Like a scene from some Hollywood thriller, a team of U.S. Marshals stormed a warehouse in Irvington, New Jersey, last summer to intercept a shipment of evildoers from Pakistan. The reason you probably haven’t heard about the raid is that the objective was not to seize Al Qaeda operatives or white slavers, but $80,000 worth of basmati rice contaminated with weevils, beetles, and insect larvae, making it unfit for human consumption. In regulation-speak, the food was “adulterated,” because “it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food.”

Americans take food safety very seriously. Still, many consumers tend to ignore Mother Nature’s contaminants while they worry unduly about high technology, such as the advanced technologies that farmers, plant breeders, and food processors use to make our food supply the most affordable, nutritious, varied, and safe in history.

For example, recombinant dna technology — also known as food biotechnology, gene-splicing, or genetic modification (gm) — is often singled out by critics as posing a risk that new allergens, toxins, or other nasty substances will be introduced into the food supply. And, because of the mainstream media’s “if it bleeds, it leads” approach, news coverage of food biotech is dominated by the outlandish claims and speculations of anti-technology activists. This has caused some food companies — including fast-food giant McDonald’s and baby-food manufacturers Gerber and Heinz — to forgo superior (and even cost-saving) gene-spliced ingredients in favor of ones the public will find less threatening.

Scientists agree, however, that gene-spliced crops and foods are not only better for the natural environment than conventionally produced food crops, but also safer for consumers. Several varieties now on the market have been modified to resist insect predation and plant diseases, which makes the harvested crop much cleaner and safer. Ironically (and also surprisingly in these litigious times), in their eagerness to avoid biotechnology, some major food companies may knowingly be making their products less safe and wholesome for consumers. This places them in richly deserved legal jeopardy.


Don’t trust Mother Nature

Every year, scores of packaged food products are recalled from the American market due to the presence of all-natural contaminants like insect parts, toxic molds, bacteria, and viruses. Because farming takes place out-of-doors and in dirt, such contamination is a fact of life. Fortunately, modern technology has enabled farmers and food processors to minimize the threat from these contaminants.

The historical record of mass food poisoning in Europe offers a cautionary tale. From the ninth to the nineteenth centuries, Europe suffered a succession of epidemics caused by the contamination of rye with ergot, a poisonous fungus. Ergot contains the potent toxin ergotamine, the consumption of which induces hallucinations, bizarre behavior, and violent muscle twitching. These symptoms gave rise at various times to the belief that victims were possessed by evil spirits. Witch-hunting and persecution were commonplace — and the New World was not immune. One leading explanation for the notorious 1691–92 Salem witch trials also relates to ergot contamination. Three young girls suffered violent convulsions, incomprehensible speech, trance-like states, odd skin sensations, and delirious visions in which they supposedly saw the mark of the devil on certain women in the village. The girls lived in a swampy meadow area around Salem; rye was a major staple of their diet; and records indicate that the rye harvest at the time was complicated by rainy and humid conditions, exactly the situation in which ergot would thrive.

Worried villagers feared the girls were under a spell cast by demons, and the girls eventually named three women as witches. The subsequent panic led to the execution of as many as 20 innocent people. Until a University of California graduate student discovered this link, a reasonable explanation had defied historians. But the girls’ symptoms are typical of ergot poisoning, and when the supply of infected grain ran out, the delusions and persecution likewise disappeared.

In the twenty-first century, modern technology, aggressive regulations, and a vigorous legal liability system in industrialized countries such as the United States are able to mitigate much of this sort of contamination. Occasionally, though, Americans will succumb to tainted food picked from the woods or a backyard garden. However, elsewhere in the world, particularly in less-developed countries, people are poisoned every day by fungal toxins that contaminate grain. The result is birth defects, cancer, organ failure, and premature death.

About a decade ago, Hispanic women in the Rio Grande Valley of Texas were found to be giving birth to an unusually large number of babies with crippling and lethal neural tube defects (ntds) such as spina bifida, hydrocephalus, and anencephaly — at a rate approximately six times higher than the national average for non-Hispanic women. The cause remained a mystery until recent research revealed a link between ntds and consumption of large amounts of unprocessed corn like that found in tortillas and other staples of the Latino diet.

The connection is obscure but fascinating. The culprit is fumonisin, a deadly mycotoxin, or fungal toxin, produced by the mold Fusarium and sometimes found in unprocessed corn. When insects attack corn, they open wounds in the plant that provide a perfect breeding ground for Fusarium. Once molds get a foothold, poor storage conditions also promote their post-harvest growth on grain.

Fumonisin and some other mycotoxins are highly toxic, causing fatal diseases in livestock that eat infected corn and esophageal cancer in humans. Fumonisin also interferes with the cellular uptake of folic acid, a vitamin that is known to reduce the risk of ntds in developing fetuses. Because fumonisin prevents the folic acid from being absorbed by cells, the toxin can, in effect, induce functional folic acid deficiency — and thereby cause ntds — even when the diet contains what otherwise would be sufficient amounts of folic acid.

The epidemiological evidence was compelling. At the time that the babies of Hispanic women in the Rio Grande Valley experienced the high rate of neural tube defects, the fumonisin level in corn in that locale was two to three times higher than normal, and the affected women reported much higher dietary consumption of homemade tortillas than in women who were unaffected.

Acutely aware of the danger of mycotoxins, regulatory agencies such as the U.S. Food and Drug Administration and Britain’s Food Safety Agency have established recommended maximum fumonisin levels in food and feed products made from corn. Although highly processed cornstarch and corn oil are unlikely to be contaminated with fumonisin, unprocessed corn or lightly processed corn (e.g., cornmeal) can have fumonisin levels that exceed recommended levels.

In 2003, the Food Safety Agency tested six organic cornmeal products and twenty conventional corn meal products for fumonisin contamination. All six organic corn meals had elevated levels — from nine to 40 times greater than the recommended levels for human health — and they were voluntarily withdrawn from grocery stores.


A technical fix

The conventional way to combat mycotoxins is simply to test unprocessed and processed grains and throw out those found to be contaminated — an approach that is both wasteful and dubious. But modern technology — specifically in the form of gene-splicing — is already attacking the fungal problem at its source. An excellent example is “Bt corn,” crafted by splicing into commercial corn varieties a gene from the bacterium Bacillus thuringiensis. The “Bt” gene expresses a protein that is toxic to corn-boring insects but is perfectly harmless to birds, fish, and mammals, including humans.

As the Bt corn fends off insect pests, it also reduces the levels of the mold Fusarium, thereby reducing the levels of fumonisin. Thus, switching to the gene-spliced, insect-resistant corn for food processing lowers the levels of fumonisin — as well as the concentration of insect parts — likely to be found in the final product. Researchers at Iowa State University and the U.S. Department of Agriculture found that Bt corn reduces the level of fumonisin by as much as 80 percent compared to conventional corn.

Thus, on the basis of both theory and empirical knowledge, there should be potent incentives — legal, commercial, and ethical — to use such gene-spliced grains more widely. One would expect public and private sector advocates of public health to demand that such improved varieties be cultivated and used for food — not unlike requirements for drinking water to be chlorinated and fluoridated. Food producers who wish to offer the safest and best products to their customers — to say nothing of being offered the opportunity to advertise “New and Improved!” — should be competing to get gene-spliced products into the marketplace.

Alas, none of this has come to pass. Activists have mounted intractable opposition to food biotechnology in spite of demonstrated, significant benefits, including reduced use of chemical pesticides, less runoff of chemicals into waterways, greater use of farming practices that prevent soil erosion, higher profits for farmers, and less fungal contamination. Inexplicably, government oversight has also been an obstacle, by subjecting the testing and commercialization of gene-spliced crops to unscientific and draconian regulations that have vastly increased testing and development costs and limited the use and diffusion of food biotechnology.

The result is jeopardy for everyone involved in food production and consumption: Consumers are subjected to avoidable and often undetected health risks, and food producers have placed themselves in legal jeopardy. The first point is obvious, the latter less so, but as described first by Drew Kershen, professor of law at the University of Oklahoma, it makes a fascinating story: Agricultural processors and food companies may face at least two kinds of civil liability for their refusal to purchase and use fungus-resistant, gene-spliced plant varieties, as well as other superior products.


Food for thought

In 1999 the Gerber foods company succumbed to activist pressure, announcing that its baby food products would no longer contain any gene-spliced ingredients. Indeed, Gerber went farther and promised it would attempt to shift to organic ingredients that are grown without synthetic pesticides or fertilizers. Because corn starch and corn sweeteners are often used in a range of foods, this could mean changing Gerber’s entire product line.

But in its attempt to head off a potential public relations problem concerning the use of gene-spliced ingredients, Gerber has actually increased the health risk for its baby consumers — and, thereby, its legal liability. As noted above, not only is gene-spliced corn likely to have lower levels of fumonisin than conventional corn; organic corn is likely to have the highest levels, because it suffers greater insect predation due to less effective pest controls.

If a mother some day discovers that her “Gerber baby” has developed liver or esophageal cancer, she might have a legal case against Gerber. On the child’s behalf, a plaintiff’s lawyer can allege liability based on mycotoxin contamination in the baby food as the causal agent of the cancer. The contamination would be considered a manufacturing defect under product liability law because the baby food did not meet its intended product specifications or level of safety. According to Kershen, Gerber could be found liable “even though all possible care was exercised in the preparation and marketing of the product,” simply because the contamination occurred.

The plaintiff’s lawyer could also allege a design defect in the baby food, because Gerber knew of the existence of a less risky design — namely, the use of gene-spliced varieties that are less prone to Fusarium and fumonisin contamination — but deliberately chose not to use it. Instead, Gerber chose to use non-gene-spliced, organic food ingredients, knowing that the foreseeable risks of harm posed by them could have been reduced or avoided by adopting a reasonable alternative design — that is, by using gene-spliced Bt corn, which is known to have a lower risk of mycotoxin contamination.

Gerber might answer this design defect claim by contending that it was only responding to consumer demand, but that alone would not be persuasive. Product liability law subjects defenses in design defect cases to a risk-utility balancing in which consumer expectations are only one of several factors used to determine whether the product design (e.g., the use of only non-gene-spliced ingredients) is reasonably safe. A jury might conclude that whatever consumer demand there may be for non-biotech ingredients does not outweigh Gerber’s failure to use a technology that is known to lower the health risks to consumers.

Even if Gerber was able to defend itself from the design defect claim, the company might still be liable because it failed to provide adequate instructions or warnings about the potential risks of non-gene-spliced ingredients. For example, Gerber could label its non-gene-spliced baby food with a statement such as: “This product does not contain gene-spliced ingredients. Consequently, this product has a very slight additional risk of mycotoxin contamination. Mycotoxins can cause serious diseases such as liver and esophageal cancer and birth defects.”

Whatever the risk of toxic or carcinogenic fumonisin levels in non-biotech corn may be (probably low in industrialized countries, where food producers generally are cautious about such contamination), a more likely scenario is potential liability for an allergic reaction.

Six percent to 8 percent of children and 1 to 2 percent of adults are allergic to one or another food ingredient, and an estimated 150 Americans die each year from exposure to food allergens. Allergies to peanuts, soybeans, and wheat proteins, for example, are quite common and can be severe. Although only about 1 percent of the population is allergic to peanuts, some individuals are so highly sensitive that exposure causes anaphylactic shock, killing dozens of people every year in North America.

Protecting those with true food allergies is a daunting task. Farmers, food shippers and processors, wholesalers and retailers, and even restaurants must maintain meticulous records and labels and ensure against cross-contamination. Still, in a country where about a billion meals are eaten every day, missteps are inevitable. Dozens of processed food items must be recalled every year due to accidental contamination or inaccurate labeling.

Fortunately, biotechnology researchers are well along in the development of peanuts, soybeans, wheat, and other crops in which the genes coding for allergenic proteins have been silenced or removed. According to University of California, Berkeley, biochemist Bob Buchanan, hypoallergenic varieties of wheat could be ready for commercialization within the decade, and nuts soon thereafter. Once these products are commercially available, agricultural processors and food companies that refuse to use these safer food sources will open themselves to products-liability, design-defect lawsuits.


Property damage and personal injury

Potato farming is a growth industry, primarily due to the vast consumption of french fries at fast-food restaurants. However, growing potatoes is not easy, because they are preyed upon by a wide range of voracious and difficult-to-control pests, such as the Colorado potato beetle, virus-spreading aphids, nematodes, potato blight, and others.

To combat these pests and diseases, potato growers use an assortment of fungicides (to control blight), insecticides (to kill aphids and the Colorado potato beetle), and fumigants (to control soil nematodes). Although some of these chemicals are quite hazardous to farm workers, forgoing them could jeopardize the sustainability and profitability of the entire potato industry. Standard application of synthetic pesticides enhances yields more than 50 percent over organic potato production, which prohibits most synthetic inputs.

Consider a specific example. Many growers use methamidophos, a toxic organophosphate nerve poison, for aphid control. Although methamidophos is an epa-approved pesticide, the agency is currently reevaluating the use of organophosphates and could ultimately prohibit or greatly restrict the use of this entire class of pesticides. As an alternative to these chemicals, the Monsanto Company developed a potato that contains a gene from the bacterium Bacillus thuringiensis (Bt) to control the Colorado potato beetle and another gene to control the potato leaf roll virus spread by the aphids. Monsanto’s NewLeaf potato is resistant to these two scourges of potato plants, which allowed growers who adopted it to reduce their use of chemical controls and increase yields.

Farmers who planted NewLeaf became convinced that it was the most environmentally sound and economically efficient way to grow potatoes. But after five years of excellent results it encountered an unexpected snag. Under pressure from anti-biotechnology organizations, McDonald’s, Burger King, and other restaurant chains informed their potato suppliers that they would no longer accept gene-spliced potato varieties for their french fries. As a result, potato processors such as J.R. Simplot inserted a nonbiotech-potato clause into their farmer-processor contracts and informed farmers that they would no longer buy gene-spliced potatoes. In spite of its substantial environmental, occupational safety, and economic benefits, NewLeaf became a sort of contractual poison pill and is no longer grown commercially. Talk about market distortions.

Now, let us assume that a farmer who is required by contractual arrangement to plant nonbiotech potatoes sprays his potato crop with methamidophos (the organophosphate nerve poison) and that the pesticide drifts into a nearby stream and onto nearby farm laborers. Thousands of fish die in the stream, and the laborers report to hospital emergency rooms complaining of neurological symptoms.

This hypothetical scenario is, in fact, not at all far-fetched. Fish-kills attributed to pesticide runoff from potato fields are commonplace. In the potato-growing region of Prince Edward Island, Canada, for example, a dozen such incidents occurred in one 13-month period alone, between July 1999 and August 2000. According to the un’s Food and Agriculture Organization, “normal” use of the pesticides parathion and methamidophos is responsible for some 7,500 pesticide poisoning cases in China each year.

In our hypothetical scenario, the state environmental agency might bring an administrative action for civil damages to recover the cost of the fish-kill, and a plaintiff’s lawyer could file a class-action suit on behalf of the farm laborers for personal injury damages.

Who’s legally responsible? Several possible circumstances could enable the farmer’s defense lawyer to shift culpability for the alleged damages to the contracting food processor and to the fast-food restaurants that are the ultimate purchasers of the potatoes. These circumstances include the farmer’s having planted Bt potatoes in the recent past; his contractual obligation to the potato processor and its fast-food retail buyers to provide only nonbiotech varieties; and his demonstrated preference for planting gene-spliced, Bt potatoes, were it not for the contractual proscription. If these conditions could be proved, the lawyer defending the farmer could name the contracting processor and the fast-food restaurants as cross-defendants, claiming either contribution in tort law or indemnification in contract law for any damages legally imposed upon the farmer client.

The farmer’s defense could be that those companies bear the ultimate responsibility for the damages because they compelled the farmer to engage in higher-risk production practices than he would otherwise have chosen. The companies chose to impose cultivation of a non-gene-spliced variety upon the farmer although they knew that in order to avoid severe losses in yield, he would need to use organophosphate pesticides. Thus, the defense could argue that the farmer should have a legal right to pass any damages (arising from contractually imposed production practices) back to the processor and the fast-food chains.


Why biotech?

Companies that insist upon farmers’ using production techniques that involve foreseeable harms to the environment and humans may be — we would argue, should be — legally accountable for that decision. If agricultural processors and food companies manage to avoid legal liability for their insistence on nonbiotech crops, they will be “guilty” at least of externalizing their environmental costs onto the farmers, the environment, and society at large.

Food biotechnology provides an effective — and cost-effective — way to prevent many of these injurious scenarios, but instead of being widely encouraged, it is being resisted by self-styled environmental activists and even government officials.

It should not fall to the courts to resolve and reconcile what are essentially scientific and moral issues. However, other components of society — industry, government, and “consumer advocacy” groups — have failed abjectly to fully exploit a superior, life-enhancing, and life-saving technology. Even the biotechnology trade associations have been unhelpful. All are guilty, in varying measures, of sacrificing the public interest to self-interest and of helping to perpetuate a gross public misconception — that food biotechnology is unproven, untested, and unregulated.

If consumers genuinely want a safer, more nutritious, and more varied food supply at a reasonable cost, they need to know where the real threats lie. They must also become better informed, demand public policy that makes sense, and deny fringe anti-technology activists permission to speak for consumers.

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