WASHINGTON -- Having decided in March that bovinesomatotropin (BST) is safe, the FDA's veterinary medicinecommittee, with its food committee, on Thursday turned itsattention to whether milk from cows that have been given thehormone should be labeled.

"The agency has stated, 'Whether information is material ...depends not on the abstract worth of the information, but onwhether consumers view such information as important," saidLucy Russell, the FDA's assistant chief counsel for foods.

But "not all material facts are required to be disclosed," Russellsaid. "In the food context, the agency has expressed concernthat requiring warnings for ingredients that cause only mildidiosyncratic responses would overexpose consumers towarnings and decrease their effectiveness."

At Thursday's hearing, 58 witnesses told the committees whymilk from cows given the growth hormone should or should notbe labeled. Among those opposing a labeling requirement wererepresentatives from Monsanto Corp., which manufactures BST,and at least 11 food and livestock-related trade associations,such as the National Pork Producers Council and theInternational Dairy Foods Association. On the opposite side ofthe debate were at least 13 consumer groups, including Dumpthe National Dairy Board and a handful of small foodmanufacturers and chefs, including Ben Cohen of Ben & Jerry'sice cream.

Holding such a hearing was "unprecedented," FDACommissioner David Kessler told BioWorld. Also unprecedentedis the amount of attention Kessler has paid to this issue. Heattended the entire hearing in March and was present onThursday until mid-afternoon. The committees will continue tohear arguments today.

Although the Joint Food and Veterinary Medicine AdvisoryCommittee has already dealt with health and safety issues,Kessler asked the members to consider these issues once again,along with labeling.

The final decision, which may come today, would normally bemade by the head of the committee, Gerald Guest. But Guestsaid at the March hearing that Kessler would make the rulinghimself.

One source told BioWorld on Thursday that Kessler is walking afine line between his sympathy for consumer groups whooppose the drug and insist on labeling, and the politics of thesituation, which are stacked against them. Only one veterinarycommittee member voted against approval in March, and onlyfour food committee members have consumer backgrounds, thesource told BioWorld. At least 29 of the 30 members of theJoint Committee were present on Thursday.

The precedent for labeling a safe food purely for theinformational benefit of consumers is the National OrganicProduction Act, which was passed under the 1990 farm bill,Joan Gussow, a member of the Food Committee and a consumeractivist, told BioWorld.

However, Andrew Kimbrell, legal counsel for the Coalition forResponsible Technology in Madison, Wisc., said his group hasalready submitted a petition with more than 3,000 signaturesto FDA under the federal Food, Drug and Cosmetic Act torequire labeling. He argued that labeling for food irradiation --required because more than 80 percent of comments on theissue had urged it and because the method changesorganoleptic properties of foods -- was a valid precedent forlabeling BST. He warned that his organization would file alawsuit if labeling is not required.

The biotechnology trade organization has opposed labelingbecause "labeling would set a bad precedent for the biotechindustry," said Richard Godown, senior vice president of theIndustrial Biotechnology Association. It would constitutedecision-making by economic and political criteria, rather thanscientific, he told BioWorld.

"Eleven consumer surveys ... have consistently shown thatconsumers would prefer milk from untreated cows," saidMichael Hansen, research associate for Consumer PolicyInstitute of Consumers Union. And in five studies that raisedthe question, consumers favored labeling by margins rangingfrom 68 percent in a University of Wisconsin survey to 95percent in a survey by the University of Missouri and 98percent in one done by Johanna Dairy.

-- David C. Holzman Washington Editor

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

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