Final Report (all chapters)

eligibility” rule, and a “good tissue practice” rule, 15 all of which have been finalized, pending
some minor changes.
Of particular interest to the present discussion are the first two rules on “establishment
registration” and ”donor eligibility.” The first rule simply requires all tissue manufacturers,
including ART programs and sperm and oocyte banks, to register with the FDA and to provide a
listing of the human tissues produced, stored, or manipulated. Registration consists of a one-page
form, to be updated twice a year. 16 Upon completion of the registration process, it will be
possible for the first time to determine the exact number and type of reproductive tissue facilities
in the United States. While the number of ART programs is well-known, no accurate information
was available until recently on the number of sperm and oocyte banks operating in the United
States. Estimates ranged from less than 100 to more than 1,000. 17 Its simplicity notwithstanding,
this rule is an essential element of any regulatory infrastructure aimed at monitoring the ART
industry.
Donor screening and testing requirements set forth in the second rule (“donor eligibility”)
are not central to the present discussion. The rule would be of considerable import if Congress
decided to monitor and/or regulate the trade of reproductive tissues. As discussed in chapter 6,
most countries that recently have passed regulation in the area of reproductive medicine have
restricted, in some cases severely, the free and commercial trade of reproductive tissues. The
“donor eligibility” rule requires not only that donors be screened and tested, but that the
reproductive tissue establishments maintain documentation about all reproductive tissues. The
rule has detailed provisions for the information that must be attached to reproductive tissues at
all times. 18 In addition to the test results, a unique identification code associated with the donor
must be included. Tissue banks must retain these records for at least 10 years.
If the U.S. public, through Congress or a regulatory agency, determined that the trade of
oocytes should be permitted but only as a non-commercial activity, the “donor eligibility” rule
would considerably facilitate the agency’s monitoring and enforcement efforts. To this end, the
labeling requirements would have to be updated to include some basic financial information
about each transaction. More generally, this rule may also be regarded as a first important step
15
16
17
18
Department of Health and Human Services (Food and Drug Administration), "21 CFR Parts 207, 807, and 1271.
Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final
Rule," Federal Register 66, no. 13 (2001).
Department of Health and Human Services (Food and Drug Administration), "21 CFR Parts 210, 211, 820, and
1271. Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products,"
Federal Register 69, no. 101 (2004).
Department of Health and Human Services (Food and Drug Administration), "21 CFR Parts 16, 1270, and
1271," Federal Register 69, no. 226 (2004).
See http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3356.doc.
In 1997, Ginsberg put this number at 400, but the source was a New York Times news story whose source was
unnamed. See Karen M. Ginsberg, "FDA Approved? A Critique of the Artificial Insemination Industry in the
United States," University of Michigan Journal of Law Reform 30 (1997), p.826.
Department of Health and Human Services (Food and Drug Administration), "21 CFR Parts 16, 1270, and
1271," p.1271.55.
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