Biotechnology Regs Raise Ruckus

A new set of biotechnology regulations for the state of Minnesota, approved by an administrative law judge in mid-March, have many researchers in the state alarmed. The scientists are disturbed not so much by the rules themselves--which require the obtaining of state permits for field tests of transgenic plants and microbes and the registration of labs working with recombinant organisms--as by the atmosphere surrounding their drafting. According to Jeff Tate, a plant physiologist at the University of Minnesota and a spokesman for the Minnesota Biotechnology Association, activists opposed to biotechnology were heavily involved in the development of the Minnesota rules, written to codify biotech legislation passed over the past two years. Tate says these activists could erect barriers to field testing of transgenic plants by petitioning for public hearings on each permit application and by instituting negative publicity campaigns. By contrast, in North Carolina--the only other state with such sweeping regulations--the state biotech- nology council claims that researchers have fared well under North Carolina's two-year- old permit process, which was developed in a probiotechnology environment. Richard Zink, who as assistant director of the plant industry division at the Minnesota Department of Agriculture will administer the permit process, says, "There's no doubt that environmental groups have targeted Minnesota with this issue." Tate says the targeting includes outbursts by members of the Minnesota Food Association at a news conference announcing the test of a new strain of bioengineered alfalfa and the packing of public hearings with antibiotechnology zealots. But Zink says that under the rules, it will be an interdisciplinary group of academic scientists, not citizen groups, that will make the decisions on issuing permits. "These releases will proceed on a fairly routine basis," he says. But he concedes that the new permitting process could tie up his limited staff and bog down the process. It is also still unclear how effective citizen groups will be in using the process to block field tests to which they are opposed. For Tate, one especially troubling aspect of the rules is the requirement that all labs working with recombinant organisms, whether aimed at the agricultural or the human therapeutic sector, must register with the state and certify compliance with National Institutes of Health guidelines for containment of the organisms within the confines of a laboratory. First of all, containment is a myth, says Tate. Organisms, especially microbes, will inevitably be carried into the outside world. He expects that the citizen groups will make trouble over this issue. The lists of names and addresses that the self-certification process will produce are frightening in themselves, says Tate. He fears that labs will be vandalized by antibiotech activists in the same manner as labs targeted by animal rights groups. Political Climates Ruth Shuman is a geneticist and president of Gentra Systems Inc., a startup based in Minneapolis working on recombinant veterinary products. Gentra also has an office in Research Triangle Park, N.C., and Shuman says the difference in political climate between the states is striking. She is enthusiastic about the North Carolina rules and feels they work to promote biotechnology by providing a known and predictable state regulatory environment. "But here in the state of Minnesota, the state legislature decided to listen to fringe groups," she says. "I think Minnesota has taken a very adversarial role here, and it will be difficult to accomplish a promotion of biotechnology with these regulations." As she interprets the regulations, not all of which are in place, a researcher or company must obtain federal permission for an environmental release before applying for a state permit. And given the appeal provisions, the state permit process could tack an extra six months onto the overall process, a cripplingly long time for a small firm like Gentra, Shuman says. But Margo Stark, senior program associate with the Minnesota Food Association, dismisses the doom and gloom forecasts as "hysteria." She says her group does not have to power to block field releases. "I'd say we're skeptics. We have a proceed-with- caution approach," Stark says. The point her group is trying to put across is not antibiotech per se, she says, but rather that research should be focused on techniques that support the family farm, not capital-intensive corporate operations that stand to benefit the most from bioengineered plants. She also contends that the lists of labs will not lead to vandalism and says that neither her group nor any other group she is aware of is planning such activity. In the biotech research community, too, not all scientists see the rules as threatening. "I have been thinking about it [the rules] quite a bit, but at the moment I don't think it's very clear how it will affect our research," says Dave Somers, a plant geneticist at the University of Minnesota who works on transgenic corn and oats. "We will have to attempt diligently to work with these rules and see how well they work." Somers adds: "In Minnesota we have a number of citizens' groups that are very concerned and interested in various aspects of the university's role in agriculture. And I don't want to trivialize some of the concerns these groups have raised." Somers says citizens' groups have a broader agenda than biotechnology, including most notably the salvation of the family-run farm. With about 6 million acres planted in soybeans and 6 million in corn, agriculture is a high-stakes business in the state. Northrup King Co., a seed-producing firm based in Minneapolis, is not too flustered by the new rules on agricultural releases. "Once the state decides to regulate environmental releases, we're not going to question that," says spokeswoman Julie Ethier- Hickman. Besides, she says, the bulk of the company's research work is in developing hybrid strains by traditional breeding methods, and its recombinant work is years away from field releases. At that point, if the political climate were unfavorable, Northrup King has the resources to conduct its tests in other states, she says, although the firm would prefer to stay close to its home office. No `Killer Tomatoes' Is a trend toward state regulation of biotechnology developing? Terri Anderson, government affairs director for the Industrial Biotechnology Association, doesn't think so. "Minnesota is a rather unusual situation," she says. The legislation that gave rise to the recently approved Minnesota rules was enacted a couple years ago, when a wave of proposed biotech legislation was sweeping through statehouses nationwide, Anderson says. She believes the wave has ebbed: "I think we've finally gotten the word out [to state legislators] that the killer tomatoes are not going to take over the state." For instance, Utah's governor on March 13 signed a bill that would prevent county and municipal authorities from regulating biotechnology. However, the continuing delay in federal biotechnology rule- making could stimulate further state action, according to Rebecca Goldburg, a senior scientist with the Environmental Defense Fund (EDF), which gave support to citizen groups in Minnesota. "If the quasi-paralysis continues at the federal level, we will see other states passing laws on genetically engineered organisms," Goldburg says. The New York state assembly is considering legislation requiring public notification prior to the release of bioengineered organisms and that provides a state court injunction procedure to block such releases. Vermont is considering enacting a law that would establish a board to give advice on how to regulate and control biotech research. And in Alaska, a bill is under review that would prohibit the sale of milk containing recombinant bovine growth hormone. Movement at the state level on a broad slate of environmental issues, including the release of recombinant organisms, will increase as EDF and other groups turn to state legislatures, rather than to a relatively unsympathetic federal government, for what they see as necessary new regulations, says Goldburg.

Biotechnology Regs Raise Ruckus

Interested in reading more?

Become a Member of