January 29, 2004
Mad Cow Disease Raises Safety Issues Beyond the Kitchen
By DONALD G. McNEIL Jr.
The New York Times
Cows are everywhere, and they are not just for dinner anymore.
Their carcasses provide the glues that hold the human universe together, like the gelatin in Gummy Bears, the lipids in lipsticks, the foam in fire extinguishers and the rubber in tires.
With a few exceptions, public health experts say, there is little chance that these products will cause harm as a result of mad cow disease. Nonetheless, the rare exceptions are startling, like diet supplements containing raw cow brain.
On Monday, the Food and Drug Administration banned the use of dead or disabled cows in the products it regulates, as well as the use of brains, spinal cord, eyes and other high-risk parts from cows older than 30 months.
Based on a 1930 law giving it jurisdiction over cooked and canned food, the agency regulates a wide variety of products, including pizza toppings, diet pills and cosmetics.
The food agency was mirroring restrictions imposed on Dec. 30 by the Department of Agriculture, which believes that healthy animals younger than 30 months are safe.
Food-safety groups would prefer tighter restrictions, because the misfolded prion proteins believed to cause the disease have been found in a few animals under 2 years old. The European Union forbids all feeding of animal protein to farm animals.
Calculating the risk in rendered products is far more complicated than assessing it in meat.
A steak is simply grilled and eaten, while animal gelatin (it can be made from vegetables, too) involves treating bones, hides and hooves with acid, lime and heat, after which it may be dried, powdered, then become part of things like Jell-o shots and ibuprofen capsules. Cosmetics and shampoos can contain fatty oils or rendered placentas. Collagens are injected to fill wrinkles.
Prions can theoretically survive all processing steps, experts say, just as they can survive boiling, radiation or the high-pressure steam used on surgical instruments.
But there is little risk of absorbing them through the skin, and hooves, hides and fat are not highly infectious. Bone contains marrow, which may harbor prions, but the removal of the vertebrae of older cattle should lower the risk.
The food agency has continued to allow the use of meat skimmed off bones by wire brushes in soups, pizza toppings and such, assuming that the Agriculture Department's restrictions on removal of risky tissues are followed.
Dr. Murray M. Lumpkin, the F.D.A.'s principal associate commissioner, said most additives in everyday products carried little risk.
"You don't want to give people an idea that cosmetics are something you have to worry about," Dr. Lumpkin said. "They're not."
For pharmaceutical-grade gelatin, he said, his agency works with drug companies to ensure that it comes from disease-free herds. The World Health Organization says that gelatins and collagens prepared solely from hides or skins are safe.
Dr. Michael Hansen, an expert on prion diseases at Consumers Union, described an experiment in which material to be processed into gelatin was "spiked" with infected brain.
As it was processed, the concentrations "were knocked down considerably, but not down to zero," Dr. Hansen said. "So it could theoretically be a problem, but it's far down the risk hierarchy."
Cosmetics, including lipsticks, are safe, said Dr. Gerald McEwen, vice president for science of the Cosmetic, Toiletry and Fragrance Association, a trade group. By 1996, Dr. McEwen said, the industry stopped using raw ingredients made from herds that were not certified free of the disease or from high-risk parts of cattle.
The highest risk material the food agency oversees is probably "glandular" diet supplements, which may contain brains, adrenal and thyroid glands, pancreas, spleens or testicles.
For example, Health Genesis, a Florida company, sells 100-capsule bottles of bovine Brain Concentrate, promising "tissues processed at low temperature to insure rawness."
David, a salesman who would not give his last name or the name of the owner of Health Genesis, said, "This whole thing about mad cow disease is so new" and explained, "We assume it's safe because it's made available by the people who make it."
After telling a reporter that "there are people selling fried brains in Alabama," David insisted that the reporter call the manufacturer of the supplements, Rocky Fork Formulas of Newark, Ohio.
Ken Michaelis, who said he was "just the phone answerer" for Rocky Fork's president but who according to the company's Web site is one of the founders, said Rocky Fork did not make its own brain concentrate and who did was "privileged corporate information."
Mr. Michaelis said that he had not heard of Monday's F.D.A. ruling, but that he believed the concentrate was safe because "you can't get glandulars from countries with mad cow."
He could not name the country the brains came from, but said there were "tons of manufacturers," some domestic. Nor did Mr. Michaelis know how old the animals were or whether they were ever tested for
Mr. Michaelis said there was no test for prions (there are several) and insisted that "they've never been able to prove that mad cow is transmitted to humans" (health authorities emphatically disagree).