Officials: Mad Cow Risk in U.S. Very Low

N E W   Y O R K, Jan. 19, 2001 -- How do you know if the steak you are eating is free of mad cowdisease?

Did you ever wonder about the safety of those “glandular” supplements from bovine sources you’re buying off the Web to "beef up" your internal organs?

Are you sure that hepatitis vaccine you took recently does not contain any mad cow proteins?

What about the blood transfusion you recently had, which may have blood mixed in from Europeans?

So far, none of these products or medicines has been contaminated with mad cow disease in the United States. But government officials and public health experts believe all these areas bear close watching, as they are potential entry points for mad cow disease, if current rules and regulations aren’t constantly updated and monitored.

As every day brings more news from Europe about mad cow disease — with Italy reporting its first confirmed case of an infected cow this week from a slaughterhouse that supplies McDonalds, Spain reporting two new cases in cattle this week, and parts of England delaying tonsillectomies to wait for new surgical instruments to prevent human transmission of the disease — Americans are wondering more and more: Are we next?

Federal officials assure us the chance of getting mad cow disease in this country is extremely low, even with some recently exposed potential problems in U.S. livestock feed and human vaccines. But the risk is not zero, as scientists continue to grapple with the food supply, the blood supply, nutritional supplements, among other possible sources.

“I assure my nieces and nephews that it’s perfectly safe to eathamburgers and meat,” says Linda Detwiler, senior staff veterinarian with the Animal Plant Health Inspection Service of the U.S. Department of Agriculture. “But there is always more we can be doing.”

Food and Drug Administration Hearing

The Food and Drug Administration is holding a public hearingtoday to discuss whether it should further limit who candonate blood or organs in this country, based upon donors’ potentialexposure to transmissible spongiform encephalopathy.

TSEs encompass the family of diseases that infect cows, humans, sheep, deer, elk, mice andmonkeys, all creating similar neurological devastation as mad cow. Theagency also will briefly consider the nutritional supplement issue at its meeting.

Mad cow disease is thought to be caused by prions, which are as-yet poorly understood infectious agents that eat away brain tissue, giving it a spongy appearance. The human version responsible for more than 80 deaths in Britain is called variant Creutzfeldt-Jakob disease. Scientists believe victims contracted it by eating infected beef. The disease presumably spread throughout Europe by cows fed bone meal and beef by-products contaminated bythe disease.

To prevent the disease from crossing the Atlantic Ocean, since 1997 the United States Department of Agriculture (USDA) has banned live ruminants — cows, sheep, and goats — or their by-products, including meat, from entering this country if they come from Europe. Glandular material, blood and serum are within the USDA’s ban, but some products may have entered the country before restrictions were put into effect, or have very restricted exemptions.

Exceptions to the ban exist. Milk and milk products, hides andskins, protein free tallow (or meat fat), and gelatin for high-gradepharmaceuticals are allowed in, according to USDA’s Detwiler. But bovine spongiform encephalopathy risk from these sources is deemed very low. Nervous tissue from the brain or spinal cord is considered the most likely prion carrier.

Vaccine Concerns

For a few years, the FDA has recommended that manufacturers ofpharmaceutical products not use bovine material from Europe, but a recent problem with vaccine reveals some companies were not heeding that warning.

Last month, the FDA reported that several firms might have usedbovine material from Europe or from an unknown geographical origin in making vaccines. North American Vaccine’s diptheria and tetanus toxoids and acellular pertussis vaccine and SmithKline Beecham’s hepatitis A vaccine were among those that used European bovine raw materials. Vaccine manufacturers use beef protein broths and calf serum to make vaccines.

Officials say the public was at minimal risk for contracting any disease from these vaccines and has asked the firms by the end of 2001 to be more rigorous in the manufacturing processes.

The FDA only can recommend that manufacturers adhere to their rules as Congress limits the agency’s powers.

Nutritional Supplement Contamination?

Besides vaccines, nutritional supplements that use glandularmaterial — such as pituitaries, prostates, or kidneys from cows — mayprovide a way for mad cow to enter the country. The supplements containhormones presumed to act on the organs or immune system in humans. People take them to feel more vigorous.

Although the FDA says European bovine products should not be imported into this country because of an import alert ban put into effect within the past two years, infected material might have come in before the ban was put into effect.

To prevent nutritional supplement makers from using materials from infected cows, the FDA in November wrote a letter to the industry to“take all steps to assure the public that such ingredients do not come from cattle born, raised or slaughtered in countries where BSE exists.”

But some experts believe the FDA’s weak oversight of the nutritional supplement industry may put the public at some risk. “There is no way of being certain that some dietary supplement ingredients do not come from British cows,” says Dr. Peter Lurie, director of the Public Citizen Health Research Group and a member of the FDA advisory committee on mad cow disease. Lurie adds, though, that glandular supplements represent a very small percentage of the total market.

Yet Michael Hansen, a research associate at the Consumer PolicyInstitute, the research unit of Consumers Union, says Americans should avoid taking any glandular supplements, even if they are made from cows in this country, since it takes five years for mad cow disease to incubate.

The public should ask manufacturers of these products toughquestions about where “glandular” material came from, says Hansen, eventhough nutritional supplement trade groups say they use acceptedingredients.

The agency may consider regulating these glandular products more rigorously, or removing them from the shelves altogether, says an adviser to the FDA committee meeting this week.

Holes in Our Blood Supply?

To prevent the spread of mad cow into our food supply, the FDA hasprohibited American cattle from being raised on feed made from other cattle, although pigs and poultry can still eat protein extracted from cows. But problems have recently shown up in the system designed to prevent cows from eating cow-based foodstuffs.

To get a sense of how well renderers and feed mills were complying with the rules, the agency analyzed 9,947 inspections of the industry. Renderers extract protein from dead cows and provide the nutritional material to feed mills, which mix the protein with soybeans, minerals and nutrients.

Under FDA rules, renderers and feed mills have to label theirproducts to ensure that cow proteins do not sneak into the cow food supply. These firms also have to make sure feed products that contains cow proteins for pigs and poultry are strictly separated from feed designated for cattle.

Unfortunately, in an analysis of the inspections, FDA’s Center for Veterinary Medicine found a significant number of problems in labeling and other policies designed to prevent mix-ups.

The agency plans on seizing products from those firms that fail to comply with the law, since contaminated cow proteins eaten by cattle is believed to be the way the disease spread. “[Mad cow] could be here before the first signs of the disease show up,” Dr. Stephen Sundlof, director of the FDA’s veterinary medicine center. “Our intent is to make sure we stop it in its tracks.”

USDA has inspected 12,000 cattle in this country out of a total of 100 million head of cattle in the past decade and to date has not found any with mad cow disease. Detwiler says her agency would like to do more inspections.

Should Blood and Organ Donation Bans Be Widened?

Two years ago, the FDA ordered a ban on British blood to protect against variant Creuzfeldt-Jakob disease from spreading. Anyone who has lived in the United Kingdom or Ireland for more than six months between January 1980 and December 1996 is prohibited, for life, from donating blood.

To further protect the American blood supply, the agency is nowconsidering extending that ban to anyone who has lived in Europe, because of the alarming spread of the disease on the continent. On Wednesday, the Red Cross announced it plans to ask the government to extend the ban to people who have spent time in Western Europe. The Red Cross is not sure how long people would have had to been in Europe, but says six months may be the logical cutoff.

The Red Cross may extend the ban independent of any FDA action. If the FDA rejects the request, “whether we will come up with additional safety nets or be more stringent, that is something we will be deciding very quickly after this meeting,” says Red Cross director Bernadine Healy.

Also under consideration is whether there should be restrictions against residents of the United Kingdom from donating organs. The agency is also studying whether hunters of elk and deer in North America should be banned from donating blood. Chronic wasting disease, a form of TSE, has hit 15 percent of the free-ranging deer and elk in northeastern Colorado and southeastern Wyoming, and hunters may have been exposed to the infectious agent.

The advisory committee voted Thursday to ban blood donations from anyone who lived in France, England and Portugal for 10 years or more from 1980 until the present. The FDA is not bound to follow the recommendations, but the agency generally heeds such advice.