Advertisement for the MacGregor’s tomato, 1992 (courtesy of Marion Nestle)
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The Flavr Savr
ON MAY 18, 1994,the U.S. Food and Drug Administration (FDA) announced that tomatoes grown from Flavr Savr seeds, patented by Calgene, Inc., were as safe as tomatoes bred by conventional means. Newspaper reaction to this first American specimen of bioengineered produce was almost universally positive, and three days later, the new tomatoes were unveiled with great fanfare. Sales were brisk, and by June 1995, Flavr Savr tomatoes, marketed under the trade name MacGregor, were being sold in supermarkets across the country. The Flavr Savr tomato’s unique feature was that scientists had inserted a gene into the plant that could “help block the rapid deterioration of vine ripened tomatoes.”
1 For growers, this slow-to-rot trait meant that they would lose fewer tomatoes—and thereby less profit—through spoilage. For consumers, it meant that the tomato could be ripened on the vine rather than harvested when rock hard and green, as was the case with conventional factory-farmed tomatoes, which are treated with ethylene gas to speed “ripening” once they reach their destination. With its new biotech introduction, Calgene targeted the 25 percent of American consumers who refused to buy the rock-hard tomatoes during the off-season.
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Despite its great promise, all did not go well for the Flavr Savr tomato. The off-season market was complicated by hothouse tomatoes that were competitive with the Flavr Savr, and the transgenic tomatoes were significantly higher priced than ordinary tomatoes. Then there were the protests from activists, scientists, chefs, and supermarkets. Although Calgene had conducted extensive research and the FDA had approved the commercial sale of the Flavr Savr, critics raised safety concerns and condemned the bioengineered produce. Shippers and retailers found that Flavr Savr tomatoes were prone to bruising and that, even at their best, they tasted no better than other factory-farmed tomatoes. Consumer demand for them flagged once the hype had worn off, and the costs of producing and marketing the new tomato shot up. Calgene began to take on considerable debt. Less than three years after their introduction, Flavr Savr tomatoes were gone from supermarket produce bins. Yet, their introduction had opened the floodgates for other transgenic foods: within a decade, almost every American processed food contained transgenic corn or soy ingredients.
Transgenic Food
Humans have been altering the genetic makeup of plants and animals for thousands of years. Genetic mutations occur naturally in all living organisms, and when such mutations were seen as beneficial—a cow that gave more milk, a grain that survived drought, an ox that grew bigger than its sire—these advantages were reinforced through selective breeding. It took years—sometimes centuries—to develop the forerunners of today’s food plants and domesticated animals. This process was sped up in the late nineteenth century with the application of the scientific method to breeding. By the 1920s, plant scientists had refined the technique of hybridization, resulting in many highly productive crops.
In the mid-twentieth century, a very different way of modifying plants and animals arose from the pioneering work of Cambridge University scientists James Watson and Francis Crick, who had deciphered the structure of the DNA molecule, discovering that it formed a double helix. In 1953, Watson and Crick submitted a one-page paper to the British journal
Nature describing their discovery. The paper closed with the observation, “It has not escaped our notice that the specific pairing that we have postulated immediately suggests a possible copying mechanism for the genetic material.”
3 Many scientists have since contributed to the basic understanding of transgenic engineering. One significant event occurred when scientists isolated a small portion of DNA from the cytoplasm of a bacterium, spliced in a gene from another bacterium, and introduced the resulting
recombinant gene back into the original bacterium.
4 This seminal work paved the way for gene splicing in other organisms. Commercial applications for the new technology underwent exploration—first for pharmaceuticals and then for agricultural products—by start-up companies financed by venture capital. Biotech firms sprouted up, usually around universities. During the period 1971 to 1987, 350 new biotech firms sprang up; 70 new firms were formed in 1981 alone.
5One such company established during this time was Calgene, a small biotech start-up founded in 1980 in Davis, California. The company’s work on the tomato built upon research that had been under way since 1950, when the University of California, Davis, established the Tomato Genetics Cooperative (TGC). The purpose of the TGC was to “exchange information on tomato genetic research, stimulate linkage studies and preserve and distribute germplasm.” A Gene List Committee was formed to compile a list of tomato genes, and. in the decades that followed, researchers identified and categorized hundreds of those genes. Along with gene identification came a listing of sources of seeds for each gene. The TGC established a Tomato Genetics Stock Center in 1976 to facilitate access to tomato varieties with specific genes.
6 By 1977, 288 genes had been identified, and the tomato’s twelve chromosomes, easily recognizable during certain stages of its reproduction, had been mapped for marker genes.
7A noteworthy genetic trait of the tomato is that specific functions are controlled by only one gene. This characteristic—one gene per trait—has made the tomato a relatively easy organism in which to locate exact chromosomal positions, a fact that aids bioengineering techniques. Bioengineers maintained that, with the Flavr Savr, through selective breeding and naturally occurring mutations, they had produced genetically engineered tomatoes with some qualities that breeders had sought for years. But that was just the beginning of the new genetic era.
Research into genetics encouraged further investigations into the tomato’s chromosomal structure, making more sophisticated alterations possible. In the 1980s, Calgene and other biotech companies began working on splicing the tomato’s DNA,
8 and, with funding from the Campbell Soup Company, Calgene succeeded in doing so in 1988.
9 Researchers were soon able to take a gene from an organism and insert it into the genetic sequence of the tomato.
10 Thomas C. Churchwell, president of Calgene Fresh, Inc., a Calgene subsidiary, stated that the rapid softening of ripe tomatoes was initiated by an enzyme called polygalacturonase, or PG. He explained that “PG breaks down the pectin in the tomato’s cell walls so it will decay faster and allow the fruit’s seed to spread on the ground.” Calgene spliced into the tomato’s genetic makeup an extra gene that would cancel out 99 percent of the effect of the PG enzyme. Churchwell continued, “Thus, the tomato remains firmer in its last week and can be left on the vine to ripen for an extra two or three days, until it begins to flush red. It can then be picked and allowed to ripen further en route without gassing to produce redness. After a week or so of extra firmness, the Calgene tomato softens and decays like other tomatoes.”
11After extensive research, Calgene completed its work on producing a tomato with a slow-to-rot trait gene inserted, and the company was ready to put it on the market.
12 Recognizing the importance of commercializing its transgenic tomato, in August 1991 Calgene asked the FDA to review the safety of the transgenic tomato. The FDA initiated hearings on the tomato, and David A. Kessler, the FDA’s commissioner, stated at one point, “I heard no dissent today on the safety evaluation of the Flavr Savr tomato, and the committee thought that the evaluation of the Flavr Savr was exceptionally thorough.” The transgenic tomato sailed through the FDA’s Food Advisory Committee after Calgene produced a substantial amount of scientific data to show that it was safe.
13Critics, meanwhile, complained about a second gene Calgene scientists had inserted “to mark the successful insertion of the one to cancel the effect of PG. This marker gene, called Kan-r, conferred resistance to the antibiotic kanamycin.” The critics believed the transgenic tomato might pass the Kan-r gene to people, “negating kanamycin’s effectiveness as a prescription drug to stop an infection.” To counter such criticism, Calgene presented data demonstrating that the Kan-r gene was quickly denatured in the stomach and ineffective in neutralizing the antibiotic.
14Upon obtaining the FDA’s approval, Calgene asked grocers to label the biotech tomato and distribute a brochure describing it. Despite its potential for success, the Flavr Savr was a financial failure, in part because Calgene was unable to provide a constant supply of Flavr Savr tomatoes. The problem was that the seeds had been developed in California, yet the plants were also to be grown in Florida, which has a different climate and soil composition. This resulted in poor crop yields in Florida. In 1995, Calgene made the decision to grow the tomatoes only in California and market them only west of the Rocky Mountains.
15 Even with this geographical downshift, the biotech tomato’s cost was twice that of the abundant conventional tomatoes flooding supermarkets year-round. In the end, consumers perceived no real advantage in the biotech tomatoes, so they saw no reason to pay more for them. Meanwhile, the futurist Jeremy Rifkin and other critics were highly vocal in their opposition to what they viewed as the unacceptable risks to humans of transgenic engineering.
16 Many grocery stores refused to sell the tomatoes, and many restaurants and chefs threatened to boycott the “mutant tomato.” As a result, Calgene racked up millions of dollars of debt each year, and, in 1996, the company withdrew the Flavr Savr tomato from the market, just two years after its introduction.
First Generation Biotech Foods
The Flavr Savr, the first transgenic whole food to be commercialized, failed, and Calgene, deeply in debt, was sold to Monsanto,
17 a chemical company known for its herbicides (including the defoliant known as Agent Orange, used by U.S. armed forces in Vietnam). Monsanto had no interest in the Flavr Savr but saw a potential in Calgene’s work for biotech cotton and canola oil. Monsanto had been experimenting with biotech food since the late 1970s. Its scientists began work on genetically modifying plant cells in 1982, and, five years later, the company started field tests of transgenic crops. Rather than focusing on tomatoes, Monsanto’s research was devoted to four staple crops: corn, cotton, soybeans, and canola.
Monsanto’s premier product was Roundup, a nontransgenic herbicide containing glyphosate, which the company had patented in 1970. The patent was scheduled to run out in 2000, and, in 1996, Monsanto released its Roundup Ready (RR) transgenic soybeans, followed by RR corn, cotton, sorghum, canola, and alfalfa. These biotech plants were tolerant of Roundup, which meant the herbicide could be sprayed on them without harming the crop, thus increasing yields and decreasing the use of herbicides known to cause harm to the environment.
Monsanto also bioengineered corn, cotton, and other plants, with an insecticidal protein produced by the bacterium
Bacillus thuringiensis (Bt). Bt occurs naturally in plants and in the soil. It has been used by organic farmers for fifty years to control crop-eating insects and mosquitoes. The use of transgenic Bt crops has decreased losses due to insects and lessened the application of pesticides harmful to the environment. Several potential problems have been raised, however, including the spread of Bt plants to non-Bt crops, and the possibility that the Bt gene will show up in the crops’ close wild relatives, such as teosinte or
Tripsacum, to produce a superweed that would be resistant to insects. Concern has also been expressed that the widespread presence of Bt might produce a superbug resistant to all means of eradication. To date, no such problems have been detected.
18One problem that did emerge, in September 2000, was the discovery of traces of Aventis Bt corn, marketed as StarLink, in taco shells manufactured by Kraft Foods and in some other food products. StarLink corn had been approved for animal but not for human consumption. In December 2000, the Environmental Protection Agency reported that an independent panel of scientists had concluded that StarLink corn had a “medium likelihood” of causing allergic reactions; several people filed lawsuits alleging they had suffered such effects after consuming items identified as potentially containing StarLink. Companies recalled 300 products possibly having traces of StarLink corn.
19 StarLink was subsequently pulled off the market in the United States.
In March 1990, the FDA approved the use of bioengineered recombinant chymosin in cheese making. The engineered chymosin is a substitute for the naturally occurring enzyme traditionally scraped from the lining of calves’ stomachs. Today, about 90 percent of American hard cheese contains this transgenic enzyme, and little controversy has surrounded this application of bioengineering. But controversy greeted its next decision, three years later, when the FDA approved Monsanto’s application for recombinant bovine growth hormone (rBGH), also known as recombinant bovine somatotropin (rBST), which increases lactation in dairy cows by 10 to 20 percent. This transgenic hormone, marketed under the name Posilac, is in regular use in many nonorganic dairies. The concerns relate to animal welfare, the fear the hormone will contaminate local water supplies, and potential harm to the health of those who consume milk produced by cows injected with rBGH/rBST. Others have dismissed the concerns and pointed to the environmental advantages of having fewer cows producing more milk. More than 120 studies have shown that “rBST poses no risk to human health.” Whatever the debate, Monsanto estimates that one-third of all dairy cows in America are injected with Posilac.
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Frankenfoods
Even before the Flavr Savr’s brief appearance, opposition to transgenic foods had begun to mount. In 1992, the FDA established guidelines for testing the safety of foods derived from any and all plant-breeding techniques, including transgenic ones. Having concluded that transgenic foods contained no new or special safety risks, the FDA deemed its guidelines exempted transgenic plants from case-by-case review. This raised concerns among many Americans. Sheldon Krimsky, a professor at Tufts University, wrote a
New York Times op-ed piece, “Tomatoes May Be Dangerous to Your Health,” attacking the FDA’s decision not to require special safety testing for transgenic foods.
21 A Boston College English professor, Paul Lewis, responded with a letter to the editor in which the coinage “Fran - kenfood” first appeared, referring to all transgenic foods then under development. In 1992, a coalition of organic farmers and restaurateurs, consumer and environmental groups, and animal-welfare organizations formed the Pure Food Campaign (PFC) to stop transgenic foods. The PFC was led by San Francisco State University professor Jeremy Rifkin, who strongly opposed bioengineering, which he characterized as “a form of annihilation every bit as deadly as nuclear holocaust and even more profound.”
22 In Europe, opposition to transgenic foods was even stronger, and many organizations, such as Greenpeace, an international environmental organization, oppose all biotech foods.
While there are many arguments offered against transgenic foods, the major ones are health issues, environmental concerns, the review process, labeling of transgenic foods, and corporate control of the food supply. Heath issues raised include allergenicity, as in the case of StarLink corn. Environmental concerns are many and complex, but, in large part, they relate to the possible escape of transgenic plants into wild populations. There are also concerns that transgenic plants will so dominate agriculture that plant diversity will be lost. Reliance on too few plant strains makes for a potential disaster if one of these strains is destroyed by pests or disease.
Some consumer groups are concerned about the lack of labeling of transgenic foods; many people unknowingly eat foods with transgenic ingredients. There are also concerns related to intellectual property rights. Virtually all the patents on these plants are held by large transnational corporations. Monsanto alone controls 90 percent of the patents on transgenic crops.
23 This, observers believe, gives one company too much control over the field of transgenic foods and over the American food supply as a whole.
There are those, on the other hand, who reject these concerns. “Americans have consumed more than a trillion servings of foods that contain gene-spliced ingredients,” said Henry I. Miller, former head of the FDA’s Office of Biotechnology from 1989 to 1993 and coauthor of
The Frankenfood Myth. “There hasn’t been a single untoward event documented, not a single ecosystem disrupted or person made ill from these foods,” he claimed in 2005 during an interview with the health and nutrition author and
New York Times columnist, Jane Brody. Miller continued: “That is not something that can be said about conventional foods, where imprecise methods of genetic modification actually have caused illnesses and deaths.”
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Flavr Effects
Despite the Flavr Savr’s financial failure, it opened the way for all the biotech foods that followed. As a result of its review of the Flavr Savr, the FDA established guidelines, in 1992, for the review process related to all transgenic foods, and, two years later, it established a consultation process to help producers meet the safety standards set forth in these guidelines. Since 1994, the FDA has judged many transgenic foods to be as safe as their conventional counterparts. In 1999, Jim Maryanski, the biotechnology coordinator for the FDA, acknowledged the monumental role of the Flavr Savr in establishing the new industry.
25Since 1996, the planting of biotech crops has experienced double-digit growth every year. By 2008, transgenic plantings had swelled to 92 percent for soybeans and 80 percent for corn.
26 Similar percentages hold for crops producing cooking oil, such as cotton and canola. Since many processed foods are made using corn, soybean, or vegetable-oil products, food manufacturers routinely include transgenic ingredients in the foods they produce. In 2003, the Grocery Manufacturers of America estimated that between 70 and 75 percent of all processed foods in U.S. grocery stores may contain ingredients from transgenic plants. In the period 2002 to 2006, plantings of Bt corn and herbicide-tolerant corn sky-rocketed. Although soy, corn, cotton, and canola constitute the largest proportion of transgenic crops, others, such as sweet potatoes, tomatoes, papayas, chili peppers, sweet peppers, peanuts, and sunflowers, are also currently on the market. Today, experts estimate that 80 percent of baby formulas, bread, cereal, frozen pizzas, hot dogs, tortilla chips, and sodas contain at least one transgenic ingredient.
27These “first generation” products will soon be joined by second-generation transgenic foods. During the past few years alone, the U.S. Department of Agriculture has approved more than 1,000 new biotech plants for use by farmers. New transgenic varieties of corn, cotton, canola, and soybeans are under development, and a number of other bioengineered foods, including apples, bananas, lettuce, potatoes, rice, strawberries, sugar beets, and wheat, are being developed. Biotech foods will likely make up an increasingly large percentage of the foods sold in supermarkets, forever altering what Americans eat.
Postscript
In August 2008, Monsanto announced the sale of Posilac to Eli Lilly and Company’s subsidiary Elanco Animal Health for $300 million.
28Computer whiz Bill Gates has expressed considerable interest in biotech foods, especially for potential use in Africa to feed the continent’s rapidly growing population.
29 In July 2008, the National Research Council, the National Academy of Science’s research arm, released a report, funded by the Bill and Melinda Gates Foundation, arguing in part for the development of genetically engineered crops that could be grown in sub-Saharan Africa and South Asia.
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