[Pflienews] PharmFacts E-News Update: Irving analysis: OH Bill to 'ban cloning' vetoed by Guv, needs a lot of homework!
PFLI PharmAid Center
pfli at pfli.org
Sat Jun 14 10:57:54 MDT 2008
*PharmFacts E-News Update -- 14 June 2008 AD
*
/This picture diagrams the difference between SCNT (cloning) and normal
sexual reproduction. Note that in SCNT the embryo/baby is destroyed in
order to harvest the stem cells.
/
Dianne N. Irving, MA, PhD
© June 13, 2008
*"Ohio 'pro-life' Bill to 'Ban' Human Cloning Needs Homework"*
http://www.pfli.org/articles/20080614irving_ohsb174analysis.html
Although the assumption must be that any group calling itself "pro-life"
is sincere in its efforts to protect the most vulnerable of human
beings, e.g., human embryos, from exploitation and destruction, the
current bill so offered in the State of Ohio leaves a great deal to be
desired, and if passed would not fulfill its claimed purpose of being a
"total human cloning ban" because of the presence of multiple legal
loopholes. Although the following concerns were sent to various
publicly vocal groups, no explanations or clarifications were
forthcoming. I leave it to the readers to decide for themselves if this
proposed bill would indeed legally "ban" all human cloning. All
comments, and proofs, are most welcome. My comments follow directly
after identifying specific problematic sections of the proposed bill.
DNI
************************************************************
[emphases added]
http://www.legislature.state.oh.us/bills.cfm?ID=127_SB_174
OHIO GENERAL ASSEMBLY
As Introduced
127^th General Assembly
Regular Session 2007-2008
S.B. No. 174
*Senator Buehrer *
*Cosponsors: Senators Carey, Coughlin, Gardner, Schuler *
* *
* *
*A BILL*
*To amend section 3701.99 and to enact section 3701.94 of the Revised
Code _to prohibit human cloning_.*
*_Comments_: Doesn't specify if the prohibition applies only to the use
of state funds, or also applies to the use of private funds. Also,
would need to see the wording of and definitions in the law they are
amending. Needless to say, there could be language in the original law
or legal document that could negate language in this proposed bill.*
*
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: *
*Section 1. That section 3701.99 be amended and section 3701.94 of the
Revised Code be enacted to read as follows:*
*Sec. 3701.94. *
*_(_**A) As used in this section:*
*(1) _"DNA" means human deoxyribonucleic acid._*
*_Comments_: While it is true that "DNA" refers to deoxyribonucleic
acid (human /and/ non-human), one wonders why this bill refers only to
"human" DNA, and why this scientific definition is even part of this
bill, since there is no further reference in this bill's formal
definitions to any "DNA". Again, would it have anything to do with
items in the original law they are amending? For example, what would
the original bill state about any "non-human" DNA, if anything
(implications for the creation and use of human/non-human chimeras)?
Again, if they define "human genome" in the original bill only in terms
of /nuclear/ DNA, then such a definition of "human genome" would be
scientifically erroneous, since the human genome consists of both
nuclear and extra-nuclear DNA (i.e., DNA in the chromosomes outside the
nucleus in the cytoplasm of the cell, such as mitochondrial DNA). If
this is the case, then they would not have to address the scientific and
ethical problems involving the presence of /foreign mitochondrial DNA in
the cloned embryo/ when using any human nuclear transfer cloning
techniques (either somatic cell nuclear transfer or germ line cell
nuclear transfer). Nor would they have to worry about any immune
rejection problems caused in patients into whom such cells were
injected, even if donor patient cells were used to create the cloned
embryo. Such problems would be defined away -- legally.*
* *
*(2) "Human blastocyst" means an early stage human embryo that is five
to seven days _after conception_*.
*_Comments_: _The bill fails to legally define "conception"_. So its
legal meaning is up for grabs. Internationally recognized human
embryologists O'Rahilly and Muller rejected the use of the term
"conception" as scientifically erroneous and misleading [see **Ronan
O'Rahilly and Fabiola Müller, /Human Embryology & Teratology/ (New
York: Wiley Liss, 1994), p. 19]. They also rejected as scientifically
erroneous and purely political the related term "pre-embryo" (or any of
its various "substitutes"), after the term's formal rejection many years
ago by the international /Nomina Embryologica/ Committee [see O'Rahilly
and Muller, ibid., (2001), p. 88]. In turn, the use of the false term
"pre-embryo" would rapidly result in the false definition of both
"pregnancy" and "conception' to mean "implantation" by professional
medical organizations such as ACOG (American College of Gynecologists)
and a multitude of other professional organizations and governmental
departments (see partial list below). And is prolife aware that the
term "conception" is already legally defined in many states as
"implantation"?*
*See, e.g.: Philip G. Peters, Jr. "The Ambiguous Meaning of Human
Conception," /University of California Davis Law Review/, 40, no. 1
(2006): 199--228 [available from
http://lawreview.law.ucdavis.edu/issues/Vol40/Issue1/DavisVol40No1_Peters.pdf.
See also the abstract, at Social Science Research Network (SSRN),
available from
http://papers.ssm.com/sol3/papers.cfm?abstract_id=694102; also
available from Westlaw and Lexisnexis]; *
*Elizabeth Spahn and Barbara Andrade, "Mis-Conceptions: The Moment of
Conception in Religion, Science, and Law," /University of San Francisco
Law Review/ 32, (1998): pp. 261--295; erroneously defining "conception"
as "implantation".*
* *
*As noted, the term "conception" is often mis-defined, even in major
professional reports and literature, government regulations, other
state, national, and international laws and regulations as meaning
"implantation" (5--7 days post-fertilization) based on the erroneous
term "pre-embryo" or its various "substitutes".*
*See, e.g.: /Miller-Keane Encyclopedia & Dictionary of Medicine,
Nursing & Allied Health/, 7th ed. (Philadelphia, Penn. 2003), p. 406 -
erroneously defines "conception" as "the onset of pregnancy, marked by
implantation of the blastocyst"; John Walton, Paul B. Beeson, Ronald
Bodley, eds. /Oxford Companion to Medicine/ (Oxford 1986), p. 254 -
erroneously defines "conception" as "the fertilization of an ovum by a
spermatozoon and the implanting of the resulting zygote"; Richard
Sloane, /Sloane-Dorland Annotated Medical-Legal Dictionary/, 1992
Supplement (St. Paul 1992), p. 131 - erroneously defines "conception" as
"the onset of pregnancy, marked by implantation of the blastocyst";
American College of Obstetricians and Gynecologists, /Ethics in
Obstetrics and Gynecology/, 2nd ed., No. 97 (2004, pp. 957, 958 --
erroneously defines "preembryo" as the "product of fertilization before
14 days and the arrival of the primitive streak"; American Fertility
Society Ethics Committee, "Ethical Considerations of the New
Reproductive Technologies", /Fertility and Sterility/ 46, Supplement 1
(September1986): 27S; American Medical Association Council on Ethical
and Judicial Affairs, /CEJA Report/ 1--I--94, "Pre--Embryo Splitting"
(1994); American Society of Reproductive Medicine Ethics Committee
Report, "Human Somatic Cell Nuclear Transfer," /Fertility and Sterility/
74, no. 5 (November 2000): 873--876; American Society of Reproductive
Medicine, "Chapter 16: Experimentation on the Preembryo," /Fertility and
Sterility/ 87, no. 4, Supplement 1 (April 2007): S52--S58; British
House of Lords, /The Human Fertilisation and Embryology (Research
Purposes) Regulations 2001/, no. 188; California Advisory Committee:
/Cloning Californians: Report of the California Advisory Committee on
Human Cloning/ (Sacramento, Calif. January 11, 2002) - chaired by
Irving Weissman, terms "preembryo" and "ball of cells" to refer to the
early embryo used throughout report; Institute of Medicine and National
Research Council, Committee on the Basic Science Foundations of
Medically Assisted Conception, /Report of a Study and Workshop Papers/,
"Medically Assisted Conception: An Agenda for Research," (1989); *
*National Academy of Sciences, Commission on Life Sciences, "Comparison
of Stem Cell Production With Reproductive Cloning," in /Stem Cells and
the Future of Regenerative Medicine/ (2002); National Academy of
Sciences, Committee on Science, Engineering, and Public Policy,
/Scientific and Medical Aspects of Human Reproductive Cloning: How Is
Reproductive Cloning Done?/ (2002); National Bioethics Advisory
Commission, /Cloning Human Beings: Report and Recommendations of the
National Bioethics Advisory Commission/, (Rockville, Md. June 1997);
National Institutes of Health , /Human Embryo Research Panel Meetings/
(Washington, D.C. 1994) - using term "pre-embryo" in: February 2
meeting, pp. 27, 31, 50--80, 85--87, 104--106; February meeting. 3, 1994
meeting, pp. 6--55; April 11 meeting, pp. 23--41, 9--22; National
Institutes of Health, Office of Science Policy Analysis, /Cloning:
Present Uses and Promises/ (Washington, D.C. January 29, 1998);
National Science Foundation and U. S. Dept. of Commerce, /Converging
Technologies for Improving Human Performance: Nanotechnology,
Biotechnology, Information Technology and Cognitive Science/, edited by
Mihail C. Roco and William Sims Bainbridge (Washington, D.C., June
2002); New Zealand Parliament, /Human Assisted Reproductive Technology
Bill (1996); Supplementary Order Paper 2003/, no. 80, May 14, 2003,
Bills Digest No. 972; The Twins Foundation, "New Ways to Produce
Identical Twins---A Continuing Controversy", /Research Update/ 9, no. 1
(1994).*
* *
*The point is that if "conception" means "implantation", then the bill
would not cover any human embryos before implantation, /whether sexually
or asexually reproduced/. Thus early human embryos could be used in
research, regardless of their method of reproduction; prenatal genetic
diagnosis, the use of abortifacients, etc., would also not be covered up
to 5-7 days of development. Someone needs to check the original law
that this bill is amending, as well as any other operative laws, codes,
or regulations in Ohio, for any formal legal definitions there,
including the term "conception".*
* *
*/If "conception" means "fertilization"/ (sexual reproduction only),
then the bill does not apply to any human embryos reproduced by ANY
asexual methods -- and thus using these same embryos at any
developmental stage in research would be legal by default. This would
even include naturally occurring human identical twins reproduced in a
woman's body (we are all aware of such persons), as well as all
asexually reproduced living human embryos reproduced /in vitro/ by all
human genetic engineering techniques (including SCNT).*
*A _blastocyst_ has an _outer layer_ of cells known as the trophoblast,
and an _interior group of cells_ that is the inner cell mass.*
*_Comments_: Note that there are TWO stages of the early human embryo
that are defined as "blastocysts" according to the /Carnegie Stages of
Early Human Embryonic Development/: Stage 3 is called the "free
blastocyst"; Stage 4 is called the "implanting blastocyst". Both
Stages are found both /in vivo/ (while the embryo is moving through the
fallopian tube toward the uterus to implant) and /in vitro/ (while the
embryo is in the lab dish). This bill is vague as to whether both
Stages are included in the term "blastocyst". One worries especially
about the "free blastocyst" -- both /in vivo/ and /in vitro/ -- as that
would make such embryos more vulnerable to exploitation due to any legal
loopholes present in this amendment.*
* Also, this description of the blastocyst was taken
advantage of by the McCormick/Grobstein "pre-embryo" mantra, in which
they fully agreed that before 14-days there is a human being present,
but not a human /person/ (for them the ethically significant "fact").
They also claimed that /only/ the cells of the "inner cell mass"
constituted the "embryo proper"; the outer cell layer was considered as
just a bunch of cells by them. This is scientifically erroneous. The
/combination of both cells layers/ is the /whole /embryo. Also, there
is no clear divide between the two layers of the embryo; there are
exchanges of cells between the two layers. Thus some cells from the
outer cell layer end up in the human adult, and some cells from the
inner cell layer become part of the umbilical cord, etc. Again, why are
they giving these formal legal definitions here in this amendment, when
there is seemingly no further reference to them needed?*
*(3) "_Human cloning_" means the creation of a _human zygote,_ _human
blastocyst_, or human embryo by any means _other than the fertilization
of a human egg by a human sperm_.*
*_Comments_: Sounds good, but ....*
*-- / "other than the fertilization of a human egg by a human sperm"/;
if "conception" means "implantation" [ e.g. as commonly referred to by
the "false science" of pro-abortion groups like ACOG and others, etc.,
as referenced above], then this would not legally apply to embryos
before implantation, and thus the use of such same embryos would be
legal, as would the use of abortifacients, etc.*
*-- /"human zygote"/; according to the /Carnegie Stages/ /of Early
Human Embryonic Development/, the "embryo" begins when the sperm
penetrates the oocyte; the "zygote" refers only to the last part of
Stage One. Therefore, defining the earliest embryo as beginning only at
the zygote phase would leave the embryo before that time vulnerable to
exploitation. Such embryos would not be covered by this amendment.
This would include extensive cloning and genetic engineering research,
e.g. pronuclei transfer, insertion of artificial genes and chromosomes,
etc.*
*-- /"human blastocyst"/; if this phrase refers only to the embryo at
Stage 4 (implanting blastocyst), then it would not legally cover the
embryo at Stage 3 (free blastocyst), either /in vivo/ or /in vitro/.*
*(4) _"Human embryo"_ means an organism of the species homo sapiens
during _the earliest stages_ of development from _one cell_ up to eight
weeks.*
*_Comments_: What could they possibly mean by the phrase, "earliest
stages"? That's a rather vague definition, given the issues. How
"early" do they mean? If they mean the "zygote", then the developing
/embryo/ at Stage 1 /before/ the final formation of the zygote is not
covered by this amendment, thus allowing all sorts of cloning and other
genetic engineering reproduction.*
*(5) "Human _zygote_" means a _one-cell human embryo_.*
*_Comment_: /Ibid./ The human embryo begins /before/ the zygote phase,
at the penetration of the oocyte by the sperm (or artificially, when the
DNA of the cell/s is appropriately differentiated as an organism rather
than as just a cell (or, when the "matter is appropriately organized").*
*_(B) Except as provided in division (C) of this section_**, no person
or governmental entity shall knowingly do any of the following:*
*_ _**_Comment_: * *Precisely what is "provided in division (C) --
otherwise know as the "exceptions clause" in most legislation? Is this
a problematic "exception" clause? Did anyone check for any "scientific"
definitions used in division (C)?*
*(1) Perform or attempt to perform human cloning;*
* **_Comments_: Of course, this depends entirely on how "human cloning"
is being legally defined here (see above), and there are obvious
problems; also depends on the formal legal definitions used in the law
being amended, as well as any formal legal definitions of any of these
terms in any other current laws, regulations in Ohio -- including their
legal definition of "conception".*
*(2) Participate in the performance or attempted performance of _human
cloning_;*
*(3) Send or receive a _human embryo_ that is produced by _human
cloning_ or any product derived from that _embryo_.*
*_Comments_: Depends on how one is defining "human embryo" in this bill
(e.g., it would not include the developing human embryo /before/ the
final zygote phase); it might not include the human embryo at the free
blastocyst Stage, or before implantation, etc., given their other
definitions in this bill. Also depends on how they define "cloning".*
*
*
*(C) _Nothing in this section shall restrict the areas of scientific
research_ that do not involve the creation or use of a _human embryo_
produced by _human cloning_ or any product derived from a _human embryo_
produced by _human cloning_. *
*_Comments_: Otherwise known as the "exceptions clause". Again,
depends on the definitions of relevant terms (above).*
*The _areas of research that are not restricted by this section
include_, but are not limited to, the use of nuclear transfer _or other
cloning techniques_ to produce molecules, DNA, tissues, organs, plants,
animals other than humans, or cells other than human embryos.*
*_Comments_: This "exceptions" clause is usually used, but also
contains several potential legal loopholes, especially those that could
allow extensive human cloning and other human genetic engineering
techniques. FYI, see my article on how to write a human cloning ban
which covers this "exception" clause, available at:
http://www.lifeissues.net/writers/irv/irv_87updatedefinitions.html. For
example: *
*9. The "prohibition" or "exception" clauses* *in legislation also
provide opportunities for loopholes. Many of them are caused by using
problematic terms as noted above -- especially: (1) the use of the
plural term "cellS" only, which would leave out of protection the SINGLE
CELL EMBRYO; and (2) the use of terms such as "DNA molecules", etc.,
which would allow the "parts" of the single-cell embryo (e.g., genes,
chromosomes, pronuclei, nuclei, mitochondria, etc.) to be used in
extensive genetic engineering research. Therefore the terms used in
these clauses must also be very carefully scrutinized before legally
"allowing" legitimate research to continue.
***
*As has been pointed out, "cloning" is not the whole problem. Cloning
is only one kind of genetic engineering; there are many kinds of
cloning and many kinds of genetic engineering that have already been
used and that are already contemplated that are "reproductive
techniques". Cf. see the article:
http://www.lifeissues.net/writers/irv/irv_25scientificrefer1.html.
Many of the legal loopholes in such legislation concern those other
kinds of genetic engineering techniques that are used as "reproductive
technologies", but not considered "cloning" as so defined in such bills.*
* *
* *
* **Sec. 3701.99. (A) Whoever violates division (C) of section 3701.23,
division (C) of section 3701.232, division (C) of section 3701.24,
division (B) of section 3701.25, division (I) of section 3701.262,
division (D) of section 3701.263, or sections 3701.46 to 3701.55 of the
Revised Code is guilty of a minor misdemeanor on a first offense; on
each subsequent offense, the person is guilty of a misdemeanor of the
fourth degree.*
*(B) Whoever violates section 3701.82 of the Revised Code is guilty of a
misdemeanor of the first degree.*
*(C) Whoever violates section 3701.352 or 3701.81 of the Revised Code is
guilty of a misdemeanor of the second degree.*
*_(D) Whoever violates section 3701.94 of the Revised Code shall be
subject to the following:_*
*_(1) A term of /imprisonment/ of not more than two years;_*
*_Comments_:* *Generally, the use of imprisonment or high fines in a
bill signals the court to pay more attention to the literal meaning of
the formal definitions used in a law, rather than to a more vague
"interpretation" of what was /possibly/ meant. Thus, this bill, if
passed into law, would probably interpret the above definitions (as well
as those of the rest of the original law which is being amended)
precisely as formally defined -- thus NOT covering all sorts of things
and possibilities.*
*(2) If the offender derives pecuniary gain as a result of the
violation, a fine of not less than two hundred fifty thousand dollars
and not more than an amount equal to two times the amount of the gross
pecuniary gain if that amount is more than two hundred fifty thousand
dollars.*
*Section 2. That existing section 3701.99 of the Revised Code is hereby
repealed.*
------------------------------------------------------------------------
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