January 11, 2004 Newsday By Kathleen Kerr

While the FDA can't impose fines on companies that don't comply with rules that were set up in 1997 to help hold off the disease, the agency can seize products it believes are tainted, or shut down or prosecute noncompliant operations.

Steve Solomon, deputy director of the FDA's office of regional operations, said the letters are reserved for serious deviations from the rules, noting, "We prioritize based on risk. We would not have sent the warning letter if we did not consider it significant."

Since 1997, the agency has inspected 12,000 companies and found that most are in compliance with regulations that prohibit feeding certain protein products that can carry mad cow disease to animals such as cows and sheep that are hoofed, even-toed and have four-chambered stomachs.

One of the most prominent companies to receive a warning letter was Tyson Foods, the giant known for its meat products.

Tyson spokesman Gary Mickelson said last week that the company was warned in February 2002 that its Wallula, Wash., beef production plant hadn't properly labeled the ground-up animal kidneys, pancreases and livers that it made for use in pet food, failing to note explicitly that the product should not be fed to cattle or other ruminant animals.

Mickelson said the company initially appealed the warning because it believed the pet food was unlikely to be fed to cows. But later, he said, Tyson discontinued the appeal. "It was never really resolved," Mickelson said, noting that the company now uses the required labeling.

The U.S. concern about cattle food stems from the knowledge that feed containing mammalian proteins is believed to have been responsible for the mad cow outbreak in Britain that began in the mid-'80s.

Along with labeling problems, some FDA letters warned that some companies weren't properly cleaning equipment that was being used to process both feed that contained the proteins and feed that did not, opening up the possibility of contamination. Other companies that were cited failed to establish required cleanup procedures.

Currently, two companies that handle products used in animal food -- Ameri-Pac, Inc. of St. Joseph, Mo., and Halter Feed and Grain in Massillon, Ohio -- are out of compliance with the 1997 regulations because of labeling problems. But both told Newsday last week they have corrected the problems.

In the past, the FDA has faced criticism for failing to adequately enforce the 1997 regulation. In 2002, for instance, a report by the General Accounting Office found that the FDA did not act quickly enough after the feed rules were implemented to compel companies to keep the prohibited proteins out of cattle feed.

A GAO spokeswoman said Friday a follow-up report will be released later this year. Late last month, the FDA announced it had compliance frommore than 99 percent of feed operators in an aggressive effort to "vigorously enforce" the 1997 law.