Group says biotech monitoring insufficient
By Paul Elias
Associated Press
SAN FRANCISCO — Federal regulators aren't equipped to monitor the effects of approved genetically engineered products on human health and the environment, a nonpartisan research group warned yesterday.
The Pew Initiative on Food and Biotechnology said there's no evidence that genetically engineered products have caused harm. But Pew warns that the regulatory system will be further challenged because more genetically engineered products are expected to be approved in the near future and there's scant oversight once products reach the market.
The Washington, D.C.-based Pew Initiative's 128-page report concluded there are "unresolved questions about the government's proper role in addressing issues that arise after products are in the marketplace."
Soy, corn, canola and cotton are the only four approved biotechnology crops grown widely in the United States. But thousands of experimental crops are being grown, including plants engineered with human genes to produce medicines.
The Pew report pointed to two recent biotech mishaps as cause for concern.
In 2000, it was discovered that StarLink corn, an engineered product not approved for human consumption, was mixed with regular corn in a number of cases.
Last year, Prodigene Inc. was caught mixing corn genetically engineered to be a drug with soy beans meant for the food supply.
"Our analysis casts doubt on the preparedness of the current postmarket oversight program to achieve its traditional objectives, including the enforcement of regulatory restrictions and the detection and correction of unanticipated health or environmental problems," Michael Taylor and Jody Tick wrote in the report.
Federal regulators concede that most of their biotechnology oversight occurs before products are approved for market. They argue that their pre-approval review is rigorous and, once approved, a product is presumed safe.
"We feel confident that once we complete our review and approval, that those foods are safe," said James Maryanski, biotech coordinator at the Food and Drug Administration. "That continues to be our assessment."
Maryanski said no health problems have been associated with biotech food. He also said the FDA continues to examine its biotechnology review process, especially as it relates to plants genetically engineered to grow pharmaceuticals.
At the U.S. Department Agriculture, which regulates all biotech crops grown in the United States, officials said they are in the middle of an extensive analysis of how to monitor engineered plants. A National Academies of Sciences committee already has raised similar concerns voiced in the Pew report, said the USDA's top biotech regulator, Cathy Smith.
"We continue to evolve our regulations," Smith said.
While some biotechnology critics argued yesterday that the Pew report didn't criticize regulators enough, the lobbying outfit for the biotechnology industry said proper regulation is already in place.
"The report raises a non-issue," said Lisa Dry, a spokeswoman for the Biotechnology Industry Organization. "The federal agencies have all the statutory authority they need, and they give these products stringent scrutiny before they go to market."
Dry also said regulators have the power to recall approved products that may be found to be harmful.
The topic is of interest in Hawai'i. Earlier this week, the Environmental Protection Agency announced it had fined Pioneer Hi-Bred operations on Kauai'i $72,000 for failing to immediately report a false-alarm test that showed genetically modified corn pollen had possibly contaminated other plants at Pioneer's Waimea Research Station.
It was the second fine for Pioneer Hi-Bred's genetically modified plant research site on Kaua'i.
The USDA has also begun an investigation into an unrelated case of genetic contamination at a nearby plot of Pioneer research corn.
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