The proposed rules come in the wake of a series of recalls in the United States and other countries that were triggered by the discovery of StarLink, a bio-engineered form of corn not approved for human use, in products on supermarket shelves.
Under the proposed regulations, to be published in the federal register on Thursday, companies would have to notify the FDA of new biotech products at least four months before they are to be put on the market.
Companies now are not required to have the FDA review new biotech crops, although most do so voluntarily.
The rules address "what is of most concern to consumers that is making our process more open and transparent and making it mandatory," said FDA Administrator Jane Henney.
But consumer advocates say under the new rules, the FDA gives biotech companies too much latitude, accepting their scientific data rather than testing GM food itself.
Carol Tucker Foreman, director of the Consumer Federation of America's Food Policy Institute, said that under the proposed regulations, "The company asserts that the product is safe, and the FDA accepts that assertion."
"Well, of course the company thinks their product is safe," Foreman said.
Henney says it doesn't make sense for the government to do testing when it considers genetically altered crops to be the same as regular food a policy position the FDA has held since the first Bush administration that was upheld by a federal judge last fall.
"We didn't hear any scientific evidence brought forward that would cause us to think that any products that we have approved are unsafe," she said.
Biotech and food companies, hoping to head off more stringent regulation, had asked for the new review policy and labeling guidelines. The companies say further regulation is unnecessary and are concerned that mandatory labeling of gene-altered products could raise unnecessary public fears about the foods and strangle the industry.
Under the new rules, scientific descriptions of the new products, including information about genetic modification and the potential to cause allergic reactions, would be posted on the Internet during the agency's review. Some of the data could be kept confidential if companies show FDA the information involves trade secrets.
The FDA also proposed voluntary guidelines Wednesday for food companies to follow if they label foods as biotech-free or promote biotech ingredients.
"The increased openness and accountability that will flow from the changes FDA announced today provide renewed grounds for the confidence American consumers have in our food supply and the regulatory system to ensure its safety," said Carl Feldbaum, president of the Biotechnology Industry Organization.
Consumer advocates said industry had too much influence over the rules.
"It's clear the FDA has bent over backwards to placate the biotech industry and has done so at the expense of the American consumer," said Joe Mendelson, legal director of the Center for Food Safety.
Consumer groups are now setting their sights on Congress, hoping for a law to force testing and labels.
Genetic engineering in agriculture involves splicing a gene from one organism, such as a bacterium, into a plant or animal to confer certain traits, such as drought tolerance or insect resistance in the case of plants.
Genetically engineered varieties of soybeans and corn became popular with farmers in the late 1990s and are found in products throughout supermarkets. Monsanto Co. has created a herbicide-resistant wheat that is expected to come on the market as early as 2003. Biotech varieties of fruit, rice, vegetables, fish and livestock are in various stages of development.
According to the Union of Concerned Scientists, American farmers are allowed to use biologically-altered seed for corn, cotton, soybeans, sugarbeet, flax, papaya, potato, squash and tomato.
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