[House Report 108-21]
[From the U.S. Government Publishing Office]
108th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 108-21
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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.