[Congressional Record Volume 151, Number 49 (Thursday, April 21, 2005)]
[Senate]
[Pages S4120-S4123]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HATCH (for himself, Mrs. Feinstein, Mr. Specter, Mr. 
        Kennedy, and Mr. Harkin):
  S. 876. A bill to prohibit human cloning and protect stem cell 
research; to the Committee on the Judiciary.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:
  Mr. HATCH. Mr. President, I am very pleased to join with Senators 
Feinstein, Specter, Kennedy, and Harkin to introduce the Human Cloning 
Ban and Stem Cell Research Protection Act of 2005. This bill could help 
usher in the next great era of medical treatment. At the same time, it 
will criminalize the offensive practice of reproductive cloning.
  If you remember when Jonas Salk discovered the polio vaccine, you 
will recall what a revolutionary step that was, to be able to stop 
ravaging diseases before they hit their victims. It led to a whole new 
way of practicing medicine and paved the way for the vaccines and 
treatments that we take for granted today.
  I believe we are on the verge of a similar step, a new generation in 
medical research and treatment, thanks to the incredible potential of 
stem cells. Stem cell research--particularly, embryonic stem cell 
research--holds great promise. To quote Nobel Laureate Dr. Harold 
Varmus, ``The development of cell lines that may produce almost every 
tissue of the human body is an unprecedented scientific breakthrough. 
It is not too unrealistic to say that this research has the potential 
to revolutionize the practice of medicine and improve the quality and 
length of life.''
  As Dr. Varmus noted, embryonic stem cells appear to have the amazing 
potential to transform themselves into any of the more than 200 types 
of cells that form the human body. These cells

[[Page S4121]]

could be the key to understanding much about human health and disease 
and may yield new diagnostic tests, treatments, and cures for diseases 
such as diabetes, cancer, heart disease, Parkinson's, autoimmune 
diseases, and many, many others.
  Stem cell research could potentially be the scientific advance that 
takes the practice of medicine not just to the next level, but to five 
or ten levels above and beyond. Like my colleagues, I believe there is 
an urgent need for uniformity in the rules governing stem cell research 
in America. But let me just stress one aspect of that need: ethics. 
Without the National Institutes of Health setting the ethical 
guidelines for stem cell research, we invite a host of problems. Most 
of us feel strongly that human reproductive cloning is wrong, for 
example. But where should the lines be drawn with regard to embryonic 
stem cell research--particularly, somatic cell nuclear transfer and the 
use of cell lines derived from IVF embryos?
  The NIH is the obvious and crucial choice to help set the ethical 
boundaries. Our bill will ban outright any attempt at bringing to life 
a cloned human being. It will also prohibit research on any embryo 
created through somatic cell nuclear transfer beyond 14 days, require 
informed consent of donors, prohibit profiteering from donated eggs, 
and mandate separation of the egg collection site from the research 
laboratory.
  The NIH will help determine other suitable ethical guidelines in 
allowing this critical research to go forward with Federal funding and 
at federally-funded institutions. There is no question in my mind that, 
when they do, the rest of the world will follow.
  Now, the last time we introduced this bill, there was interest in the 
fact that I, as a strongly pro-life senator, would be the lead sponsor. 
I think we have put that issue behind us, as more pro-life lawmakers 
have expressed their support for this research. The fact is, I have 
never believed that life begins in a Petri dish. And as I travel across 
my home State of Utah, more and more Utahns, whether they are pro-life 
or not, come up to me and say, ``Orrin, we're with you on this. You're 
doing the right thing.''
  That support is building across the country, and we must act. If we 
do not seize this opportunity, other countries could take the leading 
role in medicine's next great advance. We will lose the chance to set 
ethical guidelines, we will lose doctors to overseas research 
institutions, and most importantly, we will lose the chance to offer 
new hope to American and other patients who are waiting in desperation 
for treatments and cures.
  I urge the Senate to take up and pass this bill, and I look forward 
to the work ahead.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 876

       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 Ban and Stem 
     Cell Research Protection Act of 2005''.

     SEC. 2. PURPOSES.

       It is the purpose of this Act to prohibit human cloning and 
     to protect important areas of medical research, including 
     stem cell research.

                 TITLE I--PROHIBITION ON HUMAN CLONING

     SEC. 101. PROHIBITION ON HUMAN CLONING.

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


               ``CHAPTER 16--PROHIBITION ON HUMAN CLONING

       ``301. Prohibition on human cloning

     ``Sec. 301. Prohibition on human cloning

       ``(a) Definitions.--In this section:
       ``(1) Human cloning.--The term `human cloning' means 
     implanting or attempting to implant the product of nuclear 
     transplantation into a uterus or the functional equivalent of 
     a uterus.
       ``(2) Human somatic cell.--The term `human somatic cell' 
     means any human cell other than a haploid germ cell.
       ``(3) Nuclear transplantation.--The term `nuclear 
     transplantation' means transferring the nucleus of a human 
     somatic cell into an oocyte from which the nucleus or all 
     chromosomes have been or will be removed or rendered inert.
       ``(4) Nucleus.--The term `nucleus' means the cell structure 
     that houses the chromosomes.
       ``(5) Oocyte.--The term `oocyte' means the female germ 
     cell, the egg.
       ``(6) Unfertilized blastocyst.--The term `unfertilized 
     blastocyst' means an intact cellular structure that is the 
     product of nuclear transplantation. Such term shall not 
     include stem cells, other cells, cellular structures, or 
     biological products derived from an intact cellular structure 
     that is the product of nuclear transplantation.
       ``(b) Prohibitions on Human Cloning.--It shall be unlawful 
     for any person or other legal entity, public or private--
       ``(1) to conduct or attempt to conduct human cloning;
       ``(2) to ship the product of nuclear transplantation in 
     interstate or foreign commerce for the purpose of human 
     cloning in the United States or elsewhere; or
       ``(3) to export to a foreign country an unfertilized 
     blastocyst if such country does not prohibit human cloning.
       ``(c) Protection of research.--Nothing in this section 
     shall be construed to restrict practices not expressly 
     prohibited in this section.
       ``(d) Penalties.--
       ``(1) Criminal penalties.--Whoever intentionally violates 
     paragraph (1), (2), or (3) of subsection (b) shall be fined 
     under this title and imprisoned not more than 10 years.
       ``(2) Civil penalties.--Whoever intentionally violates 
     paragraph (1), (2), or (3) of subsection (b) shall be subject 
     to a civil penalty of $1,000,000 or three times the gross 
     pecuniary gain resulting from the violation, whichever is 
     greater.
       ``(3) Forfeiture.--Any property, real or personal, derived 
     from or used to commit a violation or attempted violation of 
     the provisions of subsection (b), or any property traceable 
     to such property, shall be subject to forfeiture to the 
     United States in accordance with the procedures set forth in 
     chapter 46 of title 18, United States Code.
       ``(e) Right of Action.--Nothing in this section shall be 
     construed to give any individual or person a private right of 
     action.''.

     SEC. 102. OVERSIGHT REPORTS ON ACTIONS TO ENFORCE CERTAIN 
                   PROHIBITIONS.

       (a) Report on Actions by Attorney General to Enforce 
     Chapter 16 of Title 18.--Not later than 1 year after the date 
     of enactment of this Act, the Comptroller General shall 
     prepare and submit to the Committee on the Judiciary of the 
     Senate and the Committee on the Judiciary of the House of 
     Representatives a report that--
       (1) describes the actions taken by the Attorney General to 
     enforce the provisions of chapter 16 of title 18, United 
     States Code (as added by section 101);
       (2) describes the personnel and resources the Attorney 
     General has utilized to enforce the provisions of such 
     chapter; and
       (3) contain a list of any violations, if any, of the 
     provisions of such chapter 16.
       (b) Report on Actions of State Attorneys General to Enforce 
     Similar State Laws.--
       (1) Definition.--In this subsection and subsection (c), the 
     term ``similar State law relating to human cloning'' means a 
     State or local law that provides for the imposition of 
     criminal penalties on individuals who are determined to be 
     conducting or attempting to conduct human cloning (as defined 
     in section 301 of title 18, United States Code (as added by 
     section 101)).
       (2) Report.--Not later than 1 year after the date of 
     enactment of this Act, the Comptroller General shall prepare 
     and submit to the Committee on the Judiciary of the Senate 
     and the Committee on the Judiciary of the House of 
     Representatives a report that--
       (A) describes any similar State law relating to human 
     cloning;
       (B) describes the actions taken by the State attorneys 
     general to enforce the provisions of any similar State law 
     relating to human cloning;
       (C) contains a list of violations, if any, of the 
     provisions of any similar State law relating to human 
     cloning; and
       (D) contains a list of any individual who, or organization 
     that, has violated, or has been charged with violating, any 
     similar State law relating to human cloning.
       (c) Report on Coordination of Enforcement Actions Among the 
     Federal and State and Local Governments With Respect to Human 
     Cloning.--Not later than 1 year after the date of enactment 
     of this Act, the Comptroller General shall prepare and submit 
     to the Committee on the Judiciary of the Senate and the 
     Committee on the Judiciary of the House of Representatives a 
     report that
       (1) describes how the Attorney General coordinates the 
     enforcement of violations of chapter 16 of title 18, United 
     States Code (as added by section 101), with enforcement 
     actions taken by State or local government law enforcement 
     officials with respect to similar State laws relating to 
     human cloning; and
       (2) describes the status and disposition of--
       (A) Federal appellate litigation with respect to such 
     chapter 16 and State appellate litigation with respect to 
     similar State laws relating to human cloning; and
       (B) civil litigation, including actions to appoint 
     guardians, related to human cloning.
       (d) Report on International Laws Relating to Human 
     Cloning.--Not later than 1 year after the date of enactment 
     of this Act, the Comptroller General shall prepare and submit 
     to the Committee on the Judiciary of the Senate and the 
     Committee on the Judiciary of the House of Representatives a 
     report that--

[[Page S4122]]

       (1) describes the laws adopted by foreign countries related 
     to human cloning;
       (2) describes the actions taken by the chief law 
     enforcement officer in each foreign country that has enacted 
     a law described in paragraph (1) to enforce such law; and
       (3) describes the multilateral efforts of the United 
     Nations and elsewhere to ban human cloning.

  TITLE II--ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION RESEARCH

     SEC. 201. ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION 
                   RESEARCH.

       Title IV of the Public Health Service Act (42 U.S.C. 281 et 
     seq.) is amended by adding at the end the following:


  ``part J--ethical REQUIREMENTS FOR NUCLEAR TRANSPLANTATION RESEARCH

     ``SEC. 499A. ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION 
                   RESEARCH, INCLUDING INFORMED CONSENT, 
                   INSTITUTIONAL REVIEW BOARD REVIEW, AND 
                   PROTECTION FOR SAFETY AND PRIVACY.

       ``(a) Definitions.--
       ``(1) In general.--The definitions contained in section 
     301(a) of title 18, United States Code, shall apply for 
     purposes of this section.
       ``(2) Other definitions.--In this section:
       ``(A) Donating.--The term `donating' means giving without 
     receiving valuable consideration.
       ``(B) Fertilization.--The term `fertilization' means the 
     fusion of an oocyte containing a haploid nucleus with a male 
     gamete (sperm cell).
       ``(C) Valuable consideration.--The term `valuable 
     consideration' does not include reasonable payments--
       ``(i) associated with the transportation, processing, 
     preservation, or storage of a human oocyte or of the product 
     of nuclear transplantation research; or
       ``(ii) to compensate a donor of one or more human oocytes 
     for the time or inconvenience associated with such donation.
       ``(b) Applicability of Federal Ethical Standards to Nuclear 
     Transplantation Research.--Research involving nuclear 
     transplantation shall be conducted in accordance with subpart 
     A of part 46 of title 45, or parts 50 and 56 of title 21, 
     Code of Federal Regulations (as in effect on the date of 
     enactment of the Human Cloning Ban and Stem Cell Research 
     Protection Act of 2003), as applicable:
       ``(c) Prohibition on Conducting Nuclear Transplantation on 
     Fertilized Eggs.--A somatic cell nucleus shall not be 
     transplanted into a human oocyte that has undergone or will 
     undergo fertilization.
       ``(d) Fourteen-Day Rule.--An unfertilized blastocyst shall 
     not be maintained after more than 14 days from its first cell 
     division, not counting any time during which it is stored at 
     temperatures less than zero degrees centigrade.
       ``(e) Voluntary Donation of Oocytes.--
       ``(1) Informed consent.--In accordance with subsection (b), 
     an oocyte may not be used in nuclear transplantation research 
     unless such oocyte shall have been donated voluntarily by and 
     with the informed consent of the woman donating the oocyte.
       ``(2) Prohibition on purchase or sale.--No human oocyte or 
     unfertilized blastocyst may be acquired, received, or 
     otherwise transferred for valuable consideration if the 
     transfer affects interstate commerce.
       ``(f) Separation of In Vitro Fertilization Laboratories 
     From Locations at Which Nuclear Transplantation Is 
     Conducted.--Nuclear transplantation may not be conducted in a 
     laboratory in which human oocytes are subject to assisted 
     reproductive technology treatments or procedures.
       ``(g) Civil Penalties.--Whoever intentionally violates any 
     provision of subsections (b) through (f) shall be subject to 
     a civil penalty in an amount that is appropriate for the 
     violation involved, but not more than $250,000.''.
  Mrs. FEINSTEIN. Mr. President, today Senators Hatch, Kennedy, 
Specter, Harkin and I are introducing legislation to ban human 
reproductive cloning, while ensuring that important medical research 
goes forward under strict oversight by the federal government.
  Simply put, this legislation will enable research to be conducted 
that provides hope to millions of Americans suffering from paralysis 
and debilitating diseases including Juvenile Diabetes, Parkinson's, 
Alzheimer's, cancer and heart disease.
  Every member of this body knows someone--whether it's a parent or 
grandparent, a child or a friend--who suffers from one of these 
diseases. That is why this legislation is so critical. We must act now 
to protect promising research that will bring hope to those who suffer.
  I now that every member of this body would agree that human 
reproductive cloning is immoral and unethical. It should be outlawed by 
Congress and the President. That is exactly what this bill does.
  It prohibits any person from conducting or attempting to clone a 
human being. It also prohibits shipping materials for the purpose of 
human cloning in interstate or foreign commerce and prohibits the 
export of an unfertilized blastocyst to a foreign country if such 
country does not prohibit human cloning.
  Any person that violates this prohibition is subject to harsh 
criminal and civil penalties. They include: imprisonment of up to 10 
years in federal prison.
  Fines of up to $1 million or three times the gross profits resulting 
from the violation, whichever is greater.
  This legislation draws a bright line between human reproductive 
cloning and promising medical research using somatic cell nuclear 
transplantation for the sole purpose of deriving embryonic stem cells.
  Somatic cell nuclear transplantation is the process by which 
scientists derive embryonic stem cells that are an exact genetic match 
as the patient. Those embryonic stem cells will one day be used to 
correct defective cells such as non-insulin producing or cancerous 
cells. Then those patients will not be forced to take immuno-
suppressive drugs and risk the chances of rejection since the new cells 
will contain their own DNA.
  It is truly astonishing that somatic cell nuclear transplantation 
research may one day be used to regrow tissue or organs that could lead 
to treatments and cures for diseases that afflict up to 100 million 
Americans. What we are talking about here is research that does not 
even involve sperm and an egg.
  I believe it is essential that this research be conducted with 
Federal Government oversight and under strict ethical requirements.
  That is why the legislation: Mandates that eggs used in this research 
be unfertilized.
  Prohibits the purchase or sale of unfertilized eggs--to prevent 
``embryo farms'' or the possible exploitation of women.
  Imposes strong ethics rules on scientists, mandating informed consent 
by egg donors, and include safety and privacy protections.
  Prohibit any research on an unfertilized blastocyst after 14 days--
After 14 days, an unfertilized blastocyst begins differentiating into a 
specific type of cell such as a heart or brain cell and is no longer 
useful for the purposes of embryonic stem cell research.
  Requires that all egg donations be voluntary, and that there is no 
financial or other incentive for egg donations.
  Requires that nuclear transportation occur in labs completely 
separate from labs that engage in in vitro fertilization.
  And for those who violate or attempt to violate the ethical 
requirements of the legislation, they will be subject to civil 
penalties of up to $250,000 per violation.
  Embryonic stem cell research that is currently being done using 
private funds, in animal models, and by scientists overseas continues 
to show great promise and potential. This progress will not be 
sustained in the U.S. without additional stem cell lines for federally-
funded research and without strict federal oversight of this research.
  Senator Hatch and I have argued this point for years. What has 
happened since the President limited federally-funded research to only 
those embryonic stem cell lines derived prior to August 9, 2001?
  Researchers have made a number of advancements confirming the promise 
of embryonic stem cells using animal models and private research 
dollars. In the absence of federal policy on embryonic stem cell 
research and human reproductive cloning, States have taken action 
creating a patchwork of state laws under varying ethical frameworks. 
Fewer researchers are choosing to go into this field given the void 
created by Federal inaction.
  Last January, a study published by researchers from the University of 
California San Diego and the Salk Institute for Biological Studies 
confirmed that all 22 existing federally-approved stem cell lines are 
tainted by mouse feeders cells and cannot be used in humans.
  Researchers at the Whitehead Institute in Cambridge, MA, used 
embryonic stem cells created by somatic cell nuclear transplantation to 
cure a genetic defect in mice.
  Researchers at Sloan-Kettering Cancer Center in New York found that 
embryonic stem cells produce proteins

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that can help ailing organs repair themselves.
  Stanford scientists were able to relieve diabetes symptoms in mice by 
using special chemicals to transform undifferentiated embryonic stem 
cells of mice into cell masses that resemble islets found in the mouse 
pancreas.
  In the absence of federal legislation, we have seen a patchwork of 
State laws under varying ethical frameworks and this is extremely 
worrisome. In total, 30 States have passed laws pertaining to stem cell 
research and there is tremendous variety in those laws.
  California launched a $3 billion initiative to fund embryonic stem 
cell research including somatic cell nuclear transplantation research 
which bans human reproductive cloning.
  At least 6 academic centers in California including UC San Francisco, 
Stanford, UCLA, UC Berkeley, UC Irvine and UC Davis have already begun 
developing facilities where this embryonic stem cell research will be 
conducted and are all actively recruiting stem cell biologists from 
across the country.

  New Jersey has proposed a $380 million initiative to fund embryonic 
stem cell research.
  Wisconsin has proposed investing $750 million to support embryonic 
stem cell research.
  By contrast, Arkansas, Iowa, North Dakota, South Dakota and Michigan 
have specifically prohibited nuclear transfer used to create stem 
cells. And 22 other States have enacted laws on the matter.
  What this means is researchers and research money are now moving to 
States with pro-research laws and pro-research Governors.
  There is clearly a void that needs to be filled--and it can only be 
filled by the Federal Government.
  To be clear, this is research that involves an unfertilized 
blastocyst. No sperm are involved. It is conducted in a petri dish and 
cannot occur beyond 14 days. It is also prohibited from ever being 
implanted into a woman to create a child.
  For those who believe that the clump of cells in a petri dish that we 
are talking about is a human life, that is a moral decision each person 
must make for himself, but to impose that view on the more than 100 
million of our parents, children and friends who suffer from 
Parkinson's, diabetes, Alzheimer's and cancer is immoral.
  As former Senator and Episcopal minister John C. Danforth said 
recently in an op-ed in the New York Times, ``Criminalizing the work of 
scientists doing such research would give strong support to one 
religious doctrine, and it would punish people who believe it is their 
religious duty to use science to heal the sick.
  This is exactly why the legislation I am introducing with my 
colleagues Senators Hatch, Kennedy, Specter and Harkin is needed. I 
urge the Senate to take up and pass this bill and help turn the hopes 
of millions of Americans into reality.
  I ask unanimous consent that the attached letter be printed in the 
Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                                     Coalition for the Advancement


                                          of Medical Research,

                                   Washington, DC, April 21, 2005.
     Senator Dianne Feinstein,
     U.S. Senate, 331 Hart Senate Office Building Washington, DC.
       Dear Senator Feinstein, On behalf of the Coalition for the 
     Advancement of Medical Research (CAMR), I am writing to add 
     our strong support for the introduction of the Human Cloning 
     Ban and Stem Cell Research Protection Act of 2005. Along with 
     Senator Orrin Hatch (R-UT), Senator Arlen Specter (R-PA), 
     Senator Ted Kennedy (D-MA), and Senator Tom Harkin (D-IA), 
     your leadership in protecting research using somatic cell 
     nuclear transfer (SCNT), also known as therapeutic cloning, 
     is greatly appreciated.
       This year, Congress will address the future of biomedical 
     research and the Nation's efforts to prevent, treat, and cure 
     such debilitating diseases as cancer, juvenile diabetes, ALS, 
     Parkinson's disease, spinal cord injuries and many more. Let 
     me be clear, CAMR supports a ban on reproductive cloning; it 
     is unsafe and unethical. Given the scientific potential of 
     SCNT and regenerative medicine, however, we strongly support 
     the bill's effort to allow for this research, which may 
     provide essential tools allowing scientists to develop the 
     promise of embryonic stern cell research. I am sure you will 
     agree, therapeutic cloning is about saving and improving 
     lives. It is fW1damemally different from human reproductive 
     cloning; it produces stem cells, not babies.
       CAMR applauds your leadership in sponsoring legislation 
     that ensures cures for devastating diseases continue to be 
     developed. We look forward to working with you.
           Thank you,
                                                     Daniel Perry,
                                                        President.
  Mr. KENNEDY. It is a privilege to join Senator Hatch, Senator 
Feinstein, Senator Specter and Senator Harkin in sponsoring the Human 
Cloning Ban and Stem Cell Research Protection Act of 2005. This 
bipartisan proposal will outlaw human cloning and open the way to 
proper, ethical cures for our most feared diseases.
  Using cloning to reproduce a child is improper and immoral--and our 
legislation will make it illegal. Medicine must advance hand in hand 
with ethics, and the legislation we introduce today will make certain 
that American research sets the gold standard for ethical oversight.
  But it is wrong to deny the great potential of medical research using 
the remarkable new techniques of stem cell research, which can save 
lives by preventing, treating, and curing a wide range of severe 
diseases and disabilities.
  We see the benefits of investment in biotechnology all around us. 
Fifty years ago last week, Jonas Salk announced the first polio 
vaccine. Imagine a world without that extraordinary discovery--where 
peoples everywhere lived in fear of the polio virus and the devastation 
it brings.
  Thirty years ago, Congress was considering whether to ban research on 
recombinant DNA--the very foundation of biotechnology.
  Time after time, we heard of the medical advances that this new field 
of research would bring. Then--as now--some dismissed this promise as a 
pipe dream and urged Congress to forbid it. We chose instead to vote 
for new hope and new cures. Today, countless Americans and persons 
throughout the world are already benefiting from the new treatments 
that biotechnology has brought. Why call a halt?
  In the 1980s Congress made the right choice, again, by rejecting 
attempts to outlaw in vitro fertilization, a technique that has 
fulfilled the hopes and dreams of thousands of parents who would never 
have been able to have a child.
  Our debate today is no different and Congress should do all it can to 
support lifesaving research, not prohibit it.
  Other nations are more than willing to leave us behind. The potential 
of this research is so immense that some of our best scientists are 
already leaving America to pursue their dreams in research laboratories 
in other countries. We need to stop that exodus before it becomes a 
nightmare. Do we really want to wake up 10 years from now and hear that 
a former American scientist in another land has won the Nobel Prize in 
medicine for a landmark discovery in stem cell research?
  The misguided fears of today can't be allowed to deny the cures of 
tomorrow. I commend my colleagues for their leadership on this 
important legislation, and I hope the Senate will act quickly to 
approve this urgently needed bill.
                                 ______