HR 2172 IH
107th CONGRESS
1st Session
H. R. 2172
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
June 14, 2001
Mr. GREENWOOD (for himself, Mr. WOLF, Mr. OWENS, Mr. NEAL of Massachusetts,
Mr. PALLONE, Mrs. MCCARTHY of New York, Mr. DEUTSCH, Mr. GILLMOR, and Ms.
DEGETTE) 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 with the intent to initiate a pregnancy; or
`(B) to ship or transport the cellular product resulting from human
somatic cell nuclear transfer 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 nucleus of a human
somatic cell into an egg cell from which the nucleus 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 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).
`(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) 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.
`(f) RIGHT OF ACTION- This section may not be construed as establishing
any private right of action.'.
(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--
`(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.
END