By Lisa Seachrist

Washington Editor

WASHINGTON - The FDA unveiled on Wednesday its plan to regulate foods created with the aid of biotechnology. The initiative largely formalizes a consultation process that has been voluntary to date.

The proposal calls for developers of bioengineered foods and animal feeds to notify the FDA four months before they intend to market such products. The agency also will require that specific information be submitted with that notification in order to assess safety, labeling or adulteration issues.

Noting that nearly all companies comply with the voluntary process, food and biotechnology industry representatives praised the new rules, not because they would offer increased safety, but because they would bolster consumer confidence in biotech foods.

"Every member company we work with has been through this premarket process," said Lisa Dry, communications director for the Biotechnology Industry Organization (BIO). "We don't really think the regulations are necessary, but if it to any degree helps to increase public confidence in biotech foods, that's important."

The FDA hasn't yet announced the exact type of information that food developers would be required to submit to the agency. However, it has said it intends to make all submitted information - with the exception of trade secrets - and the agency's conclusions available to the public via an FDA web site.

Dry noted BIO, in collaboration with the Council of Biotechnology Information, already has been posting safety information for agricultural biotechnology products on its web site, http://www.whybiotech.com.

"We feel in order for consensus to be reached, people need to have easy access to this information," Dry said.

In addition to creating a web site, the FDA will augment its food and veterinary medicine advisory committees by adding scientists with agricultural biotechnology expertise. The agency also announced its intention to draft labeling guidelines for manufacturers who wish to label their foods as being made with or without the use of bioengineered ingredients.

This proposal, in particular, has earned high praise from food industry representatives. Much of the current debate over labeling for bioengineered foods centers on people who don't want to consume such products and want to know which foods are bioengineered. Timothy Willard, spokesman for the National Food Processors Association in Washington, said the labeling move recognizes public sentiment over biotech foods may change.

"You need to make sure people are making truthful and non-misleading claims with their labels," Willard said. "Right now, people think the only thing you would want to say is a product is biotech-free. But, down the road, if there is a benefit for a particular food produced with biotechnology, we may want to inform people about that."

For example, should food developers use biotechnology to create allergen-free peanuts, it is likely the producer would want to put that on the label.

Brian Sansoni, spokesman for the Grocery Manufacturers of America, agreed with Willard's assessment and noted the regulatory process needs to be as transparent as possible.

"By making the process transparent it will help end the mistrust of bioengineered food products," Sansoni said. "And it should be no major problem for manufacturers making this process more transparent."

While industry largely praised FDA's plan, some members of Congress took issue with it. In a statement, Sen. Barbara Boxer (D-Calif.) called the voluntary labeling guidelines "hollow" because it leaves the decision to label the foods up to the manufacturers, most of whom have chosen not to label.

Rep. Dennis Kucinich (D-Ohio), who introduced a bill that would require labels on biofoods, called the agency's proposal inadequate and an attempt to deflect the concerns of consumers.

BIO, GMA, and NFPA all oppose such plans because they may give the impression biofoods are less safe than conventionally produced foods.

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