Men who acknowledge having had homosexual sex within the previous five years will not be allowed to make anonymous sperm donations under new rules that the Food and Drug Administration is expected to announce today.
New York State already bars gay men from donating sperm anonymously, and most of the nation's sperm banks have similar restrictions because of concerns over transmission of H.I.V., the virus that causes AIDS.
But a prominent gay rights group nonetheless denounced the new federal rules. Matt Foreman, executive director of the National Gay and Lesbian Task Force, said that the regulations were misplaced because H.I.V. tests were fast and very effective.
"It's one thing to base these rules on legitimate scientific concerns, but it's another to reinforce baseless stereotypes," Mr. Foreman said.
The rules are part of a years-long effort by federal drug regulators to strengthen the oversight of the harvesting, sale and medical use of human tissue, mostly from corpses. The federal government has long had rules governing the trade and use of blood and organs. But the extraction and use of things like bones, veins, corneas, ligaments and sperm by nearly 150 companies have largely gone unregulated.
This lack of oversight has led to at least one death and scores of injuries. Brian Lykins died in 2001 after routine knee surgery because the bone transplant he received was infected with virulent bacteria. An investigation revealed that the cadaver from which Mr. Lykins's transplant tissue was extracted had been unrefrigerated for 19 hours.
At least 66 people have received serious infections after similar transplants, according to information provided by the Centers for Disease Control and Prevention.
The new rules govern the screening and testing of potential donors of all kinds of tissue. All donors must be tested for infections with H.I.V., the hepatitis B and C viruses, syphilis and Creutzfeld-Jakob disease, the human form of mad cow. Sperm donors must also be screened for sexually transmitted diseases, including chlamydia and gonorrhea.
Gay men and others prohibited from anonymously donating sperm and other tissues will still be able to donate to friends and family members who are known to them.
Activists have been pleading for years with the Food and Drug Administration to announce its tissue rule, and since 1997 the agency has been saying that the rules would be announced within months.
When asked what took so long, Peter Pitts, an agency spokesman, said, "It's not a question of how long it takes, it's a question of getting it right."
Steven Lykins, Brian Lykins's father, said that the rules that will be announced today are nearly identical to those proposed by the agency in 1999.
"Why it's taken so long is a question that I've been asking over and over again," Mr. Lykins said.
Most sperm banks already freeze and quarantine specimens for six months, testing the donor at the beginning and end of that period, said Russ Bierbaum, chairman of the reproductive council of the American Association of Tissue Banks. Mr. Bierbaum also owns Reprotech, a sperm bank in Roseville, Minn. Since most anonymous sperm donors make routine donations, such testing is not difficult to perform, he said.
Besides the tests, donors must be asked a series of questions about their social lives. Sexually active gay men and people who use drugs intravenously will be barred from donations. If the donor is dead, the questions must be asked of a family member or doctor who is familiar with the medical history of the donor.
The regulations make extensive record-keeping requirements of tissue companies.
Mr. Pitts of the F.D.A. said that the agency was simply adopting rules already in place at most sperm banks.
There are approximately a million tissue transplants every year, double the number five years ago, said Bob Rigney, chief executive of the American Association of Tissue Banks. Some 83 tissue banks are members of the association and voluntarily abide by guidelines that mirror the new federal rules, Mr. Rigney said.
But an additional 70 tissue banks are not members of the association, Mr. Rigney said.
Mr. Rigney said that the new rules would not make transplants any more difficult to get but might make them more expensive. "The new rules will add considerable validation requirements that will be costly to implement," he said.
Senator Susan Collins, Republican of Maine, said she hoped that at least some tissue banks would be put out of business because of the tightening restrictions.
"I view that as a positive thing to force out of business those tissue banks that are responsible for most of the problems," Ms. Collins said.
The F.D.A. is expected to adopt more rules governing the handling, processing and storing of tissues later this year. Those rules are expected to be much more extensive and difficult to carry out "but they're by far the most important," said Ms. Collins, who has held hearings about the need for the new rules for years.
