Wary of a Farmyard Frankenstein, Officials Keep Eye on Gene Splicing : Science: But firms developing new strains of hardier plants say maze of emerging state and federal rules cloud the future for important breakthroughs.
In a farm field 60 miles south of Minneapolis, researchers at the Northrup King seed company are conducting two genetic engineering trials on corn this summer. Their goal? To make corn plants that are invulnerable to a virus and to a pesky insect that each year ruins an estimated $400 million or more of American crops.
It seems a noble effort, especially in this farm-rich state. But rising concerns among some Minnesota environmentalists and lawmakers about the safety of biotechnology has clouded the future of such research.
Although the Food and Drug Administration announced in May that it would not impose new regulations on genetically engineered foods--seemingly easing the road to market for a flood of miracle products--a handful of states are questioning the safety of this brave new world by imposing stricter laws.
Minnesota’s new rules, considered the nation’s toughest, force researchers to get state permits before releasing genetically engineered organisms outside of their laboratories. They also call for environmental review by state agencies.
North Carolina and Hawaii also have their own rules, although they are less stringent.
If more states follow, officials of the nation’s budding biotechnology business worry that it could become tangled in a web of different state laws.
The debate takes place against the backdrop of what is projected to become a $50-billion-a-year industry by 1995. Gene splicing and the other tools of genetic engineering are expected to revolutionize the marketplace.
To date the products have remained mostly a futuristic possibility, but a host of companies like California-based Calgene Inc. are moving closer to bringing genetically engineered marvels like rot-resistant tomatoes to the nation’s kitchens, and disease-resistant seed and animals to its farms.
Minneapolis-based Northrup King Co. has spent millions of dollars trying to develop genetically engineered seeds, but it remains years from bringing them to market.
In experimental fields in Stanton, corn genetically transformed to resist the Maize Dwarf Mosaic Virus grows side by side with regular hybrid corn. The regular corn will soon bear distinctive mosaic patterns along the leaves. The virus stunts young corn plants and reduces yields of mature plants.
“Right now there’s nothing farmers can do about viruses,” said Ron Meeusen, the company’s director of biotechnology. “There are a few somewhat resistant varieties, but otherwise they just take it on the chin.”
Meeusen and co-workers have devised a way to halt the virus by using gene splicing. They insert a gene that prevents the virus from moving through the plant and multiplying.
To create the virus-resistant corn, the company isolates a gene that prevents the virus from multiplying. Researchers force the gene into corn plant cells with an electric shock that forces cell membranes open. Or they shoot the virus-resistant gene inside the cell with a microscopic shotgun. Once transformed, the cells are grown into whole plants.
Another experiment is designed to foil the European corn borer, an insect that burrows into corn stalks and starts eating. The plant then drops its ears of corn and collapses.
Northrup King is creating a resistant plant using gene splicing. The plant ends up producing a bacterial protein that kills the borer without the use of insecticides.
In both cases, to test the transformed corn now growing in the field, researchers go out and inoculate it with diseases and pests.
But to prevent the genetically altered corn from escaping into the environment, researchers plant border rows that are designed to catch pollen. They also make sure that the field is far enough away from other cornfields to prevent contamination.
Both experiments have the approval of the U.S. Department of Agriculture, which regulates such releases under its Plant Pest Act or Plant Quarantine Act. Now, under state rules, Northrup King must also obtain state approval for future field experiments.
“When it comes to state regulations, we would have a very difficult time if we had to register 51 times, for 50 states and the federal government,” said Northrup’s Meeusen. “It ranges from almost unimaginably difficult to impossible. But we certainly recognize that states have the right to regulate within their borders. We have to work with them.”
Advocates of state regulation say the federal government is taking too much of a hands-off approach to biotechnology business. They say states have a right and a responsibility to protect public health by keeping tabs on what kinds of genetic engineering research are under way.
“The latest federal rules contain a Catch 22,” said Phyllis Kahn, a state legislator who was a key sponsor of the Minnesota law regulating biotechnology. “They say we won’t regulate anything unless it’s dangerous, but how do you know whether it’s dangerous unless you regulate it?
“We’re probably dealing with not so much the escape of killer corn, but the unwanted release of transmissible elements,” said Kahn, who has a doctorate in biophysics and molecular biology. “What if the gene that makes super-growing corn is transferred to a weed? We could get a super-growing thistle or dandelion.”
The debate over state regulation has mushroomed into a major business issue. Critics, including numerous scientists and businesses, say cumbersome and costly state regulation could drive biotechnology research out of the state altogether. Applicants will be asked to pay an estimated $5,000 to $15,000 to cover the cost of evaluating the application.
The state rules were passed too quickly, are subject to further revision and add bureaucracy without benefit, said Jeff Tate, secretary of the Minnesota Biotechnology Assn., a trade group.
“If state regulation is deemed necessary then there should be stable regulation so that companies know what to expect,” Tate said. “These rules are not stable.”
Nationwide, there are more than 100 genetically engineered products in the pipeline due to come to market by the middle of the decade. Companies planning production facilities in the Midwest may simply bypass Minnesota altogether, Tate said.
“We have on record more than 300 releases in the U.S.,” he said. “There is not one case where one behaved in an unpredicted way and posed risk to human health and safety. Yet people still cry wolf.”
Most genetically engineered farm and food research is supervised at the federal level by the Department of Agriculture, the FDA or the Environmental Protection Agency, sometimes with overlapping jurisdiction.
A no-new-regulations mood of the White House was clearly illustrated in May when the FDA announced that foods created with the tools of genetic engineering will be treated like any other foods.
The FDA will take a “risk-based” approach, scrutinizing products believed to be risky, rather than all genetically engineered foods.
For example, it might require a company selling corn containing a gene from a peanut plant to disclose that fact to protect people who are allergic to peanuts.
At the USDA, which has already issued more than 300 genetic engineering release permits throughout the country, the approach has been similar. No applications have yet been turned down.
But that does not mean the department is ignoring safety concerns of the states, according to John Payne, associate director of biotechnology, biologics and environmental protection at the USDA’s Animal and Plant Health Inspection Service.
Within 30 days of receiving an application, the USDA consults the affected states. “We ask for their advice and consent on that preliminary application and always respond to their comment before approving an application,” Payne said.
Many states, including California, have concluded that their existing rules are adequate to handle the new technologies of genetic engineering, he added.
But California’s approach is weak at best, said Michael Picker, West Coast director of the National Toxics Campaign Fund, part of a coalition of environmental groups monitoring the genetic engineering issue. The state’s interagency approach and reliance on federal oversight mean that many experiments simply fall through the cracks and are not monitored by the state at all, said Picker, based in Sacramento. “If anything, they’re rolling over and playing dead,” he said of state government.
Wes Ervin, the state’s biotechnology coordinator, has a different view. “We have delegated to federal agencies like EPA and FDA that they should be the people to protect our environment,” Ervin said. “If you don’t trust them that’s more a philosophical argument than a matter of science.”
Others feel that the government puts too much faith in the companies and universities conducting the research.
“The feds are saying ‘We’re regulating, but we’re not requiring that people inform us or supply us with information. We’re going to trust them to let us know if there is a danger.’ I don’t think that’s regulation, that’s a voluntary system,” said Margo Stark, a senior program associate with the Minnesota Food Assn., a citizens group.
Especially disturbing, Stark said, is the notion that federal rules may not require companies to label genetically engineered products as such, leaving consumers in the dark about what they are buying.
“This is a significantly more powerful technology than traditional agriculture,” Stark said. “You can put human genes into animals and plants. Conventional agriculture can’t do that.”
