Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
The irrationality of CBER’s actions is further illustrated by their
consequences: to avoid disease risk, CBER inadvertently encourages
conduct that poses a greater hazard. If CBER can shut down private,
individual donors providing semen for artificial insemination but cannot
regulate those providing natural insemination, the latter may become the
only free option for women seeking donated semen. CBER’s interpretation
of the regulations thus increases the likelihood that a donee lacking funds to
purchase semen from a bank will engage in sexual intercourse with donors,
even if this would mean that she had to engage in an adulterous sexual act
or violate her sexual orientation. Natural insemination carries a greater risk
to both partners: each is exposed to the other’s bodily fluids, as well as
potential contagion spread via skin-to-skin contact. To create a regulatory
regime that increases the very type of risk that it seeks to minimize is
irrational on its face.
Issuance of a cease-manufacture order, like any action by an
administrative agency, must be “rational, based on consideration of the
relevant factors, and within the scope of the authority delegated to the
agency by the statute.” 148 However, CBER’s extension of 21 C.F.R. Part
1271 to donor like Arsenault is irrational and failed to consider important
factors bearing on disease risk, as noted above. Moreover, individuals
seeking to conceive a child together have a protected constitutional interest
in procreative liberty, but this important factor received little or no attention
from CBER in its analysis of 21 C.F.R. Part 1271. The government’s brief
described Arsenault as “attempting to circumvent the protections afforded
[non-traditional] ‘families,’” 149 yet ignoring the individual interests of the
recipients and assumed that the government’s proper role is to step in and
constitutionally grounded limitations on federal regulatory authority under the Commerce
Clause, U.S. CONST. art I, § 8, cl. 3, even as interpreted broadly by cases such as Gonzales v.
Raich, 545 U.S. 1, 16-17 (2005). Under our system of federalism, the federal government’s
regulatory authority is not untrammeled but rather is constitutionally limited; purely
intrastate noneconomic activity is outside of the purview of federal regulation. See U. S. v.
Morrison, 529 U.S. 598, 602, 611 (2000) (characterizing family law, marriage, divorce, and
childrearing as “areas of traditional state regulation” that are outside of the ambit of federal
regulatory authority and outlining constitutional limits on the federal government’s
regulatory authority under the Commerce Clause). Moreover, such a broad assertion of
federal power to regulate private procreative choices would bring individual-rights concerns
to the fore with additional urgency. See also infra Part V.
