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Oversight on Bioengineered Crops Is Poor, Report Says

By Rick Weiss
Washington Post Staff Writer
Thursday, December 16, 2004; Page A09

Federal oversight of crops genetically engineered to produce medications in their seeds and leaves is inadequate to prevent unwanted contamination of food crops, according to an analysis released yesterday by a scientific advocacy group. As a result, the report concludes, consumers are at risk of inadvertently dosing themselves with prescription drugs while eating a morning bowl of cereal.

The report, which biotech executives and regulators denounced as overwrought, is the latest to look at the small but rapidly growing "pharma" sector of agriculture, in which corn, soybeans and other plants are being designed to produce high-tech drugs or industrial compounds in their tissues.

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The approach has many advantages over traditional systems for manufacturing those products, including potential cost savings, the report concludes. But it also raises the specter of accidental contamination of the food supply with blood thinners, hormones or any of the scores of biologically active compounds being made experimentally in plants.

"No one -- not consumers, not food companies, not biotech companies -- wants to discover drugs in our cornflakes," said Margaret Mellon of the Union of Concerned Scientists (UCS), a group long critical of the federal regulatory scheme for agricultural biotechnology.

The group commissioned six independent experts in the fields of agronomy, entomology and ecology to conduct an analysis of the fledgling industry, which makes a few chemicals for industrial uses and an array of drugs, none of which is yet approved for marketing. The analysis concluded that significant changes are needed in the way the Agriculture Department oversees the cultivation of such plants if the risk of contamination is to be brought close to zero.

"Genes can move in pollen by wind or insects. Seeds can get stuck in machinery or mixed in storage and transportation systems. There are very many routes of vulnerability," panel chairman David Andow of the University of Minnesota said yesterday in a telephone news conference timed to coincide with release of the report, "A Growing Concern: Protecting the Food Supply in an Era of Pharmaceutical and Industrial Crops."

The expert panel -- which Andow said operated independently of the UCS -- recommended that any one of three approaches be taken: Grow pharma crops in geographically isolated parts of the country; set up a harvest, storage and processing system completely separate from the existing network of farm equipment, silos and other facilities used to grow and store food crops; or ban all outdoor cultivation of food crops engineered to make medications or chemicals -- a move that would require companies to switch to less familiar plant species for their pharma experiments.

The UCS called for such a ban yesterday, saying it is unrealistic to think that any other system could prevent cross-contamination.

History shows that genetic isolation of crops is a challenge. In 2002, for example, ProdiGene Inc. botched efforts to contain a pig vaccine it was developing in corn. With contamination of field corn and soybeans suspected, large quantities of those crops had to be burned, and the USDA began to develop new rules.

In March 2003, those rules went into effect. They require larger buffer zones around pharma fields to decrease the odds that gene-altered pollen will drift onto conventional crops; dedicated farm equipment to make sure altered seeds and other plant parts do not get mixed with food crops; a sevenfold increase in federal inspections of experimental fields; and other restrictions.

Those safeguards are "absolutely" adequate, said Cindy J. Smith, deputy administrator of biotechnology regulation for the USDA's Animal and Plant Health Inspection Service, which oversees pharma crops. Smith noted there were only 44 acres devoted to U.S. field trials of such crops this year.

The guidelines are "very stringent" said Lisa Dry, a spokeswoman for the Biotechnology Industry Organization. "This is not some cavalier, 'Let's grow some duckweed and make some drugs!' "

Andrew Baum, president and chief executive of SemBioSys Genetics Inc., a Calgary-based pharma crop company growing drugs in safflower, said food crops are ideal for the new science because their biology is so well understood. He said he opposes a ban but welcomes governmental oversight, if nothing else, to allay the emerging business sector's liability concerns.

"We realize that if we screw this up, we're out of business," Baum said. "We want regulation, and we want it visible. I mean, bring it on."

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