Analysis of Legislative and Regulatory Chaos in the U.S.: Asexual Human Reproduction and Genetic Engineering


1. Obviously, the current OHRP definition of "fetus" applies only to products of "conception", i.e., "fetuses" reproduced sexually (i.e., fertilization, the use of a sperm and an oocyte). Therefore they would not apply to any human "fetuses", much less any human embryos -- or their stem cells -- reproduced asexually, e.g., by means of human cloning (all techniques), human genetic engineering, artificially constructed, etc.

2. There is no definition for "embryo" in these federal regulations. Indeed, if "fetus" is erroneously defined as beginning at implantation, and if these regulations are silent on any entity that exists before implantation -- an interesting "pre-embryo substitute" -- then for all intents and purposes, there is no embryo at any time to which these federal regulations could apply -- from fertilization through 8 weeks, in vitro or in vivo, sexually or asexually reproduced!

3. The current OHRP federal regulations erroneously define "fetus" as beginning to exist at implantation (5-7 days post fertilization) -- which is truly absurd. The accurate scientific definition of "fetus" refers to the developing human being from 9 weeks post-fertilization through birth. But this would allow human embryo research to be performed simply by calling it "human fetal research". And what happens if the definition of "fetus" were suddenly to be accurately defined as "beginning at 9 weeks of development"? Such a document could then be applied backwards to preexisting documents, and once again all human embryos would likewise be left unprotected.

4. The current OHRP definition of "pregnancy" is also from implantation (5-7 days post-fertilization) until delivery -- again, a scientifically absurd definition. The accurate scientific definition of normal "pregnancy" refers to a woman who is carrying a new unique living individual human embryo (human being) from fertilization (in her fallopian tubes) through birth. Only in artificial reproduction, e.g., in vitro fertilization (IVF), or any other artificial reproductive technique, is the woman "pregnant" beginning at implantation. Therefore, again, these regulations would not cover the early human embryo reproduced either sexually or asexually, either in vitro or in vivo, before implantation (5-7 days) or through 8 weeks of development. Nor would they cover the case of a woman who is pregnant through normal sexual reproduction while the embryo is still in her fallopian tube and has not yet implanted. (Thus procedures such as "embryo flushing" would not be covered by these regulations). Nor would they cover the woman who is pregnant with an asexually reproduced human embryo or fetus (or even a chimera) from implantation until delivery -- and that would include human embryos and fetuses reproduced asexually by "twinning" (embryo splitting). Feminists of the world, take notice!

5. Within the federal government, compliance by other federal departments and agencies with these DHHS federal regulations is voluntary only through the Common Rule. At the moment, only the following federal departments and agencies have voluntarily agreed to comply with these federal regulations, under the Common Rule: Department of Agriculture, Department of Energy, National Aeronautics and Space Administration, Department of Commerce, Consumer Product Safety Commission, International Development Cooperation Agency, Agency for International Development, Department of Housing and Urban Development, Department of Justice, Department of Defense, Department of Education, Department of Veterans Affairs, Environmental Protection Agency, National Science Foundation, Department of Transportation.69

Does this mean that any of these governmental departments and agencies can change their minds and decide to not voluntarily comply with these federal regulations? And what about other critical departments and agencies who want to engage in such research that are not part of the Common Rule, e.g., the FDA, the CIA, etc.? Are they now exempt from following these federal regulations?

6. The Secretary of DHEW (now DHHS) is authorized to waive restrictions of these federal regulations for various reasons, including "the advancement of science".

7. These federal regulations apply to the use of federal funds only. The use of private funds for such research is not affected.

CONCLUSION: Obviously, because of the scientifically erroneous definitions used, these current OHRP federal regulations pose serious problems if applied to a variety of current research issues. Not only would they not apply to any research involving human embryos or fetuses reproduced asexually (including twins/triplets); they would also not apply to research involving human embryos reproduced sexually either. They would allow the use of all human embryos, from the beginning of their existence via either sexual or asexual methods of reproduction through 8 weeks of development -- in vivo or in vitro -- in any kind of research, including all human cloning, human embryonic stem cell, and human genetic engineering research -- for either "therapeutic" or "reproductive" purposes. Nor does there seem to be any guarantee that specified government departments or agencies must involuntarily continue to subscribe to these regulations; nor would they now cover any research performed in non-compliant federal departments or agencies using federal funds. Indeed, the Secretary can waive these regulations for specified reasons.

B. The NIH Revitalization Act (1993) [Public Law 103-43]

Another federal document that is often cited and is incorporated into later federal documents is the NIH Revitalization Act (1993) -- or Public Law 103-43. This is a most historic Act, as for years before its passage the federal government had placed a moratorium on all fetal research and IVF research (which is in essence human embryo research). Because of a change in wording that was slipped in "without notice" at the last minute, this Act nullified that moratorium, and IVF "research" (aka, human embryo research) was for the first time eligible for federal funding. That is, the former requirement for the recommendation of an Ethics Advisory Board before approving any such research was left out of the language used in the final bill. In the almost arrogant words of bioethics journalist Joseph Palca in the Hastings Center Report:

Legislation with sweeping impact often can seem quite obscure and innocuous. Consider this example. Title I, Subtitle A, Part III, Section 121, Paragraph (c) of the National Institutes of Health revitalization Act of 1993 contains the following sentence: "The provisions of section 204(d) of part 46 of title 45 of the Code of Federal Regulations (45 CFR 46.204(d) ) shall not have any legal effect." On its face, this sentence would not seem to merit much attention, and in fact, as the bill sailed through Congress this past year, it didn't get much. But little more than a year ago, this sentence would probably have prompted a presidential veto, because for the first time in more than a decade, it allows the federal government to fund research on in vitro fertilization (IVF). What a difference a year makes.

... With the election of Bill Clinton, NIH officials saw a new opportunity. ... So with lobbying support from the American Fertility Society, and the willing cooperation of Senator Edward Kennedy (D-Mass.) and Representative Henry Waxman (D-Calif.), they hit on the strategy of simply eliminating the requirement that the Ethics Advisory Board approve IVF research projects. Language doing that was slipped into the NIH Revitalization Act of 1993, and President Clinton signed the act last summer. The most strident opposition to the act came because it explicitly removed the ban of federal funding for transplantation research using fetal tissue from induced abortions, so Title I, Subtitle A, Part III, Section 121, Paragraph (c) attracted very little attention.

Duane Alexander, director of the National Institute of Child Health and Human Development, decided shortly after the act passed that it would be prudent to revisit the guidelines laid down for IVF research by the Ethics Board in 1979, since new research was bound to raise new issues. So he sought and received permission to create an ad hoc advisory panel to address the subject of IVF and embryo research.

...The panel is supposed to give a new set of guidelines to the director of NIH next June. After that, the government should start supporting a much broader portfolio of research in the new world reproductive technology. Quite an achievement for one small sentence.70 (emphases added)

Additionally, in 1988 the NIH Human Fetal Tissue Transplant Panel Report had concluded that both human embryo and human fetal research were, essentially, "ethical" (according to "bioethics" principles, and based on the scientifically erroneous term "pre-embryo" and its use in the bioethics "delayed personhood" arguments). President Clinton signed the NIH Revitalization Act into law in 1993. In 1994 the NIH Human Embryo Research Panel was appointed, which found most such research "ethical".

It didn't take long for people to realize what a whopper of a mistake the passage of the NIH Revitalization Act was, and hence the "Dickey Amendment" quickly ensued (addressed below). The Dickey Amendment made it illegal for federal funds to be used in certain kinds of human embryo research, and it must be continuously attached to on-going NIH Revitalization Act fiscal renewing bills.

Taking a quick look at the NIH Revitalization Act (or Public Law 103-43, as amended), one can quickly observe, again, that it only applies to research involving sexually reproduced human cells and tissues. For example, Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)) is part of the 1993 NIH Revitalization Act. The only relevant formal definition, which is at 498A(g), is that for "human fetal tissue", which refers only to tissues or cells obtained "after a spontaneous or induced abortion, or after a stillbirth". Therefore, this law does not cover any human tissue or cells obtained from asexually reproduced human embryos or fetuses:

Public Law 103-43, as amended; June 10, 1993
National Institutes of Health Revitalization Act of 1993
Title I -- General Provisions Regarding Title IV of Public Health Service Act
Subtitle A - Research Freedom
Part II -- Research on Transplantation of Fetal Tissue
Sec. 111. Establishment of Authorities

SEC. 498A.(a)(2)

(2) SOURCE OF TISSUE - Human fetal tissue may be used in research carried out under paragraph (1) regardless of whether the tissue is obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth.71 (emphases added)


1. Note that "human fetal tissue" refers only to tissue obtained after a spontaneous or induced abortion, or after a stillbirth. Thus such "tissue" is derived through sexual reproduction only. Therefore the Act does not apply to "fetal tissue" derived asexually.

The same problem is found in the formal definition of "human fetal tissue", as well as a blurring of the difference between an "embryo" and a "fetus":

SEC. 498B.
(d) DEFINITIONS - For purposes of this section:
(1) The term 'human fetal tissue' has the meaning given such term in section 498A

SEC 498A.
(g) DEFINITION- For purposes of this section, the term 'human fetal tissue' means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.'. (emphases added)

2. So now the term "fetal tissue" can apply to embryos as well as to fetuses -- even when sexually reproduced! Since the "embryonic period" is actually from fertilization through 8 weeks, then this definition would allow the use of tissues or cells from dead human embryos from fertilization through 8 weeks -- as well as from dead fetuses from 9 weeks onward. Thus one could get around the "restrictions" of the Dickey Amendment and perform human embryo research simply by calling it "fetal tissue research" (which is now legal) and by using living embryos and fetuses.

3. Since there is no formal definition in this Act for either "fetus" or for "embryo", the authority of which federal document applies to research involving even those human embryos or fetuses reproduced sexually -- the current OHRP federal regulations, where there is also no definition of "embryo", and where "fetus" is scientifically erroneously defined as "beginning at implantation"?

4. How, by whom, and using what established standards, is a human embryo or a human fetus to be determined to be "dead", when "brain death" criteria could not apply?

5. As pointed out before, this Act claims that such research is "ethical" because of the conclusions of the 1988 NIH Human Fetal Tissue Transplant Report (also grounded on the Belmont Report's "bioethics principles", and the mythological "pre-embryo"):

(2) STANDING APPROVAL REGARDING ETHICAL STATUS- In the case of any proposal for research on the transplantation of human fetal tissue for therapeutic purposes, the issuance in December 1988 of the Report of the Human Fetal Tissue Transplantation Research Panel shall be deemed to be a report-- (A) issued by an ethics advisory board pursuant to section 492A(b)(5)(B)(ii) of the Public Health Service Act (as added by section 101 of this Act); and (B) finding, on a basis that is neither arbitrary nor capricious, that the nature of the research is such that it is not unethical to conduct or support the research.73 (emphases added)

Thus what is "ethical" has been determined by the Advisory Board of NIH, based on the "pre-embryo" myth, conflation of the terms "embryo" and "fetus", and the federal "bioethics" principles.

6. This Act applies to the use of federal funds only. The use of private funds for such research is not affected.

CONCLUSION: Because of the specified "source" from which materials are derived, and because of the scientifically erroneous definition of "fetal tissue" used, the NIH Revitalization Act (1993) would clearly not apply to any research involving living asexually reproduced human embryos or fetuses, and would even allow the use of human embryos and fetuses sexually reproduced in research. Because of the lack of any accurate scientific definition of "embryo" or of "fetus", this Act would also allow research using human embryonic and fetal cells derived by sexual reproduction/fertilization -- as long as they were somehow determined to be "dead".

C. The Dickey Amendment

As noted above, the passage of the 1993 NIH Revitalization Act allowed, among other things, IVF (human embryo) research to be federally funded for the first time. The swift reaction came in the form of the Dickey-Wicker Amendment, which supposedly filled in that legal gap and prohibited federal funds to be used in "human embryo research". The current Dickey Amendment must be understood in terms of its references to several of the earlier federal documents discussed above, as well as in relation to the currently pending federal "bans" on human cloning:

SEC. 510. (a) None of the funds made available in this Act may be used for --
(1) the creation of a human embryo or embryos for research purposes; or
(2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

(b) For purposes of this section, the term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.74 (emphases added)


1. Note the "or" -- otherwise known in legal jargon as a possible "disjunctive". But for our purposes here, I will assume that both (1) and (2) are considered inclusive.

2. In part (1) above, the Dickey Amendment states that funds are available for the use of already existing IVF-produced human embryos for "research" purposes. But what about for "reproductive purposes"?75 This Amendment does not address the use of human embryos -- sexually or asexually reproduced -- for "reproductive purposes". Nor is this writer aware of any current federal documents that do.

The phrases "for research purposes" and "for reproductive purposes" take on new meaning and significance considering the current deconstruction of these controversial phrases by research cloners such as Weissman et al. (See Part One, Section D supra). If their definitions of "research purposes" were used to interpret the Dickey Amendment, then the Dickey Amendment could allow the use of federal funds for the cloning of human embryos for "research purposes" -- aka, "stem cell research" -- as well as the derivation and use of human embryonic stem cells derived from those cloned human beings.

3. In part (2b) above, the phrase, "the creation of a human embryo or embryos ... derived by ... cloning " sounds hopeful -- until one focuses on the later definition of that phrase: "'human embryo or embryos' ... derived by ... cloning ... from one or more human gametes or human diploid cells." Have we here at least some attempt to address the use of human embryos that are asexually reproduced?

Unfortunately, there is no definition in this Amendment for "cloning". The only current operative definition of "cloning" seems to be in the currently pending federal human cloning "bans". However, "cloning" is defined there only in terms of the somatic cell nuclear transfer (SCNT) cloning technique -- thus not addressing the use of all other human cloning or other asexual genetic engineering techniques to reproduce living human embryos. Further, even the definitions of "SCNT" used in these bills are scientifically erroneous -- since the products of SCNT are never actually "virtually genetically identical" to any donor because of the significant differences in mitochondrial DNA in the product. Nor are SCNT products "virtually genetically identical" to any "existing or previously existing human being".76 That is, such products are always genetically unique, having never existed before. In fact, one of those "total cloning bans" (Stearns') formally defines the product of SCNT as just a cell -- an "oocyte"! No human organism there! It would seem, then, that these pending federal bills could not protect any asexually reproduced human beings, nor be of help in interpreting this Amendment.

There is a similar problem with this Amendment's reference to "from one or more human gametes or human diploid cells". None of the major terms used here are defined in this Amendment, and so one looks again to the possible use of the current pending federal cloning "bans" for definitions. There, "diploid cell" is so vaguely defined as to imply that only somatic cells are diploid, while in fact both somatic cells and all germ line cells are diploid. Thus this vague definition of "diploid" would not cover the use of diploid germ line cells in nuclear transfer experiments to asexually reproduce human embryos -- nor stem cells derived from them. Nor would it cover the use of totipotent primitive germ line cells in the asexual reproduction of new human embryos by twinning.

Indeed, there are also several methods of asexually reproducing human embryos without the use of "human gametes or human diploid cells". Such methods would include genetic engineering techniques which blur the distinction between cloning and genetic engineering, e.g., pronuclei transfer, mitochondrial transfer, the use of DNA-recombinant gene transfer (both somatic and germ line), the use of natural or artificially constructed human DNA molecules, etc. All one has to do to access the lengthy list of such current published scientific studies is to search on PubMed.77

4. In (2), the phrase, "greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2)" is used.

The phrase "in utero" implies sexual reproduction, but in fact both sexually and asexually reproduced human embryos and fetuses could be implanted "in utero". Since this Amendment could not apply to asexually reproduced human embryos or fetuses, as demonstrated above, this Amendment could not cover implanting them in utero. Also, this passage refers to the authority of the current OHRP federal regulations. But as pointed out above, the current OHRP federal regulations do not cover any human embryos or fetuses that have been asexually reproduced. Nor do they apply to embryos sexually reproduced -- through 8 weeks. None of these early human beings fall under the definition of "human subjects" in these federal OHRP regulations. Nor do they apply to stem cells derived from either sexually or asexually reproduced human embryos. Thus such an appeal to these OHRP federal regulations or to the Dickey Amendment for purposes of protecting human beings asexually reproduced, or stem cells derived from them, is an exercise in futility

Further, in the current (2001) OHRP federal regulations there is no such reference as "46.208(a) (2). Subpart B in the current regulations stops at "46.207".78

5. There are, however, other sections in Subpart B that refer to the use of "fetuses" in research (sections 204 and 207) which might shed some interesting light on when and under what circumstances living human "fetuses" reproduced sexually could be used in purely experimental research.

§46.204 concerning research involving pregnant women or fetuses (erroneously defined!) states that they may be involved in research if all of the following conditions are met:

(a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;

(b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means;

(c) Any risk is the least possible for achieving the objectives of the research;79 (emphases added)

Note that neither the definitions of "embryo" or of "fetus" have been accurately defined in any documents so far. Thus for our purposes here, since "fetus" is misdefined as beginning at implantation in the OHRP regulations, living human embryos (from fertilization through 8 weeks) that have been sexually reproduced may be used in research where there is some "prospect of direct benefit" to them. The same is true for sexually reproduced living human fetuses from 9 weeks until birth. If there is no prospect of direct benefit, then the "risk" allowed may not be greater than "minimal" -- and if "important biomedical knowledge" cannot be obtained by any other means. "Minimal risk" is defined in these regulations as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." [Subpart A, §46.102 Definitions, i)]

One has to wonder, then, how one knows empirically what "the probability and magnitude of harm or discomfort" are in the course of purely experimental research for living human embryos (from fertilization through 8 weeks) and living human fetuses (from 9 weeks through birth) that are equivalent to "those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" -- much less how this relates to living human embryos and fetuses asexually reproduced! I'd like to see that data. One also has to wonder how one knows empirically whether or not experimental interventions on sexually reproduced human embryos and fetuses might hold out the prospect for direct benefit to them, who decides (the IRB that is stacked with conflicts of interests?), and what is to be considered "important biomedical knowledge" that "cannot be obtained by any other means"?

§46.207 is also interesting. This section addresses "research not otherwise approvable" which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, "fetuses", or neonates ("in general" I presume, and thus by definition not for their direct benefit, but for "the advancement of scientific knowledge"):

The Secretary will conduct or fund research that the IRB does not believe meets the requirements of Sec. 46.204 or Sec. 46.205 only if:

(a) The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates; and

(b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in the Federal Register, has determined either:

(i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates;

(ii) The research will be conducted in accord with sound ethical principles;80 (emphases added)

Again, assuming the accurate definitions of "human embryo" and "fetus", even if an IRB does not agree to the above conditions, the Secretary of DHHS may approve purely experimental research using "human embryos" if he agrees with his chosen "experts" that the research is important in order to "advance scientific knowledge" -- and if it is "in accord with sound ethical principles" -- specifically, the Belmont bioethics principles! And the same holds true for the use of pregnant women in such research. Thus this section provides no real protection for the use of either sexually or asexually reproduced human embryos or fetuses because of the erroneous scientific definitions used in these OHRP federal regulations. And one is left with the ultimate political question: Can the Secretary of DHHS trump any and all other federal documents -- even the "statements" and "directives" of the President of the United States? Curious minds want to know.

6. In part (2) above, the use of the phrase, "and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b))" is likewise inapplicable since, as demonstrated above, that Act can only apply to the use of cells and tissues derived from sexually reproduced and dead human embryos or fetuses.

7. In (2b) above, the use of the phrase "not protected as a human subject under 45 CFR 46" is most interesting. Indeed, as already noted, the definition of "a human subject" in those federal regulations simply does not apply to any human embryos -- whether reproduced sexually or asexually. Thus those OHRP federal regulations do not provide any protections whatsoever for any of these human embryos when used in any research; nor did the earlier OPRR federal regulations. Yet the Dickey Amendment's attempt to protect even human embryos sexually reproduced, much less asexually reproduced, by including them as "human subjects" fails because the Amendment gives no formal definition of "a human embryo", when it begins to exist, or "cloning" either, thus opening the legal door for it to be rejected due to vagueness. Finally, the Dickey Amendment would also seem to contradict the definition of "a human subject" in the current OHRP Guidelines on Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles (analyzed infra).

8. Again, the Dickey Amendment applies to the use of federal funds only. The use of private funds for such research is not affected.

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