
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: SATURDAY, November 6, 1993                   TAG: 9311060068
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-10   EDITION: METRO 
SOURCE: Associated Press
DATELINE: WASHINGTON                                LENGTH: Medium

HORMONE TO INCREASE MILK OUTPUT GETS FDA OK

The Food and Drug Administration approved a genetically engineered hormone Friday to increase the milk output of cows. It declined to require labels for food from animals treated with the product, saying the milk and meat would be safe to consume.

Saying it could find no threat to human or animal health, the agency gave St. Louis-based Monsanto Co. permission to market recombinant bovine somatotropin, or BST, ending a nine-year application process.

However, a 90-day moratorium imposed by Congress at the urging of Sen. Russell Feingold, D-Wis., means dairy farmers won't immediately be using the genetic copy of a hormone that naturally occurs in cattle.

The delay will give the White House Office of Management and Budget time to study the impact of increased production on dairy farmers, some of whom complain use of the hormone could drive them out of business.

It was the first time the FDA has decided such a matter, but others are bound to follow as foods containing bioengineered ingredients trickle into the market.

The agency is expected to decide soon whether to approve the Flavr Savr tomato, developed by Calgene Inc. The tomato, altered so it stays ripe longer, is the first whole, genetically altered food.

BST is different, because it enhances production and does not change the makeup of the milk.

The budget office study also will examine the possibility that consumers would reject milk, butter, cheese, ice cream or ground beef if they knew cows might be treated with the hormone.

But in announcing approval, the FDA commissioner, Dr. David Kessler, said "the public can be confident that milk and meat from BST-treated cows is safe to consume." Kessler called BST "one of the most extensively studied animal drug products to be reviewed by the agency."

"There is virtually no difference in milk from treated and untreated cows," said Kessler, explaining why the agency declined to require labeling. "In fact, it's not possible using current scientific techniques to tell them apart."

The genetically engineered product increases milk output by supplementing a cow's natural BST, a hormone produced by the pituitary gland. Milk from treated cows has been found to have the same nutritional value and composition as milk from untreated cows, FDA said.

In announcing approval, the FDA noted from clinical trials that treated cows have a slight increase in mastitis, or infected udders. Opponents said that would raise the risk that antibiotics used to treat the infections would find their way into milk. That, they argued, would pose a risk to people with allergies to antibiotics and encourage the development of antibiotic-resistant illnesses in humans.

by CNB