FDA Attempts to Rein in Cow Products

WASHINGTON, Jan 26, 2004 (United Press International via COMTEX) -- The Food and Drug Administration said Monday it intends to reinforce animal feed regulations to prevent the spread of mad cow disease in U.S. cattle.

In particular, the agency is banning the use of cattle blood and blood products in all animal feed, but particularly in cattle feed. This action comes as new research suggests bovine spongiform encephalopathy -- also known as mad cow disease -- might be transmitted via blood.

At a late afternoon news briefing, FDA commissioner Dr. Mark McClelland said the agency will publish new regulations intended to "strengthen a series of firewalls designed to protect Americans" from BSE.

The firewalls, McClelland said, include controls on imported animals and animal products and surveillance of the U.S. cattle population for the presence of BSEs. The latter, he said, led to finding the first mad-cow-infected animal in America -- a cow in Washington state that apparently was imported from Canada.

The third firewall, and the subject of the new regulations, is FDA's 1997 animal feed ban, which prohibits feeding of most animal protein to cows, sheep and goats. The fourth firewall, which was announced recently by the U.S. Department of Agriculture -- after protests were lodged by consumer and public health advocacy groups -- involves banning cattle tissues from the human food supply if they are known to be at high risk for carrying the agent of BSE.

In addition, McClelland explained, both the FDA and USDA are engaged in response planning to contain the spread of tissues from any BSE-positive animal. This contingency response plan, which had been developed over the past several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.

The new regulations will ban a range of cattle-derived material from human food -- including dietary supplements -- and cosmetics "so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates," Health and Human Services secretary Tommy Thompson said in a statement.

"We are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle," McClelland said. "FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we intend to increase our enforcement efforts to assure compliance with our enhanced regulations."

FDA's new rules -- issued on an interim basis, with opportunities later for public comment and revisions -- will ban the following materials from FDA-regulated human food, dietary supplements and cosmetics:

-- Any material from so-called downer cattle, defined as animals that cannot walk;

-- Any material from cattle that died before reaching the slaughter plant;

-- So-called specified risk materials, or SRMs, known to harbor the highest concentrations of prions, the malformed proteins thought to be the cause of BSE -- including brains, skulls, eyes and spinal cords of cattle 30 months or older, as well as a portion of the small intestine and tonsils from all cattle, regardless of their age or health, and

-- Mechanically separated beef, which was shown during the mad cow outbreak in England in the 1980s and '90s as a potential carrier of SRMs.

In addition, along with banning blood and blood products from cattle feed, McClelland said the FDA will ban the use of poultry litter as a cattle feed ingredient. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter collected from poultry confinement areas. The material has been used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other.

John Taylor, of FDA's Office of Regulatory Affairs, explained that poultry feed is allowed legally to contain cattle meat and bone meal, which is prohibited from being fed to cattle. He said the concern is spillage of poultry feed in the chicken house that could end up back as cattle feed.

Another rule will ban human plate waste as a cattle feed ingredient. Plate waste consists of uneaten meat and other meat scraps currently collected from some large restaurant operations and rendered into meat and bone meal for animals.

"The use of 'plate waste' confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the agency's ability to fully enforce the animal feed rule," the agency said in a statement.

Last, the FDA will require equipment, facilities or production lines to be confined to serving non-cattle feeds if they use protein that is prohibited from being fed to cattle. At present, McClelland said, facilities process or handle both prohibited and non-prohibited materials and make both cattle and non-cattle feed, which could lead to cross-contamination.

Taylor said FDA intends to step up its inspection procedures in 2004. By itself, the agency will conduct 2,800 inspections and will fund 3,100 contract inspections of feed mills, renderers and other firms that handle animal feed and feed ingredients via state regulatory agencies. He said FDA will also receive data on 700 additional inspections, for a total of 3,800 in the coming year, which should cover 100 percent of known renderers and feed mills that process products prohibited in cattle feed.

"These steps represent the strictest system ever to monitor whether BSE products enter this country," Taylor told reporters.

"FDA waited more than a month after the discovery of the first US mad cow to take today's action," said John Stauber, executive director of the Center for Media and Democracy in Madison, Wis., and co-author of "Mad Cow USA" (Common Courage Press, 1997).

"The steps announced today should have been taken years ago and they still fall far short of what is needed," Stauber told United Press International. "The United States should follow the lead of the EU nations by banning all feeding of slaughterhouse waste to livestock, and testing millions of U.S. cattle for mad cow disease. Anything less is still too little, and way too late."

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Phil Berardelli is UPI's Science & Technology Editor. E-mail sciencemail@upi.com

Copyright 2004 by United Press International.