"Ohio 'prolife' Bill to 'Ban' Human Cloning; Needs Homework"

Dianne N. Irving
copyright June 13, 2008
Reproduced with Permission

Although the assumption must be that any group calling itself "prolife" 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 them, 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]



As Introduced

127th General Assembly
Regular Session 2007-2008

S.B. No. 174

Senator Buehrer
Cosponsors: Senators Carey, Coughlin, Gardner, Schuler


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.

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 Mller, 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 ....

(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.