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[House Report 107-172]
[From the U.S. Government Publishing Office]

107th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    107-172

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PROVIDING FOR CONSIDERATION OF H.R. 2505, HUMAN CLONING PROHIBITION ACT 
                                OF 2001

                                _______
                                

   July 30, 2001.--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. 214]

    The Committee on Rules, having had under consideration 
House Resolution 214, 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. 2505, the 
Human Cloning Ban Act of 2001, a structured rule providing one 
hour of debate in the House 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 the 
bill.
    The rule provides that the amendments recommended by the 
Committee on the Judiciary now printed in the bill shall be 
considered as adopted. The rule makes in order the amendment 
printed in this report, if offered by Representative Scott or a 
designee, which shall be separately debatable for 10 minutes 
equally divided and controlled by the proponent and an 
opponent. The rule further makes in order the amendment in the 
nature of a substitute printed in this report, if offered by 
Representative Greenwood or a designee, which shall be 
considered as read and shall be separately debatable for one 
hour equally divided and controlled by the proponent and an 
opponent. The rule waives all points of order against the 
amendment in the nature of a substitute printed in this report.
    Finally, the rule provides one motion to recommit with or 
without instructions.

           SUMMARY OF AMENDMENTS MADE IN ORDER UNDER THE RULE

    Scott: Provides for a study, conducted by the General 
Accounting Office, to be reported to Congress within 4 years of 
enactment, to assess the need (if any) for amendment of the 
prohibition on human cloning; and provides that the study 
should include a discussion of new developments in medical 
technology, the possibility of medical advances, public 
attitudes, and ethical views.
    Greenwood/Deutsch/DeGette/Schiff: Makes it a criminal act, 
subject to criminal and civil penalties, to use somatic cell 
nuclear transfer, or the products from this technology, to 
initiate a pregnancy or with the intent to initiate a 
pregnancy; makes it illegal to ship, mail, transport, or 
receive the products of somatic cell nuclear transfer if the 
products will be used to initiate a pregnancy; specifically 
protects other uses of somatic cell nuclear transfer, including 
therapeutic cloning; requires all individuals or companies who 
plan to perform somatic cell nuclear transfer to register with 
the Secretary and attest that they know that initiating a 
pregnancy through such means is illegal; provides that such 
registration is deemed confidential, following the same fashion 
as the FDA's treatment of trade secrets when a company files an 
Investigational New Drug application; preempts future state 
laws that are different from federal cloning law or prohibit 
protected types of research; sunsets the ban ten years after 
enactment; requires those who break the law to forfeit 
equipment, other property, and any monetary gains; requires a 
study by the Institute of Medicine on the properties of 
embryonic, fetal and adult stem cells.
    Text of amendments made in order under the rule:

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

    Page 4, after line 8, insert the following:

SEC. 3. STUDY BY 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 4 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 it considers appropriate.
                              ----------                              

     2. An Amendment To Be Offered by Representative Greenwood of 
  Pennsylvania, or Representative Deutsch of Florida, or a 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 
2001''.

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 2001, 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.--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) 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 2001.
  ``(e) Right of Action.--This section may not be construed as 
establishing any private right of action.
  ``(f) Definition.--For purposes of this section, the term 
`person' includes governmental entities.
  ``(g)  Sunset.--This section and section 301(bb) 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 
2001.''.
  (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:
  ``(bb) 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(bb) shall be imprisoned not more than 10 years or 
fined in accordance with title 18, United States Code, or 
both.''.
          (3) Civil penalty.--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(bb) shall be 
liable to the United States for a civil penalty in an amount 
not to exceed the greater of--
          ``(A) $1,000,000; 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 paragraph (1) of 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 paragraph (1) or (2) of 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(bb), 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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