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King's College London - Health: More than a medical matter





Sperm donor told to halt production by US regulator

12 December 2011

By Dr Nadeem Shaikh

Appeared in BioNews 637

A man in the United States is reportedly being investigated by the US Food and Drug Administration (FDA) after offering his sperm for donation. Mr Trent Arsenault, a 36 year-old computer security expert from California, has set up a website offering his sperm without charge to anyone who wishes to use it to have a baby.

 

The FDA wrote to Arsenault in 2010, ordering him to 'cease manufacturing'. Although Arsenault says he is not a 'business', the letter states his service counts as 'a firm or establishment... that recovers and distributes semen, and therefore is a manufacturer of human cells', and as such, comes under the FDA's jurisdiction.

 

Arsenault's website explains his background, ethnicity, personal hobbies and medical reports with his sperm count. It also contains copies of tests for sexually transmitted diseases (STDs). An FDA inspection did not, however, find sufficient evidence that he was following legally required procedures to prevent the spread of certain STDs.

 

In its letter to Arsenault, the FDA said: 'Because of your failure to provide adequate protections against the risks of communicable disease transmission... you must cease manufacturing until compliance with the regulations... has been achieved'.

 

FDA investigators estimated that Arsenault made 328 sperm donations to 46 recipients between 2006 and 2010. His website displays photos of fourteen children whom he has helped father since his first donation to a school teacher in 2004, and he says that he has received over 20,000 email inquiries. Low income or same-sex couples who often face problems applying to licensed sperm banks are particularly keen to use his service, he says.

 

Arsenault disputes the FDA's claims. 'The semen is provided fresh (unfrozen) and is transferred immediately to the recipient', he said. 'Health of the mother and child is my utmost concern'. Arsenault says he does not believe his one-man operation comes under the FDA's rules regarding commercial operations and is continuing to donate sperm until the case against him proceeds to a formal hearing, reports CBS San Francisco.

 

Two women are currently pregnant with children conceived with his sperm. 'It is helping people in need', said Arsenault. 'I don’t make any money, I don't charge people anything. And it's just helping childless couples have children'.

 

A 'known donor agreement' posted on Arsenault's website stipulates that a recipient relinquishes any rights they may have against the donor to hold him 'legally, financially, or emotionally responsible' for any resulting children. The agreement states the donor shall have no paternal rights with any resulting children and would not demand custody or visitation rights.

 

The online version of the agreement contains an 'STD Re-Testing Waiver' which clarifies the 'donor' is a 'sexually intimate partner', under the regulations, for whom it says re-testing is not required. Recipients of the sperm are asked to hand the waiver to Arsenault at the first donation pick-up.

 

The FDA regulates human reproductive tissue including donated eggs and sperm. Its website states any establishment that performs one or more manufacturing steps for the recovery, processing, storage, labelling, packaging or distribution of human cells or tissue, must register with FDA. Sperm banks in California and regulated both by the FDA and state department of health.

 

SOURCES & REFERENCES
Donor Agreement
| 20 September 2010
 
Fox News | 08 December 2011
 
SFist | 07 December 2011
 
NBC Bay Area | 08 December 2011
 
New York Daily News | 12 December 2011
 
US Food and Drug Administration | 01 November 2010
 

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