I. Introduction: Human Cloning Is One Kind of Human Genetic Engineering
II. Tools for Identifying Loopholes
III. Analysis of Loopholes in Delaware Human Cloning Bill 2004 - Both Human Cloning and Human Genetic Engineering
In the frantic rush to get a total ban on all human "cloning", are legislators being blind-sided with loopholes that effectively guarantee the legalization of something even more ominous -- human genetic engineering? The issue of human genetic engineering is barely being publicly discussed, yet techniques to accomplish it are being expanded exponentially in both the private and the governmental research sectors, while the public focuses only on the narrower issue of human cloning.
Indeed, by defining the term "cloning" itself too narrowly, much legislation permits most other kinds of human cloning, as well as human genetic engineering, to slip beneath the radar.
Despite the many different formal and working scientific definitions of "cloning" techniques explicitly and easily found in many scientific texts and numerous other official sources, it is well known that especially IVF and reproductive biology researchers have been worried that any restrictions on human cloning would negatively impact their research and "therapy" interests -- hence their efforts to have the term "cloning" narrowly defined to mean only "somatic cell nuclear transfer" (SCNT):
The news this week that a maverick Chicago researcher intends to defy President Clinton's voluntary moratorium on human cloning may accelerate Congressional efforts to make cloning illegal. Infertility specialists warn that bills now before Congress might go beyond cloning to stifle research on important new infertility therapies. INFERTILITY RESEARCHERS TAKE PAINS to define cloning in the narrowest terms, as a process that would use the nucleus from a single mature cell and place it in a woman's egg from which the nucleus had been removed - then jolting that hybrid cell to life with electricity. No sperm need be involved, so the baby's genetic material would all come from just one person. While many infertility specialists recoil at the prospect of such "solo" cloning, there are critical aspects of the process that could help infertile couples. A number of infertility programs across the country are working on treatments that might be called "near-cloning." Doctor Jamie Grifo is a leading infertility researcher at New York University. (emphasis in original) [Stephen Smith, "Cloning Bans Could Have Impact on Infertility Treatments" (January 9, 1998), at: http://www.geometry.net/detail/basic_i/infertility_family_science_page_no_3.html
After analyzing dozens of legislations on human cloning and human embryonic stem cell research, it would seem that such a "narrow" definition of "human cloning" has obviously had a very deleterious effect on the ability of many legislatures to competently draft truly leek-prove total bans on all human cloning techniques.
But what about loopholes in which free-ranging human genetic engineering is deceptively embedded? Especially given the marked increase in international efforts to pull together many "converging technologies" expressly for human genetic engineering purposes - e.g., nanotechnology, biotechnology, information technology, and cognitive technology -- perhaps more attention needs to be paid to identifying such latent loopholes in human cloning legislation that can result in far worse consequences than just the "cloning" of human beings. The State of Delaware human cloning legislation is a case in point, with at least 57 such latent loopholes.
This article will not go into great detail on the subject of human engineering. But before addressing some of the loopholes in the Delaware bill, a few comments on human cloning and human genetic engineering technologies might be helpful, since many of them would be legalized -- for both "therapeutic" and "reproductive" purposes -- in most legislative "total" and "partial" bans on human cloning.
Perhaps what is least understood is that human cloning is a form of human genetic engineering. By allowing the other cloning techniques to fall beneath the radar, such legislation also thereby allows other human genetic engineering techniques to fall beneath the radar as well. A few examples might help make this clearer.
First, in the real world, the products of human cloning - like the products of human genetic engineering - are not perfect "copies" of or "genetically identical to" any donor, nor to any "existing or previously existing" human being. In both cases the products are genetically unique - having never existed before in any human being -- and this includes the products of SCNT. [The single exception (theoretically) is cloning by means of twinning.] So to formally define human cloning or human genetic engineering in such terms will automatically create loopholes that will allow the artificial reproduction of genetically unique human beings by means of both cloning and other genetic engineering technologies.
Second, both human cloning and human genetic engineering can start with already existing human beings sexually or asexually reproduced, parts of already existing human beings, or human parts that have been "artificially constructed". Using vague or scientifically inaccurate language that obscures these facts in the formal definitions of a Bill will also automatically create loopholes that will allow the artificial reproduction of genetically unique human beings by means of both cloning and genetic engineering technologies.
Third, SCNT using adult somatic cells is hardly the only technique that can be used to clone a human being - i.e., an organism. One can also clone a human being by means of transferring the nucleus of a diploid germ line cell (GLCNT), of the single-cell human being called a zygote (incorrectly referred to as just a "fertilized egg" - emphasis on "egg"), or of somatic cells from the earliest human embryo, fetus and young child. One can also clone human beings by means of twinning (also referred to as "fission", "embryo multiplication", "blastomere separation, and "blastocyst splitting"), etc. All of this has already been accomplished with animals for at least 25 years, and with humans for over 10 years - especially in IVF and reproductive science research laboratories. Yet because of the "narrow" definition of "cloning" encouraged by the researchers, such real human cloning slips under the radar.
Likewise, one can also genetically reproduce (or clone) molecules of human DNA. Molecules of human DNA constitute human genes, and human genes constitute human chromosomes. Human chromosomes are found not just in the nucleus of a human cell; they are also found outside the nucleus in the cytoplasm of the cell (e.g., mitochondrial DNA). Therefore, the "human genome" is defined in human genetics textbooks in terms of all of the human DNA in the cell - both nuclear and extra-nuclear - not just in terms of the nuclear DNA.
Thus any of these human DNA sources can be artificially cloned - including human DNA molecules, genes and chromosomes -- resulting in a genetically engineered human being whose genome would be different were such interventions not attempted. And those genetic changes would be duplicated and passed down (cloned) through future generations through sexual reproduction (fertilization). Examples of techniques using such genetic materials include pronuclei transfer (pronuclei are sets of haploid chromosomes), mitochondrial transfer, DNA-recombinant germ line gene transfer, the use of "artificially constructed" genetic materials, etc. Such genetic interventions can take place at the molecular, the gene, the chromosomal, the nuclear and the organism levels as well. Using vague or scientifically inaccurate language that obscures these facts in the formal definitions of a Bill will also automatically create loopholes that will allow the artificial reproduction of genetically unique human beings by means of both cloning and other genetic engineering technologies.
It might also be mentioned that all of these cloned and genetically engineered products can soon be "gestated" in "artificial wombs". Thus even these terms, if used too restrictively in formal definitions of a Bill, can also result in such processes and "organs" falling beneath the radar.
Are all of these technologies examples of "human cloning", or are they examples of "human genetic engineering"? I would argue that they are both. Both result in artificially reproduced "products" which are in some ways genetically the same or similar, and in some ways genetically unique. Both the original human being used or constructed (including the single-cell human zygote), as well as the generations of human beings to follow, would automatically clone (duplicate) the genetic changes engineered into the original human being.
Are all of these technologies unethical? Some probably are; some probably aren't. But until the language used to define them is factually, accurately, honestly, and realistically sorted out in professional and in public debates, the ethics too will slip under the radar.
Finally, genetic engineering of individual human beings in turn leads to social engineering. This can be accomplished by means of many seemingly unrelated methods - e.g., abortion, the use of abortifacients, genetic pre-selection, "blastocyst self-selection", "designer babies", imposed poverty, population control, etc. But although social engineering is not specifically addressed here, it needs to be understood that human cloning and human genetic engineering constitute at least some of the stepping stones to it.
Please note below some considerations that might help in identifying latent loopholes in legislation supposedly specific for cloning, stem cell research, genetic engineering, abortion, or other related issues:
For help in analyzing and identifying erroneous language in legislation that could create various kinds of "loopholes" that would result in much human cloning not being prohibited by the Bill, and for an extensive list of accurate scientific definitions to use that are in concert with the international nomenclature, please see my article (especially the endnotes), at:
"Playing God by manipulating man: Facts and frauds of human cloning", presented twice at the Missouri Catholic Conference Annual Assembly Workshop, Jefferson City, MO (October 4, 2003), at:
For a short but detailed example of the accurate and correct scientific terms and phrases to use in any legislation on human cloning or human embryonic stem cell research, please see my article at,
"How to Build a Better Human Cloning Bill or Treaty" (March 18, 2004), at: http://www.lifeissues.net/writers/irv/irv_24buildcloningbill.html
With the above considerations in place, let me begin with a short summary of the findings of my analysis of loopholes in this Bill. By really getting "picky" with just the definitions used in this Bill, I hope to demonstrate just how pervasive such loopholes are, and the amazing extent to which they would allow a myriad of various types of human cloning and human genetic engineering activities:
IN SUM, the numerous LOOPHOLES (57) identified in this Bill - especially those provided in the formal definitions of the Bill, even those found in terms used within each phrase used in the formal definitions - would result in this Bill not prohibiting a great deal of human cloning and human genetic engineering - for both therapeutic and reproductive purposes. These loopholes are constructively identified in order to help those in the State of Delaware to understand some of the problems with how this Bill is currently drafted, and to help them express their concerns to the Committee and other State officials so that a real "total ban" on human cloning can ultimately be accomplished. On close and careful examination, this Bill would not prohibit, among other things, the use of any cloning or genetic engineering techniques, to reproduce (a) human and non-human embryos or (b) human/non-human chimeras or (c) artificially constructed embryos - using either somatic or germ line cells from unborn or born human or animal sources or artificially constructed sources - and be gestated to birth either in a woman's uterus or in an artificial womb, if so intended - for both therapeutic and reproductive purposes.
Loopholes identified are consecutively numbered below (bolded).
Emphases are used throughout for those not familiar with the scientific terms.
Dr. Dianne N. Irving, M.A., Ph.D.
SPONSOR: Sen. Venables; Sen Bunting; Rep. Ewing
DELAWARESTATE SENATE
142nd GENERAL ASSEMBLY
SENATE BILL NO. 55
AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO A CLONING PROHIBITION AND RESEARCH PROTECTIONS ACT
Section 1. Amend Title 16, Delaware Code by inserting a new Chapter as follows:
"Chapter 30. Cloning prohibition and Research Protection Act
No person shall create or attempt to create a human being using somatic cell nuclear transfer or other cloning technologies.
-- Note: The soundness and validity of this specific "Prohibition" will rise or fall depending on those formal definitions in the Bill (below) of each term or phrase used in this Prohibition sentence, e.g., the formal definitions of (a) "create a human being",(b) "somatic cell nuclear transfer", and (c) "cloning". The "Prohibition" of this Bill will also rise or fall depending on the other formal definitions listed in the Bill (below) that are essentially and fundamentally related to this "Prohibition", e.g., the formal definitions of (d) "creating a human child", (e) an "embryo", (f) "enucleated", (g) "fetus", (h) "gestation", (i) "nucleus", (j) "oocyte", (k) "somatic cell" - and (l) the conflating of the definitions of "sexual" vs. "asexual" human reproduction strongly implied therein.
Considering the phrases and definitions of terms used in this specific Prohibition in comparison with the formal definitions of terms used in this Bill:
(a) "create a human being": The Bill should make it clear that the immediate product of both sexual (fertilization) and asexual (cloning) human reproduction is a single-cell organism, a zygote, a human being, who then proceeds to grow and develop him/herself as known scientifically for over a hundred years and as documented for many decades in the Carnegie Stages of Early Human Development. These objective scientific facts are now vastly documented in science, especially in human embryology and human molecular genetics text books and by the International Nomina Embryologica Committee. (Please see an extensive list of such accurate scientific references in concert with the Nomina Embryologica Committee in my article, "Playing God ...", noted above).
If any false scientific definitions of "a human being" and when he/she begins to exist are used in the Bill whereby the term "human being" does not refer at least to the earliest single-cell human embryo (zygote) reproduced immediately after sexual or asexual human reproduction, then "therapeutic" cloning would be allowed by the Bill, and possibly even "reproductive" cloning.
This can happen, e.g., when "a human being" is defined in the Bill as not beginning to exist until some point in time after the single-cell stage of the developing human organism (the zygote) - such as referring to "implantation" or "birth", by the use of scientifically erroneous terms such as "pre-embryo" or the "pre-embryonic stage", a "bunch of stem cells", a "fertilized egg", just "embryonic tissues", etc. -- or simply by the use of false human embryology to "document" scientifically (and erroneously) any such false terms without using the term "pre-embryo" per se. Such false scientific terms are what I refer to as "pre-embryo substitutes". Their effect is the same - to attempt to ascribe a "reduced moral status" to the earliest human embryos, or indeed to imply that there are no human embryos or organisms there at all - just "stem cells". The term "pre-embryo" has been formally rejected by the International Nomina Embryologica Committee, and would likewise apply to any of its "substitutes".
Unfortunately, this Bill contains a number of "pre-embryo substitutes". For example, a "human child" is formally defined in the "Definitions" section of this Bill (in Par. 3002, below) as existing at the earliest at implantation, in a woman's uterus, only with the intention of allowing it to gestate and be born, and only if produced with the SCNT cloning method. (Other human cloning or human genetic engineering methods are not acknowledged in this formal definition).
Likewise, this formal definition of a "human child" itself is composed of terms and phrases which are erroneously defined and contradictory in the formal definitions section. For example, the formal definitions of an "embryo", of a "fetus", and of "gestation" specifically do not refer to the earliest single-cell embryo and some subsequent early stages of development - either sexually or asexually reproduced, in vivo or in vitro. Nor do they specify these embryos and fetuses as "human" only, but rather can be applied to many non-human embryos and fetuses or to human/non-human chimeras as well. Again, the formal definition of "fetus" refers generally to "vertebrates", and to fetuses that are "unborn or unhatched" - a bizarre definition of any fetus, using language that should only be applied to the earliest embryos - and to embryos reproduced both sexually and asexually, in vivo and in vitro. Several of these same formal definitions use language that could be applied to the cloning of both human embryos and human/non-human chimeras by using "artificially constructed" parts. Finally, no where does this Bill prohibit the use of the artificial womb to use human or non-human embryos and fetuses - sexually or asexually reproduced -- for purposes of pure experimentation or for later implantation in a uterus (non-human or human). In fact, this Bill is less about "human cloning" and more about human genetic engineering - both in vitro and in vivo.
Therefore, the "Prohibition" in this Bill would not recognize the following living human beings as "human children", and thus this Bill would not prohibit their reproduction or use for either research or reproductive purposes: (1) sexually or asexually reproduced human embryos living in vitro from the single-cell zygote stage until such time as he/she were implanted; (2) sexually or asexually reproduced human embryos or fetuses after implantation if they were not intended to be fully gestated or born; (3) sexually or asexually reproduced developing human beings at any unborn stage of development who were reproduced using all other human cloning techniques [e.g., by germ line cell nuclear transfer (GLCNT), twinning (blastomere separation or blastocyst splitting), pronuclei transfer, mitochondrial transfer, genetic engineering, etc.]; (4) sexually or asexually reproduced human/non-human chimeras, reproduced in vivo or in vitro, implanted or not implanted; (5) artificially constructed human embryos and fetuses, or artificially constructed human/non-human chimeras; (6) any of the above organisms developing in an artificial womb. Therefore, given the formal definitions provided in the Bill, the "Prohibition" section of this Bill would not prohibit the reproduction/construction or use of any of the above living human beings or human/non-human chimeras.
(b) "using somatic cell nuclear transfer": Because of the erroneous and/or ambiguous formal definitions of "enucleated", "oocyte", "somatic cell", "nucleus", and "nuclear transfer" used below, (7) this Bill does not prohibit the cloning of human beings by the real SCNT cloning technique, accurately defined.
(c) "or other cloning technologies": It would be important to specifically include the phrase "other cloning [or genetic engineering] technologies" here, since SCNT is only one of many different kinds of cloning or genetic engineering techniques that could be used to clone human beings. However, in the formal definition of "human children" already referred to, only the SCNT cloning technique is articulated. Therefore, the inclusion of the phrase "or other cloning technologies" in this "Prohibition Section" would be superseded in this Bill by the formal definitions below, and thus (8) this Bill would not prohibit the cloning of human beings using all other human cloning techniques.
If one wants to argue that the terms "cloning" and "genetic engineering" refer to two different exclusionary categories of activities, and that the term "genetic engineering" does not include "cloning", then (9) the asexual reproduction of human beings by many other means of genetic engineering techniques would still be allowed under this Bill.
Therefore, the claim in the "Prohibition" section of this Bill - that "No person shall create or attempt to create a human being using somatic cell nuclear transfer or other cloning technologies" - is contradicted by the formal definitions of terms and phrases used in the claim itself. Hence no cloning of human beings or of human/non-human chimeras is actually prohibited by this Bill - and thus are allowed.
The following words, terms and phrases, when used in this chapter, shall have the meanings ascribed to them in this section, except where the context clearly indicates a different meaning: -- "meanings ascribed to them in this section": That is, these are the formal definitions of the Bill, and they would thus supersede other definitions used elsewhere in the Bill (as in Sec. 3001 the "Prohibitions").
-- "Embryo": Given the rest of the definition, should be "embryos".
-- "organisms": This definition of "embryo" would apply to both human and to non-human embryos. Thus (10) this Bill would not prohibit the cloning of non-human embryos, or human/non-human chimeras.
Also, although a real distinction can be made between embryos (which are "organisms") and individual embryonic "cells" (which are only parts of organisms), there is one exception that is usually missed in these debates. The single-cell zygote which is the immediate product of both sexual and asexual reproduction - including human/non-human chimeras -- is both a single "cell" as well as an "organism". That is, the zygote is a single-cell organism - a human being. Since the above definition only vaguely refers to "early stages", and does not specifically include all early stages" - such as the single-cell zygote stage --, (11) this Bill would not prohibit the cloning of any human embryos or human/non-human chimeras in the earliest stages of growth and development, using any cloning techniques.
-- "early stages": The "embryonic period" includes the developing human being from its immediate existence after cloning or fertilization through 8 weeks. The phrase "early stages" would not necessarily include the earliest human stages of developing embryos - reproduced either sexually or asexually, in vitro or in vivo -- who are at Stage One of the Carnegie Stages, i.e., the single-cell human organism called the "zygote". Nor would it necessarily include the living developing human being at Stages Two, Three, Four, and possibly Five. This kind of ambiguity in the language is a classic "pre-embryo substitute" - i.e., the term "pre-embryo" is not used, but the implication is that there is NO EMBRYO present immediately after either sexual or asexual human reproduction - rather, e.g., there are only "a bunch of stem cells". Therefore (12) this Bill would not prohibit the use of all human cloning techniques to reproduce real living early human embryos from the single-cell zygote organism through at least part of Stage Five of growth and development.
Nor, again, is the "embryo" specified as human, non-human, or chimera. Therefore, (13) this Bill would not prohibit the use of all human cloning techniques to reproduce non-human organisms or human/non-human chimeras.
Next Page: (b) 'Enucleated' the removal of the nucleus of a cell.
1, 2