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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Human Cloning Ban 
and Stem Cell Research Protection Act of 2005’’. 
SEC. 2. PURPOSES. 
It is the purpose of this Act to prohibit human 
cloning and to protect important areas of medical re-
search, including stem cell research.
TITLE I—PROHIBITION ON 
HUMAN CLONING 
SEC. 101. PROHIBITION ON HUMAN CLONING. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) is amended by add-
ing at the end the following: 
‘‘CHAPTER X—PROHIBITION ON HUMAN 
CLONING 
‘‘SEC. 1001. PROHIBITION ON HUMAN CLONING. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) HUMAN
CLONING.—The term ‘human 
cloning’ means implanting or attempting to implant 
the product of nuclear transplantation into a uterus 
or the functional equivalent of a uterus. 
‘‘(2) 
HUMAN
SOMATIC
CELL.—The 
term 
‘human somatic cell’ means any human cell other 
than a haploid germ cell. 
‘‘(3) NUCLEAR TRANSPLANTATION.—The term 
‘nuclear transplantation’ means transferring the nu-
cleus of a human somatic cell into an oocyte from 
which the nucleus or all chromosomes have been or 
will be removed or rendered inert. 
‘‘(4) NUCLEUS.—The term ‘nucleus’ means the 
cell structure that houses the chromosomes.
‘‘(5) OOCYTE.—The term ‘oocyte’ means the fe-
male germ cell, the egg. 
‘‘(6) UNFERTILIZED
BLASTOCYST.—The term 
‘unfertilized blastocyst’ means an intact cellular 
structure that is the product of nuclear transplan-
tation. Such term shall not be construed to include 
any biological product derived from an intact cellular 
structure that is the product of nuclear transplan-
tation, including stem cells, other cells, and cellular 
structures. 
‘‘(b) PROHIBITIONS ON HUMAN CLONING.—It shall 
be unlawful for any person or other legal entity, public 
or private— 
‘‘(1) to conduct or attempt to conduct human 
cloning; 
‘‘(2) to ship the product of nuclear transplan-
tation in interstate or foreign commerce for the pur-
pose of human cloning in the United States or else-
where; or 
‘‘(3) to export to a foreign country an 
unfertilized blastocyst if such country does not pro-
hibit human cloning. 
‘‘(c) PROTECTION OF RESEARCH.—Nothing in this 
section shall be construed to restrict practices not ex-
pressly prohibited in this section.
‘‘(d) RIGHT OF ACTION.—Nothing in this section 
shall be construed to give any individual or person a pri-
vate right of action.’’. 
(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: 
‘‘(hh) The violation of paragraph (1), (2), or (3) of 
section 1001(b) (relating to human cloning).’’. 
(2) CRIMINAL PENALTIES.—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 per-
son who violates section 301(hh) shall be imprisoned 
not more than 10 years and fined in accordance with 
title 18, United States Code, or both.’’. 
(3) CIVIL PENALTIES.—Section 303 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 333) 
is amended by adding at the end: 
‘‘(g)(1) Any person who violates section 301(hh) shall 
be liable to the United States for a civil penalty in an 
amount not to exceed the greater of— 
‘‘(A) $10,000,000; or
‘‘(B) an amount equal to three times the 
amount of the gross pecuniary gain resulting from 
the violation. 
‘‘(2) Paragraphs (3) through (5) of subsection (f) 
apply with respect to a civil penalty under this subsection 
to the same extent and in the same manner as such para-
graphs (3) through (5) apply with respect to a civil penalty 
under subsection (f).’’. 
(4) FORFEITURE.—Section 303 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333), as 
amended by paragraph (3), is amended by adding at 
the end the following: 
‘‘(h) Any property, real or personal, derived from or 
used to commit a violation or attempted violation of sec-
tion 301(hh), or any property traceable to such property, 
shall be subject to forfeiture to the United States in ac-
cordance with the procedures set forth in chapter 46 of 
title 18, United States Code.’’. 
SEC. 102. OVERSIGHT REPORTS ON ACTIONS TO ENFORCE 
CERTAIN PROHIBITIONS. 
(a) REPORT ON ACTIONS BY SECRETARY OF HHS 
TO ENFORCE PROHIBITION ON HUMAN CLONING.—Not 
later than 1 year after the date of the enactment of this 
Act, the Secretary of Health and Human Services shall 
prepare and submit to the Committee on the Judiciary of
the Senate and the Committee on Energy and Commerce 
of the House of Representatives a report that— 
(1) describes the actions taken by the Secretary 
to enforce the provisions of chapter X of the Federal 
Food, Drug, and Cosmetic Act (as added by section 
101); 
(2) describes the personnel and resources the 
Secretary has utilized to enforce the provisions of 
such chapter; and 
(3) contains a list of violations, if any, of the 
provisions of such chapter. 
(b) REPORT ON COORDINATION OF ENFORCEMENT 
ACTIONS AMONG FEDERAL, STATE, AND LOCAL GOVERN-
MENTS WITH RESPECT TO HUMAN CLONING.— 
(1) REPORT.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary of 
Health and Human Services shall prepare and sub-
mit to the Committee on the Judiciary of the Senate 
and the Committee on Energy and Commerce of the 
House of Representatives a report that— 
(A) describes how the Secretary coordi-
nates the enforcement of violations of section 
301(hh) of the Federal Food, Drug, and Cos-
metic Act (as added by section 101) with en-
forcement actions taken by State or local gov-
ernment law enforcement officials with respect 
to similar State laws relating to human cloning; 
and 
(B) describes the status and disposition 
of— 
(i) Federal appellate litigation with re-
spect to such section 301(hh) and State 
appellate litigation with respect to similar 
State laws relating to human cloning; and 
(ii) civil litigation, including actions to 
appoint guardians, related to human 
cloning. 
(2) DEFINITION.—In this subsection, the term 
‘‘similar State law relating to human cloning’’ means 
a State or local law that provides for the imposition 
of criminal penalties on individuals who are deter-
mined to be conducting or attempting to conduct 
human cloning (as defined in section 1001 of the 
Federal Food, Drug, and Cosmetic Act (as added by 
section 101)). 
(c) REPORT ON INTERNATIONAL LAWS RELATING TO 
HUMAN CLONING.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall prepare and submit to the Congress 
a report that—
(1) describes the laws adopted by foreign coun-
tries related to human cloning; 
(2) describes the actions taken by the chief law 
enforcement officer in each foreign country that has 
enacted a law described in paragraph (1) to enforce 
such law; and 
(3) describes the multilateral efforts of the 
United Nations and elsewhere to ban human cloning. 
TITLE 
II—ETHICAL 
REQUIRE-
MENTS FOR NUCLEAR TRANS-
PLANTATION RESEARCH 
SEC. 201. ETHICAL REQUIREMENTS FOR NUCLEAR TRANS-
PLANTATION RESEARCH. 
Title IV of the Public Health Service Act (42 U.S.C. 
281 et seq.) is amended by adding at the end the fol-
lowing: 
‘‘PART J—ETHICAL REQUIREMENTS FOR 
NUCLEAR TRANSPLANTATION RESEARCH 
‘‘SEC. 
499A. 
ETHICAL 
REQUIREMENTS 
FOR 
NUCLEAR 
TRANSPLANTATION RESEARCH, INCLUDING 
INFORMED CONSENT, INSTITUTIONAL RE-
VIEW BOARD REVIEW, AND PROTECTION FOR 
SAFETY AND PRIVACY. 
‘‘(a) DEFINITIONS.—
‘‘(1) IN GENERAL.—The definitions contained 
in section 1001(a) of the Federal Food, Drug, and 
Cosmetic Act shall apply for purposes of this section. 
‘‘(2) OTHER DEFINITIONS.—In this section: 
‘‘(A) DONATING.—The term ‘donating’ 
means giving without receiving valuable consid-
eration. 
‘‘(B) FERTILIZATION.—The term ‘fertiliza-
tion’ means the fusion of an oocyte containing 
a haploid nucleus with a male gamete (sperm 
cell). 
‘‘(C) 
VALUABLE
CONSIDERATION.—The 
term ‘valuable consideration’ does not include 
reasonable payments— 
‘‘(i) associated with the transpor-
tation, processing, preservation, or storage 
of a human oocyte or of the product of nu-
clear transplantation research; or 
‘‘(ii) to compensate a donor of one or 
more human oocytes for the time or incon-
venience associated with such donation. 
‘‘(b) APPLICABILITY OF FEDERAL ETHICAL STAND-
ARDS TO NUCLEAR TRANSPLANTATION RESEARCH.—Re-
search involving nuclear transplantation shall be con-
ducted in accordance with subpart A of part 46 of title
45, or parts 50 and 56 of title 21, Code of Federal Regula-
tions (as in effect on the date of the enactment of the 
Human Cloning Ban and Stem Cell Research Protection 
Act of 2005), as applicable. 
‘‘(c) PROHIBITION
ON
CONDUCTING
NUCLEAR 
TRANSPLANTATION ON FERTILIZED EGGS.—A somatic 
cell nucleus shall not be transplanted into a human oocyte 
that has undergone or will undergo fertilization. 
‘‘(d) FOURTEEN-DAY RULE.—An unfertilized blasto-
cyst shall not be maintained more than 14 days from its 
first cell division, not counting any time during which it 
is stored at temperatures less than zero degrees centi-
grade. 
‘‘(e) VOLUNTARY DONATION OF OOCYTES.— 
‘‘(1) INFORMED CONSENT.—In accordance with 
subsection (b), an oocyte may not be used in nuclear 
transplantation research unless such oocyte shall 
have been donated voluntarily by and with the in-
formed consent of the woman donating the oocyte. 
‘‘(2) PROHIBITION ON PURCHASE OR SALE.— 
No human oocyte or unfertilized blastocyst may be 
acquired, received, or otherwise transferred for valu-
able consideration if the transfer affects interstate 
commerce.
‘‘(f) SEPARATION OF IN VITRO FERTILIZATION LAB-
ORATORIES
FROM
LOCATIONS
AT
WHICH
NUCLEAR 
TRANSPLANTATION IS CONDUCTED.—Nuclear transplan-
tation may not be conducted in the same laboratory or 
other physical facility in which human oocytes are subject 
to assisted reproductive technology treatments or proce-
dures. 
‘‘(g) CIVIL PENALTIES.—Whoever intentionally vio-
lates any provision of subsections (b) through (f) shall be 
subject to a civil penalty in an amount that is appropriate 
for the violation involved, but not more than $250,000.’’. 
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