I 

108TH CONGRESS 

1ST SESSION H. R. 801

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 

FEBRUARY 13, 2003

Mr. GREENWOOD (for himself, Mr. DEUTSCH, Ms. DEGETTE, Ms. ESHOO, 

and Mr. KIRK) 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 2003’’. 

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, or the 

9 product of such technology, to initiate a preg10 nancy or with the intent to initiate a pregnancy; 

11 or 

12 ‘‘(B) to ship, mail, transport, or receive the 

13 product of such technology knowing that the 

14 product is intended to be used to initiate a 

15 pregnancy. 

16 ‘‘(2) DEFINITION.—For purposes of this sec17 tion, the term ‘human somatic cell nuclear transfer 

18 technology’ means transferring the nuclear material 

19 of a human somatic cell into an egg cell from which 

20 the nuclear material has been removed or rendered 

21 inert. 

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

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

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

25 technology to clone molecules, DNA, cells, or tissues. 
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1 ‘‘(2) The use of mitochondrial, cytoplasmic, or 

2 gene therapy. 

3 ‘‘(3) The use of in vitro fertilization, the admin4 istration of fertility-enhancing drugs, or the use of 

5 other medical procedures (excluding those using 

6 human somatic cell nuclear transfer or the product 

7 thereof) to assist a woman in becoming or remaining 

8 pregnant. 

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

10 technology to clone or otherwise create animals other 

11 than humans. 

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

13 microbiological, or agricultural research or practices) 

14 not expressly prohibited in subsection (a). 

15 ‘‘(c) REGISTRATION.—

16 ‘‘(1) IN GENERAL.—Each individual who in17 tends to perform human somatic cell nuclear trans18 fer technology shall, prior to first performing such 

19 technology, register with the Secretary his or her 

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

21 of an individual who performed such technology be22 fore the date of the enactment of the Cloning Prohi23 bition Act of 2003, the individual shall so register 

24 not later than 60 days after such date). The Sec25 retary may by regulation require that the registra-
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1 tion provide additional information regarding the 

2 identity and business locations of the individual, and 

3 information on the training and experience of the in4 dividual regarding the performance of such tech5 nology. 

6 ‘‘(2) ATTESTATION BY RESEARCHER.—A reg7 istration under paragraph (1) shall include a state8 ment, signed by the individual submitting the reg9 istration, declaring that the individual is aware of 

10 the prohibitions described in subsection (a) and will 

11 not engage in any violation of such subsection. 

12 ‘‘(3) CONFIDENTIALITY.—Information provided 

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

14 disclosed to the public by the Secretary except to the 

15 extent that—

16 ‘‘(A) the individual submitting the reg17 istration has in writing authorized the disclo18 sure; or

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

20 individual or any place of business of the indi21 vidual. 

22 ‘‘(d) APPLICABILITY OF HUMAN SUBJECT PROTEC23 TION STANDARDS.—

24 ‘‘(1) IN GENERAL.—Research involving human 

25 somatic cell nuclear transfer technology shall be con-
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1 ducted in accordance with parts 50 and 56 of title 

2 21, Code of Federal Regulations, subject to para3 graph (2). Individuals whose cells are used for such 

4 research shall be considered human subjects for pur5 poses of such parts. 

6 ‘‘(2) INFORMED CONSENT.—

7 ‘‘(A) DONOR OF HUMAN CELLS.—In re8 search involving human somatic cell nuclear 

9 transfer technology, human cells may be used 

10 only if, in addition to requirements that apply 

11 under parts 50 and 56 of title 21, Code of Fed12 eral Regulations, the individual who provides 

13 the cells makes a statement in writing, which is 

14 signed by the individual, declaring that—

15 ‘‘(i) the individual donates the cells 

16 for purposes of such research; 

17 ‘‘(ii) the individual understands that 

18 Federal law regulates such technology and 

19 establishes a crime relating to the use of 

20 the technology to initiate a pregnancy; and 

21 ‘‘(iii) the individual does not intend 

22 for the cells to be used to initiate a preg23 nancy. 

24 ‘‘(B) ATTESTATION BY RESEARCHERS.—In 

25 research involving human somatic cell nuclear 
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1 transfer technology, human cells may be used 

2 only if, in addition to requirements that apply 

3 under parts 50 and 56 of title 21, Code of Fed4 eral Regulations, the individual with the prin5 cipal responsibility for conducting the research 

6 makes a statement in writing, which is signed 

7 by the individual, declaring that the consent of 

8 the donor of the cells for the cells to be used 

9 in such research was obtained in accordance 

10 with this subsection. 

11 ‘‘(e) PREEMPTION OF STATE LAW.—This section su12 persedes any State or local law that—

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

14 authorizations regarding human somatic cell nuclear 

15 transfer technology that are different than, or in ad16 dition to, those established in subsection (a) or (c); 

17 or 

18 ‘‘(2) with respect to humans, prohibits or re19 stricts research regarding or practices constituting—

20 ‘‘(A) somatic cell nuclear transfer; 

21 ‘‘(B) mitochondrial or cytoplasmic therapy; 

22 or 

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

24 tissues, or organs; 
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1 except that this subsection does not apply to any State 

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

3 date of the enactment of the Cloning Prohibition Act of 

4 2003. 

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

6 construed as establishing any private right of action. 

7 ‘‘(g) DEFINITION.—For purposes of this section, the 

8 term ‘person’ includes governmental entities. 

9 ‘‘(h) SUNSET.—This section and section 301(hh) do 

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

11 occurs on or after the expiration of the 10-year period be12 ginning on the date of the enactment of the Cloning Prohi13 bition Act of 2003.’’. 

14 (b) PROHIBITED ACTS.—

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

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

17 amended by adding at the end the following: 

18 ‘‘(hh) The violation of section 1001(a), or the failure 

19 to register in accordance with section 1001(c).’’. 

20 (2) CRIMINAL PENALTY.—Section 303(b) of the 

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

22 333(b)) is amended by adding at the end the fol23 lowing: 

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

25 violates section 301(hh) shall be imprisoned not more than 
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1 10 years or fined in accordance with title 18, United 

2 States Code, or both.’’. 

3 (3) CIVIL PENALTIES.—Section 303 of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333) 

5 is amended by adding at the end the following: 

6 ‘‘(h)(1) Any person who violates section 301(hh) or 

7 section 1001(d) shall be liable to the United States for 

8 a civil penalty in an amount not to exceed the greater of—

9 ‘‘(A) $10,000,000; or 

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

11 gross pecuniary gain derived from such violation 

12 multiplied by 2. 

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

14 apply with respect to a civil penalty under this subsection 

15 to the same extent and in the same manner as such para16 graphs (3) through (5) apply with respect to a civil penalty 

17 under subsection (g).’’. 

18 (4) FORFEITURE.—Section 303 of the Federal 

19 Food, Drug, and Cosmetic Act, as amended by para20 graph (3), is amended by adding at the end the fol21 lowing: 

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

23 used to commit a violation of section 301(hh), or any prop24 erty traceable to such property, shall be subject to for25 feiture to the United States.’’. 
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1 SEC. 3. STUDY BY INSTITUTE OF MEDICINE. 

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

3 Human Services (referred to in this section as the ‘‘Sec4 retary’’) shall request the Institute of Medicine to enter 

5 into an agreement with the Secretary under which such 

6 Institute conducts a study to—

7 (1) review the current state of knowledge about 

8 the biological properties of stem cells obtained from 

9 embryos, fetal tissues, and adult tissues; 

10 (2) evaluate the current state of knowledge 

11 about biological differences among stem cells ob12 tained from embryos, fetal tissues, and adult tissues 

13 and the consequences for research and medicine; and 

14 (3) assess what is currently known about the 

15 ability of stem cells to generate neurons, heart, kid16 ney, blood, liver and other tissues and the potential 

17 clinical uses of these tissues. 

18 (b) OTHER ENTITIES.—If the Institute of Medicine 

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

20 the Secretary shall enter into an agreement with another 

21 appropriate public or nonprofit private entity to conduct 

22 the study. 

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

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

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

26 and a report describing the findings made in the study 
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1 is submitted to the Committee on Energy and Commerce 

2 in the House of Representatives and the Committee on 

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

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