Americans now have an opportunity to express their opinionabout whether produce modified through genetic engineeringshould be labeled. On Wednesday, the FDA requestedcomments on this issue in a notice in the Federal Register.

According to current FDA policy, promulgated last May, a"radical" change in a food item, affecting nutrition or safety,would have to be evaluated by the FDA prior to the productgoing to market, Brad Stone, an agency spokesman, toldBioWorld. Such changes might include a tomato with no vitaminC or a fruit containing an introduced allergen.

But the agency would rather not require labeling, partlybecause, as FDA Commissioner David Kessler stated last week incongressional testimony, most of biotechnology's additions tofood products would involve fats, proteins and carbohydratesthat are already in food. Hence, safety is not a problem.

The issue of what and how to label is extremely complex. Forexample, the Register asks, "Are there circumstances in which aconstituent that results from genetic engineering wouldconstitute an ingredient?" Or is there "a basis in science todifferentiate between constituents added by" different genetictechniques?

When FDA published its Food Biotechnology Statement in May1992, it received more than 3,300 comments, indicating thatconsumers have a wide variety of concerns. Some people, forexample, said they wish to avoid eating animal genes. However,at last week's hearing Kessler pointed out that such geneswould merely be copies of animal genes and not animalmaterial per se.

Like Kessler, most people in the biotechnology industry wouldrather not label genetically engineered produce. "I feel verystrongly that we have a pretty good regulatory system in thiscountry both through FDA and the (Environmental ProtectionAgency," said Jim Gramlich, president of the agriculturalresearch division of American Cyanamid Co. of Wayne, N.J. "Isee no reason to label process."

But Richard Godown, senior vice president of the IndustrialBiotechnology Association, welcomes the request for commentsbecause he believes public debate will lead to "the rightanswer," which he said "is not mandatory labeling." Godownfavors the premarket notification that FDA's Stone described(xxx).

Not everyone in the industry fears that labeling would drivecustomers from genetically engineered produce. Calgene Fresh,a subsidiary of Calgene Inc. of Davis, Calif., will voluntarilylabel its Flavr Savr tomato as an educational strategy, saidStephen Benoit, the company's vice president for marketing. "Itwill tell consumers why our tomato tastes better."

Calgene will thus avoid one of the prongs of Jeremy Rifkin'sPure Food Campaign. "We are identifying probably two majorsupermarket chains, and will ask people to write to the CEO toask that they not carry any genetically engineered food that'snot labeled," said Ted Howard, the campaign's executivedirector.

He added that the FDA can expect to be flooded with comments.Although only a week has passed since the campaign provided600 stores across the country with forms that consumers canfill out to support the campaign and receive more information,"we've received at least 10,000, and we haven't even heardfrom all the stores," said Howard. "We're going to send (thesepeople) a packet that will include four to five key activitiespeople can undertake. One will certainly be to write to FDA."

-- David C. Holzman Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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