U.S. easing regulations on biotech Environmentalists say move is risky


In an attempt to ease rules for biotechnology companies, the Bush administration said yesterday that federal agencies should regulate only new products that could pose a substantial risk to the public health or environment.

Environmentalists expressed concern that the ultimate effect might be to allow genetically altered organisms into the environment without controls, but federal officials said they will retain their legal authority to ensure that products are safe.

In the past, companies trying to get approval to marketany genetically modified product were required to go through a lengthy testing process. Under the new policy, federal agencies would not assume a product is unsafe and needs review.

President Bush, in announcing the easing of regulations, said yesterday that the $4 billion biotechnology industry could grow to a $50 billion industry in a decade "if we let it. The rewards we will reap include new medicines, safer ways to clean up hazardous wastes and a revolution for agriculture."

Biotechnology companies use genetically altered organisms to create new products, such as disease-resistant tomatoes, corn plants that resist pests or fast-growing fish.

"You can use genetic engineering to create thousands of organisms unlike any in nature," said Margaret Mellon, director of the biotechnology policy center at the National Wildlife Federation in Washington. "We risk them doing something we don't want them to do."


Environmentalists argue that the release of these geneti

cally engineered crops or animals could have environmental or health risks, but many companies complain that the process of getting a product to market is burdened by lengthy and unnecessary safety reviews.

The new policy "is nothing different from what we have been saying to the various agencies for the last seven or eight years," said Alan Goldhammer, director of technical affairs for the Industrial Biotechnology Association, a trade group. "We have argued that they ought to look at the risk of the products."

But Mr. Goldhammer said it is difficult to say what the effect might be on the industry until the Food and Drug Administration and the Environmental Protection Agency issue proposed regulations.

In writing the new regulations, the White House said, the agencies should look at whether a product poses a significant risk and not simply that it is a new technology.

"The thrust is that the technology ought to be lightly regulated," Dr. Mellon said. However, she added that the policy is only advisory.

In addition, she said, the document "on its face leaves lots of wiggle room for the agencies . . . and it has broken a five-year log jam on the issuance of regulation . . . which is good."

Hank Habicht, the Environmental Protection Agency deputy administrator, said the new policy "is not so much a question of less protective or more protective . . . . The real benefit is that it clarifies the rules of the game."

He said the agency is comfortable that it retains regulatory authority over these new technologies while allowing companies get potentially beneficial products to market before investors give up.

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