Worried about the inadvertent spread of new bioengineered plants that produce drugs and chemicals, the Agriculture Department said it would revise rules and study whether to adopt a risk-based system to protect the environment and food supply.
Agriculture Secretary Ann Veneman said her agency is doing environmental studies as a first step toward revamping controls over biotech products. Federal regulators must try to anticipate and keep pace with the rapidly evolving science behind biotech crops, she said.
“Our regulatory system must be both rigorous and flexible and based on sound science principles and mitigation of risks,” Veneman said Thursday.
The agency aims to protect conventional plants and to ease requirements for monitoring long-term environmental effects of genetically engineered plants. The department issued a statement saying it also may use the process for allowing products onto the market “to provide flexibility for long-term monitoring.”
The changes could affect millions of acres of future crops of genetically engineered corn, cotton, soybeans and canola. Experts expect the changes will make it more difficult for companies to get approval for plants that pose a high risk to the environment and human health.
Potential impact areas
The new regulations likely will have the biggest effect on companies that genetically engineer plants to contain drugs or industrial products, said Martina Newell-McGloughlin, director of a University of California biotech research program, based in Davis. No such products are on the market yet.
They probably wouldn’t apply to crops already approved, such as the widely used biotech corn variety, Bt, that contains a built-in insecticide, she said.
A risk-based system could mean that permits would be issued based on the level of risk that plant traits could be spread inadvertently to conventional plants, said Newell-McGloughlin.
“The more risky, the more hoops you have to go through; the less risky, the less hoops,” she said.
The department, which has regulated biotech crops since 1987, said its regulations have ensured the safe field testing of more than 10,000 genetically engineered crops. It has allowed more than 60 such products to go onto the market.
This week, however, a National Research Council panel advised that more controls are needed on genetic engineering of animals and plants. It said current ones are inadequate to protect the environment and wildlife — particularly transgenic fish, shellfish, trees, grasses and microbes — from contamination.
How tight to regulate?
The latest studies could prompt the government to allow some biotech crops into the environment without regulation and to ease controls on genetically engineered insects, said Joseph Mendelson, legal director for the Center for Food Safety, an anti-biotech group.
“That doesn’t solve the problem of either crops that have already been commercialized without a full environmental review or are currently in the pipeline,” said Mendelson, whose group has pushed for more government studies on genetically engineered grasses, pharmaceuticals and wheat designed to tolerate a widely used herbicide.
“They’re going to create a situation where they approve a plant for commercial use that still has risks that haven’t been fully analyzed. To me, that’s a loosening regulation,” he said.
Brian Milberg, public policy director of the National Corn Growers Association, a trade group, said the current standards prevent the spread of biotech traits from plants grown to produce drugs.
But he said the new rules open the possibility of easing controls on biotech plants that pose a low risk of spreading traits.
Last year, the department told the biotech industry it would increase inspections of crops that have been genetically engineered to make medicine and chemicals as part of an effort to protect food crops from contamination.
The USDA is taking public comments through March 23 via [email protected]. Comments must be in the body of the mail, not attached. Background is online at www.aphis.usda.gov/lpa/issues/biotechcomp/biotechcomp.html.
