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

Dianne N. Irving
Copyright October 4, 2004
Edited October 20, 2004
Reproduced with Permission

ABSTRACT: Because of the massive scientific and legal deficiencies addressed in detail below, it is crystal clear that the accumulative body of U.S. legislation, regulations, and related documents on human embryo and fetal research, human embryonic stem cell research (especially when stem cells are derived from cloned human embryos), human cloning, and other human genetic engineering activities over the last 30 years represents total chaos -- legally banning and regulating nothing. Many of these federal documents as incorporated into newer ones also contradict each other. All but one document applies to the use of federal funds only. The use of private funds is not mentioned.

Most of these documents explicitly apply only to human embryos and fetuses that are sexually reproduced. The two that explicitly refer to "cloning" give no formal definition for that term, thus would likely be interpreted as erroneously defined in the pending federal "total human cloning bans" -- thus banning nothing. "Cloning" in those documents is consistently erroneously misdefined -- and defined only in terms of somatic cell nuclear transfer (SCNT), itself misdefined. Indeed, a great deal of human cloning and human genetic engineering is definitionally slipped through huge loopholes in the "formal definitions" and the "prohibition" or "restriction" sections of some of these documents. No documents expressly address living human embryos and fetuses that are asexually reproduced by other human genetic engineering processes.

The scientific definitions of the terms "human embryo", "human fetus", "when they begin to exist", and "fetal tissue" are so erroneous that they arrogantly defy the international nomenclature's objective scientific standards. Instead, the following documents are riddled with the false mythological language of the "pre-embryo" or "pre-embryo substitutes", purposefully and irresponsibly confusing the debates on both sexual and asexual human reproduction, on fertility "treatments", on patient disease advocacy, and on biotechnology/bioengineering.

The legal result is that these documents are contradictory and unenforceable due to vagueness, banning or regulating no human cloning or other human genetic engineering activities. Yet they continue to form the ever-expanding foundation for legal and regulatory stare decisis to be applied in the future to the next round of bills, regulations and related documents dealing with these critical issues. Because of the abject failure of this legislative process over the last 30 years, the personal and societal harm that could result from such legislative and regulatory chaos is, put simply, horrendous. Yet "bioethics" -- the official ethics of the U.S. government -- would condone it all as "ethical". [To go directly to the detailed analyses of these federal documents, please go directly to Part Two, pg. 20.]

Documents addressed: the Federal OHRP Regulations (formerly, OPRR); the NIH Revitalization Act (1993); the Dickey Amendment; the OHRP Guidelines on HESC, Germ Cells, etc.; Federal Policy on Human Embryonic Stem Cell Research; the Child Health Insurance Program Act; Congressional Amendment Re Patenting Human Organisms; pending Congressional cloning bills.

[No religious, theological or prolife arguments are used in these analyses. Scientific comments are in concert with the international nomenclature.1 Emphases used throughout to help those unfamiliar with some of the issues.]

Table Of Contents

Part One

I. Introduction

  1. The issue is not cloning -- it is genetic engineering
  2. Who Cares?
  3. What is "ethical"?

Ii. Common Causes Of Legislative And Regulatory Chaos

Iii. Legal Ramifications


Analyses: Are Asexually Reproduced Human Beings Really Protected By Any U.S. Federal Documents?

Part One

I. Introduction

"Also, there is a current legal challenge arguing that actually the [British] licensing Authority, the HFEA, has no authority over cloned embryos, because the existing law defines an embryo as the result of fertilisation, and with cloning -- or cell nuclear transfer, the Dolly process -- no fertilisation has taken place."2 (Sarah Sexton, "New Reproductive and Genetic Technologies ...", May 2001)

After analyzing the U.S. federal documents concerning scientific research below, perhaps nothing better sums up the confusion and legislative/regulatory chaos experienced than the famous Vaudeville comedy routine of Abbot and Costello, "Who's on first?". Here in the United States we are constantly assured that "such and such" a law or regulation is already in place to protect innocent living human embryos -- whether reproduced sexually (fertilization) or a-sexually (cloning, genetic engineering). Not to worry.

But is that really the case? Unfortunately, after taking a hard look at these documents, the answer to that question must be negative. No one's "on first" -- from either side of the aisle.3

The inability of the law to keep up with the rapid advances in science is not new.4 But such unenforceable forces of laws and regulations that are drafted through ignorance are one thing. What British writer Sexton is pointing to is a quite different phenomenon, and one that cries out to be identified and acknowledged: laws and regulations purposefully drafted incoherently in order to advance unethical research without fear of later legal accountability or public scrutiny.

The British Authority's authority -- or lack thereof -- that Sexton cites crystallizes this issue. Indeed, not only does the British Authority fail to include all of the processes (both sexual and asexual) that can be used to reproduce new human beings, it also mis-defines "cloning" only in terms of the somatic cell nuclear transfer method (SCNT) -- a method which itself is also mis-defined! The result, as Sexton notes, is legislative chaos, which then leads to both intellectual and moral chaos.

A. The issue is not cloning -- it is genetic engineering

Human cloning is only one of many different methods available to do human genetic engineering -- itself a tool for social engineering. In the real world the accurate scientific fact is that human beings can be reproduced both sexually and asexually. Not all human beings are reproduced sexually (i.e., via fertilization, the use of a sperm and an oocyte). They can be reproduced by quite a variety of asexual reproductive processes as well, e.g., by a natural in vivo cloning process known as "twinning" (such as in naturally occurring human monozygotic twins/triplets). "Twinning" can also take place artificially in vitro. It is unquestionably a cloning technique,5 and is variously referred to in IVF as blastomere separation, blastocyst splitting, embryo splitting, embryo multiplication, etc. Unless one is aware of the different terms used to describe it, the cloning of human beings by means of the asexual process of twinning could be misunderstood by the public and easily slip through legislative and regulatory loopholes.

Human beings can also be artificially reproduced asexually in vitro by many other kinds of cloning techniques such as somatic cell nuclear transfer (SCNT), germ line cell nuclear transfer (GCLNT), pronuclei transfer, and by various other genetic engineering techniques such as the use of artificially constructed chromosomes, sperms, oocytes or embryos,6 etc. -- even nurtured in non-human animals or artificial wombs.7 Much of this research is already being done in IVF clinics and labs around the world, especially since they have already honed the methods and developed the tools for decades through prior animal cloning and genetic engineering research.

Further, both sexual and asexual reproductive techniques can be used in combination to reproduce new living human beings, e.g.: pronuclei transfer before or after fertilization or cloning producing human/human chimeras and human/non-human chimeras (e.g., transgenic animals), and mitochondria transfer before or after fertilization or after cloning. There is also the use of DNA-recombinant germ line gene transfer before or after fertilization or cloning, in which foreign genes will be transferred into human sperms and oocytes or into new single-cell embryos and then passed down for generations through both sexually and asexually reproduced progeny, etc.

Indeed, what we have before us is the "convergence of technologies"8 applied to the reproduction and genetic engineering of new living human beings -- for both research and reproductive purposes. Much of this research has already been done using both public and private funds, and performed in both public and private laboratories, including IVF clinics and using IVF clients. All of these artificial reproductive techniques used to asexually reproduce new living human beings are included in the scientific definition of "human genetic engineering", and this is how the term will be broadly understood and used in the following analysis.

B. Who Cares?

For those who are weary of or uninterested in the abortion or human embryo research debates, perhaps they might reconsider their monumental apathy when they understand clearly that the issues surrounding human cloning and human genetic engineering affect us all. A great deal more than just the killing of irrelevant "little embryos" is involved. It also involves the cells dissected from those bioengineered embryos being transplanted or injected into sick patients in order to "cure their diseases" -- cells that could well end up growing into all sorts of dangerous tumors, etc., instead. We are talking about desperate infertile women and men who line up at the doors of IVF clinics -- who could so easily be used as guinea pigs for some artificial reproductive technology researchers' curiosities and grant monies as well, and the women who could likely suffer horrific physical and psychological damage when these experimental embryos are implanted in them and start to go haywire. How does a woman really know what is being implanted inside her? We are talking about the purposeful creation of disabled and diseased human embryos just in order to study, and then kill or implant, them. We are talking about the impossibility of any of these "participants" in research being able to give truly ethically or legally valid informed consent because of the scientific misrepresentation of what research is really taking place.

We are talking about mutant and aberrant viruses and bacteria (and who knows what else) that escape labs where sloppy and ignorant technicians work, and infect whole geographical areas including people and food supplies, etc. We are talking about pharmaceutical drugs and products -- even make-up -- pressed on an unsuspecting public for endless ailments, conditions and "health", with no serious studies performed as to their damaging side-effects. No studies, no evidence. And we are talking about health care and insurance industries -- indeed, entire state and federal budgets -- that could literally fold under the excessive economic burden of eventually caring for all of these human casualties. These examples are just the tip of the proverbial iceberg. No wonder so much of the legislation and "informed consent" forms concerning such research include "exclusions of liability" clauses for researchers and associates for any harms or injuries that result. Everyone has a stake in these controversial issues.

C. What is "ethical"?

What has changed in debates on the "ethics" of such research is the recent formal "birth of bioethics", mandated by the U.S. Congress in 1974 and fulfilled by the National Commission in 1978.9 "Bioethics" is in fact the new machine that is running and "justifying" most of it. Indeed, "bioethics" -- at first referred to as "federal ethics", or "the Georgetown mantra" -- is explicitly used as the very foundation of most of the U.S. laws, regulations and guidelines concerning such research that are analyzed below.

"Legislating ethics" by any governmental body in a pluralistic, multicultural, democratic society would seem to be an oxymoron, a dubious effort at best, and an ominous tool at worst -- a concern succinctly articulated by Robert Morison (professor emeritus of biology at Cornell and original Hastings Center scholar) in his evaluation of the proposed new 'bioethics" of the National Commission:

"What one fears is that the Commission may become the mechanism whereby the speculations of the ethicists become the law of the land. It is already far too easy for abstract notions of right and wrong to emerge as deontological rules which begin their public life as 'guidelines' but culminate in the force of law."10 (emphases added)

Indeed, Morison's concerns were well-placed. As we shall see in the analysis below, the "ethical" recommendations of the bioethics commissions did indeed form the explicit basis of many guidelines, regulations and laws -- both private and public, national and international -- including those of Great Britain and the United States.

Recently even one of the Founders and loyal architects of secular bioethics over the years has amazingly admitted -- as have other bioethics Founders before him, e.g., Daniel Callahan, Gilbert Meilaender, Renee Fox, etc. -- that bioethics simply cannot work, either theoretically or practically, especially with these current complex issues involving genetic engineering:

"Secular bioethics poses questions that can be recognized as important, though it lacks the resources to answer them. Secular bioethics may retain the sense that there should be moral limits to the use of germ line genetic engineering, but it lacks the basis to justify limits in principle. ... Within this impoverished moral context, human biological nature can only appear to be a contingent outcome of spontaneous mutations, selective pressure, the constraints of physical laws, and random catastrophes. Such a bioethics, deprived of ultimate orientation, can provide no ground in principle for forbidding cloning, germ line genetic engineering, or the fundamental recasting of human nature."11 (emphases added)

Coextensive with the "birth" of this precarious "ethics" was the formulation and perpetuation of purposefully false, erroneous, and misleading "scientific" definitions that immediately became imbedded into our laws and regulations. What this article fundamentally chronicles is the long march of that corrupt "stare decisis" originating over 30 years ago in both the U.S. National Research Act (1974) and the British Warnock Committee Report (1985). It is long past time for all nations to rethink such precarious "bioethical" and "scientific" foundations of law and public policy making -- for even the greater good.


Before exploring in detail whether or not the same legal and regulatory conundrum exists here as in Great Britain, a few general observations about some of the causes of this legislative chaos are in order. Such observations might be especially helpful to those unfamiliar with the issues before turning to the detailed analyses of U.S. federal documents that follow, where only brief reference to these points will be noted. Without frankly acknowledging the fundamental truth and reality of these causes it is impossible to identify their cancerous effects so deeply embedded within the legislative documents analyzed below, or to do anything about them. To willingly deny them is to willingly maintain the status quo.

A. Applies Only To Use of Federal Funds

Most people assume that when a federal law is passed that it covers all such activities in the U.S. But this is far from true. Almost all the laws and regulations analyzed below apply to the use of federal funds only -- and sometimes to a particular governmental department only. Most assuredly "professional" bioethicists know this, as recently made clear by long time bioethics advocate Jeffrey Kahn, Director, Center for Bioethics at the University of Minnesota:

"The sometimes overlooked fact is that embryo research is and has long been legal under the laws of our country. Federal funds may not be used for most embryo research, but any and all such research is permitted so long as it is supported by non-public funding, a position endorsed most recently by none other than the Bush Administration. To the extent that the law represents society's sense of at least our basic moral rules, as I believe it does, the fact that embryo research is fully legal is meaningful. This context is crucial to understanding the facts in the debate about embryonic stem cell research ..."12

The use of private funds and institutions in support of such research has always been allowed to continue unabated and unhindered by any federal -- or often even state -- laws or regulations. Such private funds could even originate overseas. Thus a law to ban or to regulate some specific type of research is not really a "total" ban or regulation if it only applies to the use of federal (or state) funds. The lack of knowledge of this fact among the public -- and even among many officials -- has engendered a false sense of security about such laws and regulations.

B. Human Beings Are Reproduced Both Sexually And Asexually

One dilemma for the British Authority, as Sexton points out, is that because of their scientifically erroneous definition of "embryo" only in terms of sexual reproduction in their earlier legal documents, they have now thereby precluded themselves from regulating any human cloning (or genetic engineering) research when such documents are cited as authority in the newer ones, since all such research involves the use of asexually reproduced human embryos. But the objective scientific fact is that human beings can be reproduced both sexually and asexually, and the immediate product of either reproductive process is a new living individual human being, a single-cell human embryo.13

A similar problem exists here in the United States,14 where many state and federal legal documents define all human beings as "beginning to exist at fertilization/conception". As inclusive and scientifically enlightened as this might sound, it automatically excludes from the fraternity of humankind -- and from the purview of the law -- all a-sexually reproduced human beings -- including naturally occurring human monozygotic twins/triplets in vivo, as well as those artificially reproduced a-sexually in vitro in the lab by any technique. U.S. documents analyzed below will suffer the same defect, and thus cannot be cited as authority for or be applied to issues of asexual human reproduction dealing with, e.g., human cloning and human genetic engineering.

Next Page: C. Definitions of a "human organism" and a "human cell"
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