[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 801 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 801

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
               cloning of humans, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 13, 2003

 Mr. Greenwood (for himself, Mr. Deutsch, Ms. DeGette, Ms. Eshoo, and 
  Mr. Kirk) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
               cloning of humans, 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 ``Cloning Prohibition Act of 2003''.

SEC. 2. PROHIBITION AGAINST HUMAN CLONING.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended by adding at the end the following:

                       ``CHAPTER X--HUMAN CLONING

                  ``prohibition against human cloning

    ``Sec. 1001. (a) Nuclear Transfer Technology.--
            ``(1) In general.--It shall be unlawful for any person--
                    ``(A) to use or attempt to use human somatic cell 
                nuclear transfer technology, or the product of such 
                technology, to initiate a pregnancy or with the intent 
                to initiate a pregnancy; or
                    ``(B) to ship, mail, transport, or receive the 
                product of such technology knowing that the product is 
                intended to be used to initiate a pregnancy.
            ``(2) Definition.--For purposes of this section, the term 
        `human somatic cell nuclear transfer technology' means 
        transferring the nuclear material of a human somatic cell into 
        an egg cell from which the nuclear material has been removed or 
        rendered inert.
    ``(b) Rule of Construction.--This section may not be construed as 
applying to any of the following:
            ``(1) The use of somatic cell nuclear transfer technology 
        to clone molecules, DNA, cells, or tissues.
            ``(2) The use of mitochondrial, cytoplasmic, or gene 
        therapy.
            ``(3) The use of in vitro fertilization, the administration 
        of fertility-enhancing drugs, or the use of other medical 
        procedures (excluding those using human somatic cell nuclear 
        transfer or the product thereof) to assist a woman in becoming 
        or remaining pregnant.
            ``(4) The use of somatic cell nuclear transfer technology 
        to clone or otherwise create animals other than humans.
            ``(5) Any other activity (including biomedical, 
        microbiological, or agricultural research or practices) not 
        expressly prohibited in subsection (a).
    ``(c) Registration.--
            ``(1) In general.--Each individual who intends to perform 
        human somatic cell nuclear transfer technology shall, prior to 
        first performing such technology, register with the Secretary 
        his or her name and place of business (except that, in the case 
        of an individual who performed such technology before the date 
        of the enactment of the Cloning Prohibition Act of 2003, the 
        individual shall so register not later than 60 days after such 
        date). The Secretary may by regulation require that the 
        registration provide additional information regarding the 
        identity and business locations of the individual, and 
        information on the training and experience of the individual 
        regarding the performance of such technology.
            ``(2) Attestation by researcher.--A registration under 
        paragraph (1) shall include a statement, signed by the 
        individual submitting the registration, declaring that the 
        individual is aware of the prohibitions described in subsection 
        (a) and will not engage in any violation of such subsection.
            ``(3) Confidentiality.--Information provided in a 
        registration under paragraph (1) shall not be disclosed to the 
        public by the Secretary except to the extent that--
                    ``(A) the individual submitting the registration 
                has in writing authorized the disclosure; or
                    ``(B) the disclosure does not identify such 
                individual or any place of business of the individual.
    ``(d) Applicability of Human Subject Protection Standards.--
            ``(1) In general.--Research involving human somatic cell 
        nuclear transfer technology shall be conducted in accordance 
        with parts 50 and 56 of title 21, Code of Federal Regulations, 
        subject to paragraph (2). Individuals whose cells are used for 
        such research shall be considered human subjects for purposes 
        of such parts.
            ``(2) Informed consent.--
                    ``(A) Donor of human cells.--In research involving 
                human somatic cell nuclear transfer technology, human 
                cells may be used only if, in addition to requirements 
                that apply under parts 50 and 56 of title 21, Code of 
                Federal Regulations, the individual who provides the 
                cells makes a statement in writing, which is signed by 
                the individual, declaring that--
                            ``(i) the individual donates the cells for 
                        purposes of such research;
                            ``(ii) the individual understands that 
                        Federal law regulates such technology and 
                        establishes a crime relating to the use of the 
                        technology to initiate a pregnancy; and
                            ``(iii) the individual does not intend for 
                        the cells to be used to initiate a pregnancy.
                    ``(B) Attestation by researchers.--In research 
                involving human somatic cell nuclear transfer 
                technology, human cells may be used only if, in 
                addition to requirements that apply under parts 50 and 
                56 of title 21, Code of Federal Regulations, the 
                individual with the principal responsibility for 
                conducting the research makes a statement in writing, 
                which is signed by the individual, declaring that the 
                consent of the donor of the cells for the cells to be 
                used in such research was obtained in accordance with 
                this subsection.
    ``(e) Preemption of State Law.--This section supersedes any State 
or local law that--
            ``(1) establishes prohibitions, requirements, or 
        authorizations regarding human somatic cell nuclear transfer 
        technology that are different than, or in addition to, those 
        established in subsection (a) or (c); or
            ``(2) with respect to humans, prohibits or restricts 
        research regarding or practices constituting--
                    ``(A) somatic cell nuclear transfer;
                    ``(B) mitochondrial or cytoplasmic therapy; or
                    ``(C) the cloning of molecules, DNA, cells, 
                tissues, or organs;
except that this subsection does not apply to any State or local law 
that was in effect as of the day before the date of the enactment of 
the Cloning Prohibition Act of 2003.
    ``(f) Right of Action.--This section may not be construed as 
establishing any private right of action.
    ``(g) Definition.--For purposes of this section, the term `person' 
includes governmental entities.
    ``(h)  Sunset.--This section and section 301(hh) do not apply to 
any activity described in subsection (a) that occurs on or after the 
expiration of the 10-year period beginning on the date of the enactment 
of the Cloning Prohibition Act of 2003.''.
    (b) Prohibited Acts.--
            (1) In general.--Section 301 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 331) is amended by adding at the end 
        the following:
    ``(hh) The violation of section 1001(a), or the failure to register 
in accordance with section 1001(c).''.
            (2) Criminal penalty.--Section 303(b) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 333(b)) is amended by adding 
        at the end the following:
    ``(7) Notwithstanding subsection (a), any person who violates 
section 301(hh) shall be imprisoned not more than 10 years or fined in 
accordance with title 18, United States Code, or both.''.
            (3) Civil penalties.--Section 303 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at 
        the end the following:
    ``(h)(1) Any person who violates section 301(hh) or section 1001(d) 
shall be liable to the United States for a civil penalty in an amount 
not to exceed the greater of--
            ``(A) $10,000,000; or
            ``(B) an amount equal to the amount of any gross pecuniary 
        gain derived from such violation multiplied by 2.
    ``(2) Paragraphs (3) through (5) of subsection (g) apply with 
respect to a civil penalty under this subsection to the same extent and 
in the same manner as such paragraphs (3) through (5) apply with 
respect to a civil penalty under subsection (g).''.
            (4) Forfeiture.--Section 303 of the Federal Food, Drug, and 
        Cosmetic Act, as amended by paragraph (3), is amended by adding 
        at the end the following:
    ``(i) Any property, real or personal, derived from or used to 
commit a violation of section 301(hh), or any property traceable to 
such property, shall be subject to forfeiture to the United States.''.

SEC. 3. STUDY BY INSTITUTE OF MEDICINE.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall request the 
Institute of Medicine to enter into an agreement with the Secretary 
under which such Institute conducts a study to--
            (1) review the current state of knowledge about the 
        biological properties of stem cells obtained from embryos, 
        fetal tissues, and adult tissues;
            (2) evaluate the current state of knowledge about 
        biological differences among stem cells obtained from embryos, 
        fetal tissues, and adult tissues and the consequences for 
        research and medicine; and
            (3) assess what is currently known about the ability of 
        stem cells to generate neurons, heart, kidney, blood, liver and 
        other tissues and the potential clinical uses of these tissues.
    (b) Other Entities.--If the Institute of Medicine declines to 
conduct the study described in subsection (a), the Secretary shall 
enter into an agreement with another appropriate public or nonprofit 
private entity to conduct the study.
    (c) Report.--The Secretary shall ensure that, not later than three 
years after the date of the enactment of this Act, the study required 
in subsection (a) is completed and a report describing the findings 
made in the study is submitted to the Committee on Energy and Commerce 
in the House of Representatives and the Committee on Health, Education, 
Labor, and Pensions in the Senate.
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