Fearing a Field of Genes

The field had just been harvested, the soybean plants cut down to brown nubs, when a federal inspector arrived. He paced the small plot in southeastern Nebraska, eyes on the furrowed dirt.

Then he saw them: a few crumpled corn stalks strewn among the brittle bits of beans.

The discovery rattled America’s food industry, for this was not ordinary corn. It had been genetically engineered to produce an “edible vaccine” to protect piglets from diarrhea. And now the stubble on the ground suggested that it had been swept into the autumn soy harvest -- mixed with beans that would soon be processed into dozens of groceries, from ice cream to salad dressing.

The manufacturers that make those groceries have been staunch supporters of engineered food. But the mix-up last month in Nebraska infuriated them. After years of backing biotechnology, they drew the line -- and raised an alarm.

Joining forces with the antibiotech activists they have long viewed as the enemy, food lobbyists are pushing for much tougher restrictions on the latest advance in the genetic revolution: engineering crops to “grow” pharmaceuticals and chemicals. They fear a threat to public health -- and to their business interests, as well -- if crops bearing a hepatitis vaccine or a cancer drug slip into the food supply. So, they are demanding federal regulation to strictly limit where and how the experimental plants are grown.

From baby formula to margarine to chicken soup, about 70% of processed food on the country’s shelves contains engineered ingredients, such as soybeans genetically modified so they can be grown with fewer herbicides. Deconstructed, the biotech crops sound a bit freakish: The beans, for instance, are spliced with DNA from a cauliflower virus and a petunia plant. But they are extensively tested and approved for human consumption.

Corn that produces a swine vaccine is not.

“We’re one of the strongest defenders of using biotechnology in agriculture. But this is something different,” said Rhona Applebaum, executive vice president of the National Food Processors Assn.

Scientists tinkering with DNA transfers are developing crops that will produce insulin, chemotherapy drugs, herpes treatments, blood thinners -- even enzymes used to make laundry detergent. They’re testing them in dozens of “biopharm” fields across the country, from California to Maryland, North Dakota to Texas.

The experimental crops look in every way like normal corn, rice or barley. And that makes them “an intolerable risk” to the food supply, said James Bair, vice president of the North American Millers’ Assn., which represents grain processors.

Even the most strident critics of “biopharming” acknowledge that in most cases, consumers would probably suffer no ill effects if trace amounts of these new crops made their way into groceries.

Some of the biopharm products mimic antibodies naturally found in the human body. Others are effective only if injected into the bloodstream; eaten, they would dissolve harmlessly in the gut.

Still, none of the experimental crops has been subjected to food safety tests. Some could, conceivably, be dangerous in high doses. Others could trigger allergic reactions.

“With some vaccines, there could potentially be a threat of overdose [although] it’s not something I would stay up late worrying about,” said Charles Arntzen, a plant biologist at Arizona State University who is growing a cholera vaccine in tomatoes.

Although the health risk may be low, the FDA will not allow the food supply to be tainted by any compound that has not been approved for human consumption. If even a few biopharm cornstalks were mistakenly sent to a processing plant, every grocery made with that mill’s cornmeal would be recalled. Food manufacturers envision an economic disaster, with consumer confidence plunging at home and foreign markets for U.S. groceries slamming shut.

“If their product goes awry, that doesn’t just damage [the biotech company’s] stock. It has the potential for a very broad ripple effect,” said Stephanie Childs, a spokeswoman for the Grocery Manufacturers of America.

“Our concerns are obvious,” said Mark Dollins, a spokesman for Quaker Oats.

That anxiety is heightened because there is no way to test whether a given batch of corn headed to a grain mill contains a swine vaccine, or a contraceptive, or an enzyme used to tan leather.

Such tests exist for the engineered crops used in groceries; food processors routinely analyze their ingredients with DNA probes that can detect a single biotech kernel in a bin of 50,000. It would be fairly easy to develop similar tests for biopharm products, but only if the scientists engineering them release the details of their DNA modifications. The federal government does not require them to do so, and so far, none has.

“We’ve had calls from food processors asking, ‘What about our cornmeal? How can we be sure [biopharm grains] aren’t in it?’ And at this point in time, they can’t be sure,” said John Fagan, president of Genetic ID, a biotechnology testing firm.

That’s why the Nebraska contamination was so unsettling to many in the food industry. The biopharm corn, engineered to protect baby pigs from a gastrointestinal disease, was grown in the summer of 2001 for ProdiGene, a leading biotech firm based in College Station, Texas. The firm paid a Nebraska farmer to grow the corn under conditions laid out by the U.S. Department of Agriculture. It was isolated from nearby crops and surrounded by a buffer of sterile plants to catch any drifting pollen.

The corn crop grew well, and ProdiGene harvested it in the fall for testing. A few months later, in the spring of 2002, the farmer who owned the test field planted it with soybeans, for sale to food mills. The USDA required ProdiGene to regularly inspect the field to make sure no leftover biopharm corn had taken root amid the soy.

ProdiGene sent inspectors to look over the field several times last summer, according to Anthony Laos, the company’s chief executive. Finding no stray corn, they discontinued inspections in late August. But a few dormant seeds apparently sprouted in early fall.

USDA inspectors, who visit most test fields just once a growing season, spotted the errant cornstalks in October and ordered the farmer to pull them. Laos can only surmise that the farmer missed a few because, when the USDA returned a month later, the stubble on the ground suggested that the corn had been harvested along with the soy.

The USDA soon tracked the harvest to a storage elevator in Aurora, Neb. By then, the beans had been mixed with the bounty from several farms. The agency incinerated all 500,000 bushels -- a harvest worth nearly $3 million.

This month, the USDA ordered ProdiGene to pay for the destroyed beans. The company must also pay an unprecedented $250,000 fine.

Biotech backers warn against using the incident as an excuse to quash a promising new industry. Biopharming, they argue, can revolutionize health care. Developing nations short on clean syringes could distribute edible vaccines instead. Pharmaceutical production could be sped up and simplified -- a matter of seeding a few acres, rather than building a $500-million factory.

“There are selfish and powerful [food industry] trade groups in Washington who want to be overly safe,” said Sen. Charles E. Grassley (R-Iowa). “I’m concerned that any new regulation be based on science, not emotion.”

Agriculture Secretary Ann M. Veneman has signaled that she understands that concern, telling a farmers’ group this month: “We don’t want to stifle growth, but we have to have a strong and credible regulatory system.”

She is requesting comments on a 15-page list of proposed guidelines for the industry -- all phrased as suggestions, not mandates.

Among the reforms under consideration: moving experimental fields out of the Midwest’s Corn Belt; marking biopharm plants as distinct, perhaps by dyeing their leaves a different color, and setting aside fields and equipment exclusively for experimental crops.

Biotech firms could support some of those measures “to make sure these plants stay where they belong,” said Lisa Dry, a spokeswoman for Biotechnology Industry Organization, a Washington-based industry trade group.

The one proposal they refuse to consider: requiring scientists to use non-food crops for their experiments.

Some biopharm engineers are testing tobacco, cotton, even weeds. But corn is by far the most common medium. It’s considered the easiest to work with because its seeds are stable, it’s easy to store and its biology is so well understood. Several companies, including ProdiGene, say they will not give it up.

“That’s a non-starter,” Dry said. “We believe these crops can be managed.”

Those calling for a ban on biopharm food crops are not so confident. They see the mix-up on the Nebraska soybean field as the latest in a troubling string of slips that cast doubt on the industry’s ability to keep experimental crops off dinner plates.

Several weeks before the Nebraska mix-up, for instance, the USDA had warned ProdiGene about a close call with another field, this one in Iowa. The circumstances were remarkably similar: A farmer had planted soy after ProdiGene’s crop of swine-vaccine corn was harvested. But he neglected to pull stray cornstalks. Concerned that biopharm pollen could have drifted into adjacent fields, the USDA ordered 155 acres of nearby food crops burned.

Meanwhile, biotechnology giant Monsanto has been struggling for two years to track down a strain of genetically modified canola that was inadvertently mixed with seeds distributed to farmers. The herbicide-resistant canola had not been approved for planting, although regulators now say it is perfectly safe.

The most dramatic lapse occurred two years ago, when biotech corn approved only for animal feed made its way into more than 300 brands of taco shells, corn breads and other processed foods. The corn, known as StarLink, was not designed to produce drugs or chemicals, but regulators were concerned it could cause allergies in humans.

“It showed how easy it was for a gene we thought we had under control to get into the food chain,” said Jane Rissler, a member of the Union of Concerned Scientists, a group skeptical of biotechnology.

Unwilling to risk another such slip, food industry lobbyists now demand an ironclad guarantee that no trace of any biopharm compound will ever get into the food supply. In one voice, they insist on 100% protection.

That’s a standard that Laos, the ProdiGene chief executive, deems unattainable.

“Nothing we do in this world,” he said, “is risk-free.”