[House Report 108-21]
[From the U.S. Government Publishing Office]



108th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                     108-21

======================================================================



 
PROVIDING FOR CONSIDERATION OF H.R. 534, HUMAN CLONING PROHIBITION ACT 
                                OF 2003

                                _______
                                

 February 26, 2003.--Referred to the House Calendar and ordered to be 
                                printed

                                _______
                                

   Mrs. Myrick, from the Committee on Rules, submitted the following

                              R E P O R T

                       [To accompany H. Res. 105]

    The Committee on Rules, having had under consideration 
House Resolution 105, by a nonrecord vote, report the same to 
the House with the recommendation that the resolution be 
adopted.

                SUMMARY OF PROVISIONS OF THE RESOLUTION

    The resolution provides for consideration of H.R. 534, the 
Human Cloning Prohibition Act of 2003, under a structured rule. 
The rule provides one hour of general debate, equally divided 
and controlled by the chairman and ranking minority member of 
the Committee on the Judiciary. The rule waives all points of 
order against consideration of the bill.
    The rule makes in order only those amendments printed in 
this report. The rule provides that amendments may be offered 
only in the order printed in this report, may be offered only 
by a Member designated in this report, shall be considered as 
read, shall be debatable for a time specified in this report 
equally divided and controlled by the proponent and an 
opponent, and shall not be subject to amendment. The rule 
waives all points of order against the amendments. The rule 
waives all points of order against the amendments. Finally, the 
rule provides one motion to recommit with or without 
instructions.
    The waiver of all points of order against consideration of 
the bill in the rule includes a waiver of clause 4(a) of rule 
XIII (requiring a three-day layover of the committee report), 
which is needed because the committee report was not filed 
until Tuesday, February 25, 2003 and the bill may be considered 
by the House as early as Thursday, February 27, 2003.

                            COMMITTEE VOTES

    Pursuant to clause 3(b) of House rule XIII the results of 
each record vote on an amendment or motion to report, together 
with the names of those voting for and against, are printed 
below:

Rules Committee record vote No. 3

    Date: February 26, 2003.
    Measure: H.R. 534.
    Motion by: Mr. Frost.
    Summary of motion: To make in order the amendment offered 
by Representative Lofgren to provide an exemption for stem cell 
research for the purpose of therapeutic research to treat 
Parkinson's disease, Alzheimer's disease, diabetes, cancer, 
heart disease, spinal cord injury, multiple sclerosis, severe 
burns, or other diseases.
    Results: Defeated 3 to 7.
    Vote by Members: Goss--Nay; Pryce--Nay; Hastings (WA)--Nay; 
Myrick--Nay; Sessions--Nay; Reynolds--Nay; Frost--Yea; 
Slaughter--Yea; McGovern--Yea; Dreier--Nay.

Rules Committee record vote No. 4

    Date: February 26, 2003.
    Measure: H.R. 534.
    Motion by: Mrs. Slaughter.
    Summary of motion: To make in order the amendment offered 
by Representative Scott to provide an exemption to allow the 
shipping, receipt, or importation for use in medical treatment 
of any product derived from an embryo (including pluripotent 
stem cells) if such product is unable to develop into a full 
human being.
    Results: Defeated 3 to 7.
    Vote by Members: Goss--Nay; Pryce--Nay; Hastings (WA)--Nay; 
Myrick--Nay; Sessions--Nay; Reynolds--Nay; Frost--Yea; 
Slaughter--Yea; McGovern--Yea; Dreier--Nay.

Rules Committee record vote No. 5

    Date: February 26, 2003.
    Measure: H.R. 534.
    Motion by: Mr. McGovern.
    Summary of motion: To make in order the amendment offered 
by Representatives Jackson-Lee and Nadler to provide an 
exemption to allow for the transfer of nuclei from somatic 
cells into unfertilized eggs to derive embryonic stem cells for 
the purpose of creating genetically diverse embryonic stem cell 
lines.
    Results: Defeated 3 to 7.
    Vote by Members: Goss--Nay; Pryce--Nay; Hastings (WA)--Nay; 
Myrick--Nay; Sessions--Nay; Reynolds--Nay; Frost--Yea; 
Slaughter--Yea; McGovern--Yea; Dreier--Nay.

Rules Committee record vote No. 6

    Date: February 26, 2003.
    Measure: H.R. 534.
    Motion by: Mr. McGovern.
    Summary of motion: To make in order the amendment offered 
by Representative Wu to repeal the ban on human cloning five 
years after its enactment.
    Results: Defeated 3 to 7.
    Vote by Members: Goss--Nay; Pryce--Nay; Hastings (WA)--Nay; 
Myrick--Nay; Sessions--Nay; Reynolds--Nay; Frost--Yea; 
Slaughter--Yea; McGovern--Yea; Dreier--Nay.

           SUMMARY OF AMENDMENTS MADE IN ORDER UNDER THE RULE

    (Summaries derived from information provided by sponsors.)
    1. Scott--Provides for a study by the General Accounting 
Office (GAO) to assess the need (if any) for amendment of the 
prohibition on human cloning. GAO must report its finding to 
Congress within 2 years. (10 minutes)
    2. Stearns--Expresses the Sense of the Congress that other 
nations should establish equivalent prohibitions on cloning. 
(10 minutes)
    3. Greenwood/Deutsch/DeGette/Kirk/Eshoo/Schiff--Substitute. 
Defines human somatic cell nuclear transfer with the intent to 
initiate a pregnancy as a criminal act subject to criminal and 
civil penalties. Makes it illegal to ship or transport the 
products of human somatic cell nuclear transfer if the products 
will be used to initiate a pregnancy. Criminal penalties 
include imprisonment of up to 10 years. Civil penalties include 
fines up to $10,000,000 or 2 times the pecuniary gain from 
cloning. Provides for forfeiture of equipment, other property 
and any monetary gains from human cloning. Requires all 
individuals or companies who plan to perform human somatic cell 
nuclear transfer to register with the Food and Drug 
Administration. Requires all research be conducted with 
Institutional Review Board oversight and with informed consent 
of the donors of the cells to be used. Protects other uses of 
somatic cell nuclear transfer (including cloning of molecules, 
DNA, cells, or tissues). Protects in vitro fertilization, the 
administration of fertility-enhancing drugs, or the use of 
other medical procedures to assist a woman in becoming or 
remaining pregnant. Requires a study by the Institute of 
Medicine on the properties of embryonic, fetal and adult stem 
cells. Preempts future state laws that are different from the 
federal cloning law or prohibit protected types of research. 
Sunsets 10 years after enactment. (60 minutes)

            TEXT OF AMENDMENTS MADE IN ORDER UNDER THE RULE

 1. An Amendment To Be Offered by Representative Scott of Virginia, or 
                 His Designee, Debatable for 10 Minutes

  Add at the end of the bill the following:

SEC. 3. STUDY BY THE GENERAL ACCOUNTING OFFICE.

  (a) In General.--The General Accounting Office shall conduct 
a study to assess the need (if any) for amendment of the 
prohibition on human cloning, as defined in section 301 of 
title 18, United States Code, as added by this Act, which study 
should include--
          (1) a discussion of new developments in medical 
        technology concerning human cloning and somatic cell 
        nuclear transfer, the need (if any) for somatic cell 
        nuclear transfer to produce medical advances, current 
        public attitudes and prevailing ethical views 
        concerning the use of somatic cell nuclear transfer, 
        and potential legal implications of research in somatic 
        cell nuclear transfer; and
          (2) a review of any technological developments that 
        may require that technical changes be made to section 2 
        of this Act.
  (b) Report.--The General Accounting Office shall transmit to 
the Congress, within 2 years after the date of enactment of 
this Act, a report containing the findings and conclusions of 
its study, together with recommendations for any legislation or 
administrative actions which in considers appropriate.
                              ----------                              


2. An Amendment To Be Offered by Representative Stearns of Florida, or 
                 His Designee, Debatable for 10 Minutes

    Add at the end the following:

SEC.  . SENSE OF CONGRESS.

    It is the sense of the Congress that each foreign country 
should establish a prohibition substantially equivalent to the 
prohibition established by the amendments made by this Act.
                              ----------                              


    3. An Amendment in the Nature of a Substitute To Be Offered by 
 Representative Greenwood of Pennsylvania, or His Designee, Debatable 
                             for 60 Minutes

  Strike all after the enacting clause and insert the 
following:

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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