The battle over biopharming isn't confined to the Rocky Mountains. Pharmaceutical crops are part of a large and expanding realm of research, one that aims to use domesticated plants to produce both drugs and industrial chemicals.

Few of these products have hit the market yet. One of the first -- and only -- commercial ventures is a laboratory chemical called Avidin, made from proteins produced by genetically modified corn. The industry estimates that plant-made pharmaceuticals are at least three years away from drugstore shelves, but pharmaceutical and industrial crops have been planted outdoors in field trials since the early '90s. Open-air experiments have been carried out at some 275 sites in more than 30 states.

Though corn is the workhorse of these experiments, tests have been conducted with alfalfa, tomatoes, barley, soybeans, lettuce and other plants. More than a dozen companies, ranging from small start-ups to familiar names such as Monsanto and DuPont, have invested in the work.

Problem is, most of this science is shrouded in secrecy. Biotechnology companies are not required to release research data or the location of testing sites to the public, and even state officials are not informed of the exact locations of sites.

Charles Benbrook, a former executive director of the board of agriculture at the National Academy of Sciences, says the vast majority of risk-assessment experiments have been carried out by the biotechnology companies themselves. "And let's face it," he says, "they don't have a super-strong financial incentive to document that their own technology is going to lead to problems."

Federal regulators, long friendly to biotechnology, haven't pressed very hard for more independent information or greater corporate openness. Their oversight of plant-made pharmaceuticals is further complicated by a somewhat murky division of responsibilities between the Department of Agriculture and the Food and Drug Administration.

The shortcomings of the federal system became apparent in September of last year, when federal inspectors found that pollen from pharmaceutical corn in Iowa might have spread to more than 150 acres of nearby food corn. Later that fall, they found that corn from a test plot in Nebraska had been mixed with some half a million bushels of food-grade soybeans. Both the United States and the European Union have a zero-tolerance policy for pharmaceutical plants in food crops, so the beans had to be destroyed before they reached consumers.

The incidents hit the national news and provided rich fodder for activist groups (Greenpeace activists scaled the Aurora, Neb., silo and unfurled a huge banner reading "This Is Your Food on Drugs!") The company responsible for both contamination incidents, the Texas-based start-up ProdiGene, was required to pay $250,000 in fines and about $3.5 million in cleanup costs.

In late March of this year, however, the Washington Post reported that the federal government had quietly eased ProdiGene's pain with an interest-free loan. The deal may eventually save the company about half a million dollars.

The Department of Agriculture recently imposed tougher rules on open-air plantings of pharmaceutical plants, including a mile-wide separation between most pharmaceutical corn and food corn, and it is expected to establish similar rules for industrial crops. Margaret Jones, a department researcher, emphasizes that the ProdiGene incidents were an "anomaly" that should not shut down the industry and says the new rules should prevent similar mishaps in the future. "You can only account for human error, sometimes, when it happens," she says.

To some, this is small comfort. "It's become very, very clear that the industry can't keep its genes under control -- it can't keep its proverbial pants zipped," says Marion Nestle, the chair of Nutrition and Food Studies at New York University and the author of the recent book "Safe Food." "Biology doesn't work like that."

Recent Stories