U.S. Food and Drug Administration (FDA) is claiming that Trent Arsenault, a California man who has fathered 14 children through sperm donation and has four more on the way, is breaking the law, and it's spent over a year trying to get him to stop.

Arsenault, 36, of Fremont, Calif., has been branded a manufacturer of human cells since he uses his sperm to help women get pregnant. That classification requires him to donate through regulated sperm banks or clinics.

Instead, Trent Arsenault sets up donations through his web site, trentdonor.org. And until he's forced by a court order to cease manufacture, he has no intention of stopping.

14 Children, 348 Donations

Trent Arsenault has a system down.

Couples looking to conceive with donated sperm visit his web site and go through his medical records, which include information about his personality and background, childhood immunization records and the negative results of a battery of sexually transmitted disease (STD) tests.

If they want to go through with a donation, they'll send Arsenault a window of time when the woman will be ovulating. When she reaches the optimal time for conception, she contacts Arsenault, who stores a fresh sperm donation in a sterile cup for the woman to pick up.

Trent Arsenault began his private sperm donations when he answered an online ad from a Bay Area couple back in 2006 that were having trouble conceiving.

He considered working through a sperm bank, which offers both money and anonymity, but decided instead to create his own system. He liked the idea of having a relationship with the couple in question, being able to help low-income couples struggling with infertility, and the possibility of having a relationship with the children.

Arsenault has fathered 14 children so far, though both he and the parents sign a contract beforehand absolving him of fathering rights or responsibilities. More than 20,000 requests have gone through his web site, and has given 348 sperm donations to 46 women.

It's helping people in need, Arsenault told Fox News. I don't make any money, I don't charge people anything. And it's just helping childless couples have children.

'We have legitimate concerns.'

For the FDA, however, it's about far more than that. A legal dispute between federal regulators and Arsenault has been going on for over a year.

In 2010, FDA officials sent a letter to the sperm donor demanding that he stop donating sperm to couples and shut down his web site.

Ordering him to cease manufacturing, the FDA told Arsenault, who works as a computer security expert in Silicon Valley, that he was not following the proper regulations governing safety practices for cell or tissue donation.

Federal regulations state that sperm donors must undergo several blood tests for communicable diseases like HIV, Hepatitis B and C and syphilis at least seven days before every donation.

Though Arsenault is tested frequently, almost none of his blood tests occurs within seven days of his sperm donations, nor is he documenting the process through an approved sperm bank or clinic.

We have legitimate concerns, Shelly Burgess, an FDA spokeswoman, said.

For now, Trent Arsenault is allowed to continue donations until a case hearing. If he is found in violation of U.S. FDA regulations, he could face a $100,000 fine and up to a year in prison.

'You're taking a risk.'

From the perspective of the U.S. Food and Drug Administration, both Trent Arsenault and the couples he helps are playing with fire.

The FDA views Arsenault as a manufacturer of human cells, meaning his firm or establishment (or, in this case, his web site) recovers and distributes semen.

By operating outside a regulated system, and by not having scheduled testing on an almost obsessive basis, Arsenault is in fact putting the woman he impregnates at risk.

There's this thought process that they [a couple struggling with infertility] can use somebody they know and it's okay, Dr. Mitch Rosen, director of the UCSF Fertility Preservation Center, told The Chronicle. But just because you 'know' someone, doesn't mean you know them... you're taking a risk.

Arsenault's Sperm is 'Pretty Good'

Arsenault, however, has a different view of his relationship to the women to whom he donates sperm, and is fighting with the help of his lawyers to continue doing so.

 On the health front, Arsenault insists that he is checked frequently enough, and takes the necessary precautions, to avoid contracting a communicable disease.

He adheres to a healthy lifestyle, a fact he promotes on his web site, and claims his sperm, which Rosen admits is pretty good, is top-quality due to a low-calorie all-organic diet.

But the issue for this sperm donor is not so much that his donations don't match FDA regulations as that he feels the FDA has no right to interfere in the first place.

Sperm Donation or Intimate Partnership?

Arsenault's lawyers, who work for the nonprofit legal firm Cause of Action in Washington, D.C., are defending their client's decision to donate sperm based on the notion that these are intimate partner relationships.

Arsenault enters into [a] mutually desired partnership with childless couples, and is petitioning for a hearing to prove that although he doesn't have sex with his recipients, he is a sexually intimate partner with them, making him a possible exemption to FDA regulations.

As The Huffington Post points out, traditional sperm donation is actually a vast infrastructure of regulations and businesses. It often costs somewhere between $355 to $715 to purchase just one vial of semen. It may not even succeed in getting the woman pregnant on the first try.

One of Trent Arsenault's partners, who called herself Krista, is pregnant for the third time with his sperm, after miscarrying twice. She views the relationship as a highly intimate one, and feels it should be exempt from federal regulation.

'The government is reaching into the bedroom.'

Arsenault thinks he's being targeted by the FDA because he has a web site where he promotes a cheaper, faster and easier way for couples to get pregnant than the federal government can provide.

But he sees his case, quite rightly, as about something more than that.

What the FDA is doing infringes on reproductive rights. The government is reaching into the bedroom, Arsenault told The Chronicle.

There's no precedence for my case. Whatever happens to me kind of sets the future up for all the other people in these situations - the couples plus the donors.

For people like Brandon J. Hill, meanwhile, who is a researcher with the Kinsey Institute, Arsenault's case is intriguing not so much for the sperm donations themselves as for what the FDA's actions imply about what constitutes sex, sexual behavior and sexual intimacy.

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.

'It's not strange or weird to want to help people.'

In the meantime, Trent Arsenault continues to donate, and keeps the web site running at full capacity.

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.

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.