I 

109TH CONGRESS 

1ST SESSION H. R. 1822 

To prohibit human cloning and protect stem cell research. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 26, 2005 

Mrs. BONO (for herself, Ms. DEGETTE, Mr. CASTLE, Mr. MARKEY, and Mr. 

BASS) introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL 

To prohibit human cloning and protect stem cell research. 

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 ‘‘Human Cloning Ban 

5 and Stem Cell Research Protection Act of 2005’’. 

6 SEC. 2. PURPOSES. 

7 It is the purpose of this Act to prohibit human 

8 cloning and to protect important areas of medical re9 search, including stem cell research. 
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1 TITLE I—PROHIBITION ON 

2 HUMAN CLONING 

3 SEC. 101. PROHIBITION ON HUMAN CLONING. 

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

5 Cosmetic Act (21 U.S.C. 301 et seq.) is amended by add6 ing at the end the following: 

7 ‘‘CHAPTER X—PROHIBITION ON HUMAN 

8 CLONING 

9 ‘‘SEC. 1001. PROHIBITION ON HUMAN CLONING. 

10 ‘‘(a) DEFINITIONS.—In this section: 

11 ‘‘(1) HUMAN CLONING.—The term ‘human 

12 cloning’ means implanting or attempting to implant 

13 the product of nuclear transplantation into a uterus 

14 or the functional equivalent of a uterus. 

15 ‘‘(2) HUMAN SOMATIC CELL.—The term 

16 ‘human somatic cell’ means any human cell other 

17 than a haploid germ cell. 

18 ‘‘(3) NUCLEAR TRANSPLANTATION.—The term 

19 ‘nuclear transplantation’ means transferring the nu20 cleus of a human somatic cell into an oocyte from 

21 which the nucleus or all chromosomes have been or 

22 will be removed or rendered inert. 

23 ‘‘(4) NUCLEUS.—The term ‘nucleus’ means the 

24 cell structure that houses the chromosomes. 
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1 ‘‘(5) OOCYTE.—The term ‘oocyte’ means the fe2 male germ cell, the egg. 

3 ‘‘(6) UNFERTILIZED BLASTOCYST.—The term 

4 ‘unfertilized blastocyst’ means an intact cellular 

5 structure that is the product of nuclear transplan6 tation. Such term shall not be construed to include 

7 any biological product derived from an intact cellular 

8 structure that is the product of nuclear transplan9 tation, including stem cells, other cells, and cellular 

10 structures. 

11 ‘‘(b) PROHIBITIONS ON HUMAN CLONING.—It shall 

12 be unlawful for any person or other legal entity, public 

13 or private— 

14 ‘‘(1) to conduct or attempt to conduct human 

15 cloning; 

16 ‘‘(2) to ship the product of nuclear transplan17 tation in interstate or foreign commerce for the pur18 pose of human cloning in the United States or else19 where; or 

20 ‘‘(3) to export to a foreign country an 

21 unfertilized blastocyst if such country does not pro22 hibit human cloning. 

23 ‘‘(c) PROTECTION OF RESEARCH.—Nothing in this 

24 section shall be construed to restrict practices not ex25 pressly prohibited in this section. 
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1 ‘‘(d) RIGHT OF ACTION.—Nothing in this section 

2 shall be construed to give any individual or person a pri3 vate right of action.’’. 

4 (b) PROHIBITED ACTS.— 

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

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

7 amended by adding at the end the following: 

8 ‘‘(hh) The violation of paragraph (1), (2), or (3) of 

9 section 1001(b) (relating to human cloning).’’. 

10 (2) CRIMINAL PENALTIES.—Section 303(b) of 

11 the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 333(b)) is amended by adding at the end the 

13 following: 

14 ‘‘(7) Notwithstanding subsection (a), any per15 son who violates section 301(hh) shall be imprisoned 

16 not more than 10 years and fined in accordance with 

17 title 18, United States Code, or both.’’. 

18 (3) CIVIL PENALTIES.—Section 303 of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333) 

20 is amended by adding at the end: 

21 ‘‘(g)(1) Any person who violates section 301(hh) shall 

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

23 amount not to exceed the greater of— 

24 ‘‘(A) $10,000,000; or 
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1 ‘‘(B) an amount equal to three times the 

2 amount of the gross pecuniary gain resulting from 

3 the violation. 

4 ‘‘(2) Paragraphs (3) through (5) of subsection (f) 

5 apply with respect to a civil penalty under this subsection 

6 to the same extent and in the same manner as such para7 graphs (3) through (5) apply with respect to a civil penalty 

8 under subsection (f).’’. 

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

10 Food, Drug, and Cosmetic Act (21 U.S.C. 333), as 

11 amended by paragraph (3), is amended by adding at 

12 the end the following: 

13 ‘‘(h) Any property, real or personal, derived from or 

14 used to commit a violation or attempted violation of sec15 tion 301(hh), or any property traceable to such property, 

16 shall be subject to forfeiture to the United States in ac17 cordance with the procedures set forth in chapter 46 of 

18 title 18, United States Code.’’. 

19 SEC. 102. OVERSIGHT REPORTS ON ACTIONS TO ENFORCE 

20 CERTAIN PROHIBITIONS. 

21 (a) REPORT ON ACTIONS BY SECRETARY OF HHS 

22 TO ENFORCE PROHIBITION ON HUMAN CLONING.—Not 

23 later than 1 year after the date of the enactment of this 

24 Act, the Secretary of Health and Human Services shall 

25 prepare and submit to the Committee on the Judiciary of 
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1 the Senate and the Committee on Energy and Commerce 

2 of the House of Representatives a report that— 

3 (1) describes the actions taken by the Secretary 

4 to enforce the provisions of chapter X of the Federal 

5 Food, Drug, and Cosmetic Act (as added by section 

6 101); 

7 (2) describes the personnel and resources the 

8 Secretary has utilized to enforce the provisions of 

9 such chapter; and 

10 (3) contains a list of violations, if any, of the 

11 provisions of such chapter. 

12 (b) REPORT ON COORDINATION OF ENFORCEMENT

13 ACTIONS AMONG FEDERAL, STATE, AND LOCAL GOVERN14 MENTS WITH RESPECT TO HUMAN CLONING.— 

15 (1) REPORT.—Not later than 1 year after the 

16 date of the enactment of this Act, the Secretary of 

17 Health and Human Services shall prepare and sub18 mit to the Committee on the Judiciary of the Senate 

19 and the Committee on Energy and Commerce of the 

20 House of Representatives a report that— 

21 (A) describes how the Secretary coordi22 nates the enforcement of violations of section 

23 301(hh) of the Federal Food, Drug, and Cos24 metic Act (as added by section 101) with en25 forcement actions taken by State or local gov-
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1 ernment law enforcement officials with respect 

2 to similar State laws relating to human cloning; 

3 and 

4 (B) describes the status and disposition 

5 of— 

6 (i) Federal appellate litigation with re7 spect to such section 301(hh) and State 

8 appellate litigation with respect to similar 

9 State laws relating to human cloning; and 

10 (ii) civil litigation, including actions to 

11 appoint guardians, related to human 

12 cloning. 

13 (2) DEFINITION.—In this subsection, the term 

14 ‘‘similar State law relating to human cloning’’ means 

15 a State or local law that provides for the imposition 

16 of criminal penalties on individuals who are deter17 mined to be conducting or attempting to conduct 

18 human cloning (as defined in section 1001 of the 

19 Federal Food, Drug, and Cosmetic Act (as added by 

20 section 101)). 

21 (c) REPORT ON INTERNATIONAL LAWS RELATING TO

22 HUMAN CLONING.—Not later than 1 year after the date 

23 of the enactment of this Act, the Secretary of Health and 

24 Human Services shall prepare and submit to the Congress 

25 a report that— 
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1 (1) describes the laws adopted by foreign coun2 tries related to human cloning; 

3 (2) describes the actions taken by the chief law 

4 enforcement officer in each foreign country that has 

5 enacted a law described in paragraph (1) to enforce 

6 such law; and 

7 (3) describes the multilateral efforts of the 

8 United Nations and elsewhere to ban human cloning. 

9 TITLE II—ETHICAL REQUIRE10 MENTS FOR NUCLEAR TRANS11 PLANTATION RESEARCH 

12 SEC. 201. ETHICAL REQUIREMENTS FOR NUCLEAR TRANS13 PLANTATION RESEARCH. 

14 Title IV of the Public Health Service Act (42 U.S.C. 

15 281 et seq.) is amended by adding at the end the fol16 lowing: 

17 ‘‘PART J—ETHICAL REQUIREMENTS FOR 

18 NUCLEAR TRANSPLANTATION RESEARCH 

19 ‘‘SEC. 499A. ETHICAL REQUIREMENTS FOR NUCLEAR 

20 TRANSPLANTATION RESEARCH, INCLUDING 

21 INFORMED CONSENT, INSTITUTIONAL RE22 VIEW BOARD REVIEW, AND PROTECTION FOR 

23 SAFETY AND PRIVACY. 

24 ‘‘(a) DEFINITIONS.— 
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1 ‘‘(1) IN GENERAL.—The definitions contained 

2 in section 1001(a) of the Federal Food, Drug, and 

3 Cosmetic Act shall apply for purposes of this section. 

4 ‘‘(2) OTHER DEFINITIONS.—In this section: 

5 ‘‘(A) DONATING.—The term ‘donating’ 

6 means giving without receiving valuable consid7 eration. 

8 ‘‘(B) FERTILIZATION.—The term ‘fertiliza9 tion’ means the fusion of an oocyte containing 

10 a haploid nucleus with a male gamete (sperm 

11 cell). 

12 ‘‘(C) VALUABLE CONSIDERATION.—The 

13 term ‘valuable consideration’ does not include 

14 reasonable payments— 

15 ‘‘(i) associated with the transpor16 tation, processing, preservation, or storage 

17 of a human oocyte or of the product of nu18 clear transplantation research; or 

19 ‘‘(ii) to compensate a donor of one or 

20 more human oocytes for the time or incon21 venience associated with such donation. 

22 ‘‘(b) APPLICABILITY OF FEDERAL ETHICAL STAND23 ARDS TO NUCLEAR TRANSPLANTATION RESEARCH.—Re24 search involving nuclear transplantation shall be con25 ducted in accordance with subpart A of part 46 of title 
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1 45, or parts 50 and 56 of title 21, Code of Federal Regula2 tions (as in effect on the date of the enactment of the 

3 Human Cloning Ban and Stem Cell Research Protection 

4 Act of 2005), as applicable. 

5 ‘‘(c) PROHIBITION ON CONDUCTING NUCLEAR

6 TRANSPLANTATION ON FERTILIZED EGGS.—A somatic 

7 cell nucleus shall not be transplanted into a human oocyte 

8 that has undergone or will undergo fertilization. 

9 ‘‘(d) FOURTEEN-DAY RULE.—An unfertilized blasto10 cyst shall not be maintained more than 14 days from its 

11 first cell division, not counting any time during which it 

12 is stored at temperatures less than zero degrees centi13 grade. 

14 ‘‘(e) VOLUNTARY DONATION OF OOCYTES.— 

15 ‘‘(1) INFORMED CONSENT.—In accordance with 

16 subsection (b), an oocyte may not be used in nuclear 

17 transplantation research unless such oocyte shall 

18 have been donated voluntarily by and with the in19 formed consent of the woman donating the oocyte. 

20 ‘‘(2) PROHIBITION ON PURCHASE OR SALE.— 

21 No human oocyte or unfertilized blastocyst may be 

22 acquired, received, or otherwise transferred for valu23 able consideration if the transfer affects interstate 

24 commerce. 
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1 ‘‘(f) SEPARATION OF IN VITRO FERTILIZATION LAB2 ORATORIES FROM LOCATIONS AT WHICH NUCLEAR

3 TRANSPLANTATION IS CONDUCTED.—Nuclear transplan4 tation may not be conducted in the same laboratory or 

5 other physical facility in which human oocytes are subject 

6 to assisted reproductive technology treatments or proce7 dures. 

8 ‘‘(g) CIVIL PENALTIES.—Whoever intentionally vio9 lates any provision of subsections (b) through (f) shall be 

10 subject to a civil penalty in an amount that is appropriate 

11 for the violation involved, but not more than $250,000.’’. 

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