Adoption isn't the only way that gay men and lesbians are forming families. By taking advantage of the technological advances of recent years, the gay community is experiencing its own biological baby boom.

But some gay activists are warning that regulations under consideration by the Food and Drug Administration could turn that into a baby bust. A coalition of queer activist groups and gay-friendly sperm banks say the proposed FDA regulations would not only ban men from being anonymous sperm donors, but would erect costly and time-consuming barriers for gay men who want to father children through artificial insemination with a woman of their own choosing.

"The proposed regulations ... almost eliminate the possibility of [gay men] having biological children," the coalition states in a May 17 letter sent out to news organizations. "The FDA's regulations would override California laws and would be a program of mass sterilization by regulation."

The coalition includes the Gay and Lesbian Medical Association, the National Center for Lesbian Rights (NCLR), the American Civil Liberties Union of Northern California, the Sperm Bank of California, and Rainbow Flag Health Services and Sperm Bank.

The FDA does not currently regulate sperm banks and, while no proposed regulations have been officially released by the administration, the coalition said the regulations have been drafted and were outlined at an April 8 seminar in Irvine, Calif., by Ruth Solomon, director of the Human Tissue Program in the FDA's Center for Biologics Evaluation and Research.

According to the coalition's accounts of Solomon's presentation, the proposed regulations would do two things: exclude men who have had sex with other men within the past five years from being anonymous donors and force noncelibate gay "directed donors"--those who chose a specific woman with whom to father children--to freeze and quarantine their sperm for six months. Only one in six men have sperm that can survive the freezing process well enough to meet the World Health Organization's minimum standard of fertility.

 "The only way that some of these 84 percent who have minimal [sperm] survival after freezing may use their sperm is by expensive and invasive high-tech fertility methods," the coalition says. "The price for these methods range up to $12,000 per attempt with very low success rates."

As for the ban on anonymous sperm donors, the coalition says it is unnecessary. The industry's current standard for anonymous donors is the same as the one the FDA wants to require for directed donors--freezing sperm for six months to allow for re-testing of the donor. Because the "window" period between the time it takes for an infected person's blood to test positive for HIV is one to three months, that standard is sufficient, the coalition says.

Leland Traiman, executive director of Rainbow Flag Health Services, who attended the Irvine seminar, said that to justify the policy the FDA cites a single case of a man--who was not gay or bisexual--who took longer than three months to seroconvert.

"They're saying all gay men should be excluded because of one heterosexual man in Utah," Traiman said. "They're wasting our tax dollars to regulate an industry that is amazingly self-regulated."

Traiman began Rainbow Flag Health Services three-and-a-half years ago. More than 80 percent of his sperm donors are gay, as are most of those who come to him to have children through directed donors. The latter group makes up about a third of his business. "These regulations would force me to shut down," he said.

Christine Hwang, a staff attorney for the NCLR, said lesbians as well as gay men will suffer if the regulations become law. "Because lesbian couples have extended families within the gay community it is not uncommon for them to choose as a father or sperm donor a gay man," she said.

Rather than facing a six-month wait, thousands of dollars in extra expenses or being denied their choice of donor, some prospective parents will resort to do-it-yourself insemination methods, Hwang said. "They're just going to use fresh sperm and if it hasn't gone through a rigorous procedure they could possibly be infected," she said. 

The proposed regulations appear to be at least partially based on the CDC's current, non-binding guidelines for the fertility industry. Those guidelines which ban gays from serving as either anonymous or directed donors, already make it difficult for gay men to find sperm banks willing to accept them. Spokesmen for both the FDA and CDC have said such rules aren't discriminatory because they don't specifically mention sexual orientation, referring instead to "men who have had sex with other men in the last five years."

FDA spokeswoman Lenore Gelb confirmed that such restrictions are being considered as part of a "proposed framework" for regulating some biological and human tissue products. Traiman quoted Solomon as saying that the proposed regulations were receiving final interdepartmental reviews and would be released for a 90-day public comment period late this year.

If approved, the FDA regulations would override state laws. New York is the only state that currently has a broad ban on gay sperm donors. California's health and safety code currently allows the use of fresh or frozen sperms for directed donations as long as the donor has been appropriately screened and the woman has been counseled about the possible risks. The California Health Department has recently drafted new regulations, which have not yet been approved, that do not discriminate against gay men.

To comment on the proposed regulations, write Secretary Donna Shalala, U.S. Department of Health and Human Services, 200 Independence Avenue S.W., Washington, D.C., 20201; call 877/696-6775; or e-mail hhsmail@os.dhhs.gov.