Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
observing FDA-approved protocol; 71 persons who have resided in the
United Kingdom, Europe, or specified African countries for certain
proscribed periods (and persons whose “sexual partners” were born in
certain African countries); 72 U.S. military personnel and “civilian military
employees” and their dependents, if they resided at certain U.S. military
bases during the 1980s; 73 persons who have shared a house or apartment
with someone who has certain forms of hepatitis within the past year; 74
prospective donors who have been diagnosed with certain forms of mental
illness; 75 and anyone who was detained in “juvenile detention, lock up, jail
or prison” for more than 72 hours in the past year (irrespective of the
person’s guilt or innocence and regardless of whether he was charged with a
crime). 76 The foregoing list of “relevant social behaviors” is illustrative, not
exhaustive. The FDA’s proffered reason for recommending that anyone
who engaged in this type of “relevant [ i.e., undesirable] social behavior”
from the donor pool is, of course, that the foregoing are “risk factors for
relevant communicable disease agents and diseases.” 77
The FDA also has specific requirements to screen for communicable
diseases. Semen donor-eligibility determinations must include screening
and testing for human immunodeficiency virus (HIV), types 1 and 2;
hepatitis B virus; hepatitis C virus; human transmissible spongiform
encephalopathy diseases, including Creutzfeldt-Jakob disease (the human
form of “mad cow disease”); treponema pallidum, a spirochete that can
cause syphilis or other infectious diseases; types I and II of human T-lymphotropic virus, a human RNA retrovirus that causes certain cancers;
cytomegalovirus; chlamydia trachomatis; and neisseria gonorrhea. 78
Additionally, the FDA has noted that certain other diseases pose sufficient
disease risk to justify screening including West Nile virus, sepsis, and
vaccinia (the virus used in smallpox vaccinations). 79 Moreover, semen
banks must use FDA licensed, approved, or cleared donor screening tests
and be certified to perform such testing on human specimens either under
the Clinical Laboratory Improvement Amendments (CLIA) or equivalent
requirements as determined by the Centers for Medicare and Medicaid
Id. pt. IV(E)( 23), ( 25), ( 27), at 19.
Id. pt. IV(E)( 24).
Id. pt. IV(E)( 9), at 15.
Id. pt. IV(E)( 20), at 18.
Id. pt. IV(E)( 8), at 15.
Id. pt. IV(E), at 14.
21 C.F.R § 1271.75(a)-(c) (2012).