Marion Nestle. Cambridge World History of Food. Editor: Kenneth F Kiple & Kriemhild Conee Ornelas, Volume 2, Cambridge University Press, 2000.
Food biotechnology—the use of recombinant deoxyribonucleic acid (rDNA) and cell fusion techniques to confer selected characteristics upon food plants, animals, and microorganisms (Mittal 1992; Carrol 1993)—is well understood as a means to increase agricultural productivity, especially in the developing world. The great promise of biotechnology is that it will help solve world food problems by creating a more abundant, more nutritious, and less expensive food supply. This theoretical promise is widely appreciated and beyond dispute (Rogers and Fleet 1989; U.S. Congress 1992).
Nonetheless, food biotechnology has elicited extraordinary levels of controversy. In the United States and in Europe, the first commercial food products of genetic engineering were greeted with suspicion by the public, vilified by the press, and threatened with boycotts and legislative prohibitions. Such reactions reflect widespread concerns about the safety and environmental impact of these products, as well as about their regulatory status, ethical implications, and social value. The reactions also reflect public fears about the unknown dangers of genetic engineering and deep distrust of the biotechnology industry and its governmental regulators (Davis 1991; Hoban 1995).
Biotechnology industry leaders and their supporters, however, dismiss these public concerns, fears, and suspicions as irrational. They characterize individuals raising such concerns as ignorant, hysterical, irresponsible, antiscientific, and “troglodyte,” and they describe “biotechnophobia” as the single most serious threat to the development, growth, and commercialization of the food biotechnology industry (Gaull and Goldberg 1991: 6). They view antibiotechnology advocates as highly motivated and well-funded and believe them to be deliberately “interweaving political, societal and emotional issues … to delay commercialization and increase costs by supporting political, non-science-based regulation, unnecessary testing, and labelling of foods” (Fraley 1992: 43).
In the face of this controversy, industry leaders have concluded that their most important challenge is to find ways to allay public fears (U.S. Congress 1991a) and to “assure the public that the new food technologies are not only beneficial to society, but safe” (Gaull and Goldberg 1991: 9).
This divergence in industry and public viewpoints can be traced to the conflict inherent in the two basic goals of the food biotechnology industry: (1) to benefit the public by developing agricultural products that will solve important food problems, and (2) to benefit the industry itself through the successful commercial marketing of these products. Although development of genetically engineered food products might well be expected to meet both goals, such is not always the case. One problem is the lack of a viable market, which experts view as a major barrier to research on food problems of the developing world (Hodgson 1992). Another centers on industry needs for rapid returns on investment; such needs constitute a driving force in decisions about research and development and cause industry leaders to view legitimate public questions about the use, safety, or social consequences of particular food products as threats to the entire biotechnology enterprise.
This chapter examines the reasons why so potentially useful an application of molecular techniques to food product development has elicited so great a level of controversy in the United States and elsewhere. Using the situation in the United States as a case study, it reviews key issues of economics, marketing, and risk that have affected the development and implementation of regulatory policies for the commercial products of food biotechnology, particularly those that affect food safety, allergenicity, environmental impact, and intellectual property rights. It also addresses issues that have influenced public perceptions of these products and describes how these issues have affected industry and public responses to the first genetically engineered food products released in the United States. Finally, it suggests implications of the present controversy for future product development, industry actions, and public policies.
The Promise
There seems little doubt that biotechnology holds great promise for addressing world food problems, most notably the overall shortfall in food production now expected early in the twenty-first century (Fraley 1992). No theoretical barriers impede the use of the techniques of molecular and cellular genetics to improve the quantity and quality of the food supply, to increase food safety, and to reduce food costs (Reilly 1989; U.S. Congress 1992; Hayenga 1993).Table VII.7.1 lists the wide range of potential applications of food biotechnology that as of the mid-1990s were under investigation or are theoretically possible. Such applications could greatly increase world food production, especially given the conditions of poor climate and soil typical of many developing countries (Swaminathan 1982).
Table VII.7.1. Theoretical and current applications of food biotechnology
| Improve the flavor, texture, freshness, or nutrient content of |
| fruit and vegetables. |
| Modify seed storage proteins to increase their concentration of |
| limiting amino acids such as lysine or tryptophan. |
| Alter the chain length and degree of saturation of plant seed oils. |
| Increase plant production of specialty chemicals such as sugars, |
| waxes, phytooxidants, or pharmaceutically active chemi- |
| cals. |
| Increase levels of vitamins and other nutrients in plant food crops. |
| Decrease levels of caffeine or other undesirable substances in |
| plant food crops. |
| Increase resistance of crops to damage by insect or microbial pests. |
| Increase resistance of crops to “stress” by frost, heat, salt, or |
| heavy metals. |
| Develop herbicide-resistant plants to improve weed control. |
| Enable crop plants to be grown under conditions of low input |
| of fertilizers, pesticides, or water. |
| Enable major crop plants to fix atmospheric nitrogen. |
| Develop plant foods containing antigens that can vaccinate |
| human against disease. |
| Increase the efficiency of growth and reproduction of food- |
| producing animals. |
| Create disease-resistant animals. |
| Develop animal veterinary vaccines and diagnostic tests. |
| Allow cows to produce milk containing recombinant human |
| milk proteins that can be used in infant formulas. |
| Create microorganisms, enzymes, and other biological products |
| useful in food processing. |
| Develop microorganisms capable of convertin environmental |
| waste products—plastics, oil, pesticides, or PCBs—into |
| usable animal feeds. |
The potential for such improvements in the food supply constitute the principal basis for industry and government conclusions that “biotechnology is the most important scientific tool to affect the food economy in the history of mankind” (Gaull and Goldberg 1991: 150), that “biotechnology promises consumers better, cheaper, safer foods” (“Biotechnology Promises” 1990: 1), and that “genetic engineering and biotechnology will create miracles to help us feed a hungry world efficiently and economically” (Sullivan 1991: 97).
Such promises, however, have not yet been fulfilled, nor are they likely to be realized in the immediate future (Messer and Heywood 1990), principally because many of the applications listed in Table VII.7.1 pose biological and technical problems of formidable complexity (Barton and Brill 1983; American Medical Association 1991). For example, many hundreds of as yet uncharacterized genes appear to be involved in the reproduction of corn (Kilman 1994b), and the more than 350 varieties of cassava (manioc) grown throughout the world seem especially resistant to transgenic transformations (Beachy 1993). But the slow progress of biotechnology in addressing world food problems should not imply that such problems cannot be solved. Given sufficient time, commitment, and funding support, the technical barriers almost certainly can be overcome.
Economic Issues
Costs and Benefits
Technical problems, however, are not the most important barriers to the application of food biotechnology to world agricultural productivity. Instead, the greatest barrier derives from the need of the industry to recover the costs of research and development and to maximize return on investment (Harlander 1989). Research costs are not trivial: The average genetically modified plant requires about $10 million (U.S.) to develop and about six years to become marketable (Ollinger and Pope 1995). Thus, the expected returns on such an investment need to be substantial (U.S. Congress 1991a). Although no products had as yet been brought to market, food biotechnology was considered in the early 1990s to have “a huge potential to make money” (Kim 1992a: B1). At that time some experts suggested that the value of the industry would increase to at least $50 billion by the year 2000 (Leary 1992a) and that the prices of biotechnology stocks would rise by 25 percent annually well into the 1990s (Somerville 1993).
To date, however, stock market returns have not reflected such projections. Although the biotechnology industry increased in sales, revenues, and numbers of companies and employees from 1989 to 1993, net losses also increased steadily during that period (Waldholz 1994). One notable exception has been the Monsanto Company; its stock prices gained 75 percent in 1995 (Fritsch and Kilman 1996) and another 70 percent in 1996 (Wadman 1996). Monsanto officials estimated that their products of plant biotechnology would earn $2 billion by the year 2000 and that sales would grow to $6 or $7 billion by 2005 and to $20 billion by 2010 (Feder 1996).
The generally poor performance of other food biotechnology stocks has been attributed to uneven management, corporate shortsightedness, and product failures (Hamilton 1994). It also has been attributed to lack of government investment. Although overall federal investment in biotechnology research exceeded $4 billion in 1994, only 5 percent of these funds supported agricultural projects; in contrast, 41 percent were applied to drug development (Caswell, Fuglie, and Klotz 1994). By the mid-1990s, only a few products had come to market, and their degree of acceptability was as yet unknown. The resulting uncertainties in profitability explain industry preoccupation with issues of federal regulation, intellectual property, and public perception (Fraley 1992).
The need for return on investment has encouraged the industry to focus on the development of products that are most technically feasible, rather than those that might be most useful to the public or to developing countries. To date, food biotechnology research has tended to concentrate on agronomic traits that most benefit agricultural producers and processors. These include control of insects, weeds, plant diseases, and ripening, and production of crops that will resist insects and tolerate herbicides (Office of Planning 1988; Olempska-Beer et al. 1993). Research also has focused on the development of foods that will last longer on the shelf and cost less to process (U.S. Congress 1991a; Barnum 1992).A 1988 survey of 74 food processing firms that used biotechnology methods found that of their research projects, 27 percent were devoted to enzymes (such as those used in cheese manufacture), 15 percent to sweeteners, 11 percent to flavors, fragrances, and colors for prepared food products, and 10 percent to better detection of contaminants; the remaining 37 percent were concentrated on product development and processing methods (Reilly 1989). A more recent study reported that chemical and pesticide companies have obtained 41 percent of all permits for field testing of genetically engineered plants (Ollinger and Pope 1995).
In 1990, the leading 36 agrochemical and agricultural biotechnology companies together spent nearly $400 million on such research and development, but an order of magnitude less (“puny” by comparison) on projects designed to address agricultural problems of the developing world (Hodgson 1992: 49). Such problems—and their biotechnological solutions—are well defined (Bokanga 1995; Knorr 1995). Although many sources of private and public funding are available to support biotechnology projects in developing countries (Chambers 1995), these are fragmented, poorly coordinated, and often promote donors’ priorities rather than those of the recipients (Messer 1992). One well-established research institute dedicated to improving crops in developing countries reports little success in obtaining industry financing or support beyond the permission to use patent-protected techniques “for specific crops under certain circumstances” (Beachy 1993: 61). Such observations have led commentators to conclude: “Nearly 20 years into the gene-splicing revolution, the industry has ballooned to well over 1,000 public or private companies that have raised about $20 billion. Yet 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 …” (Hamilton 1990: 43).
Marketing Barriers
To assure adequate returns on investment, the biotechnology industry must create and sell new products. These products, however, compete with other products in a market that is already highly competitive because the United States vastly over-produces food (Stillings 1994). In 1990, for example, the U.S. food supply made available an average of 3,700 kcal/day for every man, woman, and child in the country (Putnam and Allshouse 1996), even though adult men require two-thirds that amount, women about half, and children even less (National Research Council 1989). Because the amount of energy that any one person can consume is finite, such overproduction implies that a choice of any one food product will preclude choice of another.
Food marketers compete for consumer purchases through two principal means: advertising and new product development. Retail sales of food generated $791 billion in 1994. In the same year, food marketers spent $9.8 billion on direct consumer advertising and about twice that amount on retail promotion in trade shows, product placements, point-of-purchase campaigns, and other incentives. From 1984 to 1994, food companies introduced 125,000 new products into U.S. markets, more than 15,000 of them in 1994 alone (Economic Research Service 1994; Gallo 1995). Nevertheless, such efforts have failed to improve overall growth in the food processing sector, which has increased at less than 1 percent per year since the late 1940s, a rate considered stagnant by comparison to other industries. In so competitive an environment, biotechnology is seen as a crucial force for development of new products that will increase the country’s overall economic productivity (Reilly 1989).
Risk Issues
Tryptophan Supplements
From the standpoint of the biotechnology industry and its supporters, genetically engineered foods are no different from foods produced by conventional genetic crosses. Therefore, industry supporters argue that any risks associated with these foods are extremely small and greatly outweighed by their benefits (Gaull and Goldberg 1991; Miller 1991; Falk and Bruening 1994). Critics, however, insist that food biotechnology raises safety concerns that in the absence of prior experience are difficult to define, predict, or quantify. They point, as an example, to the case of tryptophan supplements to illustrate the unknown hazards of commercial biotechnology.
In 1989, health officials linked tryptophan supplements from a single manufacturer to an unusual syndrome of muscle pain, weakness, and increased blood levels of certain white cells (eosinophils), a constellation of symptoms termed eosinophilia-myalgia syndrome (Centers for Disease Control 1989). Eventually, more than 1,500 cases of illness and nearly 40 deaths were attributed to the use of such supplements as a self-medication for insomnia and other conditions (Roufs 1992; Mayeno and Gleich 1994). Because tryptophan is a normal amino acid component of all proteins, investigators believed that toxic contaminants must have developed during the manufacturing process. This process involved the creation of a strain of bacteria genetically manipulated to produce high levels of tryptophan and extraction of this amino acid through a series of purification steps (Fox 1990).
To date, characterization of the toxic components remains incomplete (Mayeno and Gleich 1994). Although it appears unlikely that the genetic engineering methods were directly at fault (Philin et al. 1993), their use to modify a bacterial strain created a situation in which toxic products were formed, albeit inadvertently (Aldhous 1991). This example suggests that concerns about the unknown hazards of biotechnology have some basis in experience.
Allergenicity
Because genes encode proteins, and proteins are allergenic, the introduction of allergenic proteins into previously nonallergenic foods could be another unintended consequence of plant biotechnology. In a finding described as “Another shadow … cast over the agricultural biotechnology industry …” (Winslow 1996: B6), researchers have now demonstrated that an allergenic protein from Brazil nuts can be transferred to soybeans, and that people with demonstrable allergies to Brazil nuts react similarly to soybeans that contain the Brazil-nut protein (Nordlees et al. 1996).
The Brazil-nut soybeans were developed as a means to increase the content of the amino acid methionine in animal feeds, which must otherwise be supplemented with methionine to promote optimal growth. The Brazil-nut protein is especially rich in methionine and its gene was a logical choice as a donor. Nuts, however, are often allergenic, and the investigators happened to have collected serum samples from people known to be allergic to Brazil nuts. Thus, they had in place all the components necessary to test for allergies to Brazil-nut proteins. Such components are rarely available for testing other potentially allergenic proteins, however.
Adverse reactions to food proteins can be documented in just 2 percent of adults and 8 percent of children (Sampson and Metcalfe 1992), but many more people are expected to develop food sensitivities as proteins are increasingly added to commercially prepared foods. Soy proteins, for example, already are very widely used in infant formulas, meat extenders, baked goods, and dairy replacements. Most biotechnology companies are using microorganisms rather than food plants as gene donors. Although these microbial proteins do not appear to share sequence similarities with known food allergens (Fuchs and Astwood 1996), few of them have as yet entered the food supply. At the present time, their allergenic potential is uncertain, unpredictable, and untestable (Nestle 1996).
As discussed in the following section, allergenicity raises complicated regulatory issues. Under a Food and Drug Administration (FDA) policy established in 1992, the manufacturer of the Brazil-nut soybeans was required to—and did—consult the FDA about the need for premarket testing. Because testing proved that the allergenic protein had been transmitted, the company would have been required to label its transgenic soybeans. Because the company had no simple method in place to separate soybeans intended for animal feed from those intended for human consumption, it withdrew its transgenic soybeans from the market. This action was interpreted by supporters of the FDA policy as evidence of its effectiveness.
Others, however, viewed this event as further evidence that the FDA policy could not protect consumers against lesser-known transgenic allergens to which they might be sensitive and, therefore, favored industry. The lack of a requirement for labeling was of particular concern, as avoidance is often the only effective way to prevent allergic reactions. In 1993, the FDA requested public comment on whether and how to label food allergens in transgenic foods (FDA 1993). Then, in 1994, the FDA drafted a rule that would require companies to inform the agency when developing new transgenic foods, in part to help resolve safety issues related to allergenicity. Implementation of such a rule seemed unlikely, however, especially because the biotechnology industry demanded that any such requirement be limited in scope and “sunset” after three years (“Bio Favors” 1994). To date, the FDA has not reported or acted on the public comments related to labeling of transgenic allergens.
Policy Issues
Regulation
Current debates about the regulation of food biotechnology center on a conflict between issues of safety on the one hand and a broad range of ecological, societal, and ethical issues on the other. For the industry and its supporters, safety is the only issue of relevance. Because the safety of most genetically engineered products is well supported by science, regulations appear to create unnecessary barriers to further research and economic growth (Gaull and Goldberg 1991; Miller 1991). For critics, however, regulations must be designed to protect the public not only against known safety risks but also against those that cannot yet be anticipated (Mellon 1991). In addition, as discussed in the next sections, critics view safety as only one component of a far broader range of concerns about the impact of biotechnology on individuals, society, and the environment—issues that might also demand regulatory intervention. For government officials, regulation of food biotechnology must find the proper balance between oversight of the industry and encouragement of its efforts to develop and market new food products (U.S. General Accounting Office 1993). Thus far, the balance achieved by existing regulatory policies has satisfied neither the industry nor consumer groups.
Table VII.7.2 outlines key historical events in the development of policies for regulation of food biotechnology. This history has resulted in current regulatory policies that affect three key areas of concern: food safety, environmental protection, and intellectual property rights.
Table VII.7.2. Key events in the histroy of the commercialization of food products of biotechnology in the United States
| 1930 | Congress passes Plant Patent Act, extending protection to |
| distinct, asexually propagated varieties. | |
| 1970 | Plant Variety Protection Act extends patent rights to new |
| sexually propagated plant varieties. | |
| 1973 | Cohn and Boyer clone insulin gene using rDNA technology. |
| 1975 | Asilomar Conference suggests guidelines for rDNA |
| research. | |
| 1976 | Genentech established as the first company dedicated to |
| exploitation of rDNA technology. NIH publishes safety | |
| guidelines for rDNA research. | |
| 1980 | U.S. Supreme Court rules that microorganisms may be |
| patented (Diamond v. Chakrabarty); first patent issued | |
| for rDNA construction to Cohn and Boyer. Genentech | |
| stock sets Wall Street record (share price rises from $35 to | |
| $89 in 20 minutes). Congress passes amendments to Patent | |
| Acts allowing nonprofit institutions and small businesses to | |
| retain titles to patents developed with federal funds. | |
| 1982 | Recombinant insulin approved for use. Transgenic plant |
| prodcued using agrobacterium transformation system. | |
| 1983 | A plant gene is transferred from one species to another. |
| Executive order permits large businesses to hold title to | |
| patents developed with federal funds. | |
| 1985 | The Environmental Protection Agency (EPA) issues use |
| permit to Advanced Genetic Sciences for release of organ- | |
| isms genetically engineered to lack ice-nucleation pro- | |
| teins. Patent Office extends protection to corn with | |
| increased levels of tryptophan (ex parte Hibberd). FDA | |
| authorizes sales of meat and milk from cows treated with | |
| recombinant bovine somatotropin (rbST); reaffirms safety | |
| of these foods in 1988, 1989, and 1990. | |
| 1986 | Office of Science and Technology Policy issues Coordi- |
| nated Framework for the Regulation of Bio-Technology, | |
| partitioning regulatory responsibility among USDA, EPA, | |
| FDA, and, to a lesser extent, NIH (51 FR 23302, June 26). | |
| Congress passes Technology Transfer Act permitting com- | |
| panies to commercialize government-sponsored research. | |
| USDA develops transgenic pigs carrying the gene for | |
| human growth hormone. | |
| 1987 | Tomatoes with a gene for insect resistance are field-tested. |
| USDA requires field-testing permits only for genetically | |
| engineered organisms that present risks to plants (52 FR | |
| 22892, July 16). | |
| 1988 | Patent Office extends patent protection to genetically |
| engineered animals. | |
| 1990 | Food and Drug Administration (FDA) approves recombi- |
| nant chymosin (rennet) as generally recognized as safe | |
| (GRAS). NIH issues statement that rbST is safe. | |
| 1992 | FDA announces policy on foods derived from new plant |
| varieties (57 FR 22984, May 29). USDA grants Calgene, | |
| Inc. permision to field-test the Flavr Savr tomato. | |
| 1993 | FDA requests data and information on labeling issues |
| related to foods derived from biotechnology (58 FR | |
| 25837, April 28); approves rbST for commercial use (58 | |
| FR 59946, November 12); requests public comment on | |
| whether and how to label food allergens in transgenic | |
| foods. Congress issues moratorium on use of rbST. Patent | |
| Office resumes granting patents on genetically engineered | |
| animals. | |
| 1994 | Congressional moratorium on rbST expires. |
| USDA reaffirms policies that genetically engineered livestock | |
| and poultry are subject to existing regulations for slaughter, | |
| research, and inspection (59 FR 12582, March 17). | |
| FDA publishes interim guidance on voluntary labeling of | |
| milk from cows treated with rbST and forbids statements | |
| such as “rbST-free” (59 FR 6279, February 10); concludes | |
| consultation with Calgene, Inc., finding no significant differ- | |
| ence between the Flavr Savr and other tomatoes with a his- | |
| tory of safe use (59 FR 26647, May 23); approves use of | |
| aminoglycoside 3′-phosphotransferase II (the kanamycin- | |
| resistance gene) for use in developing new varieties of toma- | |
| toes, oilseed rape, and cotton (59 FR 26700, May 23); con- | |
| cludes consultation approving seven other genetically | |
| altered plants, including tomatoes, squash, potato, cotton, | |
| and soybeans. | |
| EPA announces that federal pesticide laws will apply to | |
| toxins and other substances introduced into crop plants | |
| through genetic engineering (59 FR 60496, November 23). | |
| 1996 | Congress requires USDA to discontinue its advisory com- |
| mittee on food biotechnology and close its Office of Agri- | |
| cultural Biotechnology. | |
| Allergen from Brazil nuts is transmitted to transgenic soy- | |
| beans; transgenic herbicide resistance is transmitted to | |
| weeds, raising environmentalist concerns. | |
| Monsanto plants Bt cotton, herbicide (Roundup)-resistant | |
| soybeans. Ciba-Geigy plants herbicide-resistant corn. Both | |
| encounter consumer resistance in Europe. The European | |
| Union approves the soybeans, requires committee discus- | |
| sion of the corn, approves the corn but requires labeling | |
| of transgenic crops. |
Table VII.7.3. Safety issues raised by food biotechnology
| Unanticipated health effects resulting from genetic manipulations. |
| Increase in levels of naturally occurring toxins or allergens. |
| Activation of dormant toxins or allergens. |
| Introduction of known or new toxins, allergens, or antinutri- |
| ents. |
| Adverse changes in the composition, absorption, or metabolism |
| of key nutrients. |
| Increase in antibiotic-resistant microorganisms through use of |
| antibiotic marker genes. |
| Transmission of herbicide resistance to weeds. |
| Adverse changes in the nutrient content of animal feed. |
| Increased levels of toxins in plant by-products fed to animals. |
Food Safety
From the first, gene cloning experiments elicited safety concerns, mainly focused on the potential hazards of releasing new organisms with unknown properties into the environment. At a conference in 1975, scientists suggested stringent guidelines for research studies employing recombinant DNA techniques. The following year, the National Institutes of Health required researchers to follow similar guidelines. In subsequent years, as understanding of the techniques improved, concerns about safety diminished and the guidelines were modified accordingly. Nevertheless, common genetic methods for food modification involving, for example, bacteria that cause crown gall (a plant disease), marker genes for antibiotic resistance, and insertion of genes from one living species into another, continued to elicit debate about the known and unknown hazards of such techniques (International Food Biotechnology Council 1990). Table VII.7.3 summarizes the principal safety issues that have been raised by the use of food biotechnology.
In 1986, the White House Office of Science and Technology Policy (OSTP) developed a “Coordinated Framework” for regulating biotechnology based on the premise that its products were no different from those developed through conventional techniques, and that existing laws and agencies were sufficient for their regulation. OSTP specified the distribution of regulatory responsibility among the various federal agencies. Under laws then in effect, responsibility for the regulation of food biotechnology involved no less than three offices reporting directly to the president; four major federal agencies; eight centers, services, offices, or programs within agencies; and five federal committees—all operating under the authority of 10 distinct acts of Congress (U.S. Congress 1992).
As might be expected, critics immediately identified a substantial lack of coordination, duplication of effort, overlapping responsibility, and gaps in oversight in this regulatory framework (Mellon 1988; Fox 1992). Because the principal laws affecting food safety were written before biotechnology became an issue, they did not necessarily apply to the new methods (Browning 1992).Thus, the confusing and uncertain regulatory status of recombinant products stimulated the food biotechnology industry to demand more precise guidance from the FDA. The President’s Council on Competitiveness, a group dedicated to reducing regulations that impede industry, strongly supported such demands (Leary 1992b).
In response, the FDA developed a formal policy for the regulation of plant foods produced through biotechnology (FDA 1992). The agency designed this policy to be “scientifically and legally sound and … adequate to fully protect public health while not inhibiting innovation” (Kessler et al. 1992: 1832). The policy presumed that foods produced through rDNA techniques raised no new safety issues and could be regulated by the FDA’s postmarket authority for foods “Generally Recognized as Safe” (GRAS). Therefore, safety evaluation would focus on changes in the “objective characteristics” of foods—new substances, toxins, allergens, or nutrients—and not on the techniques used to produce them. Under this policy, the FDA would invoke its testing requirements for new food additives, and would require industry consultation, only if the transgenic foods contained unusual or potentially toxic components (e.g., allergens). This new biotechnology policy required no premarket safety evaluation, premarket approval by the FDA, or special labeling of the new foods.
The response of the industry to these “election-year efforts by the White House to provide … as much regulatory relief as possible,” was enthusiastic and viewed as “a very strong incentive for investment in the agricultural/food biotechnology area” (Ingersoll 1992: B1). One investment analyst summarized the new policy as an “assurance that after all a company’s planning for a picnic, the government won’t rain on it” (Kim 1992b: B3).
By contrast, consumer groups criticized the policy as inadequate to protect public safety and threatened to respond with mail campaigns and legal challenges (Hoyle 1992). A group of leading chefs in New York City called for an international boycott of genetically engineered foods, with one quoted as saying:
I don’t want a biotechnician in a lab coat telling me it’s a better tomato … I think mother nature does a great job on her own. These people are tampering with the ecosystem and will cause problems. But what is most disturbing to me is the idea of selling the food without a label. (“Chefs Urge Boycotting” 1992: C6)
Critics of the policy were especially concerned about the lack of requirements for premarket testing and labeling (Hopkins, Goldburg, and Hirsch 1991). Commentators wondered whether this policy of “least regulatory resistance” actually might increase public suspicion of genetically engineered foodstuffs (Hoyle 1992), especially in light of increasing press attention to “Frankenfoods” (O’Neill 1992). In response to such concerns, a federal study recommended formal review of the entire federal regulatory framework for food biotechnology in order to establish a better regulatory balance between promotion of the industry and protection of the public (U.S. General Accounting Office 1993).
Despite the controversy, the FDA implemented its policy. By late 1994, the agency had approved the marketing of tomatoes genetically engineered to reach optimal ripening after they were picked, milk from cows treated with a recombinant growth hormone, a virus-resistant squash, an insect-resistant potato, an herbicide-resistant cotton (used to make seed oil for animal feed), and herbicide-resistant soybeans (Associated Press 1994).
Environmental Impact
The “Coordinated Framework” affirmed that the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) were the primary agencies responsible for regulating agricultural biotechnology (see Table VII.7.2). Under the authority of two laws—the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA)—the EPA was authorized to regulate genetically engineered organisms used to control insects and other pests, including those viral and bacterial, as well as any genetically engineered chemicals that might be hazardous to humans or to the environment. The EPA classified rDNA as such a substance and began to require biotechnology companies to obtain permits prior to the manufacture or release of their agricultural products (Caswell et al. 1994).
EPA policies were designed to address concerns that widespread agricultural use of new kinds of living species might present direct risks to human health. Such risks, however, are seen as minimal by environmentalists as well as by experts sympathetic to the industry (Mellon 1988; Miller 1994). Instead, the chief concern of environmental advocates is that agricultural biotechnology poses uncertain—but potentially grave—ecological risks. They offer considerable evidence to support the possibility that biotechnological organisms might displace existing plants and animals, create new plant pathogens, disrupt ecosystems, reduce crop diversity, and change climate patterns (Mellon 1988; Rissler and Mellon 1993). In addition, environmentalists are even more concerned about the impact of biotechnology on ongoing efforts to promote more widespread use of sustainable agricultural practices. They note, for example, that a large proportion of agricultural biotechnology research is dedicated to the development of herbicide-resistant crops, and that such research stimulates reliance on chemical herbicides to manage pests (Goldburg et al. 1990).
Thus, the EPA’s 1994 decision to apply federal pesticide laws to toxins and other pesticidal substances introduced into crop plants through rDNA techniques was especially controversial. The biotechnology industry opposed it as an anachronistic and scientifically indefensible decision and noted that the EPA should instead have considered a risk-based regulatory system focusing on the organisms themselves rather than on the processes by which they were created. For the industry, the EPA decision would undoubtedly “exert a profoundly negative effect” on research into biological pest management strategies, particularly those unlikely to provide a sufficient financial return (Miller 1994: 1817).
Environmental advocates, although “pleased that EPA plans to regulate such crops the way it regulates traditional chemical pesticides,” were also dissatisfied; they noted that the EPA rules focused “too narrowly on the development of genetically engineered, toxin-producing crops,” and were insufficiently attentive to the potential hazards of herbicide-resistant crops that were virtually certain to bring about increases in the use of potentially damaging herbicides (Environmental Defense Fund 1994: 1).The marketing by the Monsanto Company of soybeans genetically engineered to be resistant to Roundup, a widely used herbicide also produced by that company, has only heightened such concerns (Feder 1996; Fritsch and Kilman 1996).
Environmentalist doubts about the adequacy of EPA regulatory policies were further stimulated by two events in 1996. That year, farmers planted 2 million acres with cotton engineered by the Monsanto Company to contain Bt (Bacillus thuringiensis), a soil bacterium that produces a compound toxic to cotton bollworms and other common insect pests. Bt has long been a key component of pest management in sustainable agricultural systems. When the Bt crop failed to protect thousands of acres of cotton against bollworms, observers feared that so large a planting had induced selection for insects resistant to Bt, thereby rendering the toxin useless for sustainable or any other type of agriculture (Kaiser 1996). EPA officials were reported to have asked Monsanto to test the surviving bollworms for Bt resistance, but to have admitted “… that further evaluation of the crop is entirely dependent on Monsanto’s own reporting” (Benson, Arax, and Burstein 1997: 68).
Also in 1996, researchers reported that oilseed rape (canola) plants genetically engineered to resist herbicides readily transmitted herbicide resistance to related weed plants—plants that could reproduce rapidly (Mikkelsen, Anderson, and Jorgensen 1996). This report led critics to charge that transgenic crops could lead to the creation of “superweeds” and, therefore, to “ecological catastrophe.” Despite this charge, federal officials continued to argue that monitoring of herbicide resistance should not be their responsibility: “… it is the developer of the product that has the interest in assuring that resistance does not build up” (Kling 1996: 181).Well before the time this statement was published, however, Congress had removed the USDA from involvement in biotechnology policy by eliminating funding for its advisory committee on biotechnology research and its Office of Agricultural Biotechnology (Fox 1996).
Intellectual Property Rights
United States intellectual property laws grant rights to patent owners to exclude everyone else from making, using, or selling the protected product for at least 17 years. Patents were first granted to plant varieties developed through asexual propagation in 1930. In 1970, Congress extended these rights to new varieties of plants developed through traditional genetic methods of sexual propagation. In 1980, the Supreme Court granted patent rights to microorganisms developed through rDNA techniques, and the Patent Office issued the first patent for such an organism. Patent rights were further extended to genetically engineered plants in 1985 and to animals in 1988 (U.S. Congress 1989, 1991a).
The patenting of biotechnological microorganisms and plants provided a major incentive for the growth of the food biotechnology industry, and patent rights are believed to have greatly stimulated such growth during the 1980s. Within just a few years, however, patent awards were challenged by industry and government officials in the United States, Canada, and Europe. By 1995, the U.S. Patent Office had issued 112 patents for genetically engineered plants. Among these were exclusive patent rights to one company for all forms of bioengineered cotton and to another for all uses of the “antisense” genes that were used to create the Calgene tomato (see later section on the “Flavr Savr” tomato).The breadth of such patents “… stunned the agricultural biotechnology community … It was as if the inventor of the assembly line had won property rights to all mass-produced goods …,” and numerous lawsuits were soon filed (Stone 1995: 656).
The patenting of animals has generated even greater debate, particularly from animal-rights organizations and other groups concerned that the genetic engineering of farm animals might adversely affect family farmers, be cruel to animals, and endanger other living species (U.S. Congress 1989). The principal arguments for and against the patenting of transgenic animals are summarized in Table VII.7.4 (U.S. Congress 1991a).
Table VII.7.4. The principal arguments for and against the patenting of transgenic animals Sources: U.S.Congress (1989) and Fox (1992).
| Arguments for patenting transgenic animals |
| Patent laws regulate inventiveness, not commercial uses. |
| Patenting is an incentive to research and development. |
| Patenting enables the biotechnology industry to compete in |
| international markets. |
| Patenting is preferable to trade secrets. |
| Patenting rewards innovation and entrepreneurship. |
| Arguments against patenting transgenic animals |
| Metaphysical and theological considerations make patenting |
| untenable. |
| Patenting involves inappropriate treatment of animals. |
| Patenting reflects inappropriate human control over animal life. |
| Patenting disturbs the sanctity and dignity of life. |
| Most other countries do not permit patenting of animals. |
| Patenting could cause adverse economic effects on developing |
| countries. |
| Patenting promotes environmentally unsound policies. |
| Animal patents will increase costs to consumers and producers. |
| Animal patents will result in further concentration in agricul- |
| tural production. |
| Patent holders will derive unfair benefits from royalties on suc- |
| ceeding generations of patented animals. |
Perhaps in response to concerns about such issues, the Patent Office ceased issuing patents for transgenic animals in 1988. In 1993, it resumed processing of the 180 animal patent applications that had accumulated during this “self-imposed moratorium” (Andrews 1993). By that time, far fewer companies were attempting to patent farm animals, largely because persistent technical problems and concerns about costs had encouraged them to shift to more profitable areas of research. But lobbyists against animal patents, such as Jeremy Rifkin, a leading antibiotechnology advocate, continued to protest Patent Office policies on both philosophical and economic grounds:
We believe the gene pool should be maintained as an open commons, and should not be the private preserve of multinational companies … this is the Government giving its imprimatur to the idea that there is no difference between a living thing and any inert object … it’s the final assault on the sacred meaning of life and life process. (Andrews 1993)
International Trade
Soybeans are used in more than 60 percent of all the processed foods sold in European markets (Wolf 1997). Transgenic, herbicide-resistant soybeans constituted 2 percent of the 59 million tons grown in the United States in 1996, their first year of production (Ibrahim 1996). Corn exports to Europe were valued at $500 million in 1995 (Wadman 1996). Transgenic Bt corn, also herbicide-resistant, was expected to account for half of the nearly $25 billion in annual sales in the United States within just a few years (Wolf 1997). Clearly, any action interfering with acceptance of transgenic crops would have grave economic consequences.
But European consumers were highly resistant to the idea of transgenic foods. This resistance has been attributed in part to memories of Nazi eugenics during World War II (Dickman 1996), in part to concerns that the antibiotic-resistance marker gene used in constructing the corn might spread to animals and to people, and in part to fears generated by the 1996 food-safety crisis over “mad cow” disease in England. The transmission of antibiotic-resistant bacteria from animals and milk to people had been demonstrated some years earlier (Holmberg et al. 1984; Tacket et al. 1985) but did not involve plants. The transmission of “mad cow” disease, although poorly understood, also did not appear to involve plants (Smith and Cousens 1996). European consumers, however, also were reacting to broader issues related to what they viewed as the arrogance of American officials who were claiming the superiority of their food safety criteria and were attempting to control trading policies through sanctions against European countries conducting business with Iran, Libya, or Cuba.
The transgenic soybeans and corn were approved as safe by the governments of the United States, Canada, and Japan. The European Union (EU) approved the import and processing of transgenic soybeans in April 1996. It referred the approval of the transgenic corn to scientific committees in June, thus raising the possibility that Europe might refuse corn from the United States and thereby cause a “corn war” (Wadman 1996). In October, Jeremy Rifkin announced the initiation of a worldwide boycott of genetically engineered crops produced in the United States. Rifkin was joined in this effort by an official of EuroCommerce, a trade association representing a large number of retail and commerce groups in 20 European countries, who called for separation and labeling of products using these grains so that European consumers could decide whether to buy them (Jones 1996).As the official later explained:
Our message from our customers is that for whatever reason they would prefer not to have it in their foodstuffs … I am telling the American exporters to please, in this season, if you are wise, don’t ship those soybeans to Europe because you may trigger a lasting reaction. And, if you must, separate and label them. (Ibrahim 1996: D1)
Surveys reported that 85 to 90 percent of European consumers wanted genetically engineered foods to be labeled as such (Ibrahim 1996: D24). Labeling, however, would require strict separation of genetically engineered from the usual varieties of corn or soybeans. Producers considered such separation impractical. If consumers refused to buy transgenic corn, or the European Union banned its import, U.S. producers would lose more than half a billion dollars in corn sales alone. This situation generated “tremendous interest” in a small company in Iowa that was marketing a test that could identify soybeans, corn, and other plants that had been genetically engineered (Wadman 1996). In December, the EU approved the genetically modified corn, leading the biotechnology industry to be “… optimistic that Europeans will come around to the benefits of genetically engineered crops” (Wolf 1997: 8).The EU ruling required labeling of genetically modified foods, however: “We must not miss this opportunity to repeat our clear signal that better labeling is one of the ways forward in this area” (“EU Approves” 1997: 1).
In Canada, a proposal to establish a central bio-technology regulatory agency met with opposition from farm, consumer, and industry groups, all of which viewed the current system of joint regulation by the departments of health and agriculture as satisfactory. Industry groups were especially concerned that government policies provide explicit regulations for the development and introduction of new plant varieties. Consumer proposals for labeling were opposed by the Canadian Federation of Agriculture:
Canada must be in step with our major partners to ensure that Canada’s labeling policy does not conflict … and thereby reduce the competitiveness of Canadian producers … The development of labeling regulations must recognize that the imposition of a labeling regime that is not based on science would have a negative trade implication for Canada. (Elliott 1996: 3)
Public Perceptions
Because food is overproduced in the United States and the West generally, and because the food industry is so competitive, biotechnology industry leaders view consumer acceptance of their products as an issue of critical importance: “Both the industrial and scientific communities have lagged in their understanding of the importance of the public’s attitude toward biotechnology … It is the consumer—the poorly informed and uninitiated average individual—who holds the key to our future” (Walter 1995: 216).
Consumer surveys do indeed document a fundamental public misunderstanding of basic food safety issues. Many surveys have reported a large proportion of respondents to be deeply concerned about the hazards of pesticides or irradiation, whether or not they believe these hazards to be more important (Food Marketing Institute 1994) or less important (Lynch and Lin 1994) than the far greater dangers of microbial contamination.
Because of the importance of consumer attitudes to the future of the industry and to federal regulatory efforts, various agencies in the United States and Canada have conducted surveys designed specifically to reveal consumer perceptions of food biotechnology. The methods used to obtain this information have varied among the surveys, and their results are not strictly comparable. Nevertheless, the results of such surveys have proven remarkably consistent over time, and they reveal an internally consistent logic of considerable predictive value.
At least three surveys have examined public attitudes toward agricultural biotechnology in the United States. In 1986, the Office of Technology Assessment commissioned the Harris organization to conduct focus groups and to administer a telephone survey of a national probability sample of 1,273 adults on perceptions of science, genetic engineering, and biotechnology (U.S. Congress 1987). In 1992, the USDA commissioned a telephone study of the attitudes of 1,228 consumers, along with a series of focus groups (Hoban and Kendall 1993; Zimmerman et al. 1994). In addition, Rutgers University researchers conducted a telephone survey of 604 New Jersey residents in May of 1993 (Hallman and Metcalfe 1993).
The results of these surveys are summarized in Table VII.7.5. Despite differences in method, population, and year, they yielded virtually identical responses that provide a consistent picture of public attitudes toward food biotechnology. Although respondents to all three surveys displayed a limited understanding of science and technology, they expressed high levels of interest in those fields, as well as high expectations that food biotechnology would produce benefits for them and for society as a whole. The respondents were concerned about the potential and unknown dangers of genetically engineered foods, but they believed that the benefits of biotechnology outweighed any risks, and they strongly supported continued federal funding of food biotechnology research.
It is especially noteworthy that the survey participants preferred some genetically engineered food products to others. They were most likely to accept products that appeared to be beneficial to health or society, to save money or time, to be safe, or to improve the environment.
Safety considerations, although often the focus of biotechnology debates (Hopkins et al. 1991), did not emerge in these surveys as the most important public concern. Instead, survey respondents appeared most troubled by ethical issues related to food biotechnology. Thus, they were more willing to accept genetically engineered foods that involved plants rather than animals, that did not harm animals, and that did not involve the transfer of animal genes into plants. These views derived from value systems that encompassed issues extending far beyond food safety (see Table VII.7.4), and the importance of such value systems to consumer perceptions of biotechnology cannot be overestimated:
Whatever the actual saliency of these ethical charges and critiques, obviously fundamental social, cultural, and religious values are at stake, arising out of broad cultural traditions and interests. Animal biotechnology, coupled to the engines of corporate economics, is felt to threaten fundamental and traditional moral, religious, and cultural orientations (Donnelley, McCarthy, and Singleton 1994: S21).
Table VII.7.5. Public perceptions of food biotechnology
| Respondents | U.S. Congress | Hoban and | Hallman and | |
| express | (1987) | Kendall (1993) | Metcalfe (1993) | |
| Great interest in food biotechnology | ✓ | ✓ | ✓ | |
| Limited understanding of science and techniques | ✓ | ✓ | ✓ | |
| Expectations that food biotechnology will benefit them and society | ✓ | ✓ | ✓ | |
| Concerns about unknown risks | ✓ | ✓ | ✓ | |
| Expectations that benefits will outweigh risks | ✓ | ✓ | ✓ | |
| Belief that government should continue to fund food-biotechnology research | ✓ | ✓ | ✓ | |
| Greater willingness to accept products that | Directly benefit health, consumers, or society | ✓ | ✓ | ✓ |
| Save money or time | – | ✓ | ✓ | |
| Are safe | ✓ | ✓ | ✓ | |
| Help improve the environment | ✓ | ✓ | ✓ | |
| Involve plants rather than animals | ✓ | ✓ | ✓ | |
| Do not harm animals | ✓ | – | ✓ | |
| Do not involve transfer of animal genes into plants | – | ✓ | – | |
| Distrust of government credibility related to science and technology | ✓ | ✓ | ✓ | |
| Distrust of government regulatory ability | ✓ | ✓ | ✓ | |
| Distrust of the biotechnology industry | ✓ | ✓ | ✓ | |
| Belief that food biotechnology should be regulated | ✓ | ✓ | ✓ | |
| Belief that biotechnology-derived food products should be labeled | ✓ | ✓ | ✓ |
All three surveys confirmed substantial public distrust of government credibility in scientific and technical safety matters and in the ability of government to regulate food biotechnology appropriately. Respondents were equally skeptical of the ability of the biotechnology industry to make decisions in the public interest. For these reasons, all three surveys indicated that the large majority of respondents wanted genetically engineered food products to be labeled as such. A 1993 survey conducted in Canada reported similar results (Walter 1995).
Industry leaders have tended to interpret such results—scientific misunderstanding, fear of unknown dangers, concern about animal welfare, distaste for transgenic experiments, and demand for regulation and food labeling—as evidence for public irrationality (Gaull and Goldberg 1991;Walter 1995).They and others further interpret these survey results as strongly supporting the need for comprehensive education campaigns to inform consumers about the safety and benefits of biotechnology (Bruhn 1992; Hoban and Kendall 1993;Walter 1995).
Such interpretations miss the most strikingly useful conclusion to be drawn from these surveys: Consumer acceptance of food biotechnology is entirely product-specific. The survey results clearly demonstrate that the public will readily accept genetically engineered products that are perceived as filling important needs: “People appear to be far more focused on the characteristics of products than the process used to create those products. People may be willing to overlook their objections to genetic engineering if its products produce specific benefits” (Hallman and Metcalfe 1993: 3).
The results of the Canadian survey further support this conclusion:
The Canadian public tends to consider biotechnology products individually, based mainly on their potential benefits. For example, the general concept of transferring genetic material from one plant to another was accepted by 51% of the respondents. This support jumped to 70% if the transfer improved plant nutritional value, though it slid to only 36% if the transfer only improved plant color … Products with laudable goals were strongly supported, while those with dubious benefit were rejected. (Walter 1995: 216)
Such results demonstrate that the key issue in consumer acceptance of genetically engineered foods is the value of the specific product to public health and welfare. The implication of these results is equally clear: If the food biotechnology industry wants consumers to accept its products without protest, it must market products worthwhile to the public as well as to the industry.
Predictive Implications: U.S. Case Studies
The survey results also suggest an analytical framework for predicting the degree of difficulty with which a given genetically engineered food is likely to achieve public acceptance in the United States. This analysis presumes that consumer acceptance is predicated on the importance of a product, its safety, and its ethical value. To predict whether a product will be acceptable, one need only ask the questions listed in Table VII.7.6. If the answers to all three questions are affirmative, the product is highly likely to be accepted by the great majority of consumers. To the extent that the answers are negative or equivocal, consumer resistance is likely to increase. Consumer responses to the genetically engineered products that have been approved for marketing in the United States constitute case studies that illustrate the predictive value of such questions.
Table VII.7.6. Analytical framework for predicting public acceptance of a food product of biotechnology
| 1. | Is the food valuable? Will it |
| Increase nutrient content? | |
| Increase food availability? | |
| Decrease food cost? | |
| Improve food taste? | |
| Grow better under difficult conditions? | |
| Reduce use of herbicides and pesticides? | |
| 2. | Is the food safe for people and for the environment? |
| 3. | Is the food ethical? Does it avoid |
| Harm to animals? | |
| Insertion of animal genes into plants? |
Pharmaceuticals
By the early 1990s, the FDA had approved at least 15 recombinant drugs for use in human subjects. Recombinant insulin, for example, was the first to receive approval, in 1982.This drug is of unquestioned utility (U.S. Congress 1991a). It solves problems of scarcity and quality, as it can be produced in unlimited quantities. Its amino acid structure is identical to that of human insulin, and it is, therefore, superior to insulin obtained from the pancreas of pigs or cows. It is safe and raises no ethical issues. Recombinant insulin readily meets all three criteria for consumer acceptance, and it is neither surprising nor inconsistent that activists against biotechnology in the United States have never protested its use.
Chymosin
Recombinant enzymes used in food manufacture also have been accepted readily. Chymosin, an enzyme used to coagulate milk to make cheese, was traditionally extracted from the stomachs of calves and sold as part of a mixture called rennet. The enzyme was difficult to extract, varied in quality, and was scarce and expensive. Through rDNA techniques, the gene for chymosin was transferred to bacteria that can be grown in large quantities. Chymosin derived from this process was approved for food use in 1990 (U.S. Congress 1991a). This action elicited no noticeable complaints from biotechnology critics, not only because the manufacturer saw “little to gain from waving the biotech flag,” but also “because the alternative is slaughtering baby calves” (Kilman 1994b: R7). This product also meets the three criteria for consumer acceptance: It is more useful, more ethical, and just as safe as the product it replaced.
The “Flavr Savr” Tomato
Americans have come to expect tomatoes to be available on a year-round basis. The market for fresh tomatoes was estimated at between $3 and $5 billion annually in the early 1990s (Fisher 1994; Hilts 1994). In 1993, American farmers produced nearly 16 pounds of fresh tomatoes per capita and another 77 pounds per capita for processing (Putnam and Allshouse 1994). But supermarket tomatoes, bred for disease resistance, appearance, and durability, have long been the bane of consumers longing for “backyard” taste and freshness (Mather 1995).
Beginning in the mid-1980s, Calgene, a California-based biotechnology company, invested $25 million and eight years of effort to develop a tomato with a reversed (and, therefore, blocked) gene for ripening. This process was designed to permit it to be picked and marketed at a more mature stage of ripeness and taste (U.S. Congress 1991a). Calgene expected this “Flavr Savr” tomato to capture at least 15 percent of the market for fresh tomatoes as soon as it became available (Kim 1992b).The company planned to market—and label—the tomato as genetically engineered to taste better.
As the first company to develop such a food, Calgene voluntarily sought FDA guidance on the tomato’s regulatory status in 1989, long before it was ready to market. In 1990, Calgene requested an FDA advisory opinion as to whether the gene for resistance to the antibiotic kanamycin, used as part of the genetic engineering process, could be used as a marker in producing tomatoes and other crops. The following year, Calgene requested a more formal FDA “consultation” on whether the Flavr Savr would be subject to the same regulations as conventional tomatoes, and, in 1992, the company published a comprehensive report on the tomato’s safety and nutrient content (Redenbaugh et al. 1992).
The following year, Calgene filed a petition with the FDA to approve the kanamycin-resistant gene as a food additive. The FDA reviewed this request under its 1992 policy and also requested an opinion from its Food Advisory Committee (FDA 1994a; Hilts 1994). In its review, and during the committee hearings, the FDA insisted that the discussion focus exclusively on safety questions. Consumer and other representatives on the committee said they were “… frustrated by a debate that, to them, ignores other key issues that affect consumers’ preferences for foods, such as religious, ethical, or aesthetic criteria … They also say that such foods should carry labels” (Fox 1994: 439).
The FDA decision, in 1994, that “all relevant safety questions about the new tomato had been resolved” (FDA 1994a) was greeted as “terrific news for the industry,” and the price of Calgene stock increased slightly (Fisher 1994: B7). Consumer groups, however, charged that the FDA review of the tomato had been an anomaly because the approval system had been entirely voluntary. Certain antibiotechnology advocacy groups threatened picket lines, “tomato dumpings,” boycotts, and legal challenges (Leary 1994). Most analysts, however, believed that consumers would accept the tomato if they perceived its improved taste to be worth what it would cost (O’Neill 1994). Although the price was originally expected to be twice that of conventional varieties (Sugawara 1992), the cost of the tomato was reduced in test markets to compete with locally grown products (Biotech 1994). By the summer of 1996, however, supplies of the tomato were still too limited to determine its level of acceptance.
From the answers to the questions in Table VII.7.6, some consumer resistance should be expected. Although the Flavr Savr is demonstrably safe, it raises issues related to its impact on small tomato growers. Its benefit to the public is restricted to taste. Perhaps most important, its higher costs identify the Flavr Savr as a luxury product targeted to an upscale market.
To Calgene, however, the tomato was well worth the huge investment of time, money, and effort; indeed, it was said that part of the effort involved providing members of Congress with bacon, lettuce, and Flavr Savr sandwiches (Stix 1995). FDA approval of the tomato paved the way for subsequent approval of the company’s seed oils, herbicide-resistant cotton, and other genetically engineered crops, raising hopes that Calgene would at last obtain a return on its investment. The company was reported to have lost more than $80 million since its formation in the early 1980s (McMurray 1993), and it continued to report losses during 1994. In June 1995, Monsanto, the manufacturer of recombinant bovine somatotropin (see next section), purchased 49.9 percent of Calgene, thus becoming the leading supplier of fresh tomatoes in the nation (Fisher 1995).
Bovine Somatotropin
The story of recombinant bovine somatotropin (rbST), the first food product to be approved by the FDA under its 1992 policy, best illustrates how issues of societal benefit, safety, and ethics contribute to consumer resistance to biotechnology. The product, a growth hormone that increases milk production in cows by at least 10 to 20 percent (Pell et al. 1992), has elicited an extraordinary level of debate. Its very name is controversial: Most proponents use its scientific name, rbST, whereas critics tend to use its more readily understandable common name, Beef (or Bovine) Growth Hormone, abbreviated rBGH (Daughaday and Barbano 1990). For purposes of consistency, this chapter employs the term rbST.
The Monsanto Company developed rbST in the mid-1980s and promoted it as a means to make dairy farming more efficient. Although such efficiency would seem to be of great benefit to consumers, critics soon raised questions about the product’s effects on human health, animal welfare, and the economic viability of small dairy farms (U.S. Congress 1992). They also raised issues related to consumers’ freedom of choice in the marketplace: When the FDA ruled that milk from cows treated with rbST cannot be so labeled.
For the industry and its supporters, concerns about factors other than safety were seen as irrelevant and highly threatening to the future of agricultural biotechnology; if rbST failed in the marketplace, the entire industry would be in jeopardy (Schneider 1990). Accordingly, this hormone and an equivalent product for pigs were extolled as:
Biotechnological miracles that would give consumers more for their money at less cost to the environment. Yet these and other long-tested products … are likely to be mired in continuing controversies instigated more by ignorance, nostalgia and a Luddite view of technology than by understanding and actual fact … whether such improvements will ever reach the marketplace will depend largely on how well consumers accept BST (Brody 1993: C17).
Yet rbST was controversial almost from its inception. By 1989, during periods of testing on commercial farms and research centers in nearly every major dairy state (Schneider 1989, 1990), rbST had become the target of groups concerned about family farms as well as of those suspicious of genetic engineering (Sun 1989). As a result, supermarket chains announced that they would not carry milk from rbST-treated cows, and dairy companies such as Ben and Jerry’s stated that their products would carry label statements that opposed the use of rbST (Schneider 1989). The state legislatures of Wisconsin and Minnesota temporarily banned the sale of rbST, an action considered extraordinary in the case of a product not yet approved for commercial use (Schneider 1990). By 1992, four major supermarket chains, two large manufacturers of dairy products, and the nation’s largest dairy cooperative had joined the boycott (Miller 1992), as had many small farmers, dairy cooperatives, and groceries (Day 1994). Such a level of protest might easily have been anticipated, as rbST raised many of the issues suggested by the questions in Table VII.7.6.
Safety Issues
Bovine somatotropin stimulates milk production, and the natural hormone is always present in cow’s milk in low concentrations. Milk from rbST-treated cows contains both the natural hormone and rbST; these are almost identical and cannot easily be distinguished, complicating efforts to require labeling. The hormone is unlikely to be harmful to humans, even though its concentration is higher in milk from treated cows. Its protein structure differs from that of the human hormone and it is biologically inactive in humans. Moreover, like all proteins, the cow hormone is largely broken down in the human intestinal tract. The hormone had been tested on 21,000 cows, and described in more than 900 research papers by 1992, with no indication of untoward effects on human health (Miller 1992).
Despite this evidence, critics continued to raise doubts about safety because of concerns about two factors that might be present in rbST milk: insulin-like growth factor-I (IGF-I) and antibiotics (Blayney 1994). Treatment with rbST increases concentrations of IGF-I in cows’ milk, raising concerns that this factor might stimulate premature growth in infants and cancers in adults. Proponents of rbST argue that the factor appears to be relatively inactive in rats, is denatured in infant formulas, and seems unlikely to be absorbed by the human digestive tract in sufficient amounts to be harmful (Juskevich and Guyer 1990).A federal study has confirmed that IGF-I concentrations are indeed higher in rbST-treated cows but concluded that more research would be needed to determine whether the higher levels posed any risk (U.S. General Accounting Office 1992b).
The second concern arose because cows treated with rbST develop udder infections (mastitis) more frequently than untreated cows. Such infections are treated with antibiotics that can appear in milk and meat and, theoretically, contribute to human antibiotic resistance. Although federal regulations require testing for antibiotic residues in milk, the FDA tests for only a small fraction of animal drugs in common use—just 4 out of 82 in one study—leading to charges that the agency lacks a comprehensive strategy for monitoring animal drugs (U.S. General Accounting Office 1992a). These concerns led yet another federal committee to recommend discontinuation of rbST marketing until antibiotic risks could be evaluated; at the same time, the committee called for development of a feasibility study of rbST labeling to provide information to the public (U.S. General Accounting Office 1992b). As discussed here, these recommendations were not implemented.
In 1990, Monsanto-sponsored scientists reported in a leading medical journal that rbST milk was safe for human consumption and that FDA studies had answered all safety questions (Daughaday and Barbano 1990). That same year, FDA scientists reviewed more than 130 studies of the effects of rbST on cows, rats, and humans and concurred in the conclusion that the hormone did not affect human health (Juskevich and Guyer 1990). The publication of this last report in a prestigious scientific journal was judged “unprecedented,” as it gave the appearance of a conflict of interest: The FDA seemed to be acting as a proponent of a drug that it had not yet approved (Gibbons 1990). Critics viewed the report as “part of a campaign by the four companies developing the drug and portions of the dairy industry to calm the public’s concern…. The review could not have been conducted without the permission of the manufacturers to disclose their own confidential studies on the safety of the drug” (Schneider 1990: A18). Nevertheless, a panel of experts recruited by the National Institutes of Health (NIH) also concluded that milk from rbST-treated cows was essentially the same—and as safe—as milk from untreated cows (Office of Medical Applications 1991).
Animal Welfare
Because treatment of cows with rbST increases milk production, concerns have also been expressed about the effect of the drug on the health and reproductive ability of the animals. In addition to increasing cases of mastitis, injections of rbST have been reported to produce localized reactions at the injection sites in some cows (Pell et al. 1992; U.S. General Accounting Office 1992b). Despite FDA and industry assertions that appropriate herd-management practices can minimize such problems, they are nonetheless regularly reported. Between March 1994 and February 1995, for example, more than 800 farmers filed complaints with the FDA about animal health problems related to the use of rbST.Yet, according to the FDA, such reports “raise no new animal health concerns” (“Over 800 Farmers” 1995: 6).
Dairy Farming
In the opinion of many, arguments about the safety of rbST have tended to obscure “the real issue—the economic impact of BGH once it hits the market” (Sun 1989: 877). For years, dairy production has exceeded demand, resulting in large surpluses of milk, butter, and other dairy products; such surpluses are purchased by the government to maintain prices (Schneider 1989). Common use of rbST will almost certainly increase milk production, but the effects of this increase on prices to farmers and costs to consumers and the government are difficult to predict. One estimate has suggested that the use of rbST will lead to a 2 percent decrease in prices paid to farmers and, therefore, to a 1 percent decline in farm income by 1999 (U.S. Congress 1991b).Any decline in milk consumption, coupled with increasing supplies, might be expected to accelerate trends toward the elimination of small dairy farms (Schneider 1994b). Federal spending on dairy price supports might also increase, although such an increase could be offset by the lower costs of federal commodity distribution programs (Blayney 1994).
Whether rbST milk will cost less is uncertain. The industry contends that the use of the hormone will reduce farm production costs because equivalent amounts of milk can be produced by fewer cows. Although it might seem logical that creation of milk surpluses would lead to lower prices, any price decline stimulates higher levels of federal spending to protect farm incomes (Kilman 1994b). Most commentators—but not all (U.S. Congress 1991b)—believe that at least some dairy farmers will be forced out of business.
Regulation
In 1985, the FDA permitted Monsanto to use the drug on an experimental basis (Schneider 1989). The agency reaffirmed the safety of rbST milk and meat in 1988, 1989, and again in 1990 (Miller 1992), as did the NIH in 1990 (Office of Medical Applications 1991) and the Office of Technology Assessment in 1991 (U.S. Congress 1991b). FDA approval of rbST as a new animal drug product appeared imminent (Miller 1992), but in August 1993, Congress enacted a 90-day moratorium on rbST sales. In fact, the Senate, concerned about the fate of small dairy farms, had approved a moratorium lasting an entire year, but House opposition forced this compromise (“BGH Moratorium” 1993).
After lengthy deliberations, advisory committee consultations, and public hearings, the FDA approved Monsanto’s rbST as a new animal drug in November 1993. In announcing the decision, the FDA commissioner stated: “There is virtually no difference in milk from treated and untreated cows … in fact, it’s not possible using current scientific techniques to tell them apart … we are confident this product is safe for consumers, for cows and for the environment” (Schneider 1993: 1).
FDA approval applied only to the Monsanto product, although approval of products from other companies was expected to follow (“FDA Approves” 1993). Industry representatives hailed the FDA decision as a strong signal that the administration intended to reduce regulatory barriers, as a victory for Monsanto, and as a “banner day for agricultural biotechnology” (Schneider 1993: 9). The actual effect of the ruling, however, would not be seen until the moratorium on sales ended. In the meantime, Monsanto was reported to be giving the product to farmers at no cost (“FDA Approves” 1993).
Because dairy companies, concerned about consumer reactions to rbST, had been labeling their products as “BGH-free,” industry groups requested FDA guidance on the labeling of dairy products derived from untreated cows. In February 1994, the FDA stated that it did not have the authority to require special labeling and ruled that companies might voluntarily inform customers that they were not using rbST, provided “that any statements made [we]re truthful and not misleading.” Because all milk contains some bST, milk could not be labeled as “BGH-free.” Because bST and rbST are indistinguishable, milk also could not be labeled as “rBGH-free.” However, these designations could be used if accompanied by a statement that put them in proper context: “[N]o significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows” (1994b: 6280).
Nevertheless, the state of Vermont passed legislation requiring the labeling of milk from rbST-treated cows, in conflict with FDA rulings:”Vermonters have the right to know what is in the food they eat … In particular, there is a strong public interest in knowing whether or not rBST has been used in the production of milk and milk products” (Schneider 1994d: A16). By 1996, however, industry groups had successfully challenged this law in the courts (“Court Strikes Down” 1996).
Moreover, two major milk marketers launched new brands certified as coming from untreated cows. In response, Monsanto warned dairy companies that such labels were misleading and “might create the impression that something is wrong with milk from treated cows” (Kilman 1994a: B7). By May 1994, Monsanto had sued at least two dairy companies to force them to comply with the FDA ruling. Because the dairies lacked resources as extensive as Monsanto’s, they seemed certain to lose the suits. As one report stated,”Everyone is terrified of Monsanto … it is quite ominous” (Burros 1994: C4).
International Implications
The European Community (EC) has long been skeptical about the use of growth hormones in cattle. This is the result of 1980 incidents in which consumption of baby foods containing veal from cows treated with diethylstilbestrol was associated with cases of premature sexual development in infants. Despite such skepticism, in 1987 Monsanto Europe requested approval of rbST from the EC’s Committee for Veterinary Medicinal Products (Vandaele 1992). The following year, however, the EC banned nontherapeutic use of hormones in the domestic livestock industry and soon extended the ban to countries that exported meat to the EC.
This action raised trade issues related to the use of rbST (Krissoff 1989). In 1991, the Veterinary Products Committee decided that rbST met requirements for quality, efficacy, and safety and posed no risk to consumers or cows. But this decision was overruled by the EC Directorates General, an action seen as a “blow to agricultural biotechnology” (Vandaele 1992: 148). Indeed, the EC executive committee proposed a seven-year ban on rbST use because it feared that the hormone might undermine efforts to reduce farm surpluses.
Thus, rbST became caught in a “policy paradox”; it would be manufactured by Monsanto in Europe, where it could not be sold, and then exported to the United States, where its use was permitted (Aldhous 1993). In 1995, the United States successfully persuaded the EC to declare that all Codex Alimentarius international standards for food additives, including animal drugs, should be based on science (i.e., biological safety). This was clearly an effort to force the EC to permit the use of rbST-derived milk and meat. But a straightforward motion by the United States for EC approval of rbST as posing no health risk fared less well; it was postponed until the Codex meeting scheduled for 1997 (Leonard 1995).
Industry Actions
As early as 1987, rbST was expected to become agricultural biotechnology’s first billion-dollar product (Sun 1989). In 1989, the market for rbST was estimated at $100 to $500 million annually (Schneider 1989); more recent estimates have been somewhat higher (Millstone, Brunner, and White 1994; Schneider 1994a).The potential for such a large return on investment helps to explain Monsanto’s unusually aggressive sales tactics (Feder 1995) and heavy-handed political actions to protect and promote this and its other products (Benson et al. 1997). Certainly the company took full advantage of its connections in government. FDA employees with ties to Monsanto played key roles in the agency’s review of rbST (Schneider 1994e; U.S. General Accounting Office 1994), and Monsanto enlisted an influential former congressman, to whom the secretary of agriculture owed his appointment, to encourage the USDA to prevent Congress from studying the economic effects of rbST (Engelberg 1994).
Monsanto leveled charges of plagiarism against independent researchers who had used company data to analyze counts of white blood cells (“pus,” according to critics) in rbST-treated milk, thereby preventing publication of their report (Millstone et al. 1994).The company used legal and political strategies to resist demands for labeling and recruited dairy industry executives to help persuade the FDA to establish favorable labeling guidelines. In addition, Monsanto was reported to have recruited at least two Washington law firms to monitor dairies for advertising and labeling violations and to instigate legal action against milk processors who had “inappropriately” misled customers (Schneider 1994c).
To some extent, these efforts succeeded. By March 1995, Monsanto claimed to have sold 14.5 million doses of rbST during the previous year and stated that 13,000 dairy farmers, or 11 percent of the potential market, were customers (Feder 1995). Sales were said to be especially strong in the state of New York, with 10 percent of dairy farmers reported to be using rbST. But in Wisconsin, where milk is the foundation of a $10 billion dairy industry, only 5 percent of the state’s 29,000 dairy farmers were said to be using the hormone (Schneider 1994c), and 90 percent were reported as hoping that the drug would never be widely adopted. Overall sales for the first year were estimated at $70 million, far short of what had been anticipated (Feder 1995).
Consumer Responses
The degree of consumer acceptance of rbST was also uncertain in 1995.A telephone survey of 1,004 adults suggested that use of rbST would have no impact on milk consumption, as most respondents had never heard of the drug. However, the phrasing of the survey questions, which used the term somatotropin rather than “growth hormone,” and emphasized safety rather than issues of ethics and values, may have led respondents to more favorable answers. For example, respondents answered positively (scoring 6.18 on a scale where 10 is strongly positive) to this question:
The National Institutes of Health, the American Medical Association, and several other independent medical groups have found milk from cows that receive BST is unchanged, safe, and nutritionally the same as milk currently on grocery store shelves. Given this information, how acceptable do you find the use of BST…? (Hoban 1994: 8)
The lack of labeling of rbST dairy products complicates understanding of consumer acceptance. Despite FDA rulings, surveys demonstrate overwhelming consumer support for special labeling of rbST products (Blayney 1994). Supporters of rbST have argued that the marketplace should be allowed to decide the commercial fate of the hormone (Sun 1989), but without labeling, consumers cannot easily make their opinions known.
Implications
Public skepticism about rbST relates to nearly all of the areas of concern listed in Table VII.7.6. Given the strength of these concerns, this product seems an unfortunate first choice for commercialization. United States farmers already overproduce milk, and rbST offers no clear benefit to consumers in availability, price, or quality. It will not even create more manufacturing jobs, as most rbST will be made and packaged in Europe (Hansen and Halloran 1994). That the product affects milk itself is also unfortunate: “Is there any product in the world that has tried harder to sell itself as wholesome and pure than milk? … It is a food for innocent, trusting children, culturally laden with symbolism. Any adulteration of milk … is seen as taboo” (Kolata 1994: E13).
The primary gainers from rbST, therefore, appear to be its manufacturers and the large dairy farmers who can best exploit its use. As summarized by the head of a dairy company that refuses to use rbST:
We do know that the use of BGH will increase the supply of milk at a time when we already have a tremendous surplus. It does not make any sense to exacerbate this problem with a product about which there are so many legitimate doubts, a product whose principal beneficiaries will be chemical companies and corporate agribusiness. (Cohen 1993: 1)
Policy Implications
This history indicates that the controversy over food biotechnology derives from the conflict between the industry’s need to be profitable and the desire of consumers for products that are economically and socially valuable, as well as safe. Therefore, to frame the debate about food biotechnology in terms of rational science versus an irrational public is to do a disservice to both.
Biotechnology is not inherently dangerous, and it is capable of doing much good. The public is not inherently irrational and is quite capable of judging whether genetically engineered products are worth buying. Few consumers demand that biotechnology “pack up its test tubes”; they support industry efforts to impart to food plants desirable qualities such as resistance to diseases and pests to food plants. At the moment, however, many view the great promise of biotechnology as having been betrayed (Hamilton 1990: 43).
Thus, the open contempt of policymakers and industry leaders for public misunderstanding of science and technology misses an important point. As this analysis has indicated, public views of biotechnology in the United States are product-specific and, as such, are logical, consistent, and predictable. Analysts of biotechnology policy who are aware of this logic recommend that regulators and the public decide the risks and benefits of each new product on a case-by-case basis (Davis 1991). They agree with industry that the marketplace should be allowed to determine the success of these products. They suggest that the products be labeled so that the public can make informed decisions in that marketplace and believe that if industry is producing valuable products, the label will encourage the public to purchase them.
Although it is always useful to educate the public about the benefits of science and technology, education alone will not solve problems of consumer acceptance. The analysis presented here suggests that it will continue to be difficult to convince the public that genetically engineered food products are necessary or safe as long as the principal beneficiary of food biotechnology is the industry itself. If the food biotechnology industry wants to convince the public that its products are beneficial, it will need to place far greater emphasis on the development of truly useful products, those that foster sustainable agriculture, drought- and pest-resistance, and improved nutrient quality.
This analysis also argues in favor of the development of federal regulatory mechanisms capable of addressing a much broader range of issues than just food safety. As noted by one commentator, regulations should be based on a comprehensive analysis of policy and assessment of technology that examines the full range of social and environmental consequences of technological change (Brown 1991).
That the agricultural biotechnology industry would benefit from such an analysis is evident from recent events. Developing-world countries are moving quickly to develop recombinant crops that will solve their local food problems. These efforts, which derive directly from the need to produce more food, are focusing on improvements in disease resistance and nutritional quality, especially among native plant species (Moffat 1994; Bokanga 1995). Such efforts deserve much support and should encourage food biotechnology companies in industrialized nations to focus research and development efforts on products that will benefit individuals and societies as well as the companies’ investors.