[Congressional Record Volume 144, Number 5 (Tuesday, February 3, 1998)]
[Senate]
[Pages S322-S325]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FEINSTEIN (for herself and Mr. Kennedy):
  S. 1602. A bill to amend the Public Health Service Act to prohibit 
any attempt to clone a human being using somatic cell nuclear transfer 
and to prohibit the use of Federal funds for such purposes, to provide 
for further review of the ethical and scientific issues associated with 
the use of somatic cell nuclear transfer in human beings, and for other 
purposes; to the Committee on Labor and Human Resources.


         the prohibition on cloning of human being act of 1998

  Mrs. FEINSTEIN. Mr. President, today, Senator Kennedy and I are 
introducing legislation that would prohibit, for a period of ten years, 
any person from attempting to clone a human being using somatic cell 
nuclear transfer technology.
  The reason for this legislation is simple: the cloning of a human 
being today remains scientifically dangerous, morally unacceptable, and 
ethically flawed.
  Let me be clear about the intent of this legislation right at the 
outset: I am opposed to human cloning. I do not believe it is, or will 
ever be, morally acceptable to clone human beings.
  This legislation was carefully drafted so that it would not prevent 
or interfere with vital biomedical research into cancer and other 
diseases, birth defects, infertility, and the mass production of drugs 
and vaccines.
  The Bill authorizes the continuation of the National Bioethics 
Advisory Commission, and requires the Commission to report to the 
President and the Congress in 4\1/2\ years and 9\1/2\ years on the 
science and ethical issues associated with this technology.
  The Commission's reports to Congress will also include a 
recommendation as to whether the moratorium should be continued beyond 
the ten years set by this legislation.


                   technology outpaces public policy

  The successful cloning of a sheep in Scotland last year, using a 
procedure known as somatic cell nuclear transfer, was hailed as an 
amazing scientific success.
  But it also ignited a fierce international debate about the potential 
use of this technique to clone human beings, and the ethical, legal and 
religious questions raised by such a possibility.
  Chicago-area physicist Dr. Richard Seed stirred that debate into full 
force last month when he told the media that he intends to clone human 
beings.
  He said that there were ten clinics in the United States interested 
in offering cloning services and that he believes the demand will be 
for over 200,000 cases per year, according to the American Medical 
News.
  Setting aside the fact that Dr. Seed's claims are somewhat 
implausible at the moment given the rudimentary state of cloning 
technology, he did hit a nerve.
  This is a classic example, in my view, of how the lightening speed 
with which we are able to develop new technologies can sometimes get 
ahead of society's ability to handle these advances.
  I do not believe that, today, we know enough to permit human cloning, 
or to make a permanent determination about the use of this technology.
  But, when writing laws that would have such an enormous impact on an 
entire field of science--science that includes the development of 
lifesaving 

[[Page S323]]

new therapies for disease, the prevention of birth defects, and 
fertility--Congress has a responsibility to be prudent and judicious in 
drafting legislation.

  In preparing this legislation, Senator Kennedy and I, and our staffs, 
met with representatives from: The National Bioethics Advisory 
Commission; The National Institutes of Health; The American Society for 
Reproductive Medicine; The Biotech Industry Association; The Department 
of Health and Human Services; The Food and Drug Administration.
  Included in the National Bioethics Advisory Commission were members 
of the religious and medical ethics communities.
  This bill is carefully drafted to prohibit attempts to clone a human 
being, while not impeding other important research involving somatic 
cell nuclear transfer technology, and the cloning of cells, tissues, 
DNA and animals.


                          procedure is unsafe

  One compelling reason to prohibit attempts to clone human beings at 
this time is the fact that the technology is so new that it is unsafe 
even in animals.
  Dolly, the famous cloned sheep, was the only success out of 277 
attempts, and the procedure has not been repeated successfully 
(although there are reports of the pending birth of at least one calf 
using the same cloning procedure).
  The National Bioethics Advisory Commission concluded that attempting 
to use this process to clone humans would involve unacceptable risks to 
the fetus or potential children, possibly resulting in multiple 
miscarriages, developmental abnormalities, and unknown risks to the 
mother.
  Even if and when concerns about safety are resolved, the ethical 
concerns of cloning humans still remain.
  This 10-year moratorium will allow us the time to study and debate 
this issue fully--which we as a society need to do because the science 
is not going to go away, and we will have to have a greater 
understanding of it to make informed decisions on its use.


                must not impede other important research

  The term ``cloning'' is used by scientists to describe various 
techniques that involve duplication of biological material, both animal 
and human.
  A blanket ban on cloning, or on use of the nuclear cell transplant 
technique to clone, would be too broad, and would deprive the United 
States--and the world--of invaluable biological research.
  The cloning technique that was used to produce Dolly, somatic cell 
nuclear transfer, was an extension of experiments carried out over 40 
years to facilitate understanding of how development of an animal from 
a single fertilized egg is carried out.
  The agricultural industry has been using nuclear transplantation 
research to try to improve livestock breeding.
  Biotechnology companies are exploring ways to use cloning to improve 
the production of therapeutic drugs.
  And health researchers are hoping that a greater understanding of 
nuclear transplantation cloning can lead to new treatment for human 
disease.


                                 cancer

  A report issued by the National Institutes of Health, dated January 
29, indicates that cloned tissue culture cells have allowed scientists 
to test potential chemotherapies on cancerous cells, to study the 
cellular events leading to cancer, and to mass-produce drugs and 
vaccines.


                                diabetes

  Cloning technology, using somatic cell nuclear transfer, could teach 
scientists how to augment the insulin-producing cells in diabetics 
using cells from their own bodies.
  Not only could cloning technology revolutionize the treatment for 
diabetes--it could potentially provide a cure for this debilitating 
disease.


                              skin grafts

  Somatic cell nuclear transfer might also be used in the future to 
create skin grafts for people who are severely burned.
  In severe burn cases, many times there is not enough healthy skin on 
the victim to perform a skin graft, so doctors are forced to use skin 
from cadavers or skin cells grown in tissue culture.
  In both cases, the skin is genetically different from the burn 
victim, and while it provides material for emergency grafting, this 
skin is ultimately rejected and the patient must undergo numerous 
grafting.
  Somatic cell nuclear transfer cloning could allow skin to be 
generated from virtually any of the burn victim's cells, which would be 
genetically identical and therefore should not be rejected.
  The life-saving possibilities for this technology are enormous:
  The creation of nerve stem cells to treat neurodegenerative diseases 
such as multiple sclerosis, Lou Gehrig's disease, Alzheimer's disease, 
Parkinson's disease, and to help repair injuries of the spinal cord.
  Bone marrow stem cells, for the treatment of leukemia, sickle cell or 
other blood diseases.
  Liver cells to treat liver damage.
  Muscle cells to treat muscular dystrophy and heart disease.
  Cartilage-forming cells to reconstruct joints damaged by injury or 
arthritis.
  The cloning of cells in culture has reduced the use of live animals 
in research and has allowed studies of human cells that could not be 
done otherwise.
  As scientists from NIH clearly warn, without future research 
exploring this cloning technology, these and other potential life-
saving possibilities will be unrealized.
  NIH scientists also make clear that all of these possibilities can be 
accomplished without using this technology to create, or attempt to 
create, a human being.
  A letter signed by more than 50 medical and patient organizations 
sent to Members of Congress last week warning very clearly of the 
danger in drafting legislation to ban cloning.
  In the letter they say:

       Poorly crafted legislation to ban the cloning of human 
     beings may put at risk biomedical research, such as the use 
     of cloning techniques on human cells, genes and tissues, 
     which is vital to finding the cures to the diseases and 
     ailments which our organizations champion.


             the differences with the president's proposal

  The bill we are introducing today is very similar to the President's 
bill which he sent to Congress on June 10, 1997. But it differs from 
the President's in five important aspects.
  First, it adds additional provisions to prevent anyone from cloning 
or even attempting to clone a human being. In addition to the outright 
prohibition on cloning a human being, the bill prohibits the use of 
Federal funds for such a purpose. Furthermore, the bill prohibits 
shipping the product of somatic cell nuclear transfer in interstate or 
foreign commerce for the purpose of attempting to clone a human being. 
This provision will ensure that no one may attempt to evade the law by 
shipping the product of somatic nuclear cell transfer overseas for the 
purpose of cloning a human being.
  Second, it stiffens already tough penalties in the President's bill 
to deter any attempt at cloning a human being. The bill provides a 
penalty of $1,000,000 or three times the gross gain or loss from such a 
violation, whichever is greater. In addition, the bill provides that 
any property used in an attempt to violate the act, as well as any 
property traceable to such an attempted violation, will be forfeited. 
Furthermore, the Attorney General, who is solely empowered to enforce 
the act, is granted the power of injunction to immediately enjoin 
violations.
  Third, the bill preempts state laws that prohibit or restrict 
research regarding, or practices of, somatic cell nuclear transfer, 
mitochondrial or cytoplasmic therapy, or the cloning of molecules, DNA, 
cells, tissues, organs, plants, animals, or humans.
  This provision is important because I believe we need a consistent 
national policy and we should discourage the practice of ``forum 
shopping'' from state to state for lenient laws.

  This bill is not intended to preempt state laws such as California 
Penal Code Title 9, Chapter 12, Section 367g, and California Business 
and Professions Code Division 2, Chapter 5, Article 12, Section 2260, 
which require that physicians and other medical personnel obtain signed 
written consent from patients before sperm, ova, or embryos are used 
for any purpose other than reimplantation in the same patient or in 
their spouse, and require that any use

[[Page S324]]

of sperm, ova, or embryos of donors comply with the written intent of 
the donor.
  The California statues were passed in order to address serious 
allegations by at least 60 California families, that medical personnel 
at fertility clinics at the University of California at Irvine and the 
University of California at San Diego transferred donors' sperm, ova, 
or embryos to researchers or implanted them in other women, without 
donors' knowledge or consent. These allegations raise grave concerns 
about serious violations of personal integrity and privacy. This 
legislation is in no way intended to preempt or interfere in any way 
with these California statutes, or with related statutes that would 
have a similar effect.
  Fourth, the bill we are introducing urges the President to cooperate 
with foreign countries to enforce restrictions on human cloning. Other 
countries are moving to ban human cloning and we should join them so 
that scientists cannot evade our laws by moving their operations 
offshore.
  Finally, our bill establishes a 10-year ban, as opposed to the 5-year 
ban in the President's recommended legislation.
  It is conceivable that there could be incredible scientific 
breakthroughs with cloning technology over the next 3 to 5 years.
  But developing a legal and moral framework for understanding of the 
potential use and abuse of this technology will take much longer.
  This legislation sunsets after 10 years, during which time the 
National Bioethics Advisory Commission must keep Congress and the 
President informed on the status of the science, its potential uses for 
society, and make recommendations on whether to continue the 
prohibition.
  Congress can extend the ban temporarily or permanently at any time 
during or after the ten year period if it so chooses.


                               conclusion

  Creating life outside of the normal reproductive process has 
challenged many of our basic beliefs--never more so than with the 
notion of cloning a human being.
  It is important that we as a society engage in a rigorous public 
debate to fully understand the science, the dangers, the potential 
benefits, and the moral and legal implications of this technology.
  Throughout history, science has empowered humankind to achieve things 
never before believed possible. Our challenge is to harness this power 
without losing control over our own lives, or the moral compass that 
guides us.
  I urge my colleagues to support this legislation.
  Mr. President, I ask unanimous consent to submit for the Record the 
letter to which I referred.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                                                 February 2, 1998.

         Regarding: Legislation to Ban Cloning of Human Beings

       Dear Member: We are writing to express our concern about 
     legislation pending in the Congress to ban the cloning of 
     entire human beings.
       Let us be clear. We oppose the cloning of a human being. We 
     see no ethical or medical justification for the cloning of a 
     human being and agree with the conclusions of the National 
     Bioethics Advisory Commission (NBAC) that it is unacceptable 
     at this time for anyone in the public or private sector, 
     whether in a research or clinical setting, to create a human 
     child using somatic cell nuclear transfer technology. We 
     recognize that this application of the technology raises 
     fundamental ethical and social issues. This technology is not 
     currently safe to use in humans.
       The American Society for Reproductive Medicine, the 
     Biotechnology Industry Organization, and the Federation of 
     American Societies of Experimental Biology have all stated 
     that their members will not seek to clone a human being. 
     These three associations include essentially every researcher 
     or practitioner in the United States who has the scientific 
     capability to clone a human being.
       We agree with NBAC in its report on cloning that: ``It is 
     notoriously difficult to draft legislation at any particular 
     moment that can serve to both exploit and govern the rapid 
     and unpredictable advances of science.'' Poorly crafted 
     legislation to ban the cloning of human beings may put at 
     risk biomedical research, such as the use of cloning 
     techniques on human cells, genes and tissues, which is vital 
     to finding the cures to the diseases and ailments which our 
     organizations champion. Cancer, diabetes, allergies, asthma, 
     HIV/AIDS, eye diseases, spinal cord injuries, Guillain-Barre 
     syndrome, Gaucher disease, stroke, cystic fibrosis, kidney 
     cancer, Alzheimer's disease, tuberous sclerosis, tourette 
     syndrome, alcoholism, autoimmune diseases, osteoporosis, 
     Parkinson's disease, infertility, heart disease, diseases of 
     aging, ataxia telangiectasia and many other types of research 
     will benefit from the advances achieved by biomedical 
     researchers.
       We urge the Congress to proceed with extreme caution and 
     adhere to the ethical standard for physicians, ``first do no 
     harm.'' We believe that there are two distinct issues here, 
     cloning of a human being and the healing which comes from 
     biomedical research. Congress must be sure that any 
     legislation which it considers does no harm to biomedical 
     research which can heal those with deadly and debilitating 
     diseases.
       Please keep patients' concerns in mind as you proceed in 
     analyzing this very complicated issue.
           Sincerely,
         AIDS Action Council; Allergy and Asthma Network/Mothers 
           of Asthmatics, Inc.; Alliance for Aging Research; 
           Alzheimer Aid Society; American Academy of Optometry; 
           American Academy of Pediatrics; American Association 
           for Cancer Education; American Association for Cancer 
     Research; American Autoimmune Related Diseases 
     Association; American College of Cardiology; American 
     College of Medical Genetics; American Diabetes 
     Association; American Heart Association; American 
     Paralysis Association; American Pediatric Society.
         American Society for Reproductive Medicine; American 
           Uveitis Society; Americans for Medical Progress; 
           Association of Medical School Pediatric Department 
           Chairmen; Association of Pediatric Oncology Nurses; 
           Asthma & Allergy Foundation of America; A-T Children's 
           Project; Cancer Research Foundation of America; Cancer 
           Care, Inc.; Cancervive; Candlelighter's Childhood 
           Cancer Foundation; Cystic Fibrosis Foundation; 
           Foundation for Biomedical Research; Guillain-Barre 
           Syndrome Foundation International; International 
           Patient Advocacy Association.
         Joint Council of Allergy, Asthma and Immunology; Juvenile 
           Diabetes Foundation International; Kent Waldrep 
           National Paralysis Foundation; Log Cabin AIDS Policy 
           Institute; National Alliance for Eye and Vision 
           Research; National Alliance of Breast Cancer 
           Organizations (NABCO); National Association for 
           Biomedical Research; National Campaign to End 
           Neurological Disorders; National Coalition for Cancer 
           Research; National Foundation for Cancer Research; 
           National Gaucher Foundation; National Kidney Cancer 
           Association; National Osteoporosis Foundation; National 
           Patient Advocate Foundation; National Stroke 
           Association.
         National Tuberous Sclerosis Association; Oncology Nurses 
           Association; Outpatient Ophthalmic Surgery Society, 
           Inc.; Parkinson's Action Network; Radiation Research 
           Society; Research! America; Research Society on 
           Alcoholism; RESOLVE; Roswell Park Cancer Institute; 
           Society for Pediatric Research; Tourette Syndrome 
           Association, Inc.

  Mr. KENNEDY. Mr. President, several months ago, the world learned of 
one of the most astounding developments in modern biology: the cloning 
of a sheep named Dolly. This extraordinary scientific achievement 
awakened widespread concern about the possibility of a brave new world, 
where human beings would be cloned and where individuals would seek to 
achieve a kind of immortality by reproducing themselves. There is 
widespread agreement among scientists, ethicists, and ordinary 
Americans that production of human beings by cloning should be 
prohibited, at least until the possibilities and pitfalls of this 
scientific procedure are better understood.
  The President reacted rapidly to this scientific advance and the 
unprecedented issues it raised by asking the National Bioethics 
Advisory Commission to study the issue and make recommendations. The 
Commission recommended that creation of human beings by cloning should 
be banned for several years, and the Administration has submitted 
legislation to implement this recommendation.
  The legislation that Senator Feinstein and I are introducing today 
will assure the American public that reproducing human beings by 
cloning will be prohibited. It largely follows the President's 
legislation and the Recommendations of the Commission. It makes it 
illegal to produce human beings by cloning and establishes strict 
penalties for those who try to do so. In addition, it prohibits anyone 
from beginning the cloning process in this

[[Page S325]]

country and carrying out the implantation step in another country.
  But just as important as what the bill does is what it does not do. 
It does not seek to use public concern about cloning to establish a 
back door ban on research into human development.
  A prohibition that goes too far could outlaw needed research on the 
prevention, treatment, and cure of cancer.
  It could outlaw needed research on fertility, to help birth defects, 
and hereditary diseases.
  It could outlaw needed research on the cure of spinal cord injuries.
  All of these various kinds of research have broad support in Congress 
and the country. Yet a blunderbuss ban on human development research 
could easily interfere with this important and life-saving research, or 
even halt it altogether.
  In addition, the FDA has jurisdiction over human cloning and will act 
vigorously to shut down any clinic that operates without FDA approval. 
The FDA must find that human cloning is safe and effective. Given the 
current state of the science, the DFA would almost certainly decide 
that a human cloning procedure is not safe at the current time. The FDA 
approval process is not a permanent ban on human cloning, but it 
effectively bans the procedures for the near future.
  The American Medical Association and over forty national medical 
organizations and research groups have voiced support for the kind of 
research that is urgently needed to continue the progress we are making 
against a wide range of diseases. Benjamin Younger, the Executive 
Director of the American Society for Reproductive Medicine, has said, 
``We must work together to ensure that in our effort to make human 
cloning illegal we do not sentence millions of people to needless 
suffering because research and progress into their illness cannot 
proceed.''
  The legislation we are introducing today will do what the American 
people want--ban the production of human beings by cloning. It strikes 
the proper balance between assuring that human beings will not be 
reproduced through cloning and allowing needed research to continue. I 
hope that Congress will act promptly to enact this legislation.

                          ____________________