Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
After a semen bank performs the testing and screening described above,
it must retain records and interpretation of the tests, the name and address
of the testing laboratory, and the resulting donor eligibility determination,
including the name of the responsible person who made the donor eligibility
determination, and the date of the determination. 81 These records must be
maintained for least ten years. 82 The donated semen itself must be kept in a
container labeled with a distinct identification code, the results of the donor
eligibility determination, and a summary of the records used to make the
determination. 83 These records must also accompany the sample if it is
distributed or transported. 84
Even donors who are initially deemed “eligible” to assist women who
want to conceive children via AI, can subsequently be excluded from the
donor pool based on changes in their “relevant social behavior.” Indeed, 21
C.F.R. Part 1271.75(e), which allows for an “abbreviated donor screening
procedure on repeat donations,” explicitly instructs “establishments that
perform donor screening” to “determine and document” any changes in
the repeat donor’s “relevant social behavior” that could “make the donor
As one can see, sperm banks are subject to a comprehensive set of
regulatory obligations applicable to gamete donation. They must conduct
extensive reviews of donors’ medical records and “relevant social
behaviors” and test donors for a wide variety of diseases within a week of
the donation itself using government-approved tests in labs meeting
government-approved standards. The expense of performing these
screening and testing procedures, as well as the cost of maintaining records
of the results for at least a decade, highlights the necessity of
professionalization, economies of scale, and perhaps most importantly,
monetary compensation for institutions performing these functions.
However, not every donation triggers the full slate of precautions.
C. Donations Exempt from Part 1271’s Requirements
Perhaps the most important exception to the Part 1271 requirements is
80. 21 C.F.R § 1271.80(c) (2012); ELIGIBILITY GUIDANCE, supra note 67, pt. V( 2), at 25.
Where the establishment accepting the donation contracts with another entity to perform
testing, the establishment is responsible for ensuring that the testing facility complies with
current good tissue practice requirements. 21 C.F.R § 1271.150(c) (2012).
81. 21 C.F.R § 1271.55(d)( 1) (2012).
82. 21 C.F.R § 1271.55(d)( 4) (2012).