Thousands more people who have lived or traveled in Europe will be barred from donating blood, beginning next spring, as a new precaution against mad cow disease.
The Food and Drug Administration already bans blood donations from people who have spent at least six cumulative months in Britain between 1980 and 1996, the worst period of that country's mad cow outbreak.
The FDA said Monday it would tighten its restrictions, barring donors who have spent at least three cumulative months in Britain during that time and, eventually, travelers to other parts of Europe.
The new precautions will be phased in between spring and fall 2002, giving blood banks months to hunt for new donors and keep the nation's already tight blood supply from becoming tighter.
Blood donors may find Monday's announcement confusing. That's because the American Red Cross next month will begin turning away donors under even tighter restrictions — people who have spent three months in Britain or six months anywhere in Europe since 1980.
The FDA allows blood banks to adopt stricter precautions than it recommends. But FDA officials insist that because mad cow disease is only a theoretical risk to the blood supply, a more gradual nationwide change will provide comparable safety without causing shortages in parts of the country that rely heavily on blood from travelers and military personnel, or even blood imported directly from Europe.
"There is a need to strike a careful balance between increasing the safety of the blood supply while at the same time ensuring that blood products are available," said FDA blood chief Dr. Jay Epstein.
Mad cow disease is a brain-destroying illness that first surfaced in British cattle but now has spread to cattle in much of Europe. A human form, called "new variant Creutzfeldt-Jakob disease," apparently spread by eating infected beef, has claimed more than 90 lives in Britain and parts of Europe.
Mad cow disease has never been found in U.S. cattle, and the new CJD has never been diagnosed here, although Americans can get a similar disease, regular CJD. There is no evidence the human form can spread through blood transfusions, but donors are restricted just in case.
Under the FDA's proposal, by May 31 blood banks would have to bar donors who have:
Spent three cumulative months or more in Britain from 1980 through 1996.
Spent five cumulative years or more in France from 1980 to the present.
Spent six months or more, as American military personnel or dependents, on bases in Northern Europe from 1980 through 1990, and elsewhere in Europe from 1980 through 1996. That's when British beef was sold on those U.S. bases.
Received a blood transfusion in Britain since 1980.
In fall 2002, FDA would bar donors who spent a cumulative five years or more anywhere in Europe since 1980, and end New York's imports of blood from Europe, which accounts for more than 25% of that city's supply.
The FDA estimates the new restrictions will bar 5% of blood donors. The FDA has estimated that the Red Cross' stricter rules could cut blood donors by 9%. But the Red Cross, which supplies half the nation's blood supply, argues the impact won't be that big — and that it already is replacing lost donors with a major recruitment campaign.
America's Blood Centers, which provides the other half of the nation's blood supply, praised the FDA for gradually implementing the new restrictions.
As for donors who are barred, regardless of which blood bank turns them away: Don't worry about your own health, Epstein stressed.
"We would expect the vast, vast majority ... are in fact uninfected," he said. "But there is no screening test that could be used on donors. The only available tool we can apply to improve blood safety is to avoid the use of blood from people who may have had these exposures."
The FDA's proposal is open for public comment for 30 days; the agency expects to finalize the rules by year's end.
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