The Three Mile Island of Biotech?
"The regulatory system isn't working. It looks like we've got pharmaceutical chaos in the fields," says former North Dakota Agriculture Commissioner Sarah Vogel. "I'm not sure that some of these people in Washington or the corporate boardrooms quite understand the threat these incidents tell us are being created for food safety and the future of American agriculture." Part of the problem, according to Jean Halloran, who directs Consumers Union's Consumer Policy Institute, is that technological advances have outpaced not just regulations but basic questions of whether biopharming should be allowed at all. "What's infuriating is that there has been no public debate on whether we should be proceeding to this technology. They just went ahead and did it," Halloran says of an industry that, for the most part, is policed only with vague guidelines and threats of action if, as in the case of ProdiGene's plots, something goes really wrong. "We're in the middle of an official comment period on a set of guidelines--not regulations, just guidelines--at the same time that we are learning that we've got these problems with the testing. Doesn't that sound like we've missed a step?"
After the near-disaster in Hamilton County, there may be some scaling back of the explosive growth in the number of biopharm test plots in corn-growing states. ProdiGene and USDA officials talk of "isolating" the firm's open-air test fields, just beyond the edge of the cornbelt in Nebraska's Sand Hills or perhaps in the Southwest. But independent observers who know about farming and food safety are skeptical about this kind of self-regulation. They note that roughly 20 percent of the nation's corn production--including that of much of Nebraska--occurs outside the "drug-free zone" that BIO advanced and then abandoned. More significant, they argue that open-air test plots are not necessarily "isolated" by distance from traditional food crops.
Iowa State's Harl explains that even an isolated field can be hit with a tornado or heavy winds that will drop a kernel of corn far from the test plot. "Birds, deer, runoff from fields into rivers--it's hard to list all the ways that seeds and kernels can be carried substantial distances," says Harl, who adds that because of consumer confidence and liability concerns, "ultimately, I think we are going to conclude that we have to produce a zero-contamination rule. That requires us to control the total environment--and that means in a greenhouse."
Federal regulators have begun to feel pressure to tighten regulation of biopharm experiments and production, and not just from environmental, consumer and grocery industry groups, which have long been troubled by the prospect of drug crops contaminating food crops. In November Senate majority leader Tom Daschle and Agriculture Committee chair Tom Harkin wrote Agriculture Secretary Ann Veneman to ask "whether existing procedures and safeguards are sufficient to ensure that similar incidents do not occur in the future." A more energetic push came from the National Food Processors Association, whose president, John Cady, said the USDA and the FDA "should impose a stringent and mandatory regulatory framework to ensure protection of the US food supply and US food exports from any inadvertent or even intentional contamination by plant-made materials that have not been approved for human food and animal feed purposes." At the same time, however, farm groups allied with agribusiness--chief among them the American Farm Bureau Federation--issued a statement reaffirming their faith in biotech crops and essentially asking federal officials to continue encouraging biopharming.
Harl, who has served on the USDA's Advisory Committee on Agricultural Biotechnology, says federal agencies are going to have to fundamentally alter their approach to biopharming. "This is part of a broader regulatory phenomenon that has not been faced yet. If we are going to allow this type of production, then we have to ramp up the regulatory regimen," he says. The USDA, the FDA and the EPA must resolve turf wars over which agency is in charge of regulating not just test plots but, potentially, wide-scale production of pharmaceutical crops. That will require development of a regulatory regimen that makes public the details about where biopharm fields are planted and where biopharm products are being processed, and that insures regular testing through all the steps of food processing to assure that pharmaceutical crops are not being mixed with food crops. "We won't have discipline until we have testing at every point of commingling," Harl says. "We have some tests, but they are not what they must be: fast, easy and cheap."
Before any of these steps occur, however, Jean Halloran of Consumers Union suggests a more fundamental move. "We should ask whether pharmaceutical products should be engineered into food plants in the first place," she says. "Our view is that the answer to the question should be no." She notes that the drugs that biopharming promises to deliver can be gotten through other means. "The practical aspects of trying to keep these pharmaceutical plants separate from the regular food plants is an insurmountable problem," she says. "It just can't be done. It can't be done because of the fallibility of human beings. It can't be done because you can't control pollen flow. It can't be done because you can't control mother nature that way. And if you can't control mother nature and fallible human beings, we've come to the conclusion that you shouldn't try."