How to Build a Better Human Cloning Bill or Treaty

Dianne N. Irving
copyright March 18, 2004
Reproduced with Permission

I. Introduction

Surely one of the most critical issues before the world today is the issue of human cloning. Legislators, politicians, diplomats, researchers, concerned organizations, national and international bodies, and many others around the world have been rushing to set in place legislation and treaties to deal properly and responsibly with this crisis. But it is important to "get it right" the first time around.

The "pros" and "cons" of human cloning research have already been dealt with at length in the literature, so they will not be reviewed here. Rather, after having published analyses of dozens of state, national, federal and international legislative attempts to ban human cloning research, I simply wish to offer seriously considered suggestions for the use of scientifically accurate language and definitions to be used in such endeavors in order to prevent loopholes which would result in much human cloning not being really banned. Many of these accurate definitions can also be used in bills and treaties concerning related issues, e.g., human embryonic stem cell research, human genetic engineering, abortion, the use of abortifacients, conscience clauses, IVF and other artificial reproductive technology research and regulation, etc.


II. Common sources of "loopholes"

Note that each and every individual "loophole" discussed below that permits human cloning by default (and most bills have literally dozens of such loopholes) thus permits it for both "therapeutic" and for "reproductive" human cloning. Here are several common sources of such loopholes:

A. Leaving specific items out of the bill or treaty:

Many people do not realize that if a bill or treaty does not specifically address an issue, then they do not apply to it. Thus, e.g., leaving out certain human cloning techniques in a bill means that the bill will not ban the use of those forms of human cloning techniques -- and thus they will be allowed.

B. Mis-defining scientific terms:

By mis-defining an important scientific term in a bill or treaty means, e.g., that they will not ban the real technique, or, e.g., apply to the product of that technique. It is shocking how many "scientific experts" who are consulted on these scientific definitions are either academically unqualified to do so (i.e., do not have the relevant scientific degree), or are simply ignorant of the current scientific literature. The result is that many of the "scientific" definitions of major terms used are erroneous and mis-defined -- thus creating loopholes to be later exploited. Documented written proof of each scientific definition, from the scientifically relevant field, should be required of each such "expert" before incorporating it into a bill or a treaty.

C. Using contradictory definitions:

Consider that any single definition used in a bill or a treaty depends on and is locked-into the definitions of all relevant terms used in that definition. All such definitions must coincide exactly with each other. So it is not enough to have a definition of "cloning"; you must also make sure that any term used in that definition, or used elsewhere in the bill or treaty, is also accurately defined and consistently used throughout. Otherwise, one definition cancels out the other definition, creating "loopholes" -- and the bill will ban nothing. Nor will the bill be enforceable in the courts due to "vagueness", etc.

D. Most human clones, or biogenetically engineered human embryos, would be genetically unique:

Most human embryos reproduced by most human cloning techniques would actually be genetically unique -- i.e., having never existed before. Thus to use the phrase "of an existing or previously existing human being" to refer to the product of human cloning would not be a scientifically accurate description of the cloned or genetically engineered human embryo -- thus creating yet another loophole in the bill or treaty.

E. Loopholes in the "Prohibition" section of a bill or treaty:

As noted above, if a bill or treaty does not specifically articulate something, then it is not covered by the bill or treaty (and thus is allowed). Often there is a "prohibition" section in which are listed specific items which the bill or treaty would definitely not cover. Loopholes can be created in this "prohibition" section by using scientifically erroneous terms, ambiguous terms, and confusing phrases -- which contradict those used and defined in the formal "definition" section. Such ambiguities and contradictions can be legal grounds for a court to render the bill or treaty as "unenforceable".

F. "Dumbing-down":

It is my deep concern that the legislative effort should first and foremost be to acknowledge the true objective, most accurate, and most current scientific facts in concert with the international nomenclature requirements concerning all of these activities, and only then try to sort them out in terms of which ones are ethically acceptable and which ones are not. This will require both extensive scientific knowledge of the state of the art of these "converging technologies", as well as very sophisticated and careful definitions. No dumbing-down or making them "simple". No "writing them in crayon". This does not mean that entire theses need to be constructed. But it does indicate the need to acknowledge that in these sophisticated scientific issues and debates, the "devil is in the details", so to speak. By dumbing-down the details one thereby automatically creates legislative loopholes.

G. Legal ramifications of using erroneous definitions:

Not only could the above conditions lead to overt or subtle legislative "loopholes" that would permit human cloning by default, such false science and loopholes also then becomes bad law once these bills are passed, and are then legally required to be applied to all related legal cases in the future as "legal precedent" (stare decisis).


III. Need to acknowledge the rapid pace of science, new techniques

In reading any number of current bills and treaties I am seeing efforts to "allow" or to sneak in some unethical reproductive techniques that most people -- even some scientists -- might not be aware of, but which are clearly nevertheless already in use (as a quick internet and library search will verify). Thus, e.g., in the following definitions I am attempting to cover the use of cloning advances in human bioengineering, such as in the use of nanotechnology (e.g., artificially constructed chromosomes and other parts of human cells, entire human cells, tissues, organs, and organisms starting with nano-molecules, etc.), and in human genetic engineering (e.g., designer babies, eugenics, etc.). [Note that the current New Zealand bill allows for the use of artificially constructed sperm, oocytes and embryos, and the Canadian bill allows for the use of artificially constructed "reproductive materials". See "note" on nanotechnology below.]

Such various types of human cloning will be used to duplicate or to permanently genetically modify new living human beings. Since the "human genome" is scientifically defined as consisting of all of the human DNA in an entire human cell, that would include both nuclear and cytoplasmic DNA (e.g., mitochondrial DNA). Thus a permanent genetic change in any human DNA in a human organism changes that human being's genome. Examples include cloning new genetically unique human beings by means of "molecular cloning" -- as distinct from techniques using whole organisms, e.g., by means of twinning.

Most of these "newer" and "advanced" reproductive techniques have already been used for over 25 years in animal cloning, and at least for the last 10 years in many forms of human cloning and IVF techniques (e.g., blastomere separation, blastomere splitting, pronuclei transfer, etc.). These more refined forms of human cloning are far superior to the nuclear transfer techniques (SCNT, GLCNT), since researchers have more extensive "control" over the genetic programming and reprogramming required. So I have attempted to cover at least some of those other "reproductive technologies" used for human cloning in the definitions below.

Obviously, the following definitions should also specifically cover cloning techniques that we are already aware of (and that are being used), e.g., human cloning by means of "twinning" (blastomere separation and blastocyst splitting) which is already advertised on many IVF Clinic websites, somatic cell nuclear transfer (SCNT), germ line cell nuclear transfer (GLCNT), pronuclei transfer, mitochondrial transfer, and germ line gene transfer.

The following definitions would also cover the formation of human/human chimeras (who would be fully human beings) cloned by means of pronuclei transfer, but not so clearly cover the formation of human/animal chimeras since those are not human beings. The worry with these chimeras is, however, that they could use "back-breeding" techniques known for centuries to isolate and recover the "human" genetic materials from such chimeras and then use them to a-sexually reproduce or genetically alter a new human being -- thus by-passing the prohibitions. Nor does it cover parthenogenesis, but again the worry is that they could use the new techniques to "dedifferentiate" [de-program] the "46" chromosomes in a diploid oocyte to clone a new human being and simply call it "parthenogenesis". Hopefully those two cloning techniques would also fall under the definitions below if brought to vigorous public debate.


IV. "Cloning" definitions, and "Prohibition" Sections

The following terms and phrases are suggested for use in the "Definitions" and "Prohibition" sections of a bill or a treaty on human cloning -- or other related documents. Note that all definitions are in concert with each other, as well as being scientifically accurate and current. These definitions are just a start, subject to change given new information, and any questions or constructive comments would be quite welcome. [For extensive scientific references in concert with the international nomenclature of human embryology used to document all of the following suggested definitions, please see Irving, ""Playing God by manipulating man: Facts and frauds of human cloning"(October 4, 2003), at: http://www.lifeissues.net/writers/irv/irv_22manipulatingman1.html, or
http://www.mocatholic.org/uploads/IrvingCloning3.pdf,
http://www.uffl.org/irving/irvplayinggo.pdf, and
http://www.uffl.org/irving/irvplayinggoappen.pdf.

A. "Cloning" definitions:

Human being: any organism who begins to exist immediately by means of sexual or a-sexual reproduction/construction and who possesses a genome specific for and consistent with an individual member of the human species.


Human genome: The total nuclear and extra-nuclear DNA genetic materials that constitute an organism as an individual member of the human species.


Cloning: the duplication, or near-duplication, of molecules, any part(s) of a cell, a single cell, cells, tissues, organs, or organisms using any technique.


Cloning techniques: any technique used to duplicate, or to near-duplicate, molecules, part(s) of a cell, a single cell, cells, tissues, organs, or organisms.


Human cloning: (a) organisms: the duplication, or near-duplication, of a whole human being using any cloning technique; or, the use of part(s) of human cellular, subcellular or artificial materials for the purpose of duplicating a whole human being using any technique; (b) molecules: permanently altering the human genome in successive reproductive generations by means of the duplication, or near duplication, of human genetic materials using any sexual reproductive technique or construction and/or any a-sexual reproductive technique or construction.

Cloned human being: A human being who is a-sexually reproduced using any technique.

B. "Prohibition" Sections:

The typical "prohibition" section in these bills states:

SCIENTIFIC RESEARCH- Nothing in this section restricts areas of scientific research not specifically prohibited by this section, including research in the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans.'"

At least here the Bill is acknowledging that there are "other cloning techniques". But the awkwardness and use of double negatives in this sentence could be confusing, thus open to challenge in the courts. Because of the use of specific language in this prohibition one could argue that some cloning of human organisms (human beings) would be allowed. For example:


1. "molecules, DNA": Some cloning of human embryos is accomplished by means of pronuclei transfer. For example, the male pronucleus from the just-fertilized oocyte of one human embryo, and the female pronucleus from the just-fertilized oocyte of another human embryo can be removed by micromanipulation and placed together in an enucleated oocyte, which is then stimulated, and a new cloned human embryo would be reproduced. In fact, such embryos would be human/human chimeras. Human pronuclei are not whole cells, nor whole nuclei, but only parts of nuclei - just molecules, and they are molecules of DNA. Therefore the prohibition in the Bill would allow the cloning of human embryos by means of pronuclei transfer for both "therapeutic" and "reproductive" purposes. The same problem exists with the use of artificially constructed sperm, oocytes and/or embryos (please see explanation note below).


2. "cells other than human embryos": would not cover the cloning of a single cell -- such as the single-cell human zygote - using all cloning techniques for both "therapeutic" and "reproductive" purposes. Nor would it cover -- depending on when during the fertilization process a new human being begins to exist -- the use of pronuclei transfer for both "therapeutic" and "reproductive" purposes, since pronuclei are only parts of a single cell.


3. "tissues": many researchers use the phrase "human tissues" to refer to what are in reality totipotent diploid human primordial germ line cells. Thus the cloning of new human beings by means of twinning these totipotent cells, or cloning them by means of nuclear transfer, for both "therapeutic" and "reproductive" purposes, would not be covered if the researchers' deceptive definition of "tissues" is accepted.

Therefore, I would suggest the following changes in the above "typical" prohibition section:

SCIENTIFIC RESEARCH - Nothing in this section restricts areas of scientific research not specifically prohibited by this section, including research in the use of nuclear transfer or other techniques to produce human molecules, DNA, cell/cells, tissues, organs, plants, or animals unless used for the purpose of cloning a human being using any technique.


V. Note on the use of "artificially constructed" materials in human cloning:

For those who are still unaware, there are already National Institutes of Nanotechnology in over 40 different countries, including the United States. Such cloning, using "artificially constructed" chromosomes, sperms, oocytes, and embryos, is included in the current New Zealand bill on human artificial reproductive technologies (HART Bill): "gamete means ---- (a) an egg or a sperm, whether mature or not; or (b) any other cell (whether naturally occurring or artificially formed or modified) that --- (i) contains only 1 copy of all or most chromosomes; and (ii) is capable of being used for reproductive purposes." http://www.justice.govt.nz/pubs/other/pamphlets/2003/hart/Supp_order_paper.pdf.

The term "reprogenetics" is coined in a recent "Special Supplement" of The Hastings Center Report (July/August 2003) at (http://www.thehastingscenter.org/news/features/repro%20supplement.pdf), the first sentence of which refers to reprogenetics as "one big embryo experiment". The term refers collectively to the converging of several scientific technologies, especially multiple artificial human reproductive techniques (e.g., IVF and cloning) and human genetics research - other wise known as eugenics. The term is similar to such others as "trans-humanism", "post-humanism", "futurism", etc. - i.e., the remaking of human nature by the use of experimental reproductive and genetic techniques. Such are the stated goals of "nano/bio/info/cogno", supported by this government and many internationally popular "futuristic" programs, e.g., see Converging Technologies for Improving Human Performance (National Science Foundation, and the U.S. Dept. of Commerce, June 2002); you can find the report at: http://itri.loyola.edu/ConvergingTechnologies/Report/NBIC pre publication.pdf (or at http://www.wtec.org/reports.htm). See also, for example, the current New Zealand cloning bill, which defines a "gamete" as including "any other cell (whether naturally occurring or artificially formed or modified) that contains only 1 copy of all or most chromosomes; and is capable of being used for reproductive purposes." [Human Assisted Reproductive Technology Bill: Supplementary Order Paper [HART SOP], April 2003, at http://www.justice.govt.nz/pubs/other/pamphlets/2003/hart/Supp_order_paper.pdf.


See also recent legal analysis of "nanocloning" at:
http://www.blankrome.com/publications/Articles/WolfsonNanotechnology.pdf
22 Biotechnology Law Report 376
Number 4 (August 2003)
Mary Ann Liebert, Inc.

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