Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
the exception for donations that will be immediately transferred into a
sexually intimate partner (SIP) of the semen donor. An establishment that
“only recovers reproductive cells or tissue and immediately transfers them
into a sexually intimate partner of the cell or tissue donor” is not required to
register or list its HCT/Ps with CBER. 86 Similarly, “[r]eproductive cells or
tissue donated by a sexually intimate partner of the recipient for
reproductive use” are exempt from Part 1271’s requirements to screen, test,
and conduct donor eligibility determinations. 87 Thus, many of the
burdensome and costly FDA regulations do not apply if a donation comes
from the recipient’s sexually intimate partner, and the definition of that term
becomes vital to individuals who seek to give or receive donated semen in a
purely private, non-clinical context.
The FDA distinguishes sexually intimate partners from so-called
“directed donors.” A directed reproductive donor is defined in 21 C.F.R.
Part 1271.3(l) as “a donor of reproductive cells or tissue (including semen,
oocytes, and embryos to which the donor contributed the spermatozoa or
oocyte) to a specific recipient, and who knows and is known by the
recipient before donation.” 88 Importantly, the term directed reproductive
donor “does not include a sexually intimate partner.” 89 Under FDA
regulations, a donor eligibility determination is mandatory for directed
donations of reproductive tissue, as are screening and tests for disease. 90
Thus, if a donor is “known” but is not an SIP, the regulatory burden is much
greater, and the FDA imposes the aforementioned screening, testing,
labeling, and records requirements, most of which are impracticable for
private individuals to follow.
By implication, then, the FDA’s HCT/P regulations distinguish between
sexually intimate heterosexual couples and others: heterosexual sexually
intimate couples need not adhere to the same regulatory strictures as
married women whose husbands happen to be infertile, single women,
86. 21 C.F.R § 1271.15(e) (2012).
87. 21 C.F.R. § 1271.90(a)( 2) (2012).
88. 21 C.F.R. § 1271.3(I) (2012).
89. Id. See also 69 F.R. § 29,786, 29793. “We have also clarified the definition by
noting that directed reproductive donors do not include sexually intimate donors, who are
excepted from screening and testing requirements under § 1271.90. This change is intended
to make clear that, for the purpose of this rule, there are three categories of reproductive
donors, subject to three different sets of requirements listed as follows: ( 1) The anonymous
donor, to whom all the donor-eligibility requirements apply; ( 2) the directed reproductive
donor, whose reproductive cells and tissue may be used even if the donor is determined
ineligible; and ( 3) the sexually intimate partner, for whom testing and screening are not
required (discussed in section III.D. 11 of this document).”
90. 21 C.F.R. § 1271.50 (2012); U.S. FOOD & DRUG ADMIN., VACCINES, BLOOD, AND
BIOLOGICS (Apr. 19, 2012), http://www.fda.gov/biologicsbloodvaccines/guidance