Last fall, the Food and Drug Administration hand-delivered an order to cease manufacturing to a seemingly unremarkable recipient, a soft-spoken, 36-year-old man from Fremont, Calif., who works in computer security. The contents of that letter, however, were anything but ordinary. The agency was demanding that Trent Arsenault comply with federal regulations or stop giving away his fresh semen to women hoping to have a baby.
Since Arsenault made his first free sperm donation in 2006, answering a Listserv request from a Bay Area teacher who is now mother to a 4-year-old boy, he claims to have fathered 13 children, with four more on the way. Arsenault posts this information, as well as details about his appearance (blonde hair, brown eyes), hobbies (bird watching, Native American history) and what he calls his "sperm donor friendly diet" (twice daily fruit-and-raw-milk smoothies) on his website, Trentdonor.org. The site provides his latest physicals and tests for sexually transmitted diseases, and explains how women wanting to use his sperm can contact him.
The real trouble for Arsenault began in 2010, when the FDA's Center for Biologics Evaluation and Research inspected his home and found him in violation of numerous regulations, including failing to properly protect himself against communicable diseases. A year earlier, an FDA investigator had emailed Arsenault, requesting an opportunity to discuss the activities advertised on his website. During the meeting, Arsenault completed what is known as a human cells and tissues establishment registration form, indicating he was a "directed" or known donor and, as such, subject to federal regulation. Arsenault admits he filled out the form not because he fully understood its meaning and implications, but because he was eager to comply with the FDA's wishes.
Since that time, Arsenault has been fighting the agency's efforts to shut him down -- in particular, disputing the notion that he is a "manufacturer" of sperm, given that he packages his semen and distributes it in a cup. He has petitioned for a hearing to prove that even though he does not have sex with his recipients, he is a sexually intimate partner to them (a term the FDA currently does not define) and therefore is exempt from regulatory requirements that apply to manufacturers.
So far, Arsenault's requests have been denied, and he now faces potential financial penalties and jail time. What the FDA decides to do with the case, however, has consequences beyond Arsenault's fate, for it has stirred debate within a small pocket of the world of assisted reproduction about what sexual intimacy is and whether the government really wants any part of that discussion.
"Trent believes he is a sexually intimate partner with these women," said Daniel Epstein, executive director of Cause of Action, the Washington, D.C.-based public interest nonprofit representing him. "And it shouldn't be up to the FDA to define how private individuals define intimacy."
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Traditional sperm "donation" is something of a misnomer. The act of transferring frozen sex cells to women hoping to conceive is big business in the U.S., carried out primarily by large, commercial institutions. They recruit scores of donors and then spend months screening them for STDs and genetic diseases in accordance with federal regulations aimed at preventing the spread of communicable diseases, before freezing their sperm with liquid nitrogen. Sperm donors -- the majority of whom request anonymity -- are typically paid between $50 and $100 per sample.
For the women, the process can be expensive. Donor specimens at institutions like California Cryobank, one of the best-established in the industry, run from $355 to $715 per vial, and many women require several attempts before becoming pregnant.
But while such institutions are the public, for-profit face of sperm donation, a free system of exchange has long existed under the radar.
"For a long time, particularly among lesbian couples, there have been informal networks of exchange," said Rene Almeling, a professor of sociology at Yale and author of "Sex Cells: The Medical Market for Eggs and Sperm."
"Women would turn to a friend or relative to supply donated sperm," Almeling continued, explaining many could not afford to visit a sperm bank or simply preferred to work with a known donor. "[These networks] have existed probably as long as women have been trying to conceive."
There are no reliable national data about how many women visit sperm banks or seek out more informal donations, but Almeling said the popularity of free exchanges has increased within the last decade -- particularly online. Arsenault, who has generated much media attention, has become the public face of this trend.
Nowhere is the uptick more evident than at Free Sperm Donor Registry (soon to be renamed The Known Donor Registry), a website that aims to serve as a community resource for individuals who want to have children through private sperm donation.
Its founder, Bethany Gardner, started the site -- which currently has some 4,300 members -- after she and her wife struggled to find and connect with other known donors when they decided to have a baby several years back.
Gardner believes Arsenault's case may have implications for her community and is staunchly opposed to the FDA's attempts to shut him down. She fully buys into the notion that adults who meet to exchange bodily fluids with the express aim of making a baby without question enter into a sexually intimate partnership, even if they don't come into physical contact.
"The concept that a man who puts sperm in a cup is somehow illegal is ridiculous to me. It's ridiculous!" Gardner said. "From a PR perspective, we don't want people to think about, to associate sex with this. But from a policy perspective, it's a private sex act between two consulting adults."
Brandon J. Hill, a research associate with the Kinsey Institute, said there is no concrete, universal definition of what constitutes sex or even sexual behavior. This is the case, he said, within both the culture and the law, the latter of which tends to speak in broad, even cautious terms when it comes to sex and sexuality.
"I would be very wary of any government-issued definition of sex," Hill said. "If the FDA set a precedent to define sexually intimate partnership, it could really fan out to the NIH [National Institutes of Health] and institutions like that. It would create very muddy waters."
But that is exactly what Arsenault's brief may pressure the Center for Biologics Evaluation and Research to do.
The brief asks that the denial of his request for a hearing be overturned, giving Arsenault an opportunity to provide documentation and testimony proving that he is, indeed, a sexually intimate partner to his donees, or that the earlier order to cease "manufacturing" be rescinded altogether. Either way, it may force the FDA to consider the question of what sexual intimacy entails and whether the agency wants to define the term outright. Even if it does not, what the agency decides may signal what it believes a sexually intimate partner to be. (A spokesperson for the FDA said that because the investigation is ongoing, it is unable to comment.)
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According to Arsenault's attorneys, one group that may be particularly affected by the investigation are lesbian women -- and not just because if Arsenault shuts down, interested Bay Area women would have to look elsewhere for a donor. (Arsenault estimates that 80 percent of his clients are lesbians.)
The brief contends that by stopping Arsenault in the name of limiting disease risk, the Center for Biologics Evaluation and Research "inadvertently encourages conduct that poses a greater hazard." In other words, the suggestion goes, if the FDA decides that Arsenault and his donees do not have a sexually intimate partnership, the women would have to turn to sperm banks, although many cannot afford them and some think frozen sperm is less likely than fresh to lead to pregnancy. (Dr. Paula Amato, an OB-GYN with Oregon Health & Science University, said the latter point may not matter much in the case of donors with a normal sperm count.) Or the women would have to have intercourse with men to obtain the sperm directly -- an activity the FDA would not regulate.
Gardner said that her Free Sperm Donor Registry -- whose clients she believes are 70 percent lesbians -- is aware of the potential ripples. Although she believes Arsenault made a critical error in registering with the FDA, a move that distinguished him from many other donors who escape regulators' notice, his case may still draw negative attention to an option that allows lesbians to conceive, like most heterosexual couples, in the privacy of their own home.
It is an option that Gardner believes must be protected, and one that is often misunderstood by heterosexuals.
"We went to the doctor the other day, the OB-GYN, and we told her we were trying to conceive at home," Gardner said. "And she was like, 'Really? You are trying to do this yourself at home?' I looked at her and said most babies are conceived at home. The thought that lesbians can only have a baby with a doctor's help ... I'm not infertile. I just don't have sperm."
For his part, Arsenault said he does not see the issue as gay or straight, but as a violation of reproductive rights. He claims to stay up nights, worrying about how the case will turn out and what these women will do if he is closed down.
Why, then, is he so loath to comply with federal regulations on human cells, tissues and tissue-based products, so that he can continue donating? Why doesn't he simply abide by rules the FDA says are meant to make donation safe, by preventing the introduction, transmission and spread of communicable diseases?
He said cost is a major factor, as the testing can add up to "tens of thousands of dollars." And then there is the point he cannot get past: Arsenault believes the FDA simply has no right to intervene.
The women seem to agree.
In April 2010, Krista, a gay, 39-year-old marketing executive in the Bay Area (who asked that only her first name be used), began trying to conceive with Arsenault's sperm. After finding him online, speaking with him and completing the three-page donor agreement available on his website, Krista and her partner drove to Arsenault's home at the right time in her menstrual cycle, texting when they had arrived.
Fifteen minutes later, Arsenault emerged with his sperm in a cup, which one of the women placed between her legs to keep warm on their 35-minute drive home. When they arrived, Krista's partner drew the sperm into a syringe and inserted into Krista's vagina while she relaxed with her legs up high -- not because of any scientific proof that position works, she admitted, but because of the mental comfort it afforded her.
Traditional intercourse? No. But Krista, who has become pregnant and miscarried with Arsenault's sperm twice and is currently pregnant again, said that the relationship is highly intimate and, as such, should be exempt from regulation.
"Every couple I've met with says this: 'We're really worried about what will happen with the FDA case, because we don't know if it will put our future plans on hold,'" Arsenault explained. "Families with a babies already don't know if they will be able to have a sibling or not."
"A lot of people think this is creepy -- that the whole donation thing is about a donor wanting to make a million copies of himself," Arsenault continued. "I disagree with that. It's not strange or weird to want to help people. That's my primary motivation."
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