift.30 Many such problems can be unintended consequences of large-scale plantings of transgenic crops, and they greatly trouble environmentalists. As I will soon explain, effects on monarch butterflies are the most political of such consequences, but let's look first at the environmental Many such problems can be unintended consequences of large-scale plantings of transgenic crops, and they greatly trouble environmentalists. As I will soon explain, effects on monarch butterflies are the most political of such consequences, but let's look first at the environmental benefits benefits claimed for transgenic crops. claimed for transgenic crops.
Environmental Benefits As evidence for the benefits produced by genetically engineered crops, the industry notes how quickly growers have adopted them. In theory, the crops should help growers. At the time farmers first began to plant transgenic crops, they were using more than 80 million pounds of conventional pesticides (a term that includes both insecticides and herbicides). Reducing the use of these chemicals should produce economic as well as health benefits, and a major argument for the value of transgenic crops is that they eliminate the need for hazardous pesticides-except Roundup, of course-by millions of pounds annually. This idea is central to the biotechnology industry's public relations efforts. The advertisement shown in figure 17 figure 17, for example, promotes the ecological advantages of transgenic crops. This advertisement, which much resembles those for the cigarette-selling Marlboro Man, is clearly meant to suggest that genetically engineered crops will save family farms.
As with all issues related to food biotechnology, its benefit to farmers is subject to debate. Also like the other issues, this one is complicated and lacks a firm research base on which to resolve outstanding questions. By 2001, most observers agreed that transgenic cotton required less use of pesticides than conventional cotton, but only in certain areas. In Arizona, for example, the use of transgenic cotton led to a breathtaking decline in the need for pesticides against budworms and bollworms: from 400,000 pounds in 1995 to just 2,000 pounds in 2000. In other states growing such cotton, however, the overall use of pesticides increased increased.31 When it comes to corn and soybeans, however, the evidence is wide open to interpretation. Here are just a few observations: U.S. farmers who planted When it comes to corn and soybeans, however, the evidence is wide open to interpretation. Here are just a few observations: U.S. farmers who planted Bt Bt corn in 1997 did much better economically than farmers who planted conventional corn, but in 1998 they did worse, largely because so much corn was produced that prices fell and the costs of seeds and pesticides increased. Transgenic crops-cotton as well as corn and soybeans-contributed to an overall decline in pesticide use of 2.5 million pounds from 1997, or just 1% of total pesticide use. Infestations with the European corn borer were relatively low that year, suggesting that fewer pesticides would have been applied anyway. corn in 1997 did much better economically than farmers who planted conventional corn, but in 1998 they did worse, largely because so much corn was produced that prices fell and the costs of seeds and pesticides increased. Transgenic crops-cotton as well as corn and soybeans-contributed to an overall decline in pesticide use of 2.5 million pounds from 1997, or just 1% of total pesticide use. Infestations with the European corn borer were relatively low that year, suggesting that fewer pesticides would have been applied anyway.32 In contrast, an analysis of data from 1999 found that Roundup Ready soybeans alone saved $216 million in the costs of controlling weeds and required 19 million fewer applications of herbicides. The contradictions in these results are due to the large number of variables that have to be considered in such analyses, many of them constantly changing, and some easier to measure than others. In contrast, an analysis of data from 1999 found that Roundup Ready soybeans alone saved $216 million in the costs of controlling weeds and required 19 million fewer applications of herbicides. The contradictions in these results are due to the large number of variables that have to be considered in such analyses, many of them constantly changing, and some easier to measure than others.33 What seems most evident from attempts to evaluate benefits is that it is still too early to do so. We do not yet know the overall effects of transgenic crops on cost, productivity, and use of pesticides. What seems most evident from attempts to evaluate benefits is that it is still too early to do so. We do not yet know the overall effects of transgenic crops on cost, productivity, and use of pesticides.
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FIGURE 17. In 2001, the biotechnology industry's public relations campaign featured the equivalent of the Marlboro Man. Rather than cigarettes, however, this advertisement promotes the industry's view of the ecological advantages of transgenic crops (reduced pesticide use, soil conservation), and consequent benefits to society (farm preservation). In 2002, a series of elegant photographs promoted the benefits of genetically modified corn, soybeans, cotton, and papaya.
Indeed, one of the chief complaints of environmentalists is that transgenic crops will increase increase the use of agricultural chemicals, especially of Monsanto's Roundup. Farmers planted Roundup Ready soybeans on just 1 million acres in 1996 but on 48 million acres in 2001; they applied Roundup to 20% of farm acres in 1995 but to 62% in 1999. the use of agricultural chemicals, especially of Monsanto's Roundup. Farmers planted Roundup Ready soybeans on just 1 million acres in 1996 but on 48 million acres in 2001; they applied Roundup to 20% of farm acres in 1995 but to 62% in 1999.34 Roundup generates billions of dollars in annual sales, and Monsanto benefits twice; it sells the herbicide Roundup generates billions of dollars in annual sales, and Monsanto benefits twice; it sells the herbicide and and the seeds for the crops that resist it. The company's studies show that Roundup Ready soybeans survive when doused with the chemical, and are as nutritious when fed to rats as conventional soybeans. the seeds for the crops that resist it. The company's studies show that Roundup Ready soybeans survive when doused with the chemical, and are as nutritious when fed to rats as conventional soybeans.35 Whether the use of Roundup is environmentally beneficial is, of course, a debatable issue. Monsanto points out that it registered Roundup as an herbicide in 1974 with minimal subsequent evidence of hazard: "Consumers benefit from Roundup Ready soybeans because farmers can control weeds better . . . with less herbicide while using a herbicide with the best environmental profile." To bolster that argument, the company cites two lines of research: Roundup binds so tightly to soil particles that the chemical does not harm nearby vegetation (and, therefore, is unlikely to move to groundwater), and it decomposes naturally to benign substances. Whether the use of Roundup is environmentally beneficial is, of course, a debatable issue. Monsanto points out that it registered Roundup as an herbicide in 1974 with minimal subsequent evidence of hazard: "Consumers benefit from Roundup Ready soybeans because farmers can control weeds better . . . with less herbicide while using a herbicide with the best environmental profile." To bolster that argument, the company cites two lines of research: Roundup binds so tightly to soil particles that the chemical does not harm nearby vegetation (and, therefore, is unlikely to move to groundwater), and it decomposes naturally to benign substances.36 Critics, however, raise alarms about the heavy use of this product: Roundup may induce weeds to develop resistance; it may poison fish, earthworms, or other beneficial creatures; and it may disrupt soil ecology. From a biochemical standpoint, resistance to Roundup is not difficult to achieve. Its active chemical, glyphosate, inhibits the action of an enzyme that helps make three amino acids needed to construct plant proteins. Plants cannot make proteins when this enzyme is blocked. Bacteria, however, are well known to produce a mutant variant of this enzyme that is completely unaffected by glyphosate; they do so through "point" mutations (mutations that alter just one amino acid) or mutations that cause the enzyme to be produced in such large amounts that glyphosate becomes ineffective. Such mutations could occur in plants as well as in bacteria. The transfer of Roundup resistance to weeds through pollination also is probable, and has already occurred. The idea of widespread resistance to Roundup is not improbable, and it alarms the industry as well as environmentalists.37 The most highly critical statements about the use, toxicity, and persistence in soil of Roundup can be traced to an exhaustive scientific review published in 1995. The review identifies toxic effects from the chemical itself as well as from ingredients used in its formulation. It describes studies on experimental animals in which Roundup caused eye and skin irritation, cardiac depression, gastrointestinal distress, reduced weight gain, increased frequency of tumors, and reduced sperm counts. In people, Roundup appears as the most common cause of pesticide-related illness among landscape workers and the third most common cause of such illness among agricultural workers. Roundup residues persist in vegetables a year after treatment and in soil for more than a year. Researchers report that Roundup produces toxic effects on beneficial insects, fish, birds, and earthworms; eliminates vegetation used as food and shelter for animals and birds; and reduces the activity of bacteria that fix nitrogen and perform other "friendly" tasks.38 Whether these effects are worse than those produced by the pesticides replaced by Roundup is a question that demands further research. In the absence of convincing studies, such decisions are a matter of opinion. Whether these effects are worse than those produced by the pesticides replaced by Roundup is a question that demands further research. In the absence of convincing studies, such decisions are a matter of opinion.
Underlying questions about the potential risks of transgenic plantings are more general concerns about what Roundup Ready and Bt Bt crops might do to biodiversity. The huge amount of U.S. farmland devoted to transgenic crops borders on crops might do to biodiversity. The huge amount of U.S. farmland devoted to transgenic crops borders on monoculture monoculture-the planting of one variety of a crop to the exclusion of all others. The lack of biological diversity means that any point of vulnerability leaves monocultured crops open to overwhelming attack by insects, weeds, or diseases-and to catastrophic losses. Such vulnerability is illustrated by the splitting of stems of Roundup Ready soybeans when grown in hot climates. When this happened, observers guessed that crop losses could reach 40%. They wondered if the biochemical changes that induce resistance to glyphosate might also cause plants to produce a form of cellulose (lignin) that becomes brittle in hot temperatures typical of southern states and tropical countries.39 From such examples, it should be evident that questions about the relative risks and relative benefits of genetically modified foods cannot be answered without further research and experience. As I explain in chapter 7 chapter 7, the industry and its sympathetic government regulators decided in advance-using a strictly science-based approach to risk assessment-that the foods were safe and that few precautions were necessary, and they assumed that any unanticipated consequences of transgenic foods could be handled appropriately by existing regulations. As it turned out, unexpected consequences revealed the inadequacies of this approach. Some examples follow.
THE POLITICS OF UNEXPECTED CONSEQUENCES.
Critics of food biotechnology insist that without prior experience, transgenic foods raise safety issues that are difficult to define, predict, or quantify but that nevertheless should be taken seriously and evaluated in advance-before the foods are grown extensively and enter the food supply. They invoke the precautionary principle (discussed in the introduction). As support for the need for precaution, they cite the examples to which we now turn. These examples explain why safety issues-especially those that cannot easily be resolved by scientific studies-become matters of politics. A precautionary approach threatens the economics of the entire agricultural biotechnology enterprise. the foods are grown extensively and enter the food supply. They invoke the precautionary principle (discussed in the introduction). As support for the need for precaution, they cite the examples to which we now turn. These examples explain why safety issues-especially those that cannot easily be resolved by scientific studies-become matters of politics. A precautionary approach threatens the economics of the entire agricultural biotechnology enterprise.
Toxic Contaminants: Tryptophan Supplements The classic case of the unanticipated consequences of nutritional-if not food-biotechnology concerns supplements of the amino acid tryptophan. Like all amino acids, tryptophan is a component of proteins in all organisms. Supplements of tryptophan have been used for years as self-medication for insomnia and neurological conditions. In the 1980s, companies began to genetically engineer bacteria to produce larger amounts of tryptophan so that this amino acid would be easier to collect and purify. In 1989, tryptophan supplements produced by a Japanese petrochemical company, Showa Denko, caused eosinophilia-myalgia syndrome (EMS), an unusual constellation of symptoms of muscle pain, weakness, and increased blood levels of white cells (eosinophils). Eventually, more than 1,500 people who had taken the supplements became ill, and about 40 died. The FDA prevented further marketing of the supplement, and the company stopped making it.40 This example might just indicate that genetic techniques sometimes lead to unexpected problems, but this particular situation had additional implications. Because tryptophan is a normal component of body proteins, investigators did not think that the genetic engineering processes were at fault. Instead, they suspected that a toxic substance emerged during the manufacturing process, and they attempted to identify it. Victims, however, sued Showa Denko for about $2 billion, thereby introducing liability as an intervening factor. The company not only refused to cooperate with FDA investigations but also tried to discredit the scientists who had linked the syndrome to its product. Showa Denko demanded prepublication copies of the studies under the Freedom of Information Act (most scientists would find this intimidating as well as a nuisance) and used a carefully selected advisory committee to argue that the studies were done poorly and could not be reproduced.
Furthermore, the company sponsored its own research studies, organized a conference to announce the results, and paid for publication of the conference papers as a supplement to the Journal of Rheumatology Journal of Rheumatology. Not unexpectedly, the sponsored researchers raised questions and produced data that appeared to exonerate Showa Denko. In contrast, the one independent paper ("prepared by US Government employees and entirely funded by the US Government") concluded that the Showa Denko tryptophan supplement caused the EMS epidemic. The government scientists charged that the studies sponsored by Showa Denko were based on supposition, surmise, and conjecture. [They] direct attention toward potential biases or confounding events with a low probability of having occurred and a still lower probability of having had a substantial effect on the studies reviewed. In so doing, they direct the reader's attention away from the combined weight of evidence of the studies, which strongly supports a causal association of Showa Denko LT [tryptophan] and epidemic EMS.41 To date, the toxic component remains "incompletely characterized," making it difficult to institute preventive measures. In this case, the company's self-interested stance not only interfered with finding the cause of the disease but also failed to resolve lingering uncertainties about the safety of the genetic engineering processes used in manufacturing the supplements.
Toxic Proteins: The Pusztai Affair Next we turn to the possibility that genetic engineering might cause foods foods to produce toxic substances, in this case, lectins. Lectins are proteins in plants that are naturally toxic to insects and nematode worms. They do not bother us because we cook lectin-rich foods-kidney beans, for example-long enough to unravel the structure of the proteins and destroy their function. In 1998, an investigator in Scotland announced that rats became ill when they ate transgenic lectins, thereby initiating a political furor of quite astonishing proportions. to produce toxic substances, in this case, lectins. Lectins are proteins in plants that are naturally toxic to insects and nematode worms. They do not bother us because we cook lectin-rich foods-kidney beans, for example-long enough to unravel the structure of the proteins and destroy their function. In 1998, an investigator in Scotland announced that rats became ill when they ate transgenic lectins, thereby initiating a political furor of quite astonishing proportions.
This story begins soon after the peak of the mad cow disease epidemic in Great Britain, a crisis that resulted not only in the downfall of the British beef industry but also in the loss of public confidence in scientists and government (see concluding chapter). In this context, Dr. Arpad Pusztai, a long-time researcher at the Rowett Research Institute in Aberdeen, applied for and won a competitive contract to see how rats might react to consuming transgenic potatoes containing lectins. Dr. Pusztai isolated genes for lectins from snowdrop plants and transferred them into potatoes. For comparison, he physically inserted purified lectins into other potatoes. He fed the transgenic potatoes to one group of rats and the lectin-added conventional potatoes to another group. All of the rats reacted badly to lectins, but the ones fed the transgenic potatoes fared worse.42 On August 10, 1998, Dr. Pusztai-bravely or foolishly, depending on one's point of view-appeared on television to announce that the rats fed transgenic potatoes showed signs of growth retardation and some immune system dysfunctions. He said: "If you gave me the choice now, I wouldn't eat it," and it would be "very, very unfair to use our fellow citizens as guinea pigs." On August 10, 1998, Dr. Pusztai-bravely or foolishly, depending on one's point of view-appeared on television to announce that the rats fed transgenic potatoes showed signs of growth retardation and some immune system dysfunctions. He said: "If you gave me the choice now, I wouldn't eat it," and it would be "very, very unfair to use our fellow citizens as guinea pigs."43 Dr. Pusztai based these comments on studies not yet published or subjected to peer review. Industry officials charged that because of his remarks, "the whole of the biotechnology industry had gone up in smoke," and they would now be faced with consumer opposition that would take years to undo.44 The head of the Rowett Institute defended the work at first, but quickly changed his mind. After reviewing the data and judging it flawed, he sealed Dr. Pusztai's laboratories, forced him to retire, barred him from speaking to the press, and ordered a formal audit of his data-actions that received front-page press attention and did nothing to calm public alarm about food biotechnology in Great Britain or Europe. The head of the Rowett Institute defended the work at first, but quickly changed his mind. After reviewing the data and judging it flawed, he sealed Dr. Pusztai's laboratories, forced him to retire, barred him from speaking to the press, and ordered a formal audit of his data-actions that received front-page press attention and did nothing to calm public alarm about food biotechnology in Great Britain or Europe.
As might be expected from a review of provisional results, the audit committee decided that the data did not support Dr. Pusztai's conclusions. Dr. Pusztai again reviewed his own data and said that they did. Furthermore, he conducted his own peer review; he sent copies of his research reports and the television transcript to scientists who requested these documents, and asked them them to evaluate the materials. In February 1999, more than 20 scientists from at least 13 countries called a press conference to announce that the findings were just as Dr. Pusztai had claimed. to evaluate the materials. In February 1999, more than 20 scientists from at least 13 countries called a press conference to announce that the findings were just as Dr. Pusztai had claimed.45 Public calls for a moratorium on food biotechnology research followed immediately. Most scientists (other than the 20 supporters) strongly doubted that genetically modified lectins could have harmed the rats, although they thought the potatoes might have been induced to express higher levels of Public calls for a moratorium on food biotechnology research followed immediately. Most scientists (other than the 20 supporters) strongly doubted that genetically modified lectins could have harmed the rats, although they thought the potatoes might have been induced to express higher levels of other other toxic substances. When the British government rejected demands for a moratorium, critics charged that government officials were "in the pocket of the biotech industry" and had offered huge sums to biotechnology companies to induce them to work in Britain. They also noted that Monsanto had bought off the Rowett Institute in advance with a toxic substances. When the British government rejected demands for a moratorium, critics charged that government officials were "in the pocket of the biotech industry" and had offered huge sums to biotechnology companies to induce them to work in Britain. They also noted that Monsanto had bought off the Rowett Institute in advance with a 140,000 grant.46 In May, the British Royal Society weighed in with an anonymous review that judged Dr. Pusztai's studies flawed and inconclusive. Dr. Pusztai called this clandestine peer review "deprecable because many influential committees are redolent with advisors linked to biotechnology companies."47 The The Lancet Lancet, a leading medical journal, agreed, calling the Royal Society's review "a gesture of breathtaking impertinence."43 The Prince of Wales expressed sympathy for Dr. Pusztai's plight. Industry commentators, however, said Dr. Pusztai was "largely responsible for the British public's mistrust of genetically modified food" as well as for subsequent governmental actions to regulate, label, or ban genetically modified foods. The Prince of Wales expressed sympathy for Dr. Pusztai's plight. Industry commentators, however, said Dr. Pusztai was "largely responsible for the British public's mistrust of genetically modified food" as well as for subsequent governmental actions to regulate, label, or ban genetically modified foods.48 In October 1999, in an act that itself generated a huge outcry, the Lancet Lancet published Dr. Pusztai's data as a short research letter. The journal fueled the controversy by including another report in the same issue suggesting that snowdrop lectins interact with human white blood cells in some peculiar way that demands further investigation. An editorial in the same issue, however, stated that such experiments were incomplete, insignificant, inadequately controlled, and uninterpretable. published Dr. Pusztai's data as a short research letter. The journal fueled the controversy by including another report in the same issue suggesting that snowdrop lectins interact with human white blood cells in some peculiar way that demands further investigation. An editorial in the same issue, however, stated that such experiments were incomplete, insignificant, inadequately controlled, and uninterpretable.49 Justifying the journal's decision to publish evidently flawed research, the Justifying the journal's decision to publish evidently flawed research, the Lancet Lancet's editor chided critics for their "failure to understand the new, and apparently unwelcome, dialogue of accountability that needs to be forged between scientists and the public." He quite sensibly pointed out, "Risks are not simply questions of abstract probabilities or theoretical reassurances. What matters is what people believe about these risks and why they hold those beliefs. [The] data are preliminary and non-generalisable, but at least they are now out in the open for debate."50 By one report, a member of the Royal Society with ties to biotechnology companies accused the editor of acting immorally by publishing research known to be "untrue" and implied that doing so would "have implications for his personal position." With or without such threats, the editor's argument did not convince scientists skeptical of the quality of the research, and they heavily criticized the journal for publishing it.51 Whatever the scientific merits of Dr. Pusztai's work, his treatment reinforced public suspicions that no group with a vested interest in food biotechnology would act in the public interest. If a problem with transgenic foods did emerge, the government and much of the scientific establishment would support the industry above all other considerations. Whatever the scientific merits of Dr. Pusztai's work, his treatment reinforced public suspicions that no group with a vested interest in food biotechnology would act in the public interest. If a problem with transgenic foods did emerge, the government and much of the scientific establishment would support the industry above all other considerations.
Killing Monarch Butterflies We now turn to the most widely publicized-and most fiercely debated-example of unintended consequences-the effects of Bt Bt crops on crops on friendly friendly insects, in this case, monarch butterflies. Monarch butterflies lay their eggs on milkweed plants that grow throughout fields of corn. Of course the insects, in this case, monarch butterflies. Monarch butterflies lay their eggs on milkweed plants that grow throughout fields of corn. Of course the Bt Bt toxin kills monarch larvae that hatch from the eggs; the toxin is toxin kills monarch larvae that hatch from the eggs; the toxin is supposed supposed to kill insect larvae. When Cornell University investigators dusted laboratory milkweed leaves with pollen from to kill insect larvae. When Cornell University investigators dusted laboratory milkweed leaves with pollen from Bt Bt corn, the results were only to be expected: the test larvae grew more slowly and died more quickly than those fed leaves dusted with pollen from conventional corn or with no pollen at all. corn, the results were only to be expected: the test larvae grew more slowly and died more quickly than those fed leaves dusted with pollen from conventional corn or with no pollen at all.52 This research note, taking up less than a page in a scientific journal (albeit the prestigious This research note, taking up less than a page in a scientific journal (albeit the prestigious Nature Nature), elicited an immediate response: "Will the conjectured absence of butterflies flapping their wings on Iowa farms provoke political firestorms among Washington policymakers?" Indeed, yes. Farmers did not want to be termed "butterfly-killers," and neither did Congress. Legislators proposed an appropriation of $200,000 to study the effect of transgenic foods on monarch butterflies and also introduced legislation to require labeling.53 Monarch butterflies became the symbol of antibiotechnology protests, as illustrated in Monarch butterflies became the symbol of antibiotechnology protests, as illustrated in figure 18 figure 18.
From the industry standpoint, killing butterflies and other friendly insects is normal collateral damage, no worse than the effects of conventional pesticides. Using this argument to deflect appeals for preservation of an already endangered species, however, would be unlikely to succeed. Thus, the industry employed different strategies. The first was to discredit the science by pointing out, correctly, that one small laboratory study should not be taken too seriously until it is confirmed. Second, the industry funded new studies, reportedly at $100,000 each, to repeat the work in field trials. Third, it organized a scientific symposium to publicize the results of those trials.54 The industry-funded studies produced the expected conclusion: transgenic crops pose no risk to monarch butterflies. This outcome was so certain that the industry sponsors distributed a news release The industry-funded studies produced the expected conclusion: transgenic crops pose no risk to monarch butterflies. This outcome was so certain that the industry sponsors distributed a news release prior prior to the conference: "Scientific symposium to show no harm to monarch butterfly." to the conference: "Scientific symposium to show no harm to monarch butterfly."55 The conference itself, however, proved rather contentious. Some participants complained about manipulation by the industry: "It was dirty pool and the fox was guarding the chicken coop. . . . It was not conclusive." The conference itself, however, proved rather contentious. Some participants complained about manipulation by the industry: "It was dirty pool and the fox was guarding the chicken coop. . . . It was not conclusive."56 Independent scientists were appalled by the industry's heavy-handed control of a meeting at which researchers-many with only preliminary results to report-were supposed to be presenting and discussing them in a careful and deliberate manner. Independent scientists were appalled by the industry's heavy-handed control of a meeting at which researchers-many with only preliminary results to report-were supposed to be presenting and discussing them in a careful and deliberate manner.
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FIGURE 18. The FDA's Washington, DC, hearings on genetically modified foods in November 1999, drew demonstrators dressed as monarch butterflies. This photograph appeared in the New York Times Magazine New York Times Magazine, December 12, 1999. ( 1999 AP/Wide World Photos by J. Scott Applewhite. Reprinted with permission.) Further studies attempted to resolve the issue. One reported that pollen from Bt Bt corn did not harm black swallowtail butterflies. The authors concluded, "at least some potential nontarget effects of the use of transgenic plants may be manageable," but "the plain fact of the matter is that growing food has nontarget effects. . . . Our challenge is to minimize them." corn did not harm black swallowtail butterflies. The authors concluded, "at least some potential nontarget effects of the use of transgenic plants may be manageable," but "the plain fact of the matter is that growing food has nontarget effects. . . . Our challenge is to minimize them."57 Another found just the opposite, but came to the same conclusion: Another found just the opposite, but came to the same conclusion: Bt Bt pollen on milkweeds in corn fields caused "significant mortality" of monarch butterfly larvae: "This is telling us that with naturally deposited pollen there's a good probability you'll get some mortality." pollen on milkweeds in corn fields caused "significant mortality" of monarch butterfly larvae: "This is telling us that with naturally deposited pollen there's a good probability you'll get some mortality."58 Although it might seem self-evident that Bt Bt pollen kills "nontarget" insects as well as those it is intended to control, the industry and its federal regulators have taken heroic-and expensive-steps to prove the trivial nature of such collateral damage. In December 1999, the EPA "called in" (translation: asked for) comments from researchers on the toxicity of pollen kills "nontarget" insects as well as those it is intended to control, the industry and its federal regulators have taken heroic-and expensive-steps to prove the trivial nature of such collateral damage. In December 1999, the EPA "called in" (translation: asked for) comments from researchers on the toxicity of Bt Bt corn pollen. In February 2000, the U.S. Department of Agriculture (USDA) held a conference to respond to that call-in and to set research priorities for determining the safety of corn pollen. In February 2000, the U.S. Department of Agriculture (USDA) held a conference to respond to that call-in and to set research priorities for determining the safety of Bt Bt pollen for monarch butterflies. Its own in-house researchers spent two years investigating this question (conclusion: "negligible" risk). pollen for monarch butterflies. Its own in-house researchers spent two years investigating this question (conclusion: "negligible" risk).59 In September 2000, the EPA issued a preliminary report concluding that the butterfly population was not at risk from In September 2000, the EPA issued a preliminary report concluding that the butterfly population was not at risk from Bt Bt pollen. In the meantime, agricultural biotechnology companies had pooled resources in partnership with those agencies to fund extensive field trials. The results of these trials appeared as a collection of six papers in the pollen. In the meantime, agricultural biotechnology companies had pooled resources in partnership with those agencies to fund extensive field trials. The results of these trials appeared as a collection of six papers in the Proceedings of the National Academy of Sciences Proceedings of the National Academy of Sciences in September 2001. The final paper concluded, "The impact of in September 2001. The final paper concluded, "The impact of Bt Bt corn pollen from current commercial hybrids on monarch butterfly populations is negligible." Its lead author said, "I don't think there's a need to consider monarchs at risk due to this technology." The corn pollen from current commercial hybrids on monarch butterfly populations is negligible." Its lead author said, "I don't think there's a need to consider monarchs at risk due to this technology." The New York Times New York Times headline repeated the conclusion: "Reports say threat to monarch butterflies is 'negligible.'" headline repeated the conclusion: "Reports say threat to monarch butterflies is 'negligible.'"60 My reading of this extraordinary scientific effort to prove the obvious comes to a slightly different interpretation: negligible under some circumstances, but not others. The papers provide substantial evidence that certain types of Bt Bt corn produce more lethal pollen than others. They find that monarch butterflies are more likely to survive in fields planted with lower amounts of genetically modified corn, treated with lower levels of insecticides, and weeded less vigorously (unweeded fields contain more milkweed plants). The butterflies survive better when they are not near the center of the fields where pollen counts are higher, and when rain washes the pollen off the milkweed plants. corn produce more lethal pollen than others. They find that monarch butterflies are more likely to survive in fields planted with lower amounts of genetically modified corn, treated with lower levels of insecticides, and weeded less vigorously (unweeded fields contain more milkweed plants). The butterflies survive better when they are not near the center of the fields where pollen counts are higher, and when rain washes the pollen off the milkweed plants.
Such results may be debatable, but no such debate took place-for reasons of politics. The papers were to appear just at the time the EPA was about to decide whether to renew the licenses (registrations) for planting Bt Bt corn and cotton. The EPA asked the journal to release the papers on the Internet prior to publication so the agency would appear to have considered the results in coming to the decision-one it had already made. corn and cotton. The EPA asked the journal to release the papers on the Internet prior to publication so the agency would appear to have considered the results in coming to the decision-one it had already made.60 In announcing the decision, the EPA said: "Adhering to a process that emphasized up-to-date scientific data and methodologies, numerous opportunities for public involvement, and balanced decision-making, EPA maintained a transparent review process to ensure that the decision was based on sound science." In announcing the decision, the EPA said: "Adhering to a process that emphasized up-to-date scientific data and methodologies, numerous opportunities for public involvement, and balanced decision-making, EPA maintained a transparent review process to ensure that the decision was based on sound science."61 Critics did not find the process so transparent, not only because they had no chance to review the studies beforehand, but also because some of the data had been classified as "confidential business information" in an unusual concession to the industry. When the EPA did make the confidential information available, it required readers to agree not to copy or discuss it. In this instance, as in so many others, science alone cannot settle social questions of transparency or trust. Critics did not find the process so transparent, not only because they had no chance to review the studies beforehand, but also because some of the data had been classified as "confidential business information" in an unusual concession to the industry. When the EPA did make the confidential information available, it required readers to agree not to copy or discuss it. In this instance, as in so many others, science alone cannot settle social questions of transparency or trust.
THE POLITICS OF RISKS AND BENEFITS.
When dealing with questions about the risks of genetically modified foods, industry leaders are fond of saying that nobody has died yet from eating them. This may be a correct assessment, but it misses the point. In a situation in which the risks of genetically modified foods are questionable but so are the benefits, point of view becomes the critical factor in interpretation. Regardless of the remoteness of safety concerns, the intensity of criticism-and the vulnerability of the industry-have prompted government agencies to take safety issues seriously. In 2002 alone, the General Accounting Office (GAO) chided the FDA for not doing a better job of validating information provided by food biotechnology companies, disclosing its evaluation methods, and developing new testing methods to ensure the safety of genetically modified foods. The White House Office of Science and Technology Policy asked the FDA, EPA, and USDA to strengthen restrictions on field testing to prevent escape of transgenes, and scientific panels of the National Academies urged more careful safety evaluation of genetically modified plants and animals.62 Regardless of the outcome of such actions, the safety questions discussed here-whether genetically modified foods cause allergies, antibiotic resistance, higher production of lectins, or the death of monarch butterflies, and whether they decrease or increase the use of pesticides-are not necessarily the primary issues. Genetically modified foods already already pervade the food supply. The experiment is in progress; its results will emerge in due course. Whether such an experiment is in the public interest-or for that matter is in the interest of the industry-will also be revealed in time. If food biotechnology is political, it is because the public has no choice but to participate in this experiment. Thus, the important question is pervade the food supply. The experiment is in progress; its results will emerge in due course. Whether such an experiment is in the public interest-or for that matter is in the interest of the industry-will also be revealed in time. If food biotechnology is political, it is because the public has no choice but to participate in this experiment. Thus, the important question is who gets to decide who gets to decide. In the next chapter, we will consider how agricultural biotechnology companies-particularly Monsanto-convinced regulatory agencies that questions about societal risks and benefits do not need to be addressed before planting transgenic foods, that the foods require no special labels, and that the public has no choice about whether to consume them.
CHAPTER 7.
THE POLITICS OF.
GOVERNMENT OVERSIGHT.
AMONG THE LESSONS OF THE STARLINK CORN EPISODE IS THIS: genetically modified ingredients pervade the U.S. food supply, but consumers cannot identify them because the foods are not labeled. This situation was not inevitable. Federal agencies made "science-based" decisions that transgenic foods are equivalent to conventional foods (DNA is DNA no matter where it comes from) and require no special regulatory oversight. In this chapter, we will see how the biotechnology industry lobbied successfully for this approach, using the now familiar mantra: the techniques are inherently safe, the products are no different than those produced through traditional genetics, and labeling is not only unnecessary but misleading. genetically modified ingredients pervade the U.S. food supply, but consumers cannot identify them because the foods are not labeled. This situation was not inevitable. Federal agencies made "science-based" decisions that transgenic foods are equivalent to conventional foods (DNA is DNA no matter where it comes from) and require no special regulatory oversight. In this chapter, we will see how the biotechnology industry lobbied successfully for this approach, using the now familiar mantra: the techniques are inherently safe, the products are no different than those produced through traditional genetics, and labeling is not only unnecessary but misleading.
In choosing this approach, federal regulators permitted companies to develop genetically modified foods without having to alert regulatory agencies (premarket notification), evaluate the safety of the products in advance (premarket testing), or label them once they were ready to market. In approving transgenic foods, they restricted the debate to science-based issues of safety. If the foods appeared safe for human health they could be marketed: plant first, then deal with problems. As discussed earlier, this approach differs from the method required by the precautionary principle: demonstrate safety before before planting. The science-based approach also excluded debate about the societal issues summarized in planting. The science-based approach also excluded debate about the societal issues summarized in table 2 table 2 ( (page 17). The regulatory agencies interpreted their mandates to mean that they could not consider dread-and-outrage factors when making decisions about genetically modified foods.
This chapter examines how food biotechnology companies achieved a "plant first" regulatory environment. To understand the politics of the current system, we must recall that Congress wrote the principal laws affecting food safety in 1906, long before anyone knew anything about DNA, let alone transgenic foods. As noted earlier, the discovery of recombinant DNA techniques in the 1970s stimulated discussion about how to assure their safety. At hearings in 1983, Congress reviewed arguments for federal regulation of biotechnology. The following year, under pressure from the pharmaceutical industry, the White House Office of Science and Technology Policy (OSTP) proposed a "Coordinated Framework" for the regulation of biotechnology and issued a final version in 1986. The pharmaceutical industry argued that because DNA is DNA, drugs produced through recombinant techniques require no special considerations, laws, or agencies. The OSTP agreed and established four principles: (1) existing laws are sufficient for regulation, (2) regulation applies to the products, not the processes by which they were developed, (3) safety should be assessed on a case-by-case basis, and (4) agencies should coordinate their regulatory efforts.1 This last principle would prove especially challenging because the Coordinated Framework distributed regulatory responsibilities among a large number of federal entities: three offices reporting directly to the president; three cabinet-level federal agencies; two major subagencies within one cabinet-level agency; eight centers, services, offices, or programs within major agencies; and five federal committees-all operating under the authority of 10 distinct acts of Congress. Any regulatory plan of that complexity suggests that coordination will be difficult-impossible is more like it-and that oversight will be plagued from the start by gaps, duplication of effort, and overlapping responsibilities. Like the oversight scheme for food safety, the Coordinated Framework reveals the need for a single food agency.
The Coordinated Framework applies to foods as well as drugs and assigns three agencies to their regulation, two at the cabinet level-the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA)-and a subagency of a third (the Department of Health and Human Services), the Food and Drug Administration (FDA). Genetically modified foods, however, do not easily fit into the existing regulatory categories of these agencies, leaving much room for interpretation. Moreover, the three agencies operate under different laws. The Plant Pest Act allows the USDA to regulate transgenic crops as plant pests plant pests when they contain genes or regulatory DNA segments from potentially harmful organisms: insects, nematodes, slugs, and snails, but also bacteria, fungi, and viruses. Because just about all gene donors are on this list, most transgenic plants require USDA permits to allow them to be field-tested, transported through interstate commerce, or imported. Over time, the USDA has modified its regulations to make it easier for companies to plant genetically engineered crops without having to obtain permits. when they contain genes or regulatory DNA segments from potentially harmful organisms: insects, nematodes, slugs, and snails, but also bacteria, fungi, and viruses. Because just about all gene donors are on this list, most transgenic plants require USDA permits to allow them to be field-tested, transported through interstate commerce, or imported. Over time, the USDA has modified its regulations to make it easier for companies to plant genetically engineered crops without having to obtain permits.2 In contrast, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires the EPA to "register" transgenic foods as plant-pesticides plant-pesticides (or, as they are now called, (or, as they are now called, plant-incorporated protectants plant-incorporated protectants). If a crop is bioengineered to contain the toxin from Bacillus thuringiensis Bacillus thuringiensis ( (Bt), for example, the EPA considers it to contain a pesticide and regulates the plant as it would any pesticidal chemical. Ordinarily, makers of Bt Bt crops must submit voluminous information about the toxin's effects on health and the environment, but the EPA can and does grant exceptions. crops must submit voluminous information about the toxin's effects on health and the environment, but the EPA can and does grant exceptions.
To further complicate matters, the FDA regulates transgenic foods as food additives food additives under the provisions of the Food, Drug, and Cosmetic Act. Unless food additives are generally recognized as safe (GRAS), meaning that they have a history of safe use, they require premarket approval; manufacturers must submit evidence demonstrating "reasonable certainty" that an additive will not be harmful if used appropriately. In practice, the FDA has jurisdiction over all genetically modified foods, although it shares regulatory authority over plants that have to be field-tested or transported across state lines with USDA, and those containing the under the provisions of the Food, Drug, and Cosmetic Act. Unless food additives are generally recognized as safe (GRAS), meaning that they have a history of safe use, they require premarket approval; manufacturers must submit evidence demonstrating "reasonable certainty" that an additive will not be harmful if used appropriately. In practice, the FDA has jurisdiction over all genetically modified foods, although it shares regulatory authority over plants that have to be field-tested or transported across state lines with USDA, and those containing the Bt Bt toxin with EPA. Dealing separately with two-let alone three-agencies is guaranteed to be a lengthy, complicated, and expensive process, and food biotechnology companies complain that the regulations are cumbersome and restrictive. They also complain that the regulations are contrary to the intention of the Coordinated Framework because they hold genetically modified foods to toxin with EPA. Dealing separately with two-let alone three-agencies is guaranteed to be a lengthy, complicated, and expensive process, and food biotechnology companies complain that the regulations are cumbersome and restrictive. They also complain that the regulations are contrary to the intention of the Coordinated Framework because they hold genetically modified foods to higher higher safety standards than conventional foods. safety standards than conventional foods.3 To evaluate such contentions, let's begin by examining the FDA's role in regulating transgenic foods and the ways in which the biotechnology industry has influenced that role. To evaluate such contentions, let's begin by examining the FDA's role in regulating transgenic foods and the ways in which the biotechnology industry has influenced that role.
THE FDA'S "SCIENCE-BASED" APPROACH The FDA's main function is to regulate drugs, and its food activities are decidedly secondary. By the early 1990s, the FDA had approved at least 15 recombinant drugs for medical use, with recombinant insulin among the earliest in 1982. The benefits of many of these drugs seem evident. Recombinant insulin, unlike that obtained from pigs, has an amino acid structure identical to that of human insulin and can be produced in unlimited quantities. So can recombinant enzymes used in food manufacture such as chymosin, an enzyme used to coagulate milk in the early steps of cheese making. In the past, cheese makers obtained chymosin as part of a mixture called rennet, which had to be extracted from the stomachs of calves and was expensive and of inconsistent composition. Scientists bioengineered the gene for chymosin into bacteria, and the FDA approved the recombinant enzyme in 1990. Such drugs and enzymes elicited few objections from critics of biotechnology, mainly because of the obvious advantages. Transgenic chymosin, for example, does not require the slaughter of baby calves. Also, manufacturers did not publicize its origin, as they saw "little to gain from waving the biotech flag."4 Transgenic drugs did not become controversial until they affected food more directly, as was the case with the cow growth hormone, recombinant bovine somatotropin (rbST)-a drug that affects Transgenic drugs did not become controversial until they affected food more directly, as was the case with the cow growth hormone, recombinant bovine somatotropin (rbST)-a drug that affects milk milk. Because the approval process for this drug was so evidently political-interweaving considerations of science, safety, commercial objectives, and societal issues-and because it paved the way for subsequent FDA approval of transgenic foods, the case of bovine growth hormone is worth close examination.
The Politics of Bovine Growth Hormone (BGH): More Milk The politics of this animal drug begin with its very name. Proponents of the drug use the scientific term bovine somatotropin bovine somatotropin (bST), whereas critics tend to use the more recognizable (bST), whereas critics tend to use the more recognizable bovine growth hormone bovine growth hormone (BGH). Both put an (BGH). Both put an r r in front to distinguish the genetically engineered drug from the natural hormone in cows. For simplicity, this chapter uses rBGH. Whatever it is called, the recombinant hormone increases milk production in cows by 1020%. It proved controversial from the start, and questions about its safety continue to be debated, especially in Canada and Europe. Monsanto developed the bioengineering capacity to create rBGH in the early 1980s, and the company quickly promoted it as a means to increase the efficiency of dairy farming. Although this use might appear to be of great benefit to consumers as well as to farmers, critics soon raised questions about the possibility of adverse effects of the drug on human health, animal welfare, and the economic viability of small dairy farms. Furthermore, consumers would have no choice about whether to buy products resulting from use of the hormone, as milk from cows treated with rBGH (shorthand: rBGH milk) would not be labeled as genetically engineered. in front to distinguish the genetically engineered drug from the natural hormone in cows. For simplicity, this chapter uses rBGH. Whatever it is called, the recombinant hormone increases milk production in cows by 1020%. It proved controversial from the start, and questions about its safety continue to be debated, especially in Canada and Europe. Monsanto developed the bioengineering capacity to create rBGH in the early 1980s, and the company quickly promoted it as a means to increase the efficiency of dairy farming. Although this use might appear to be of great benefit to consumers as well as to farmers, critics soon raised questions about the possibility of adverse effects of the drug on human health, animal welfare, and the economic viability of small dairy farms. Furthermore, consumers would have no choice about whether to buy products resulting from use of the hormone, as milk from cows treated with rBGH (shorthand: rBGH milk) would not be labeled as genetically engineered.5 When the FDA approved rBGH as a new animal drug in 1993, available analytical methods could not easily distinguish milk from treated and untreated cows.6 Because the naturally occurring BGH in cow's milk was indistinguishable from rBGH, the agency ruled that labeling would be misleading because the milks are the same. Monsanto and other biotechnology companies viewed disclosure as a threat to the future of agricultural biotechnology. If rBGH failed in the marketplace, the entire industry might be in jeopardy. The industry extolled rBGH and the equivalent hormone in pigs as "biotechnological miracles that would give consumers more for their money at less cost to the environment," but worried that "ignorance, nostalgia and a Luddite view of technology" would prevent the drugs-but also transgenic foods in general-from reaching the marketplace. Because the naturally occurring BGH in cow's milk was indistinguishable from rBGH, the agency ruled that labeling would be misleading because the milks are the same. Monsanto and other biotechnology companies viewed disclosure as a threat to the future of agricultural biotechnology. If rBGH failed in the marketplace, the entire industry might be in jeopardy. The industry extolled rBGH and the equivalent hormone in pigs as "biotechnological miracles that would give consumers more for their money at less cost to the environment," but worried that "ignorance, nostalgia and a Luddite view of technology" would prevent the drugs-but also transgenic foods in general-from reaching the marketplace.7 Industry leaders had grounds for concern. By 1989, when Monsanto was testing rBGH on commercial farms in nearly every important dairy state, the drug was already under attack by groups concerned about family farms as well as by those suspicious of any kind of genetic engineering. Several supermarket chains refused to carry milk from rBGH-treated cows, and the owners of Ben & Jerry's announced that they would label ice cream packages with a statement opposing use of the hormone. Before the drug had even been approved for commercial use, the state legislatures of Wisconsin and Minnesota temporarily banned sales of rBGH. By 1992, four major supermarket chains, two large manufacturers of dairy products, and the nation's largest dairy cooperative joined the boycott, as did many small farmers, dairy cooperatives, and grocery chains.8 The Safety Issues. Bovine somatotropin stimulates milk production. The hormone, a protein, is always present in cow's milk at low concentrations. Milk from rBGH-treated cows contains both the natural and recombinant hormones. Neither the natural nor the recombinant hormone is likely to affect human health; the cow hormones differ in structure from the human hormone, are not biologically active in humans, and do not promote human growth. Furthermore, like all proteins, cow hormones are largely digested to their constituent amino acids and, therefore, inactivated in the human digestive tract.
In 1990, Monsanto said that its studies had satisfied any doubts about whether rBGH milk is safe for human consumption. That year, FDA scientists reviewed more than 130 studies of the effects of rBGH on cows, rats, and humans and also concluded that the hormone does not affect human health. Critics called this conclusion an unprecedented display of conflict of interest: FDA scientists had produced a favorable evaluation of evidence in support of a drug not yet approved by their agency. Others accused the FDA of colluding with Monsanto because agency scientists could not have conducted the review unless the company had disclosed confidential studies that were not available for evaluation by the general scientific community. A panel of experts recruited by the National Institutes of Health (NIH), however, concluded that milk from rBGH-treated cows was essentially the same-and therefore as safe-as milk from untreated cows. According to one rBGH supporter, the hormone had been tested on 21,000 cows and described in more than 900 research papers by 1992 with no indication of harm to human health.9 Nevertheless, critics continued to raise doubts about the safety of rBGH-milk on two grounds: antibiotics and a substance called insulin-like growth factor-1 insulin-like growth factor-1 (IGF-1). The concern about antibiotics derives from observations that cows given rBGH develop more frequent infections of their udders (mastitis). The more milk cows produce, the more likely they are to develop mastitis, and rBGH increases milk production. Because farmers treat the infections with antibiotics that can linger in milk and meat, eating foods from treated animals might contribute to selection for antibiotic-resistant bacteria. On this basis, the General Accounting Office (GAO) urged the FDA not to approve rBGH until issues related to mastitis could be resolved. Federal regulations require the FDA to test for antibiotic residues in milk, but the agency is able to test for just a small fraction of animal drugs in common use-just 4 out of 82 in one study-suggesting a lack of ability to monitor such substances. Because of this regulatory gap, another federal committee recommended that the FDA ban rBGH until the antibiotic risks could be evaluated. The Republican administration in power in 1992, however, was committed to a policy of industry deregulation, and it ignored the recommendations. (IGF-1). The concern about antibiotics derives from observations that cows given rBGH develop more frequent infections of their udders (mastitis). The more milk cows produce, the more likely they are to develop mastitis, and rBGH increases milk production. Because farmers treat the infections with antibiotics that can linger in milk and meat, eating foods from treated animals might contribute to selection for antibiotic-resistant bacteria. On this basis, the General Accounting Office (GAO) urged the FDA not to approve rBGH until issues related to mastitis could be resolved. Federal regulations require the FDA to test for antibiotic residues in milk, but the agency is able to test for just a small fraction of animal drugs in common use-just 4 out of 82 in one study-suggesting a lack of ability to monitor such substances. Because of this regulatory gap, another federal committee recommended that the FDA ban rBGH until the antibiotic risks could be evaluated. The Republican administration in power in 1992, however, was committed to a policy of industry deregulation, and it ignored the recommendations.10 IGF-1 concerns critics for three reasons: (1) rBGH increases levels of this factor in cow's milk, (2) IGF-1 in cows is chemically identical to human IGF-1, and (3) higher levels of IGF-1 in cow's milk might stimulate premature growth in human infants or cancer in adults. It is difficult to evaluate this last contention given the current state of research. Population studies associate high levels of IGF-1 in blood with a higher risk of prostate cancer in men and breast cancer in premenopausal (but not post-menopausal) women and, perhaps, with a greater risk of high blood pressure, but these findings do not necessarily have anything to do with drinking milk; high IGF-1 levels could be due to genetic or other dietary causes.11 The factor ought to be inactivated during processing and digestion, but some seems to be absorbed intact. The research gaps have encouraged lingering doubts, demands for reassessment of the safety of rBGH, and lawsuits against the FDA. They also encouraged one anti-rBGH activist, Robert Cohen, to go on a hunger strike in 1999-one of the more extreme forms of protest against foods made with transgenic ingredients. The factor ought to be inactivated during processing and digestion, but some seems to be absorbed intact. The research gaps have encouraged lingering doubts, demands for reassessment of the safety of rBGH, and lawsuits against the FDA. They also encouraged one anti-rBGH activist, Robert Cohen, to go on a hunger strike in 1999-one of the more extreme forms of protest against foods made with transgenic ingredients.12 The Social Issues. Protests about the safety of rBGH obscure an underlying issue-its economic impact. The production of milk in the United States has long exceeded demand, and the government has long subsidized the dairy industry through purchases of surplus milk. Monsanto contends that costs to farmers will decline because fewer cows will produce more milk, and the savings will be passed on to consumers. This last benefit seems doubtful, mainly because dairy prices are tightly linked to federal support programs. If prices fall, levels of taxpayer-supported federal spending would increase to protect farm incomes. Critics also raise concerns about the effects of rBGH on the cows themselves; higher milk production stresses cows and leads to more frequent mastitis and sores at injection sites (an issue of animal rights). Although Monsanto asserts that appropriate veterinary and herd-management practices minimize such problems, farmers report them regularly. The FDA, however, views these complaints as raising no new concerns about animal health.13 Use of rBGH also raises questions about effects on rural life. If people drink less milk to avoid rBGH, or if it increases veterinary costs, the drug might contribute to the ongoing attrition of small dairy farms. Jerry Cohen, then an owner of Ben & Jerry's, told the FDA Food Advisory Committee in 1993: "We do know that the use of BGH will increase the supply of milk at a time when we already have a tremendous surplus. It does not make any sense to exacerbate this problem with a product about which there are so many legitimate doubts, a product whose principal beneficiaries will be chemical companies and corporate agribusiness."14 That the product affects milk itself raises issues. As ethicist Arthur Caplan explained, "Is there any product in the world that has tried harder to sell itself as wholesome and pure than milk? . . . It is a food for innocent, trusting children, culturally laden with symbolism. Any adulteration of milk . . . is seen as taboo." That the product affects milk itself raises issues. As ethicist Arthur Caplan explained, "Is there any product in the world that has tried harder to sell itself as wholesome and pure than milk? . . . It is a food for innocent, trusting children, culturally laden with symbolism. Any adulteration of milk . . . is seen as taboo."15 Despite this range of concerns, Monsanto only needed to overcome doubts about the safety of the drug for human health to obtain FDA approval. Despite this range of concerns, Monsanto only needed to overcome doubts about the safety of the drug for human health to obtain FDA approval.
Monsanto's Campaign for Approval. Monsanto's efforts to obtain FDA approval for rBGH began as soon as it produced the drug. At the company's request, the FDA permitted distribution of rBGH for limited use on an experimental basis in 1985, and subsequently affirmed the safety of rBGH milk and meat in 1988, 1989, and again in 1990, as did the NIH in 1990 and the Office of Technology Assessment (OTA) in 1991. When the FDA's approval of rBGH as a new animal drug appeared imminent in August 1993, Congress imposed a 90-day moratorium on sales. The U.S. Senate, concerned about the fate of small dairy farms, asked for a moratorium lasting an entire year, but House opposition forced a compromise resulting in the shorter time limit.16 After lengthy deliberations, advisory committee consultations, and public hearings, the FDA approved rBGH as a new animal drug in November 1993 and ruled that milk produced by cows treated with the hormone would not need to be labeled. In announcing this decision, FDA commissioner Dr. David Kessler stated: "There is virtually no difference in milk from treated and untreated cows. . . . In fact, it's not possible using current scientific techniques to tell them apart. We have looked carefully at every single question raised, and we are confident this product is safe for consumers, for cows and for the environment." After lengthy deliberations, advisory committee consultations, and public hearings, the FDA approved rBGH as a new animal drug in November 1993 and ruled that milk produced by cows treated with the hormone would not need to be labeled. In announcing this decision, FDA commissioner Dr. David Kessler stated: "There is virtually no difference in milk from treated and untreated cows. . . . In fact, it's not possible using current scientific techniques to tell them apart. We have looked carefully at every single question raised, and we are confident this product is safe for consumers, for cows and for the environment."17 The FDA approval applied only to Monsanto's rBGH, although approvals for similar products from other companies seemed sure to follow. Industry representatives hailed the decision as a victory for Monsanto, an indication of reduced regulatory barriers, and a precedent for approving forthcoming products of agricultural biotechnology. The FDA approval applied only to Monsanto's rBGH, although approvals for similar products from other companies seemed sure to follow. Industry representatives hailed the decision as a victory for Monsanto, an indication of reduced regulatory barriers, and a precedent for approving forthcoming products of agricultural biotechnology.
This resounding success was no accident. As early as 1987, business analysts expected rBGH to generate millions of dollars in annual sales. The potential for large returns on investment explains Monsanto's unusually aggressive sales tactics and political actions to promote this otherwise problematic product. Public relations firms working for Monsanto engaged in the usual sorts of lobbying activities in support of rBGH approval but also sent "secret agents and spies" to infiltrate citizen's groups opposed to use of the hormone.18 As a member of the FDA Food Advisory Committee, I attended hearings on rBGH prior to its approval. The FDA had invited interested companies to provide one witness each. Monsanto sent As a member of the FDA Food Advisory Committee, I attended hearings on rBGH prior to its approval. The FDA had invited interested companies to provide one witness each. Monsanto sent nine nine, some of them supposedly "independent" witnesses (one was a pregnant dairy farmer from upstate New York) whose connections to the company emerged only when FDA officials required them to declare who paid for their travel to the meeting. The company took full advantage of its connections in government, enlisting an influential former Congressman-to whom the secretary of agriculture owed his appointment-to discourage federal studies of the economic effects of rBGH.19 Monsanto wielded other kinds of influence. It withheld consent to publish a peer-reviewed article by independent researchers who used the company's data to measure amounts of white blood cells-an indicator of mastitis-in rBGH milk. Monsanto reserved the right to publish its own data first but delayed doing so for several years; this delay effectively prevented the FDA from considering the independent analysis during the rBGH approval process. Monsanto researchers argued that mastitis white cell counts depend on how much milk is produced, whether or not the cow is treated with rBGH. In contrast, the independent investigators found milk from rBGH-treated cows to contain more white cells, although they could not say whether the higher counts were due to the drug itself or to the higher milk yield. Eventually, they published the results and revealed the dispute.20 In another incident, Monsanto lawyers pressured Fox Television to refuse a four-part series on rBGH commissioned by one of its Florida stations from two staff investigative reporters. The station suspended the reporters and did not air the series. The reporters documented sales of rBGH-milk by Florida grocers who had pledged not to sell it, and inadequacies in state screening methods for antibiotics in the treated milk. They also said that Monsanto had offered as much as $2 million to Canadian regulators who were considering approval of rBGH, and had made large gifts to universities whose researchers provided data in support of FDA approval. They established a Web site to describe their side of the story and filed a whistle-blower lawsuit against the television station. The case went to trial in mid-2000; it resulted in a clear win for the reporters. The jury agreed that Fox "acted intentionally and deliberately to falsify or distort the plaintiffs' news reporting on BGH," and awarded a judgment of $425,000 in damages.21 These incidents were only the most public-and documented-of Monsanto's actions, most of which took place behind closed doors in Congress, at the FDA, and (as rumored) at newspapers planning to run stories on the possible hazards of rBGH. These incidents were only the most public-and documented-of Monsanto's actions, most of which took place behind closed doors in Congress, at the FDA, and (as rumored) at newspapers planning to run stories on the possible hazards of rBGH.
Monsanto's Campaign against Labeling. Monsanto steadfastly resisted demands for labeling of rBGH milk and recruited dairy industry executives to persuade the FDA to establish favorable labeling guidelines. The company hired two Washington law firms to monitor dairies for advertising and labeling violations and to instigate legal action against milk processors who had "inappropriately" misled customers through labeling practices.22 The FDA asked the Food Advisory Committee to hear testimony on the labeling issue. A Monsanto official explained the company's position. Because its surveys indicated that 60% of consumers thought that rBGH labeling implied a safety or contamination risk, mandatory labeling would violate the spirit and intent of the labeling laws and would also "diminish the credibility of the food label and would represent a clear step backward from the wonderful progress that has been achieved." The FDA asked the Food Advisory Committee to hear testimony on the labeling issue. A Monsanto official explained the company's position. Because its surveys indicated that 60% of consumers thought that rBGH labeling implied a safety or contamination risk, mandatory labeling would violate the spirit and intent of the labeling laws and would also "diminish the credibility of the food label and would represent a clear step backward from the wonderful progress that has been achieved."23 Because the FDA seemed already to have decided the issue and the Advisory Committee's role was just that-to advise-critics viewed the hearings as a "public relations smokescreen" and "a regulatory charade." Because the FDA seemed already to have decided the issue and the Advisory Committee's role was just that-to advise-critics viewed the hearings as a "public relations smokescreen" and "a regulatory charade."24 Some dairy companies, concerned that consumers might not want to buy milk from hormone-treated cows, began labeling their products "BGH-free." Monsanto and its industry supporters objected and asked the FDA to establish guidance "rules" on the labeling of dairy products derived from cows not not treated with rBGH. In February 1994, the FDA stated that it could not require such labeling, but companies could voluntarily say they were not using rBGH, provided "that any statements made are truthful and not misleading." Although this ruling might sound permissive, the FDA considers "misleading" to apply to any suggestion that untreated milk is superior. Thus, the agency views treated with rBGH. In February 1994, the FDA stated that it could not require such labeling, but companies could voluntarily say they were not using rBGH, provided "that any statements made are truthful and not misleading." Although this ruling might sound permissive, the FDA considers "misleading" to apply to any suggestion that untreated milk is superior. Thus, the agency views BGH-free BGH-free as misleading because all milk contains some natural BGH. The term as misleading because all milk contains some natural BGH. The term rBGH-free rBGH-free also is misleading because the recombinant and natural cow hormones cannot be distinguished. Dairy companies may use such terms only if they provide an explanation of the context: "No significant difference has been shown between milk derived from rBGH-treated and non-rBGH-treated cows." also is misleading because the recombinant and natural cow hormones cannot be distinguished. Dairy companies may use such terms only if they provide an explanation of the context: "No significant difference has been shown between milk derived from rBGH-treated and non-rBGH-treated cows."25 Vermont, which boasts of its quality dairy products, defied the FDA ruling and passed legislation requiring rBGH milk to be labeled: "Vermonters have the right to know what is in the food they eat. . . . In particular, there is a strong public interest in knowing whether or not rBST has been used in the production of milk and milk products."26 Industry groups acting on behalf of Monsanto quickly and successfully challenged this law in the courts. When several major milk marketers launched new brands certified as coming from cows that had not been treated with the hormone, Monsanto warned them that their labels "might create the impression that something is wrong with milk from treated cows." Industry groups acting on behalf of Monsanto quickly and successfully challenged this law in the courts. When several major milk marketers launched new brands certified as coming from cows that had not been treated with the hormone, Monsanto warned them that their labels "might create the impression that something is wrong with milk from treated cows."27 By May 1994, Monsanto had sued at least two dairy companies on this basis, a situation that made it appear as if "everyone is terrified of Monsanto. . . . It is quite ominous." By May 1994, Monsanto had sued at least two dairy companies on this basis, a situation that made it appear as if "everyone is terrified of Monsanto. . . . It is quite ominous."28 In Vermont, only a small fraction of farmers continued to use rBGH. Companies like Ben & Jerry's used their rBGH-free status as a marketing tool, as shown in In Vermont, only a small fraction of farmers continued to use rBGH. Companies like Ben & Jerry's used their rBGH-free status as a marketing tool, as shown in figure 19 figure 19: "We oppose recombinant bovine growth hormone. The family farmers who supply our milk and cream pledge not to treat their cows with rBGH."
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FIGURE 19. Soon after the FDA's approval of recombinant bovine growth hormone (rBGH), Ben & Jerry's used product labels to display the company's policy on this drug. These statements conform to the FDA's 1994 guidelines on voluntary labeling of milk products derived from cows that had not been treated with rBGH.
Monsanto's Revolving Door to the FDA. A nagging concern throughout the deliberations over rBGH was the revolving door through which employees of Monsanto and FDA exchanged positions. In Washington, DC, the law firm King & Spalding filed a brief with the FDA on behalf of Monsanto arguing that the agency could not legally justify a labeling requirement for rBGH milk. The primary author of the document was a former FDA chief counsel.29 Furthermore, three FDA staff members involved in rBGH regulatory decisions had previously worked for Monsanto, either directly or indirectly. This connection led several members of Congress to question whether the FDA had colluded with Monsanto in approving the drug, and they demanded a GAO investigation. Furthermore, three FDA staff members involved in rBGH regulatory decisions had previously worked for Monsanto, either directly or indirectly. This connection led several members of Congress to question whether the FDA had colluded with Monsanto in approving the drug, and they demanded a GAO investigation.30 The GAO reviewed more than 40,000 pages of documents, interviewed 54 people, and evaluated the financial disclosures and conflict-of-interest statements of all FDA employees involved in the rBGH approval. Although the GAO concluded "there were no conflicting financial interests," its report raised discomfiting questions. One FDA employee, Dr. Margaret Miller, worked for Monsanto from 1985 to 1989 as a laboratory supervisor responsible for evaluating tests that measured rBGH and IGF-1 levels in cow blood, tissues, and milk. Within a year or so of leaving Monsanto, she was helping draft FDA responses to citizens' petitions seeking to halt sales of rBGH milk and to congressional queries about rBGH. She also contributed advice on matters directly related to rBGH approval. GAO investigators said she had followed the letter of federal ethics regulations, but expressed some concerns about her adherence to their spirit. They said the FDA commissioner was so "visibly surprised" in 1993 to learn of Dr. Miller's employment with Monsanto that he ordered an internal review of her activities. Although the internal review also concluded that she had not violated ethical standards, it said her participation in rBGH matters "does raise questions." The GAO reviewed more than 40,000 pages of documents, interviewed 54 people, and evaluated the financial disclosures and conflict-of-interest statements of all FDA employees involved in the rBGH approval. Although the GAO concluded "there were no conflicting financial interests," its report raised discomfiting questions. One FDA employee, Dr. Margaret Miller, worked for Monsanto from 1985 to 1989 as a laboratory supervisor responsible for evaluating tests that measured rBGH and IGF-1 levels in cow blood, tissues, and milk. Within a year or so of leaving Monsanto, she was helping draft FDA responses to citizens' petitions seeking to halt sales of rBGH milk and to congressional queries about rBGH. She also contributed advice on matters directly related to rBGH approval. GAO investigators said she had followed the letter of federal ethics regulations, but expressed some concerns about her adherence to their spirit. They said the FDA commissioner was so "visibly surprised" in 1993 to learn of Dr. Miller's employment with Monsanto that he ordered an internal review of her activities. Although the internal review also concluded that she had not violated ethical standards, it said her participation in rBGH matters "does raise questions."
GAO investigators were even more troubled by issues related to the role of Michael Taylor. Mr. Taylor, whom we encountered in chapter 2 chapter 2 as the courageous USDA official responsible for instituting Pathogen Reduction: HACCP, began his career as a lawyer with the FDA. He left the agency to work for King & Spalding, the firm representing Monsanto, but returned to the FDA in 1991 as deputy commissioner for policy, and he held that position during the time the agency conducted its rBGH safety review. At the time, Mr. Taylor had been with the FDA for more than two years, but newly passed ethical guidelines applied only to the first year of employment, so his activities were "not covered by the appearance of loss of impartiality provisions." as the courageous USDA official responsible for instituting Pathogen Reduction: HACCP, began his career as a lawyer with the FDA. He left the agency to work for King & Spalding, the firm representing Monsanto, but returned to the FDA in 1991 as deputy commissioner for policy, and he held that position during the time the agency conducted its rBGH safety review. At the time, Mr. Taylor had been with the FDA for more than two years, but newly passed ethical guidelines applied only to the first year of employment, so his activities were "not covered by the appearance of loss of impartiality provisions."31 Mr. Taylor is a coauthor of the FDA's 1992 policy statement on genetically engineered plant foods (discussed below), and he signed the Federal Register Federal Register notice on labeling of rBGH milk. Although other FDA officials responsible for those policies shared his views, court documents later released as a result of a 1999 lawsuit revealed considerable disagreement about the policies within the agency. FDA officials told the GAO that Mr. Taylor had recused himself from matters related to rBGH and "never sought to influence the thrust or content" of the agency's policies. Nevertheless, Congressman Bernard Sanders (Ind-VT) viewed Mr. Taylor's involvement as casting doubt about the impartiality of the rBGH review process. Mr. Sanders said the ethics rules in this situation "were often stretched to the breaking point and were broken on a number of occasions. The FDA allowed corporate influence to run rampant in its approval of BGH. . . . This is exactly the kind of thing that sends consumers the message that federal bureaucrats care more about corporate profits than they do about consumer health and safety. . . . The bottom line is that Monsanto's product received favorable treatment when it probably should not have." notice on labeling of rBGH milk. Although other FDA officials responsible for those policies shared his views, court documents later released as a result of a 1999 lawsuit revealed considerable disagreement about the policies within the agency. FDA officials told the GAO that Mr. Taylor had recused himself from matters related to rBGH and "never sought to influence the thrust or content" of the agency's policies. Nevertheless, Congressman Bernard Sanders (Ind-VT) viewed Mr. Taylor's involvement as casting doubt about the impartiality of the rBGH review process. Mr. Sanders said the ethics rules in this situation "were often stretched to the breaking point and were broken on a number of occasions. The FDA allowed corporate influence to run rampant in its approval of BGH. . . . This is exactly the kind of thing that sends consumers the message that federal bureaucrats care more about corporate profits than they do about consumer health and safety. . . . The bottom line is that Monsanto's product received favorable treatment when it probably should not have."32 Monsanto's Political Success. Monsanto succeeded in obtaining FDA approval of rBGH without a labeling requirement. In March 1995, the company claimed that it had sold 14.5 million doses of rBGH during the previous year and that 13,000 dairy farmers, representing 11% of the potential market, were using the hormone. Sales were especially strong in New York (where 10% of dairy farmers used the drug) and Wisconsin (15%), but were especially weak in Vermont. Although early sales fell short of expectations, Monsanto says that rBGH broke even in 1996, increased sales by 30% in 1997, and has been profitable ever since. As one sympathetic observer explained, "a profit-oriented company like Monsanto wouldn't make that kind of investment for a product that's not successful . . . rBST is saving dairy farming."33 USDA economists maintain that the controversy over use of rBGH has had little effect on consumer demand for milk, principally because of lack of evidence of harm.34 Consumer attitudes toward rBGH milk in the United States are difficult to evaluate, however, not least because of the lack of labeling. Surveys that deliberately probe outrage factors tend to identify substantial concern about the safety of rBGH, especially among people who do not trust the FDA or perceive little benefit from the product. In contrast, industry-sponsored surveys reveal lukewarm opinions on the matter. For example, respondents to a 1994 survey reacted positively, but only slightly so (scoring 6.18 on a scale where 10 is strongly positive), to this reassuring statement: "The National Institutes of Health, the American Medical Association, and several other independent medical groups have found milk from cows that receive BST is unchanged, safe, and nutritionally the same as milk currently on grocery store shelves. Given this information, how acceptable do you find the use of BST?" Consumer attitudes toward rBGH milk in the United States are difficult to evaluate, however, not least because of the lack of labeling. Surveys that deliberately probe outrage factors tend to identify substantial concern about the safety of rBGH, especially among people who do not trust the FDA or perceive little benefit from the product. In contrast, industry-sponsored surveys reveal lukewarm opinions on the matter. For example, respondents to a 1994 survey reacted positively, but only slightly so (scoring 6.18 on a scale where 10 is strongly positive), to this reassuring statement: "The National Institutes of Health, the American Medical Association, and several other independent medical groups have found milk from cows that receive BST is unchanged, safe, and nutritionally the same as milk currently on grocery store shelves. Given this information, how acceptable do you find the use of BST?"35 Despite such attempts to guide public opinion, surveys demonstrate consistent support for labeling rBGH and all transgenic products. Although the industry demands that the marketplace decide the commercial fate of the hormone, consumers cannot easily make their opinions known if the products are not labeled. One index of underlying public opinion is the spectacular growth in sales of organic ("rBGH-free") milk from $16 million in 1996 to almost $31 million in 1997, a rate of increase substantially higher than that of nearly any other food product.36 I have heard Monsanto officials say that company scientists developed rBGH because it was technically possible to do so and that they had given no thought to its societal implications. In 1996 I visited the company offices in St. Louis and met Monsanto scientists who had worked on the project. They told me that they believed rBGH would help produce more milk, and more milk would help to alleviate world food shortages. Whatever the motives, once the company committed research funding to rBGH, it needed to recoup the investment, and it appears to have done so. Furthermore, Monsanto's determined effort to achieve approval of rBGH succeeded in a more important respect. Because rBGH raised more safety issues than the transgenic foods that followed, its approval smoothed the way for subsequent FDA actions on herbicide- and I have heard Monsanto officials say that company scientists developed rBGH because it was technically possible to do so and that they had given no thought to its societal implications. In 1996 I visited the company offices in St. Louis and met Monsanto scientists who had worked on the project. They told me that they believed rBGH would help produce more milk, and more milk would help to alleviate world food shortages. Whatever the motives, once the company committed research funding to rBGH, it needed to recoup the investment, and it appears to have done so. Furthermore, Monsanto's determined effort to achieve approval of rBGH succeeded in a more important respect. Because rBGH raised more safety issues than the transgenic foods that followed, its approval smoothed the way for subsequent FDA actions on herbicide- and Bt- Bt- resistant crops. During the time the FDA was responding to pressures to approve rBGH, its staff was also working on policies for approval of transgenic foods. resistant crops. During the time the FDA was responding to pressures to approve rBGH, its staff was also working on policies for approval of transgenic foods.
The Politics of Transgenic Food Plants Until now, this chapter has examined the politics of a genetically engineered drug, albeit one involved in food production. We now turn to genetically engineered foods themselves. In mid-1992, the FDA issued a policy statement on the regulation of plant foods produced through biotechnology. Figure 20 Figure 20 outlines this policy. As explained by FDA commissioner Dr. David Kessler, the agency developed the policy to be "scientifically and legally sound and . . . adequate to fully protect public health while not inhibiting innovation." outlines this policy. As explained by FDA commissioner Dr. David Kessler, the agency developed the policy to be "scientifically and legally sound and . . . adequate to fully protect public health while not inhibiting innovation."37 He said the policy reflected the prevailing view among senior FDA officials that foods produced through recombinant DNA techniques raised no new safety concerns and therefore could be overseen by applying the agency's existing rules for food additives. In FDA-speak: "In most cases, the substances expected to become components of food as a result of genetic modification of a plant will be the same as or He said the policy reflected the prevailing view among senior FDA officials that foods produced through recombinant DNA techniques raised no new safety concerns and therefore could be overseen by applying the agency's existing rules for food additives. In FDA-speak: "In most cases, the substances expected to become components of food as a result of genetic modification of a plant will be the same as or substantially similar substantially similar to substances commonly found in food" (emphasis added). The FDA would only require premarket review for foods that contained known allergens or toxins or were substantially altered in nutrient content. to substances commonly found in food" (emphasis added). The FDA would only require premarket review for foods that contained known allergens or toxins or were substantially altered in nutrient content.38 The doctrine of substantial similarity substantial similarity, or substantial equivalence substantial equivalence as it later came to be called, meant that the FDA would be taking after-the-fact action to recall products if they caused problems. The agency's safety evaluation would focus on changes in the "objective" characteristics of foods-new substances, toxins, allergens, or nutrients-not on the techniques used to produce them. To determine whether transgenic foods raised safety concerns, the FDA would hold private "consultations" with industry. These would be as it later came to be called, meant that the FDA would be taking after-the-fact action to recall products if they caused problems. The agency's safety evaluation would focus on changes in the "objective" characteristics of foods-new substances, toxins, allergens, or nutrients-not on the techniques used to produce them. To determine whether transgenic foods raised safety concerns, the FDA would hold private "consultations" with industry. These would be voluntary voluntary. The agency would require them only when the objective characteristics raised safety questions; otherwise, companies would not need to obtain approval in advance, conduct premarket safety evaluations, or label the foods in any special way. These policies remained in place until 2001, when the FDA required premarket notification.39 [image]
FIGURE 20. The FDA's 1992 policy on the safety assessment of genetically modified plants. Companies did not need to consult FDA unless the transgenic plants contained allergens, toxins, or unusual components, or exhibited significant alterations in nutrient content. (Source: FDA. Federal Register Federal Register 57:2298423005, May 29, 1992.) 57:2298423005, May 29, 1992.) The food biotechnology industry welcomed these 1992 "efforts by the White House to provide . . . as much regulatory relief as possible," and viewed the policy as "a very strong incentive for investment in the agricultural/food biotechnology area."40 One investment analyst summarized the FDA's announcement as an "assurance that after all a company's planning for a picnic, the government won't rain on it." One investment analyst summarized the FDA's announcement as an "assurance that after all a company's planning for a picnic, the government won't rain on it."41 Consumer groups, however, criticized the policy as inadequate to protect public safety and threatened mail campaigns and legal challenges. A 1999 lawsuit, for example, obtained 44,000 pages of documents related to the FDA policy. The documents revealed that some FDA scientists had been concerned about the lack of data on safety risks and thought the policy too favorable to the industry. Overall, the (ultimately unsuccessful) lawsuit concluded, "There is more than enough evidence to convince a reasonable man or woman that current FDA policy is unscientific, unwise, irresponsible, and illegal." Consumer groups, however, criticized the policy as inadequate to protect public safety and threatened mail campaigns and legal challenges. A 1999 lawsuit, for example, obtained 44,000 pages of documents related to the FDA policy. The documents revealed that some FDA scientists had been concerned about the lack of data on safety risks and thought the policy too favorable to the industry. Overall, the (ultimately unsuccessful) lawsuit concluded, "There is more than enough evidence to convince a reasonable man or woman that current FDA policy is unscientific, unwise, irresponsible, and illegal."42 Other critics attacked the idea of substantial equivalence as a basis for policy. "Substantial equivalence," they said, "is a pseudoscientific concept because it is a commercial and political judgment masquerading as if it were scientific. It is, moreover, inherently antiscientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests. It therefore serves to discourage and inhibit potentially informative scientific research." Other critics attacked the idea of substantial equivalence as a basis for policy. "Substantial equivalence," they said, "is a pseudoscientific concept because it is a commercial and political judgment masquerading as if it were scientific. It is, moreover, inherently antiscientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests. It therefore serves to discourage and inhibit potentially informative scientific research."43 In the meantime, critics seized on the lack of labeling as a cause for action. Celebrity chefs in New York City called for a boycott of genetically engineered foods. The chef leading the boycott, Rick Moonen (then at Oceana, New York City), explained to the press: "As a chef, I am responsible for every plate of food in my restaurant. . . . The consumers put their dietetic, religious and allergic confidences in my hands, and with no requirements for safety testing, I am not permitted to fulfill my obligations. But what is most disturbing to me is the idea of selling the food without a label."44 Some commentators understood that the no-labeling policy of "least regulatory resistance" would increase public suspicion of genetically engineered foods, especially since press accounts had begun referring to them as Frankenfoods Frankenfoods, and cartoonists were taking full advantage of this satirical opportunity. Figure 21 Figure 21 gives one such example. To allay public fears, a federal study recommended a formal review of the entire federal regulatory framework for food biotechnology in order to establish a more equitable balance between promotion of the industry and protection of the public, but no such review took place. The FDA went forward with the policy and by the end of 1995 had approved the marketing of tomatoes genetically engineered to reach optimal ripening after they were picked; squash resistant to viruses; potatoes and corn resistant to insects; and cotton, corn, and soybeans resistant to herbicides. By mid-2001, the FDA had accomplished 52 consultations on these and other genetically modified food plants, meaning that they could now be marketed. gives one such example. To allay public fears, a federal study recommended a formal review of the entire federal regulatory framework for food biotechnology in order to establish a more equitable balance between promotion of the industry and protection of the public, but no such review took place. The FDA went forward with the policy and by the end of 1995 had approved the marketing of tomatoes genetically engineered to reach optimal ripening after they were picked; squash resistant to viruses; potatoes and corn resistant to insects; and cotton, corn, and soybeans resistant to herbicides. By mid-2001, the FDA had accomplished 52 consultations on these and other genetically modified food plants, meaning that they could now be marketed.45 The first of these consultations began in 1991 and concluded in 1994. Because it established the precedent for approval of subsequent foods, we now examine the politics of Calgene's delayed ripening tomato, the "Flavr Savr," and the fate of transgenic tomatoes in the United States and Great Britain. The first of these consultations began in 1991 and concluded in 1994. Because it established the precedent for approval of subsequent foods, we now examine the politics of Calgene's delayed ripening tomato, the "Flavr Savr," and the fate of transgenic tomatoes in the United States and Great Britain.
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FIGURE 21. The FDA's relaxed regulatory stance on genetically modified foods elicited this response from New Yorker New Yorker cartoonist Donald Reilly. ( The New Yorker Collection 1992 Donald Reilly from cartoonbank.com. All rights reserved.) cartoonist Donald Reilly. ( The New Yorker Collection 1992 Donald Reilly from cartoonbank.com. All rights reserved.) The Politics of Transgenic Tomatoes, Labeled To biotechnology companies looking for commercially viable projects, tomatoes are a good investment. Americans expect tomatoes to be readily available, regardless of season. In the early 1990s, American farmers were producing more than 13 pounds (5.9 kilograms) per capita of fresh tomatoes and another 75 pounds (34 kilograms) for processing; the market for fresh tomatoes was worth $35 billion annually, and that for processed tomatoes even more. Most supermarket tomatoes are bred for disease resistance, appearance, and durability rather than taste, are picked when green, and are the bane of consumers longing for "backyard" flavor and freshness. Tomatoes taste better when they are picked ripe. They also have a higher content of solids-sugars and starches-that make them more economical to process into tomato paste and sauce.46 For these reasons, several biotechnology companies were working on tomato projects. For these reasons, several biotechnology companies were working on tomato projects.
Calgene's Flavr Savr. Beginning in the mid-1980s, Calgene, a California-based biotechnology company, invested $25 million and eight years of effort to alter the gene in tomatoes that causes softening. They constructed the tomato to contain its own gene, but with the DNA in reverse order. This manipulation slowed the gene's action, delayed ripening, and allowed the tomato to be picked at a more mature stage of ripeness and taste. Calgene expected its trademarked "MacGregor's tomatoes, grown from Flavr Savr seeds," to capture at least 15% of the market as soon as they became available. The company's initial marketing strategy differed from Monsanto's approach to rBGH milk; it was utterly transparent. Calgene labeled labeled the tomatoes as genetically engineered: "Thank you for buying MacGregor's tomatoes. . . . Since 1982, the MacGregor's team of hard-working professional men and women has successfully applied the latest developments in genetic engineering, tomato plant breeding, and farming to solve an age old problem-how to supply an abundance of great-tasting tomatoes all year round." the tomatoes as genetically engineered: "Thank you for buying MacGregor's tomatoes. . . . Since 1982, the MacGregor's team of hard-working professional men and women has successfully applied the latest developments in genetic engineering, tomato plant breeding, and farming to solve an age old problem-how to supply an abundance of great-tasting tomatoes all year round." Figure 22 Figure 22 depicts the tomato-shaped package insert containing these statements. depicts the tomato-shaped package insert containing these statements.
Calgene's strategy differed from Monsanto's in another respect. In 1989, it voluntarily voluntarily sought FDA guidance on the regulatory status of this first transgenic food, long before it was ready to market. The company's motivation was quite explicit: public relations. If the FDA approved the tomato, consumers would believe it safe to eat. The ensuing ordeal lasted nearly four years. A former Calgene scientist, Dr. Belinda Martineau, recounts these events in her lively 2001 book, sought FDA guidance on the regulatory status of this first transgenic food, long before it was ready to market. The company's motivation was quite explicit: public relations. If the FDA approved the tomato, consumers would believe it safe to eat. The ensuing ordeal lasted nearly four years. A former Calgene scientist, Dr. Belinda Martineau, recounts these events in her lively 2001 book, First Fruit First Fruit. The FDA, she says, "put Calgene through the wringer" in what turned out to be "a long, hard, even painful process."47 The wringing began in 1991 with a consultation with FDA about whether the Flavr Savr would be subject to the same regulations as conventional tomatoes. The answer: not exactly. Instead, the FDA asked Calgene to provide extensive information about the tomato's safety and nutrient content. The company published a book in response to this request in 1992. Calgene then asked the FDA for a ruling on whether its scientists could use the gene for resistance to the antibiotic kanamycin (neomycin) as a selection marker, and petitioned for approval of the kanamycin-resistant gene as a food additive. While the FDA was dealing with these requests and asking for more data, the company did some public relations and lobbying. It convinced the Biotechnology Industry Organization, then a trade association of mostly pharmaceutical biotechnology companies, to represent the interests of agricultural biotechnology companies as well. Calgene officials met with high-ranking political leaders at the White House and provided members of Congress with bacon, lettuce, and Flavr Savr sandwiches. They also supplied tomatoes for press tastings and industry-sponsored events. The wringing began in 1991 with a consultation with FDA about whether the Flavr Savr would be subject to the same regulations as conventional tomatoes. The answer: not exactly. Instead, the FDA asked Calgene to provide extensive information about the tomato's safety and nutrient content. The company published a book in response to this request in 1992. Calgene then asked the FDA for a ruling on whether its scientists could use the gene for resistance to the antibiotic kanamycin (neomycin) as a selection marker, and petitioned for approval of the kanamycin-resistant gene as a food additive. While the FDA was dealing with these requests and asking for more data, the company did some public relations and lobbying. It convinced the Biotechnology Industry Organization, then a trade association of mostly pharmaceutical biotechnology companies, to represent the interests of agricultural biotechnology companies as well. Calgene officials met with high-ranking political leaders at the White House and provided members of Congress with bacon, lettuce, and Flavr Savr sandwiches. They also supplied tomatoes for press tastings and industry-sponsored events.48 I ate Flavr Savr tomatoes for lunch at a 1994 biotechnology industry meeting in New York City. I thought they tasted like I ate Flavr Savr tomatoes for lunch at a 1994 biotechnology industry meeting in New York City. I thought they tasted like tomatoes tomatoes, better than supermarket varieties but not nearly as good as those available at farmers' markets in August.
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FIGURE 22. A 1992 press kit for Calgene's genetically modified Flavr Savr tomatoes (neither approved nor marketed at that time) contained this proposed package label. The label not only disclosed the genetic modification but also explained its key elements: a reversed gene for softening and an antibiotic-resistance marker. The FDA approved the tomatoes in 1994, but Calgene never mass-marketed them.
The FDA review process went slowly because the science was in its infancy and Calgene researchers had to scramble to respond to the agency's requests. Dr. Martineau's book describes the haste with which Calgene scientists conducted the research. Eventually, the FDA ran out of issues for which it could demand evidence and asked the Food Advisory Committee to review the Calgene materials. I was a member of the committee during that review. We had no obvious reason to think the Flavr Savr unsafe. The tomato contained its own gene and seemed more innocuous than rBGH. The use of the antibiotic-resistance marker gene was the one issue debated. Nevertheless, some of us were troubled by the FDA's insistence that our discussion focus exclusively on safety questions. We were prohibited from raising any other issues-the effect that transgenic tomatoes might have on local tomato growers, for example. The benefit of the tomatoes to consumers seemed to be a taste only marginally better than that of standard supermarket varieties. Furthermore, the Flavr Savr would be expensive-two or three times the price of conventional tomatoes-and the higher cost identified it as a luxury product targeted to an upscale market. Such factors, and whether anyone needed such a tomato, were not open to consideration.
The FDA approved the tomato in May 1994, a decision enthusiastically applauded by the agricultural biotechnology industry. Some consumer groups observed that the FDA's review had been an anomaly because Calgene had volunteered for it and companies were not required to produce safety data. Some antibiotechnology groups such as the Pure Food Campaign led by Jeremy Rifkin, threatened picket lines, tomato dumpings, boycotts, and legal challenges. Mr. Rifkin said, "Calgene has miscalculated in the most profound way. It spent an enormous amount of money and it never asked the simplest question: Do people want this tomato? And I say people don't want this tomato. The bottom line is, who needs it?"49 Despite such objections, I thought people would buy the tomato if they perceived the improved taste to be worth the increased cost. Within days after the FDA approval, Calgene began test marketing the tomatoes in California and Illinois-priced competitively. By all reports the first Flavr Savr tomatoes flew off the shelves. Despite such objections, I thought people would buy the tomato if they perceived the improved taste to be worth the increased cost. Within days after the FDA approval, Calgene began test marketing the tomatoes in California and Illinois-priced competitively. By all reports the first Flavr Savr tomatoes flew off the shelves.
It soon became evident that problems other than pricing would determine the Flavr Savr's success. The company developed the tomatoes in California but grew them in Florida, where they did not easily adapt to local climate, pest, or commercial contracting conditions. During transportation, the tomatoes turned to mush. Calgene was unable to solve these problems and gave up on the product. Despite the marketing disaster, the tomato produced commercial benefits. FDA approval of the relatively benign Flavr Savr paved the way for subsequent approvals of Calgene's seed oils, herbicide-resistant cotton, and other transgenic foods. Calgene hoped that these products might prove profitable and help overcome its reported losses of more than $80 million; it continued to report losses through 1994. In 1995, Monsanto bought nearly half the company and owned all of it by 1997.50 The Flavr Savr gamble made it easier for other companies to obtain FDA approvals for their products, and the entire industry owed Calgene a debt of gratitude. Although the FDA subsequently approved transgenic tomatoes produced by other companies, no such varieties were available fresh in supermarkets late in 2002. The Flavr Savr gamble made it easier for other companies to obtain FDA approvals for their products, and the entire industry owed Calgene a debt of gratitude. Although the FDA subsequently approved transgenic tomatoes produced by other companies, no such varieties were available fresh in supermarkets late in 2002.
GM Tomato Paste. During the FDA committee review, I was surprised by Calgene's determination to grow fresh tomatoes for sale in supermarkets-no matter how upscale-because processed tomatoes seemed to be a more secure business opportunity. People eat more processed tomatoes than fresh (on pizza, for example), and the higher content of solids in transgenic tomatoes meant that turning them into sauce and paste would be more efficient and less costly. European biotechnology companies that were genetically engineering their own tomatoes understood that such price advantages could be passed along to consumers. In the halcyon preprotest days of 1996, the British company Zeneca, which had obtained FDA approval for transgenic tomatoes the previous year, began to use them in tomato paste. The British grocery chain Sainsbury sold the paste with the prominent label shown in figure 23 figure 23: MADE WITH GENETICALLY MODIFIED TOMATOES MADE WITH GENETICALLY MODIFIED TOMATOES. Sainsbury and other retailers knew their customers. Before putting the labeled paste on its supermarket shelves in January 1998, Safeway, for example, spent 15 months consulting with consumer groups, conducting focus-group research, and preparing advertising materials. Its promotional materials, like those for Calgene's Flavr Savr, reflected the company's certainty that consumers would accept the product.
Scientists have now identified the gene that makes tomatoes turn soft during ripening, and they've also found a way of switching the gene off. This means that the tomatoes can be left to ripen on the plant until they have their full flavour and colour. . . . [They] remain firm after harvesting . . . with reduced wastage. As less tomatoes go to waste, best use is made of water, a scarce commodity in California where the tomatoes are grown. In addition, as the tomatoes contain less water, less energy is used during processing. Together, these improvements mean that Safeway's tomato puree, made from genetically modified tomatoes, is available at a reduced price.51 [image]
FIGURE 23. British grocery chains sold genetically modified tomato paste labeled as such in 1998. As public opposition to such foods increased, retailers instituted GM-free policies and refused to stock products made with transgenic ingredients.
By mid-1998, Sainsbury's had sold about 1 million units of the tomato paste, and a spokesman for Safeway said that it and Sainsbury's "are adamant that their clearly labelled GM tomato purees have consistently out-performed the non-GM alternative." He also said that 99% of people who bought the "GM" puree were aware of its origins.52 This last figure hardly seems credible, even for the British population, especially because one result of the publicity generated by Dr. Pusztai's potato lectin research (discussed in This last figure hardly seems credible, even for the British population, especially because one result of the publicity generated by Dr. Pusztai's potato lectin research (discussed in chapter 6 chapter 6) was to surprise the public with the revelation that supermarkets were full of genetically modified foods.
The furor over that revelation and the subsequent events in the Pusztai affair led to consumer protests and a drop in sales of the transgenic paste. Retailers had plenty of other foods to sell and saw little reason to defend controversial items. Seven supermarket chains, Sainsbury's among them, announced that they no longer intended to sell genetically modified foods, and planned to take "reasonable steps" to ensure that the products did not contain such ingredients.53 In this instance, the political implications of a safety issue caused a successful and cheaper product to be removed from the market. In the next chapter, we will examine how antibiotechnology advocates accomplished such GM-free policies. In the meantime, let's leave the science-based approach of the FDA and consider a particularly political aspect of the EPA's regulatory approach: how one of its regulatory targets, In this instance, the political implications of a safety issue caused a successful and cheaper product to be removed from the market. In the next chapter, we will examine how antibiotechnology advocates accomplished such GM-free policies. In the meantime, let's leave the science-based approach of the FDA and consider a particularly political aspect of the EPA's regulatory approach: how one of its regulatory targets, plant-pesticides plant-pesticides, instead came to be called by a euphemism, plant-incorporated protectants plant-incorporated protectants.
THE EPA'S EUPHEMISM-BASED APPROACH The FDA is not the only agency that has to deal with questions of labeling; the EPA has its own set of labeling problems related to transgenic foods. The Coordinated Framework makes the USDA and the EPA the primary agencies for deciding whether transgenic plants are safe to grow in fields. Under the framework's curious division of responsibility, the USDA regulates herbicide-resistant plants plants such as those that are Roundup Ready, but the EPA regulates such as those that are Roundup Ready, but the EPA regulates pesticides pesticides and, therefore, Roundup itself. The laws that govern EPA actions are designed to deal with the safety of such chemical pesticides. Under those laws, the EPA requires pesticide makers to obtain permits-"registrations"-before releasing the chemicals into the environment. Registrations require safety evaluations. and, therefore, Roundup itself. The laws that govern EPA actions are designed to deal with the safety of such chemical pesticides. Under those laws, the EPA requires pesticide makers to obtain permits-"registrations"-before releasing the chemicals into the environment. Registrations require safety evaluations.
At issue was what to do about the Bt Bt toxin. The toxin is a pesticide, but it is genetically engineered into plant tissues. In 1994, as part of its response to the Coordinated Framework, the EPA proposed to apply the laws governing chemical pesticides to transgenic crop plants containing toxin. The toxin is a pesticide, but it is genetically engineered into plant tissues. In 1994, as part of its response to the Coordinated Framework, the EPA proposed to apply the laws governing chemical pesticides to transgenic crop plants containing Bt Bt and other such toxins and, by analogy, call them and other such toxins and, by analogy, call them plant-pesticides plant-pesticides. This expanded definition made sense, according to the agency, because the large-scale application of Bt Bt crops "could result in new or unique exposures of nontarget organisms, including humans." crops "could result in new or unique exposures of nontarget organisms, including humans."54 As we have seen, however, the primary concerns about transgenic crops containing such toxins are about what they might do to the environment: displace existing crops, create resistant weeds, disrupt ecosystems, reduce crop diversity, or, as the most emotionally charged of such problems, kill monarch butterflies. Furthermore, widespread plantings of transgenic As we have seen, however, the primary concerns about transgenic crops containing such toxins are about what they might do to the environment: displace existing crops, create resistant weeds, disrupt ecosystems, reduce crop diversity, or, as the most emotionally charged of such problems, kill monarch butterflies. Furthermore, widespread plantings of transgenic Bt Bt crops might undermine the use of this toxin in organic agriculture. Organic growers use crops might undermine the use of this toxin in organic agriculture. Organic growers use Bt Bt as a temporary spray that washes off in the rain. The permanent integration of the transgenic as a temporary spray that washes off in the rain. The permanent integration of the transgenic Bt Bt toxin into widely planted crops could spread the toxin into widely planted crops could spread the Bt Bt trait by pollinating related weeds or organically grown crops and promote trait by pollinating related weeds or organically grown crops and promote Bt- Bt- resistance in insect pests. resistance in insect pests.55 To monitor such possibilities, the EPA proposed that developers of transgenic plants register them in the same way as conventional pesticides; evaluate their environmental fate, ecological impact, effects on human health, and potential for inducing resistance; and label them as plant-pesticides. Despite EPA's assurance that the rules would help companies resolve regulatory uncertainties, inspire confidence, and attract investors, most segments of the industry were not pleased. Some industry groups objected that complying with these regulations would cost companies from $60,000 to $1 million per product. Others called the proposals anachronistic, burdensome, and unnecessary, and said such rules would "exert a profoundly negative effect on agricultural research and on the commercialization of biological pest management strategies." In 1996, a coalition of 11 professional societies told Congress that the EPA policy was "scientifically indefensible" because it did not require conventional vegetables to undergo such scrutiny, although many contain naturally occurring chemicals that inhibit pests. Still others called the policy an approach to regulation that "flies in the face of everything science has taught us about risk and the scientific basis of plant genetics." The biotechnology industry's position on the proposed rules was nowhere near unanimous, however, as some of the larger companies favored favored the regulations because they were likely to force smaller competitors out of business. On this basis, a spokeswoman for the Institute of Food Technologists said, "It is not in the public's interest to concentrate all of this research in a few multinational companies. . . . We want to keep the playing field level for all participants." Environmental groups, although "pleased that EPA plans to regulate such crops the way it regulates traditional chemical pesticides," thought the rules inadequately focused on the overuse of chemical herbicides and too generous with exemptions. the regulations because they were likely to force smaller competitors out of business. On this basis, a spokeswoman for the Institute of Food Technologists said, "It is not in the public's interest to concentrate all of this research in a few multinational companies. . . . We want to keep the playing field level for all participants." Environmental groups, although "pleased that EPA plans to regulate such crops the way it regulates traditional chemical pesticides," thought the rules inadequately focused on the overuse of chemical herbicides and too generous with exemptions.56 While these debates continued, the EPA operated as if the rules were in place but refrained from issuing final regulations. In 1999, the Biotechnology Industry Organization (BIO) challenged the EPA's use of "plant-pesticides" as a designation. This term, it argued, could reduce confidence in the safety of the crops because "pesticide" connotes "kill." Instead, BIO argued, the EPA should encourage consumer acceptance of transgenic crops by labeling them "plant-expressed protectants." Agency officials agreed to consider this demand.57 Two years later, just prior to renewing the registrations of several varieties of Two years later, just prior to renewing the registrations of several varieties of Bt Bt corn, the EPA dealt with the question of what to call such crops. corn, the EPA dealt with the question of what to call such crops.
The Federal Register Federal Register notice on this burning question takes up 46 pages of fine print. Parts of it are wonderfully academic and professorial, as respondents to the request for public comment paid close attention to the precise meanings of words. Some, for example, argued that "plant-pesticide" is inappropriate and inaccurate because it means "pest killer," and this meaning is wrong because genetic modifications do not kill pests but, instead, make the plants undesirable to pests or invulnerable to attack. Furthermore, plants labeled as pesticides "might be poorly received by the public, and the public perception of a promising branch of science could be tarnished." Others asked why the agency would attempt to fix something that was not broken; if the EPA changed the name "plant-pesticide" to "a more euphemistic name to satisfy one interest group, other interest groups will soon be urging it to change the names of other types of pesticide products to have better marketing potential." Others suggested alternatives such as "Frankenplants," "Pandora pesticides," or "alien pesticides." Still others contended that use of notice on this burning question takes up 46 pages of fine print. Parts of it are wonderfully academic and professorial, as respondents to the request for public comment paid close attention to the precise meanings of words. Some, for example, argued that "plant-pesticide" is inappropriate and inaccurate because it means "pest killer," and this meaning is wrong because genetic modifications do not kill pests but, instead, make the plants undesirable to pests or invulnerable to attack. Furthermore, plants labeled as pesticides "might be poorly received by the public, and the public perception of a promising branch of science could be tarnished." Others asked why the agency would attempt to fix something that was not broken; if the EPA changed the name "plant-pesticide" to "a more euphemistic name to satisfy one interest group, other interest groups will soon be urging it to change the names of other types of pesticide products to have better marketing potential." Others suggested alternatives such as "Frankenplants," "Pandora pesticides," or "alien pesticides." Still others contended that use of plant-expressed protectants plant-expressed protectants "obscures the legal issues and attempts to mislead the public into believing that these pesticides are not pesticides at all." The EPA's explanation of the reasons for its eventual decision to choose "plant-incorporated protectants" is worthy of an advanced college text in postmodern English: "obscures the legal issues and attempts to mislead the public into believing that these pesticides are not pesticides at all." The EPA's explanation of the reasons for its eventual decision to choose "plant-incorporated protectants" is worthy of an advanced college text in postmodern English: EPA believes the adjective "plant-incorporated" more accurately conveys the sense that these pesticides are produced and used in the plant. EPA will therefore utilize this adjective in concert with the term "protectant" to describe this type of pesticide. EPA chose the adjective "plant-incorporated" rather than the adjective "plant-expressed," because the word "expressed" represents a technical term of art, and in this instance it appeared preferable to use the term "incorporated" which also encompasses a meaning found in the common English dictionary . . . i.e., "joined or combined into a single unit or whole." The term "plant-incorporated" may thus be better understood by the general public than the term "plant-expressed.58 With this euphemism firmly in place, the EPA could conclude its evaluation of the health and environmental risks of five types of Bt Bt corn and renew their registrations for seven years. During these years, companies would have to collect data to demonstrate that these corn varieties did not lead to insect resistance or unexpected health or environmental consequences. The renewed registrations did not include StarLink corn. corn and renew their registrations for seven years. During these years, companies would have to collect data to demonstrate that these corn varieties did not lead to insect resistance or unexpected health or environmental consequences. The renewed registrations did not include StarLink corn.59 This example is not the only time that EPA has altered the use of terms in response to the political goals of industry. EPA registers pesticides in four categories based on their level of toxicity. All carry warning labels-or used to. Late in 2001, the agency agreed that makers of pesticides registered in the least toxic category did not need to place the word caution caution on their labels. The public, said officials, had difficulty understanding the hierarchy of warnings about regulated pesticides, which ranged from "caution" at the low end to "poison" (accompanied by a skull and crossbones) at the high end. The agency was unable to think of a milder word than "caution," so it chose to use nothing at all. on their labels. The public, said officials, had difficulty understanding the hierarchy of warnings about regulated pesticides, which ranged from "caution" at the low end to "poison" (accompanied by a skull and crossbones) at the high end. The agency was unable to think of a milder word than "caution," so it chose to use nothing at all.60 Such examples may seem trivial-humans are not much affected by the Bt Bt toxin and the least toxic pesticides are, by definition, not very toxic-but they indicate the degree to which federal agencies respond to the commercial and political concerns of the regulated industries rather than to the health or safety concerns of the public. They also reveal the lack of transparency-the openness of federal processes to public scrutiny and debate-in decision-making processes that affect this industry. Overall, they raise serious questions about inequities in the political process and the effects of such inequities on democratic institutions. The inequitable distribution of political power illustrated here is at the root of public distrust of genetically engineered foods, as we will see in the next chapter. toxin and the least toxic pesticides are, by definition, not very toxic-but they indicate the degree to which federal agencies respond to the commercial and political concerns of the regulated industries rather than to the health or safety concerns of the public. They also reveal the lack of transparency-the openness of federal processes to public scrutiny and debate-in decision-making processes that affect this industry. Overall, they raise serious questions about inequities in the political process and the effects of such inequities on democratic institutions. The inequitable distribution of political power illustrated here is at the root of public distrust of genetically engineered foods, as we will see in the next chapter.
CHAPTER 8.
THE POLITICS OF CONSUMER CONCERN.
DISTRUST, DREAD, AND OUTRAGE.
WE HAVE SEEN HOW SCIENTISTS AND FOOD BIOTECHNOLOGY COMpanies promote transgenic projects by focusing on technical achievements, safety, and visions of improving the world's food supply, as expressed by the often repeated phrase "biotechnology-and only biotechnology-can help the world produce the food necessary to meet the population needs of the 21st century." This statement, however, immediately raises credibility issues. Can biotechnology really solve world food problems? What is the industry doing now to address such problems? Are there other methods-perhaps less technical-for solving them?
Food biotechnology first developed bovine growth hormone, Bt Bt corn, and Roundup Ready soybeans, all possessing corn, and Roundup Ready soybeans, all possessing agronomic agronomic traits designed to help food producers. The industry also worked on traits designed to help food producers. The industry also worked on processing processing traits, such as insertion of the reversed gene for ripening into tomatoes. More recently, the industry began developing foods with traits, such as insertion of the reversed gene for ripening into tomatoes. More recently, the industry began developing foods with quality attributes quality attributes (such as nutrient content) that might benefit consumers directly. Until such foods become available, the public has little to gain from genetically modified foods-in price, nutritional benefit, or convenience. Evidence for benefits to the environment or to people in developing countries is also uncertain. In this situation, any risk-no matter how remote-seems pointless, especially when food biotechnology raises so many other issues of concern. (such as nutrient content) that might benefit consumers directly. Until such foods become available, the public has little to gain from genetically modified foods-in price, nutritional benefit, or convenience. Evidence for benefits to the environment or to people in developing countries is also uncertain. In this situation, any risk-no matter how remote-seems pointless, especially when food biotechnology raises so many other issues of concern.
This chapter examines the politics of consumer concerns about genetically modified foods, particularly as focused on issues that extend beyond safety and most inspire distrust: labeling, "biopiracy," genetic "pollution," and globalization. These are "outrage" issues. They emerged in response to the industry's conduct of business in its own interests and the government's collusion in promoting those interests. They are connected to "dread" issues of human and environmental safety safety, but in complicated ways. When people object to food biotechnology by focusing on safety issues, they often do so because they have no other choice. Scientists, federal regulators, and biotechnology companies dismiss outrage considerations out of hand and only permit debate about safety issues. Safety is, as we have seen, a matter of interpretation, highly political, and difficult to separate from the "who decides" factors listed in table 2 table 2 ( (page 17).
In part, the passion that underlies arguments about the safety of genetically modified foods derives from the lack of opportunity to debate their politics and their implications for society. What, for example, does it mean for us as a democratic society that more than half the foods on supermarket shelves contain genetically modified ingredients, but their presence is not labeled? Perhaps it makes no difference whatsoever, but without a formal venue for discussing such questions, people concerned about democratic values will focus on safety questions and use them to generate outrage. This chapter examines the societal issues that underlie public distrust and the reasons why they need to be included in dialogue, if not consensus, about the future of food biotechnology.
THE POLITICS OF DISTRUST.
We have seen that the narrowing of debate about food biotechnology to questions of safety has produced two unanticipated effects. The first is to induce outrage. When scientists and companies say, as they often do, "All we have to do to gain public support for food biotechnology is to educate the public that our products are safe," they frustrate anyone who cares about democracy in decision making. Such statements miss a key point: other issues also matter. A second effect, ironically, is to force the debate to focus on a greater range of safety issues, none of them easily resolved. Advocates say: You refuse to hear my concerns about the effects of food biotechnology on rural life, access to seeds, or corporate control of the food supply? Fine, let's talk about safety safety. Let's look at unintended consequences, toxins, allergens, superweeds, Bt Bt resistance, antibiotic resistance, and effects on monarch butterflies and (as discussed below) on native corn growing in Mexico. Although most scientists might dismiss such hazards as remote or of little consequence, they cannot prove the concerns insignificant. Just enough evidence exists to fuel ongoing debate and discredit any scientist or regulator who categorically states that genetically modified foods are safe. Safety matters, but so do the other issues to which we now turn. resistance, antibiotic resistance, and effects on monarch butterflies and (as discussed below) on native corn growing in Mexico. Although most scientists might dismiss such hazards as remote or of little consequence, they cannot prove the concerns insignificant. Just enough evidence exists to fuel ongoing debate and discredit any scientist or regulator who categorically states that genetically modified foods are safe. Safety matters, but so do the other issues to which we now turn.
Labeling: Transparency in Marketing Labeling continues to be a political issue rather than a simple matter of consumer information, largely because the industry opposes it so strongly and the government supports the industry's position. The public consistently demands disclosure, but the Food and Drug Administration (FDA) insists that labels would be misleading misleading. The agency's logic: labels would erroneously imply that genetically modified foods differ from conventional foods and that conventional foods are in some way superior. Although the FDA justifies this position as science based, the policy is clearly political: "Don't ask, don't tell."1 Whether genetically modified foods differ from conventional foods depends on how one views the construction methods. Based on a review of the steps needed to construct Golden Rice, for example, it is quite possible to make the opposite argument: the foods significantly differ (see tables on Whether genetically modified foods differ from conventional foods depends on how one views the construction methods. Based on a review of the steps needed to construct Golden Rice, for example, it is quite possible to make the opposite argument: the foods significantly differ (see tables on pages 158 pages 158 and and 280 280). Whether labeling implies inferiority also is debatable. If genetically modified foods offer significant advantages, why not flaunt them? Calgene intended to advertise its transgenic tomato as superior superior, and British supermarkets had no problem selling products prominently labeled as genetically modified (pages 212 and and 215 215). Alternatively, if the foods offer no advantages to consumers, the issue boils down to one of choice at the marketplace. Overall, the lack of labeling suggests that something about transgenic foods is best hidden.
The industry tries hard to prove that the public does not really care about disclosure, but independent surveys almost always report substantial support for labeling. Survey results depend on who asks the questions and how they are worded. In May 2001, for example, 62% of respondents said agree agree in response to a question asked this way: Tell me if you agree, disagree, or if you don't know whether information about genetic modification should be required on food labels. in response to a question asked this way: Tell me if you agree, disagree, or if you don't know whether information about genetic modification should be required on food labels.2 In contrast, here is an industry-sponsored question: "The U.S. Food and Drug Administration (FDA) requires special labeling when a food is produced under certain conditions: when biotechnology's use introduces an allergen or when it substantially changes the food's nutritional content, like vitamins or fat, or its composition. Otherwise, special labeling is not required. Would you say you support or oppose this policy of FDA?" Only 27% answered In contrast, here is an industry-sponsored question: "The U.S. Food and Drug Administration (FDA) requires special labeling when a food is produced under certain conditions: when biotechnology's use introduces an allergen or when it substantially changes the food's nutritional content, like vitamins or fat, or its composition. Otherwise, special labeling is not required. Would you say you support or oppose this policy of FDA?" Only 27% answered oppose oppose.3 Regardless of survey results, the makers of transgenic foods are convinced that labeling would have a chilling effect on sales. Unlike vitamin-enriched or organic foods, transgenic foods offer no obvious benefit, and the demise of the British tomato paste reinforced industry fears. Nevertheless, in July 1999 federal officials met with scientific, industry, and advocacy groups to reconsider whether genetically modified foods should be labeled. Commentators interpreted this move as a shift in policy toward regulations based less on science and more on the "dreaded social, political, and economic criteria." Soon after, "a battered Clinton administration" announced hearings for late 1999, suggesting that the FDA might admit its policy failure in this area and develop labeling rules for transgenic foods.4 This FDA action also reflected politics: Congress was getting involved in this area. In November 1999, 21 members of Congress, led by Representative Dennis Kucinich (Dem-OH), introduced legislation to require labeling of genetically modified foods. Their rationale for the Genetically Engineered Food Right to Know Act directly contradicted the position taken by the FDA. The bill assumed that because genetic engineering does does change foods in significant ways (in regulatory terms, produces a change foods in significant ways (in regulatory terms, produces a material material change), "federal agencies have failed to uphold Congressional intent by allowing genetically engineered foods to be marketed, sold and otherwise used without labeling that reveals material facts to the public." change), "federal agencies have failed to uphold Congressional intent by allowing genetically engineered foods to be marketed, sold and otherwise used without labeling that reveals material facts to the public."5 If passed, the bill would have required all foods containing genetically modified ingredients to be labeled as indicated in If passed, the bill would have required all foods containing genetically modified ingredients to be labeled as indicated in figure 24 figure 24. The label would not apply to drugs; to restaurants, bakeries, or other establishments preparing food for immediate consumption; or to organic crops inadvertently contaminated by nearby transgenic crops. Congressional support, though growing, was insufficient to pass the bill by the end of 2002.
Although the bill's initial supporters included at least three Republicans, the response was predictable: overwhelming opposition from the food industry and its supporters in the Republican-controlled House of Representatives. Food trade groups objected that the warning was unnecessary, unscientific, confusing to the public, and too big to put on labels. A representative of the National Food Processors Association said that the bill placed "Politics ahead of sound science. . . . [Kucinich] apparently believes that Congress-rather than the FDA, the scientific community or the public-is best equipped to address food biotechnology and consumer concerns. . . . Laws and regulations should be based on the best science available, rather than on political pressure from activists opposed to the use of this technology."6 In contrast, at least 18 consumer and industry groups announced support of the legislation; these included the American Corn Growers Association and the National Farmers Organization, both of which represented producers hurt by the refusal of European countries to buy their commingled conventional and transgenic crops. In contrast, at least 18 consumer and industry groups announced support of the legislation; these included the American Corn Growers Association and the National Farmers Organization, both of which represented producers hurt by the refusal of European countries to buy their commingled conventional and transgenic crops.
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FIGURE 24. The Genetically Engineered Food Right to Know Act of 1999, introduced by Representative Dennis J. Kucinich (Dem-OH), required this label on packages of foods made from genetically modified ingredients. The bill did not pass.
In preparing for the 1999 hearings, the FDA was forced to deal with societal questions it had ignored in its 1992 policy. Did the policy best serve the public? Was additional information needed? Who should be responsible for communicating such information, and how should it be made available?7 As an invited speaker to the first of the hearings, I thought they might indicate a breakthrough in FDA policy. I had heard FDA officials refer to labeling as the "L-word." Labeling caused them no end of trouble, much of it brought on by their resistance to dealing with societal considerations. I thought the FDA needed to approve labeling for three reasons: public demand, the threat of Congressional intervention, and the inability of the industry to overcome public distrust without it. The FDA argued that writing labeling rules would be difficult, as agency staff would have to establish thresholds and deal with foods with multiple ingredients. This objection seems spurious, however, as plenty of FDA officials know how to write As an invited speaker to the first of the hearings, I thought they might indicate a breakthrough in FDA policy. I had heard FDA officials refer to labeling as the "L-word." Labeling caused them no end of trouble, much of it brought on by their resistance to dealing with societal considerations. I thought the FDA needed to approve labeling for three reasons: public demand, the threat of Congressional intervention, and the inability of the industry to overcome public distrust without it. The FDA argued that writing labeling rules would be difficult, as agency staff would have to establish thresholds and deal with foods with multiple ingredients. This objection seems spurious, however, as plenty of FDA officials know how to write Federal Register Federal Register notices. Objections that genetic modification is not notices. Objections that genetic modification is not material material also seem weak. The FDA already allowed label statements for production processes: made from concentrate, previously frozen, organically grown, kosher, and irradiated, for example. also seem weak. The FDA already allowed label statements for production processes: made from concentrate, previously frozen, organically grown, kosher, and irradiated, for example.
In a move that seemed precedent breaking, the FDA conducted focus groups to assess consumer opinions about the labeling issue. To the agency's apparent surprise, practically all of the participants wanted labels to say whether foods were produced through genetic engineering. The FDA report on the focus groups said, "What is striking about participants' initial discussion of their reasons for wanting biotechnology labeling is the widespread perception that the information they want the label to provide is how the food product was produced, rather than the compositional effect of the process on the food product."8 It is understandable that the FDA found the results "striking"; the agency had already decided otherwise. While the focus groups were in progress in May 2000, the FDA proposed a plan to require premarket notification for transgenic foods but to make labeling It is understandable that the FDA found the results "striking"; the agency had already decided otherwise. While the focus groups were in progress in May 2000, the FDA proposed a plan to require premarket notification for transgenic foods but to make labeling voluntary voluntary. FDA Commissioner Jane Henney said this plan would "show that all bioengineered foods sold here in the United States today are as safe as their non-bioengineered counterparts" and "will provide the public with continued confidence in the safety of these foods."9 Six months later, after wading through 35,000 public comments on the matter, her agency issued still-interim rules for voluntary labeling. These led the Six months later, after wading through 35,000 public comments on the matter, her agency issued still-interim rules for voluntary labeling. These led the New York Times New York Times to begin its account with, "Seeking to calm public anxiety . . ." and to quote Commissioner Henney: "What any product doesn't need is for there to be suspicion on the behalf of consumers that something is being slipped by them." Because the revised rules made labeling voluntary and retained restrictions on use of the term to begin its account with, "Seeking to calm public anxiety . . ." and to quote Commissioner Henney: "What any product doesn't need is for there to be suspicion on the behalf of consumers that something is being slipped by them." Because the revised rules made labeling voluntary and retained restrictions on use of the term GM-free GM-free, consumer groups called them "purely public relations."10 The FDA's subsequent warnings to companies to stop using "GM-free" labels or to states seeking to enact GM-label laws, also did not reassure consumer groups that the agency was acting in the public interest. The FDA's subsequent warnings to companies to stop using "GM-free" labels or to states seeking to enact GM-label laws, also did not reassure consumer groups that the agency was acting in the public interest.11 What seems most surprising is how much the industry's unyielding opposition to labeling damages its own cause. If public trust is the key to successful marketing, biotechnology companies should freely disclose their methods, economic goals, and products. This idea cannot be news to the industry. In 1992, I was not alone in saying, "The labeling issue is really this simple: consumers are more likely to buy the food products of biotechnology if they think the foods are worth the price and if they trust the producer. Trust requires disclosure. . . . All the evidence suggests that consumers will welcome superior products-those that are cheaper, taste better, and have better nutritional value-no matter how they were produced."12 This advice made sense at the time. Industry leaders ignored it because they chose to blame public resistance on scientific ignorance; if people knew the foods were safe, they would buy them. Labels might suggest that the foods were This advice made sense at the time. Industry leaders ignored it because they chose to blame public resistance on scientific ignorance; if people knew the foods were safe, they would buy them. Labels might suggest that the foods were not not safe. Later events proved the error of this view. People bought the genetically modified tomatoes because they thought they tasted better or were priced competitively. Public views of biotechnology in the United States then depended on perceived benefits and, as such, were logical, consistent, and predictable. safe. Later events proved the error of this view. People bought the genetically modified tomatoes because they thought they tasted better or were priced competitively. Public views of biotechnology in the United States then depended on perceived benefits and, as such, were logical, consistent, and predictable.
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FIGURE 25. These foods bear labels designating their GM status. Those on the left are British or Irish products explicitly labeled either as genetically modified or as "GM-free." The labels of the American products on the right, all purchased in 2000, state that they do not contain genetically modified ingredients. (Photo by Shimon and Tammar Rothstein, 2000.) An alternative possibility is to decide the risks and benefits of each new food on a case-by-case basis and allow the marketplace to determine success or failure-as it does for other consumer goods. Under this approach, labeling is essential. If the foods are worth buying, labeling should encourage encourage purchase (as Calgene thought it might do for the tomato). Whether the industry's unwillingness to subject transgenic foods to marketplace forces was due to fear of rejection, arrogance, or stupidity may never be known, but this position led to results that were hardly in its best interest: public erosion of confidence, questioning of the value of purchase (as Calgene thought it might do for the tomato). Whether the industry's unwillingness to subject transgenic foods to marketplace forces was due to fear of rejection, arrogance, or stupidity may never be known, but this position led to results that were hardly in its best interest: public erosion of confidence, questioning of the value of any any genetic modification of food, demands that government regulations address the societal-as well as safety-implications of the technology, and a steady increase in the labeling of foods as "GM-free." By 2000, as shown in genetic modification of food, demands that government regulations address the societal-as well as safety-implications of the technology, and a steady increase in the labeling of foods as "GM-free." By 2000, as shown in figure 25 figure 25, many food products in Great Britain and the United States bore labels indicating whether or not they were genetically modified.
Intellectual Property Rights When biotechnology companies patent the processes for creating transgenic foods, they demonstrate that they are motivated more by interests of economic self-protection than by concerns about feeding the world. Patented transgenic foods cannot be grown without a license and, therefore, require a fee. United States intellectual property laws permit patent owners to exclude anyone else from making, using, or selling protected aspects of transgenic plants for 20 years. The roots of current patent coverage date back to 1930 when the U.S. Patent Office granted limited intellectual property rights to plants propagated through methods that did not involve pollen. In 1970, Congress extended the rights to plants developed through traditional methods of pollination and cross-fertilization. Later, the Supreme Court granted full patent rights to microbes developed through recombinant techniques; the first was patented in 1980. The Patent Office extended full protection to transgenic plants in 1985 and to transgenic animals in 1988.13 Companies viewed these extensions as an incentive to develop new products. By 1995, the Patent Office had issued 112 patents for genetically engineered plants. Companies viewed these extensions as an incentive to develop new products. By 1995, the Patent Office had issued 112 patents for genetically engineered plants.
Patents elicit public distrust of the food biotechnology industry for the six distinct reasons discussed next: ownership, enforcement, injustice, "biopiracy," animal rights, and "terminator" technology.
Ownership. Control of the "discoveries" of genetic engineering creates distrust because of the extraordinary breadth of some of the patents. One, for example, grants exclusive rights to all forms of bioengineered cotton; another covers all uses of reverse genes such as those used to create the Calgene tomato; yet another gives Monsanto exclusive rights to methods using certain antibiotic-resistance markers. Competitors of the companies holding such patents find their scope stunning, "as if the inventor of the assembly line had won property rights to all mass-produced goods," or "as if Monsanto had just patented the yellow pages as a method for finding a telephone number."14 Such concerns are quite justifiable. For example, just four companies control 65% of the patents owned by the top 30 companies working on transgenic seeds: Pharmacia (which, in 2002, owned Monsanto, Calgene, and other agricultural biotechnology companies), DuPont (Pioneer Hi-Bred), Syngenta (Zeneca, Novartis, and others), and Dow Chemical (Mycogen). Monsanto, for example, alone owns more than 100 patents for the processes used to construct transgenic corn and soybeans. Such concerns are quite justifiable. For example, just four companies control 65% of the patents owned by the top 30 companies working on transgenic seeds: Pharmacia (which, in 2002, owned Monsanto, Calgene, and other agricultural biotechnology companies), DuPont (Pioneer Hi-Bred), Syngenta (Zeneca, Novartis, and others), and Dow Chemical (Mycogen). Monsanto, for example, alone owns more than 100 patents for the processes used to construct transgenic corn and soybeans.
Enforcement. The aggressive tactics used by biotechnology companies to protect their patent rights cannot help but elicit distrust. To pick just one example: Monsanto added a $5 technology fee to each bag of Roundup Ready soybeans when the seeds became available in 1996. The company required farmers to pledge never to harvest the seeds, and to permit its agents to inspect the fields for three years. It used crop consultants and independent investigators as informants, and pursued more than 200 "plant piracy" cases in the courts. A spokeswoman explained, "Monsanto has invested a lot of money . . . and we will protect that investment."15 Injustice. Questions of justice cause distrust of genetically engineered foods because of court decisions that consistently favor the patent rights of food biotechnology companies. Biotechnology patents rank second only to software patents in generating lawsuits. In a case considered critical to the continued economic viability of the industry, an Iowa seed company challenged patent protection as monopolistic and contrary to Congressional intent. The company, Farm Advantage, purchased 600 bags of Pioneer Hi-Bred corn seed from a third company for about $54,000 and resold the seeds to customers. In 1999, Pioneer Hi-Bred sued Farm Advantage for violating its exclusive patent rights. The Farm Advantage attorney asked the court to dismiss the case. In 2001, the Supreme Court ruled in favor of Pioneer, a decision seen as a victory for companies holding patents on transgenic processes.16 A spokeswoman for Monsanto explained that the court "clearly wanted to protect the rights of investors." A spokeswoman for Monsanto explained that the court "clearly wanted to protect the rights of investors."17 Biopiracy. This is the pejorative term applied to the private appropriation of public biological resources, particularly the patenting of indigenous plants for corporate profit at the expense of poor farmers in developing countries.18 For example, a Texas company obtained a patent for several lines of basmati rice, a staple grain consumed in India for millennia and an important source of income for that country. India requested a reexamination of the patent. Although protests eventually induced the Patent Office to refuse most of the company's claims, the initial approval lent credence to the idea that U.S. companies were stealing native plants from developing countries. When Monsanto's patents on transgenic soybeans raised similar alarms in China, the company said farmers in that country could use the technology without restriction. But why, ask critics, "should someone be entitled to transfer a resource from the public domain to the private domain?" For example, a Texas company obtained a patent for several lines of basmati rice, a staple grain consumed in India for millennia and an important source of income for that country. India requested a reexamination of the patent. Although protests eventually induced the Patent Office to refuse most of the company's claims, the initial approval lent credence to the idea that U.S. companies were stealing native plants from developing countries. When Monsanto's patents on transgenic soybeans raised similar alarms in China, the company said farmers in that country could use the technology without restriction. But why, ask critics, "should someone be entitled to transfer a resource from the public domain to the private domain?"19 Patenting is unquestionably political; its ostensible purpose is to promote useful inventions that benefit society. If so, according to one academic expert, Patenting is unquestionably political; its ostensible purpose is to promote useful inventions that benefit society. If so, according to one academic expert, It is reasonable to question the extent to which plant and animal patents are likely to benefit society as a whole, particularly in an era when the Western patent system is being imposed internationally against the wishes of numerous countries. . . . If, on the other hand, the protection of the natural rights of inventors is the primary justification for patents, then it is perfectly reasonable to question the extent of those rights. In particular, it makes sense to consider what belongs in the genetic commons as discoveries and the natural heritage of humankind rather than industrial or government property.20 Animal Rights. The patenting of animals generates distrust for reasons of religion, ethics, and animal rights. Various organizations-animal-rights groups and others-believe that the genetic engineering of farm animals adversely affects family farmers, is cruel to animals, endangers living species, or is flatly unethical. Perhaps in response to such concerns, the Patent Office stopped issuing patents for transgenic animals in 1988. In 1993, it resumed processing of the 180 animal patent applications that had accumulated during the moratorium, but fewer companies were attempting to patent farm animals by that time, largely because persistent technical problems and costs had encouraged them to shift to more profitable areas of research. Lobbyists against animal patents such as Jeremy Rifkin, a leading critic of biotechnology, continue to object to Patent Office policies for reasons of philosophy and economic inequity: "We believe the gene pool should be maintained as an open commons, and should not be the private preserve of multinational companies. . . . This is the Government giving its imprimatur to the idea that there is no difference between a living thing and any inert object. . . . It's the final assault on the sacred meaning of life and life process."21 Mr. Rifkin helped organize a coalition of church groups representing 80 religious faiths and denominations to oppose patenting on the grounds that animals are creations of God, not of humans. Others also find the idea of patenting animals repugnant on moral, ethical, and religious grounds. Mr. Rifkin helped organize a coalition of church groups representing 80 religious faiths and denominations to oppose patenting on the grounds that animals are creations of God, not of humans. Others also find the idea of patenting animals repugnant on moral, ethical, and religious grounds.22 "Terminator" Technology. No patent issue elicits greater distrust of the food biotechnology industry-and of its government regulators-than patent protection through "terminator" technology. As yet another irony of the politics of food biotechnology, the terminator was the work of a USDA government government scientist who recognized that the insertion of certain genes and antibiotic-resistance marker sequences into plants could stop them from reproducing. When treated with a suitable antibiotic, these genes lead to the production of a protein that prevents seed germination. This trick prevents plants from cross-pollinating bioengineered traits into weeds (a good thing). However, it also acts as a "technology protector system," meaning that farmers cannot collect seeds and grow them. Instead, they must buy seeds protected by a biotechnology company's patents, and must do so every year. Before the USDA researcher had even developed the technology, he won a patent for it in collaboration with a seed company, Delta and Pine Land. scientist who recognized that the insertion of certain genes and antibiotic-resistance marker sequences into plants could stop them from reproducing. When treated with a suitable antibiotic, these genes lead to the production of a protein that prevents seed germination. This trick prevents plants from cross-pollinating bioengineered traits into weeds (a good thing). However, it also acts as a "technology protector system," meaning that farmers cannot collect seeds and grow them. Instead, they must buy seeds protected by a biotechnology company's patents, and must do so every year. Before the USDA researcher had even developed the technology, he won a patent for it in collaboration with a seed company, Delta and Pine Land.
When Monsanto attempted to buy Delta and Pine Land, it appeared as if the true purpose of terminator technology was to protect private property and make farmers even more dependent on seeds and chemicals controlled by corporations. Critics feared that use of this technology would devastate farmers in poor countries who typically save their seeds from one year to the next. On this basis, the Consultative Group on International Agricultural Research recommended in 1998 that its 16 member institutes ban research on terminator genes. The following year, U.S. rural development groups, alarmed about the possible effects of the technology on global food security and biodiversity, organized their constituents to demand that USDA cease sponsorship of terminator research.23 This research evoked vivid images-and street theater-of corporate science conducted for profit rather than for the good of society (see This research evoked vivid images-and street theater-of corporate science conducted for profit rather than for the good of society (see figure 26 figure 26).
The already high profile of critics of this research rose even higher in June 1999 when the president of the Rockefeller Foundation, Gordon Conway, challenged Monsanto to stop work on terminator genes. In his view, this work was so controversial that it placed the entire food biotechnology enterprise at risk-including its potential to feed the developing world. The use of this research, he said, "particularly by the poor and excluded, is being threatened by the mounting controversies in Europe and to some extent in the United States. There is a real danger that the research may be set back, particularly if field trials are banned. . . . The agricultural seed industry must disavow the use of terminator technology to produce seed sterility."24 Mr. Conway also suggested that Monsanto invest more in research to solve food problems in developing countries, and voluntarily label its products. In response, Monsanto officials issued a "terse statement" terming their conversations with Mr. Conway "frank and productive. We will continue to reach out to people like Prof. Conway to discuss the challenges and opportunities of biotechnology applications in agriculture." Mr. Conway also suggested that Monsanto invest more in research to solve food problems in developing countries, and voluntarily label its products. In response, Monsanto officials issued a "terse statement" terming their conversations with Mr. Conway "frank and productive. We will continue to reach out to people like Prof. Conway to discuss the challenges and opportunities of biotechnology applications in agriculture."25 Nevertheless, his remarks hit home. In October 1999, Monsanto announced that the company would "make no effort to market" terminator seeds (even though the possibility of doing so was still years away), thereby averting "a public relations disaster in an industry already under attack on other, more serious fronts."26 Earlier that year, a Monsanto spokesman said that "seed sterility has become a surrogate for the entire debate on biotech. . . . We are recognizing now though that there is something psychologically offensive about sterile seed in every culture." Earlier that year, a Monsanto spokesman said that "seed sterility has become a surrogate for the entire debate on biotech. . . . We are recognizing now though that there is something psychologically offensive about sterile seed in every culture."27 Other motives, however, may have influenced Monsanto's retreat on this issue. The Justice Department's antitrust division had delayed Monsanto's purchase of Delta and Pine Land. When Monsanto merged with Pharmacia and Upjohn late in 1999, it withdrew the purchase offer (lawsuits ensued). The USDA, citing the many beneficial applications of the ability to turn genes on and off, continues to conduct terminator research, leaving plenty of room for ongoing distrust-and outrage-about how government and industry plan to use this technology. Other motives, however, may have influenced Monsanto's retreat on this issue. The Justice Department's antitrust division had delayed Monsanto's purchase of Delta and Pine Land. When Monsanto merged with Pharmacia and Upjohn late in 1999, it withdrew the purchase offer (lawsuits ensued). The USDA, citing the many beneficial applications of the ability to turn genes on and off, continues to conduct terminator research, leaving plenty of room for ongoing distrust-and outrage-about how government and industry plan to use this technology.28 [image]
FIGURE 26. This flyer advertises a play produced by the San Francisco Mime Troupe in summer 2000: "In her laboratory, Dr. Synthia Allright-Bloom is hard at work on a bio-genetic engineering discovery that could feed the world." The Mime Troupe presents free plays in public parks.
Genetic "Pollution"
A third major issue of distrust arises from the inadvertent transfer of transgenic pollen to organically grown or native plant species. The high level of public concern about this issue is revealed by the political battle that took place over the USDA's proposed rules for certifying foods as "organic." Scientists and the food biotechnology industry are also concerned about pollen spread, but for a different reason-its political and economic consequences. Such consequences are best illustrated by the discovery of transgenes in native varieties ("landraces") of maize growing in Mexico, and the ensuing uproar over publication of this finding.
Organic Foods. Because practices related to organic farming were inconsistent, organic farmers attempted to set up a voluntary certification program but could not reach consensus on how to do that. They asked Congress to establish mandatory rules for designating food as organic, and legislators did so in 1990 when they passed the Organic Food Production Act and established a National Organic Standards Board to advise the USDA about implementation. The board, realizing that Congress had passed the legislation before bioengineered foods were on the market, recommended "as a policy matter" that genetically modified foods be excluded from those considered organically grown.29 In proposing standards, the USDA was especially sensitive to objections that organic organic implied criticism of other agricultural methods. In what appeared to be a compromise forced by mainstream agricultural producers, the agency asked for public comment on whether implied criticism of other agricultural methods. In what appeared to be a compromise forced by mainstream agricultural producers, the agency asked for public comment on whether organic organic could be applied to foods that had been genetically modified, irradiated, or fertilized with reprocessed sewage ("sludge"). Buried in a 120-page and especially impenetrable could be applied to foods that had been genetically modified, irradiated, or fertilized with reprocessed sewage ("sludge"). Buried in a 120-page and especially impenetrable Federal Register Federal Register notice were a few short paragraphs unlikely to shed light on the department's position on these issues. For example: notice were a few short paragraphs unlikely to shed light on the department's position on these issues. For example: We do not consider non-synthetic substances that have been treated with a synthetic substance, but which have not been chemically altered by a manufacturing process, to be synthetic under the definition given in the Act. . . . We have included toxins derived from genetically engineered bacteria on the proposed National List primarily so that we can receive comment on the proper classification of these substances and on whether they should be allowed, prohibited, or approved on a case-by-case basis.
Translation: the USDA considers genetic engineering and irradiation to be processes that do not alter the fundamental nature of food and, therefore, proposes to include transgenic foods on the Federal List of foods certified as organically grown.
When the USDA invited comments on this idea, the agency got them. By February 1998, just two months after publication of the notice, 4,000 people had filed comments, many of them along the lines of "USDA should not permit corporate agribusiness lobbyists and bureaucrats in Washington to force-feed the rules to organic farmers and their customers." In response to the deluge, the USDA postponed the comment deadline and scheduled public hearings. By March, an extraordinary grassroots campaign based on the Internet, notices on milk cartons, and other low-cost efforts had elicited 15,000 comments, nearly all of them negative. I can attest to the breadth and persistence of this effort; for weeks, I received daily electronic mail instructions about how to file comments on this issue. By the deadline, the USDA organic standards docket contained an astonishing 275,603 letters, with genetic engineering eliciting the most criticism.30 Eventually, the USDA responded to public demand and dropped the controversial proposals; it would not permit genetically modified, irradiated, sewage-fertilized foods, or animals fed antibiotics to be labeled as organic. The organic foods industry and its constituents hailed the decision as a decisive victory: "Organic food stores are no longer just little co-ops with tofu and bean sprouts. . . . They alerted their customers, and the customers rejected the proposed rules."31 Biotechnology industry representatives criticized the decision as "political, not based on any realistic assessment of risks, benefits, or science," and USDA officials reassured them that the organic standards did not "reflect a judgment about the safety or utility of biotechnology. . . . USDA has not drawn official conclusions about biotechnology labeling for conventional agriculture products. In general, USDA is doing a great deal to promote biotechnology as a key part of mainstream US agriculture efforts." Biotechnology industry representatives criticized the decision as "political, not based on any realistic assessment of risks, benefits, or science," and USDA officials reassured them that the organic standards did not "reflect a judgment about the safety or utility of biotechnology. . . . USDA has not drawn official conclusions about biotechnology labeling for conventional agriculture products. In general, USDA is doing a great deal to promote biotechnology as a key part of mainstream US agriculture efforts."
Mexican Native Corn. Plant pollen does not follow USDA rules; it follows air currents. During the FDA's 1999 food labeling hearings, organic farmers testified that genetically altered pollen threatened the ability of their crops to qualify for organic certification. Later, the StarLink episode demonstrated how easy it was to commingle genetically modified seeds with conventional seeds. By 2001, transgenes could be found anywhere anyone looked for them: in fields certified as organic, fields of conventionally grown crops, grain shipments to Japan, food aid to Latin America, fields in countries that had banned transgenic crops, and "GM-free" products. Events the following year confirmed such observations. Monsanto and Aventis CropScience admitted that genetically modified canola seeds, not yet approved by the FDA, "might have found their way" into planted crops, and Australian scientists showed that genes from genetically modified canola readily transfer to conventional canola in neighboring fields.32 Such incidents evoke images of accidents: Pandora's box and genies out of bottles. They also evoke a more sinister image-the Trojan horse-the deliberate deliberate manipulation of the food supply to undermine regulatory controls and consumer choice at the marketplace. As Friends of the Earth explained, "Legal frameworks were supposed to be adequate to ensure that GMOs wouldn't endanger the environment or human health. Biotech companies were supposed to comply with those frameworks. Regulatory bodies were supposed to monitor and oversee GMO releases to ensure they were complying with the legal frameworks. But the reality shows a completely different picture." manipulation of the food supply to undermine regulatory controls and consumer choice at the marketplace. As Friends of the Earth explained, "Legal frameworks were supposed to be adequate to ensure that GMOs wouldn't endanger the environment or human health. Biotech companies were supposed to comply with those frameworks. Regulatory bodies were supposed to monitor and oversee GMO releases to ensure they were complying with the legal frameworks. But the reality shows a completely different picture."33 Nowhere is the reality more starkly displayed than in the case of transgenic "pollution" of native maize grown in Mexico, where corn originated and where corn biodiversity is treasured. Early in 2000, letters to Science Science warned colleagues that the "introduction of transgenic maize varieties in Mexico may pose a risk to landraces or wild relatives of maize in its ancestral home," and "the direction of gene flow is more likely to occur from [transgenic] cultivars to the wild plants." According to warned colleagues that the "introduction of transgenic maize varieties in Mexico may pose a risk to landraces or wild relatives of maize in its ancestral home," and "the direction of gene flow is more likely to occur from [transgenic] cultivars to the wild plants." According to Sierra Sierra magazine, transgenic corn came to Mexico "courtesy of the North American Free Trade Agreement (NAFTA), which opened the Mexican market to cheap grain from magazine, transgenic corn came to Mexico "courtesy of the North American Free Trade Agreement (NAFTA), which opened the Mexican market to cheap grain from el norte el norte"; Mexico now imports three times as much corn from the United States as it did prior to NAFTA. To protect the country's corn heritage, Mexico banned the cultivation of transgenic varieties in 1998 but is unable to completely enforce this ruling.34 In 2001, researchers from the University of California, Berkeley, found transgenic corn growing in 15 of 22 remote areas of Oaxaca and Ixtlan and reported these findings in the prestigious British journal Nature Nature. Val Giddings of the Biotechnology Industry Organization (BIO) told a reporter from USA Today USA Today that the report posed no that the report posed no safety safety issues: "If there's any impact at all, it's likely to be positive. There are zero human health implications, zero environmental impact implications." issues: "If there's any impact at all, it's likely to be positive. There are zero human health implications, zero environmental impact implications."35 Perhaps so, but the uncontrolled spread of genetically modified traits to plants where they are not supposed to be has 100% implications for public trust in the industry and its government regulators-and for generating outrage. Perhaps so, but the uncontrolled spread of genetically modified traits to plants where they are not supposed to be has 100% implications for public trust in the industry and its government regulators-and for generating outrage.
To head off such reactions, industry supporters launched a remarkably nasty public relations campaign to discredit the Berkeley investigators. The campaign focused on their science and their politics. The researchers made two claims in the Nature Nature paper; transgenes existed in native maize, and the transgenes were unstable (meaning that they could spread more easily). The discrediting campaign focused exclusively on the second claim. A public relations firm-one that specializes in using the Internet to lobby-recruited scientists to write letters identifying flaws in the methods used to demonstrate genetic instability. On this basis, the editor of paper; transgenes existed in native maize, and the transgenes were unstable (meaning that they could spread more easily). The discrediting campaign focused exclusively on the second claim. A public relations firm-one that specializes in using the Internet to lobby-recruited scientists to write letters identifying flaws in the methods used to demonstrate genetic instability. On this basis, the editor of Nature Nature did something highly unusual (if not unprecedented) in such scientific disputes. Stopping just short of calling the paper fraudulent, he published some of the critical letters along with an editorial note: "The evidence available is not sufficient to justify the publication of the original paper." The researchers admitted some errors in methods, but reaffirmed their original conclusions. did something highly unusual (if not unprecedented) in such scientific disputes. Stopping just short of calling the paper fraudulent, he published some of the critical letters along with an editorial note: "The evidence available is not sufficient to justify the publication of the original paper." The researchers admitted some errors in methods, but reaffirmed their original conclusions.36 The public relations campaign also focused on the researchers' politics. The senior author, Dr. Ignacio Chapela, held an untenured faculty appointment in the Berkeley plant biology department that auctioned itself into partnership with Novartis in 1998. Dr. Chapela had led faculty opposition to that partnership. Other faculty had accused his coauthor, a graduate student in that department, of antibiotechnology vandalism of their experimental crops (a charge he denied). Reporters investigating the matter guessed that Monsanto and other proindustry groups were behind the public relations campaign but were hiding that connection. Colleagues sympathetic to Dr. Chapela pointed out that most of the writers of the critical letters to Nature Nature received all or part of their research funding from an institute affiliated with Novartis (by this time, Syngenta), but also had not disclosed their competing interests. received all or part of their research funding from an institute affiliated with Novartis (by this time, Syngenta), but also had not disclosed their competing interests.37 In the furor over the paper and its near retraction, one crucial fact is easily overlooked: nobody challenged the observation of transgenes in native corn. Indeed, Mexican scientists soon confirmed traces of transgenes in up to 36% of samples tested.38 In this sense, the public relations campaign succeeded brilliantly. It focused attention on complicated scientific issues and deflected attention from the crucial social issue-the escape of genetically modified traits into wild plant stocks. Regardless of the scientific merits of the research, the ferocity of the attack made it clear that neither the scientific establishment nor the biotechnology industry have much interest in keeping the new genetic traits under control. In this sense, the public relations campaign succeeded brilliantly. It focused attention on complicated scientific issues and deflected attention from the crucial social issue-the escape of genetically modified traits into wild plant stocks. Regardless of the scientific merits of the research, the ferocity of the attack made it clear that neither the scientific establishment nor the biotechnology industry have much interest in keeping the new genetic traits under control.
Globalization Globalization elicits dread and outrage for two principal reasons. The first is the potential loss of national identity and autonomy to multinational corporations bent on maximizing profit. The second is the possibility that international regulatory bodies established to deal with globalization issues might make decisions that favor corporate interests at the expense of public welfare and social justice, especially in the areas of health, environmental protection, and food safety. From a business perspective, globalization is about open markets, low wages, and minimal regulations. Regulations, from this perspective, are costly and complicated barriers to selling products on international markets. If, for example, a country decides to invoke the precautionary principle and require premarket testing and labeling of genetically modified foods, it could refuse to buy U.S. crops that were not segregated and labeled. It is easy to see how international disputes about such matters could become difficult. Such disputes are resolved through three international bodies: the World Trade Organization (WTO), the Biosafety Protocol, and the Codex Alimentarius.
The increasingly powerful WTO is the most important of these bodies. Countries belonging to the United Nations created the WTO to develop, administer, and-most notably-enforce their trade agreements. The purpose of the WTO is to promote free trade, ideally through guarantees of fair and consistent treatment of exports from all member countries. WTO rules require member states to (1) consider all other members as equal trading partners, (2) treat all foreign corporations just as they treat their own, and (3) eliminate all competitive practices that might give them an unfair advantage. In practice, however, richer countries can and do use the rules to their own advantage. The WTO especially raises suspicions because it conducts negotiations in secret.
The WTO replaced the General Agreement on Tariffs and Trade (GATT) in 1995. From 1947 to 1994, GATT nations negotiated reductions in tariffs and other trade barriers through a series of discussion "rounds" identified by their location (the Uruguay Round of 198694, for example). By the time WTO succeeded GATT, the principal negotiations no longer concerned tariffs or intellectual property rights as much as they did issues related to environmental protection and food safety. For years, critics have complained that eliminating trade barriers will force countries to adhere to the lowest common denominator in food safety and environmental standards. As evidence, they point to WTO decisions that prevent France from rejecting hormone-fed beef raised in the United States or require the United States to accept Malaysian shrimp caught in nets that trap sea turtles. If WTO decides that genetically modified foods are safe, no member country is permitted to reject them.39 One reason why President Bill Clinton invited the WTO to meet in Seattle in 1999 was to resolve the "huge biotech problem" with European countries that were refusing American exports of transgenic corn and soybeans. Although most of the public demonstrations during that meeting were aimed at globalization in general (and labor and biopiracy issues in particular), they also focused on trade issues related to genetically modified foods.40 By the time of that meeting, international and national government groups were debating whether to allow the production or import of genetically modified foods, to require them to be labeled (and, if so, at what threshold level), or to ban them outright. By the time of that meeting, international and national government groups were debating whether to allow the production or import of genetically modified foods, to require them to be labeled (and, if so, at what threshold level), or to ban them outright.