Creating new foods through biotechnology is a fairly straightforward process. To build the Flavr Savr, scientists identified the gene in tomatoes that promotes softening, copied it and put it into a tomato – but backward, to hold back the effect. So the new tomato, and all its progeny, have a new genetic trait: very slow softening. They can remain on the vine an extra couple of days, ripening and gaining flavor, without becoming too mushy to ship.
Most people tasting the Flavr Savr are impressed: it’s a superior winter tomato (box). The new technology aroused no fears among Carrot Top customers – and it shouldn’t, according to the FDA. ““Every safety aspect was examined in exquisite detail,’’ says FDA Commissioner David Kessler. Scientists at the agency spent four years scrutinizing Calgene’s data on the Flavr Savr. In April the FDA’s food-advisory committee, made up of scientists, academics and other food experts, met for three days to discuss whether the safety-review process was satisfactory. All concluded that the tomato is safe. ““The feeling was unanimous,’’ says James Maryanski, strategic manager for food biotechnology at the FDA. ““There’s no question about it.''
But judging from the transcript of the advisory-committee meeting, there were indeed questions. The members agreed that the Calgene/FDA safety review was exemplary and that the tomato is harmless. But several of the 28 participants expressed concern about the future – about other products waiting in the wings and about the way the FDA regulates biotech.
The problem is that most genetically engineered foods will not undergo the kind of thorough review given to the Flavr Savr. Calgene, as the first company to market a whole food, invited the FDA’s review, knowing that consumers would want that stamp of approval. But all the FDA requires is that a company creating a new food determine whether it differs substantially from the original or poses any health risk, such as becoming newly allergenic. In such cases it must notify the FDA. Otherwise, companies don’t even have to tell the FDA that a new, genetically engineered product is going on the market. Although Calgene is voluntarily labeling the tomato, most genetically engineered foods need not be labeled – whether, hypothetically, a peach gene is sitting in a squash, or a pig gene has been added to a carrot.
Some members of the advisory committee find this policy far too laissez faire. They want to see serious scrutiny of all biotech products. ““You can’t assume good will like Calgene’s on the part of every company that comes along,’’ says committee member Marsha Cohen, a San Francisco law professor specializing in food and drug law. Kessler says the agency is reconsidering aspects of the policy. ““We’re going to assure the safety of all foods, whether produced by traditional breeding or genetic engineering,’’ he says. But the biotech industry insists its products should not be treated differently from traditionally bred foods. ““People have been crossbreeding for a long time,’’ says Susanne Huttner, director of the Systemwide Biotechnology Research and Education Program at the University of California. ““The new technology is a refinement that lets us select one gene at a time. The risks are no different than those associated with older techniques.''
But in the past, no farmer hoping to grow a prettier green pepper was able to experiment with a gene from a pineapple, or a canary – which is where biotechnology departs sharply from traditional practices. ““This is a completely new technology,’’ says Margaret Mellon, director of the biotechnology and agriculture program at the Union of Concerned Scientists, an advocacy group. ““All the discussion of the Calgene tomato – how closely the DNA material was trimmed, how many copies of the new gene went into the tomato – these aren’t what we would ask about traditionally bred products. It’s not necessarily unsafe, but it’s foolish to pretend it’s no different.''
The toughest question about the Calgene tomato concerns the use of what’s called a marker gene. Scientists can’t tell, when they look at genetically engineered tomato seeds, whether the new gene was inserted successfully. So they attach a marker gene to it – in this case a marker gene resistant to the antibiotic kanamycin. If the new seeds are resistant to kanamycin, scientists know the engineering process worked. Many other foods in development use antibiotic-resistant markers. Calgene produced documentation to show that the kan gene would not be transferred to bacteria either in the human gut or in the soil, thus creating new legions of antibiotic-resistant bacteria. But some members of the committee urged caution. ““I’m not sure you can translate what occurs in a test tube to what happens in the field,’’ says Michael Gilmore, a microbiologist at the University of Oklahoma Health Sciences Center. ““Bacteria are very resourceful, and unlikely events turn up with fair frequency.’’ Gilmore advises going ahead with the tomato but using it as a case study, rather than a green light for the deployment of antibiotic-resistant genes.
Others at the meeting also called for prudence. ““Calgene says, “We’ve checked everything; the tomato is just the same as a regular tomato’,’’ says committee member Joan Gussow, professor of nutrition and education at Columbia Teachers College. ““But we really only know about 10 percent of the chemicals in a tomato. How can we talk about having covered the bases?’’ Questions like these, according to Huttner, are irrational. ““Some people just don’t want to see genetic engineering used in agriculture,’’ she says. In her view, biotechnology will deliver greatly improved fruits and vegetables over the next several decades – if new regulations don’t block the pipeline.
Some companies have such consumer-oriented products in development. Next year DNA Plant Technologies, in Oakland, Calif., will introduce a tomato with nearly a month’s shelf life, and in 1996 a sweeter pea and a redder, longer-lasting pepper will make their debuts. ““Within 10 years, every tomato in the store will be genetically engineered,’’ says John Bedbrook, executive vice president of DNAP.
But flavor and shelf life aren’t the primary goals of most biotech companies. More than half the biotech crops undergoing field tests worldwide have been genetically engineered for just one trait – herbicide tolerance. Calgene’s very next product is one of them: a cottonseed engineered to survive the chemical weedkiller bromoxynil. Roger Salquist, CEO of Calgene, says the chemical is ““environmentally friendly.’’ ““If you have a weed problem, you spray the herbicide on the cotton plant and it biodegrades in less than a week,’’ he says. But according to the Environmental Protection Agency, bromoxynil causes birth defects in laboratory animals and may pose a risk to farm workers. Salquist expects the cottonseed – which will be marketed jointly with the chemical – to be available next year.
Few people knowledgeable about biotechnology want to stop it in its tracks, but many are calling for a realistic assessment of the benefits versus the risks. ““Perhaps a case can be made for using the kan gene in a tomato, but what about in a tobacco plant?’’ says Gilmore. The FDA’s Kessler declared any such philosophical or speculative questions irrelevant for the advisory committee’s discussion. ““We’re talking about changing the relationship of humans to nature. We’re talking about taking charge of our own evolution. Where’s the forum for these questions?’’ asks Gussow. Capitol Hill, perhaps – but to date, Congress has shown no incli-nation to push the FDA on biotech policy.
Right now the most important decisions about biotechnology and the public good are being made by the chemical and seed companies at work on new products. ““We have an obligation to make sure there is appropriate oversight,’’ says Kessler. But gazing into the next century, it’s far from clear how the FDA expects to watchdog a flood of unlabeled new foods that look exactly like ordinary fruits and vegetables.
