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U.S. says gene-altered food won't need major testing Rules appear today; critics point to risks


WASHINGTON -- In a long-awaited policy statement, the federal government plans to announce that foods developed through biotechnology are not inherently dangerous and, except in rare cases, should not require extraordinary testing and regulation before going on the market.

Some critics of genetically engineered foods have argued that they pose new safety risks and that any containing new substances should go through the extensive testing required of new food additives. In addition, they say, any such food sold to the public should be labeled so that consumers can identify it.

Government officials have a different view. They say scientific evidence does not indicate that special precautions are warranted in most cases of gene-altered foods. The new policy holds that genetically engineered foods should be regulated just like ordinary ones unless they contain ingredients not usual for the product.

Officials of the federal Food and Drug Administration said the core of the policy was based on science and the principle that industry should have to consult the agency only on decidedly novel components of food before marketing a product.

The new policy statement was requested by the budding biotechnology industry, which has several types of genetically engineered produce almost ready for market.

According to the industry, more than a dozen companies in the United States have developed a total of almost 70 different crops, including cucumbers, potatoes and cantaloupes, that contain new proteins, enzymes or other substances that enhance their quality.

Genetic technology holds the promise of producing foods that are more nutritious, tastier and longer-lasting while requiring less fertilizer and pesticide.

One of the first of the new products consumers are likely to see is a tomato developed by Calgene Inc. of Davis, Calif., that is endowed with an extra gene that confers a longer shelf life by delaying excessive ripening.

Last November, Calgene became the first company to ask voluntarily for the federal agency to evaluate a genetically altered food.

"The industry has asked the FDA for a policy because it wants to say to the public that the FDA knows these products and stands by their safety," said a senior agency official who spoke on condition that he not be identified. "Industry wants the policy to help with product acceptability and, to an extent, for liability protection. It helps to say you are in compliance with government regulations."

Special circumstances that would require testing and regulation before a product goes on the market are outlined in the new policy. Special review would be required only when specific safety issues were raised; for example, if the gene for peanut protein, to which some people are allergic, is inserted into a tomato.

The debate over genetically engineered foods has continued for more than a decade. But many of the initial concerns raised by critics now seem less formidable and, after extensive discussion, a consensus has developed in favor of moving ahead with the technology, although with appropriate precautions.

The federal agency's policy, which would go into effect when when published in the Federal Register, was spurred by the president's Council on Competitiveness, a group headed by Vice President Dan Quayle that is charged with reducing regulations that it believes hamper U.S. industry.

Other genetically altered food products, like livestock, fish and poultry, will be regulated by the Agriculture Department, while the Environmental Protection Agency will review items like genetically engineered pesticides and disease-resistant plants.

Uncertainty over how the government might regulate the products is one of the last hurdles keeping the U.S. biotechnology industry from releasing a flood of food and plant products and maintaining its lead over international rivals in the field, the White House official said.

The agency's policy would not require special labeling of foods produced through genetic manipulation unless, as with other food additives, the result is a change in a characteristic of the food that is noticeably different from what the consumer would expect, an FDA official said.

Critics of genetically engineered foods said they opposed any policy that did not require extensive, pre-market testing of each new food and labeling to tell consumers what they were getting.

Dr. Rebecca Goldburg of the Environmental Defense Fund said the FDA policy was virtually abandoning regulation of new and untested foods.

"Genetic engineers are taking genes from bacteria, viruses and insects and adding them to fruits, grains and vegetables," Dr. Goldburg said. "They are producing foods that have never before been eaten by human beings."

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