PART TWO
SAFETY AS A SURROGATETHE IRONIC POLITICS OF FOOD BIOTECHNOLOGYLATE IN THE FALL OF 2001, I ATTENDED A TUFTS UNIVERSITY conference on agricultural biotechnology sponsored by corporations such as Aventis (producer of StarLink corn) and Monsanto (producer of genetically modified cow growth hormone, corn, soybeans, and cotton). Speaker after speaker made the same three points: (1) the number of people in the world is increasing rapidly and food production must increase to keep them from starvation; (2) because the land available for growing food is limited, biotechnology-and only biotechnology-can increase food productivity; and (3) the main barrier to producing genetically modified foods is public doubt about their safety, particularly as expressed by unscientific activist groups such as Greenpeace. conference on agricultural biotechnology sponsored by corporations such as Aventis (producer of StarLink corn) and Monsanto (producer of genetically modified cow growth hormone, corn, soybeans, and cotton). Speaker after speaker made the same three points: (1) the number of people in the world is increasing rapidly and food production must increase to keep them from starvation; (2) because the land available for growing food is limited, biotechnology-and only biotechnology-can increase food productivity; and (3) the main barrier to producing genetically modified foods is public doubt about their safety, particularly as expressed by unscientific activist groups such as Greenpeace.1 Anyone not actively tracking the politics of food biotechnology might be surprised to learn that the chief impediment to eliminating world hunger is a consumer group best known for its opposition to nuclear weapons testing, but this topic is replete with such ironies. Anyone not actively tracking the politics of food biotechnology might be surprised to learn that the chief impediment to eliminating world hunger is a consumer group best known for its opposition to nuclear weapons testing, but this topic is replete with such ironies.To explain why the ironic politics of food biotechnology deserves attention in a book about food safety, we must begin with some definitions: biotechnology biotechnology and its synonym, and its synonym, genetic engineering genetic engineering, are processes by which scientists move genes (DNA) from one organism to another to transfer desired traits. Agricultural biotechnologists move genes from bacteria, viruses, or plants into food plants (the appendix explains how this is done). We call foods containing the new genes by a variety of equivalent terms: transgenic, bioengineered, genetically engineered (GE) transgenic, bioengineered, genetically engineered (GE), genetically modified (GM), genetically modified organisms (GMO) genetically modified (GM), genetically modified organisms (GMO), and, occasionally, the pejorative Franken-foods Franken-foods.2 These chapters refer to such foods interchangeably as These chapters refer to such foods interchangeably as genetically modified, genetically engineered genetically modified, genetically engineered, and transgenic transgenic.The speakers at the Tufts conference were intoning the mantra of the food biotechnology industry, the theoretical theoretical promise that its products will solve world food problems by creating a more abundant, more nutritious, and less expensive food supply. I emphasize theoretical because this promise is not yet realized; the industry is still in its infancy. The speakers were right to be concerned about public acceptance. The commercial products of food biotechnology have caused no end of controversy. In the United States, and particularly in Great Britain, people view the new foods with suspicion, often with dread and outrage. The results: boycotts, destruction of plantings ("ecoterrorism"), legal bans, and trade disputes. Such reactions reflect misgivings about the risks of technological manipulations of food, not only to human health, but also to the environment, to the world economy, and to society as a whole. They also reflect distrust of the motives of the food biotechnology industry and of the ability of government to regulate that industry. This sense of unease-specific for some, vague for others-translates most easily to a simple response: rejection. As people often tell me, "I don't want any GM in my food." promise that its products will solve world food problems by creating a more abundant, more nutritious, and less expensive food supply. I emphasize theoretical because this promise is not yet realized; the industry is still in its infancy. The speakers were right to be concerned about public acceptance. The commercial products of food biotechnology have caused no end of controversy. In the United States, and particularly in Great Britain, people view the new foods with suspicion, often with dread and outrage. The results: boycotts, destruction of plantings ("ecoterrorism"), legal bans, and trade disputes. Such reactions reflect misgivings about the risks of technological manipulations of food, not only to human health, but also to the environment, to the world economy, and to society as a whole. They also reflect distrust of the motives of the food biotechnology industry and of the ability of government to regulate that industry. This sense of unease-specific for some, vague for others-translates most easily to a simple response: rejection. As people often tell me, "I don't want any GM in my food."To industry officials and scientists who view risk through a science-based lens, statements like that are antiscientific and irrational. In the early 1990s, they characterized any any criticism of food biotechnology as ignorant, irresponsible, hysterical, or-my favorite-troglodyte, and as a prominent symptom of a new psychiatric disorder, biotechnophobia. criticism of food biotechnology as ignorant, irresponsible, hysterical, or-my favorite-troglodyte, and as a prominent symptom of a new psychiatric disorder, biotechnophobia.3 They lamented that well-funded activist groups were deliberately "interweaving political, societal and emotional issues . . . to delay commercialization and increase costs by supporting political, non-science-based regulation, unnecessary testing, and labeling of foods." They lamented that well-funded activist groups were deliberately "interweaving political, societal and emotional issues . . . to delay commercialization and increase costs by supporting political, non-science-based regulation, unnecessary testing, and labeling of foods."4 In that tradition, the Tufts conference speakers complained about the generous funding available to Greenpeace, another irony in light of the disparity between that group's resources and those of the agricultural biotechnology industry. In that tradition, the Tufts conference speakers complained about the generous funding available to Greenpeace, another irony in light of the disparity between that group's resources and those of the agricultural biotechnology industry.From its inception, food biotechnology has raised political, societal, and emotional issues: What are the risks of genetically modified foods? What are their benefits? How are risks and benefits distributed? Who makes decisions about them? How will genetically modified foods affect local, national, and international food systems and economies? How should the foods be regulated? Should they be labeled? And: Is it ethical to create such foods in the first place? The questions about risk can be answered scientifically, but the other questions are value-based and social social. Because questions about ethics and other social matters threaten the very foundation of food biotechnology, the industry and its supporters tend to restrict discussion to questions of safety. From a science-based perspective, if genetically modified foods are safe, there is no sensible reason for regulating, labeling, or opposing them.The focus on science, safety, and risk obscures the social issues, particularly those having to do with the distribution of economic benefits. Food biotechnology is a huge business, and huge profits are at stake. To survive, the industry must make products that farmers or the public will buy. Politics enters the picture because other stakeholders in the food system have different agendas and hold different values. Scientists want to work on challenging problems that might produce health or economic gains, and, as a necessary benefit, research funding. Government regulators want to ensure that foods are safe, but they also want to avoid congressional intervention and industry lawsuits. As consumers, we all want food that is safe (or safe enough), but many of us also are concerned about social issues. Food biotechnology is political because basic questions-Who benefits? Who decides? Who controls?-require societal resolution and cannot be decided solely by the methods of science.The debates about food biotechnology are especially complicated because the science itself is so complicated. That most people cannot understand the science behind genetically modified foods is a given. But anyone, trained in science or not, can grasp whether democratic political processes are at work in making decisions about these foods. We will see how questions of democracy-and the lack of an institutional venue for debating the social implications of food biotechnology-underlie much of the distrust of the industry and its government regulators. The desire for democratic processes and the trust they inspire explain why the lack of labeling of genetically modified foods is such a critical point of debate. Labeling places the power to make decisions in the hands of consumers, not the industry.Although the safety of genetically modified foods is an important issue, it is not the only one of interest. But because safety appears to be the only legitimate legitimate ground for criticism, it acts as a surrogate for concerns about democratic processes and social implications. The StarLink corn affair is an example of the use of safety as a surrogate; the arguments focused on allergenicity (science), but the real issues had to do with the company's control over the food supply and evasion of democratic processes of government oversight (social values). The politics of food biotechnology matter because the disputes shift attention away from the underlying issues. If, for example, the roots of world hunger lie in poverty, we should be debating options for redressing economic imbalances. If we want to meet the food needs of the twenty-first century, we ought to be considering a broad range of alternatives, among which biotechnology may or may not be the best. Social problems are manifestly difficult to address, as their causes are multiple and complex. It is understandable that we might find simple, "reductionist" approaches to such problems-like genetically engineering vitamins into rice-preferable to the messy business of political action to address world poverty. ground for criticism, it acts as a surrogate for concerns about democratic processes and social implications. The StarLink corn affair is an example of the use of safety as a surrogate; the arguments focused on allergenicity (science), but the real issues had to do with the company's control over the food supply and evasion of democratic processes of government oversight (social values). The politics of food biotechnology matter because the disputes shift attention away from the underlying issues. If, for example, the roots of world hunger lie in poverty, we should be debating options for redressing economic imbalances. If we want to meet the food needs of the twenty-first century, we ought to be considering a broad range of alternatives, among which biotechnology may or may not be the best. Social problems are manifestly difficult to address, as their causes are multiple and complex. It is understandable that we might find simple, "reductionist" approaches to such problems-like genetically engineering vitamins into rice-preferable to the messy business of political action to address world poverty.This part of the book deals with how and why the safety of genetically modified foods became a surrogate for concerns about larger social issues.5 In telling this story, these chapters continue many of the themes noted earlier: industry promotion of economic self-interest at the expense of health and safety, the industry's political efforts to prevent imposition of regulatory controls and labeling requirements, the fragmentation and consequent weakness of government oversight, the imbalance in power between corporate and public interests, and the use of science as a rationale for self-interested actions. In telling this story, these chapters continue many of the themes noted earlier: industry promotion of economic self-interest at the expense of health and safety, the industry's political efforts to prevent imposition of regulatory controls and labeling requirements, the fragmentation and consequent weakness of government oversight, the imbalance in power between corporate and public interests, and the use of science as a rationale for self-interested actions.The discussion of these themes begins in chapter 5 chapter 5 with an introduction to the food biotechnology industry-its methods, promises, and realities. Much of the chapter is devoted to a discussion of the "poster child" for the benefits of genetically modified foods, Golden Rice, a rice bioengineered to contain beta-carotene, a precursor of vitamin A. with an introduction to the food biotechnology industry-its methods, promises, and realities. Much of the chapter is devoted to a discussion of the "poster child" for the benefits of genetically modified foods, Golden Rice, a rice bioengineered to contain beta-carotene, a precursor of vitamin A. Chapter 6 Chapter 6 evaluates the benefits claimed for genetically modified foods, as well as their safety risks: allergenicity, antibiotic resistance, and environmental impact. In evaluates the benefits claimed for genetically modified foods, as well as their safety risks: allergenicity, antibiotic resistance, and environmental impact. In chapter 7 chapter 7, I discuss the politics of government oversight of genetically modified foods and describe how the industry convinced federal regulatory agencies to use a strictly science-based approach to risk evaluation, thereby allowing companies to plant first, then then deal with problems (rather than requiring premarket testing). deal with problems (rather than requiring premarket testing). Chapter 8 Chapter 8 focuses on the important societal issues that spark protests against genetically modified foods: consumer choice at the marketplace (labeling), inequities in ownership of plant resources (intellectual property rights or "biopiracy"), the accidental movement of transgenes into conventional crops ("genetic pollution"), and corporate control of the food supply (globalization). Overall, these chapters provide an analysis of where the issues raised by food biotechnology stand today, and how industry, scientists, government, and the public might deal with the ongoing disputes about genetically modified foods. focuses on the important societal issues that spark protests against genetically modified foods: consumer choice at the marketplace (labeling), inequities in ownership of plant resources (intellectual property rights or "biopiracy"), the accidental movement of transgenes into conventional crops ("genetic pollution"), and corporate control of the food supply (globalization). Overall, these chapters provide an analysis of where the issues raised by food biotechnology stand today, and how industry, scientists, government, and the public might deal with the ongoing disputes about genetically modified foods.
CHAPTER 5.
PEDDLING DREAMS.
PROMISES VERSUS REALITY.
BIOTECHNOLOGY COMPANIES HAD BEEN WORKING ON AGRICULtural projects for 10 years or more when, in 1992, I received a last-minute invitation to talk about the labeling of genetically modified foods at a conference organized by Public Voice, a consumer advocacy group for food and health policy in Washington, DC. As a trained molecular biologist-though a long lapsed one-I was intrigued by the possibilities of the technology. I had not been following the field very closely and was puzzled about why an advocacy group might be concerned about labeling products that were still hypothetical. As it happened, I was not unprepared to address the question. For teaching purposes, I routinely collect scientific articles and newspaper clippings on nutrition topics, and I had accumulated a thick file on food biotechnology. The invitation provided an excuse to see what was in it.
The file surprised me. It immediately revealed that the industry's exciting promise to solve world food problems had little to do with the reality of its research and development efforts. Instead, companies were working on crop products most likely to generate returns on investment. Furthermore, industry leaders seemed to view the public not as an enthusiastic partner in enhancing the food supply but rather as a hostile force threatening their economic viability. The industry and its supporters in science, government, and business framed public questions about the safety or other consequences of food biotechnology as irrational challenges by scientifically illiterate consumers. I could not evaluate their science-based contentions that the techniques were inherently safe and the foods no different from those produced by conventional genetic crosses, however, as none had yet come to market.
Since then, the situation has changed in some ways but not in others. Once the Food and Drug Administration (FDA) approved the marketing of genetically modified foods in 1994, the production of these foods grew rapidly. By 2001, genetically modified varieties accounted for 26% of the corn and 68% of the soybeans planted in the United States as well as 69% of the cotton (the source of cottonseed oil for animal feed). Manufacturers were using ingredients made from transgenic corn and soybeans in 60% or more of processed foods on supermarket shelves-baby formulas, drink mixes, muffin mixes, fast foods, and, as we have seen, taco shells. Early in the twenty-first century, it is not possible to keep genetically modified foods out out of the food supply. of the food supply.1 What should we, as citizens and consumers, make of this situation? This chapter establishes a basis for answering that question by examining the promises of the food biotechnology industry-what it could could do-in comparison to the reality of its products and actions. do-in comparison to the reality of its products and actions.
THE THEORETICAL PROMISES.
In theory, if not yet in practice, food biotechnology holds much promise for addressing world food problems, most notably the overall shortfall in food production expected early in the twenty-first century. By some estimates, the global demand for rice, wheat, and maize will increase by 40% above current levels as early as 2020.2 To feed an increasing population on a constant area of arable land, the land must produce much more food-and do so without irreversibly damaging the environment. No technical barriers-again, in theory-prevent the use of genetic manipulations to improve the quantity and quality of the food supply, increase its safety, reduce the use of harmful pesticides and agricultural chemicals, and reduce food costs. To feed an increasing population on a constant area of arable land, the land must produce much more food-and do so without irreversibly damaging the environment. No technical barriers-again, in theory-prevent the use of genetic manipulations to improve the quantity and quality of the food supply, increase its safety, reduce the use of harmful pesticides and agricultural chemicals, and reduce food costs. Table 11 Table 11 lists examples of the stunning range of potentially beneficial applications of food biotechnology that are now available or under investigation. lists examples of the stunning range of potentially beneficial applications of food biotechnology that are now available or under investigation. Figure 11 Figure 11 illustrates a cartoonist's somewhat ironic view of such possibilities. illustrates a cartoonist's somewhat ironic view of such possibilities.
These applications could increase world food production, especially given the conditions of poor climate and environmental degradation characteristic of many developing countries, and they also could improve the nutritional quality of indigenous food plants on which so many populations depend. The potential for such improvements explains why industry leaders refer to food biotechnology as "the most important scientific tool to affect the food economy in the history of mankind," "the single most promising approach to feeding a growing world population while reducing damage to the environment," and an innovation that will "create miracles to help us feed a hungry world efficiently and economically."3 Such statements promise that food biotechnology will improve the food supply more effectively than conventional genetic techniques-those that involve selecting plants with desired traits, cross-pollinating them with related stock, and selecting and growing the progeny for many generations under field conditions. As this chapter explains, food biotechnologists consider such methods to be slow and imprecise and far inferior to their own. Such statements promise that food biotechnology will improve the food supply more effectively than conventional genetic techniques-those that involve selecting plants with desired traits, cross-pollinating them with related stock, and selecting and growing the progeny for many generations under field conditions. As this chapter explains, food biotechnologists consider such methods to be slow and imprecise and far inferior to their own.
TABLE 11. Theoretical and current applications of food biotechnology Food Plants (for human use) Improve flavor, texture, or freshness.
Increase levels of vitamins, protein, and other nutrients.
Increase production of chemicals such as sugars, waxes, or nutritionally important components.
Decrease levels of caffeine or other undesirable chemical substances.
Reduce saturated fatty acids in plant seed oils.
Produce drugs such as antibiotics, vaccines, or contraceptives.
Crop Plants (mainly for animal feed) Introduce herbicide resistance to improve weed control.
Permit growth with minimal use of fertilizers, pesticides, or water.
Increase resistance to damage by insect, fungal, viral, or other microbial pests.
Increase resistance to "stress" by frost, heat, salt, or heavy metals.
Permit fixation of atmospheric nitrogen.
Increase grain content of scarce amino acids.
Food Animals (for human use) Increase the efficiency of growth and reproduction.
Strengthen disease resistance.
Develop veterinary vaccines and diagnostic tests.
Increase milk production.
Produce milk containing pharmaceuticals.
The promise that food biotechnology will provide food for a hungry world, however, has yet to be fulfilled and is unlikely to be realized in the immediate future. Many of the applications listed in table 11 table 11 pose technical problems of formidable complexity. It is not easy to identify genes for desired traits, isolate them, insert them into plants, and provide the additional molecular components needed to make them function properly. The slow progress of biotechnology in addressing world hunger does not imply that this problem cannot be solved; given sufficient time, commitment, and funding support, the technical barriers could well be overcome. pose technical problems of formidable complexity. It is not easy to identify genes for desired traits, isolate them, insert them into plants, and provide the additional molecular components needed to make them function properly. The slow progress of biotechnology in addressing world hunger does not imply that this problem cannot be solved; given sufficient time, commitment, and funding support, the technical barriers could well be overcome.4 [image]
FIGURE 11. This political commentary, "Genetically Modified Specials," appeared as an "op-art" opposite the editorial page of the New York Times New York Times, July 15, 2000. ( 2000 Jesse Gordon and Knickerbocker Design. Reprinted with permission.) Technical problems, therefore, are a temporary barrier and are not the most important one. Instead, the main barrier to producing more food for the developing world is economic. Food biotechnology is a business, and businesses must generate returns on investment. In the food biotechnology business, economic aims (the reality) compete with humanitarian aims (the promises). These purposes conflict: one goal is to produce more and better food for an increasing population, but another is to produce foods with a competitive advantage in today's global marketplace-particularly "value-added" foods processed in ways that generate benefits for consumers and higher profits for manufacturers.5 Although genetically modified foods might well be expected to meet both goals, they often do not. Like all industries, this one serves investors who demand rapid returns, and financial considerations inevitably influence decisions related to product development. The business imperatives explain why the industry continues to view legitimate public questions about the use, safety, or social consequences of particular products as threats to the entire biotechnology enterprise. Without substantial changes to the economic realities of food biotechnology, its feed-the-world potential remains an unfulfilled promise. Although genetically modified foods might well be expected to meet both goals, they often do not. Like all industries, this one serves investors who demand rapid returns, and financial considerations inevitably influence decisions related to product development. The business imperatives explain why the industry continues to view legitimate public questions about the use, safety, or social consequences of particular products as threats to the entire biotechnology enterprise. Without substantial changes to the economic realities of food biotechnology, its feed-the-world potential remains an unfulfilled promise.
THE ECONOMIC REALITIES.
If food biotechnology companies are primarily businesses, then their primary concern is to recover the costs of research and development and to maximize returns on investment. Research costs can be high; it takes years and hundreds of millions of dollars to bring a genetically engineered food to market. Nevertheless, even before the FDA approved the first such food for production, business analysts viewed the industry as one with a huge market potential. In 1992, they predicted that the value of the industry would increase to at least $50 billion by the year 2000. As late as 1998, some were predicting that worldwide sales could exceed $300 billion by 2010. These predictions were overly optimistic, but food biotechnology is still big business. Worldwide sales of genetically modified crops rose from $1.6 billion in 1998 to about $2.2 billion in 1999, and are now expected to rise to $25 billion by 2010.6 Regardless of the accuracy of such estimates, the rapid expansion of the food biotechnology industry is impressive. By 1998, about 1,400 companies had invested more than $110 billion in agricultural biotechnology, and the FDA had approved about 50 food products for marketing. By 2001, genetically engineered crops were growing on at least 109 million acres throughout the world, a 25-fold expansion just since 1996. Although 80% of the acres were in North America, Argentina, and China, 10 other countries also had substantial plantings and more than 40 countries permitted field trials of one crop or another, most intended for animal feed.7 Despite the recent decline in planting of genetically engineered corn that occurred as a result of European opposition (discussed in Despite the recent decline in planting of genetically engineered corn that occurred as a result of European opposition (discussed in chapter 8 chapter 8), some segments of the industry are doing very well.
One especially successful agricultural biotechnology company is Monsanto, which has played an unusually active-some might say aggressive-role in the industry. Monsanto is a multinational company based in St. Louis, Missouri, whose corporate motto used to be Food, Health, Hope Food, Health, Hope.8 After the company merged with Pharmacia & Upjohn in 2000 to form an agricultural unit of Pharmacia, it changed the slogan to After the company merged with Pharmacia & Upjohn in 2000 to form an agricultural unit of Pharmacia, it changed the slogan to A Single Focus: Agriculture/A Renewed Purpose: Value A Single Focus: Agriculture/A Renewed Purpose: Value. Monsanto employed about 14,000 people worldwide in 2002. Its agricultural biotechnology products exceed financial expectations. Its stock price rose by 75% in 1995 and by another 70% in 1996; at that time, company officials estimated that their products would earn $2 billion by the year 2000, $67 billion by 2005, and $20 billion by 2010. By 2000, sales exceeded $5 billion, well ahead of projections.9 Not all companies are this fortunate or skilled. In 1998, for example, just 8 out of 350 publicly traded food biotechnology companies were profitable.10 Business analysts attribute the typically poor performance to uneven management, corporate shortsightedness, and product failures. Most companies were slow to invest sufficient funds in research, as was the U.S. government. Investors are leery of regulatory hurdles and consumer opposition. Financial imperatives require food biotechnology companies to work on projects that are technically feasible and likely to repay the costs of investment in short order. Thus, they focus research efforts on "input traits" that will make crops easier and less expensive to grow through control of weeds, plant diseases, ripening, insects, or herbicide-resistance, or will make foods last longer on the shelf and cost less to process. If these characteristics benefit the public, they do so invisibly. Most of the financial rewards go to the companies that produce the seeds and chemicals. In some situations, farmers also benefit. Business analysts attribute the typically poor performance to uneven management, corporate shortsightedness, and product failures. Most companies were slow to invest sufficient funds in research, as was the U.S. government. Investors are leery of regulatory hurdles and consumer opposition. Financial imperatives require food biotechnology companies to work on projects that are technically feasible and likely to repay the costs of investment in short order. Thus, they focus research efforts on "input traits" that will make crops easier and less expensive to grow through control of weeds, plant diseases, ripening, insects, or herbicide-resistance, or will make foods last longer on the shelf and cost less to process. If these characteristics benefit the public, they do so invisibly. Most of the financial rewards go to the companies that produce the seeds and chemicals. In some situations, farmers also benefit.11 Monsanto applies its research budget for agricultural biotechnology, which exceeds the combined total of all the publicly funded tropical research institutes in the world, almost exclusively to temperate-zone agricultural problems. The company brilliantly designs its principal agricultural products to establish control of the entire industry. Its flagship product is the herbicide Roundup. Monsanto scientists genetically engineer soybeans and corn to be "Roundup Ready," so their crops grow happily when doused with that herbicide while the competing weeds are killed. Farmers who buy Monsanto's seeds also buy Monsanto's herbicide. The company began selling Roundup Ready soybeans in 1996; just two years later, farmers planted them on one-third of U.S. soybean farmland, covering 25 million acres. The company's research "pipeline" mainly emphasizes Roundup Ready crops designed for animal feed. Monsanto's emphasis on these crops is understandable; annual sales of Roundup exceed those of the next six leading herbicides combined. The company also produces a variety of crops genetically engineered to contain a toxin derived from Bacillus thuringiensis Bacillus thuringiensis ( (Bt). As we saw in the introductory chapter, the Bt Bt toxin inhibits the growth of insect pests and has been used for years as a spray on organic farms. Monsanto's patent-protected innovation was to genetically engineer the toxin inhibits the growth of insect pests and has been used for years as a spray on organic farms. Monsanto's patent-protected innovation was to genetically engineer the Bt Bt toxin into the plant itself so that insect resistance would not wash off in the rain. toxin into the plant itself so that insect resistance would not wash off in the rain.
Monsanto's crops grow mainly in the United States and other industrialized countries. Because developing countries lack a viable market for such products, few agricultural biotechnology companies can afford to invest in solutions to the food problems of the developing world. The agricultural needs of developing countries are well defined, and numerous private and public agencies support useful projects, but these funding sources are not coordinated and often tend to favor the priorities of donors more than recipients.12 For years, Dr. Roger Beachy, the director of a U.S. biotechnology research institute devoted to improving crops in developing countries, complained that he could get little support from industry beyond permission to use patent-protected techniques "for specific crops under certain circumstances." For years, Dr. Roger Beachy, the director of a U.S. biotechnology research institute devoted to improving crops in developing countries, complained that he could get little support from industry beyond permission to use patent-protected techniques "for specific crops under certain circumstances."13 As complaints about the disparity between the promises and the realities of food biotechnology became more strident, companies began to put more resources into projects that might benefit the developing world. Monsanto's scientists, for example, are genetically engineering oilseeds to contain beta-carotene, a precursor of vitamin A. This vitamin is especially lacking in undernourished populations, and its addition to the diet produces an almost miraculous range of health improvements.14 Development of such products is time-consuming and expensive, and success is uncertain. Companies introduced genetically engineered papaya in Hawaii, for example, to replenish an entire industry ravaged by viral disease. The fruit grew well in the first seasons, but its developers remain cautious about its long-term viability: "We'd all be nuts to say that this is the final solution. . . . Biological systems evolve." Development of such products is time-consuming and expensive, and success is uncertain. Companies introduced genetically engineered papaya in Hawaii, for example, to replenish an entire industry ravaged by viral disease. The fruit grew well in the first seasons, but its developers remain cautious about its long-term viability: "We'd all be nuts to say that this is the final solution. . . . Biological systems evolve."15 This comment reflects yet another reality; it is one thing to develop a food in a laboratory but quite another to grow it successfully under field conditions. A 1994 statement by one business analyst still applies: "Nearly 20 years into the gene-splicing revolution . . . no one has cured cancer or produced a bioengineered miracle of loaves and fishes for a hungry third world. The industry is still peddling dreams." This comment reflects yet another reality; it is one thing to develop a food in a laboratory but quite another to grow it successfully under field conditions. A 1994 statement by one business analyst still applies: "Nearly 20 years into the gene-splicing revolution . . . no one has cured cancer or produced a bioengineered miracle of loaves and fishes for a hungry third world. The industry is still peddling dreams."16 Such doubts enrage industry supporters in the United States and, sometimes, in developing countries. Florence Wambugu, for example, is a plant pathologist from Kenya who has worked with Monsanto since 1992 to develop a genetically modified sweet potato that can survive infection from a virus that otherwise would greatly reduce crop yields. At the Tufts University conference I attended in 2001, she predicted that the bioengineered potato would increase worldwide sweet potato production by at least 15%, increase the income of farmers by $41 million, and improve the food security of 1 million people-without any increase in the costs of production. Ms. Wambugu is an eloquent and forceful promoter of biotechnology as the solution to worldwide food shortages, and she does not mince words about the harm caused by "antibiotech lobbies": Antibiotechnology protesters . . . deny developing countries like my home, Kenya, the resources to develop a technology that can help alleviate hunger, malnutrition and poverty. . . . As an African, I know that biotech is not a panacea. It cannot solve problems of inept or corrupt governments, underfunded research, unsound agricultural policy, or a lack of capital . . . but as a scientist, I also know that biotech is a powerful new tool that can help address some of the agricultural problems that plague Africa. The protesters have fanned the flames of mistrust of genetically modified foods through a campaign of misinformation. These people and organizations have become adept at playing on the media's appetite for controversy to draw attention to their cause. But the real victim in this controversy is the truth. . . . I know of what I speak, because I grew up barefoot and hungry.17 In 2001, her sweet potato was in field trials, and the level of its productivity or acceptance would not be known for some time. Nevertheless, Monsanto has used the potato in its public relations campaigns since 1996 ("the sweet potato project will ultimately be a major contribution to food security for some of the poorest farmers in the world"), and the Biotechnology Information Council, which runs an industry-sponsored public relations campaign, also uses her work: "Florence Wambugu helped develop sweet potato varieties that are resistant to a complex set of viruses that can wipe out three-fourths of Kenyan farmers' harvest. . . . Similar techniques are being used to improve other staple crops of the developing world, including cassava, banana, and potato."18 These statements are promises. The crops are not yet in production, but the public relations materials do not emphasize that point. These statements are promises. The crops are not yet in production, but the public relations materials do not emphasize that point.
The most highly publicized example of the gap between promises and reality is "Golden Rice," genetically engineered to contain beta-carotene, a precursor of vitamin A. Although this rice also is not yet in production, it has been the industry's primary advertising tool to promote the humanitarian benefits of food biotechnology (see figure 12 figure 12). This rice raises a variety of issues that illustrate some further points about the interweaving of science and politics in food biotechnology, as we will now see MAKING RICE "GOLDEN"
Much of the promise of food biotechnology depends on its science, but the realities depend on social as well as scientific factors. Nowhere is this distinction better illustrated than in the case of Golden Rice. To understand why the interplay between the scientific and societal issues makes genetically modified foods so political political, we need to begin with an explanation of the extraordinary scientific achievement involved in creating Golden Rice.
Biotechnology versus Traditional Plant Genetics Scientists who are puzzled by public distrust of food biotechnology tend to see its techniques as extensions of those of traditional plant genetics but superior because they are more efficient and precise. Traditional plant breeding can be tedious. Suppose, for example, that you would like to create a tomato with a thicker skin so it can be transported without getting crushed. Using the typical genetic methods, you would grow many kinds of tomatoes and look for a rare plant that produces tomatoes with thicker skins. You might also treat tomato embryos with chemicals or radiation to induce mutations; if you are lucky, a mutation will lead to fruit with a thicker skin. You then grow seeds from these tomatoes into plants, select progeny plants with thicker skins, cross them (through pollination) with tomato plants with other desirable traits, and, eventually, end up with thick-skinned tomatoes that breed true. A process like this involves luck as well as skill, takes an average of six to eight years of growing cycles, and can (and often does) result in a tasteless supermarket tomato. Other such manipulations created the full array of fruits, vegetables, and crops that make our food supply so abundant. It is safe to say that virtually all plants that constitute part of today's food supply were genetically manipulated in one way or another. Traditional genetic manipulations permit the transfer of genes only between members of the same species or those that are closely related-apples and pears, for example. In contrast, agricultural biotechnology extends these techniques to address problems of efficiency, time, and species limits on transferable traits.
[image]
FIGURE 12. This advertisement for the benefits of Golden Rice is part of an industry public relations campaign to promote public acceptance of genetically modified foods; it appeared frequently in 2001 in publications such as the New Yorker, Scientific American New Yorker, Scientific American, and the New York Times New York Times. The text fails to emphasize that the rice, which "could help alleviate more suffering and illness than any single medicine," is not yet available.
Because both traditional plant genetics and biotechnology involve similar manipulations and because they both achieve the same result-insertion of new segments of DNA into a plant's existing DNA-biotechnologists maintain that the plants they develop are no different from those produced in old-fashioned ways, and should not be viewed or treated differently by regulatory agencies or the public. As we will see (and as the appendix explains in further detail), the steps involved in creating a transgenic plant are numerous and complex, and they introduce DNA segments that may come from unrelated organisms. Do these differences matter? The response is no no if one focuses on the similarities: DNA is DNA no matter where it comes from. The response is if one focuses on the similarities: DNA is DNA no matter where it comes from. The response is yes yes if one focuses on differences or the societal implications of the technology. Points of view govern such responses and lead to political controversy. if one focuses on differences or the societal implications of the technology. Points of view govern such responses and lead to political controversy.
Golden Rice: The Science Plant bioengineering is accomplished through recombinant recombinant DNA technology, through which the DNA segments that comprise a desirable gene from bacteria, for example, are inserted (recombined) permanently into the DNA of an entirely different organism-in this case, a plant. Scientists using recombinant techniques have created insect- and herbicide-resistant crops by taking genes from bacteria and transferring them to corn and soybeans. To develop Golden Rice, they recombined genes and DNA regulatory segments from daffodils, peas, viruses, and bacteria to induce rice to make beta-carotene in its endosperm-the white, starchy part of the grain. Rice, like all grains, consists of three principal parts: a surrounding sheath of nutrient-rich bran, an inner endosperm containing starch and a little protein, and an embryo, which draws on the energy and nutrients in the grain when it begins to grow into a plant (see DNA technology, through which the DNA segments that comprise a desirable gene from bacteria, for example, are inserted (recombined) permanently into the DNA of an entirely different organism-in this case, a plant. Scientists using recombinant techniques have created insect- and herbicide-resistant crops by taking genes from bacteria and transferring them to corn and soybeans. To develop Golden Rice, they recombined genes and DNA regulatory segments from daffodils, peas, viruses, and bacteria to induce rice to make beta-carotene in its endosperm-the white, starchy part of the grain. Rice, like all grains, consists of three principal parts: a surrounding sheath of nutrient-rich bran, an inner endosperm containing starch and a little protein, and an embryo, which draws on the energy and nutrients in the grain when it begins to grow into a plant (see figure 13 figure 13). Rice makes small amounts of beta-carotene in its bran layers, but not in the endosperm. Most people just eat the endosperm, however, because millers remove the bran layers when they convert brown rice to white rice (which is why white rice in the United States is enriched with several vitamins and iron).
[image]
FIGURE 13. The metabolic steps through which plants make beta-carotene from precursor molecules, and animals convert beta-carotene to vitamin A. An enzyme carries out each step. Rice bran contains information for the complete set of enzymes to make beta-carotene, but some enzymes are inactive in the endosperm. To create Golden Rice, scientists obtain genes (DNA) for the missing enzymes from other plants and bacteria and insert them into the DNA of rice (see tables 12 tables 12 and and 16 16, pages 158 pages 158 and and 280 280).
Rice bran and highly pigmented fruits and vegetables (such as melons or carrots) make beta-carotene in a series of steps in which precursor molecules are converted to beta-carotene by specific enzymes (which are proteins), one for each step. Rice endosperm lacks three of the required enzymes. To insert beta-carotene, researchers Ingo Potrykus and Peter Beyer and their colleagues in Switzerland and Germany obtained genes for the missing enzymes from daffodils and bacteria. They also isolated genes or regulatory DNA segments from peas, viruses, and other bacteria to help the recombinant enzymes function in rice endosperm. After a decade of effort during the 1990s, the techniques worked. The scientists made rice that contained beta-carotene and identified it immediately by its yellow color (hence: Golden Rice). They published this work in 2000. Figure 13 Figure 13 illustrates the pathway of biosynthesis of beta-carotene and the enzymes replaced by genetic engineering. The pathway illustrates an important distinction: beta-carotene is not the same as vitamin A but is a illustrates the pathway of biosynthesis of beta-carotene and the enzymes replaced by genetic engineering. The pathway illustrates an important distinction: beta-carotene is not the same as vitamin A but is a precursor precursor of the actual vitamin. We (and other mammals) have enzymes that convert beta-carotene to vitamin A in our bodies. of the actual vitamin. We (and other mammals) have enzymes that convert beta-carotene to vitamin A in our bodies.19 The technical challenges involved in moving genes from one organism to another-daffodils and bacteria to rice, for example-are daunting, even to experts. Scientists must find the genes for the missing enzymes, reproduce them, and make them function. The "make function" part is particularly challenging. Genes do not work independently. They have to be regulated regulated, which means in this case that the rice needs to be "told" when, where, and for how long the genes for making beta-carotene should do so. Scientists must also find, duplicate, and transfer the genes or DNA segments for these regulatory functions into the rice along with the genes for the missing enzymes. Accomplishing these tasks is a technical tour de force tour de force-an art as well as a science-not least because of the extraordinary number of genes and factors required, each requiring its own separate bioengineering step carried out in just the right order. As an illustration of the complexity of this work, table 17 table 17 in the appendix ( in the appendix (page 302) summarizes the less less complicated of the two approaches used to insert beta-carotene genes into rice. complicated of the two approaches used to insert beta-carotene genes into rice.
Complicated as they are, the genetic engineering steps are only the first first part of realizing the humanitarian benefits of Golden Rice. The inserted genes must be transmitted to seeds; the rice must continue to make beta-carotene when taken out of the laboratory and grown in fields; people must accept, buy, and eat the rice; and the beta-carotene must be absorbed, split into vitamin A, and function in the human body. part of realizing the humanitarian benefits of Golden Rice. The inserted genes must be transmitted to seeds; the rice must continue to make beta-carotene when taken out of the laboratory and grown in fields; people must accept, buy, and eat the rice; and the beta-carotene must be absorbed, split into vitamin A, and function in the human body. Table 12 Table 12 lists these requirements in greater detail. These additional tasks also can be difficult to accomplish. One production problem, for example, is the relative instability of transgenic plants with multiple inserted genes; such plants tend to lose the transgenic traits over several generations. Another is that the scientists engineered beta-carotene into a variety of rice that grows best in temperate zones. To succeed in developing countries, the technology must be transferred to locally grown varieties. lists these requirements in greater detail. These additional tasks also can be difficult to accomplish. One production problem, for example, is the relative instability of transgenic plants with multiple inserted genes; such plants tend to lose the transgenic traits over several generations. Another is that the scientists engineered beta-carotene into a variety of rice that grows best in temperate zones. To succeed in developing countries, the technology must be transferred to locally grown varieties.
TABLE 12. Research steps required to genetically engineer and to produce and use Golden Rice containing beta-carotene, a precursor of vitamin A Research steps required to genetically engineer and to produce and use Golden Rice containing beta-carotene, a precursor of vitamin A Basic Research (see (see table 17 table 17 in appendix for further details) in appendix for further details) Isolate the desired genes and regulatory DNA segments from daffodils, bacteria, peas, and viruses.Transfer the genes and segments to rice embryos.Grow the embryos; select the rare embryos that accept the desired genes and segments.Grow the transgenic embryos into plants.Harvest seeds from the plants.Test the seeds for beta-carotene.Repeat the procedures in rice strains able to grow in tropical climates.
Production Research Grow the transgenic rice for several generations to ensure the stability of the beta-carotene trait.Evaluate the plants for environmental effects, presence of allergens, changes in nutrient composition, or unwanted effects on yield.Obtain regulatory approval to grow the rice commercially.Obtain regulatory approval to market the rice.Produce the rice in sufficient quantities for distribution and marketing.
Consumer Research Conduct studies to determine the degree of consumer acceptance of the rice.Conduct dietary studies to evaluate patterns of consumption of the rice among vitamin Adeficient individuals and population groups.
Clinical Research Conduct biochemical studies to determine how much beta-carotene is absorbed from the rice, and whether consuming the rice increases levels of vitamin A in the body.Conduct clinical studies to determine whether consuming the rice is associated with a reduction in symptoms of vitamin A deficiency and improvements in health and survival among individuals and population groups.
The degree of acceptance by consumers is also a matter of concern. Preliminary surveys suggested that some people found the yellow color unattractive; they thought someone might have urinated on the rice. Scientists can remove the undesirable color by inserting the genes for the additional enzymes in the pathway to vitamin A (which is colorless), but these steps only add to the technical difficulties. Table 12 Table 12 explains why promotion of Golden Rice as a means to prevent vitamin A deficiency is premature. At best several more years of work will be needed to bring it to market. explains why promotion of Golden Rice as a means to prevent vitamin A deficiency is premature. At best several more years of work will be needed to bring it to market.
Golden Rice: The Politics White rice is the principal source of energy (calories) for one-third or more of the world's population, but it is not a source of vitamin A. Only animals make vitamin A; plants make beta-carotene, its precursor. The lack of vitamin A is the single most important cause of blindness among children in developing countries and a major contributor to deaths among malnourished children and adults. Children who are even mildly deficient in vitamin A are at increased risk for early death, but health authorities can prevent an astonishing proportion of such deaths-more than half-with supplements of vitamin A (not beta-carotene). Supplements are relatively inexpensive and need to be taken once every six months or so, but because they cannot always be obtained by the people who need them most, fortification of a commonly consumed food might be another way to solve a serious world health problem. beta-carotene). Supplements are relatively inexpensive and need to be taken once every six months or so, but because they cannot always be obtained by the people who need them most, fortification of a commonly consumed food might be another way to solve a serious world health problem.20 Since 1984, the Rockefeller Foundation has dispensed about $4 million annually to fund genetics projects to improve one characteristic or another of rice plants, and it considers Golden Rice to be the greatest achievement of this program. Moving Golden Rice beyond the research stage, however, unexpectedly encountered political problems. Ironically, one of the difficulties was a confrontation with patent rights, as a "thicket of intellectual property claims" governed use of the technology. The companies most likely to benefit from the public relations generated by Golden Rice, among them Monsanto and AstraZeneca, hold proprietary patent rights to as many as 70 of the materials or DNA segments needed for its construction. To solve the legal problems connected with using the technology, Dr. Potrykus and his colleagues contracted with AstraZeneca to market the rice in the United States and other industrial markets. In return, AstraZeneca agreed to help make the technology available to the developing world. It gave the technology to the International Rice Research Institute in the Philippines where scientists are crossing Golden Rice with locally grown varieties. AstraZeneca also said it would give the Golden Rice seeds to farmers earning less than $10,000 a year (a figure that includes most farmers in developing countries) and allow farmers to save the seeds to plant in future years. Monsanto also agreed to give up its intellectual property rights for this rice.21 These concessions appear exceedingly generous, but Golden Rice is unlikely to have much commercial potential in developing countries. Its public relations value, however, is enormous. In July 2000, the cover of Time Time displayed a photograph of Dr. Potrykus with the headline "This rice could save a million kids a year . . . but protesters believe such genetically modified foods are bad for us and our planet. Here's why." The story noted that it was "no wonder the biotech industry sees Golden Rice as a powerful ally in its struggle to win public acceptance. No wonder its critics see it as a cynical ploy." displayed a photograph of Dr. Potrykus with the headline "This rice could save a million kids a year . . . but protesters believe such genetically modified foods are bad for us and our planet. Here's why." The story noted that it was "no wonder the biotech industry sees Golden Rice as a powerful ally in its struggle to win public acceptance. No wonder its critics see it as a cynical ploy."22 Cynics might indeed raise eyebrows at the advertisement shown in Cynics might indeed raise eyebrows at the advertisement shown in figure 14 figure 14, a component of the biotechnology industry's public relations campaign in 2001. The advertisement features a photograph of a child of indeterminate ethnicity eating a "vitamin-enriched" breakfast cereal presumably made from Golden Rice. It says, "Thanks to biotechnology, researchers are developing a new kind of rice with beta-carotene. . . . In the future it could help prevent serious illnesses, such as blindness or anemia, for many people in developing parts of the world."
Dr. Potrykus-frustrated by the encumbrances of industry patent rights on the one hand and objections by antibiotechnology advocates on the other-emphasizes the humanitarian benefits of his research. He told the Tufts University conference that the 40,000 people dying from malnutrition every day need the technology just to survive. Malnutrition, he said, pose[s] immense medical problems for developing countries. Traditional interventions are helpful, but require additional and complementary actions. . . . Applied in "humanitarian projects" they could substantially and sustainably improve the health and life of the poor. Whether the poor will benefit, does neither depend upon scientific, patent right, or economic problems, nor upon socioeconomic, consumer health, or environmental risks. It depends mainly upon the political "success" of radical anti-GMO organizations. Those who try to prevent careful exploitation in humanitarian projects must be taken responsible for their damage.23 By "those," Dr. Potrykus meant Greenpeace: "Is there any problem left that could interfere with the exploitation of 'Golden Rice' to the benefit of the poor and disadvantaged in developing countries? It is unfortunate that the answer is yes: Greenpeace . . . and associated GMO opponents regard 'Golden Rice' as a 'Trojan Horse.'. . . By their singular logic, the success of 'Golden Rice' has to be prevented under all circumstances, irrespective of the damage to those for whose interest Greenpeace pretends to act."24 Dr. Potrykus is correct in his assessment of the motivations of Greenpeace. From that organization's standpoint, Golden Rice obscures fundamental issues of societal values-in this case, poverty and control over resources-and is a techno-fix imposed by corporations and scientists without consulting recipients about whether they want it or not. Greenpeace says that the true purpose of Golden Rice is to convince people to accept genetically modified foods. Dr. Potrykus is correct in his assessment of the motivations of Greenpeace. From that organization's standpoint, Golden Rice obscures fundamental issues of societal values-in this case, poverty and control over resources-and is a techno-fix imposed by corporations and scientists without consulting recipients about whether they want it or not. Greenpeace says that the true purpose of Golden Rice is to convince people to accept genetically modified foods.
[image]
FIGURE 14. This biotechnology industry advertisement appeared late in 2001 inside the front cover of Food Safety Food Safety, a publication of the National Restaurant Association's Educational Foundation. The text suggests that Golden Rice could help prevent nutritional deficiencies among people in the developing world, presumably by replacing the current vitamin-enriched breakfast cereals.
If Greenpeace frustrates scientists and biotechnology industry officials, it is in part because its tactics are so effective. For one thing, Greenpeace fights science with science. In February 2001, the group challenged the fundamental premise (and promise) of Golden Rice. Greenpeace calculated that adults would have to eat at least 20 pounds pounds (9 kilograms) of Golden Rice to meet daily vitamin A recommendations. Greenpeace called Golden Rice nothing but "fool's gold" and said, "It is shameful that the biotech industry is using starving children to promote a dubious product. . . . This isn't about solving childhood blindness, it's about solving biotech's public relations problem." (9 kilograms) of Golden Rice to meet daily vitamin A recommendations. Greenpeace called Golden Rice nothing but "fool's gold" and said, "It is shameful that the biotech industry is using starving children to promote a dubious product. . . . This isn't about solving childhood blindness, it's about solving biotech's public relations problem."25 Greenpeace did its homework. It took at face value the scientists' own estimate that a daily intake of 300 grams (nearly 11 ounces) of Golden Rice should provide the equivalent equivalent of 100 units of vitamin A. As noted earlier, beta-carotene must be converted to vitamin A in the body. This process is usually incomplete, however, and the amount that is converted into vitamin A is a matter of sharp debate. The scientists who developed Golden Rice assumed that 6 molecules of beta-carotene would yield 1 of vitamin A, whereas U.S. estimates suggest a conversion ratio of 12 to 1. of 100 units of vitamin A. As noted earlier, beta-carotene must be converted to vitamin A in the body. This process is usually incomplete, however, and the amount that is converted into vitamin A is a matter of sharp debate. The scientists who developed Golden Rice assumed that 6 molecules of beta-carotene would yield 1 of vitamin A, whereas U.S. estimates suggest a conversion ratio of 12 to 1.
Greenpeace took the scientists' figures and compared them to recommended levels of vitamin A intake for the U.S. population. By U.S. standards, 300 grams (11 ounces) of Golden Rice provides one-third the recommended level of daily intake of vitamin A for a child aged one to three years, one-seventh the level recommended for an adult woman, and one-ninth the level for an adult man. By such standards, young children would need to eat nearly 33 ounces of raw rice per day, which, when cooked, would amount to 99 ounces, or about 6 pounds-an absurdly large amount. If the Golden Rice scientists had used the higher U.S. conversion ratio, that quantity doubles to an even more absurd 12 pounds.26 It must be understood that the U.S. standard is deliberately set high to meet the nutritional needs of about 98% of the population; people with average requirements can prevent vitamin A deficiency at much lower levels of intake.27 Nevertheless, to meet just 10% of the U.S. standard, young children would still need to eat more than a pound of cooked rice a day. The Greenpeace analysis made it clear that on quantitative grounds alone, Golden Rice would constitute-at best-a partial solution to health problems caused by vitamin A deficiency. Nevertheless, to meet just 10% of the U.S. standard, young children would still need to eat more than a pound of cooked rice a day. The Greenpeace analysis made it clear that on quantitative grounds alone, Golden Rice would constitute-at best-a partial solution to health problems caused by vitamin A deficiency.
As might be anticipated, the Greenpeace estimations elicited outraged arguments from scientists and the industry. As a nutritionist, I particularly appreciated the arguments because they raged around the kinds of basic questions my colleagues and I like to discuss in nutrition science courses: What standards are appropriate for the intake of nutrients by individuals and populations? How much beta-carotene is converted to vitamin A in the body? How much vitamin A is required to prevent or alleviate the symptoms or consequences of deficiency? The arguments also dealt with an important question in applied applied nutrition: Should nutritional standards for developing countries be the same as or lower than those for industrialized countries? This question is political rather than scientific because of its implications: lower nutrient standards make populations appear to be better nourished. They also make Golden Rice appear to be more effective. nutrition: Should nutritional standards for developing countries be the same as or lower than those for industrialized countries? This question is political rather than scientific because of its implications: lower nutrient standards make populations appear to be better nourished. They also make Golden Rice appear to be more effective.
Dr. Potrykus acknowledged: "Greenpeace has identified a weak point in the strategy of using Golden Rice for reducing vitamin A deficiency." He then countered with new calculations based on standards less "luxurious" than those of the United States-those of India, for example. He said, "Golden Rice is not supposed to provide 100% of the vitamin Asupply, but to . . . [be] complementing other dietary components." On this basis, he estimated that 50% of the standard for a child in India could be met by about 100 grams of Golden Rice per day (a quite reasonable 9 ounces, cooked), and that this amount could be reduced even further if his group could bioengineer the rice to contain higher levels of beta-carotene. Although he still viewed the Greenpeace objections as morally irresponsible, he said he shared "Greenpeace's disgrace about the heavy PR campaign of some agbiotech [agricultural biotechnology] companies using results from our experiments. . . . I stressed, however, also, that I am grateful to all those companies, which donated free licenses . . . to allow for the humanitarian use of Golden Rice in developing countries."28 The president of the Rockefeller Foundation, Gordon Conway, also agreed that the industry was overselling the promise of Golden Rice: The food industry . . . has featured the golden grains as part of a $50 [million] campaign to promote GM foods. The message is that GM is not just about profits, it can save children's lives. All of this hype is premature and dangerous. The science that led us to Golden Rice is at a very early stage. Until the product is fully developed and tested, no one can be sure how well it will work. . . . But some anti-GM activists would like the work to be stopped before we know its real value.29 In this statement, Mr. Conway also expressed a common theme: Golden Rice holds so much promise that no questioning of its value is justified.
As it turns out, if Greenpeace activists had known a bit more about basic and applied nutrition, they could have provided even further cause for skepticism about the promise of Golden Rice. To begin with, the "bioavailability" of beta-carotene, the amount that is absorbed and converted to vitamin A, is quite low-10% or less by some estimates-which explains why conversion ratios to vitamin A may be as high as 12 to 1. Also, an enzyme (from the intestine or liver) splits beta-carotene into two molecules of vitamin A (see figure 13 figure 13). Like all enzymes, this one is a protein that must be synthesized in the body. Beta-carotene, like vitamin A, is fat-soluble, meaning that it requires some fat in the diet to aid its absorption and transport. People whose diets are adequate in fat and protein are able to use beta-carotene more efficiently than those who are malnourished. Furthermore, vitamin A deficiency is often the most visible manifestation of generalized protein-energy malnutrition, in part caused by intestinal or parasitic infections that interfere with the absorption of beta-carotene and its conversion to vitamin A.30 We do not yet know the extent to which malnourished children-those most at risk of vitamin A deficiency-can absorb and use the beta-carotene in Golden Rice. In addition to such doubts, Golden Rice may prove costly. The companies may be donating the We do not yet know the extent to which malnourished children-those most at risk of vitamin A deficiency-can absorb and use the beta-carotene in Golden Rice. In addition to such doubts, Golden Rice may prove costly. The companies may be donating the technology technology to create the rice, but farmers will still have to sell it, and people will still have to pay for it. Moreover, in many countries where vitamin A deficiency is common, food sources of beta-carotene are plentiful, but people believe the foods inappropriate for young children, do not cook them enough to make them digestible, or do not consume enough fat to permit much in the way of absorption. It remains to be seen whether the beta-carotene in Golden Rice will fare better under such circumstances. Overall, vitamin A deficiency is a complicated health problem affected by cultural and societal factors as well as dietary factors. In this situation, the genetic engineering of a single nutrient or two into a food, while attractive in theory, raises many questions about its benefits in practice. to create the rice, but farmers will still have to sell it, and people will still have to pay for it. Moreover, in many countries where vitamin A deficiency is common, food sources of beta-carotene are plentiful, but people believe the foods inappropriate for young children, do not cook them enough to make them digestible, or do not consume enough fat to permit much in the way of absorption. It remains to be seen whether the beta-carotene in Golden Rice will fare better under such circumstances. Overall, vitamin A deficiency is a complicated health problem affected by cultural and societal factors as well as dietary factors. In this situation, the genetic engineering of a single nutrient or two into a food, while attractive in theory, raises many questions about its benefits in practice.
In 2001, I sent a brief letter outlining these nutritional points to the Journal of the American Dietetic Association Journal of the American Dietetic Association.31 An electronic copy appeared on the Internet and drew responses from colleagues around the world. A British scientist (who identified himself as a Fellow of the Royal Society) wrote, "It would seem to me that the simplest way to find out if vitamin A rice [ An electronic copy appeared on the Internet and drew responses from colleagues around the world. A British scientist (who identified himself as a Fellow of the Royal Society) wrote, "It would seem to me that the simplest way to find out if vitamin A rice [sic] works as a vitamin supplement is to try it out. If it doesn't then what has been lost except a lot of hot air and propaganda; on the other hand if it does work and your letter has delayed its introduction, could you face the children who remain blind for life as a consequence?"
The writer seems to suggest that even if beta-carotene contributes just a little to alleviating vitamin A deficiency, no questioning of the theoretical premise of Golden Rice-and, by implication, food biotechnology-is acceptable. Anyone who raises questions about the potential value of Golden Rice bears moral responsibility for 500,000 cases of childhood blindness and millions of deaths from vitamin A deficiency each year. What I find most striking about such views is their implication that complex societal problems-in this case, malnutrition-are more easily solved by private-sector, commercially driven science than by societal decisions and political actions.
We already know that questions about the ability of Golden Rice to help people overcome deficiencies of vitamin A will not be answerable for several years. While waiting for the results of future research, it is worth considering more immediate ways to solve problems of vitamin A deficiency. Taken together, the many nutritional, physiological, and cultural factors that affect vitamin A status suggest that the addition of a single nutrient to food will have limited effectiveness. Instead, a combination of supplementation, fortification, and dietary approaches is likely to be needed-approaches such as promoting the production and consumption of fruits and vegetables rich in beta-carotene, educating people about how to use such foods, and improving the quantity and variety of foods in the diet (so beta-carotene can be better absorbed). Perhaps most helpful would be basic public health measures such as providing adequate supplies of clean water (to prevent transmission of diarrheal and parasitic diseases). Long-term solutions to the problem of vitamin A deficiency in particular, and malnutrition in general, continue to depend on societal interventions such as education, housing, health care, employment, and income-all more difficult and complicated, but ultimately more likely to be effective, than genetic engineering. Can genetic engineering usefully contribute to such efforts? Possibly, but that question cannot yet be answered.32 In the meantime, the industry's public relations campaign continues. In the meantime, the industry's public relations campaign continues.
One notable feature of the debates about Golden Rice is that its safety did not emerge as a major point of contention. Greenpeace found much to criticize without emphasizing safety issues but did raise one such issue-environmental effects: "GE rice, like other genetically modified organisms (GMOs) released into the environment, is a form of living pollution and its environmental impact is not only unpredictable and uncontrollable but also irreversible."24 Dr. Potrykus responded to this charge by explaining that Golden Rice is no different from ordinary rice: "As the pathway [of beta-carotene synthesis] is already in rice (and in every green plant), and the difference is only in its activity in the endosperm, it is very hard to construct any selective advantage for Golden Rice in any environment, and therefore, any environmental hazard." What most concerned Dr. Potrykus was the threat that Greenpeace might engage in ecoterrorism and interfere with test plantings. He warned Greenpeace, "If you plan to destroy test fields to prevent responsible testing and development of Golden Rice for the humanitarian purpose, you will be accused of contributing to a crime against humanity." Dr. Potrykus responded to this charge by explaining that Golden Rice is no different from ordinary rice: "As the pathway [of beta-carotene synthesis] is already in rice (and in every green plant), and the difference is only in its activity in the endosperm, it is very hard to construct any selective advantage for Golden Rice in any environment, and therefore, any environmental hazard." What most concerned Dr. Potrykus was the threat that Greenpeace might engage in ecoterrorism and interfere with test plantings. He warned Greenpeace, "If you plan to destroy test fields to prevent responsible testing and development of Golden Rice for the humanitarian purpose, you will be accused of contributing to a crime against humanity."33 In the next chapter, we will examine environmental and other potential risks of genetically modified foods as a basis for evaluating the industry's contention: if genetically modified foods are safe, no opposition to them is justified. We will also examine how Greenpeace and other groups concerned about broader societal issues use questions about safety to raise dread and outrage and rally public support for their goals.
CHAPTER 6.
RISKS AND BENEFITS.
WHO DECIDES?.
IN JUNE 2001, THE PEW CHARITABLE TRUST'S INITIATIVE ON Food and Biotechnology, a project devoted to establishing an "independent and objective source of credible information on agricultural biotechnology," conducted a survey of public attitudes toward transgenic foods in the United States. In answer to the question "How concerned are you about the safety of eating genetically modified foods in general?" two-thirds (65%) of respondents expressed some level of concern, and the rest expressed little. Food and Biotechnology, a project devoted to establishing an "independent and objective source of credible information on agricultural biotechnology," conducted a survey of public attitudes toward transgenic foods in the United States. In answer to the question "How concerned are you about the safety of eating genetically modified foods in general?" two-thirds (65%) of respondents expressed some level of concern, and the rest expressed little.1 These results seemed to indicate a fairly high level of anxiety about genetically modified foods. But do they? The answers to questions about food biotechnology sometimes depend on who is asking them. A few months later, in September 2001, the industry-sponsored International Food Information Council (IFIC) asked the question in a different way: "What, if anything, are you concerned about when it comes to food safety?" Only 2% of respondents thought to mention genetically modified foods (as compared to the 30% who mentioned microbial pathogens and the 25% who mentioned food packaging). These results seemed to indicate a fairly high level of anxiety about genetically modified foods. But do they? The answers to questions about food biotechnology sometimes depend on who is asking them. A few months later, in September 2001, the industry-sponsored International Food Information Council (IFIC) asked the question in a different way: "What, if anything, are you concerned about when it comes to food safety?" Only 2% of respondents thought to mention genetically modified foods (as compared to the 30% who mentioned microbial pathogens and the 25% who mentioned food packaging).2 Regardless of the degree of concern expressed, the surveys suggest that relatively few people are likely to reject genetically engineered foods entirely on principle (but see Regardless of the degree of concern expressed, the surveys suggest that relatively few people are likely to reject genetically engineered foods entirely on principle (but see figure 15 figure 15).
Like most else about food biotechnology, surveys of consumer attitudes are political. Industry leaders worry deeply about public acceptance and want to reassure consumers that transgenic foods are safe. It is very much in their interest to demonstrate that the public is unconcerned, and very much in the interest of antibiotechnology advocates to demonstrate the opposite. Surveys matter, and those devoted to food biotechnology constitute their own growth industry. Researchers have developed careers based on asking people what they think about genetically modified foods.
[image]
FIGURE 15. Peter Steiner's drawing appeared in the New Yorker New Yorker, July 24, 2000. The boy's comment is a modern version of a dinner conversation depicted by Carl Rose in that magazine in 1928: "It's broccoli, dear." "I say it's spinach, and I say the hell with it." ( The New Yorker New Yorker Collection 2000 Peter Steiner from cartoonbank.com. All rights reserved.) Collection 2000 Peter Steiner from cartoonbank.com. All rights reserved.) My personal collection of consumer surveys dates back to 1987, when the now defunct congressional Office of Technology Assessment (OTA) commissioned the Harris organization to convene focus groups and conduct telephone interviews on the topic. Since then, government agencies, university groups, industry groups, professional groups, national magazines, Internet sites, survey organizations, and individual researchers have all tried their hand at figuring out what consumers think about genetically modified foods. Groups like the Pew Initiative and IFIC conduct frequent surveys to try to capture changes in attitudes over time.3 [image]
FIGURE 16. Sylvia's dreams of science are based on some of the earliest and most attractive promises of agricultural biotechnology. ( 1990 Nicole Hollander. Used with permission.) Despite substantial differences in the surveys-when they were conducted, who asked the questions, how the questions were worded, what they probed, and who answered them-the results are remarkable for their overall consistency consistency. I think the following statements constitute a fair summary: Most people do not know very much about the scientific basis of food biotechnology but are intrigued by its promises. They expect the foods to produce benefits for society and, perhaps, for themselves. Although they are uneasy about the safety of the foods (a dread factor), they think the benefits likely to outweigh any risks. They are more likely to favor some genetically engineered foods over others, particularly those that seem to improve health or the environment, or that might save money or time. The cartoon in figure 16 figure 16 nicely captures these views. On the other hand, the surveys also reveal considerable doubt about the government's ability to ensure the safety of the new foods and even greater doubt about the industry's willingness to make decisions in the public interest-particularly because genetically engineered foods are not labeled (an important outrage factor). As we will see in the next chapter, people in other countries share these attitudes but are more explicitly outraged by the ways biotechnology companies exercise control of the food supply. nicely captures these views. On the other hand, the surveys also reveal considerable doubt about the government's ability to ensure the safety of the new foods and even greater doubt about the industry's willingness to make decisions in the public interest-particularly because genetically engineered foods are not labeled (an important outrage factor). As we will see in the next chapter, people in other countries share these attitudes but are more explicitly outraged by the ways biotechnology companies exercise control of the food supply.4 The results of these surveys come as no surprise. They are fully consistent with the research on risk communication discussed in the introduction, and they have considerable predictive value. Most people are vaguely or somewhat uneasy about eating the foods, mainly because they are not convinced that the industry and government are doing much to ensure safety or act in the interest of consumers. The lack of labeling is a critical factor: "What are they trying to hide from us?" Food biotechnology leaders, however, behave as if safety is a sufficient reason for trust: if the foods are safe, there is no reason to reject them. The surveys reveal that other concerns-those summarized in table 2 table 2 ( (page 17)-are just as important as safety and are often more important. Such concerns derive from personal values, perceptions, and beliefs that view biotechnology in general, and food biotechnology in particular, as morally, ethically, philosophically, or economically questionable.5 As I discuss in As I discuss in chapter 8 chapter 8, many antibiotechnology advocates raise fundamental questions about protection of democratic institutions when they point out the ways in which the industry uses science and politics to achieve commercial goals.
Others raise more personal issues of values. In 1998, at the peak of the furor over genetically modified foods in Great Britain, for example, none other than His Royal Highness, Prince Charles, wrote of food biotechnology: "I happen to believe that this kind of genetic modification takes mankind into realms that belong to God, and to God alone. . . . We simply do not know the long-term consequences for human health and the wider environment of releasing plants bred in this way. . . . It is the unforeseen unforeseen consequences which present the greatest cause for concern. . . . I personally have no wish to eat anything produced by genetic modification, nor do I knowingly offer this sort of produce to my family or guests." consequences which present the greatest cause for concern. . . . I personally have no wish to eat anything produced by genetic modification, nor do I knowingly offer this sort of produce to my family or guests."6 One might hardly think it productive to argue with such beliefs, but biotechnology stimulates theological as well as secular debate. Derek Burke, the former chairman of the British government's scientific committee on novel foods, took the secular route: "He [the prince] is raising one more food scare. As far as we can see, the risks of genetically engineering crops are very, very low. You can't walk away from changing the world."7 A Vatican official also weighed in: "We are increasingly encouraged that the advantages of genetic engineering of plants and animals are greater than the risks. . . . We cannot agree with the position of some groups that say it is against the will of God to meddle with the genetic make-up of plants and animals." Pope John Paul II disagreed; at an outdoor mass attended by 50,000 farmers, he said that using biotechnology to increase production was contrary to God's will and that when farmers "forget this basic principle and become tyrants of the earth rather than its custodians . . . sooner or later the earth rebels." A Vatican official also weighed in: "We are increasingly encouraged that the advantages of genetic engineering of plants and animals are greater than the risks. . . . We cannot agree with the position of some groups that say it is against the will of God to meddle with the genetic make-up of plants and animals." Pope John Paul II disagreed; at an outdoor mass attended by 50,000 farmers, he said that using biotechnology to increase production was contrary to God's will and that when farmers "forget this basic principle and become tyrants of the earth rather than its custodians . . . sooner or later the earth rebels."8 Officials thought it necessary to counter religious arguments, because such values Officials thought it necessary to counter religious arguments, because such values matter matter. Prince Charles's statements contributed to a sharp increase in public opposition to transgenic foods in Great Britain.9 British attitudes toward food biotechnology are more extreme than those found in the United States, but what most strongly emerges from surveys on both sides of the Atlantic is the importance of trust. If people do not trust the industry, they must rely on their governments for assurance that food is safe and worth eating. If they do not trust government, they worry more about safety. When, as discussed in chapter 7 chapter 7, U.S. government agencies made industry-friendly decisions to approve transgenic foods exclusively on the basis of science-based perceptions of risk-completely discounting all other considerations-they created a trust vacuum. Without an opportunity to consider the commercial, societal, and political implications of science-based approaches, advocacy groups focused on the one issue open for debate-safety. This chapter examines the health and environmental safety issues raised by genetically modified foods. In looking at these issues, we will see that despite protestations of industry and government to the contrary, it is impossible to separate science from politics in matters related to the safety of these foods.
HEALTH CONCERNS.
When scientists first discovered how to move genes from one organism to another, they wondered whether such manipulations could be harmful to health or to the environment. In 1975, researchers met in Asilomar, California, to review the potential hazards of genetic manipulations. To prevent unanticipated problems that might emerge from the new recombinant DNA techniques, they proposed stringent research guidelines. The National Institutes of Health (NIH) soon required recipients of its research grants to follow such guidelines. In an extreme example of caution, residents of Cambridge, Massachusetts, debated whether such experiments should be allowed within the city limits. Later, when time and experience reassured people about the safety of the techniques, the guidelines became less restrictive. In retrospect, the intense anxiety-dread and outrage-about early genetic engineering experiments strikes many scientists as inappropriate to the low level of risk.10 They view objections to food biotechnology as equally inappropriate. They view objections to food biotechnology as equally inappropriate.
Industry scientists working on early food biotechnology projects considered their work fundamentally similar to conventional genetics. If the foods did pose risks, these would be small and outweighed by benefits. Indeed, industry leaders believe that the projects are so interesting and potentially beneficial (and, of course, economically viable) that they raise no safety issues whatsoever. Critics disagree. In particular, they question the safety of genetic engineering manipulations that use (1) genes from bacteria responsible for diseases in plants, (2) genes for antibiotic resistance as "selection markers" (see page 176), and (3) regulatory DNA sequences transferred from one organism to another. They wonder whether "in the transgenic plant the harmonious interdependence of the alien gene and the new host's protein-mediated systems is likely to be disrupted in unspecified, imprecise, and inherently unpredictable ways."11 Critics ask whether the new proteins made by genetically modified plants might cause allergic reactions. They question the wisdom of planting vast areas of land with crops modified to resist herbicides or insects: will such plants transfer herbicide resistance to unwanted weeds, or toxin resistance to harmful insects? Government regulations do not require agricultural biotechnology companies either to answer such questions in much detail or to do very much to identify the potential consequences of releasing transgenic foods into the environment (consequences such as those that occurred with StarLink corn). The government not only fails to require labeling of genetically modified foods but actively opposes attempts to label such foods. All of this means that companies can decide for themselves what foods to produce and market, and consumers have little choice in the matter. Questions of safety, therefore, cannot be addressed without dealing with issues of regulation, oversight, trust, and control-politics. With politics in mind, we can now examine the principal safety issues: allergenicity, antibiotic resistance, and harm to the environment.
Allergens It makes sense to think that introducing the DNA for a new gene into a food would also cause that food to make a new protein. That, after all, is the function of genes and the very purpose of food biotechnology. It also makes sense that some people might develop allergic reactions to the new protein; some proteins are allergens. In theory, any food protein can be allergenic. In practice, however, just eight foods cause 90% of food allergies: milk, eggs, soy, and wheat in children, and peanuts, tree nuts, shellfish, and fish in adults. When susceptible people eat these foods, most react with mild symptoms (itching, for example), but for others the result can be deadly. True food allergies-those that involve components of the immune system and threaten life-are relatively rare. Doctors diagnose them in less than 8% of children and 2% of adults in the United States.12 Whether the new transgenic proteins in foods might cause allergies is not easy to answer, mainly because many of the transgenes come from microbes never used as food. Furthermore, food allergies are a highly neglected area of medical research, and depressingly little is known about the structural features of proteins that induce immune reactions. Because exceptions are frequent, the few generalizations are highly tentative: allergenic proteins appear to occur in high concentrations in foods, to share some structural similarities, to be less easily digested to their constituent amino acids than are nonallergenic proteins, and to require multiple exposures to induce reactions.
Surveillance of food allergies also is limited. The widespread use of soy proteins-transgenic or not-in foods such as infant formulas, meat extenders, baked goods, and dairy replacements might be expected to increase the prevalence of soy allergies, but the increase would be difficult to detect unless it affected large numbers of people. Worse, because methods to diagnose food allergies are unavailable or imprecise, the allergenic potential of most genetically modified foods is uncertain, unpredictable, and not easily tested.13 These research limitations make genetically engineered foods especially vulnerable to charges that newly introduced genes will cause plants to produce allergenic proteins. Industry-friendly scientists recognize that such charges are based on "reasoned concern" but complain that they also are based on "fear through ignorance, and political motivation."14 Antibiotechnology advocates raise the issue of allergenicity not only because it is scientifically justifiable but also because the industry is unable-or rarely tries-to prove that a newly introduced protein is Antibiotechnology advocates raise the issue of allergenicity not only because it is scientifically justifiable but also because the industry is unable-or rarely tries-to prove that a newly introduced protein is not not an allergen (witness StarLink). The government does not require biotechnology companies to test for allergens, and they rarely do. For one thing, testing is difficult. For another, testing is hardly in a company's best interest. Monsanto scientists, for example, wondered whether making soybeans "Roundup Ready" would make them more allergenic. They voluntarily tested and found the proteins in their soybeans to be similar in structure and quantity to those in conventional soybeans. On this basis, they assumed that no new allergens had been introduced but were not required to test for that possibility. an allergen (witness StarLink). The government does not require biotechnology companies to test for allergens, and they rarely do. For one thing, testing is difficult. For another, testing is hardly in a company's best interest. Monsanto scientists, for example, wondered whether making soybeans "Roundup Ready" would make them more allergenic. They voluntarily tested and found the proteins in their soybeans to be similar in structure and quantity to those in conventional soybeans. On this basis, they assumed that no new allergens had been introduced but were not required to test for that possibility.15 Like testing for microbial pathogens, testing for allergens is risky: you might find one. Like testing for microbial pathogens, testing for allergens is risky: you might find one.
Indeed, finding an allergen in a new transgenic food is a disheartening experience, and not only for its maker: it is a "shadow . . . cast over the agricultural biotechnology industry."16 One such shadow emerged in the mid-1990s when scientists working for the venerable agricultural company Pioneer Hi-Bred created a transgenic soybean to solve a nutritional problem-the need for sulfur-in poultry feed. Chicken feathers are strong because their proteins are linked tightly with sulfur. The sulfur comes from sulfur-containing amino acids, particularly one called methionine. Soybean proteins are relatively low in methionine, and soy-based chicken feed must be supplemented with this amino acid-a troublesome expense. Proteins enriched with methionine might solve this problem. As it happens, Brazil nuts contain a particular protein with two unusual characteristics: it is exceptionally rich in methionine; it also is present in large amounts (it accounts for 18% of all the proteins in Brazil nuts). Pioneer Hi-Bred scientists isolated the gene for the Brazil nut protein and transferred it into soybeans. They recognized, however, that a protein present in such high concentration might be the very one responsible for allergies to Brazil nuts. One such shadow emerged in the mid-1990s when scientists working for the venerable agricultural company Pioneer Hi-Bred created a transgenic soybean to solve a nutritional problem-the need for sulfur-in poultry feed. Chicken feathers are strong because their proteins are linked tightly with sulfur. The sulfur comes from sulfur-containing amino acids, particularly one called methionine. Soybean proteins are relatively low in methionine, and soy-based chicken feed must be supplemented with this amino acid-a troublesome expense. Proteins enriched with methionine might solve this problem. As it happens, Brazil nuts contain a particular protein with two unusual characteristics: it is exceptionally rich in methionine; it also is present in large amounts (it accounts for 18% of all the proteins in Brazil nuts). Pioneer Hi-Bred scientists isolated the gene for the Brazil nut protein and transferred it into soybeans. They recognized, however, that a protein present in such high concentration might be the very one responsible for allergies to Brazil nuts.
Thus, they thought it prudent to find out if their transgenic soybeans caused problems for people allergic to Brazil nuts. Ordinarily, this study would be impossible because few laboratories have the biological materials needed to test for food allergens. By coincidence, Nebraska researchers had collected blood samples from people known to be allergic to Brazil nuts, and they happened to have on hand all the components necessary to do the tests. To the company's dismay, the experiments "succeeded." People allergic to Brazil nuts exhibited the same kinds of blood and skin reactions when exposed to proteins extracted from the transgenic soybeans. Despite a substantial investment in development of the soybean feed, Pioneer Hi-Bred discontinued the project.17 It must be understood that the Food and Drug Administration (FDA) did not require the company to do such studies, nor do most companies conduct them. As discussed in chapter 8 chapter 8, allergenicity and other safety concerns about transgenic foods raise complex regulatory issues. Under a policy developed by the FDA in 1992, the company was encouraged-but not required-to consult FDA staff about the need to test products before marketing them.18 Pioneer Hi-Bred, a company with a long tradition of ethical practice dating back to the days of its founder, Henry Wallace, did so voluntarily. Once testing revealed the allergenicity of the transgenic protein, FDA policy required the company to label its soybeans as genetically modified. Although the soybeans were intended for chicken feed, the company could not imagine how the beans could be kept separate from the human food supply, and it withdrew them. Pioneer Hi-Bred, a company with a long tradition of ethical practice dating back to the days of its founder, Henry Wallace, did so voluntarily. Once testing revealed the allergenicity of the transgenic protein, FDA policy required the company to label its soybeans as genetically modified. Although the soybeans were intended for chicken feed, the company could not imagine how the beans could be kept separate from the human food supply, and it withdrew them.
In this unique instance, the company recognized that the gene donor came from a food known to be allergenic, was able to obtain blood samples from people allergic to Brazil nuts, and ended the project. Supporters of the FDA policy interpreted these events as a demonstration of its effectiveness; the soybeans never entered the food supply. Others, however, thought that this case proved that the FDA policy favored industry and could not protect consumers against less well studied transgenic proteins. The next case might not be so ideal, and the public less fortunate. Transgenic foods do not have to be labeled (see chapter 7 chapter 7), and avoidance is often the only only effective way to prevent food allergies. Without labels, people with food allergies have no choice. effective way to prevent food allergies. Without labels, people with food allergies have no choice.
In 1993, the FDA asked for public comment on whether and how to label food allergens in transgenic foods and held a conference the next year to consider developing rules on this issue. The agency never released such rules, however, almost certainly because of industry pressure. The initial FDA proposals required "premarket notification"-informing the agency in advance about development of transgenic foods-but the biotechnology industry objected. Industry leaders wanted limits on any any rules governing the safety of transgenic allergens and demanded that they "sunset" (be withdrawn and disappear) after three years. rules governing the safety of transgenic allergens and demanded that they "sunset" (be withdrawn and disappear) after three years.19 Since then, international groups have had problems reaching consensus on the level of risk posed by transgenic allergens but do agree about how to minimize risk: developers should gradually introduce products into test markets and then monitor their effects. Since then, international groups have had problems reaching consensus on the level of risk posed by transgenic allergens but do agree about how to minimize risk: developers should gradually introduce products into test markets and then monitor their effects.13 This approach, no matter how sensible, will not be easy to implement. The unresolved status of FDA policy on transgenic allergenicity means that the industry retains This approach, no matter how sensible, will not be easy to implement. The unresolved status of FDA policy on transgenic allergenicity means that the industry retains voluntary voluntary responsibility for protecting the public against uncommon or unidentified allergens in genetically modified foods. responsibility for protecting the public against uncommon or unidentified allergens in genetically modified foods.
One especially ironic aspect of this situation is that the food biotechnology industry, in achieving an unregulated marketplace, made itself vulnerable to charges of producing allergens (through lack of testing) and covering up the hazards of transgenic foods (through lack of labeling). The StarLink corn episode illustrates this irony. Pioneer Hi-Bred knew in 1996 that soybeans intended for chicken feed could not possibly be kept separate from those intended for human consumption. As described in the introductory chapter, both Aventis and the Environmental Protection Agency (EPA) ignored this lesson at great cost. With their success in finding evidence of StarLink corn in common food products and revealing gaps in the regulatory system for genetically modified foods, advocates could use allergenicity-a safety issue-as a means to oppose the industry's economic and political goals. StarLink's owner could not demonstrate the safety of the corn to the satisfaction of EPA advisory committees and was forced to withdraw it from the market, albeit too late.20 Supposedly scientific arguments about the degree to which transgenic foods might be allergenic reflect underlying concerns-less easily debated-about who is entitled to decide what people eat. Supposedly scientific arguments about the degree to which transgenic foods might be allergenic reflect underlying concerns-less easily debated-about who is entitled to decide what people eat.
Antibiotic Resistance A second legitimate safety issue is antibiotic resistance. In chapter 1 chapter 1, we saw how the routine use of antibiotics as growth promoters in cows and chickens favored the emergence of resistant microbial pathogens, rendering the antibiotics useless against human infections. Plant biotechnology raises similar concerns. In creating new plant varieties, agricultural biotechnologists link genes for antibiotic resistance to the genes they want to transfer into plants; these genes act as selection markers to identify the rare plants that actually accept the new genes. This selection system works because the plants that take up the antibiotic-resistance marker genes are the only ones to survive when grown in a broth containing the antibiotics (see appendix). Given the importance of antibiotic resistance as a public health problem, it makes sense to ask whether genetically engineered foods contribute to that problem. Answering that question requires a brief discussion of how antibiotics work.
Molds and bacteria naturally produce chemicals-antibiotics-that interfere with the growth or reproduction of other other bacteria but are not nearly so toxic to animals or humans. Antibiotics act by blocking specific steps in the synthesis of structures or in metabolic processes unique to bacteria: cell walls (penicillin), cell membranes (polymyxin B), proteins (streptomycin, chloramphenicol, tetracycline), nucleic acids (rifampin), or folic acid vitamins (sulfonamide, trimethoprim). When animals or humans take antibiotics appropriately-in the right dose for the right length of time-the drugs suppress the growth of all sensitive bacteria. Bacteria, however, are exceedingly small, and the normal digestive tract contains hundreds of billions of them. Among this multitude, some are likely to lack the target structure; these grow in the presence of the antibiotic. Penicillin, for example, has no effect on bacteria that lack cell walls. Bacteria can acquire antibiotic resistance by mutations that change the structure of DNA and favor survival or produce enzymes that destroy the antibiotics or pump them out. The use of low-dose antibiotics "selects" for such bacteria; the drugs kill off most competing bacteria and allow the resistant ones to proliferate. bacteria but are not nearly so toxic to animals or humans. Antibiotics act by blocking specific steps in the synthesis of structures or in metabolic processes unique to bacteria: cell walls (penicillin), cell membranes (polymyxin B), proteins (streptomycin, chloramphenicol, tetracycline), nucleic acids (rifampin), or folic acid vitamins (sulfonamide, trimethoprim). When animals or humans take antibiotics appropriately-in the right dose for the right length of time-the drugs suppress the growth of all sensitive bacteria. Bacteria, however, are exceedingly small, and the normal digestive tract contains hundreds of billions of them. Among this multitude, some are likely to lack the target structure; these grow in the presence of the antibiotic. Penicillin, for example, has no effect on bacteria that lack cell walls. Bacteria can acquire antibiotic resistance by mutations that change the structure of DNA and favor survival or produce enzymes that destroy the antibiotics or pump them out. The use of low-dose antibiotics "selects" for such bacteria; the drugs kill off most competing bacteria and allow the resistant ones to proliferate.21 The use of marker genes for antibiotic resistance in plant biotechnology raises additional concerns. Perhaps the genes for such characteristics will jump to other bacteria, and the bacteria will become resistant to multiple multiple antibiotics. Scientists transfer new genes into plants by using special pieces of bacterial DNA called plasmids. Plasmids often contain three kinds of genes relevant to this discussion: (1) genes that enable them to "infect" and transfer selected genes into plants, (2) genes for antibiotic resistance, and (3) genes that enable them to infect many different kinds of bacteria (see appendix). Plasmid-containing bacteria in the intestines of animals or people could transmit antibiotic resistance to other bacteria, some of which might be pathogenic. This possibility is not just theoretical. Some pathogenic bacteria once easily controlled by penicillin are now thoroughly resistant to that drug, and others in ground meat have been found to resist treatment by as many as 12 antibiotics. antibiotics. Scientists transfer new genes into plants by using special pieces of bacterial DNA called plasmids. Plasmids often contain three kinds of genes relevant to this discussion: (1) genes that enable them to "infect" and transfer selected genes into plants, (2) genes for antibiotic resistance, and (3) genes that enable them to infect many different kinds of bacteria (see appendix). Plasmid-containing bacteria in the intestines of animals or people could transmit antibiotic resistance to other bacteria, some of which might be pathogenic. This possibility is not just theoretical. Some pathogenic bacteria once easily controlled by penicillin are now thoroughly resistant to that drug, and others in ground meat have been found to resist treatment by as many as 12 antibiotics.22 Such findings explain why the continued use of low-dose antibiotics in farm animals elicits so much concern. They also explain why health officials want food biotechnologists to stop using clinically important antibiotics as selection markers. They want to avoid any chance-no matter how improbable-that transgenic plants might "lose" their recombinant antibiotic-resistance markers and transmit them to soil bacteria, to animals, or to people. In the worst-case scenario, a plant gene might recombine with the DNA of bacteria living in the intestines of animals or people and pass the trait for antibiotic resistance along to disease-causing bacteria. The antibiotic used in the selection process would then be ineffective as a treatment option. Alternatively, the antibiotic might be useless if people taking it were eating foods containing genes for resistance to that drug.
Perhaps because most scientists believe that such possibilities are exceedingly remote, the question of antibiotic-resistance markers also exists in a regulatory vacuum. Attempts to regulate transgenic antibiotic resistance began in 1990, when Calgene, an agricultural biotechnology company, asked the FDA for an opinion about whether it could use a gene for resistance to the antibiotic kanamycin (neomycin) as a selection marker for constructing transgenic tomatoes and canola oilseeds. This particular resistance gene specifies production of an enzyme able to inactivate kanamycin and related antibiotics. By the time the FDA issued its 1992 policy on genetically engineered plants, kanamycin already already was in use as a selectable marker for development of more than 30 transgenic crops. In that policy, the FDA made no particular recommendation about antibiotic-resistant marker genes but said that its scientists were evaluating the issue. was in use as a selectable marker for development of more than 30 transgenic crops. In that policy, the FDA made no particular recommendation about antibiotic-resistant marker genes but said that its scientists were evaluating the issue.18 In 1993, hoping to elicit a decisive response, Calgene petitioned the FDA to permit use of the kanamycin-inactivating enzyme as a "food additive" in genetically modified foods and cotton. In 1994, the FDA convened a meeting of its Food Advisory Committee to consider the Calgene petition. In 1993, hoping to elicit a decisive response, Calgene petitioned the FDA to permit use of the kanamycin-inactivating enzyme as a "food additive" in genetically modified foods and cotton. In 1994, the FDA convened a meeting of its Food Advisory Committee to consider the Calgene petition.
I was one of four consumer representatives to that committee at the time, all of us united in what turned out to be the minority opinion. We were troubled by the lack of satisfactory answers to our questions about the probability of transferring antibiotic resistance. We urged caution but were heavily outvoted. After the meeting, FDA officials correctly reported that committee members "generally" approved the agency's regulatory approach and agreed that Calgene had addressed the relevant scientific questions. Thus, the FDA ruled that Calgene's evidence met the legal definition of safety for food additives: reasonable certainty that no harm would result from use.
Calgene contended that the kanamycin-inactivating enzyme (like all enzymes, a protein) would be destroyed by cooking or normal digestive processes and was unlikely to function in the intestine. But could the gene gene for antibiotic resistance jump from food or soil to bacteria in the intestines of animals or people? The FDA considered this suggestion too highly improbable to be worth discussion. In approving the kanamycin-inactivating enzyme as a food additive, the FDA explained that its policy is not to regulate genes or DNA: "DNA is present in the cells of all living organisms, including every plant and animal used for food by humans or animals, and is efficiently digested. . . . The DNA that makes up the [kanamycin-resistance] gene does not differ from any other DNA and does not itself pose a safety concern." for antibiotic resistance jump from food or soil to bacteria in the intestines of animals or people? The FDA considered this suggestion too highly improbable to be worth discussion. In approving the kanamycin-inactivating enzyme as a food additive, the FDA explained that its policy is not to regulate genes or DNA: "DNA is present in the cells of all living organisms, including every plant and animal used for food by humans or animals, and is efficiently digested. . . . The DNA that makes up the [kanamycin-resistance] gene does not differ from any other DNA and does not itself pose a safety concern."23 In its decision, the FDA emphasized that safety "does not-and cannot-require proof beyond any possible doubt that no harm will result under any conceivable circumstance." Nevertheless, the agency agreed to consider further requests for use of selection markers for resistance to other antibiotics on a case-by-case basis. Subsequently, various groups challenged the FDA about the safety and regulatory status of antibiotic-resistance marker genes and, in late 1996 and early 1997, the agency consulted with outside experts about whether the use of such genes might cause problems. On the basis of those discussions, the FDA drafted a guidance statement for industry. This reassuring document said that antibiotic-resistance genes in food were "not of great concern," as the chance that they might be transferred from plants to bacteria in the intestine or environment was "remote."24 It is difficult to know how to interpret the FDA's decisions or guidance suggestions. Either transgenic transfer of antibiotic resistance is a problem or it is not. The FDA's use of the word "remote" suggests that marker genes require no special attention, but its nonbinding guidance document advises developers to evaluate the use of these genes quite carefully. Developers of new plant varieties, according to the FDA, should find out whether their marker genes involve clinically important antibiotics and whether they could transfer resistance to bacteria. If so, developers should use something else. Furthermore, if an antibiotic is the only only one available to treat a particular infection in animals or people, it should not be used at all. one available to treat a particular infection in animals or people, it should not be used at all.
The inherent ambiguity of the agency's position seemed certain to-and did-elicit contentious comments, but the FDA did not respond to them. In the meantime, countries throughout Europe used concerns about antibiotic resistance as a basis for bans on the development and growth of transgenic food plants, and U.S. groups also used the issue to raise objections about food biotechnology. In 2001, when the Department of Health and Human Services (DHHS), the FDA's parent agency, released the Action Plan to Combat Antimicrobial Resistance Action Plan to Combat Antimicrobial Resistance, its principal recommendation to prevent such problems was a public education campaign to reduce the clinical use of antibiotics-not to reduce antibiotic use in animals.25 Overall, the relaxed regulatory environment demanded by the food biotechnology industry raises many of the outrage issues listed in table 2 table 2. No matter how remote the health hazards might be, the industry's antiregulatory stance does little to inspire trust. If anything, the stance invites criticism on safety and other grounds. As we will now see, similar considerations affect issues related to the environmental effects-risks and benefits-of genetically modified foods.
ENVIRONMENTAL ISSUES: RISKS AND BENEFITS.