Safe Food: The Politics of Food Safety (38 page)

FIGURE 21
. The FDA’s relaxed regulatory stance on genetically modified foods elicited this response from
New Yorker
cartoonist Donald Reilly. (© The New Yorker Collection 1992 Donald Reilly from cartoonbank.com. All rights reserved.)

To biotechnology companies looking for commercially viable projects, tomatoes are a good investment. Americans expect tomatoes to be readily available, regardless of season. In the early 1990s, American farmers were producing more than 13 pounds (5.9 kilograms) per capita of fresh tomatoes and another 75 pounds (34 kilograms) for processing; the market for fresh tomatoes was worth $3–5 billion annually, and that for processed tomatoes even more. Most supermarket tomatoes are bred for disease resistance, appearance, and durability rather than taste, are picked when green, and are the bane of consumers longing for “backyard” flavor and freshness. Tomatoes taste better when they are picked ripe. They also have a higher content of solids—sugars and starches—that make them more economical to process into tomato paste and sauce.
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For these reasons, several biotechnology companies were working on tomato projects.

Calgene’s Flavr Savr
. Beginning in the mid-1980s, Calgene, a California-based biotechnology company, invested $25 million and eight years of effort to alter the gene in tomatoes that causes softening. They constructed the tomato to contain its own gene, but with the DNA in reverse order. This manipulation slowed the gene’s action, delayed ripening, and allowed the tomato to be picked at a more mature stage of ripeness and taste. Calgene expected its trademarked “MacGregor’s tomatoes, grown from Flavr Savr seeds,” to capture at least 15% of the market as soon as they became available. The company’s initial marketing strategy differed from Monsanto’s approach to rBGH milk; it was utterly transparent. Calgene
labeled
the tomatoes as genetically engineered: “Thank you for buying MacGregor’s tomatoes. . . . Since 1982, the MacGregor’s team of hard-working professional men and women has successfully applied the latest developments in genetic engineering, tomato plant breeding, and farming to solve an age old problem—how to supply an abundance of great-tasting tomatoes all year round.”
Figure 22
depicts the tomato-shaped package insert containing these statements.

Calgene’s strategy differed from Monsanto’s in another respect. In 1989, it
voluntarily
sought FDA guidance on the regulatory status of this first transgenic food, long before it was ready to market. The company’s motivation was quite explicit: public relations. If the FDA approved the tomato, consumers would believe it safe to eat. The ensuing ordeal lasted nearly four years. A former Calgene scientist, Dr. Belinda Martineau, recounts these events in her lively 2001 book,
First Fruit
. The FDA, she says, “put Calgene through the wringer” in what turned out to be “a long, hard, even painful process.”
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The wringing began in 1991 with a consultation with FDA about whether the Flavr Savr would be subject to the same regulations as conventional tomatoes. The answer: not exactly. Instead, the FDA asked Calgene to provide extensive information about the tomato’s safety and nutrient content. The company published a book in response to this request in 1992. Calgene then asked the FDA for a ruling on whether its scientists could use the gene for resistance to the antibiotic kanamycin (neomycin) as a selection marker, and petitioned for approval of the kanamycin-resistant gene as a food additive. While the FDA was dealing with these requests and asking for more data, the company did some public relations and lobbying. It convinced the Biotechnology Industry Organization, then a trade association of mostly pharmaceutical biotechnology companies, to represent the interests of agricultural biotechnology companies as well. Calgene officials met with high-ranking political leaders at the White House and provided members of Congress with bacon, lettuce, and Flavr Savr sandwiches. They also supplied tomatoes for press tastings and industry-sponsored events.
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I ate Flavr Savr tomatoes for lunch at a 1994 biotechnology industry meeting in New York City. I thought they tasted like
tomatoes
, better than supermarket varieties but not nearly as good as those available at farmers’ markets in August.

FIGURE 22
. A 1992 press kit for Calgene’s genetically modified Flavr Savr tomatoes (neither approved nor marketed at that time) contained this proposed package label. The label not only disclosed the genetic modification but also explained its key elements: a reversed gene for softening and an antibiotic-resistance marker. The FDA approved the tomatoes in 1994, but Calgene never mass-marketed them.

The FDA review process went slowly because the science was in its infancy and Calgene researchers had to scramble to respond to the agency’s requests. Dr. Martineau’s book describes the haste with which Calgene scientists conducted the research. Eventually, the FDA ran out of issues for which it could demand evidence and asked the Food Advisory Committee to review the Calgene materials. I was a member of the committee during that review. We had no obvious reason to think the Flavr Savr unsafe. The tomato contained its own gene and seemed more innocuous than rBGH. The use of the antibiotic-resistance marker gene was the one issue debated. Nevertheless, some of us were troubled by the FDA’s insistence that our discussion focus exclusively on safety questions. We were prohibited from raising any other issues—the effect that transgenic tomatoes might have on local tomato growers, for example. The benefit of the tomatoes to consumers seemed to be a taste only marginally better than that of standard supermarket varieties. Furthermore, the Flavr Savr would be expensive—two or three times the price of conventional tomatoes—and the higher cost identified it as a luxury product targeted to an upscale market. Such factors, and whether anyone needed such a tomato, were not open to consideration.

The FDA approved the tomato in May 1994, a decision enthusiastically applauded by the agricultural biotechnology industry. Some consumer groups observed that the FDA’s review had been an anomaly because Calgene had volunteered for it and companies were not required to produce safety data. Some antibiotechnology groups such as the Pure Food Campaign led by Jeremy Rifkin, threatened picket lines, tomato dumpings, boycotts, and legal challenges. Mr. Rifkin said, “Calgene has miscalculated in the most profound way. It spent an enormous amount of money and it never asked the simplest question: Do people want this tomato? And I say people don’t want this tomato. The bottom line is, who needs it?”
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Despite such objections, I thought people would buy the tomato if they perceived the improved taste to be worth the increased cost. Within days after the FDA approval, Calgene began test marketing the tomatoes in California and Illinois—priced competitively. By all reports the first Flavr Savr tomatoes flew off the shelves.

It soon became evident that problems other than pricing would determine the Flavr Savr’s success. The company developed the tomatoes in California but grew them in Florida, where they did not easily adapt to local climate, pest, or commercial contracting conditions. During transportation,
the tomatoes turned to mush. Calgene was unable to solve these problems and gave up on the product. Despite the marketing disaster, the tomato produced commercial benefits. FDA approval of the relatively benign Flavr Savr paved the way for subsequent approvals of Calgene’s seed oils, herbicide-resistant cotton, and other transgenic foods. Calgene hoped that these products might prove profitable and help overcome its reported losses of more than $80 million; it continued to report losses through 1994. In 1995, Monsanto bought nearly half the company and owned all of it by 1997.
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The Flavr Savr gamble made it easier for other companies to obtain FDA approvals for their products, and the entire industry owed Calgene a debt of gratitude. Although the FDA subsequently approved transgenic tomatoes produced by other companies, no such varieties were available fresh in supermarkets late in 2002.

GM Tomato Paste
. During the FDA committee review, I was surprised by Calgene’s determination to grow fresh tomatoes for sale in supermarkets—no matter how upscale—because processed tomatoes seemed to be a more secure business opportunity. People eat more processed tomatoes than fresh (on pizza, for example), and the higher content of solids in transgenic tomatoes meant that turning them into sauce and paste would be more efficient and less costly. European biotechnology companies that were genetically engineering their own tomatoes understood that such price advantages could be passed along to consumers. In the halcyon preprotest days of 1996, the British company Zeneca, which had obtained FDA approval for transgenic tomatoes the previous year, began to use them in tomato paste. The British grocery chain Sainsbury sold the paste with the prominent label shown in
figure 23
:
MADE WITH GENETICALLY MODIFIED TOMATOES
. Sainsbury and other retailers knew their customers. Before putting the labeled paste on its supermarket shelves in January 1998, Safeway, for example, spent 15 months consulting with consumer groups, conducting focus-group research, and preparing advertising materials. Its promotional materials, like those for Calgene’s Flavr Savr, reflected the company’s certainty that consumers would accept the product.

Scientists have now identified the gene that makes tomatoes turn soft during ripening, and they’ve also found a way of switching the gene off. This means that the tomatoes can be left to ripen on the plant until they have their full flavour and colour. . . . [They] remain firm after harvesting . . . with reduced wastage. As less tomatoes go to waste, best use is made of water, a scarce commodity in California where the tomatoes are grown. In addition, as the tomatoes contain less water, less energy is used during processing. Together, these improvements mean that Safeway’s tomato puree, made from genetically modified tomatoes, is available at a reduced price.
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FIGURE 23
. British grocery chains sold genetically modified tomato paste labeled as such in 1998. As public opposition to such foods increased, retailers instituted GM-free policies and refused to stock products made with transgenic ingredients.

By mid-1998, Sainsbury’s had sold about 1 million units of the tomato paste, and a spokesman for Safeway said that it and Sainsbury’s “are adamant that their clearly labelled GM tomato purees have consistently out-performed the non-GM alternative.” He also said that 99% of people who bought the “GM” puree were aware of its origins.
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This last figure hardly seems credible, even for the British population, especially because one result of the publicity generated by Dr. Pusztai’s potato lectin research (discussed in
chapter 6
) was to surprise the public with the revelation that supermarkets were full of genetically modified foods.

The furor over that revelation and the subsequent events in the Pusztai affair led to consumer protests and a drop in sales of the transgenic paste. Retailers had plenty of other foods to sell and saw little reason to defend controversial items. Seven supermarket chains, Sainsbury’s among them, announced that they no longer intended to sell genetically modified foods, and planned to take “reasonable steps” to ensure that the products did not contain such ingredients.
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In this instance, the political implications of a safety issue caused a successful and cheaper product to be removed from the market. In the next chapter, we will examine how antibiotechnology advocates accomplished such GM-free policies. In the meantime, let’s leave the science-based approach of the
FDA and consider a particularly political aspect of the EPA’s regulatory approach: how one of its regulatory targets,
plant-pesticides
, instead came to be called by a euphemism,
plant-incorporated protectants
.