U F L

UNIVERSITY

FACULTY  FOR  LIFE

A multidisciplinary association of scholars speaking out for human life

 

120 New North Building, Georgetown University, Washington, D.C.  20057

 

 

UFL Board of Directors: 

 

C. N. Abromaitis, PhD          Keith Cassidy, PhD               Teresa Collett, JD               Robert Crnkovich, LLD

Department of English          Department of History            South Texas School of Law        Law Center

Loyola College                 University of Guelph             Houston, TX                      Georgetown University

Baltimore, MD                  Guelph, Ontario                                                   Washington, D.C.   

 

John F. Crosby, PhD            Richard J. Fehring, DNSc         Jorge Garcia, PhD                Dianne Nutwell Irving, PhD

Department of Philosophy       Department of Nursing            Department of Philosophy         Department of Philosophy

Franciscan U. of Steubenville  Marquette University             Rutgers University               Dominican House of Studies

Steubenville, OH               Milwaukee, WI                    New Brunswick, NJ                Washington, D.C.

 

Thomas M. King, SJ, PhD        Joseph Koterski, SJ, PhD         Teresa Lamonica, MSN, PN         Robert J. Spitzer, SJ, PhD

Department of Theology         Department of Philosophy         Department of Nursing            Department of Philosophy

Georgetown University          Fordham University               Georgetown University            Seattle University

Washington, D.C.               Bronx, NY                        Washington,D.C.                  Seattle, WA

 

Patricia A. Wesley, MD         Francis E. Zapatka, PhD

Emeritus, School of Medicine   Department of Literature

Yale University                The American University

New Haven, CT                  Washington, D.C.

 

 

 

Senator Sam Brownback

303 Hart Senate Office Building

Washington, D.C.  20510

 

Congressman Dave Weldon

332 Cannon House Office Building

Washington, D.C.  20515-0195

 

May 27, 2001

 

Dear Senator Brownback and Congressman Weldon:

 

            I am contacting you, as a member of the Board of Directors of the University Faculty For Life, concerning your co-sponsoring of the Human Cloning Ban 2001 that is currently before the U.S. House and the U.S. Senate for consideration.

The University Faculty for Life was founded in 1989 to promote research, dialogue and publication among faculty members who respect the value of human life from its inception at fertilization or cloning to natural death.  Abortion, infanticide and euthanasia, as well as human embryo and human fetal research, human embryonic stem cell research, and human cloning, are highly controversial topics, but we believe they should not be resolved by the shouting, newsbites and slogans that have dominated popular presentations.  Because we believe the evidence is on our side, we would like to assure a hearing for our views in the academic community, as well as in the social and political communities -- hence our concerns expressed to you here regarding certain concerns we have with the Brownback/Weldon Human Cloning Bill as it is currently written.

The basic issues and concerns of the University Faculty For Life have many dimensions -- political, social, legal, medical, biological, psychological, ethical and religious. We do not have a detailed statement of orthodoxy;  rather we have provided an interdisciplinary forum in which scholars can discuss these issues.  Since 1990 the UFL has published a newsletter, Pro Vita;  since 1991 it has held an annual conference at various university campuses;  and since 1992 the Conference Proceedings have been published in book form and distributed to members and hundreds of university libraries. We have sent letters to public figures who misstate biological facts and submitted three amicus curiae briefs on the life issues to the Supreme Court (two of which I authored on "fetal personhood").

 

The University Faculty For Life includes as its goals the following:

·         To provide a forum to foster multidisciplinary dialogue and collaboration among professors concerned about human life.

·         To educate the community, including politicians and the U.S. Congress, about life issues and the rational and factual reasons behind pro-life positions.

·         To make available academic materials and resources for pro-life groups, including bibliographies and videotapes of conferences and lectures.

 

The University Faculty For Life is also communicating our similar concerns about legislation on these related issues to groups and organizations both here and abroad.

 

We would like to applaud you for your courageous efforts to ban all forms of human cloning in the United States, in the public as well as in the private sectors.  The issue of human cloning, as you well know, is closely related to the issues of human embryo research, human fetal tissue transplant research, human embryonic stem cell research, etc. -- all issues fraught with debate and concern.  The University Faculty For Life strongly supports ethical research, but also agrees that immediate federal legislative action must be taken to prevent unethical human research in these areas.

However, on closer inspection of your human cloning bill, it would seem that some of the language is too narrow to accomplish a total ban, and would instead inadvertently allow the cloning of living human beings by means of several other cloning techniques not addressed in your bill.  The cloning of living human beings could also be permitted in your bill by virtue of certain omissions of critical terms, and by the use of certain scientifically inaccurate terms.

Given your goal to ban all cloning of human beings, and given the perception of those who would want to support your efforts to ban all cloning of human beings, we hope that the comments and suggestions to follow will be of help to you and your staff as you continue your efforts in this critical piece of legislation. If it is not your intention to ban all human cloning, then we suggest that your intention to only ban some cloning of human beings be stated unambiguously in the beginning of the bill so that people will correctly understand what they are supporting.

We also wish to note that we recently communicated to you our concerns about your human cloning bills, but as yet have not received any responses.  These scientific concerns are not just relevant to a bill on human cloning.  As you well realize, they are likewise relevant to other proposed legislation dealing with the integrally related issues of abortion, human embryo research,  human embryonic stem cell research, human chimera research, etc.  It goes without saying that your legislation, if passed by our U.S. Congress, will have an immediate impact on similar laws, guidelines  and regulations passed in our individual states, as well as in other countries around the world.  Of course, any legislation passed by our U.S. Congress on these several critically important issues will in effect act as a "role model" for similar legislation here and abroad.  Such legislation impacts greatly on the health and well-being of the individual members of all of our societies.  It is difficult to imagine many issues that would effect our society's health and well-being more than the actual manipulation and permanent designing of the future members of the human species.

In summary form, I have copied below for you again the following sections contained in our expressed comments and concerns to you for your kind consideration:

 

--  Part 1:   General, and specific, comments expressing UFL concerns about certain passages in the Brownback/Weldon Human Cloning Bill as currently posted on THOMAS, [emphasis used to aid those unfamiliar with the science],

 

--  Part 2:  A copy of the current Brownback/Weldon Human Cloning Bill as posted on THOMAS.

 

Finally, for your further information, I will also forward to your offices upon request a copy of a recently published article of mine, "When do human beings begin? 'Scientific' myths and scientific facts" -- all fully scientifically referenced, and objectively demonstrating that the immediate product of fertilization and of cloning is a new living human being.  My formal written testimony on human cloning presented before the House hearings on human cloning as an invited member of the Science Panel are already available to you, complete with 50+ xerox pages on record from the several human embryology and human genetics textbooks from which I quote in that paper.  I am also willing to send to you a copy of my 400-page doctoral dissertation on human embryo research (Georgetown University, 1991), along with a number of peer-reviewed published articles of mine on cloning and these interrelated research issues, if that would be helpful to you.

We are looking forward to your kind responses to our concerns expressed in this communication, and thank you very much in advance for your thoughtful consideration.

 

 


Best regards,

 


Dr. Dianne N. Irving, M.A., Ph.D.

Member of the Board of Directors

University Faculty For Life

5108 Randall Lane

Bethesda, MD  20816-1917

301-229-4176   FAX 301-229-8748

DNIrving@aol.com


 

 

 

 

 

 

 

 

 

 

 

(ă Dianne N. Irving, M.A., Ph.D., May 27, 2001)

 

PART 2:  COMMENTS ON CURRENT POSTING OF BROWNBACK/WELDON HUMAN CLONING BILLS

 

A.  General Comments:

In general, as we are certain you are aware, it is a long-established objective scientific fact that the immediate product of human fertilization is a newly existing, genetically unique, individual living human being -- the single-cell human zygotic embryo.[1]  This is also the beginning of the embryonic period[2] as well as the beginning of normal pregnancy in the fallopian tube of the woman.[3]  These scientific facts are not new;  indeed it has been established scientifically since 1880-1885, with publication of the three-volume tomb, Anatomie menschlicher Embryonen, (Vogel, Leipzig) by Wilhelm His, the founder of human embryology.[4]  The immediate product of human cloning is likewise a newly existing, genetically unique, individual human being.  Hence it is critically important that the United States Congress recognizes that all human beings should be equally protected from harm in any research, including any human embryo research -- which by definition includes human embryonic stem cell research, IVF research and "therapy", and human cloning.

Thus the current version of the Brownback/Weldon Human Cloning Bill is to be heartily commended for courageously recognizing that the popular so-called distinction between "therapeutic" and "reproductive" human cloning is a distinction without a difference -- a false distinction, and that both forms of human cloning should be banned.  Once brought into existence, a living human being continues to exist as such, regardless of the purposes for which he/she is going to be used.  It is also commendable that your bill recognizes that any ban against the cloning of human beings should apply to both the private and the public sectors, and the use of both private and public funds (as, e.g., in Great Britain).

However, there are specific provisions in this bill which would still allow for both "therapeutic" cloning and "reproductive" cloning of human beings , in both the private and public sectors, using both private and public funds.  We would respectfully suggest again that if your real intention with this bill is to narrowly ban only one method used for the cloning of human beings, but wish to allow other forms of human cloning, you might consider stating that clearly and succinctly at the beginning of your bill so that people understand what it is they are "supporting".  If, instead, your intention with this bill is to ban all cloning, both privately and publicly, using both private and public funds, we would suggest the following problems with the language of the bill as it now stands:

 

1.  The fact that this bill only bans one method of human cloning (as "cloning" is formally defined in your definitions), i.e., only the "somatic cell nuclear transplant" method of human cloning, it thereby allows all other methods of human cloning -- both "therapeutic" and "reproductive", in the private and the public sectors, using both private and public funds.  That is, it would allow the cloning of human beings by such methods of cloning as "parthenogenesis", and "embryo splitting"  -- i.e. "blastomere separation", "blastocyst  splitting", or "fission",  also referred to as "embryo multiplication".[5]  These are forms of cloning as well as forms of human embryo research .  Since IVF-produced human embryos are usually implanted or frozen at the 2-to 16-cell stage of human embryonic development[6], they would be prime candidates for the cloning of human beings by means of "embryo multiplication", i.e., human cloning.

 It is an objective scientific fact that as long as the cells of the early human embryo are still intact as parts of the whole embryo, these totipotent cells are correctly termed "stem cells".  However, once these cells (or, "blastomeres") are separated from the whole embryo, each of these totipotent, or even pluripotent, cells are no longer "stem cells".  Single cells, and even groups of cells, are each capable of "healing" themselves (called "regulation"), and reverting back to being a whole human being.  This is indeed what takes place naturally in human monozygotic twinning.[7]  "Embryo splitting", therefore, is also a form of human cloning by which "identical copies" of human beings are produced.

 

 

2.  By the use of the term "asexual" in the formal definition of "cloning", it would not cover "sexual" human cloning, i.e., the duplication or copying of human DNA by means of DNA-recombinant human germ-line gene transfer to human gametes or human embryos in vitro, which genetic changes are then "copied" by normal sexual reproduction through the subsequent generations.[8]

3.  By restricting the ban to the cloning of chromosomal nuclear DNA only, the bill would not ban cloning of extra-chromosomal and extra-nuclear DNA, e.g., as found in several organelles inside and outside the cell nucleus.[9]

 

4.  The use of a scientifically  incorrect definition of "somatic cell", and the obvious lack of any reference to "germ-line cells", which are also diploid and therefore capable of being cloned [10] (i.e., the kind of cells used, e.g., in "fetal stem cell" research) would also allow both "therapeutic" and "reproductive" cloning of human beings  -- by SCNT or by any cloning methods other than SCNT -- using human germ-line cells instead of human somatic cells.

 

5.  Human germ-line cells would also, therefore, not be precluded from being obtained from living or dead human subjects for the purposes of cloning human beings or their use in stem cell research.

 

6.  The very problematic issue of the cloning of human chimeras is not even addressed or banned in this bill. 

 

7.  In fact, if determined by one definition of "cloning" used in this bill, virtually no human cloning would be banned by this bill.

 

8.  Nor would consultation with NBAC, or any similarly appointed and non-elected group, at a later date be advisable.

 

We hope that these general, and the following specific, comments may be helpful to you as you strive to construct a bill that will truly ban all forms of human cloning, both in the private and the public sectors, using private and public funds. We hope that further clarification of the language used in this bill will be forthcoming in the U.S. Senate and U.S. House hearings.  Perhaps there is still time to have these scientific issues discussed openly, adequately, honestly, and timely -- and any scientific claims to the contrary be required to be backed up with explicit, written, sound and valid scientific proof.  I have copied just the relevant sections of the Brownback/Weldon bills below that concern us, and have commented further in more detail on those sections.

 

 

B.  Specific Comments on Language in the Bill:  (The specific quotes from the Brownback/Weldon Cloning Bill are in LARGE TYPE to distinguish them from my comments which are in smaller type):

I.  "SEC. 301. DEFINITIONS.  IN THIS CHAPTER: (1) "HUMAN CLONING -- THE TERM "HUMAN CLONING" MEANS HUMAN ASEXUAL REPRODUCTION, ACCOMPLISHED BY INTRODUCING THE NUCLEAR MATERIAL OF A HUMAN SOMATIC CELL INTO A FERTILIZED OR UNFERTILIZED OOCYTE WHOSE NUCLEUS HAS BEEN REMOVED OR INACTIVATED TO PRODUCE A LIVING ORGANISM (AT ANY STAGE OF DEVELOPMENT) WITH A HUMAN OR PREDOMINANTLY HUMAN GENETIC CONSTITUTION."


1.  This definition of cloning only refers to one -- of several -- methods of cloning, i.e., "somatic cell nuclear transfer."  However, there are several other methods of cloning, or making "copies" of human beings, e.g., embryo splitting (e.g., "blastomere separation", "blastocyst splitting", "fission", etc.), parthenogenesis, etc.  Therefore, this bill would not apply to nor ban those other methods of cloning human beings.  Therefore this bill does not ban all cloning of human beings, in the private or public sectors, using private or public funds, for "therapeutic" or "reproductive" purposes.

 

2. By restricting the ban to the cloning of chromosomal nuclear DNA only, the bill would not ban cloning of extra-chromosomal and extra-nuclear DNA, e.g., as found in several organelles inside and outside the cell nucleus.

 

3.  This definition of cloning only refers to "asexual" cloning.  Therefore it would not technically apply to other kinds of indirect cloning, or "copying" of "enhanced" human genetic information by means of, e.g., the use of DNA-recombinant gene germ line "therapy", which is really accomplished through the generations by means of sexual reproduction, rather than immediately by means of asexual reproduction.  Therefore this bill does not ban all cloning of human beings, in private or in public sectors, using private or public funds, for "therapeutic" or "reproductive" purposes.

            DNA-recombinant gene germ-line "therapy" is a form of "positive eugenics", as so defined by researchers themselves,[11] and essentially accomplishes the same thing eventually as normal eugenic cloning.  It also involves the human germ-line cells, now referred to simply, and erroneously, in the debates as "fetal stem cells."

 

II.  "(2) SOMATIC CELL - THE TERM 'SOMATIC CELL' MEANS A DIPLOID CELL (HAVING A COMPLETE SET OF CHROMOSOMES) OBTAINED OR DERIVED FROM A LIVING OR DECEASED HUMAN BODY AT ANY STAGE OF DEVELOPMENT."


1.  This definition of "somatic cell" is incomplete and therefore scientifically erroneous.  There are two general kinds of cells in the human body -- somatic cells and germ-line cells.  They are both diploid -- i.e., they both contain the complete set of human chromosomes (i.e., "46" chromosomes), and therefore both kinds of human cells can both be cloned.  Somatic cells, by definition are "any cells of the human body *** except *** the germ -line cells."  Therefore this bill uses a scientifically incorrect definition of "somatic cell", thereby allowing the cloning of human beings by means of using human germ-line cells.

Therefore, because the definition of the term "somatic cells" is scientifically incorrect, and because this legislative language is altogether "silent" on germ-line cells, there is nothing in this bill that would ban the cloning human beings by using human germ-line cells -- by any  cloning methods, in the private and public sectors, using private and public funds, for "therapeutic" or "reproductive" purposes.

It is also important to point out that most people are not aware of the fact that the "fetal stem cells" at issue in the stem cell debates are in fact examples of human germ-line cells.  Those "fetal stem cells" are not somatic cells.  And, in fact, they are also not "fetal" cells, since they are usually obtained from later human embryos (the embryonic period begins at fertilization or cloning and extends to the end of 8 weeks of development).  Obviously, the two issues of "stem cell research" and of "cloning" are intimately related.  Stem cells provide a continuous source of human cells that can be cloned to produce more human beings.

 

2.  Therefore, there is also a related problem with the reference in this bill to "A DIPLOID CELL (HAVING A COMPLETE SET OF CHROMOSOMES) OBTAINED OR DERIVED FROM A LIVING OR DECEASED HUMAN BODY AT ANY STAGE OF DEVELOPMENT."  Since these human germ-line fetal cells are not mentioned in this bill, and since they are not "somatic cells", human germ-line cells could still be obtained from living and deceased human bodies (cadavers) at any stage of development, and then used to clone human beings, by any method of cloning, for both "therapeutic" and "reproductive" purposes, in the private and public sectors, using private and public funds.

III.  "SEC. 302. PROHIBITION ON HUMAN CLONING ... (D) SCIENTIFIC RESEARCH - NOTHING IN THIS SECTION SHALL RESTRICT AREAS OF SCIENTIFIC RESEARCH NOT SPECIFICALLY PROHIBITED BY THIS SECTION,".


1.  As this clause states, and is commonly understood, if the legislative language is "silent" on an issue, then the bill does not cover it.  In this specific case, because the bill is "silent" on all other forms of cloning other than somatic cell nuclear transfer, and because "somatic cell" is scientifically misdefined, and because there is virtually no mention of human germ-line cells, this bill would not ban all other forms of human cloning, nor would it cover the cloning of germ-line cells to produce human beings, even using all forms of cloning, nor does this bill ban the recovery of human germ-line cells from living or dead human beings for purposes of cloning human beings, nor does it ban the cloning of human beings by means of embryo splitting (e.g., "blastomere separation", "blastocyst splitting", "fission", etc.).  Therefore, "therapeutic" and "reproductive" cloning of human beings are not banned by this bill, using any method of cloning, in the private or the public sectors, using private or public funds.

 

2.  This bill is also "silent" on research which involves the forming or using of human chimeras.  Chimera research is also a form of human cloning, in that it involves the "copying" of human DNA in another individual.  Chimera research would also be a form of human embryo research because:  (a) theoretically, a human/animal chimera could be "back-bred"[12] to produce a new whole human embryo (human being);  and, (b) the source of the human DNA used in such chimera research could be living human embryos or fetuses.  Therefore, this bill would not ban human cloning by means of the formation of human chimeras;  additionally, this bill would also sanction a form of human embryo research.

 

IV. " ... INCLUDING RESEARCH IN THE USE OF NUCLEAR TRANSFER OR OTHER CLONING TECHNIQUES"


1.  As long as the formal definition of "cloning" does not formally and specifically include all other methods of cloning, the reference here to "other cloning techniques" is irrelevant.

 

V.  --  "(2) THE PRESIDENT SHOULD COMMISSION A STUDY, TO BE CONDUCTED BY THE NATIONAL BIOETHICS ADVISORY COMMISSION OR A SUCCESSOR GROUP, OF THE ARGUMENTS FOR AND AGAINST THE USE OF CLONING TO PRODUCE HUMAN EMBRYOS SOLELY FOR RESEARCH, WHICH STUDY SHOULD -- (A) INCLUDE A DISCUSSION OF THE NEED (IF ANY) FOR HUMAN CLONING TO PRODUCE MEDICAL ADVANCES, THE ETHICAL AND LEGAL ASPECTS OF HUMAN CLONING, AND THE POSSIBLE IMPACT OF ANY DECISION TO PERMIT HUMAN CLONING FOR RESEARCH UPON EFFORTS TO PREVENT HUMAN CLONING FOR REPRODUCTIVE PURPOSES;"


1.  Quite frankly, regardless if it is the currently appointed and non-elected NBAC, or any other such appointed and non-elected group, the real issue to consider is how easily these "committees" can be "stacked", the use of erroneous science during their deliberations and debates, the use of "bioethics" ethics -- or any other "ethics" -- to determine what is in fact ethical, and to determine public policy on the basis of the consensus of a small appointed and non-elected group using that "consensus ethics".  In bioethics we refer to the work of such commissions as "federal ethics", "commissioning ethics", or "government by commission".[13]  It would be quite easy to come to the same predetermined conclusions on this and all other issues as other such "committees" have come over the years.  Once this "committee" meets, it could easily reverse any bans on human cloning -- including this one -- or "cover" it by using different definitions of "human being", "human embryo", "cloning", "what is scientifically being done or used in such experiments", "what is ethical", etc.  As one of the founding scholars of The Hastings Center, Robert Morison,  perceptively put it in a letter:  "  ...  but I fear for the future. ... 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.'"  As bioethics Commissioner Al Jonsen noted, Morison's letter was "a sobering reminder of the anomalous role of an "ethics commission" in a pluralistic, secular society."[14]

Therefore, there should be no dependence on NBAC or any similar appointed and non-elected committee to determine these critical  public policy issues.  NBAC was a creation of "bioethics" and turned into reality by President Clinton.  It is the "Ethics Advisory Board" that the many had consistently prevented from being formed for decades for obvious reason, before Clinton appointed it in 1995.  It should be allowed to have its term expire, and these critical public policy issues decided by other more democratic means.

 

VI.  "SEC.4. SENSE OF CONGRESS. ... (B) ... IN PROHIBITING THE ASEXUAL PRODUCTION OF A NEW HUMAN ORGANISM THAT IS GENETICALLY VIRTUALLY IDENTICAL TO AN EXISTING OR PREVIOUSLY EXISTING HUMAN BEING;"

 

1.  As explained above, the use of the term "asexual" would not cover "sexual" methods of cloning, of copying human beings via, e.g., DNA-recombinant germ-line gene transfer, with subsequent copying of those genes via sexual reproduction through the generations.

 

2.  By defining "cloning" here in terms of "a new human organism that is genetically virtually identical to an existing or previously existing human being", no real cloning of human beings whatsoever would be covered by this bill.

            In somatic cell nuclear transfer, for example, the resulting human embryo would contain genetic DNA from both the donor cell (i.e., the "nuclear DNA") and the recipient cell (i.e., the mitochondrial DNA).  Therefore there is really no such thing as a "genetically virtually identical" human clone.

            Furthermore, the resulting human embryo would also be genetically different from either the donor or the recipient cells due to "crossing-over" of the chromosomes during meiosis, as well as to genetic mutations of the developing embryo caused by the culture media, random environmental circumstances, developmental abnormalities, etc.  In fact, no clone is ever really so "virtually identical".

            Therefore, by the selective use of the term "asexual reproduction", this bill would not ban sexual methods of human cloning.  And by defining a clone here as "genetically virtually identical", this bill would in fact not ban  any methods of cloning human beings.

 

 

PART 2:  BROWNBACK/WELDON HUMAN CLONING BILL   (April 26, 2001):

[Also introduced in the House by Rep. Weldon:   HR 1644 IH,  107th CONGRESS,  1st Session,  April 26, 2001;  as posted on THOMAS:  <http://thomas.loc.gov/cgi-bin/query/D?c107:2:./temp/~c1073WGJB2::>]

 

[The followed Senate version of the bill was introduced in the Senate by Sen. Brownback;  as posted on THOMAS:  <http://thomas.loc.gov/cgi-bin/query/D?c107:1:./temp/~c1073WGJB2::>]

Human Cloning Prohibition Act of 2001 (Introduced in the Senate)

S 790 IS

107th CONGRESS

1st Session

S. 790

To amend title 18, United States Code, to prohibit human cloning .

 

IN THE SENATE OF THE UNITED STATES

April 26, 2001

Mr. BROWNBACK (for himself, Mr. BOND, and Mr. SMITH of New Hampshire) introduced the following bill; which was read twice and referred to the Committee on the Judiciary

 

A BILL

To amend title 18, United States Code, to prohibit human cloning .

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Human Cloning Prohibition Act of 2001'.

 

SEC. 2. FINDINGS.

Congress finds that--

(1) some individuals have announced that they will attempt to clone human beings using the technique known as somatic cell nuclear transfer already used with limited success in cloning sheep and other animals;

(2) nearly all scientists agree that such attempts pose a massive risk of producing children who are stillborn, unhealthy, or severely disabled, and considered opinion is virtually unanimous that such attempts are therefore grossly irresponsible and unethical;

(3) efforts to create human beings by cloning mark a new and decisive step toward turning human reproduction into a manufacturing process in which children are made in laboratories to preordained specifications and, potentially, in multiple copies;

(4) creating cloned live-born human children (sometimes called `reproductive cloning' ) begins by creating cloned human embryos, a process which some also propose as a way to create embryos for research or as sources of cells and tissues for possible treatment of other humans;

(5) the prospect of creating new human life solely to be exploited and destroyed in this way has been condemned on moral grounds by many, as displaying a profound disrespect for life, and recent scientific advances indicate that there are fruitful and morally unproblematic alternatives to this approach;

(6)(A) it will be nearly impossible to ban attempts at `reproductive cloning' once cloned human embryos are available in the laboratory because--

(i) cloning would take place within the privacy of a doctor-patient relationship;

(ii) the transfer of embryos to begin a pregnancy is a simple procedure; and

(iii) any government effort to prevent the transfer of an existing embryo, or to prevent birth once transfer has occurred would raise substantial moral, legal, and practical issues; and

(B) so, in order to be effective, a ban on human cloning must stop the cloning process at the beginning; and

(7) collaborative efforts to perform human cloning are conducted in ways that affect interstate and even international commerce, and the legal status of cloning will have a great impact on how biotechnology companies direct their resources for research and development.

SEC. 3. PROHIBITION ON HUMAN CLONING .

(a) IN GENERAL- Title 18, United States Code, is amended by inserting after chapter 15, the following:

`CHAPTER 16--HUMAN CLONING

`Sec.

`301. Definitions.

`302. Prohibition on human cloning .

`Sec. 301. Definitions

`In this chapter:

`(1) HUMAN CLONING - The term `human cloning' means human asexual reproduction, accomplished by introducing the nuclear material of a human somatic cell into a fertilized or unfertilized oocyte whose nucleus has been removed or inactivated to produce a living organism (at any stage of development) with a human or predominantly human genetic constitution.

`(2) SOMATIC CELL- The term `somatic cell' means a diploid cell (having a complete set of chromosomes) obtained or derived from a living or deceased human body at any stage of development.

`Sec. 302. Prohibition on human cloning

`(a) IN GENERAL- It shall be unlawful for any person or entity, public or private, in or affecting interstate commerce--

`(1) to perform or attempt to perform human cloning ;

`(2) to participate in an attempt to perform human cloning ; or

`(3) to ship or receive the product of human cloning for any purpose.

`(b) IMPORTATION- It shall be unlawful for any person or entity, public or private, to import the product of human cloning for any purpose.

`(c) PENALTIES-

`(1) IN GENERAL- Any person or entity that is convicted of violating any provision of this section shall be fined under this section or imprisoned not more than 10 years, or both.

`(2) CIVIL PENALTY- Any person or entity that is convicted of violating any provision of this section shall be subject to, in the case of a violation that involves the derivation of a pecuniary gain, a civil penalty of not less than $1,000,000 and not more than an amount equal to the amount of the gross gain multiplied by 2, if that amount is greater than $1,000,000.

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

(b) CLERICAL AMENDMENT- The table of chapters for part I of title 18, United States Code, is amended by inserting after the item relating to chapter 15 the following:

301'.

SEC. 4. SENSE OF CONGRESS.

It is the sense of Congress that--

(1) the Federal Government should advocate for and join an international effort to prohibit human cloning , as defined in section 301 of title 18, United States Code, as added by this Act; and

(2) the President should commission a study, to be conducted by the National Bioethics Advisory Commission or a successor group, of the arguments for and against the use of cloning to produce human embryos solely for research, which study should--

(A) include a discussion of the need (if any) for human cloning to produce medical advances, the ethical and legal aspects of human cloning , and the possible impact of any decision to permit human cloning for research upon efforts to prevent human cloning for reproductive purposes;

(B) include a review of new developments in cloning technology which may require that technical changes be made to section 3 of this Act, to maintain the effectiveness of this Act in prohibiting the asexual production of a new human organism that is genetically virtually identical to an existing or previously existing human being; and

(C) be submitted to Congress and the President for review not later than 5 years after the date of enactment of this legislation.


 

[1] Keith Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology (6th ed. only) (Philadelphia:  W.B. Saunders Company,  1998), p. 18:  "Human development is a continuous process that begins when an oocyte (ovum) from a female is fertilized by a sperm (or spermatozoon) from a male.  (p. 2);   ibid.:   ... but the embryo begins to develop as soon as the oocyte is fertilized.  (p. 2);   ibid.:  Zygote:  this cell results from the union of an oocyte and a sperm.   A zygote is the beginning of a new human being (i.e., an embryo).  (p. 2);    ibid.:  Human development begins at fertilization, the process during which a male gamete or sperm ... unites with a female gamete or oocyte ... to form a single cell called a zygote.  This highly specialized, totipotent cell marks the beginning of each of us as a unique individual."

William J. Larsen, Essentials of Human Embryology (New York: Churchill Livingstone, 1998), p. 17:  "Human embryos begin development following the fusion of definitive male and female gametes during fertilization" (p. 1);  ibid.: ... "These pronuclei fuse with each other to produce the single, diploid, 2N nucleus of the fertilized zygote.  This moment of zygote formation may be taken as the beginning or zero time point of embryonic development."

Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York:  Wiley-Liss, 1994), pp. 5, 19, 55:  "Fertilization is an important landmark because, under ordinary circumstances, a new, genetically distinct human organism is thereby formed.  (p. 5);   ibid.:  Fertilization is the procession of events that begins when a spermatozoon makes contact with a secondary oocyte or its investments ...  (p. 19);   ibid.:  The zygote ... is a unicellular embryo."  (p. 19);  ibid: "The ill-defined and inaccurate term pre-embryo, which includes the embryonic disc, is said either to end with the appearance of the primitive streak or ... to include neurulation.  The term is not used in this book."  (p. 55).

 

[2] Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York:  Wiley-Liss, 1994), p. 55:  “Prenatal life is conveniently divided into two phases: the embryonic and the fetal. The embryonic period proper during which the vast majority of the named structures of the body appear, occupies the first 8 postovulatory weeks. ... [T]he fetal period extends from 8 weeks to birth ...

Bruce M. Carlson, Human Embryology & Developmental Biology (St. Louis, MO:  Mosby, 1999), p. 447:   After the eighth week of pregnancy the period of organogenesis (embryonic period) is largely completed, and the fetal period begins."

 

[3] Bruce M. Carlson, Human Embryology & Developmental Biology (St. Louis, MO:  Mosby, 1999), p. 2: "Human pregnancy begins with the fusion of an egg and a sperm. ...  finally, the fertilized egg, now properly called an embryo, must make its way into the uterus ...."

 

[4] Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York:  Wiley-Liss, 1994), p. 3.

[5] See, for example, Prof. Dr. Mithhat Erenus, "Embryo Multiplication" (<http://www.hekim.net/~erenus/20002001/asistedreproduction/micromanipulation/embryo_multiplication.htm>):   "In such cases, patients may benefit from embryo multiplication, as discussed in the study by Massey and co-workers. ... Since each early embryonic cell is totipotent (i.e., has the ability to develop and produce a normal adult), embryo multiplication is technically possible.  Experiments in this area began as early as 1894, when the totipotency of echinoderm embryonic cells was reported  ... In humans, removal of less than half of the cells from an embryo have been documented.  No adverse effects were reported when an eighth to a quarter of the blastomeres were removed from an embryo on day 3 after insemination. ...  Further evidence supporting the viability and growth of partial human embryos is provided by cryopreservation.  After thawing four-cell embryos, some cells may not survive, leaving one-, two-, or three-cell embryos.  These partial embryos survive and go to term, but at a lower rate than whole embryos. ... Based on the results observed in lower order mammals, the critical period of development to ensure success in separating human blastomeres should be at the time of embryonic gene expression, which is reported in humans to be between the four- and eight-cell stages. .... The second potential method of embryo multiplication is blastocyst splitting. ... Embryo multiplication by nuclear transfer has been used in experimental cattle breeding programs. ... IVF clinics routinely replace multiple (three to four) embryos into the uterus to increase the chances of a successful pregnancy.  For couples who have less than three quality embryos for transfer, blastomere separation could be of benefit."

 

[6] Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York:  Wiley-Liss, 1994), p. 20:   "In vitro fertilization involves the removal of an oocyte from an ovary under negative pressure, its culture and fertilization, and transfer of the embryo to the uterus.  Successful IVF (Steptoe and Edwards) began with oocyte recovery, in vitro fertilization and culture, transfer of an 8-cell embryo to the uterus, and the birth of a girl in 1978.  The various types of new reproductive technology, however, have important ethical, legal, and social implications that are under constant discussion.

                "IVF involves the following steps.  Ovarian hyper-stimulation is achieved by hormonal administration, usually hMG to induce follicular growth and hCG to encourage ovulation, so that a number of ovarian follicles develop for retrieval of pre-ovulatory oocytes.  Follicular development is monitored by biochemical procedures (serum estradiol level) and ultrasound (to determine follicular size and position).  Pre-ovulatory follicles are aspirated through the abdominal wall (laparoscopy) by direct visualization of the ovaries, or through the vagina (transvaginal) or through the bladder (transvesical ultrasound-directed oocyte recovery).  The aspirated follicular fluid is then examined for the presence of oocytes, which are cultured.  Insemination by the addition of numerous spermatozoa in vitro may result in fertilization and early development of embryos.  The embryos are then cultured and transferred (ET).  This involves the placement by catheter of several  1- to 16-cell embryos or (preferably) blastocysts in the fundus of the uterus, where implantation may occur in a relatively small number of instances.  A higher rate is obtained by transferring an embryo to a uterine tube (zygote intratubal transfer) rather than to the uterus, or (as an alternative to IVF) by transferring gametes to a uterine tube (gamete intratubal transfer) and allowing intratubal fertilization to occur."

Bruce Carlson, Human Embryology & Developmental Biology (St. Louis, MO:  Mosby, 1999), 2nd ed.,  p. 35:  "... The embryos are usually allowed to develop to the two- to eight-cell stage before they are considered ready to implant into the uterus."

                Keith Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology (Philadelphia:  W.B. Saunders, 1998), 6th ed. only, p. 39:   "Successful transfer of four- to eight-cell embryos and blastocysts to the uterus after thawing is now a common practice (Fugger et al., 1991) ... Embryos and blastocysts resulting from in vitro fertilization can be preserved for long periods by freezing them with a cryoprotectant (e.g., glycerol)."

 

[7] Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York:  Wiley-Liss, 1994, p. 23:   " ... The embryo enters the uterine cavity after half a week, when probably at least 8-12 cells are present and when the endometrium is early in its secretory phase (which corresponds to the luteal phase of the ovarian cycle).  Each cell (blastomere) is considered to be still totipotent (capable, on isolation, of forming a complete embryo), and separations of these early cells is believed to account for one-third of cases of monozygotic twinning."

Bruce Carlson, Human Embryology & Developmental Biology (St. Louis, MO:  Mosby, 1999), 2nd ed., pp. 44-49:   "Early mammalian embryogenesis is considered to be a highly regulative process.  Regulation is the ability of an embryo or an organ primordium to produce a normal structure if parts have been removed or added.  [Note at bottom of page:  Opposed to regulative development is mosaic development, which is characterized by the inability to compensate for defects or to integrate extra cells into a unified whole.  In a mosaic system, the fates of cells are rigidly determined, and removal of cells results in an embryo or a structure that is missing the components that the removed cells were destined to form.  Most regulative systems have an increasing tendency to exhibit mosaic properties as development progresses].  At the cellular level, it means that the fates of cells in a regulative system are not irretrievably fixed and that the cells can still respond to environmental cues.  Because the assignment of blastomeres into different cell lineages is one of the principal features of mammalian development, identifying the environmental factors that are involved is important.

                "Of the experimental techniques used to demonstrate regulative properties of early embryos, the simplest is to separate the blastomeres of early cleavage-stage embryos ad determine whether each one can give rise to an entire embryo.  This method has been used to demonstrate that single blastomeres, from two- and sometimes four-cell embryos can form normal embryos, ....".  (p. 44)

                "Fate mapping experiments are important in embryology because they allow one to follow the pathways along which a particular cell can differentiate.  Fate mapping experiments, which involve different isozymes of the enzyme glucose phosphate isomerase, have shown that all blastomeres of an eight-cell mouse embryo remain totipotent;  that is, they retain the ability to form any cell type in the body.  Even at the 16-cell stage of cleavage, some blastomeres are capable of producing progeny that are found in both the inner cell mass and the trophoblastic lineage.  (p. 45)

                 " Another means of demonstrating the regulative properties of early mammalian embryos is to dissociate mouse embryos into separate blastomeres and then to combine the blastomeres of two or three embryos.  The combined blastomeres soon aggregate and reorganize to become a single large embryo, which then goes on to become a normal-appearing tetraparental or hexaparental mouse.  By various techniques of making chimeric embryos, it is even possible to combine blastomeres to produce interspecies chimeras (e.g., a sheep-goat).  (p. 45)

                ... " The relationship between the position of the blastomeres and their ultimate developmental fate was incorporated into the inside-outside hypothesis.  The outer blastomeres ultimately differentiate into the trophoblast, whereas the inner blastomeres form the inner cell mass, from which the body of the embryo arises.  Although this hypothesis has been supported by a variety of experiments, the mechanisms by  which the blastomeres recognize their positions and then differentiate accordingly have remained elusive and are still little understood.  If marked blastomeres from disaggregated embryos are placed on the outside of another early embryo, they typically contribute to the formation of the trophoblast.  Conversely, if the same marked cells are introduced into the interior of the host embryo, they participate in formation of the inner cell mass.  Outer cells in the early mammalian embryo are linked by tight and gap junctions ...  Experiments of this type demonstrate that the developmental potential or potency (the types of cells that a precursor cell can form) of many cells is greater than their normal developmental fate (the types of cells that a precursor cell normally forms)."  (p. 45)

                ... " Classic strategies for investigating developmental properties of embryos are (1) removing a part and determining the way the remainder of the embryo compensates for the loss (such experiments are called deletion experiments) and (2) adding a part and determining the way the embryo integrates the added material into its overall body plan (such experiments are called addition experiments).  Although

some deletion experiments have been done, the strategy of addition experiments has proved to be most fruitful in elucidating mechanisms controlling mammalian embryogenesis.  (p. 46)

                "Blastomere removal and addition experiments have convincingly demonstrated the regulative nature (i.e., the strong tendency for the system to be restored to wholeness) of early mammalian embryos.  Such knowledge is important in understanding the reason exposure of early human embryos to unfavorable environmental influences typically results in either death or a normal embryo.  (p. 46)

                "One of the most powerful experimental techniques of the last two decades has been the injection of genetically or artificially labeled cells into the blastocyst cavity of a host embryo.  This technique has been used to show that the added cells become normally integrated into the body of the host embryo, additional evidence of embryonic regulation.  An equally powerful use of this technique has been in the study of cell lineages in the early embryo.  By identifying the progeny of the injected marked cells, investigators have been able to determine the potency (the range of cell and tissue types that an embryonic cell or group of cells is capable of producing) of the donor cells."  (p. 46)

                "Some types of twinning represent a natural experiment that demonstrates the highly regulative nature of early human embryos, ...".  (p. 48)

                "Monozygotic twins and some triplets, on the other hand, are the product of one fertilized egg.  They arise by the subdivision and splitting of a single embryo.  Although monozygotic twins could ... arise by the splitting of a two-cell embryo, it is commonly accepted that most arise by the subdivision of the inner cell mass in a blastocyst.  Because the majority of monozygotic twins are perfectly normal, the early human embryo can obviously be subdivided and each component regulated to form a normal embryo."  (p. 49)

 

William J. Larsen, Essentials of Human Embryology (New York:  Churchill Livingstone, 1998), p. 325:   [Monozygotic twinning]  "If the splitting occurred during cleavage -- for example, if the two blastomeres produced by the first cleavage division become separated -- the monozygotic twin blastomeres will implant separately, like dizygotic twin blastomeres, and will not share fetal membranes.  Alternatively, if the twins are formed by splitting of the inner cell mass within the blastocyst, they will occupy the same chorion but will be enclosed by separate amnions and will use separate placentae, each placenta developing around the connecting stalk of its respective embryo.  Finally, if the twins are formed by splitting of a bilaminar germ disc, they will occupy the same amnion."  (p. 325)

Geoffrey Sher, Virginia Davis, and Jean Stoess, In Vitro Fertilization: The A.R.T. of Making Babies (copyright 1998 by authors;  information by contacting Facts On File, Inc., 11 Penn Plaza, New York, NY 10001), pp. 20:  "(2) the fertilized egg, which has not yet divided, is now known as a zygote;  (3) the egg begins to divide and is now known as an embryo; at this point each blastomere, or cell, within the embryo is capable of developing into an identical embryo."

 

[8] Bruce Carlson, Human Embryology & Developmental Biology (St. Louis, MO:  Mosby, 1999), pp. 46-47; William J. Larsen, Human Embryology (New York: Churchill Livingstone, 1997), pp. 22-28;   Benjamin Lewin (ed.), Genes III (New York: John Wiley & Sons, 1987), pp. 353-354.  The use of germ-line gene "therapy" by U.S. scientists has recently been published, producing genetically altered human infants.  See, Dr. David Whitehouse, "Genetically altered babies born: Mitochondria contain genes outside the

cell's nucleus", BBC News Online, <http://news.bbc.co.uk/hi/english/sci/tech/newsid_1312000/1312708.stm>).

                See also, Tom Strachan and Andrew Read, Human Molecular Genetics: Second Edition (New York:  Wiley-Liss, 1999), pp. 539-541], "The ethics of human germ line therapy":

                "All current gene therapy trials involve treatment for somatic tissues (somatic gene therapy).  somatic gene therapy, in principle, has not raised many ethical concerns.  Clearly, every effort must be made to ensure the safety of the patients, especially since the technologies being used for somatic gene therapy are still at an underdeveloped stage.  However, confining the treatment to somatic cells means that the consequences of the treatment are restricted to the individual patient who has consented to this procedure. ... The same technology has the potential, of course, to alter phenotypic characters that are not associated with disease, such as height for instance.  Such genetic enhancement, although not currently considered, can be expected to pose greater ethical problems;  attempts to produce genetically enhanced animals have not been a success and in some cases have been spectacular failures (Gordon, 1999).

                Germline gene therapy, involving the genetic modification of germline cells (e.g., in the early zygote), is considered to be entirely different.  It has been successfully practiced on animals (e.g., to correct beta-thalassemia in mice).  However, thus far, it has not been sanctioned for the treatment of human disorders, and approval is unlikely to be given in the near future, if ever.

Human germline gene therapy has not been practiced because of ethical concerns and limitations of the technology for germline manipulation.  The lack of enthusiasm for the practice of germline gene therapy can be ascribed to three major reasons:

[a] The imperfect technology for genetic modification of the germline

Germline gene therapy requires modification of the genetic material of chromosomes, but vector systems for accomplishing this do not allow accurate control over the integration site or event. In somatic gene therapy, the only major concern about lack of control over the fate of the transferred genes is the prospect that one or more cells undergoes neoplastic transformation. However, in germline gene therapy, genetic modification has implications not just for a single cell: accidental insertion of an introduced gene or DNA fragment could result in a novel inherited pathogenic mutation.

[b] The questionable ethics of germline modification

Genetic modification of human germline cells may have consequences not just for the individual whose cells were originally altered, but also for all individuals who inherit the genetic modification in subsequent generations. Germline gene therapy would inevitably mean denial of the rights of these individuals to any choice about whether their genetic constitution should have been modified in the first place (Wivel and Walters, 1993). Some ethicists, however, have considered that the technology of germline modification will inevitably improve in the future to an acceptably high level and, provided there are adequate regulations and safeguards, there should then be no ethical objections (see, for example, Zimmerman, 1991). At a recent scientific research meeting in the USA some scientists have also come out in support of such a development (Wadman, 1998).

From the ethical point of view, an important consideration is to what extent technologies developed in an attempt to engineer the human germline could subsequently be used not to treat disease but in genetic enhancement. There are powerful arguments as to why germline gene therapy is pointless. There are serious concerns, therefore, that a hidden motive for germline gene therapy is to enable research to be done on germline manipulation with the ultimate aim of germline-based genetic enhancement. The latter could result in positive eugenics programs, whereby planned genetic modification of the germline could involve artificial selection for genes that are thought to confer advantageous traits.

The implications of human genetic enhancement are enormous. Future technological developments may make it possible to make very large alterations to the human germline by, for example, adding many novel genes using human artificial chromosomes (Grimes and Cooke, 1998). Some people consider that this could advance human evolution, possibly paving the way for a new species, homo sapientissimus. To have any impact on evolution, however, genetic enhancement would need to be operated on an unfeasibly large scale (Gordon, 1999).

Even if positive eugenics programs were judged to be acceptable in principle and genetic enhancement were to be practiced on a small scale, there are extremely serious ethical concerns. Who decides what traits are advantageous? Who decides how such programs will be carried out? Will the people selected to have their germlines altered be chosen on their ability to pay? How can we ensure that it will not lead to discrimination against individuals? Previous negative eugenics programs serve as a cautionary reminder. In the recent past, for example, there have been horrifying eugenics programs in Nazi Germany, and also in many states of the USA where compulsory sterilization of individuals adjudged to be feeble-minded was practiced well into the present century.

[c] The questionable need for germline gene therapy

Germline genetic modification may be considered as a possible way of avoiding what would otherwise be the certain inheritance of a known harmful mutation. However, how often does this situation arise and how easy would it be to intervene? A 100% chance of inheriting a harmful mutation could most likely occur in two ways. One is when an affected woman is homoplasmic for a harmful mutation in the mitochondrial genome and wished to have a child. The trouble here is that, because of the multiple mitochondrial DNA molecules involved, gene therapy for such disorders is difficult to devise.

A second situation concerns inheritance of mutations in the nuclear genome. To have a 100% risk of inheriting a harmful mutation would require mating between a man and a woman both of whom have the same recessively inherited disease, an extremely rare occurrence. Instead, the vast majority of mutations in the nuclear genome are inherited with at most a 50% risk (for dominantly inherited disorders) or a 25% risk (for recessively inherited disorders). In vitro fertilization provides the most accessible way of modifying the germline. However, if the chance that any one zygote is normal is as high as 50 or 75%, gene transfer into an unscreened fertilized egg which may well be normal would be unacceptable: the procedure would inevitably carry some risk, even if the safety of the techniques for germline gene transfer improves markedly in the future. Thus, screening using sensitive PCR-based techniques would be required to identify a fertilized egg with the harmful mutation. Inevitably, the same procedure can be used to identify fertilized eggs that lack the harmful mutation.  Since in vitro fertilization generally involves the production of several fertilized eggs, it would be much simpler to screen for normal eggs and select these for implantation, rather than to attempt genetic modification of fertilized eggs identified as carrying the harmful mutation."

 

[9] Benjamin Lewin (ed.), Genes VII (New York:  Oxford University Press, pp. 81-86, 174-175, 546;   Tom Strachan and Andrew Read, Human Molecular Genetics: Second Edition (New York:  Wiley-Liss, 1999), pp. 60, 140-141.

 

[10] William J. Larsen, Essentials of Human Embryology (New York:  Churchill Livingstone, 1998), p. 4:  "like all normal somatic (non-germ- cells), the primordial germ cells contain 23 pairs of chromosomes, or a total of 46."

Bruce Carlson, Human Embryology & Developmental Biology (St. Louis, MO:  Mosby, 1999), p.2:  "In a mitotic division, each germ cell produces two diploid progeny that are genetically equal."

Tom Strachan and Andrew Read, Human Molecular Genetics: Second Edition (New York:  Wiley-Liss, 1999), p. 28"A subset of the diploid body cells constitute the term lineThese give rise to specialized diploid cells in the ovary and testis that can divide by meiosis to produce haploid gametes (sperm and egg). ...  The other cells of the body, apart from the germline, are known as somatic cells ... most somatic cells are diploid ...".

Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York:  Wiley-Liss, 1994), pp. 13-14:  "Gametogenesis is the production of germ cells (gametes), i.e., spermatozoa and oocytes.  These cells are produced in the gonads, i.e., the testes and ovaries respectively.  The gametes are believed to arise by successive divisions from a distinct line of cells (the germ plasm), and the cells that are not directly concerned with gametogenesis are termed somatic. ... The reduction of chromosomal number from 46 (the diploid number) to 23 (the haploid number) is accomplished by a cellular division termed meiosis. ... Primordial germ cells ... are difficult to recognize in very young human embryos.  Claims for them have been made as early as in the blastocyst, and they are believed to be segregated at latest by 2 weeks and possibly much earlier."

Keith Moore and T.V.N. Persaud, The Developing Human:  Clinically Oriented Embryology,   (Philadelphia, PA:  W.B. Saunders Company, 1998), 6th ed. only, p. 18:  "Meiosis is a special type of cell division that involves two meiotic cell divisions;  it takes place in germ cells only.  Diploid germ cells give rise to haploid gametes (sperms and oocytes).

 

[11] Tom Strachan and Andrew Read, Human Molecular Genetics: Second Edition (New York:  Wiley-Liss, 1999), p. 541:  " There are powerful arguments as to why germline gene therapy is pointless. There are serious concerns, therefore, that a hidden motive for germline gene therapy is to enable research to be done on germline manipulation with the ultimate aim of germline-based genetic enhancement. The latter could result in positive eugenics programs, whereby planned genetic modification of the germline could involve artificial selection for genes that are thought to confer advantageous traits."

[12] Back-breeding has been done "naturally" for centuries by farmers using plants and animals.  See discussions of back-breeding in, e.g.:  <http://www.aces.edu/department/extcomm/publications/he/he-728/he-728.htm>, HE-728, New June 1996. Jean Olds Weese, Extension Food Science Specialist, Associate Professor, Nutrition and Foods, Auburn University:   "Farmers have been trying for years to improve crop yields from both plants and animals. This has been accomplished through cross-breeding in animals and grafting in plants.  Through this selective mating the plant or animal receives the genes from another plant or animal that will improve a trait in that species.  The problem with this is that along with this one good trait comes several traits that may not be so positive. This is because plants have more than 100,000 genes and with each gene comes a character trait. After cross-breeding two plants, the farmer must then go through back-breeding to keep the good traits and breed out the bad traits."

<http://www.cmf.gc.ca/en/cf/1998/vol3/html/1998fca22348.p.en.html>, president and Fellows of Harvard College v. Canada (Commissioner of Patents):   "What is involved here is the insertion of the myc gene and the subsequent breeding, cross-breeding and back-breeding of a mouse.  ... The inventors were able to "backcross" and in-breed in order to obtain offspring with more widely varying sites of the new myc gene. ... As described by the Commissioner, 'analysis of the DNA of the resulting transgenic offspring indicated that the injected oncogene was transmitted through the germline in a ratio consistent with Mendelian inheritance of single loci.'   In other words, the transgene will be passed on to the offspring in accordance with the ordinary principles of inheritance. "

<http://www.biology.iupui.edu/biocourses/K338/338_14.html>, Cogenic MHC Mouse Strains: 
" Syngenic (mice with all identical locus) Cogenic (mice with all identical locus, except a single genetic locus) Cogenic mice are isolated by inter-breeding, selection, back-breeding for at least 12 generations."

 

[13] See, e.g., Albert R. Jonsen, The Birth of Bioethics (New York:  Oxford University Press, 1998), pp. 342, esp. Chapter 4, "Commissioning Bioethics: The Government in Bioethics, 1974-1983;   David J. Rothman, Strangers at the Bedside:  A History of How Law and Bioethics Transformed Medical Decision Making (New York:  BasicBooks/Perseus Books, L.L.D., 1991), esp. Chapter 9, "Commissioning Ethics";   Dianne Nutwell Irving, "What is 'bioethics'?", in Joseph W. Koterski (ed.),  University Faculty For Life:   Proceedings of the Conference 2000 (in press).

 

[14] Albert R. Jonsen, The Birth of Bioethics, ibid., pp. 109-110.