Delaware State Cloning "Ban": Loopholes Form Blueprints for Human Genetic Engineering

(b) 'Enucleated' the removal of the nucleus of a cell.

-- "of a cell": Note: It is true that the term "enucleated" refers to the removal of the nucleus "of a cell". But there are two major categories of human cells: somatic, and germ line (the precursors of the final sex gametes). Both cell types are diploid, and thus both types of human cells can be cloned by means of the "nuclear transfer" cloning technique (somatic cell nuclear transfer, or SCNT, and germ line cell nuclear transfer, or GLCNT).

Both of these diploid cell types are not explicitly identified in this definition, therefore (14) this Bill does not prohibit the cloning of human beings by means of germ line cell nuclear transfer (GLCNT).

Also, the earliest of these germ line cells -- the "primitive germ line cells" - are said to be found in the developing human embryo as early as two weeks after fertilization. These primitive germ line cells are totipotent, and therefore can be cloned by means of the "twinning", or "embryo-splitting", cloning technique (blastomere separation and blastocyst splitting). The individual cells of the inner cell mass of the blastocyst are also totipotent, and thus could also be cloned by twinning. Therefore (15) this Bill does not prohibit the cloning of human beings by means of twinning using totipotent primitive germ line cells or using totipotent cells from the inner cell mass.

Not only can nuclear transfer be used with both somatic and germ line cells, it can also be used with the diploid single-cell zygote (organism). This definition does not identify the zygote as an organism, therefore (16) this Bill would not prohibit the cloning of human zygotes by means of either SCNT or GLCNT. Indeed, one can clone by nuclear transfer any diploid cell in a human body - embryo, fetus, child, adult. Therefore, (17) this Bill does not prohibit the cloning of human beings by means of nuclear transfer using embryonic, fetal, child or adult diploid body cells.

This definition does not state whether "a cell" is that of a human, of a non-human, or of a chimera. Therefore, (18) this Bill does not prohibit the cloning of non-human embryos or of human-nonhuman chimeras.

Finally, this definition does not prohibit the use of artificially constructed chromosomes, nuclei or cells. Therefore, (19) this Bill would not prohibit the cloning of human embryos, non-human embryos, or human/non-human chimeras by using an artificially constructed "cell".

(c) 'Fetus' means an unborn orunhatched //vertebrate//especially after attaining the basic structural plan of its kind.

-- "an unborn or unhatched//vertebrate": This is a rather astounding, and worrisome, definition of a "fetus" -- of any vertebrate. I'd like to see a xerox copy of the pages from the human embryology textbooks from which the terms "hatched" or "unhatched" are used to refer to a "fetus". If this Bill is about only those vertebrates that are "human", and if the developmental embryology of different species of vertebrates differs quite significantly, then why use the generic term "vertebrate" - unless vertebrates other than humans, e.g., human/animal chimeras, are part of the intention of this Bill? We have already seen the same kind of vagueness used above in the formal definitions of "embryo" and of "enucleated" - vagueness that could be applied to both human and non-human embryos. Indeed, we will see more of it in the following formal definitions as well.

The terms "embryo" and "fetus" simply refer to the same developing human being at different stages of growth and development. An "embryo" begins immediately after both sexual and asexual human reproduction and continues through the eighth week. A "fetus" begins at the beginning of nine weeks through birth. The only entity to which the terms "hatched" and "unhatched" refers in human embryology is the very earliest human embryo, from Stage One through Stage Three (the "free blastocyst" and part of Stage Four (the "implanting blastocyst") - before, or during, implantation. Each of these earliest of human embryos - whether reproduced sexually or asexually -- are surrounded by a protective membrane called the "zona pellucida". This membrane slowly dissolves as the already existing embryo moves through the fallopian tubes and then tries to implant in the uterus (about 5-7 days after zygote formation).

In in vitro fertilization (IVF, sexual reproduction), the zona is sometimes mechanically dissolved by the technician while still in the petri dish - otherwise it will not be able to implant when inserted into the uterus. In such circles the embryo is thus said to have "hatched" - i.e., the zona surrounding the early embryo has dissolved. (The fallopian tubes are usually by-passed). If the zona does not dissolve, the embryo cannot implant, and it will die. The same would be true for an embryo reproduced by cloning before it was implanted. Certainly by the end of Stage Four, there is no zona remaining in normal human embryogenesis; the embryo has "hatched" and is implanting - and the zona does not grow back again at some later stage of development - especially many weeks later during the fetal period!

Thus to refer to the human "fetus" (from nine weeks through birth) as "unhatched" is impossible. The terms "hatched" and "unhatched" can only refer to the earliest human embryos, e.g., those desired to be used in "therapeutic" research (and later in "reproductive" research), and those desired to be implanted in a "womb". Yet the Bill makes no reference to "unhatched" embryos, and the only formal definition of "embryo" in the Bill does not apply to the earliest human embryos that do go through the "hatching" phase -- embryos reproduced either sexually or asexually.

This is another example of a "pre-embryo substitute", i.e., the terms "hatched" and "unhatched", which can only refer to the earliest human embryos, are applied (erroneously) to the nine-week and older fetus. The result is that "embryos" no longer exist; only "fetuses" do - "unborn or hatched".

Finally, this definition ignores the reality of artificial wombs being used to gestate developing human beings throughout all developmental stages - including the fetal period. It also ignores the use of "artificially constructed" chromosomes, sperm, oocytes and embryos that could be produced and allowed to develop to the fetal stage.

The language chosen for this definition also raises the question of why a Bill to ban human cloning contains language that could also refer to the formation of human embryos and fetuses reproduced by fertilization (IVF). What is the connection implied in this Bill between human and other kinds of embryos reproduced by fertilization (sexual reproduction), and those reproduced by cloning (asexual reproduction)?

Because of such a grossly ambiguous and scientifically erroneous definition of "fetus", (20) this Bill would not prohibit the cloning of human or non-human embryos or (21) the cloning of human/animal chimeras -- using any cloning techniques. (22) This Bill would also not prohibit the use of sexually reproduced human or non-human embryos, or human/non-human chimeras, in destructive cloning research. Nor would (23) this Bill prohibit the cloning of human or non-human embryos, or human/non-human chimeras, to be used in artificial wombs, (24) or to be "artificially constructed".

-- "especially": This Bill claims that a "fetus" (of any "kind" of "vertebrate"!) exists after the structural plan of the body is formed, but not exclusively. That is, the term as defined could also apply before the structural plan of the body is formed - i.e. to the human or non-human embryo or chimera reproduced by cloning before the end of eight weeks of development. Why?

The scientific fact is that in human embryology the basic "structural plan of the body" is only completed at the end of the last week of the embryonic period - i.e., at the end of the eighth week. It is precisely the final appearance of the basic structural plan of the body that distinguishes the "embryonic" from the "fetal" periods of development. From nine weeks through birth the developing human being is said to be in the "fetal period". So it is a given that the basic structural plan of the body is completed and the fetal period begins at nine weeks.

Therefore, there is no factual basis in human embryology for the term "especially" in this definition of "fetus". The basic structural plan of the body is simply not completed any time before the fetal period begins. But the definition used here would extend part of the "fetal period" backwards into the "embryonic period" - thus making the older more developed embryos defined as "fetuses" instead. Thus (25) this Bill would not prohibit later-stage embryos from being reclassified as "fetuses". This could mean, e.g., that if "fetal tissue" research is legal, but "human embryo research" - including cloning and genetic engineering - is not, these later-stage embryos could still be "legally" used as "fetuses" in fetal tissue research - both "therapeutic" and "reproductive".

(d) 'Gestation' means the period during which an embryo develops, inside the uterus, into a fetus that is ready to be born.

-- "embryo": The term "embryo" has been formally defined as not including the earliest embryos - whether reproduced sexually or asexually, existing in vivo or in vitro -- whether human, non-human, or human/non-human chimeras, or whether used in artificial wombs or "artificially constructed". Therefore, by definition, (26) this Bill would not prohibit such early embryos to eventually be "gestated" or "born".

-- "inside the uterus": This formal definition does not specify whether the "uterus" is that of a female human, a non-human animal, or an artificial uterus.

Also, in normal sexual reproduction the human embryo first exists in the fallopian tube of the mother, then travels down the tube to implant into the uterus. Thus the use of the phrase "inside the uterus" would not apply to the developing human embryos as they exist outside the mother's uterus in vitro (IVF), or when they exist in vivo in her fallopian tubes (where they can be removed by "embryo flushing").

Thus (27) this Bill would not prohibit the cloning of human beings using any cloning techniques, and even their manipulation in vivo in the fallopian tube (before the embryo implants). And since the term "embryo" is defined so that it could refer to human and non-human embryos, to human/non-human chimeras, or to artificially constructed embryos, (28) this Bill would not prohibit such embryos from being "gestated" inside a uterus - of human females, female animals, or in artificial wombs.

-- "ready to be born": In the formal definition of the "creation of a human child" (below), only an unborn who is implanted with the intention of gestation and birth is a "human child". That means that an unborn human being, who is not intended for gestation and birth, is not a "human child" - even it if he or she is "ready". Therefore, this Bill (29) allows for the cloning of human and non-human embryos, using any cloning techniques, and their manipulation in vivo through nine months of "gestation" - if intended.

(e) 'Nucleus' means cell structure that houses the chromosomes, and thus the genes.

-- "houses the chromosomes, and thus the genes": This is a scientifically false definition of a "nucleus". It implies that all chromosomes and all genes exist only in a nucleus. This is not scientific fact. There are chromosomes (and thus genes) both inside and outside the nucleus - e.g., in mitochondria which exist outside the nucleus. There are also encased sets of haploid chromosomes called "pronuclei" which exist after fertilization or cloning for some time before syngamy (or the crossing over of the maternal and paternal chromosomes) which are used for cloning in pronuclei transfer. This definition also does not make a distinction between nuclei that exist in somatic cells and those that exist in germ line cells. Nor does it acknowledge "genes" that can be artificially transferred from without, using techniques such as DNA-recombinant gene transfer. Therefore, this Bill would (30) allow human cloning by means of mitochondrial transfer and by pronuclei transfer, (31) all human cloning using all cloning techniques using germ line cells, and (32) DNA-recombinant gene transfer - both somatic and germ line (eugenics).

(f) 'Oocyte' means the female germ cell, the egg.

-- "germ cell ... egg": This term is used ambiguously. The term "germ cell" can apply to a human female oocyte that is used as the "recipient" cell in nuclear transfer cloning, i.e., that has been enucleated. It can also refer to an oocyte that is used as the donor cell in nuclear transfer cloning. That is, an oocyte is diploid (until and unless it is fertilized by a sperm) - and thus can itself be cloned using nuclear transfer techniques. The nucleus of an oocyte can be transferred into another oocyte that has been enucleated, and thus cloned.

Since germ line cells are not specifically included in this Bill as "diploid", and because the definition of a "human child" is formally defined in this Bill only in terms of somatic cells, (33) this Bill would allow the cloning of human beings by means of germ line cell nuclear transfer (GLCNT). Since "cloning" is formally defined in this Bill only in terms of the SCNT cloning technique, (34) this Bill would allow the use of germ line cells in human cloning using all other human cloning techniques. Since the earliest germ line cells, called "primitive germ line cells" are also totipotent, (35) this Bill would allow primitive germ line cells to be cloned using "twinning" cloning techniques (e.g., blastomere separation and blastocyst splitting).

It is common in many cloning bills to refer to "nuclear transfer" being conducted on just oocytes, as well as on "fertilized oocytes". But "fertilized oocytes" are already living human embryos. Since this Bill does not include the earliest human embryo in its formal definition of "embryo", then (36) this Bill would allow the use of nuclear transfer cloning techniques on already fertilized oocytes - i.e., on already existing single-cell living human beings.

(g) 'Somatic cell' means a mature//, diploid cell.

-- "mature": Somatic cell nuclear transfer (SCNT) can be accomplished using any diploid somatic cell - i.e., somatic cells derived from the single-cell zygote and from early embryos of subsequent stages, from late embryos (up to 9 weeks of development) as well as from fetuses, and from born young and older children and adults. By restricting the definition to "mature" somatic cells, this Bill does not address all these other somatic cells that can also be used to clone human beings by SCNT. Therefore, (37) this Bill would allow the cloning of human beings by means of SCNT using somatic cells from human beings of all stages of human development - except those from "mature" human beings.

-- "diploid cell": There are two basic categories (or subsets) of diploid cells in the human organism, BOTH of which have a complete set of chromosomes - somatic cells and germ line cells. Since both kinds of cells are diploid, both kinds of cells can be used to clone human embryos using the nuclear transfer cloning technique. By blurring the distinction between somatic cells and germ line cells, this Bill does not address the use of human germ line cells to clone human beings. Therefore (38) this Bill would allow the cloning of human embryos by means of the germ line cell nuclear transfer (GLCNT) technique.

Additionally, since primitive germ line cells are also totipotent, (39) this Bill would allow the cloning of human embryos by means of the "twinning" cloning technique.

(h) 'Somatic cell nuclear transfer' means transferring the nucleus of a somatic cell of an living or previously living //organism into an enucleated oocyte.

-- "of a somatic cell": This Bill is defining "cloning" ONLY in terms of the somatic cell nuclear transplant (SCNT) cloning technique. However, there are many other kinds of human cloning techniques that can be used to clone human beings. Therefore (40) this Bill would allow the cloning of human beings by means of, e.g.: germ line cell nuclear transfer (GLSNT); "twinning" (blastomere separation and blastocyst splitting); pronuclei transfer; mitochondria transfer; embryos cloned by means of artificially constructed sperm and/or oocytes; parthenogenesis; production of human/human chimeras and human/non-human chimeras, etc.

-- "living or previously living": Note that human embryos cloned using any human cloning techniques - e.g., SCNT, GLCNT, pronuclei transfer, mitochondrial transfer, the use of artificially constructed sperm, oocytes, embryos, etc. - would NOT be genetically identical to a "living or previously living" organism. They would be completely genetically unique, having never existed genetically as such before. Therefore () this Bill would allow the cloning of such genetically unique human embryos.

Indeed, even the cloned embryo reproduced using SCNT or GLCNT is genetically unique - having never existed before. The mitochondrial genes from the donor cell are not transferred to the embryo. Additionally, the mitochondrial genes of the recipient cell (the enucleated oocyte) are retained in the embryo. Therefore, the embryo cloned by SCNT or GLCNT is genetically unique from both the donor and from the recipient cell used. Therefore, (41) this Bill would even allow the cloning of human beings by means of the SCNT and GLCNT cloning techniques.

These cloned embryos - and thus their "stem cells" -- contain genetic materials that are different from the genes in the cells of patients into which stem cells will be injected for "therapies". This genetic incompatibility will cause immune reactions and rejections in these patients undergoing either human embryonic or adult stem cell "therapies".

-- "organism": The term "organism" is certainly applicable to both humans and non-humans, as is the term "somatic". Thus (42) this Bill would allow the use of SCNT in which the nucleus of a cell from a non-human animal or the nucleus of a cell from a human being can be used to clone human/non-human chimeras.

(i) 'The creation of a human child' means implanting into the uterus of a human female, for gestation and subsequent birth, the product of a nuclear transfer of a human//somatic cell into a enucleated human oocyte.

Note: Because of the in-depth details already provided above involving many of the same terms that are used in this formal definition of "a human child", the following comments are abbreviated:

-- "implanting into the uterus": This means that there is no "human child" existing before and until implantation. Therefore, (43) this Bill does not prohibit non-implanted human embryos -- sexually or asexually reproduced, in vitro or in vivo - from being used for experimentation. (44) Nor would it prohibit human/non-human chimeras from being used for experimentation. (45) Nor would it prohibit the reproduction of any embryos of any "kind" within an artificial womb.

-- "for gestation and subsequent birth": This means that no "human child" exists in utero unless and until implanted for the purpose of gestation and birth. Therefore, (46) this Bill does not prohibit the implantation of human embryos -- sexually or asexually reproduced, in vitro or in vivo - from being implanted in a woman's uterus. (47) Nor would it prohibit human/non-human chimeras from being implanted in a woman's uterus. (48) Nor would it prohibit the implantation of any embryos of any "kind" in an artificial womb.

-- "product of a nuclear transfer": Since the terms "human child", "embryo", "fetus", "gestation", "nucleus", "somatic cell nuclear transfer", and "human cell" are misdefined, (49) this Bill would not prohibit the cloning or implantation of human embryos -- sexually or asexually reproduced, in vitro or in vivo. (50) Nor would it prohibit human/non-human chimeras from being cloned or implanted in a woman's uterus. (51) Nor would it prohibit the implantation of any embryos of any "kind" in an artificial womb.

-- "of a human//somatic cell": Since the terms "human child", "embryo", "fetus", "nucleus", "somatic cell nuclear transfer", and "human cell" are misdefined, (52) this Bill would not prohibit the use of the SCNT, the GLCNT, or any other cloning techniques to clone or implant human embryos -- sexually or asexually reproduced, in vitro or in vivo. (53) Nor would it prohibit human/non-human chimeras, or artificially constructed embryos, from being cloned or implanted in a woman's uterus. (54) Nor would it prohibit the cloning or implantation of any embryos of any "kind" in an artificial womb.

Par. 3003. Protected Biomedical Research.

Nothing in this Chapter shall restrict other areas of biomedical and agricultural research, including but not limited to, important and promising work that involves the use of somatic cell nuclear transfer or other cloning technologies:
(a) to clone molecules, DNA, cells, and tissues; or

-- "molecules, DNA, cells, and tissues": Since the use of "somatic cell nuclear transfer or other cloning technologies" is protected in this Bill, the following use of these technologies would allow extensive cloning and genetic engineering of human beings:

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. The same is true for cloning of human beings by means of mitochondrial transfer, by DNA-recombinant germ line gene transfer (genes are also molecules of DNA), the use of artificially constructed DNA chromosomes, etc. Therefore (55) this Bill would protect the cloning of human embryos by means of such cloning techniques.

As mentioned above, the plural use of the term "cells" would not apply to the single-cell human, non-human, human/non-human chimera, or artificially constructed organism called the zygote. Therefore, (56) this Bill would protect the cloning of such single-cell organisms, using all cloning techniques.

Many researchers use the phrase "human tissues" to refer to what are in reality totipotent diploid human primordial germ line cells. Thus (57) this Bill would protect the cloning of new human beings by means of twinning these totipotent cells, or cloning them by means of nuclear transfer, if the researchers' deceptive definition of "tissues" is accepted.

(b) to develop animal or agricultural// products.

[[END OF ANALYSIS]]

Par. 3004. Penalties.

Any person who intentionally violates Par. 3001 of this Chapter shall be assessed a civil penalty equal to the greater of $250,000 or two times the gross gain from the offense."

Section 3. Nothing in this Act shall be construed to give any individual or person a private right of action.

Section 4. If any provision of this Act, or the application thereof to any person or circumstance, is held to be invalid by any court of competent jurisdiction, such invalidity shall not affect the other provisions of this Act which shall be given full force and effect without said invalid provision or application, and to that end the provisions of this Act is declared to be servable.

SYNOPSIS

This Act places a ban on human cloning while allowing cloning technologies to be used for purposes other than human cloning. In particular this Act allows such technologies to be used for the development of animal or cultural// products.

1, 2,