Gene-splicing yields brave new foods--and lots of new questions for the FDA.
Thursday, September 2, 1993
Gene-spliced tomatoes. It just didn’t have the same wholesome ring as sun-ripened raisins or garden-fresh lettuce. So the marketing minds at Calgene Fresh, Inc., brainstormed for a more consumer-friendly catch phrase to introduce the world’s first genetically engineered produce. Something less futuristic. Something that didn’t suggest the corporation was playing God. Something less – well, revealing. Flavr savr.
It seemed just the right NutraSweet-style blend of product ambiguity and commercial cadence. The idea wasn’t to conceal the breakthrough Calgene scientists had made in the biotech food industry. After all, altering the basic genetic code of a tomato by reversing the gene that causes spoiling was no modest accomplishment. The market ramifications of a vegetable with a 90 percent longer vine-and-shelf life were enormous.
But there was too much at stake - $20 million and 10 years in Flavr Savr’s development – to risk alienating the public.
At the same time, any hint of deception might provide just enough kindling for anti-biotech activists and environmentalists to spark a public backlash. Already, opponents were gathering up to pressure regulators for stricter rules on testing, registration, and labeling of gene-spliced foods.
So this fall, when Calgene rolls its ersatz vegetable carts into Midwest grocery stores to test-market its first commercial crop of Flavr Savr MacGregor tomatoes, the company will try to have it both ways. Affixed to the tomatoes themselves will be innocuous-looking Flavr Savr stickers – and informational brochures on the carts will explain how MacGregors were born and will list an 810-number question line.
According to literature put out by Calgene, the difference between Flavr Savrs and their low-tech cousins are more apparent to growers and shippers than they are to consumers. Through genetic engineering, Flavr Savr tomatoes don’t get as soft when they’re ripening as conventionally grown tomatoes, giving growers and shippers the opportunity to pick and pack Flavr Savrs when they’re red, without worrying about squishing and over-ripening.
Calgene says this difference alone will increase consumer demand for tomatoes, Since Flavr Savrs don’t soften quickly, Calgene says they’ll be available year-round.
Locally, a Monterey County-based farming company may well become the first to grow and distribute genetically engineered tomatoes.
Meyer Tomatoes, Inc., of King City, one of the biggest tomato growers in the US, has a contract with Calgene Fresh to grow Flavr Savr tomatoes in California and Mexico.
The company last winter grew Flavr Savr tomatoes in Mexico, but because Calgene didn’t have final Food and Drug Administration (FDA) blessing to sell them, Meyer had to leave the tomatoes in the field, said owner and founder Bob Meyer.
“We’ve trailed the Flavr Savr and it’s been everything they say it is,” said Meyer. “We haven’t been given the green light to put in into the consumer’s plate yet. “
Assuming Calgene gets the nod from the FDA, Meyer will probably produce the tomatoes in Culican, Mexico this winter, and in California growing regions, including Monterey County, next summer.
“The key to the success of this product will be whether we deliver on the promise of summertime taste 52 weeks a year, and one of those reasons is the technology itself,” says Stephen Benoit, vice president of marketing at Calgene Fresh. “So we are going to be talking about the technology because of the benefits it provides.”
Ultimately, Benoit says, consumers’ desire for better-tasting tomatoes year-round coupled with the right information, will diminish any apprehension shoppers might have about the science that produced this brave new food.
The Flavr Savr marketing strategy underscores the complex questions stemming from a burgeoning technology that will ultimately challenge our basic concepts of food – and that could, in the not-so-distant future, significantly alter the world’s food supply.
Cross-species products – such as juice made from tomatoes spliced with an Arctic flounder gene to inhibit frost, and potatoes carrying a chicken gene to improve disease resistance – are among the scores of future foods now being developed by about a dozen US companies.
Biotech-food-industry officials like to talk about crops that could resist drought, disease, insects, and extreme temperatures, particularly when they are accused of disregarding the social implications of the technology by setting their sights on the huge profits that may be reaped.
The financial stakes are high indeed. The Flavr Savr tomato’s debut marks a milestone for an industry that projects genetically engineered crops will be a $5 billion enterprise by the year 2000. The US Department of Agriculture reports that more than 375 permits to field-test genetically engineered crops have been issued since 1987 to corporate giants such as Monsanto, Upjohn, and Du Pont. About 100 more applications are pending.
But the advent of genetically engineered food has been greeted with as much trepidation as enthusiasm. Though most scientists agree that, at this point, there is nothing inherently dangerous about gene-spliced produce, there are a plethora of other concerns that consumers, manufacturers, activists, and government regulators are beginning to raise.
“This is a new technological revolution,” says Sheldon Krimsky, professor of urban and environmental policy at Tufts University and author of Biotechnics and Society: The Rise of Industrial Genetics. “Those of us who have historical memory recall that any technological revolution with the transforming powers that genetic engineering has – like the creation of radioactive isotopes – is likely to have both assets and liabilities.”
The FDA is wrestling with an array of scientific, environmental, health, and ethical questions, ranging from how much genetic thinking is acceptable without pre-market testing to how much consumers need to know about food that has been altered.
The latest flurry of debate follows an FDA ruling last year that, in essences, opened the American market to bioengineered foods. The new policy, spurred by the Bush administration’s now-defunct Council on Competitiveness, accepts the hypothesis that gene splicing is safe. It states that pre-market testing is necessary only if the product being introduced is “novel.”
If the end product is not a risk to consumer health and has not been altered nutritionally, then has the FDA’s blessing. Thus, if a frost-tolerant fish protein is introduced into a fruit, that’s permissible because both foods are considered safe and the transfer doesn’t have any apparent health implications.
The FDA has included in its policy a “guidance to industry” section “to assist companies with their own internal review of these new foods.” In essence, the FDA leaves it up to the industry to decide whether a product is risky enough to warrant government scrutiny.
But Krimsky says the FDA policy doesn’t go far enough to protect consumers from the potential risks that genetic engineering poses to the food supply. The FDA, he says, could have chosen to treat genetically altered foods the same way it treats food additives, thus holding them to higher safety standards. Food-additive standards would have required manufacturers to submit scientific proof that foreign genes and their byproducts do not harm consumers or reduce a food’s nutritional value.
Instead, the FDA’s policy states that a genetic variation of an existing food, if similar to what ostensibly could have been produced by traditional cross-breeding, need not be subjected to new federal regulations. In the case of cross-species gene splicing, the FDA’s current regulations cover only suspected allergens and largely leave it up to industry to determine what constitutes an allergen.
Such is the case with Flavr Savr tomatoes. But Calgene is asking the FDA for a “safety status” advisory opinion to demonstrate the tomato has undergone vigorous review. It’s a step FDA spokesman Brad Stone says may be Calgene’s way of attempting to quell any public skepticism about its product in these pioneering days of genetically engineered foods.
“Technically speaking,” Stone says, “if they’re willing to vouch for its safety, they could put it on the market.”
The FDA policy has raised the hackles of detractors ranging from West Coast chefs, some of whom are boycotting gene-spliced foods, to East Coast physicists, like Krimsky.
“The key to the success of this product will be whether we deliver on the promise of summertime taste 52 weeks a year.” – STEPHEN BENOIR VP of Marketing, Calgene Fresh
“The FDA chose the path of least resistance,” says Krimsky, who’s chairman of the Council for Responsible Genetics. “By treating genetically engineered crops like hybrid crops, they leave it up to the regulated industry to determine whether to submit the product to FDA review.”
The FDA policy is in line with the biotech industry’s belief that genetic engineering simply brings more efficiency to the traditional breeding of selection practices that have been in place for centuries.
“Genes get shuffled around a lot in nature and in man, and have for many thousands of years,” says Robert Gottlieb, a spokesman for the Massachusetts Biotechnology Council and Senior Vice-President of Feinstein Partners, a biotech consulting company. The same logic applies, he says, in such cases as tomato/flounder gene splicing: “Cross-breeding happens. Donkeys and horses are cross-bred to make mules, and nobody seems to have raised a tremendous ethical cry over that. These biotechniques are just new tools for making products.”
Supporters of genetic engineering say the technology also eliminates the randomness and imprecision that plague the traditional methods. Before biotechnicians could isolate specific genes, they say, the thousands of genes that passed from one generation to the next often carried with them new undesirable traits, as well as the sought-after improvements. As a result, it can sometimes take 20 years to develop a new plant variety that has been stripped of unwanted characteristics.
Biotechnology, including genetic engineering, allows single genetic traits to be transferred from one species to another.
“It’s a very, very powerful and fundamental set of techniques,” Gottlieb says. “You’re talking about a host of methods that are beginning to find their way into people’s lives, whether they are aware of it or not.”
With that in mind, the FDA, at the behest of the Clinton administration, is revisiting its year-old policy of genetically engineered products by considering a proposal that they be labeled.
The debate is focused not on nutritional or safety concerns. Instead, the FDA is for the first time considering mandatory labels based on a consumer “right to know.”
In a related matter, the FDA is considering whether to approve the use – and require the labeling – of bovine-growth hormone (BGH), a genetically engineered product that would be injected into dairy cows to enhance milk production.
“There is a key ethical decision that has to be made here,” says Paul Thompson, director for the Center for Biotechnology Policy and Ethics, at Texas A&M. “They’re going to have to make a choice of whether it is the responsible of the public policy to protect individual choice and consent, or apply science [proven to be safe for] the food supply. It’s an ethical dilemma because we would like to have both of those.”
Supporters of the FDA’s current policy believe requiring producers to include information that has nothing to do with the nutrition or healthfulness of their product sets a bad precedent. Moreover, they say, the practical problems of labeling products could effectively crush the industry and stymie development of important new products.
Labeling whole foods, like tomatoes, might be easy, they say. But what happens when large food manufacturers gather fruits, vegetables, and grains in massive quantities from different suppliers as ingredients for their products? How can a company determine whether an ingredient has been genetically engineered? And even if it can, should the entire product, containing even the smallest amount of a gene-spliced ingredient, be labeled as such? Should labeling be required for meat derived from animals raised on genetically altered feed?
The FDA’s Food Safety Advisory Committee is also listening to arguments presented by groups like the Pure Food Campaign, an organization spearheaded by renowned anti-biotech activist Jeremy Rifkin. Though the industry is quick to dismiss Rifkin and his supporters as zealots, the FDA acknowledges that its own regulations compel it to consider many concerns voiced by pro-labeling advocates.
For instance, FDA regulations say a product’s label is misleading if it fails to disclose all facts that pertain to the potential consequences of using the product. As it stands, the FDA may mandate approval for products that contain potential allergens. So if a gene from a peanut is spliced into a potato, special labeling might be required. But of particular concern to critics are unknown allergens created by a gene spliced into a foreign environment.
“We don’t know whether it is possible to create new configurations of food allergies by mixing proteins across species,” Krimsky explains.
Krimsky thinks companies like Calgene may not need to inform the public about the gene splicing involved in projects like Flavr Savr tomatoes, since that doesn’t introduce other species’ traits. But he firmly believes the industry is obliged to inform the millions of Americans with food allergies that new, cross-species foods may have unknown health effects.
Without such labeling, he says, “if something did go awry, you’d have no means of retrieving the cause. It precludes the possibility of finding out information on a large scale because people would not be able to report any distinction about the kind of food they eat.”
At a recent public hearing, numerous other concerns were also expressed to the FDA food advisory panel as it considered the labeling issue. Among them:
ETHICAL. Vegetarians and some whose religious beliefs embrace dietary concerns believe they have the right to know if their vegetables contain animal genes. In addition, activists from groups like the Pure Foods Campaign say the sanctity of natural food is at stake. The simple mutations about to be marketing, they say, are just a harbinger of frightening new and unrecognizable genetic combinations that, if the FDA fails to act, won’t even be subjected to mandatory testing, registration, or labeling.
ECONOMIC. Studies show that large farms are more likely to benefit from, or be able to afford, products like BGH, which increase production. Ultimately, critics argue, small and family-owned farms will be driven out of business, replaced by corporate farms.
ENVIRONMENTAL. Some observers are concerned that transgenic plants, if they’re hardier than stock, could crowd out wild plants and push those teetering on extinction over the edge. An exhaustive field test conducted by British ecologists over three years, the results of which were reported recently in the British journal Nature, found that a genetically engineered crop of rapeseed was no more invasive than an unmodified crop. Though many scientists are suspending judgment about the risks posed by other species or crop manipulations pending further study, they say the test may, at the very least, prove to be a prototype for analyzing the impact of other transgenic plants.
SOCIAL. Though advocates often talk about the prospect of using biotechnology to create resilient crops that could ease world food shortages, critics say the industry is not moving in that direction. “When we [the Council for Responsible Genetics] reviewed all the major products on the horizon in the research-and-development stage,” Krimsky says, “we could not find one that was a clear example of addressing an important global or national agriculture problem. We did find that most of the products were designed to increase the value of crops or create a market niche.”
FDA spokesman Stone says the agency’s advisory committee appears to be split along ideological lines. Scientists and academics on the committee apparently believe there is no scientific basis for requiring labeling on gene-spliced products. Consumer-advocate members are inclined to give the public the information it needs to make an informed choice.
One possible compromise under consideration is “reverse labeling.”
Like environmentally friendly products that have earned the Green Seal of approval, after review by an independent board. Reverse labeling, supporters says, would let the free market decide whether there is a place for biotech foods on supermarket shelves.
“The philosophical disagreements are not quite so pronounced on reverse labeling as they are on mandatory labeling,” Stone says of the committee’s deliberations on the proposal. Nevertheless, he says, significant problems remain, including how to verify that no ingredient in a food has been genetically engineered.
Most biotech-industry observers believe the FDA will not significantly depart from its current policy, and will thus allow manufacturers of genetically engineered food to proceed without new regulations.
“There are manipulations happening to the food supply over which consumers have no control.” DAN BARRY Pure Foods Campaign
But marketplace acceptance is as much an uncertainty as regulatory approval. “The decision-makers are you and I,” says the Massachusetts Biotechnology Council’s Gottlieb. “If nobody buys the tomato, people will stop making them. That’s basically how the American system works: let the market decide.”
It will take a skilled marketing strategy to walk the new biotech foods around the potential land mines awaiting them. At the heart of the matter is the public, which knows little more about gene splicing than what it has gleaned from Jurassic Park. Surveys conducted by the biotech industry and its detractors find that only a small portion of Americans even know that it means or food to be genetically engineered.
And that’s why a heated battle is being waged for the hearts and minds – and wallets – of the American consumer. Rifkin’s Pure food Campaign, for example, is organizing boycotts to alert consumers about the “Frankenfoods” now being developed and to pressure image-conscious companies to wash their hands of genetically engineered products.
“There are manipulations happening to the food supply over which they [consumers] have no control and for which there is very little consumer information,” says Dan Barry, executive director of the Pure Food Campaign. “We want to change that. We’re putting together an activists’ network of individuals who lead the protests outside major-supermarket headquarters, outside of food companies, and outside of dairies and dairy co-ops.”
The campaign’s primary targets so far have been Campbell Soup Company and McDonald’s, two companies with enough purchasing power to make or break a product. Campbell’s, which owns the rights to grow and use Flavr Savr tomatoes for processed products, has backed away from the plans to use it in its soups and sauces. The Pure Foods Campaign says the threat of a worldwide boycott and the effect that would have on Campbell’s rosy-cheeked image made the company think twice. Company officials deny the connection, saying the tomato simply doesn’t meet their current needs.
Rifkin and company are boycotting McDonald’s in the hope of getting a similar response. The campaign is urging McDonald’s to pledge not to use milk products derived from cows injected with BGH> So far, McDonald’s has given little hint about what it will do.
In the meantime, the biotech industry is charting its course and mulling ideas that it hopes will help quell public concern.
While Calgene is optimistic about the future of its longer-lasting, better-tasting tomato, there are a couple of forces working against the biotech company.
First, there’s the uncertainty about consumer reaction to genetic manipulation of food.
“We’re still kind of at the point where we don’t understand how the consumer will react to biotech products,” says Ed Beckman, manager of the California Tomato Board in Fresno.
“I don’t think people care how the changes are made. Focus groups [show] people don’t give a damn. They want a tomato that tastes good,” says Jim McCamanat, editor of Medical Technology Stock Letter, a Berkeley-based newsletter.
Perhaps the more important forces working against the Flavr Savr since last winter are improvements in conventionally bred tomatoes. In the last year, several seed companies have come out with conventional tomatoes that have better flavor and last longer than most tomatoes on the market. Developed mainly in Israel and Holland, these new varieties (called “extended shelf life tomatoes”) are the rage of the industry and have captured both consumer and retailer interest.
Many in the business feel Calgene may have missed its opportunity now that these improved conventionally bred tomatoes are on the market. They say if consumers can get all the attributes of a Flavr Savr in a conventionally bred tomato, why should they bother to buy more expensive genetically bred tomatoes?
Meyer Tomatoes expects to grow both Flavr Savr and the extended shelf life varieties. The market for the extended shelf tomatoes has already proved itself, but the big unknown will be whether there is a demand for the Flavr Savr.
“As biotechnology crosses the commercial threshold, what has to happen to ensure acceptance by consumers” asked an article in a recent issue of the Washington Grapevine, a trade newsletter published by the United Fresh Fruit and Vegetable Association. “There seems to be a general agreement among professionals in the field that consumer education is key – that acceptance could be substantially enhanced through education and information efforts aimed at explaining the use of biotech in ways that consumers can understand.”
But as Calgene executives know, with public opinion on gene-spliced foods still being shaped, the biotech food industry must carefully measure how much information is enough to inform and attract consumers without alarming or overwhelming them.
“One thing you ought to know,” says John McClung in the Grapevine article. “Don’t call it a ‘revolution.’ The research shows that when it comes to their food supply, consumers don’t like to think in revolutionary terms – it’s just too unsafe and uncertain a concept for anything as basic and essential as the food supply.”
Additional reporting by Jim Cole