Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
Although that language notes that routine exposure to an SIP’s body fluids
is “likely,” it does not assume that such exposure is universal, nor does it
make exposure a necessary condition for SIP status. 146
Sexual relationships in modern American society are more diverse than
ever. This poses a challenge to regulatory agencies whose enforcement
actions affect the composition of or rights afforded to these families. In
some instances, as here, the government has a choice between interpreting a
regulation to paternalistically redefine an individual’s intimate partnerships
(with the direct effect of making it more difficult for the individual to
exercise his or her reproductive rights), or reading the law in a manner that
respects differences and personal choices about the meaning of intimate
connections. By imposing its particular set of beliefs about the true
meaning of a procreative partnership, the FDA has made a deliberate
decision to apply 21 C.F.R. Part 1271 in a manner that results in serious
harms to individual autonomy.
B. Risk Reduction and 21 C.F.R. Part 1271
The government’s decision would be understandable if narrowly defining
the SIP exception actually resulted in a reduction in health risk. However,
the Arsenault case highlighted the irrationality of this interpretation in
practice. CBER asserted that it could order Arsenault to cease donating
semen to consenting adult recipients because he did not follow a plethora of
regulatory standards, which purportedly protect recipients from disease.
However, CBER’s ability to stand between a woman and the man she
wished to father her child appeared to hinge completely on the use of a
semen receptacle. If Arsenault (like some other uncompensated donors)
provided natural insemination, CBER’s position is apparently that it could
not intervene—even though such activity is riskier than the procedures
followed by Arsenault. 147
146. Suitability Determination for Donors of Human Cellular and Tissue-Based
Products, 64 Fed. Reg. 52, 696, 52, 707 (September 30, 1999) (to be codified at 21 C.F.R. §§
210, 211, 820, 1271) (Preamble to the Proposed Rule). See also Perry v. Schwarzenegger,
704 F. Supp. 2d 921, 956 (N.D. Cal. 2010), (quoting In re Marriage Cases, “This contention
[that marriage is limited to opposite-sex couples because only a man and a woman can
produce children biologically related to both] is fundamentally flawed.”) (internal citations
omitted); Id. at 956-57, (quoting Lawrence v. Texas, (Scalia, J., dissenting) “What
justification could there possibly be for denying the benefits of marriage to homosexual
couples exercising ‘the liberty protected by the Constitution’? Surely not the encouragement
of procreation, since the sterile and the elderly are allowed to marry.”) (internal citations
omitted).
147. Although CBER has not asserted that it has the authority to regulate sexual acts
between two previously unacquainted persons if the male partner has offered himself for the
sole purpose of impregnating the female, such a conclusion follows logically from many of
the arguments in its brief. Such an expansion of scope would appear to exceed
