Final Report (all chapters)

on a clinic-by-clinic basis could be expanded to monitor the health and well-being of newborn
children up to approximately one year of age. This is the age at which most birth and congenital
defects not detectable at birth become apparent. As shown in Appendix C, there remains
considerable uncertainty about the relationship between the use of ART technologies and the
frequency of various birth and genetic defects. An extended system of health monitoring would
go a long way to improving our limited knowledge of the possible risks associated with ART
technologies. Obviously, there would be costs associated with the implementation and operation
of an extended system of monitoring, costs that could be defrayed in part through user fees and
in part through governmental contributions.
The model program is clearly not designed to substantively regulate the practice of
reproductive medicine. Its requirements reveal a ubiquitous concern for procedural matters.
These requirements do not in any way impinge upon the professional autonomy and judgment of
the medical profession, or for that matter restrict the options available to prospective parents. In
fact, the statute explicitly prevents regulators from intervening directly in this field of medicine.
FCSRA prohibits “establish[ing] any regulation, standard, or requirement which has the effect of
exercising supervision or control over the practice of medicine in assisted reproductive
technology programs.” 9 In this sense, the model program should be regarded as a regulatory
infrastructure that could play a useful role should Congress decide to intervene more directly in
the field of reproductive medicine. For example, tracking the creation, import, export, and
exchange of human embryos would require only minimal changes. 10 The model program would
also facilitate detecting violations of prohibited practices, such as the for-profit trade of oocytes
or embryos, and the misuse or unauthorized destruction of embryos. 11
It should be noted that the model program as described by the CDC is comprehensive and
quite detailed. Its implementation would no doubt cause additional, and possibly significant,
costs to ART clinics. Yet the program can hardly be described as a case of administrative
overzealousness. The CDC has made clear that many requirements included in the model
program are based on existing ART programs, such as the College of American Pathologists
(CAP) certification program for embryo labs and other state, federal, and international ART
programs. 12 The addendum lists several professional organizations the CDC has consulted with
to develop this program. Thus the model program, comprehensive and cumbersome as it may be,
simply reflects the state of the art in managing embryo labs as it has emerged in consultation
with all relevant professional and trade associations.
9
10
11
12
42 USC 263a-2(i).
We are not suggesting that embryos currently are being bought and sold in large numbers. Should the donation
of cryopreserved embryos for research become common practice, tracking embryo donation would become
considerably more important.
See Department of Health and Human Services (Centers for Disease Control and Prevention), "Implementation
of the Fertility Clinic Success Rate and Certification Act of 1992 – a Model Program for the Certification of
Embryo Laboratories; Notice," Section C 39388- 91.
See Ibid. Introduction and background sections.
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