[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.