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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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Cloning Prohibition

5 Act of 2001’’.

6 SEC. 2. PROHIBITION AGAINST HUMAN CLONING.

7 (a) IN GENERAL.—The Federal Food, Drug, and

8 Cosmetic Act (21 U.S.C. 301 et seq.) is amended by add9 ing at the end the following:
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1 ‘‘CHAPTER X—HUMAN CLONING

2 ‘‘PROHIBITION AGAINST HUMAN CLONING

3 ‘‘SEC. 1001. (a) NUCLEAR TRANSFER TECH4 NOLOGY.—

5 ‘‘(1) IN GENERAL.—It shall be unlawful for any

6 person—

7 ‘‘(A) to use or attempt to use human so8 matic cell nuclear transfer technology with the

9 intent to initiate a pregnancy; or

10 ‘‘(B) to ship or transport the cellular prod11 uct resulting from human somatic cell nuclear

12 transfer technology knowing that the product is

13 intended to be used to initiate a pregnancy.

14 ‘‘(2) DEFINITION.—For purposes of this sec15 tion, the term ‘human somatic cell nuclear transfer

16 technology’ means transferring the nucleus of a

17 human somatic cell into an egg cell from which the

18 nucleus has been removed or rendered inert.

19 ‘‘(b) RULE OF CONSTRUCTION.—This section may

20 not be construed as applying to any of the following:

21 ‘‘(1) The use of somatic cell nuclear transfer

22 technology to clone molecules, DNA, cells, or tissues.

23 ‘‘(2) The use of mitochondrial, cytoplasmic, or

24 gene therapy.
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1 ‘‘(3) The use of in vitro fertilization, the admin2 istration of fertility-enhancing drugs, or the use of

3 other medical procedures to assist a woman in be4 coming or remaining pregnant.

5 ‘‘(4) The use of somatic cell nuclear transfer

6 technology to clone or otherwise create animals other

7 than humans.

8 ‘‘(5) Any other activity (including biomedical,

9 microbiological, or agricultural research or practices)

10 not expressly prohibited in subsection (a).

11 ‘‘(c) REGISTRATION.—

12 ‘‘(1) IN GENERAL.—Each individual who in13 tends to perform human somatic cell nuclear trans14 fer technology shall, prior to first performing such

15 technology, register with the Secretary his or her

16 name and place of business (except that, in the case

17 of an individual who performed such technology be18 fore the date of the enactment of the Cloning Prohi19 bition Act of 2001, the individual shall so register

20 not later than 60 days after such date). The Sec21 retary may by regulation require that the registra22 tion provide additional information regarding the

23 identity and business locations of the individual, and

24 information on the training and experience of the in-
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1 dividual regarding the performance of such tech2 nology.

3 ‘‘(2) ATTESTATION.—A registration under

4 paragraph (1) shall include a statement, signed by

5 the individual submitting the registration, declaring

6 that the individual is aware of the prohibitions de7 scribed in subsection (a) and will not engage in any

8 violation of such subsection.

9 ‘‘(3) CONFIDENTIALITY.—Information provided

10 in a registration under paragraph (1) shall not be

11 disclosed to the public by the Secretary except to the

12 extent that—

13 ‘‘(A) the individual submitting the reg14 istration has in writing authorized the disclo15 sure; or

16 ‘‘(B) the disclosure does not identify such

17 individual or any place of business of the indi18 vidual.

19 ‘‘(d) PREEMPTION OF STATE LAW.—This section su20 persedes any State or local law that—

21 ‘‘(1) establishes prohibitions, requirements, or

22 authorizations regarding human somatic cell nuclear

23 transfer technology that are different than, or in ad24 dition to, those established in subsection (a) or (c);

25 or
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1 ‘‘(2) with respect to humans, prohibits or re2 stricts research regarding or practices constituting—

3 ‘‘(A) somatic cell nuclear transfer;

4 ‘‘(B) mitochondrial or cytoplasmic therapy;

5 or

6 ‘‘(C) the cloning of molecules, DNA, cells,

7 tissues, or organs;

8 except that this subsection does not apply to any State

9 or local law that was in effect as of the day before the

10 date of the enactment of the Cloning Prohibition Act of

11 2001.

12 ‘‘(e) SUNSET.—This section and section 301(bb) do

13 not apply to any activity described in subsection (a) that

14 occurs on or after the expiration of the 10-year period be15 ginning on the date of the enactment of the Cloning Prohi16 bition Act of 2001.

17 ‘‘(f) RIGHT OF ACTION.—This section may not be

18 construed as establishing any private right of action.’’.

19 (b) PROHIBITED ACTS.—

20 (1) IN GENERAL.—Section 301 of the Federal

21 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is

22 amended by adding at the end the following:

23 ‘‘(bb) The violation of section 1001(a), or the failure

24 to register in accordance with section 1001(c).’’.
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1 (2) CRIMINAL PENALTY.—Section 303(b) of the

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

3 333(b)) is amended by adding at the end the fol4 lowing:

5 ‘‘(7) Notwithstanding subsection (a), any person who

6 violates section 301(bb) shall be imprisoned not more than

7 10 years or fined in accordance with title 18, United

8 States Code, or both.’’.

9 (3) CIVIL PENALTY.—Section 303 of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333)

11 is amended by adding at the end the following:

12 ‘‘(h)(1) Any person who violates section 301(bb) shall

13 be liable to the United States for a civil penalty in an

14 amount not to exceed the greater of—

15 ‘‘(A) $1,000,000; or

16 ‘‘(B) an amount equal to the amount of any

17 gross pecuniary gain derived from such violation

18 multiplied by 2.

19 ‘‘(2) Paragraphs (3) through (5) of subsection (g)

20 apply with respect to a civil penalty under paragraph (1)

21 of this subsection to the same extent and in the same man22 ner as such paragraphs (3) through (5) apply with respect

23 to a civil penalty under paragraph (1) or (2) of subsection

24 (g).’’.
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1 (4) FORFEITURE.—Section 303 of the Federal

2 Food, Drug, and Cosmetic Act, as amended by para3 graph (3), is amended by adding at the end the fol4 lowing:

5 ‘‘(i) Any property, real or personal, derived from or

6 used to commit a violation of section 301(bb), or any prop7 erty traceable to such property, shall be subject to for8 feiture to the United States.’’.

9 SEC. 3. STUDY BY INSTITUTE OF MEDICINE.

10 (a) IN GENERAL.—The Secretary of Health and

11 Human Services (referred to in this section as the ‘‘Sec12 retary’’) shall request the Institute of Medicine to enter

13 into an agreement with the Secretary under which such

14 Institute conducts a study to—

15 (1) review the current state of knowledge about

16 the biological properties of stem cells obtained from

17 embryos, fetal tissues, and adult tissues;

18 (2) evaluate the current state of knowledge

19 about biological differences among stem cells ob20 tained from embryos, fetal tissues, and adult tissues

21 and the consequences for research and medicine; and

22 (3) assess what is currently known about the

23 ability of stem cells to generate neurons, heart, kid24 ney, blood, liver and other tissues and the potential

25 clinical uses of these tissues.
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1 (b) OTHER ENTITIES.—If the Institute of Medicine

2 declines to conduct the study described in subsection (a),

3 the Secretary shall enter into an agreement with another

4 appropriate public or nonprofit private entity to conduct

5 the study.

6 (c) REPORT.—The Secretary shall ensure that, not

7 later than three years after the date of the enactment of

8 this Act, the study required in subsection (a) is completed

9 and a report describing the findings made in the study

10 is submitted to the Committee on Energy and Commerce

11 in the House of Representatives and the Committee on

12 Health, Education, Labor, and Pensions in the Senate.

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