Order Code RL33540
CRS Report for Congress
Received through the CRS Web
Stem Cell Research:
Federal Research Funding and Oversight
Updated July 20, 2006
Judith A. Johnson
Specialist in Life Sciences
Domestic Social Policy Division
Erin D. Williams
Specialist in Bioethical Policy
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress

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Stem Cell Research:
Federal Research Funding and Oversight
Summary
Embryonic stem cells have the ability to develop into virtually any cell in the
body, and they may have the potential to treat medical conditions such as diabetes
and Parkinson’s disease. In August 2001, President Bush announced that for the first
time, federal funds would be used to support research on human embryonic stem
cells, but funding would be limited to “existing stem cell lines.” NIH has established
a registry listing the 78 human embryonic stem cell lines that are eligible for use in
federally funded research, but only 22 cell lines are currently available. Scientists are
concerned about the quality and longevity of these 22 stem cell lines. Many believe
research advancement requires new embryonic stem cell lines, and for certain
applications, stem cells derived from cloned embryos may offer the best hope for
understanding and treating disease. However, an investigation by Seoul National
University found that scientist Hwang Woo Suk had fabricated results on deriving
patient-matched stem cells from cloned embryos — a major setback for the field.
Some have argued that adult stem cells (from bone marrow or umbilical cord
blood) should be pursued instead of embryonic stem cells because they believe the
derivation of stem cells from embryos is ethically unacceptable. Other scientists
believe adult stem cells should not be the sole target of research because of important
scientific and technical limitations. Reports issued by NIH and the Institute of
Medicine state that both embryonic and adult stem cell research should be pursued.
Some scientists are exploring the possibility of obtaining human embryonic stem
cells that bypass the destruction of living human embryos. The President’s Council
on Bioethics cited four potential alternative sources of human embryonic stem cells
in a May 2005 paper. A number of pro-life advocates support stem cell research;
those opposed are concerned that stem cell isolation requires embryo destruction.
In May 2005, the House passed H.R. 810 (Castle), which would allow federal
support of research that utilizes human embryonic stem cells regardless of the date
on which the stem cells were derived from a human embryo, thus negating the
August 2001 Bush stem cell policy limitation. In July 2006, the Senate passed H.R.
810 and President Bush vetoed it, the first veto of his presidency. An attempt in the
House to override the veto was unsuccessful. The Weldon bill, which passed the
House in the 107th and 108th and stalled in the Senate, was reintroduced in the 109th
Congress as H.R. 1357 and S. 658 (Brownback). The bill would ban the process of
cloning as well as the importation of any product derived from an embryo created via
cloning. It would ban not only reproductive applications, but also research on
therapeutic uses, which has implications for stem cell research. Advocates of the
legislative ban say that allowing any form of human cloning research to proceed
raises serious ethical issues, and will inevitably lead to the birth of a baby who is a
human clone. Critics argue that the measure would curtail medical research and
prevent Americans from receiving life-saving treatments created overseas. S. 876,
H.R. 1822, and S. 1520 ban only human reproductive cloning. This report will be
updated as needed.

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Basic Research and Potential Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Embryonic Stem Cells from IVF Embryos or Fetal Tissue . . . . . . . . . . . . . . 2
Embryonic Stem Cells Obtained via SCNT (Cloning) . . . . . . . . . . . . . . . . . 3
Stem Cells from Adult Tissue or Umbilical Cord Blood . . . . . . . . . . . . . . . . 4
Potential Applications of Stem Cell Research . . . . . . . . . . . . . . . . . . . . . . . . 5
Current Regulatory Landscape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
The Dickey Amendment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Clinton Administration Stem Cell Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Bush Administration Stem Cell Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Regulation of Stem Cell Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
National Academies Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
FDA Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
NIH Research Funding and Stem Cell Registry . . . . . . . . . . . . . . . . . . 12
State Laws that Restrict Stem Cell Research . . . . . . . . . . . . . . . . . . . . . . . . 13
Concerns Over Access to Stem Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Worldwide Survey of Stem Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Congressional Letters on Bush Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Alternative Sources of Human Embryonic Stem Cells . . . . . . . . . . . . . . . . . . . . 18
Dead Embryos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Embryo Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Biological Artifacts — Altered Nuclear Transfer . . . . . . . . . . . . . . . . . . . . 21
Dedifferentation of Somatic Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Congressional Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Stem Cell Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Cloning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Other Related Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
List of Tables
Table 1. National Institutes of Health Funding . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Table 2. NIH List of Human Embryonic Stem Cell Lines
Eligible for Use in Federal Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

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Stem Cell Research:
Federal Research Funding and Oversight
Introduction
On August 9, 2001, President Bush announced that for the first time federal
funds would be used to support research on human embryonic stem cells, but funding
would be limited to stem cell lines that had been created prior to the date of the
policy announcement. Research involving human embryonic stem cells raises a
number of ethical issues because the stem cells are located inside the embryo and the
process of removing them destroys a human embryo.1 A relatively small amount of
federal funding has been used to support human embryonic stem cell research.
Although the National Institutes of Health (NIH) identified 78 human embryonic
stem cell lines that would be eligible for use in federally funded research, most were
found to be either unavailable or unsuitable for research. Twenty-two cell lines are
currently available for research under the Bush policy. Scientists are concerned about
the quality and longevity of these 22 stem cell lines. Many believe research
advancement requires the use of new human embryonic stem cell lines.
Several states, such as California, Connecticut, Illinois, Maryland, and New
Jersey, have responded by moving forward with their own initiatives to encourage
or provide funding for stem cell research, and many others are considering similar
action.2 Proponents of these state stem cell research initiatives want to remain
competitive, as well as prevent the relocation of scientists and biotechnology firms
to other states or overseas. However, without the central direction and coordinated
research approach that the federal government can provide, many are concerned that
the states’ actions will result in duplication of research efforts among the states, a
possible lack of oversight for ethical concerns, and ultimately a loss of U.S.
preeminence in this important area of basic research.
In May 2005, the House passed the Stem Cell Research Enhancement Act of
2005 (H.R. 810). The bill would allow federal support of research that utilizes
human embryonic stem cells regardless of the date on which the stem cells were
derived from a human embryo. In July 2005, Senate Majority Leader Bill Frist
announced his support for H.R. 810. Almost one year later, in late June of 2006,
Senator Frist announced an agreement with Senate Minority Leader Harry Reid on
bringing H.R. 810 up for a vote in the Senate. Because H.R. 810 would contravene
1 For further information, see CRS Report RL33554, Stem Cell Research: Ethical Issues, by
Judith A. Johnson and Erin D. Williams.
2 For further information, see CRS Report RL33524, Stem Cell Research: State Initiatives,
by Judith A. Johnson and Erin D. Williams.

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CRS-2
the August 2001 stem cell policy, President Bush threatened a veto. The Senate
passed H.R. 810 on July 18, 2006, and the President vetoed the bill the next day; an
attempt to override the veto in the House was not successful.
Basic Research and Potential Applications
Most cells within an animal or human being are committed to fulfilling a single
function within the body. In contrast, stem cells are a unique and important set of
cells that are not specialized. Stem cells retain the ability to become some or all of
the more than 200 different cell types in the body, and thereby play a critical role in
repairing organs and body tissues throughout life. Although the term stem cells is
often used in reference to these repair cells within an adult organism, a more
fundamental variety of stem cells is found in the early-stage embryo. Embryonic
stem cells may have a greater ability to become different types of body cells than
adult stem cells.

Embryonic Stem Cells from IVF Embryos or Fetal Tissue
Embryonic stem cells were first isolated from mouse embryos in 1981 and from
primate embryos in 1995. Animal embryos were the only source for research on
embryonic stem cells until November 1998, when two groups of U.S. scientists
announced the successful isolation of human embryonic stem cells. One group, at
the University of Wisconsin, derived stem cells from five-day-old embryos produced
via in vitro fertilization (IVF).3 The work is controversial because the stem cells are
located within the embryo and the process of removing them destroys the embryo.
Many individuals who are opposed to abortion are also opposed to research involving
embryos.
The second group, at Johns Hopkins University, derived stem cells with very
similar properties from five- to nine-week-old embryos or fetuses obtained through
elective abortion.4 Both groups reported the human embryos or fetuses were donated
for research following a process of informing one or more parents and obtaining their
consent. The cells removed from embryos or fetuses were manipulated in the
3 The IVF embryos were originally created for the treatment of infertility. Excess embryos
are often frozen for future use. A couple may elect to discard their excess embryos, donate
the embryos for research, or allow another couple to adopt an embryo. The Society for
Assisted Reproductive Technology and RAND conducted a survey of more than 430
infertility clinics to determine the number of frozen embryos in the United States; 340
clinics responded to the survey. Nearly 400,000 embryos have been frozen and stored since
the late 1970s. The vast majority of embryos are being held to help couples have children
at a later date. Patients have designated 2.8%, or about 11,000 embryos, for research.
Scientists estimate these 11,000 could form up to 275 stem cell lines, perhaps much less
[http://www.rand.org/pubs/research_briefs/RB9038/index1.html].
4 Scientists and physicians use the term “embryo” for the first eight weeks after fertilization,
and “fetus” for the ninth week through birth. In contrast, the Department of Health and
Human Services (HHS) regulations define “fetus” as “the product of conception from the
time of implantation” (45 C.F.R. § 46.203).

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laboratory to create embryonic stem cell lines that may continue to divide for many
months to years. The vast majority of research on human embryonic stem cells, both
in the United States and overseas, utilizes cell lines derived via the University of
Wisconsin method.
Embryonic Stem Cells Obtained via SCNT (Cloning)
Another potential source of embryonic stem cells is somatic cell nuclear transfer
(SCNT), also referred to as cloning.5 For certain applications, stem cells derived
from cloned embryos may offer the best hope for understanding and treating disease.
In SCNT the nucleus of an egg is removed and replaced by the nucleus from a mature
body cell, such as a skin cell obtained from a patient. In 1996, scientists in Scotland
used the SCNT procedure to produce Dolly the sheep, the first mammalian clone.6
When SCNT is used to create another individual, such as Dolly, the process is called
reproductive cloning. In contrast, scientists interested in using SCNT to create
cloned stem cells allow the cell created via SCNT to develop for a few days and then
the stem cells are removed for research. Stem cells created via SCNT would be
genetically identical to the patient and thus would avoid any tissue rejection problems
that could occur if the cells were transplanted into the patient. Creating stem cells
using SCNT for research purposes is often referred to as therapeutic cloning.
Charges of ethical and scientific misconduct have clouded the reputation of
scientists involved in deriving stem cells from cloned human embryos. In February
2004, scientists at the Seoul National University (SNU) in South Korea announced
the first isolation of stem cells from a cloned human embryo. In May 2005 they
announced major advances in the efficiency of creating cloned human embryos and
in isolating human stem cells from the cloned embryos. Concerns about the
achievements of the SNU group arose in November 2005 when a U.S. co-author of
the 2005 paper accused Hwang Woo Suk, the lead researcher of the SNU group, of
ethical misconduct.7 In December 2005 scientists in South Korea began questioning
the validity of scientific evidence presented in the 2005 paper and called for an
independent analysis of the data. Later that month a Korean co-author of the 2005
paper stated to the Korean media that the research was fabricated and the paper
should be retracted; Hwang agreed to the retraction. On January 10, 2006, SNU
5 A somatic cell is a body cell. In contrast, a germ cell is an egg or sperm cell.
6 Dolly was euthanized in February 2003 after developing a lung infection. Some claim
her death at six years was related to being a clone, but her ailment may also have occurred
because she was raised indoors (for security reasons) rather than as a pastured sheep, which
often live to 12 years of age. G. Kolata, “First Mammal Clone Dies,” New York Times, Feb.
15, 2003, p. A4.
7 Gretchen Vogel, “Collaborators Split over Ethics Allegations” Science, Nov. 18, 2005, p.
1100.

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stated that results of the 2004 paper were also a deliberate fabrication.8 On July 5,
Hwang was reported to have admitted full responsibility for the 2005 fabrication.9
Scientists at the University of Newcastle, the University of Edinburgh, Harvard
University, and the University of California at San Francisco are working on deriving
patient-matched stem cells from cloned human embryos.10 The ethical and scientific
misconduct developments in South Korea as well as the unsubstantiated
announcement by Clonaid in December 2002 of the birth of a cloned child have
contributed to the controversy over research on human embryos.11
Stem Cells from Adult Tissue or Umbilical Cord Blood
Stem cells obtained from adult organisms are also the focus of research. There
have been a number of recent publications on the abilities and characteristics of adult
stem cells from a variety of different sources, such as bone marrow and the umbilical
cord following birth. Bone marrow transplantation, a type of adult stem cell therapy,
has been used for 30 years to successfully treat patients for a variety of blood-related
conditions. Several private companies (such as MorphoGen, NeuralStem, Osiris
Therapeutics, StemSource, ViaCell) are working on additional therapeutic uses of
adult stem cells. An opponent of embryonic stem cell research, David A. Prentice
of the Family Research Council, has developed a list of 65 (now 72) diseases that he
claims can be treated using adult stem cells.12 However, a letter to the online journal
of Science Magazine refutes this claim, stating that “adult stem cell treatments fully
tested in all required phases of clinical trials and approved by the U.S. Food and Drug
Administration are available to treat only nine of the conditions on the Prentice
list.”13
Opponents of stem cell research advocate that adult instead of embryonic stem
cell research should be pursued because they believe the derivation of stem cells from
either IVF embryos or aborted fetuses is ethically unacceptable. Others believe that
adult stem cells should not be the sole target of research because of important
scientific and technical limitations. Adult stem cells may not be as long lived or
capable of as many cell divisions as embryonic stem cells. Also, adult stem cells
may not be as versatile in developing into various types of tissue as embryonic stem
8 Nicholas Wade and Choe Sang-Hun, “Researcher Faked Evidence of Human Cloning,
Koreans Report,” The New York Times, Jan. 10, 2006, p. A1.
9 Annie I. Bang, “Hwang Admits Fabricating Stem Cell Data,” The Korean Herald, Jul. 5,
2006.
10 Dennis Normile, Gretchen Vogel, and Constance Holden, “Cloning Researcher Says Work
is Flawed but Claims Results Stand,” Science, Dec. 23, 2005, p. 1886-1887; Carl T. Hall,
“UCSF Resumes Human Embryo Stem Cell Work,” The San Francisco Chronicle, May 6,
2006, p. A.1.
11 For further information, see CRS Report RL31358, Human Cloning, by Judith A. Johnson
and Erin Williams.
12 [http://www.stemcellresearch.org/facts/treatments.htm] accessed on July 20, 2006.
13 Shane Smith, William Neaves and Steven Teitelbaum, “Adult Stem Cell Treatments for
Diseases?” Sciencexpress, July 13, 2006, p. 1 [http://www.sciencexpress.org].

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cells, and the location and rarity of the cells in the body might rule out safe and easy
access. For these reasons, many scientists argue that both adult and embryonic stem
cells should be the subject of research, allowing for a comparison of their various
capabilities. Reports issued by the NIH and the Institute of Medicine (IoM) state that
both embryonic and adult stem cell research should be pursued.14
In FY2004, the Consolidated Appropriations Act, 2004 (P.L. 108-199) provided
$10 million to establish a National Cord Blood Stem Cell Bank within the Health
Resources and Services Administration (HRSA). HRSA was directed to use $1
million to contract with the IoM to conduct a study that would recommend an
optimal structure for the program. The study, Cord Blood: Establishing a National
Hematopoietic Stem Cell Bank Program, was released in April 2005. The blood cell
forming stem cells found in cord blood can be used as an alternative to bone marrow
transplantation in the treatment of leukemia, lymphoma, certain types of anemia, and
inherited disorders of immunity and metabolism. The IOM report provides the
logistical process for establishing a national cord blood banking system, establishes
uniform standards for cord blood collection and storage, and provides
recommendations on ethical and legal issues associated with cord blood collection,
storage and use. For FY2005, the Consolidated Appropriations Act, 2005 (P.L. 108-
447) provided $9,941,000 for the HRSA program. For FY2006 the conference report
on the Labor-HHS-Education Appropriation Act, 2006 (P.L. 109-149, H.Rept. 109-
337) provided $4 million.
On December 20, 2005, the President signed the Stem Cell Therapeutic and
Research Act of 2005 (P.L. 109-129). The act provides for the collection and
maintenance of human cord blood stem cells for the treatment of patients and for
research. It stipulates that amounts appropriated in FY2004 or FY2005 for this
purpose shall remain available until the end of FY2007 (about $18.9 million, see
paragraph above), and authorizes $60 million over FY2007-FY2010. The act also
reauthorizes the national bone marrow registry with $186 million over FY2006-
FY2010. In addition, it creates a database to enable health care workers to search for
cord blood and bone marrow matches and links all these functions under a new name,
the C.W. Bill Young Cell Transplantation program.
Potential Applications of Stem Cell Research
Stem cells provide the opportunity to study the growth and differentiation of
individual cells into tissues. Understanding these processes could provide insights
into the causes of birth defects, genetic abnormalities, and other disease states. If
normal development were better understood, it might be possible to prevent or
correct some of these conditions. Stem cells could be used to produce large amounts
of one cell type to test new drugs for effectiveness and chemicals for toxicity. Stem
cells might be transplanted into the body to treat disease (diabetes, Parkinson’s
14 National Institutes of Health, Department of Health and Human Services. Stem Cells:
Scientific Progress and Future Research Directions, June 2001. The NIH report can be
found at [http://stemcells.nih.gov/info/scireport/]. Institute of Medicine, Stem Cells and the
Future of Regenerative Medicine, 2002. The IoM report can be found at
[http://www.nas.edu].

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CRS-6
disease) or injury (e.g., spinal cord). The damaging side effects of medical treatments
might be repaired with stem cell treatment. For example, cancer chemotherapy
destroys immune cells in patients, decreasing their ability to fight off a broad range
of diseases; correcting this adverse effect would be a major advance.
Before stem cells can be applied to human medical problems, substantial
advances in basic cell biology and clinical technique are required. In addition, very
challenging regulatory decisions will be required on any individually created tissue-
based therapies resulting from stem cell research. Such decisions would likely be
made by the Center for Biologics Evaluation and Research (CBER) of the Food and
Drug Administration (FDA). The potential benefits mentioned above would be likely
only after many more years of research. Technical hurdles include developing the
ability to control the differentiation of stem cells into a desired cell type (like a heart
or nerve cell) and to ensure that uncontrolled development, such as cancer, does not
occur. Some experiments may involve the creation of a chimera, an organism that
contains two or more genetically distinct cell types, from the same species or
different species.15 If stem cells are to be used for transplantation, the problem of
immune rejection must also be overcome. Some scientists think that the creation of
many more embryonic stem cell lines will eventually account for all the various
immunological types needed for use in tissue transplantation therapy. Others
envision the eventual development of a “universal donor” type of stem cell tissue,
analogous to a universal blood donor.
However, if the SCNT technique, or therapeutic cloning, was employed using
a cell nucleus from the patient, stem cells created via this method would be
genetically identical to the patient, would presumably be recognized by the patient’s
immune system, and thus might avoid any tissue rejection problems that could occur
in other stem cell therapeutic approaches. Because of this, many scientists believe
that the SCNT technique may provide the best hope of eventually treating patients
using stem cells for tissue transplantation.
Current Regulatory Landscape
The Dickey Amendment
Prior to an August 2001 Bush Administration decision (see below), no federal
funds had been used to support research on stem cells derived from either human
embryos or fetal tissue.16 The work at the University of Wisconsin and Johns
Hopkins University was supported by private funding from the Geron Corporation.
Private funding for experiments involving embryos was required because Congress
15 Chimeras have been created by scientists in a variety of different ways and have been the
subject of research studies for many years. Human chimeras occur naturally when two eggs
become fertilized and, instead of developing into twins, they fuse in the uterus creating a
single embryo with two distinct sets of genes. For one example, see Constance Holden,
“Chimera on a Bike?” Science, June 24, 2005, p. 1864.
16 However, federal funds have been provided for research on both human and animal adult
stem cells and animal embryonic stem cells.

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attached a rider to legislation that affected FY1996 National Institutes of Health
(NIH) funding. The rider, an amendment originally introduced by Representative Jay
Dickey, prohibited HHS from using appropriated funds for the creation of human
embryos for research purposes or for research in which human embryos are
destroyed. The Dickey Amendment language has been added to each of the Labor,
HHS, and Education appropriations acts for FY1997 through FY2006.17 For
FY2006, the provision is found in Section 509 of the Labor, HHS and Education, and
Related Agencies Appropriations Act, 2006 (P.L.109-149). It states that:
(a) None of the funds made available in this Act may be used for —
(1) the creation of a human embryo or embryos for research purposes; or

(2) research in which a human embryo or embryos are destroyed, discarded, or
knowingly subjected to risk of injury or death greater than that allowed for
research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the
Public Health Service Act (42 U.S.C. 289g(b)).
(b) For purposes of this section, the term ‘human embryo or embryos’ includes
any organism, not protected as a human subject under 45 CFR 46 [the Human
Subject Protection regulations] as of the date of enactment of this Act, that is
derived by fertilization, parthenogenesis, cloning, or any other means from one
or more human gametes [sperm or egg] or human diploid cells [cells that have
two sets of chromosomes, such as somatic cells].
Clinton Administration Stem Cell Policy
Following the November 1998 announcement on the derivation of human
embryonic stem cells, NIH requested a legal opinion from HHS on whether federal
funds could be used to support research on human stem cells derived from embryos.
The January 15, 1999, response from HHS General Counsel Harriet Rabb found that
the Dickey Amendment would not apply to research using human stem cells “because
such cells are not a human embryo within the statutory definition.” The finding was
based, in part, on the determination by HHS that the statutory ban on human embryo
research defines an embryo as an organism that when implanted in the uterus is
capable of becoming a human being. Human stem cells, HHS said, are not and
cannot develop into an organism; they lack the capacity to become organisms even
if they are transferred to a uterus. As a result, HHS maintained that NIH could
support research that uses stem cells derived through private funds, but could not
support research that itself, with federal funds, derives stem cells from embryos
because of the federal ban in the Dickey Amendment.
17 The rider language has not changed significantly from year to year (however there was a
technical correction in P.L. 109-149). The original rider can be found in Section 128 of P.L.
104-99; it affected NIH funding for FY1996 contained in P.L. 104-91. For subsequent fiscal
years, the rider is found in Title V, General Provisions, of the Labor, HHS and Education
appropriations acts in the following public laws: FY1997, P.L. 104-208; FY1998, P.L. 105-
78; FY1999, P.L. 105-277; FY2000, P.L. 106-113; FY2001, P.L. 106-554; FY2002, P.L.
107-116; FY2003, P.L. 108-7; FY2004, P.L. 108-199; and, FY2005, P.L. 108-447.

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Shortly after the opinion by the HHS General Counsel was released, NIH
disclosed that the agency planned to fund research on stem cells derived from human
embryos once appropriate guidelines were developed and an oversight committee
established. NIH Director Harold Varmus appointed a working group that began
drafting guidelines in April 1999. Draft guidelines were published in the Federal
Register on December 2, 1999. About 50,000 comments were received during the
public comment period, which ended February 22, 2000. On August 25, 2000, NIH
published in the Federal Register final guidelines on the support of human
embryonic stem cell research. The guidelines stated that studies utilizing “stem cells
derived from human embryos may be conducted using NIH funds only if the cells
were derived (without federal funds) from human embryos that were created for the
purposes of fertility treatment and were in excess of the clinical need of the
individuals seeking such treatment.” Under the guidelines, NIH would not fund
research directly involving the derivation of human stem cells from embryos; this
was prohibited by the Dickey Amendment.
Other areas of research ineligible for NIH funding under the guidelines include
(1) research in which human stem cells are utilized to create or contribute to a human
embryo; (2) research in which human stem cells are combined with an animal
embryo; (3) research in which human stem cells are used for reproductive cloning of
a human; (4) research in which human stem cells are derived using somatic cell
nuclear transfer, i.e., the transfer of a human somatic cell nucleus into a human or
animal egg; (5) research utilizing human stem cells that were derived using somatic
cell nuclear transfer; and (6) research utilizing stem cells that were derived from
human embryos created for research purposes, rather than for infertility treatment.
NIH began accepting grant applications for research projects utilizing human
stem cells immediately following publication of the guidelines; the deadline for
submitting a grant application was March 15, 2001. All such applications were to be
reviewed by the NIH Human Pluripotent Stem Cell Review Group (HPSCRG),
which was established to ensure compliance with the guidelines. James Kushner,
director of the University of Utah General Clinical Research Center, served briefly
as chair of the HPSCRG. Applications would also have undergone the normal NIH
peer-review process.18 The first meeting of the HPSCRG was scheduled for April 25,
2001. The HPSCRG was to conduct an ethical review of human pluripotent stem
cell lines to determine whether the research groups involved had followed the NIH
guidelines in deriving the cell lines. However, in mid April 2001, HHS postponed
18 According to media sources, as of Apr. 2001 only three grant applications had been
submitted to NIH, and one was subsequently withdrawn. (Washington FAX, Apr. 19, 2001.)
Presumably, scientists were reluctant to invest the time and effort into preparing the
necessary paperwork for the NIH grant application process when the prospects of receiving
federal funding were uncertain under the new Bush Administration. (P. Recer, “Stem Cell
Studies Said Hurt by Doubt,” AP Online, May 2, 2001.) In a related development, one of
the leading U.S. researchers on stem cells, Roger Pederson of the University of California,
San Francisco, decided to move his laboratory to the United Kingdom for “the possibility
of carrying out my research with human embryonic stem cells with public support.” (Aaron
Zitner, “Uncertainty Is Thwarting Stem Cell Researchers,” Los Angeles Times, July 16,
2001, pp. A1, A8.) Human embryonic stem cell research was approved overwhelmingly by
the House of Commons in Dec. 2000 and the House of Lords in Jan. 2001.

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CRS-9
the meeting until a review of the Clinton Administration’s policy decisions on stem
cell research was completed by the new Bush Administration.19 According to media
sources, the 12 HPSCRG members, whose names were not made public, represented
a wide range of scientific, ethical and theological expertise and opinion, as well as
at least one “mainstream Catholic.”20
The Bush Administration conducted a legal review of the policy decisions made
during the Clinton Administration regarding federal support of stem cell research, as
well as a scientific review, prepared by NIH, of the status of the research and its
applications. The scientific review was released on July 18, 2001, at a hearing on
stem cell research held by the Senate Appropriations Subcommittee on Labor, Health
and Human Services and Education.21 The NIH report did not make any
recommendations, but argued that both embryonic and adult stem cell research
should be pursued.
Bush Administration Stem Cell Policy
On August 9, 2001, President Bush announced that for the first time federal
funds would be used to support research on human embryonic stem cells, but funding
would be limited to “existing stem cell lines where the life and death decision has
already been made.”22 President Bush stated that the decision “allows us to explore
the promise and potential of stem cell research without crossing a fundamental moral
line, by providing taxpayer funding that would sanction or encourage further
destruction of human embryos that have at least the potential for life.” The President
also stated that the federal government would continue to support research involving
stem cells from other sources, such as umbilical cord blood, placentas, and adult and
animal tissues, “which do not involve the same moral dilemma.”
Under the Bush policy, federal funds may only be used for research on existing
stem cell lines that were derived: (1) with the informed consent of the donors; (2)
from excess embryos created solely for reproductive purposes; and (3) without any
financial inducements to the donors.23 NIH was tasked with examining the derivation
of all existing stem cell lines and creating a registry of those lines that satisfy the
Bush Administration criteria. According to the White House, this will ensure that
federal funds are used to support only stem cell research that is scientifically sound,
legal, and ethical. Federal funds will not be used for: (1) the derivation or use of
19 Rick Weiss, “Bush Administration Order Halts Stem Cell Meeting; NIH Planned Session
to Review Fund Requests,” Washington Post, Apr. 21, 2001, p. A2.
20 Ibid.
21 National Institutes of Health, Department of Health and Human Services. Stem Cells:
Scientific Progress and Future Research Directions, June 2001. The NIH scientific report
can be found at [http://stemcells.nih.gov/info/scireport/].
22 The Aug. 9, 2001, Remarks by the President on Stem Cell Research can be found at
[http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html].
23 The White House, Fact Sheet on Embryonic Stem Cell Research, Aug. 9, 2001, found at
[http://www.whitehouse.gov/news/releases/2001/08/20010809-1.html].

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CRS-10
stem cell lines derived from newly destroyed embryos; (2) the creation of any human
embryos for research purposes; or (3) the cloning of human embryos for any purpose.
Regulation of Stem Cell Research
The Common Rule (45 CFR 46, Subpart A) is a set of regulations that govern
most federally funded research conducted on human beings. Its three basic
requirements are aimed at protecting research subjects: the informed consent of
research subjects, a review of proposed research by an Institutional Review Board
(IRB), and institutional assurances of compliance with the regulations. However, ex
vivo embryos (those not in a uterus) are not considered “human subjects” for these
purposes, but federally funded research on human embryos is regulated by the Dickey
Amendment as described above. Stem cells and stem cell lines are also not
considered “human subjects,” nor are they governed by the Dickey Amendment.
Because of the current lack of federal regulation of stem cell research, the
National Academies has developed voluntary guidelines for deriving, handling and
using human embryonic stem cells. Two HHS agencies, FDA and NIH, regulate
some aspects of stem cell research, even if research on stem cell lines is not classified
as “human subjects” research. FDA, the agency that ensures the safety and efficacy
of food, drugs, medical devices and cosmetics, regulates stem cell research aimed at
the development of any “product” subject to its approval. NIH, the medical and
behavioral research agency within HHS, regulates stem cell research that it funds in
compliance with President Bush’s 2001 policy. NIH has created a Human
Embryonic Stem Cell Registry that lists the human embryonic stem cell lines that
meet the eligibility criteria as outlined in the Bush Administration stem cell policy.
National Academies Guidelines. In July 2004 the National Academies
established the committee on Guidelines for Human Embryonic Stem Cell Research
to develop voluntary guidelines for deriving, handling and using human embryonic
stem cells due to the current lack of federal regulation of such research. The stated
position of the National Academies is that there should be a global ban on human
reproductive cloning and therefore the guidelines will focus only on therapeutic and
research uses of human embryonic stem cells and somatic cell nuclear transfer.
The committee released its “Guidelines for Human Embryonic Stem Cell
Research” on April 26, 2005. The guidelines recommend that each institution
conducting human embryonic stem cell research establish an oversight committee,
including experts in the relevant areas of science, ethics and law, as well as members
of the public, to review all proposed experiments. The guidelines recommend that
a national panel also be established to oversee the issue in general on a continuing
basis. The guidelines state that culture of any intact embryo, regardless of derivation
method, for more than 14 days should not be permitted at the present time. The
creation of a chimera by insertion of any embryonic stem cells into a human embryo
or the insertion of human embryonic stem cells into a nonhuman primate embryo
should also not be permitted. The guidelines state that chimeric animals in which
human embryonic stem cells have been introduced, at any stage of development,
should not be allowed to breed. The document also provides guidance on informed
consent of donors and states that there should be no financial incentives in the

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CRS-11
solicitation or donation of embryos, sperm, eggs, or somatic cells for research
purposes.
FDA Regulation. All of the human embryonic stem cell lines listed on the
NIH Human Embryonic Stem Cell Registry (see Table 2) have been grown on beds
of mouse “feeder” cells. The mouse cells secrete a substance that prevents the human
embryonic stem cells from differentiating into more mature cell types (nerve or
muscle cells). Infectious agents, such as viruses, within the mouse feeder cells could
transfer into the human cells. If the human cells were transplanted into a patient,
these infected human cells may cause disease in the patient which could be
transmitted to close contacts of the patient and eventually to the general population.
Public health officials and regulatory agencies such as the FDA are specifically
concerned about retroviruses, which may remain hidden in the DNA only to cause
disease many years later, as well as any unrecognized agents which may be present
in the mouse cells.
The FDA defines “xenotransplantation” as “any procedure that involves the
transplantation, implantation, or infusion into a human recipient of either (a) live
cells, tissues, or organs from a nonhuman source, or (b) human body fluids, cells,
tissues or organs that have had ex vivo contact with live nonhuman animal cells,
tissues or organs.”24 Under FDA guidelines, transplantation therapy involving Bush
approved stem cell lines, which all have been exposed to mouse feeder cells, would
constitute xenotransplantation. Xenotransplantation products are subject to
regulation by the FDA under Section 351 of the Public Health Service Act (42 USC
262) and the Federal Food, Drug and Cosmetic Act (21 USC 321 et seq.). FDA has
developed guidance documents and the U.S. Public Health Service has developed
guidelines on infectious disease issues associated with xenotransplantation.25
During a Senate hearing on stem cell research held by the Health, Education,
Labor and Pensions Committee on September 5, 2001, the HHS Secretary stated that
the FDA was overseeing 17 investigational protocols involving xenotransplantation
in other areas of clinical research that involve patients. Therefore, he said, the
xenotransplantation-related public health concerns over the human embryonic stem
cell lines may not necessarily preclude the development of treatments for patients.
While the problems presented by xenotransplantation for clinical research are neither
unique to stem cell research nor insurmountable, many scientists believe it will be
preferable to use sterile cell lines when attempting to treat patients via stem cell
transplantation, and scientists have been successful in developing human embryonic
stem cells that can be maintained without the use of mouse feeder cells.26
24 Xenotransplantation Action Plan: FDA approach to the regulation of xenotransplantation.
Available at [http://www.fda.gov/cber/xap/xap.htm].
25 These documents are available at [http://www.fda.gov/cber/xap/xap.htm].
26 National Institutes of Health, Department of Health and Human Services, Stem Cells:
Scientific Progress and Future Research Directions, June 2001, pp. 95-96; Susanne Rust,
“UW Grows Animal-Free Stem Cell Lines,” The Milwaukee Journal Sentinel, Jan. 2, 2006,
p. A1.

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CRS-12
NIH Research Funding and Stem Cell Registry. The August 9, 2001,
Bush Administration policy statement on stem cell research and the NIH Stem Cell
Registry effectively replaced the NIH stem cell guidelines that were developed under
the Clinton Administration and never fully implemented. Grant proposals for
embryonic stem cell research undergo only the normal peer-review process without
the added review of the HPSCRG as had been specified under the Clinton NIH stem
cell guidelines. In February 2002, NIH announced the approval of the first
expenditures for research on human embryonic stem cells. Funding for stem cell
research by NIH is shown in Table 1. The NIH website provides additional
information about current stem cell activities and funding opportunities.27
The NIH Human Embryonic Stem Cell Registry lists stem cell lines that are
eligible for use in federally funded research and currently available to be shipped to
scientists.28 As shown in Table 2, the NIH registry originally listed universities and
companies that had derived a total of 78 human embryonic stem cell lines which
were eligible for use in federally funded research under the August 2001 Bush
Administration policy. However, many of these stem cell lines were found to be
either unavailable or unsuitable for research. As of May 23, 2006, the NIH registry
listed a total of 22 stem cell lines available from seven sources.
Table 1. National Institutes of Health Funding
($ in millions)
Stem Cell Research
FY03
FY04
FY05
FY06
FY07
Human Embryonic
20
24
40
38
39
Non-Human Embryonic
113
89
97
97
96
Human Non-Embryonic
191
203
199
200
200
Non-Human Non-Embryonic
192
236
273
274
273
517
553
609
609
608
Total, Stem Cell Research
Source: NIH Budget Office, March 10, 2006.
27 See [http://stemcells.nih.gov/research/funding/].
28 Information about the NIH Human Embryonic Stem Cell Registry is available at
[http://stemcells.nih.gov/research/registry/index.asp].

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CRS-13
Table 2. NIH List of Human Embryonic Stem Cell Lines
Eligible for Use in Federal Research
Number of stem cell
lines
Namea
Eligible
Available
BresaGen, Inc., Athens, GA
4
3
Cell & Gene Therapy Institute (Pochon CHA University), Seoul,
2
Korea
Cellartis AB, Goteborg, Sweden
3
2
CyThera, Inc., San Diego, CA
9
0
ES Cell International, Melbourne, Australia
6
6
Geron Corporation, Menlo Park, CA
7
Goteborg University, Goteborg, Sweden
16
Karolinska Institute, Stockholm, Sweden
6
0
Maria Biotech Co. Ltd. — Maria Infertility Hospital Medical
3
Institute, Seoul, Korea
MizMedi Hospital — Seoul National University, Seoul, Korea
1
1
National Center for Biological Sciences/Tata Institute of
3
Fundamental Research, Bangalore, India
Reliance Life Sciences, Mumbai, India
7
Technion University, Haifa, Israel
4
3
University of California, San Francisco, CA
2
2
Wisconsin Alumni Research Foundation, Madison, WI
5
5
Total
78
22
Source: [http://stemcells.nih.gov/research/registry/eligibilityCriteria.asp].
a. Six table entries do not have stem cell lines available for shipment to U.S. researchers because of
a variety of scientific, regulatory and legal reasons. The zeros entered in the “Available” column
indicate that “the cells failed to expand into undifferentiated cell cultures.”
State Laws that Restrict Stem Cell Research29
Many states restrict research on aborted fetuses or embryos, but research is often
permitted with consent of the parent or parents. Almost half of the states also restrict
the sale of fetuses or embryos. Louisiana is the only state that specifically prohibits
research on in vitro fertilized (IVF) embryos. Illinois and Michigan also prohibit
research on live embryos. Arkansas, Indiana, Iowa, Michigan, North Dakota and
South Dakota prohibit research on cloned embryos. Virginia may also ban research
on cloned embryos, but the statute may leave room for interpretation because human
being is not defined. (There may be disagreement about whether human being
29 The information in this section was obtained from “State Embryonic and Fetal Research
Laws,” National Council of State Legislatures website, at [http://www.ncsl.org/programs/
health/genetics/embfet.htm], visited Jul. 13, 2006.

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CRS-14
includes blastocysts, embryos or fetuses.) California, Connecticut, Massachusetts,
New Jersey and Rhode Island have laws that prohibit cloning for the purpose of
initiating a pregnancy, but allow cloning for research.
Several states limit the use of state funds for cloning or stem cell research.
Missouri forbids the use of state funds for reproductive cloning but not for cloning
for the purpose of stem cell research, and Maryland’s statutes prohibit state-funded
stem cell researchers from engaging in reproductive cloning. Arizona law prohibits
the use of public monies for reproductive or therapeutic cloning. Nebraska statutes
limit the use of state funds for embryonic stem cell research. Restrictions only apply
to state healthcare cash funds provided by tobacco settlement dollars. State funding
available under Illinois Executive Order 6 (2005) may not be used for reproductive
cloning or for research on fetuses from induced abortions.
Despite restrictive federal and state policies, many states are encouraging or
providing funding for stem cell research (in some cases therapeutic cloning as well),
as they seek to remain competitive and prevent the relocation of scientists and
biotechnology firms to other states or overseas. For further information, please see
CRS Report RL33524, Stem Cell Research: State Initiatives.
Concerns Over Access to Stem Cell Lines
Many scientists, disease advocates and others remain concerned that federally
supported research on human embryonic stem cells is limited to the number of cell
lines that meet the criteria of the August 9, 2001 Bush policy. As stated above,
currently 22 cell lines are available for research with federal dollars. Because the
pre-August 9 cell lines were developed in the early days of human stem cell research
using older 1990s techniques, the cell lines not only have the problems of
xenotransplantion (described in the previous section on FDA regulation), but they are
harder to work with, not well characterized, and genetically unstable compared to
newer stem cell lines.
In reaction to the limitations imposed by the Bush policy, several U.S. research
groups have decided to develop additional human embryonic stem cell lines using
private funding. Some research groups are using state funds as well.30
In June 2004, a team of scientists at the Reproductive Genetics Institute, a
private fertility clinic in Chicago, announced that they had isolated 50 new human
embryonic stem cell lines from frozen embryos that were donated by patients
following fertility treatment.31 By using genetic diagnosis techniques, the Chicago
team was able to create stem cell lines that carry the gene for muscular dystrophy as
30 See CRS Report RL33524, Stem Cell Research: State Initiatives, by Judith A. Johnson
and Erin Williams.
31 Gareth Cook, “Clinic in U.S. Isolates 50 Lines of Stem Cells,” Boston Globe, June 9,
2004, p. A1.

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CRS-15
well as stem cell lines with the gene for six other diseases.32 The new stem cell lines
are to be used to understand the origins of disease-related symptoms and to develop
and test new treatments.33
In March 2004, a Harvard University laboratory headed by Douglas Melton
announced that using private research dollars they had isolated 17 new human
embryonic stem cell lines.34 One year later the Harvard team had increased that
number to 28 new human embryonic stem cell lines.35 In order to perform this work
Harvard considered it necessary to build a new laboratory so that the group’s
federally funded research would be conducted separately from research on the new
stem cell lines. Likewise, although the Harvard stem cell lines are available for use
by other laboratories, any research using the new stem cell lines must be performed
at a facility that does not receive federal support. The Harvard group intends to raise
private funding to continue the work begun by Melton and his group of scientists as
well as produce cloned human embryos for research studies on juvenile diabetes,
Parkinson’s disease, and several other diseases.36
In December 2002, Stanford University announced that a gift of $12 million
from an anonymous donor would be used to establish an institute that will use
expertise in stem cell biology and cancer biology to develop novel treatments for
cancer and other diseases.37 The Institute for Cancer/Stem Cell Biology and
Medicine is headed by Dr. Irving Weissman, a Professor in Cancer Biology at
Stanford. The Institute is developing new stem cell lines, some through the process
of SCNT, to study the disease process of a wide range of disorders including cancer,
diabetes, cardiovascular disease, autoimmune disease, allergies, and neurological
disorders such as Parkinson’s and Lou Gehrig’s disease.38
In August 2002, the University of California at San Francisco established the
UCSF Developmental and Stem Cell Biology Program with a $5 million matching
grant from Andy Grove, the chairman of Intel Corporation. The program funds basic
studies (using both animal and human cells) in stem cell biology and their translation
into clinical practice with a goal of developing treatments for such diseases as
diabetes, cardiovascular disease, Parkinson’s disease, Alzheimer’s disease and spinal
cord injury. UCSF and the University of Wisconsin are the only two universities in
32 The six diseases are beta thalassemia, neurofibromatosis type 1, Marfan’s syndrome,
myotonic dystrophy, fragile X syndrome, and Fanconi’s anemia.
33 For further information, see [http://www.reproductivegenetics.com].
34 Rick Weiss and Justin Gillis, “New Embryonic Stem Cells Made Available,” Washington
Post, Mar. 4, 2004, p. A2.
35 Gareth Cook, “Harvard Provost OKs Procedure,” Boston Globe, Mar. 20, 2005, p. A29.
(Hereafter cited as Cook, “Harvard Provost OKs Procedure.”)
36 For further information, see [http://www.stemcell.harvard.com].
37 For further information, see the Stanford University Medical Center website at
[http://mednews.stanford.edu/stemcellQA.html].
38 For further information, see [http://www.stemcell.stanford.edu].

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CRS-16
the United States that have derived human embryonic stem cell lines that qualified
for inclusion on the NIH Stem Cell Registry.
Worldwide Survey of Stem Cell Lines
A worldwide survey of laboratories conducted by the Boston Globe found that
as of May 23, 2004, 128 human embryonic stem cell lines had been created since
August 9, 2001; all would be ineligible for use in federally funded research under the
Bush policy on stem cell research.39 More lines are being created in laboratories
overseas than in the United States, according to the survey. The survey found that
94 were created in labs outside the United States and 34 were created in this country.
Of the 128 lines, 51 of the new stem cell lines are currently available for use, the
remaining cell lines are not available for a variety of technical or legal reasons. For
example, some cell lines have not yet been fully characterized to determine their
stability or suitability for research. However, eventually their status is to be
determined by using laboratory techniques. In Japan, stem cell lines are not allowed
to be shipped to laboratories in other countries. In the United Kingdom, stem cell
lines cannot be shipped abroad until they have been processed by the new UK Stem
Cell Bank.40
Congressional Letters on Bush Policy
In response to concerns over access to human embryonic stem cell lines, in April
2004, a group of over 200 Members of the House of Representatives sent a letter to
President Bush requesting that the Administration revise the current stem cell policy
and utilize the embryos that are created in excess of need during the treatment of
infertile couples.41 The letter points out that an estimated 400,000 frozen IVF
embryos42 “will likely be destroyed if not donated, with informed consent of the
couple, for research.” According to the letter,
scientists are reporting that it is increasingly difficult to attract new scientists to
this area of research because of concerns that funding restrictions will keep this
research from being successful. ... We have already seen researchers move to
countries like the United Kingdom, which have more supportive policies. In
addition, leadership in this area of research has shifted to the United Kingdom,
which sees this scientific area as the cornerstone of its biotech industry.
39 Gareth Cook, “94 New Cell Lines Created Abroad since Bush Decision,” Boston Globe,
May 23, 2004, p. A14.
40 For further information on the UK Stem Cell Bank, see [http://www.nibsc.ac.uk/divisions/
cbi/stemcell.html].
41 See [http://www.house.gov/degette/news/releases/040428.pdf].
42 A survey conducted in 2002 and published in 2003 by the Society for Assisted
Reproductive Technology and RAND determined that nearly 400,000 frozen embryos are
stored in the United States, but most are currently targeted for patient use. See David I.
Hoffman et al., “Cryopreserved Embryos in the United States and Their Availability for
Research,” Fertility and Sterility, vol. 79, May 2003, pp. 1063-1069.

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CRS-17
Under the direction of the White House, NIH Director Elias A. Zerhouni sent
a letter in response to the House Members which restates the Bush Administration
position against using federal funds for research involving the destruction of human
embryos.43 The letter from NIH Director Zerhouni did contain the following sentence
which some observers believed in 2004 indicated a potential future policy shift:
“And although it is fair to say that from a purely scientific perspective more cell lines
may well speed some areas of human embryonic stem cell research, the president’s
position is still predicated on his belief that taxpayer funds should not ‘sanction or
encourage further destruction of human embryos that have at least the potential for
life.”44 At the time, White House spokesperson Claire Buchan stated that the
sentence did not indicate the president’s position had changed. Supporters of stem
cell research point out that it concedes that science could benefit from additional
stem cell lines and that the president’s position now rests solely on ethical arguments.
A letter signed by 58 Senators urging President Bush to expand the current
federal policy concerning embryonic stem cell research was sent on June 4, 2004.45
The letter states that “despite the fact that U.S. scientists were the first to derive
human embryonic stem cells, leadership in this area of research is shifting to other
countries such as the United Kingdom, Singapore, South Korea and Australia.”
On July 14, 2004, HHS Secretary Thompson announced in a letter to Speaker
of the House Dennis Hastert that NIH would establish Centers of Excellence in
Translational Stem Cell Research.46 The new centers are to investigate how stem
cells can be used to treat a variety of diseases. A National Embryonic Stem Cell
Bank is to collect in one location many of the stem cell lines that are eligible for
federal research funding. In the letter to Speaker Hastert, Secretary Thompson stated
that “before anyone can successfully argue the stem cell policy should be broadened,
we must first exhaust the potential of the stem cell lines made available with the
policy.”47 In reaction to the announcement, the President of the Coalition for the
Advancement of Medical Research stated that “creating a bank to house stem cell
lines created before August 2001 does nothing to increase the wholly inadequate
supply of stem cell lines for research.”48 On October 3, 2005, NIH announced that
it had awarded $16.1 million over four years to the WiCell Research Institute in
Wisconsin to fund the National Stem Cell Bank.49 NIH also awarded $9.6 million
43 Rick Weiss, “Bush’s Stem Cell Policy Reiterated, but Some See Shift,” The Washington
Post, May 16, 2004, p. A18.
44 Letter from Elias A. Zerhouni, Director, National Institutes of Health, to The Honorable
Diana DeGette and The Honorable Michael Castle, May 14, 2004.
45 See [http://feinstein.senate.gov/04Releases/r-stemcell-ltr.pdf].
46 Andrew J. Hawkins, “NIH Stem Cell Bank, Centers of Excellence Will Fast-Track
Translational Research, Says Thompson,” Washington FAX, July 15, 2004.
47 Ibid.
48 Ibid.
49 NIH Press Office, “NIH Awards a National Stem Cell Bank and New Centers of
Excellence in Translational Human Stem Cell Research,” Oct. 3, 2005. [http://www.nih.
(continued...)

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CRS-18
over four years to fund two new Centers of Excellence in Translational Human Stem
Cell Research, one at the University of California, Davis and the other at
Northwestern University.
Alternative Sources
of Human Embryonic Stem Cells
Most scientists involved in human embryonic stem cell research are focused on
using stem cells derived from human embryos via the methods developed by
scientists at the University of Wisconsin. However, a small number of scientists
have begun to explore ways of obtaining human embryonic stem cells that bypass the
destruction of living human embryos and, therefore, may be less troubling to those
who object to the research on moral and ethical grounds. The President’s Council
on Bioethics identified four potential methods in a paper released in May 2005.50
The four alternative methods would require additional research to determine whether
human embryonic stem cells could be generated.
Some council members, however, expressed concern that work on alternative
sources is a “diversion from the simple task at hand which is to move forward with
the established laboratory techniques ... for studying embryonic stem cell research
and biomedical cloning” and that the four proposals would “use financial resources
that would be better devoted to proposals that are likely to be more productive.”51
Laurie Zoloth, professor of Medical Humanities and Bioethics, and of Religion at
Northwestern University’s Feinberg School of Medicine, maintains that public
funding should not be used to satisfy the moral qualms of a minority and proposes
that private religious groups should consider funding research on alternative sources
of human embryonic stem cells just as Jehovah’s Witnesses supported efforts to
develop blood-saving surgical techniques to avoid transfusions.52
Dead Embryos
One possible method under discussion is deriving human embryonic stem cells
from dead embryos. Early embryos frequently fail to develop in naturally occurring
conceptions.
49 (...continued)
gov/news/pr/oct2005/od-03.htm] The website for WiCell and the National Stem Cell Bank
can be found at [http://www.wicell.org/].
50 The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, May 2005, at [http://www.bioethics.gov/reports/white_paper/
index.html].
51 Ibid., Personal Statement of Michael S. Gazzaniga, p. 76 and Personal Statement of Dr.
Janet D. Rowley, p. 90.
52 Molly Laas, “Alternative Stem Cell Derivation Methods Should Be Funded By Private
Religious Groups,” Research Policy Alert, Nov. 10, 2005.

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CRS-19
Slightly fewer than a third of all conceptions lead to a fetus that has a chance of
developing. In other words, if you were to choose [an embryo] at random and
follow it through the first week of development, the chances are less than one in
three that it would still be there at full term, even though there has been no
human intervention. Nature, it seems, performs abortions at a much higher rate
than human society. It is simply not true that most [embryos], if undisturbed,
will produce a human being. The probability that a conception will result in a
live birth is actually quite low. Note that since we have assumed that all
conceptions lead to cell division, we have almost surely overestimated the true
success rate.53
As many as 60% of IVF embryos produced by infertility clinics are judged to
be incapable of developing to live birth, according to IVF clinics, due to abnormal
appearance or failure to divide appropriately, and are not used by the infertile couple.
Although failure to divide is often caused by genetic abnormalities and might seem
to eliminate any prospect of using these embryos even for research, several studies
suggest that some normal cells may be obtained from such organismically dead
embryos and may be useful in creating stem cell lines.
The possibility that normal cells removed from dead embryos could potentially
develop into an embryo (and if transferred into a uterus — a child) would be
disturbing to some individuals. In addition, such a possibility would likely preclude
federal funding for producing stem cell lines from such cells because of restrictions
contained in the Dickey Amendment (see subsection, below, Embryo Biopsy).
Research studies to determine the precise criteria for embryonic organismic death
would be needed; however, such “natural history” studies could not be conducted
with federal dollars. Federal funding of any type of research involving human
embryos, starting with IVF then later cloning and the creation of stem cell lines from
embryos, has been blocked by various policy decisions dating back more than 25
years and is currently controlled by the Dickey Amendment (see section, above, The
Dickey Amendment and Clinton Administration Stem Cell Policy).
The President’s Council points out that this method of obtaining stem cells from
dead embryos may not be acceptable to scientists because they understandably want
to work only with the best materials. Why would scientists want to use cells derived
from dead embryos, which may be abnormal, asks the council, or even bother trying
to create these cell lines when they can use existing cell lines or derive new ones
from IVF embryos? The only advantage may be eligibility for federal funding. One
Council member points out that the proposal entails thawing out embryos to follow
the natural history of dead embryos, and because it is unknown “which embryos will
not divide and which will, some portion (about half) will continue to divide and will
be healthy embryos. What happens to these healthy embryos? ... [I]t would be
strange, while allowing large numbers of unwanted but otherwise normal and viable
IVF embryos to die, to ask scientists to make strenuous efforts to rescue cells,
53 Harold J. Morowitz and James S. Trefil, The Facts of Life: Science and the Abortion
Controversy (Oxford University Press, 1992), p. 51.

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CRS-20
potentially abnormal, only from those thawed embryos that have spontaneously
stopped dividing. ... This seems to me to be the height of folly.”54
Embryo Biopsy
A second method of obtaining embryonic stem cells without destroying the
embryo employs a technique used by IVF clinics that offer pre-implantation genetic
diagnosis (PGD). At the 6-8 cell stage, one or two cells are removed from the
embryo created via IVF; these cells are then screened for genetic or chromosomal
abnormalities before the embryo is transferred to a woman’s uterus. More than 1,000
children have been born following PGD, though it is still unclear whether subtle or
late onset injuries may occur in children born following PGD.55
In October 2005, scientists at Advanced Cell Technology of Massachusetts
announced success in deriving mouse embryonic stem cells by removing one cell
from an eight-cell mouse embryo.56 Following implantation into a surrogate mother,
the seven-cell embryos developed into healthy mice at the same rate as embryos that
had not been biopsied. However, creation of the stem cell lines was much less
efficient than when a later-stage embryo was used.
It may be possible to create human stem cell lines using cells obtained in this
manner; after cell removal, the seven-cell embryo would be used in an attempt to
initiate a pregnancy. Although it is understandable that couples who are at risk of
having a child with a genetic disease may willingly agree to the potential added risk
of PGD, said the council, it is difficult to understand what circumstances might
motivate any couple to agree to such a procedure for the sole purpose of creating
stem cell lines for research. Research studies to determine if there is a risk of harm
to a human embryo by the cell biopsy procedure could not be funded with federal
dollars due to, as mentioned above, longstanding opposition to federal support for
any type of research involving human embryos. Furthermore, research suggests, a
single cell from a sheep or rabbit 4- or 8-cell embryo is potentially capable of
developing into a normal sheep or rabbit. The possibility that a biopsied human cell
may have “the potential to develop into an embryo and a child on its own” could
preclude federal funding for producing stem cell lines from such cells because of
restrictions contained in the Dickey Amendment (see section, above, The Dickey
Amendment and Clinton Administration Stem Cell Policy).57
54 The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, May 2005, p. 21 and p. 89.
55 Ibid., pp. 24-25.
56 Nicholas Wade, “Stem Cell Test Tried on Mice Saves Embryo,” The New York Times,
Oct. 17, 2005.
57 The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, p. 29.

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Biological Artifacts — Altered Nuclear Transfer
A third possible method involves using the techniques of genetic engineering
and SCNT (cloning) to obtain embryonic stem cells from embryo-like groups of cells
which are not, in the strict sense, human embryos. In this approach, called altered
nuclear transfer (ANT), a gene in the nucleus of the somatic cell is altered, so that
normal embryo development is not possible, before the nucleus is placed within an
enucleated egg. In October 2005, scientists at the Massachusetts Institute of
Technology reported success in generating mouse embryonic stem cells utilizing the
ANT approach.58 A gene was disabled that allows for embryo implantation; gene
function can be restored later so the stem cell line is unaffected. As is the case with
SCNT, if the ANT approach is ever used to generate human embryonic stem cells a
major obstacle would be obtaining an adequate supply of human eggs. This is the
subject of intense scientific research. Researchers are trying to develop methods of
obtaining human eggs without resorting to superovulation of female patients, an
expensive procedure that some find morally questionable.
Some researchers believe ANT might serve as a temporary bridge until other
technologies are developed, such as dedifferentiation of somatic cells. Until then, if
federal support is provided, its proponents believe ANT would allow embryonic stem
cell research collaboration on a national level without the ethical concerns involved
in using leftover IVF embryos. Others believe that the procedures involved in ANT
are more complex than deriving human embryonic stem cells from normal embryos,
and many scientists “would be reluctant to attempt such challenging feats with no
rational purpose other than to satisfy the ethical objections of others.”59
Critics are concerned over the questionable morality of creating a biological
artifact with a built in genetic defect, or what might be considered as the deliberate
creation of a doomed or disabled human embryo. “Some find it aesthetically
repulsive and ethically suspect to be creating such neither-living-nor-nonliving, near-
human artifacts, a practice they regard as ethically no improvement over destroying
early embryos.”60 Proponents of the ANT approach argue that “such an entity would
be a ‘biological artifact,’ not an organism. Removal of cells from, or even
disaggregation of, this artifact would not be killing or harming, for there is no living
being here to be killed or harmed.”61 Given the ethical uncertainties, it is unclear
whether or not research involving ANT to generate human embryonic stem cells
could be supported with federal funds.
Dedifferentation of Somatic Cells
The fourth method identified by the President’s Council on Bioethics involves
the dedifferentiation of somatic cells, literally reprogramming or winding back the
58 Nicholas Wade, “Stem Cell Test Tried on Mice Saves Embryo,” The New York Times,
Oct. 17, 2005.
59 Ibid., p. 47.
60 The President’s Council on Bioethics, White Paper, p. 41.
61 Ibid., p. 37.

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clock on cell development to produce cells with the capabilities of embryonic stem
cells. In August 2005, researchers at Harvard announced qualified success at
producing a hybrid cell that has some of the characteristics of an embryonic stem
cell.62 The Harvard group fused human skin cells with human embryonic stem cells,
but the process is very inefficient — 50 million skin cells and 50 million embryonic
stem cells yielded only 10 to 20 fused cells — and all the hybrid cells have twice the
normal amount of DNA. However, Yuri Verlinski and his team at the Reproductive
Genetics Institute in Chicago claim to have created 10 patient-matched embryonic
stem cell lines, called stembrids, with the normal amount of DNA. First the nucleus,
which contains the DNA, is removed from the human embryonic stem cells and then
these enucleated cells are fused with cells from a patient.63 Alan Trounson at Monash
University in Melbourne, Australia, is working on a similar method involving cell
fusion.64
Because embryos are not involved, federal funding for research on this method
would presumably not be blocked by the Dickey Amendment. However, the
President’s Council on Bioethics expresses some concern that dedifferentiation might
proceed too far, resulting in a cell that has the capability of developing into an
embryo. This possibility would raise serious ethical issues for some, and presumably
the Dickey Amendment may again preclude the use of this method in the production
of human embryonic stem cells for research. Moreover, such an embryo would be
a clone of the individual who donated the somatic cell and any attempt to “save” such
an embryo through the implantation in a woman’s uterus would raise additional
moral and ethical questions.
Congressional Actions
Stem Cell Research
The 109th Congress addressed the issue of stem cell research in the Labor, HHS
and Education Appropriations Act, 2006 (P.L. 109-149) by again including the
Dickey Amendment, which has banned, since FY1996, almost all publically funded
human embryo research. In addition, the Science, Justice and Commerce
Appropriation Act, 2006 (P.L. 109-108) bars the Patent and Trademark Office from
spending money “to issue patents on claims directed to or encompassing a human
organism.” This restriction, which was first included in the Consolidated
Appropriations Act, 2004 (P.L. 108-199) and in the Consolidated Appropriations
Act, 2005 (P.L. 108-447), could potentially deter human stem cell research because
researchers might not be able to claim ownership of their work.
62 Rick Weiss, “Skin Cells Converted to Stem Cells,” The Washington Post, Aug. 22, 2005,
p. A1.
63 Michael LePage and Rowan Hooper, “Double Triumph in Stem Cell Quest,” New
Scientist, May 28, 2005, p. 8.
64 Rick Weiss, “Stem Cell Advances May Make Moral Issue Moot,” The Washington Post,
June 6, 2005, p. A7.

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H.R. 810 (Castle), the Stem Cell Research Enhancement Act, passed the House
on May 24, 2005 on a vote of 238-194. It would amend the Public Health Service
Act and direct the Secretary of HHS to conduct and support research that utilizes
human embryonic stem cells regardless of the date on which the stem cells were
derived from a human embryo. Stem cell lines derived after enactment must meet
ethical guidelines established by the NIH. Only embryos that were originally created
for fertility treatment purposes and in excess of clinical need are eligible for stem cell
derivation. Only embryos that the individuals seeking fertility treatments have
determined will not be implanted in a woman and will be discarded are eligible for
stem cell derivation. Written consent is required for embryo donation. The Secretary
in consultation with the Director of NIH shall promulgate guidelines 60 days after
enactment. No federal funds shall be used to conduct research on unapproved stem
cell lines. The Secretary shall annually report to Congress about stem cell research.
A companion bill, S. 471 (Specter) was introduced on February 28, 2005.
On June 29, 2006, Senate Majority Leader Bill Frist announced an agreement
to schedule a vote in the Senate on stem cell research legislation, more than a year
after the House passed H.R. 810. Under the agreement, amendments were not
allowed on a package of three bills; each needed 60 votes to pass: H.R. 810, S. 2754
(Santorum) the Alternative Pluripotent Stem Cell Therapies Enhancement Act, and
S. 3504 (Santorum) the Fetus Farming Prohibition Act. S. 3504 does not address the
issue of stem cell research but rather the use of tissue from a later stage embryo or
fetus.
The second bill in the agreement, S. 2754, was introduced on May 5, 2006. It
would amend the Public Health Service Act adding a new Section 409J “Alternative
Human Pluripotent Stem Cell Research.” The bill would require the Secretary of
HHS to develop techniques for the isolation, derivation, production, or testing of
stem cells that are capable of producing all or almost all of the cell types of the
developing body and may result in improved understanding of treatments for diseases
and other adverse health conditions, but are not derived from a human embryo.
Within 90 days of enactment, the Secretary would be required to: (1) provide
guidance concerning the next steps required for additional research; (2) prioritize
research with the greatest potential for near-term clinical benefit; and (3) take into
account techniques outlined by the President’s Council on Bioethics and any other
appropriate techniques and research. The Secretary would be required to prepare and
submit to the appropriate committees of Congress an annual report describing the
activities and research conducted. The bill authorizes such sums as may be necessary
for FY2007 through FY2009. A companion bill, H.R. 5526 (Bartlett), was
introduced on June 6, 2006.
The third bill, S. 3504, was introduced on June 13, 2006. It would amend the
Public Health Service Act to prohibit the solicitation or acceptance of human fetal
tissue obtained from a human pregnancy that was deliberately initiated to provide
such tissue, or tissue obtained from a human embryo (or fetus) that was implanted
in the uterus of a nonhuman animal. The bill was referred to the Senate Health,
Education, Labor and Pensions Committee. A companion bill, H.R. 5719 (Weldon),
was introduced on June 29, 2006, and referred to the House Energy and Commerce
Committee.

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On July 18, 2006, the Senate passed H.R. 810 (63 to 37), S. 2754 (100-0) and
S. 3504 (100-0). On the same day, the House passed S. 3504 (100-0) but failed to
pass S. 2754 with the required 2/3 vote (273-154). On July 19, 2006, President Bush
signed S. 3504 and vetoed H.R. 810, the first veto of his six years in office. An
attempt in the House on July 19 to override the veto of H.R. 810 did not receive the
required 2/3 vote (235-193).
H.R. 3144 (Bartlett), the Respect for Life Pluripotent Stem Cell Act of 2005,
was introduced on June 30, 2005. H.R. 3144 would amend the Public Health Service
Act to provide for a program at NIH to conduct and support stem cell research that
does not harm human embryos. Such research may include research on animal
embryos or human postnatal tissues or umbilical cord blood. The bill specifically
prohibits research that (1) involves the use of human embryos; (2) involves the use
of stem cells not otherwise eligible for funding by NIH; (3) involves the use of any
stem cell to create or to attempt to create a human embryo; or (4) poses a significant
risk of creating a human embryo by any means. H.R. 3144 would authorize $15
million for research in FY2006 and such sums as may be necessary for FY2007
through FY2010. H.R. 3144 was referred to the House Committee on Energy and
Commerce. H.R. 2574 (Bartlett), the Respect for Life Embryonic Stem Cell Act of
2005, introduced on May 24, 2005, appears to be an earlier version of this legislation.
A companion bill, S. 1557 (Coburn), was introduced on July 29, 2005.
Cloning
H.R. 1357 (Dave Weldon), the Human Cloning Prohibition Act of 2005, was
introduced on March 17, 2005. H.R. 1357 amends Title 18 of the United States Code
and would ban the process of human cloning as well as the importation of any
product derived from an embryo created via cloning. Under this measure, cloning
could not be used for reproductive purposes or for research on therapeutic purposes,
which would have implications for stem cell research. H.R. 1357 includes a criminal
penalty of imprisonment of not more than 10 years and a civil penalty of not less than
$1 million. H.R. 1357 is essentially identical to the measure that passed the House
in the 107th Congress (H.R. 2505) and the 108th Congress (H.R. 534). H.R. 1357 was
referred to the House Committee on the Judiciary.
A companion bill, S. 658 (Brownback), was introduced on March 17, 2005. It
is similar to H.R. 1357, except that (1) it does not contain the ban on importation of
products derived from therapeutic cloning; and (2) it would amend Title 4 of the
Public Health Service Act (42 U.S.C. §§ 289 et seq.) instead of Title 18 of the United
States Code.65 S. 658 includes a criminal penalty of imprisonment of not more than
10 years and a civil penalty of not less than $1 million. It would require GAO to
conduct a study to assess the need (if any) for any changes of the prohibition on
cloning in light of new developments in medical technology, the need for SCNT to
produce medical advances, current public attitudes and prevailing ethical views on
the use of SCNT and potential legal implications of research in SCNT. The study is
65 By seeking to amend Title 18 of the U.S. Code rather than the Public Health Service Act,
S. 658 would likely be subject to different committee jurisdiction.

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CRS-25
to be completed within four years of enactment. S. 658 has been referred to the
Senate Health, Education, Labor, and Pensions Committee.
S. 876 (Hatch), the Human Cloning Ban and Stem Cell Research Protection Act
of 2005, was introduced on April 21, 2005. A similar bill, H.R. 1822 (Bono), the
Human Cloning Ban and Stem Cell Research Protection Act of 2005, was introduced
on April 26, 2005. S. 876 would amend Title 18 of the United States Code and H.R.
1822 would amend the Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.).66
Both bills would ban human reproductive cloning but allow cloning for medical
research purposes, including stem cell research. S. 876 and H.R. 1822 include a
criminal penalty of imprisonment of not more than 10 years; S. 876 has a civil
penalty of not less than $1 million, H.R. 1822 has a civil penalty not to exceed $10
million.
S. 876 would require the Comptroller General to prepare a series of four reports
within one year of enactment. The first report describes the actions taken by the
Attorney General to enforce the prohibition on human reproductive cloning, the
personnel and resources used to enforce the prohibition, and a list of any violations
of the prohibition. A second report describes similar state laws that prohibit human
cloning and actions taken by the states’ attorney general to enforce the provisions of
any similar state law along with a list of violations. A third report describes the
coordination of enforcement actions among the federal, state and local governments.
A fourth report describes laws adopted by foreign countries related to human cloning.
H.R. 1822 requires a similar set of three reports to be prepared by the Secretary of
Health and Human Services.
S. 876 and H.R. 1822 would amend the Public Health Service Act by requiring
that human SCNT be conducted in accordance with the ethical requirements (such
as informed consent, examination by an Institutional Review Board, and protections
for safety and privacy) contained in subpart A of 45 C.F.R. Part 46,67 or Parts 50 and
56 of 21 C.F.R.68 S. 876 and H.R. 1822 have a prohibition on conducting SCNT on
fertilized human eggs (oocytes), and both state that “unfertilized blastocysts” shall
not be maintained after more than 14 days from its first cell division, aside from
storage at temperatures less that zero degrees centigrade. S. 876 and H.R. 1822
stipulate that a human egg may not be used in SCNT research unless the egg is
donated voluntarily with the informed consent of the woman donating the egg. Both
bills also specify that human eggs or unfertilized blastocysts may not be acquired,
received or otherwise transferred for valuable consideration if the transfer affects
interstate commerce. In addition, SCNT may not be conducted in a laboratory in
which human eggs are subject to assisted reproductive technology treatments or
procedures, such as in vitro fertilization for the treatment of infertility. Violation of
these provisions in S. 876 and H.R. 1822 regarding ethical requirements would result
66 Because they amend different titles of the U.S. Code, the bills would likely be subject to
different committee jurisdiction.
67 This provision specifies protections due to human beings who participate in research
conducted or supported by HHS and many other departments.
68 This provision specifies protections due to human beings who participate in research
involved in testing a drug or medical device for FDA approval.

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in a civil penalty of not more than $250,000. S. 876 has been referred to the Senate
Judiciary Committee. H.R. 1822 has been referred to the House Energy and
Commerce Committee.
S. 1520 (Feinstein), the Human Cloning Ban Act of 2005, was introduced on
July 27, 2005. S. 1520 is the same as S. 876 except that it does not require oversight
reports prepared by the Comptroller General and does not delineate specific ethical
requirements on the separate topic of SCNT research.
Supporters of a total ban on human cloning, such as that contained in H.R. 1357,
argue that a partial ban on human cloning, like the one in S. 876, would be
impossible to enforce. Critics of the total ban on human cloning argue that SCNT
creates a “clump of cells” rather than an embryo, and that the ban would curtail
medical research and prevent Americans from receiving life-saving treatments
created overseas.
The U.S. Supreme Court has recognized in past cases certain personal rights as
being fundamental and protected from government interference.69 Some legal
scholars believe a ban on human cloning may be struck down by the Supreme Court
because it would infringe upon the right to make reproductive decisions which is
“protected under the constitutional right to privacy and the constitutional right to
liberty.”70 Other scholars do not believe that noncoital, asexual reproduction, such
as cloning, would be considered a fundamental right by the Supreme Court. A ban
on human cloning research may raise other constitutional issues: scientists’ right to
personal liberty and free speech. In the opinion of some legal scholars, any
government limits on the use of cloning in scientific inquiry or human reproduction
would have to be “narrowly tailored to further a compelling state interest.”71
Other Related Legislation
S. 1373 (Brownback), the Human Chimera Prohibition Act of 2005, was
introduced on July 11, 2005. S. 1373 would amend the federal criminal code to
prohibit and to set penalties for (1) creating or attempting to create a human chimera
(a being with human and non-human tissue as specified in this act); (2) transferring
or attempting to transfer a human embryo into a non-human womb, or a non-human
embryo into a human womb; or (3) transporting or receiving a human chimera. S.
1373 would define a human chimera as (A) a human embryo into which a
non-human cell or cells (or the component parts thereof) have been introduced to
render its membership in the species Homo sapiens uncertain through germline or
other changes; (B) a hybrid human/animal embryo produced by fertilizing a human
egg with non-human sperm; (C) a hybrid human/animal embryo produced by
fertilizing a non-human egg with human sperm; (D) an embryo produced by
69 For further discussion of these issues and their relationship to human cloning, see CRS
Report RL31422, Substantive Due Process and a Right to Clone, by Jon O. Shimabukuro.
70 L.B. Andrews, “Is There a Right to Clone? Constitutional Challenges to Bans on Human
Cloning,” Harvard Journal of Law and Technology, summer 1998, pp. 643-680.
71 Ibid., p. 667.

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introducing a non-human nucleus into a human egg; (E) an embryo produced by
introducing a human nucleus into a non-human egg; (F) an embryo containing
haploid sets of chromosomes from both a human and a non-human life form; (G) a
non-human life form engineered such that human gametes develop within the body
of a non-human life form; or (H) a non-human life form engineered such that it
contains a human brain or a brain derived wholly or predominantly from human
neural tissues. S. 1373 was referred to the Senate Committee on the Judiciary. S.
659, introduced on March 17, 2005, was an earlier version of this legislation.
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