On the bluffs overlooking the Huerfano River of eastern Colorado, farmer Doug Wiley raises cattle and pigs and grows "a little dab" of melons and sweet corn. He's an organic farmer, but he hasn't bothered with official certification: "I'm what you call country certified," he says. "That means I shake your hand, look you in the eye, and invite you to come out to my place and see what I'm doing."
Wiley knows exactly what he's doing; his farm has been in his family for almost 90 years, and he's worked the same patch of dirt his entire life. He's beginning to wonder, though, if he's always going to be so rock-solid sure about what's sprouting on the land around him.
Earlier this year, Wiley learned that Meristem Therapeutics, a biotechnology company based in France, wants to test a new sort of genetically modified corn in Colorado soil. The company's crop produces proteins that can be used to manufacture lipase, an enzyme used in the treatment of digestive disorders. Optimistic backers say this corn and other "pharmaceutical" crops could one day provide cheaper, more accessible treatments for maladies ranging from the life threatening to the merely annoying. They say pharmaceutical crops might also open lucrative markets to the nation's struggling small farmers.
But to Wiley and many other Colorado farmers, Meristem represents not an opportunity but a mortal threat. Their anxieties about pharmaceutical plants might sound, at first, like an echo of the familiar debate around genetically modified foods: Wandering pollen could introduce genes into food crops or wild plants, which might then produce novel proteins; pharmaceutical plants could be accidentally mixed with food shipments; and climate changes or other environmental factors might cause inserted genes to express themselves in unexpected and unwelcome ways.
You've heard it all before, right? So has Wiley; genetically engineered food crops like pesticide-resistant corn have been grown in Colorado since the early 1990s. But even though pharmaceutical plants are borne from the same technology as their vitamin-enriched or frost-tolerant cousins, their job is quite different, often blurring the line between food and pharmacy.
Pharmaceutical plants might take the familiar forms of corn or lettuce or tomatoes, but they're not meant to be eaten; they're designed to be efficient living factories for pharmaceuticals and other therapeutic products. It's not known how stray proteins from these crops could affect human health, but anyone can predict their impact on human consumer habits. Even if there's only a small chance of contraceptives in your cornflakes, you're not likely to be buying.
None of this is welcome news to Wiley. If "biopharmed" plants were to cross with food plants in his neighborhood, or find their way into a nearby silo, visitors to his country-certified farm might start asking him questions he couldn't quite answer. He's not willing to watch this happen -- "I'd fight tooth and nail to keep farming here," he says -- so he and other skeptics have organized a remarkably dedicated opposition. Their persistent questions, complaints and criticism, directed at Meristem and at state and federal regulators, are making Colorado an uncomfortable place for the would-be biopharmer.
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."
During the publicity surrounding the ProdiGene fiasco, proponents of pharmaceutical plants decided to back out of the densely packed farm fields of the Corn Belt. In October 2002, the industry group BIO announced that its members would search for biopharming test sites further from food crops. Colorado, with its good climate, isolated fields, educated workforce, and high-powered research universities, was the obvious place for Plan B.
The Colorado Department of Agriculture, which has the authority to accept, reject or amend federal biopharming permits, started getting ready for an onslaught of field-testing applications. It put together a technical committee of university researchers and state officials to help analyze any incoming proposals, and it organized two informational panels in Colorado farming communities.
News of the ProdiGene slip-ups had spread quickly throughout rural Colorado, and the meetings attracted large, inquisitive and occasionally irate crowds. Farmers like Wiley asked if they'd be liable for any future contamination incidents, and environmentalists demanded to know more about the risks to human health and wildlife. "We're pretending we can isolate these drugs and toxic chemicals from the food supply," says Suzanne Wuerthele of the Sierra Club. "We're kidding ourselves. Contamination is inevitable."
Spurred by the meetings, biopharming opponents from around the state started gathering to strategize. They handed out hundreds of postcards at farmers' markets and local fairs, and concerned letters and e-mails started to pour into the state Department of Agriculture offices. "I couldn't have responded to every one, or I'd have done nothing but answer e-mail all day," says department policy director Jim Miller.
When the Meristem application reached state officials in May, public concern hit new heights. On May 12, amid a flurry of press attention, representatives of more than a dozen environmental and farmers' groups gathered at the state capitol to demand a moratorium on field testing of pharmaceutical crops in Colorado. Gov. Bill Owens, a Republican, did not respond to their request.
The state finally approved the Meristem application, with conditions allowing more frequent inspections, in early June. That cleared the way for the company to plant up to 30 acres of pharmaceutical corn; just a few days later, however, the company announced it was too late in the year to begin planting.
Though Meristem spokesman Emmanuel Boures said, in a recent e-mail, that his company plans return to the state next year, there may prove to be friendlier climes for pharmaceutical crops. "This would be a great place [for the technology], but the reception needs to be warmer," says Jennifer McCallum, a Denver attorney who represents Meristem. "I'm not sure I'd guide clients here in the future."
The reception might soon get even frostier. Miller, from the Colorado Department of Agriculture, says he hopes to include an environmental representative on the state's technical review committee next year. He also plans to organize a panel of activists, farmers and other citizens that will propose a list of environmental, health and economic concerns to be addressed by future applicants. Opponents say they'll keep pushing for a stricter and more transparent permit process on the state level. "The state has totally underestimated how much of a gut issue this is for people," says Jennifer Kemp of the Rocky Mountain Farmers Union.
Texas, home of ProdiGene, is also showing some skepticism about pharmaceutical food crops. The state legislature's agriculture committee recently held a hearing on a bill that would have prohibited all field testing and production of pharmaceuticals and industrial chemicals via food crops. Though the bill died in committee, it had deep-pocketed support; one witness in favor of the proposal was a representative of Frito-Lay.
Pressure on federal regulators may also be on the rise. U.S. Rep. Dennis Kucinich (D-Ohio) has just rolled out a bill that would prohibit field testing of all pharmaceutical and industrial crops. The Genetically Engineered Food Alert, a national coalition of food-safety groups, plans to pursue legal action against the U.S. Department of Agriculture.
Yet organic farmer Doug Wiley isn't reassured by the uproar. He knows Meristem won't be the last company to knock on Colorado's door -- ProdiGene has also applied for a federal permit to conduct field tests in the state -- and he's not about to count on the state or the feds to protect the genetic identity of his long-established plot of sweet corn. "Those bureaucracies have seldom made decisions that benefit rural communities," he says. "I have no faith in them at all."