Safe Food: Bacteria, Biotechnology, And Bioterrorism Part 4

The mandate of the FDA is to a.s.sure 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 a.s.suring 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 a.s.suring 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 b.u.t.terflies 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 b.u.t.terflies 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 advertis.e.m.e.nt shown in figure 17 figure 17, for example, promotes the ecological advantages of transgenic crops. This advertis.e.m.e.nt, 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 a.n.a.lysis 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 a.n.a.lyses, many of them constantly changing, and some easier to measure than others. In contrast, an a.n.a.lysis 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 a.n.a.lyses, 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 advertis.e.m.e.nt 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 ill.u.s.trated 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 a.s.sessment-that the foods were safe and that few precautions were necessary, and they a.s.sumed that any unantic.i.p.ated 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 cla.s.sic case of the unantic.i.p.ated 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 j.a.panese 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 a.s.sociation of Showa Denko LT [tryptophan] and epidemic EMS.41 To date, the toxic component remains "incompletely characterized," making it difficult to inst.i.tute 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 astonis.h.i.+ng 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 astonis.h.i.+ng 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 Inst.i.tute in Aberdeen, applied for and won a compet.i.tive 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 r.e.t.a.r.dation 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 r.e.t.a.r.dation 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 Inst.i.tute 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 Inst.i.tute 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 doc.u.ments, 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 Inst.i.tute 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 Inst.i.tute 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 rea.s.surances. 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 publis.h.i.+ng 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 publis.h.i.+ng 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 b.u.t.terflies 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 b.u.t.terflies. Monarch b.u.t.terflies lay their eggs on milkweed plants that grow throughout fields of corn. Of course the insects, in this case, monarch b.u.t.terflies. Monarch b.u.t.terflies 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 b.u.t.terflies flapping their wings on Iowa farms provoke political firestorms among Was.h.i.+ngton policymakers?" Indeed, yes. Farmers did not want to be termed "b.u.t.terfly-killers," and neither did Congress. Legislators proposed an appropriation of $200,000 to study the effect of transgenic foods on monarch b.u.t.terflies and also introduced legislation to require labeling.53 Monarch b.u.t.terflies became the symbol of antibiotechnology protests, as ill.u.s.trated in Monarch b.u.t.terflies became the symbol of antibiotechnology protests, as ill.u.s.trated in figure 18 figure 18.

From the industry standpoint, killing b.u.t.terflies 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 b.u.t.terflies. 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 b.u.t.terflies. 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 b.u.t.terfly." to the conference: "Scientific symposium to show no harm to monarch b.u.t.terfly."55 The conference itself, however, proved rather contentious. Some partic.i.p.ants 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 partic.i.p.ants 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 Was.h.i.+ngton, DC, hearings on genetically modified foods in November 1999, drew demonstrators dressed as monarch b.u.t.terflies. 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 b.u.t.terflies. 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 b.u.t.terflies. 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 b.u.t.terfly 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 b.u.t.terfly 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 b.u.t.terflies. Its own in-house researchers spent two years investigating this question (conclusion: "negligible" risk). pollen for monarch b.u.t.terflies. 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 b.u.t.terfly population was not at risk from In September 2000, the EPA issued a preliminary report concluding that the b.u.t.terfly population was not at risk from Bt Bt pollen. In the meantime, agricultural biotechnology companies had pooled resources in partners.h.i.+p 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 partners.h.i.+p 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 b.u.t.terfly 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 b.u.t.terfly 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 b.u.t.terflies is 'negligible.'" headline repeated the conclusion: "Reports say threat to monarch b.u.t.terflies is 'negligible.'"60 My reading of this extraordinary scientific effort to prove the obvious comes to a slightly different interpretation: negligible under some circ.u.mstances, 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 b.u.t.terflies 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 b.u.t.terflies 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 b.u.t.terflies 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 b.u.t.terflies 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 cla.s.sified 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 cla.s.sified 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 n.o.body has died yet from eating them. This may be a correct a.s.sessment, 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 b.u.t.terflies, 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 partic.i.p.ate 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 partic.i.p.ate 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 princ.i.p.al 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 a.s.sure 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 a.s.sessed 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 ent.i.ties: 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 a.s.signs 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 c.u.mbersome 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 c.u.mbersome 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 quant.i.ties. 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 a.n.a.lytical 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 const.i.tuent 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 Inst.i.tutes 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 (mast.i.tis). The more milk cows produce, the more likely they are to develop mast.i.tis, and rBGH increases milk production. Because farmers treat the infections with antibiotics that can linger i