By Kim Coghill

Washington Editor

WASHINGTON - Under a new rule proposed by the FDA, biotechnology companies would be required to notify the government before marketing genetically engineered food or animal feed.

Currently, such product developers voluntarily consult with the government and to date, according to the FDA, all food and feed marketed in the U.S. has gone through a consultation process.

"These measures will permit the review process to be more transparent to the public, one of the primary issues voiced during the FDA's public hearings on this issue," Jane Henney, commissioner of the FDA, said in a prepared statement.

The Washington-based Biotechnology Industry Organization released a statement in agreement with the proposed regulation, saying it is another milestone toward maintaining consumer confidence in biotechnology as an essential tool in modern food production.

"Just over a year ago, BIO, consumer groups and other interested parties participated in three public meetings to provide the Food and Drug Administration with suggestions to bolster consumer confidence in biotechnology and provide greater understanding of how biotech foods are created, regulated and labeled," Carl Feldbaum, BIO's president, said in a statement.

"The increased openness and accountability that will flow from the changes the FDA announced today provide renewed grounds for the confidence American consumers have in our food supply and the regulatory system to ensure its safety," Feldbaum said. "The U.S. regulatory system is a model around the world because it is grounded in science, not superstition or uniformed emotion."

In a separate action Wednesday, the FDA issued a draft guidance document to provide direction to manufacturers that want to voluntarily label their food products as being made with or without ingredients developed through biotechnology. The guidance will assist manufacturers in ensuring that their labeling is truthful and not misleading, the FDA said.

In a news release, the National Food Processors Association (NFPA) called both proposed rules "the right decision."

"We agree with the FDA that criteria are needed for ensuring that any label claims for 'biotech' or 'biotech-free' products are truthful and non-misleading for consumers," Rhona Applebaum, NFPA's executive vice president of scientific and regulatory affairs, said in a prepared statement. "We believe it is essential that mandatory labeling be reserved for information that is material - that is, information that goes to the safety, health, composition or nutritional value of the food."

The Grocery Manufacturers of America (GMA) also released a statement in agreement with both proposed rules, and said they are a victory for consumers.

Lisa Katic, a registered dietitian and director of scientific and nutrition policy for GMA, said there is still a need to educate the public about the science behind and the benefits that will be achieved through biotechnology. "To ensure that the public continues to support biotechnology, an education effort must be done through a cooperative effort among the business community, government, academia and consumer groups."

Written comments on the proposed rule to require premarket notification may be submitted by March 28 to Dockets Management Branch (HFA-305); Food and Drug Administration; 5630 Fishers Lane; Room 1061; Rockville, MD 20852.

Comments on the collection provisions should be mailed no later than Feb. 12 to the Office of Information and Regulatory Affairs; OMB; New Executive Office Building; 724 17th St. NW; Room 10235; Washington, DC 20503; Attn: Desk Officer for FDA.