`[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 1611 Placed on Calendar Senate (PCS)]






                                                       Calendar No. 305
105th CONGRESS
  2d Session
                                S. 1611

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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 4, 1998

 Mrs. Feinstein (for herself and Mr. Kennedy) introduced the following 
                  bill; which was read the first time

                            February 5, 1998

            Read the second time and placed on the calendar

_______________________________________________________________________

                                 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.

    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 ``Prohibition on Cloning of Human 
Beings Act of 1998''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) it has been reported that an adult sheep has been 
        cloned using a technique called somatic cell nuclear transfer;
            (2) the National Bioethics Advisory Commission (referred to 
        in this Act as the ``NBAC'') has reviewed the scientific and 
        ethical implications of the potential use of such technology to 
        clone human beings;
            (3) the NBAC has determined that--
                    (A) somatic cell nuclear transfer technology may 
                have many applications for biotechnology, livestock 
                productions, and new medical approaches including the 
                production of pharmaceutical proteins and prospects for 
                repair, regeneration, or transplant of human tissues or 
                organs; and
                    (B) the possibility of using somatic cell nuclear 
                transfer for the purposes of creating a child entails 
                significant scientific uncertainty and medical risk, 
                which could result in harm to a child;
            (4) the NBAC concluded unanimously that at this time it is 
        morally unacceptable for anyone in the public or private 
        sector, whether in a research or clinical setting, to attempt 
        to create a child using somatic cell nuclear transfer-cloning;
            (5) the consensus of the NBAC is based on current 
        scientific information indicating that this technique is not 
        safe to use in humans at this time;
            (6) in addition to issues of safety, the NBAC identified 
        many additional serious ethical concerns which they agreed 
        require a great deal more widespread and careful public 
        deliberation before this technology may be used;
            (7) the NBAC recommended a continuation of the current 
        moratorium on the use of Federal funds to support any attempt 
        to create a child by somatic cell nuclear transfer, and an 
        immediate request to all firms, clinicians, investigators, and 
        professional societies to comply voluntarily with the intent of 
        the Federal moratorium;
            (8) the NBAC further recommended that Federal legislation 
        be enacted to prohibit anyone from attempting, whether in a 
        research or clinical setting, to create a child through somatic 
        cell nuclear transfer cloning;
            (9) the NBAC also recommended that the United States 
        cooperate with other countries to enforce mutually supported 
        restrictions on this activity;
            (10) the NBAC specified that such Federal legislation 
        should include a sunset provision and that, prior to the sunset 
        date, an oversight body should review and report on the status 
        of somatic cell nuclear transfer technology and the ethical and 
        social issues associated with its use and recommend whether the 
        prohibition should be continued;
            (11) the NBAC concluded that any regulatory or legislative 
        actions undertaken to effect the foregoing prohibition should 
        be carefully written so as not to interfere with other 
        important areas of research, such as the cloning of human DNA 
        sequences and cells, which raise neither the scientific nor the 
        ethical issues that arise from the possible creation of 
        children through somatic cell nuclear transfer techniques;
            (12) the NBAC also found that cloning animals by somatic 
        cell nuclear transfer does not raise the same issues implicated 
        in attempting to use the technique to create a child, and its 
        continuation should only be subject to existing regulations 
        regarding the humane use of animals; and
            (13)(A) biomedical research facilities, including those 
        conducting cloning, and reproductive services facilities engage 
        in and affect interstate commerce;
            (B) the products of biomedical research, including cloning, 
        and the services provided by reproductive services facilities 
        move in interstate commerce;
            (C) patients travel regularly across State lines in order 
        to access reproductive services facilities; and
            (D) biomedical research facilities, including those 
        conducting cloning, and reproductive services facilities engage 
        scientists, doctors, and other staff 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--
            (1) prohibit any attempt, in this country or elsewhere, to 
        clone a human being, that is, to use the product of somatic 
        cell nuclear transfer to create a human being genetically 
        identical to an existing or deceased human being;
            (2) prohibit the use of Federal funds for any of the 
        activities described in paragraph (1); and
            (3) provide for further review of the ethical and 
        scientific issues associated with the use of somatic cell 
        nuclear transfer in humans.

SEC. 4. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    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. PROHIBITION ON CLONING.

    ``(a) Definitions.--In this section:
            ``(1) Cloning.--The term `cloning' means the production of 
        a precise genetic copy of a molecule (including DNA), cell, 
        tissue, organ, plant, animal, or human.
            ``(2) Nucleus.--The term `nucleus' means the cell structure 
        that houses the chromosomes, and thus the genes.
            ``(3) Oocyte.--The term `oocyte' means the female germ 
        cell, the egg.
            ``(4) Somatic cell.--The term `somatic cell' means a 
        mature, diploid cell.
            ``(5) Somatic cell nuclear transfer.--The term `somatic 
        cell nuclear transfer' means transferring the nucleus of a 
        somatic cell of an existing or deceased human child or adult 
        into an oocyte from which the nucleus or all chromosomes have 
        been or will be removed or rendered inert.
    ``(b) Prohibitions.--It shall be unlawful for any person or other 
legal entity, public or private--
            ``(1) to implant or attempt to implant the product of 
        somatic cell nuclear transfer into a woman's uterus;
            ``(2) to ship the product of somatic cell nuclear transfer 
        in interstate or foreign commerce for the purpose of implanting 
        the product of somatic cell nuclear transfer into a woman's 
        uterus, in the United States or elsewhere; or
            ``(3) to use funds made available under this Act, or any 
        other Act, for an activity prohibited under paragraph (1) or 
        (2).
    ``(c) Protected Research and Practices.--Nothing in this section 
shall be construed to restrict areas of biomedical and agricultural 
research or practices not expressly prohibited in this section, 
including research or practices that involve the use of--
            ``(1) somatic cell nuclear transfer or other cloning 
        technologies to clone molecules, DNA, cells, and tissues;
            ``(2) mitochondrial, cytoplasmic or gene therapy; or
            ``(3) somatic cell nuclear transfer techniques to create 
        nonhuman animals.
    ``(d) National Bioethics Advisory Commission Report.--
            ``(1) In general.--Not later than 4\1/2\ years, and 
        subsequently, 9\1/2\ years, after the date of enactment of this 
        section, the National Bioethics Advisory Commission shall 
        prepare and submit to the President and Congress a report 
        concerning--
                    ``(A) the state of the science of cloning and 
                relevant developments in cell biology;
                    ``(B) the ethical and social issues associated with 
                the potential use of this technology in humans; and
                    ``(C) the advisability of continuing the 
                prohibition established under this section.
            ``(2) Other reports.--The National Bioethics Advisory 
        Commission may produce reports in addition to the reports 
        required under paragraph (1) if the Commission determines that 
        such reports are useful to clarify any of the topics described 
        in paragraph (1), address changes in the state of science or 
        society, or modify or clarify the recommendations of the 
        Commission.
            ``(3) Continuation of commission.--The National Bioethics 
        Advisory Commission is authorized to continue for the 10-year 
        period described in subsection (i) to prepare reports under 
        this section and for other purposes as established in 
Executive Order 12975 and subsequent amendments to such Order. This 
paragraph shall be construed to supersede the termination and 
chartering provisions of section 14 of the Federal Advisory Committee 
Act (5 U.S.C. App 2).
    ``(e) Penalties.--
            ``(1) In general.--Any person who intentionally violates 
        the provisions of subsection (b) shall be fined the greater of 
        $1,000,000 or 3 times the gross pecuniary gain or loss 
        resulting from the violation.
            ``(2) Civil actions.--If a person is violating or about to 
        violate the provisions of subsection (b), the Attorney General 
        may commence a civil action in an appropriate Federal district 
        court to enjoin such violation.
            ``(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.
            ``(4) Authority.--The Attorney General shall have 
        exclusive, nondelegable enforcement authority under this 
        section.
            ``(5) Advisory opinions.--The Attorney General shall, upon 
        request, render binding advisory opinions regarding the scope, 
        applicability, interpretation, and enforcement of this section 
        with regard to specific research projects or practices.
    ``(f) Cooperation with Foreign Countries.--It is the sense of 
Congress that the President should cooperate with foreign countries to 
enforce mutually supported restrictions on the activities prohibited 
under subsection (b).
    ``(g) Right of Action.--Nothing in this section shall be construed 
to give any individual or person a private right of action.
    ``(h) Preemption of State Law.--The provisions of this section 
shall preempt any State or local law that prohibits or restricts 
research regarding, or practices constituting, somatic cell nuclear 
transfer, mitochondrial or cytoplasmic therapy, or the cloning of 
molecules, DNA, cells, tissues, organs, plants, animals, or humans.
    ``(i) Effective Date.--This section shall be effective for the 10-
year period beginning on the date of enactment of this section. The 
prohibitions contained in this section shall terminate at the 
expiration of such 10-year period.''.




                                                       Calendar No. 305

105th CONGRESS

  2d Session

                                S. 1611

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                            February 5, 1998

            Read the second time and placed on the calendar`