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For example, if a patient has heart damage, the genetic material from one of his cells could be transplanted into a human egg cell that has had its genetic material removed. After a time, stem cells are produced, coaxed into becoming heart cells, and transplanted into
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Embryonic stem cells can be coaxed into becoming any of the more than 200 types of cells in the human body, and therefore may be used to treat a vast array of diseases and disorders including heart disease, Parkinson's disease, diabetes, paralysis, Alzheimer's disease, and severe burns. Scientists at the National Academy of Sciences estimate that the combination of nuclear transplantation and stem cell therapies could spare the lives of 170,000 Americans each year.
History shows us the devastating effects of tying the hands of scientists for ideological reasons. Galileo was imprisoned for his support of Copernicus' theory that the planets revolve around the sun. Pope Boniface VIII banned the practice of cadaver dissection in the 1200's. This set back the understanding of human anatomy and the practice of medicine for over 300 years. In the 1800's, the Scottish Calvinist Church objected to the use of anesthesia during labor because the ``pain of childbirth was God's will.'' Let us not repeat the mistakes of history.
Recently 40 American Nobel laureates stated that:
legislation [that would ban all cloning ] would foreclose the legitimate use of nuclear transplantation . . . and impede progress against some of the most debilitating diseases known to man.
Former Presidents Ford and Carter have written to President Bush stating their opposition to reproductive cloning and their strong support for nuclear transplantation to produce stem cells. I believe that when the facts are weighed there will be strong bipartisan support for such a policy.
As I said, today, I, along with Senators FEINSTEIN, KENNEDY, HATCH, HARKIN, BOXER, DURBIN, MILLER, CORZINE, MIKULSKI, CLINTON, and THURMOND am introducing a bill which would prohibit human cloning while preserving important areas of medical research, including nuclear transplantation to produce stem cells.
Let me review the key provisions of the bill. It would prohibit human reproductive cloning by imposing a criminal penalty of up to 10 years in prison and a civil penalty of at least one million dollars. It would allow medical research into nuclear transplantation to produce stem cells, also known as therapeutic cloning , thereby allowing promising research towards cures for a vast array
of diseases to go forward. It would apply strict Federal ethical requirements to all nuclear transplantation research. These include informed consent, an ethics board review, and protections for the safety and privacy of research participants. The legislation imposes a $250,000 civil penalty for violation of the ethics requirements.
I believe that the Senate should act quickly to ban human cloning . In the process, we must preserve important areas of medical research, such as nuclear transplantation to create stem cells. The bill that I and my colleagues have introduced will do that in an ethical and moral way.
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:
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 2002''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Human cloning is unsafe, immoral, and unacceptable.
(2) Federal legislation should be enacted to prohibit anyone from attempting to conduct human cloning , whether using Federal or non-Federal funds.
(3) To deter human cloning , any attempt to create a human clone should be a felony subject to severe punishment.
(4) The National Academies (including the National Academy of Sciences and the Institute of Medicine) and the National Bioethics Advisory Commission recommended that any legislative action undertaken to ban human cloning should be careful not to interfere with important areas of scientific research, such as nuclear transplantation to produce stem cells.
(5) The National Academies found that there are significant differences between human cloning and nuclear transplantation. Specifically, the Academies determined that, unlike human cloning , the creation of embryonic stem cells by nuclear transplantation does not involve implantation of an embryo in a uterus and thus cannot produce a complete, live-born animal (that is, a ``clone'').
(6) The National Academies found that scientific and medical considerations that justify a ban on human cloning are not applicable to nuclear transplantation.
(7) The National Academies concluded that nuclear transplantation has great potential to increase the understanding and potential treatment of various diseases and debilitating disorders, as well as our fundamental biological knowledge. These diseases and disorders include Lou Gehrig's disease, Parkinson's disease, Alzheimer's disease, spinal-cord injury, cancer, cardiovascular diseases, diabetes, rheumatoid arthritis, and many others.
(8) The National Academies determined that nuclear transplantation research could improve our ability to transplant healthy tissue derived from stem cells into patients with damaged or diseased organs. Such research could greatly reduce the likelihood that a person's body would reject that tissue and also help obviate the need for immunosuppressive drugs, which often have severe and potentially life-threatening side effects.
(9) Based on these expert conclusions and recommendations and other evidence, nuclear transplantation is a valuable area of research that could potentially save millions of lives and relieve the suffering of countless others, and thus should not be banned.
(10) The National Academies recommended that nuclear transplantation experiments should be subject to close scrutiny under the Federal procedures and rules concerning human -subjects research.
(11) Given the need for additional oversight in this area, strict ethical requirements for human subjects research, including informed consent, safety and privacy protections, and review by an ethics board, should be prescribed for all research involving nuclear transplantation, whether using Federal or non-Federal funds.
(12)(A) Biomedical research and clinical facilities engage in and affect interstate commerce.
(B) The services provided by clinical facilities move in interstate commerce.
(C) Patients travel regularly across State lines in order to access clinical facilities.
(D) Biomedical research and clinical facilities engage scientists, doctors, and others in an interstate market, and contract for research and purchase medical and other supplies in an interstate market.
SEC. 3. PURPOSES.
It is the purpose of this Act to prohibit human cloning and to protect important areas of medical research, including stem cell research.
SEC. 4. PROHIBITION ON HUMAN CLONING .
(a) IN GENERAL.--Title 18, United States Code, is amended by inserting after chapter 15, the following:
``Sec.
``301. Prohibition on human cloning .``§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.
``(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 ; or
``(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.
``(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) or (2) of subsection (b) shall be fined under this title and imprisoned not more than 10 years.
``(2) CIVIL PENALTIES.--Whoever intentionally violates paragraph (1) or (2) 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.
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``(e) RIGHT OF ACTION.--Nothing in this section shall be construed to give any individual or person a private right of action.''.
(b) ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION RESEARCH.--Part H of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by adding at the end the following:
``SEC. 498C. ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION RESEARCH, INCLUDING INFORMED CONSENT, INSTITUTIONAL REVIEW BOARD REVIEW, AND PROTECTION FOR SAFETY AND PRIVACY.
``(a) DEFINITIONS.--In this section:
``(1) HUMAN SOMATIC CELL.--The term `human somatic cell' means any human cell other than a haploid germ cell.
``(2) 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.
``(3) NUCLEUS.--The term `nucleus' means the cell structure that houses the chromosomes.
``(4) OOCYTE.--The term `oocyte' means the female germ cell, the egg.
``(b) APPLICABILITY OF FEDERAL ETHICAL STANDARDS TO NUCLEAR TRANSPLANTATION RESEARCH.--Research involving nuclear transplantation shall be conducted in accordance with subparts A and B of part 46 of title 45, Code of Federal Regulations (as in effect on the date of enactment of the Human Cloning Prohibition Act of 2002).
``(c) CIVIL PENALTIES.--Whoever intentionally violates subsection (b) shall be subject to a civil penalty in an amount that is appropriate for the violation involved, but not more than $250,000.
``(d) ENFORCEMENT.--The Secretary of Health and Human Services shall have the exclusive authority to enforce this section.''.
Mrs. FEINSTEIN. Mr. President, I rise to join my colleagues Senators Specter, Kennedy, Hatch, Harkin and Thurmond to introduce legislation banning human cloning , but permitting valuable stem cell research to continue.
At the dawn of a new era in medicine, it would be unconscionable for Congress to prohibit medical research that offers hope to so many people with crippling and often incurable diseases. There is broad agreement across our society that human reproductive cloning should be prohibited. And our bill bans human reproductive cloning . But there is also widescale support to continue research that may yield cures for paralysis, cancer, Parkinson's disease, Alzheimer's and so many other illnesses. And our bill allows this important research to continue. Simply put, nuclear transplantation research has nothing to do with cloning humans. Rather, it has everything to do with saving lives and alleviating suffering.
The legislation we are introducing today bans human reproductive cloning , that is, creating a whole-body, carbon copy of a human being. Such cloning is unsafe, immoral, and unacceptable. Under the bill, anyone who even attempts human cloning will be subject to 10 years in jail and a minimum $1 million fine. However, the bill does not ban somatic cell nuclear transplantation. This is a technique that offers enormous potential for providing cures for diseases such as cancer, diabetes, cystic fibrosis, and heart disease as well as conditions such as spinal cord injuries, liver damage, arthritis, and burns.
Somatic cell nuclear transportation works like this: 1. The nucleus, that is, the DNA, is taken from the body cell of a sick person; 2. It is then injected into an unfertilized egg from which the nucleus has been removed; and 3. The egg is stimulated to divide and produce stem cells. These stem cells can potentially grow into any organ or tissue. This ``new'' organ or tissue would have the same DNA as the sick person and thus can be implanted without rejection by the person's body.
This could save the lives of the thousands of people every year waiting for an organ or tissue to be donated or who receive a transplant but suffer complications from powerful immuno-suppression drugs.
Today, almost 80,000 Americans are waiting for organ transplants, while hundreds of thousands more need tissue transplants. Nuclear transplantation research offers many other applications as well. It could be used to produce human proteins such as blood clotting factors that aid in healing wounds. It could yield information on stem cell differentiation, providing valuable information about the mechanism of aging and the cause of cancer. It could even be used to find a cure for cancer by teaching us how to reprogram cells. However, we must acknowledge that nuclear transplantation research, like all scientific and medical research involving human diseases and conditions, involves complex ethical issues.
Currently, this research is largely unregulated in the private sector. That is why this legislation would impose a number of ethical requirements on it, including informed consent, an ethics board review, and protections for the safety and privacy of research participants. These regulations are found in Subparts A and B of 45 CFR 46 and are incorporated in full into the bill we introduce today. Currently, these regulations apply to any research done or funded by the federal government. Our legislation would extend the regulations to all research involving somatic cell nuclear transplantation.
The bottom line is that these regulations will prevent exploitation of women as part of nuclear transplantation research and, more generally, require that researchers do this research in an ethical manner. These regulations are already routinely applied to government-funded researchers who do research on human subjects, and they seem to have worked well. Moreover, the bill provides that anyone engaging in unethical nuclear transplantation research would face up to a $250,000 fine.
I ask unanimous consent that a summary of Subparts A and B of 45 CFR 46 be printed in the RECORD directly following
my remarks.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 1.)
Ms. FEINSTEIN. I would also add that I believe that there may be a need for even greater oversight over nuclear transplantation research than is provided in the bill we introduce today.
I intend to work with my colleagues to strengthen this legislation further before it is enacted. There may well be a need to include additional provisions for regulation and oversight. For one thing, I believe that we should add the full text of Subparts A and B of 45 CFR 46 to this legislation to make clear what the bill actually says. And I will work with my colleagues to do so. Unfortunately, competing legislation goes far beyond such regulation. It would completely ban nuclear transplantation--criminalizing scientific research that offers the promise of saving the lives of millions and relieving the suffering of countless others. In fact, it would even make it a crime for a doctor to cure a patient if that cure was developed overseas from nuclear transplantation research.
I strongly oppose such legislation. I believe that passing such a sweeping ban would be a huge mistake. As is the case with many medical technologies, it is not stem cell research techniques that are the problem, but some of their potential applications. The scientific and medical evidence is overwhelming that nuclear transplantation offers the promise of curing many deadly diseases and debilitating conditions. As Professor Irving Weissman, chair of the National Academies' panel on cloning , testified before a Judiciary Committee hearing I chaired, ``[T]here are no scientific or medical reasons [for banning nuclear transplantation], and such a ban would certainly close avenues of promising scientific and medical research.'' In fact, over 80 major organizations and associations have already come out in favor of our approach.
These include the American Medical Association, National Health Council, Parkinson's Action Network, Juvenile Diabetes Research Foundation, and Federation of American Societies for Experimental Biology, which represents over 600,000 medical researchers around the country. Moreover, the leading blue-ribbon scientific and medical panels that have examined the cloning issue have also supported our approach.
The National Bioethics Advisory Commission, the National Academies' Panel on Scientific and Medical Aspects of Human Cloning , and the California Advisory Committee on Human Cloning all concluded that we should ban human reproductive cloning , but not interfere with important areas of scientific research, including nuclear transplantation.
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