Sets forth registration requirements for individuals who intend to perform human somatic cell nuclear transfer technology, including attesting that such prohibitions will not be violated.
Directs the Secretary of Health and Human Services to request the Institute of Medicine to enter into an agreement to conduct a study to: (1) review the current state of knowledge about the biological properties of stem cells obtained from embryos and fetal and adult tissues; (2) evaluate the current state of knowledge about biological differences among stem cells obtained from embryos and fetal 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.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2608 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 2608
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
July 24, 2001
Mr. Greenwood (for himself and Mr. Deutsch) 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 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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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