Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
sperm donors, their application in the Arsenault case, and the implications
of expanding the government’s regulatory authority over individuals’
procreative decisions. Part I describes the phenomenon of private sperm
donation and how it fits into the landscape of reproductive medicine. Part
II discusses federal statutes and regulations that have historically been
enforced against medical establishments involved with sperm donation.
Part III discusses the Arsenault case and the FDA’s unprecedented decision
to enforce these regulations against a private sperm donor. Part IV
examines whether the regulations and their enabling statute, in fact, cover
private sperm donor activity. Part V analyzes the possible consequences of
expanded federal regulatory authority over private, individual-to-individual
donations of sperm for artificial insemination.
I. SPERM DONATION: AN UNILLUSTRATED PRIMER
For many modern couples that want to start a family, tried and true
methods are inadequate. Heterosexual couples increasingly face fertility
challenges. But for couples or individuals without a male partner, the
obstacle is a lack of a father’s genetic contribution, and this requires the
assistance of a third party. Perhaps the most established nontraditional
route is through sperm banks. These firms, regulated by federal law and
staffed by licensed medical professionals, 17 often pay men for donations and
then sell the semen to women trying to conceive. Sperm-bank donors’
disclosure of information and degree of willingness for future contact with
the mother or child varies, but most donors are anonymous, providing data
only on medical history and physical traits, and donate on the condition of
limited potential for personal contact with resulting offspring. 18 Donors are
assessed for infectious disease risk, personal and family health history,
sperm count, motility, and resilience to freezing, and are subjected to a
physical exam and blood and urine tests for infectious and hereditary
diseases. 19 A preservative is added immediately to fresh sperm donations
by laboratory personnel, 20 and the sample is then frozen and subjected to six
months of quarantine. 21
17. 21 C.F.R § 1271.1 (2012); 21 C.F.R § 1271.170 (2012).
18. LOUISE SLOAN, KNOCK YOURSELF UP: NO MAN? NO PROBLEM! : A TELL-ALL GUIDE
TO BECOMING A SINGLE MOM (2007).
19. 21 C.F.R § 1271.50 (2005); 21 C.F.R. § 1271.75 (2005); 21 C.F.R. § 1271.80
(2005); 21 C.F.R. § 1271.85 (2005).
20. SLOAN, supra note 18, at 67.
21. 21 C.F.R § 1271.60 (2012); 21 C.F.R. § 1271.85(d) (2012). Indeed, the six-month
quarantine period is mandated by the FDA’s regulations governing HCT/P’s.