Recent state cloning bills: taking cloned
embryos into the fetal or newborn stage
The current federal bill to allow human cloning for research purposes (S. 303)
mandates the destruction of cloned embryos when they are 14 days old. However,
biotechnology interests in many states have already dropped this arbitrary time
limit to support broader proposals. One possible reason for this: The only
successful trials in using cloning to provide therapies for animals have
required developing cloned embryos to the fetal stage (to provide kidney tissue
for cows) or even to the newborn stage (to correct an immune deficiency in mice)
before usable stem cells could be harvested.† The new state bills would allow
researchers to extend this approach to humans – definitively eliminating the
distinction between “therapeutic cloning” and “reproductive cloning” the
industry has defended in the past.
California
The Health and Safety Code includes both a law on cloning, and a more recent law
(2002) on stem cell research.
- Law on stem cell research (enacted September 2002):
- 125115. The policy of the State of California shall be as follows: (a) That
research involving the derivation and use of human embryonic stem cells, human
embryonic germ cells, and human adult stem cells from any source, including
somatic cell nuclear transplantation, shall be permitted and that full
consideration of the ethical and medical implications of this research be given.
(b) That research involving the derivation and use of human embryonic stem
cells, human embryonic germ cells, and human adult stem cells, including somatic
cell nuclear transplantation, shall be reviewed by an approved institutional
review board.
[This implies that researchers can develop cloned embryos to the fetal or even
live-born stage to obtain stem cells. (“Embryonic germ cells” are obtained from
fetuses at around 8-9 weeks of development, and of course human adult stem cells
are obtained from born humans.) The scope of this law is arguably limited by the
1997 cloning law, re-enacted as permanent law in 2002:]
- Law on human cloning (enacted as five-year ban in1997, made permanent in
September 2002):
- 24185. (a) No person shall clone a human being or engage in human reproductive
cloning. (b) No person shall purchase or sell an ovum, zygote, embryo, or fetus
for the purpose of cloning a human being. (c) For purposes of this chapter, the
following definitions apply: (1) "Clone" means the practice of creating or
attempting to create a human being by transferring the nucleus from a human cell
from whatever source into a human or nonhuman egg cell from which the nucleus
has been removed for the purpose of, or to implant, the
resulting product to initiate a pregnancy that could result in the birth of a
human being. (2)
"Department" means the State Department of Health Services. (3) "Human
reproductive cloning" means the creation of a human fetus that is substantially
genetically identical to a previously born human being. The department may
adopt, interpret, and update regulations, as necessary, for purposes of
more
precisely defining the procedures that constitute human reproductive cloning.
[(c)(1) suggests that cloned embryos can be used to initiate a pregnancy as long
as this cannot result in a live birth, but (c)(3) seems to prohibit creating a
cloned “fetus” (scientifically this stage begins at 8 weeks of development).
There is an open question whether the more recent law on stem cell research is
designed to supercede this 8-week limit. The task of further defining
“reproductive cloning” is left to regulations, which would have to resolve this
apparent conflict.]
Illinois
- HB 3589, as introduced February 2003:
- The policy of the State of Illinois shall be as follows: (1) That research
involving the derivation and use of human embryonic stem cells, human embryonic
germ cells, and human adult stem cells from any source, including somatic cell
nuclear transplantation, shall be permitted and that the ethical and medical
implications of this research shall be given full consideration...
[Virtually identical to California’s 2002 law, but without
any language limiting
human cloning.]
Maryland
H.B. 482, as introduced February 2003:
-
(A) The General Assembly declares that it is the policy of the state that
research involving the derivation and use of human embryonic stem cells,
human
embryonic germ cells, and human adult stem cells from any source, including
somatic cell nuclear transplantation, shall be allowed and that full
consideration shall be given to the ethical and medical implications of this
research.
-
(B) Research involving the derivation and use of human embryonic stem cells,
human embryonic germ cells, and human adult stem cells from any source,
including somatic cell nuclear transplantation, shall be reviewed by an
institutional review board.
[Again, this is California’s language on stem cell research, without any effort
to prevent even “reproductive” cloning designed to obtain fetal and adult stem
cells. The reliance here on institutional review boards (IRBs) is especially
ironic -- in 2001, Maryland’s highest court found that the IRB at Johns Hopkins
University had collaborated with irresponsible researchers to evade federal
safety regulations and endanger inner-city children in a major research project.
The chief institution testifying in support of HB 482 in March 2003 was... Johns
Hopkins University.]
[After a March 12 hearing, this bill received a “do not pass” recommendation in
committee.]
New Jersey
S. 1909 and A. 2840, as introduced in September and October 2002 respectively:
- It is the public policy of this State that research involving the derivation and
use of human embryonic stem cells, human embryonic germ cells and human adult
stem cells from any source, including somatic cell nuclear transplantation,
shall: (1) be permitted in this State; (2) be conducted with full consideration
for the ethical and medical implications of this research; and (3) be reviewed,
in each case, by an institutional review board operating in accordance with
applicable federal regulations.
[NOTE: The same as Maryland’s language, but with an added reference to federal
regulations. In fact, there are no federal regulations that are “applicable” to
experiments in human cloning, or to experiments on embryos outside the womb,
because federal funding of such research has been banned by a separate statutory
provision in annual appropriations bills since 1996.]
- During the legislative process the following provision on cloning was added to
these bills:
- A person who knowingly engages or assists, directly or indirectly, in the
cloning of a human being is guilty of a crime of the first degree. As used in
this section, "cloning of a human being" means the replication of a human
individual by cultivating a cell with genetic material through the egg, embryo,
fetal and newborn stages into a new
human individual.
[One is not guilty of “cloning a human being” unless one brings the cloned
embryo through the fetal and newborn stages to form “a new human individual.”
This amendment only seems to underscore the fact that the bill allows use of
cloning (“somatic cell nuclear transplantation”) to produce a fetus or newborn
infant for harvesting of stem cells.]
[S. 1909 was approved by the state senate, before the bill sparked national
controversy and was withdrawn from the Assembly floor.]
New York
A. 1819 as introduced in January 2003:
- Includes a provision identical to California’s provision encouraging
- research involving the derivation and use of human embryonic stem cells, human
embryonic germ cells, and human adult stem cells from any source, including
somatic cell nuclear transplantation.
Also prohibits “human cloning,” defined as
- the replication of a single human being by cultivating a cell with genetic
material from such human being through the egg, embryo, fetal and newborn stages
resulting in the manifestation of a new human being whose genetic material has
been derived from solely from the genetic material of the first-said human
being.
[As in the New Jersey bills, one is only guilty of “human cloning” if one
maintains the cloned human “through” all stages including the newborn stage.
This leaves open the prospect of exploiting cloned embryos, fetuses and even
newborn infants for their stem cells.]
A. 6249, as introduced in March 2003:
- "Therapeutic cloning" means creating a human embryo through somatic cell nuclear
transfer for the purpose of medical or scientific research or medical treatment.
"Reproductive cloning" means creating a human embryo through somatic cell
nuclear transfer for the purpose of the gestation and subsequent birth of a
human being, or the gestating of a human embryo, created through somatic cell
nuclear transfer, or resulting fetus for that purpose...
It shall be unlawful for any person or entity to knowingly: (A) perform or
attempt to perform reproductive cloning; or (B) transfer or receive, in whole or
in part, any oocyte, embryo, fetus, or human somatic cell, for the purpose of
reproductive cloning.
Nothing in this Article shall restrict any activity not specially prohibited by
this Article, including but not limited to the following and related scientific
activity: (A) therapeutic cloning; (B) stem cell research and related
application of such research...
[The bill allows “therapeutic cloning,” defined as creating a cloned embryo for
purposes of research (no matter how long that embryo is maintained), and its
authorization of cloning for “stem cell research” is not limited to embryonic
stem cells. The bill does forbid “reproductive cloning,” but only if the purpose
of gestation is a “subsequent birth,” so this seems to allow developing cloned
embryos into the fetal stage as long as they are allowed to miscarry or are
aborted for their stem cells.]
Pennsylvania
- HB 422, as introduced February 2003:
- Research involving the derivation and use of human embryonic stem cells, human
embryonic germ cells and human adult stem cells from any source, including
somatic cell nuclear transfer, shall be authorized. Researchers shall give full
consideration to the ethical and medical implications of this research.
[California’s 2002 language, without
any provision limiting even “reproductive”
cloning.]
Texas
- SB 1034, as introduced March 2003:
- USE OF HUMAN CELLS PERMITTED... (a) A person may conduct research involving the
derivation and use of human embryonic stem cells, human embryonic germ cells,
and human adult stem cells, including cells from somatic cell nuclear
transplantation. (b) The research authorized by this section: (1) must be
conducted with full consideration for the ethical and medical implications of
the research; and (2) must be reviewed, in each case, by an institutional review
board operating in accordance with applicable federal regulations...
- HUMAN CLONING PROHIBITED; OFFENSE... A person commits an offense if the person,
directly or indirectly, knowingly engages in or assists in
the replication of a
human individual by cultivating a cell with the individual's genetic material
through the egg, embryo, fetal, and newborn stages into a new human individual.
[Virtually identical to New Jersey’s language, including the provision that one
is guilty of prohibited “human cloning” only if one brings the cloned human
through the fetal and newborn stages.]
Vermont
- H. 326, as introduced in 2003:
- Research involving the derivation and use of human embryonic stem cells, human
embryonic germ cells, and human adult stem cells from any source, including
somatic cell nuclear transplantation, shall be permitted, and full consideration
of the ethical and medical implications of this research shall be given.
[Virtually identical to California’s 2002 law. The final provision of this bill
reads: “No person acting pursuant to this chapter shall clone a human being or
engage in human reproductive cloning.” However, none of the terms are defined so
this provision has no clear meaning.]
Washington
- SB 5466, as approved by Senate committee March 6:
- It is the policy of Washington state that research involving
the derivation and
use of human embryonic stem cells, human embryonic germ cells, and human adult
stem cells from any source, including somatic cell nuclear transplantation, is
permitted upon full consideration of the ethical and medical implications of
this research.
- Includes a ban on "cloning of a human being," defined as
- asexual reproduction by implanting or attempting to implant the product of
nuclear transplantation into a uterus or substitute for a uterus
with the
purpose of producing a human being.
[Virtually identical to California’s 2002 law on the use of embryonic, fetal and
adult stem cells from cloning. Since gestation in a uterus or “substitute” is
only banned if done for the purpose of producing a “human being,” and this term
is left undefined, the bill may allow developing a cloned embryo well into the
fetal stage and then destroying the cloned fetus to obtain stem cells.]
On cow kidney study, see Lanza et al., 20 Nature
Biotechnology 689-96 (July 2002); on mouse study see Rideout et al., 109
Cell 17-27 (April 15, 2002).
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