Panel seeks simplified biotech rules


A proposal to develop regulations simplifying the approval of genetically engineered crops, pesticides and animals would mean less red tape for Maryland companies involved in genetic engineering.

In a report releasedyesterday by the White House Council on Competitiveness, headed by Vice President Dan Quayle, the panel urges regulators to evaluate products made through gene splicing just as they would treat comparable products made through traditional methods.

"I think it's important that we regulate according to product rather than process," said Rita Colwell, director of the Maryland Biotechnology Institute. "Whether it's genetically engineered, or selected to breed by classical techniques doesn't matter," she said.

The Institute, among other things, applies genetic engineering to marine plants and animals.

If adopted by government agencies, the recommendation could make it much easier for biotechnology companies to win approval for things like genetically engineered crops that resist pests or frost; "transgenic" hogs and cows that grow faster and microbes that break down sewage and toxic waste.

In essence, the report urges regulators to ignore the fact that such products are created through genetic engineering and to focus on a product's inherent characteristics.

For example, regulators looking at a new breed of pest-resistant tomato would look at the plant's likelihood of becoming an out-of-control weed and at any risk posed by a toxin the plant may give off in fighting insects. The fact that the tomato was produced through genetic engineering would be irrelevant.

"I would urge that our legislature maintain its very sensible approach to be kept informed, and to avoid regulation that would tie up the industry unnecessarily," Colwell said.

The report makes a number of other recommendations:

* Preservation of the Orphan Drug Act, which gives exclusive marketing rights to the first company that wins federal approval for a drug that is used to treat fewer than 200,000 patients annually. In the last year, a growing number of critics have complained that some "orphan" drugs have proved so lucrative that the exclusive rights have produced great profits for the companies.

* Support for a congressional proposal aimed at closing what some biotechnology companies have complained is a big loophole in the patent law. Under current law, an American company can obtain a patent covering genetically engineered cells that create valuable proteins, but foreign companies can use the novel cells abroad to create the protein and export it to the United States without fear of reprisal. The new proposal would extend patent protection for the protein and allow a company holding the patent to block imports.

* Consideration of a shift in federal funding for biotechnology research, away from medical and pharmaceutical work to agriculture, energy and environmental applications.

* Opposition to new legislative efforts in Congress to regulate biotechnology activities more closely.

Products made through biotechnology use genetic engineering to create new kinds of organisms that can serve useful purposes. In a process known as gene-splicing, a gene that stimulates the production of growth hormone, for example, can be inserted into the fertilized egg of an animal to create a new breed of animal that may grow more rapidly.

Companies are also inserting into bacteria genes that produce chemicals that kill particular insects. The bacteria then serve as tiny organic factories for the pesticide. Companies are also inserting genes directly into crop plants, hoping to develop more plant varieties that grow faster or resist pests more effectively.

At Hanover-based Crop Genetics International, a genetically engineered biopesticide designed to kill the European corn borer is currently being tested. Unlike conventional pesticides, which are sprayed on the surface of a plant, Crop Genetics' product uses a genetically altered microorganism that lives inside the plant.

The proposed policy already guides the Food and Drug Administration, which has approved a number of new genetically engineered drugs.

But change has been much slower at the Agriculture Department and the Environmental Protection Agency, which have been crafting proposed regulations since 1984 for genetically engineered products that will be released into the environment.

As a result, crop varieties and new pesticides that use genetically engineered microbes have been caught in a regulatory limbo.

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