19–008

108TH CONGRESS REPORT " HOUSE OF REPRESENTATIVES ! 1st Session 108–21

PROVIDING FOR CONSIDERATION OF H.R. 534, HUMAN 

CLONING PROHIBITION ACT OF 2003

FEBRUARY 26, 2003.—Referred to the House Calendar and ordered to be printed 

Mrs. MYRICK, from the Committee on Rules, 

submitted the following 

R E P O R T 

[To accompany H. Res. 105]

The Committee on Rules, having had under consideration House 

Resolution 105, by a nonrecord vote, report the same to the House 

with the recommendation that the resolution be adopted. 

SUMMARY OF PROVISIONS OF THE RESOLUTION

The resolution provides for consideration of H.R. 534, the Human 

Cloning Prohibition Act of 2003, under a structured rule. The rule 

provides one hour of general debate, equally divided and controlled 

by the chairman and ranking minority member of the Committee 

on the Judiciary. The rule waives all points of order against consideration of the bill. 

The rule makes in order only those amendments printed in this 

report. The rule provides that amendments may be offered only in 

the order printed in this report, may be offered only by a Member 

designated in this report, shall be considered as read, shall be debatable for a time specified in this report equally divided and controlled by the proponent and an opponent, and shall not be subject 

to amendment. The rule waives all points of order against the 

amendments. The rule waives all points of order against the 

amendments. Finally, the rule provides one motion to recommit 

with or without instructions. 

The waiver of all points of order against consideration of the bill 

in the rule includes a waiver of clause 4(a) of rule XIII (requiring 

a three-day layover of the committee report), which is needed because the committee report was not filed until Tuesday, February 

25, 2003 and the bill may be considered by the House as early as 

Thursday, February 27, 2003. 

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COMMITTEE VOTES

Pursuant to clause 3(b) of House rule XIII the results of each 

record vote on an amendment or motion to report, together with 

the names of those voting for and against, are printed below: 

Rules Committee record vote No. 3

Date: February 26, 2003. 

Measure: H.R. 534. 

Motion by: Mr. Frost. 

Summary of motion: To make in order the amendment offered by 

Representative Lofgren to provide an exemption for stem cell research for the purpose of therapeutic research to treat Parkinson’s 

disease, Alzheimer’s disease, diabetes, cancer, heart disease, spinal 

cord injury, multiple sclerosis, severe burns, or other diseases. 

Results: Defeated 3 to 7. 

Vote by Members: Goss—Nay; Pryce—Nay; Hastings (WA)—Nay; 

Myrick—Nay; Sessions—Nay; Reynolds—Nay; Frost—Yea; Slaughter—Yea; McGovern—Yea; Dreier—Nay.

Rules Committee record vote No. 4

Date: February 26, 2003. 

Measure: H.R. 534. 

Motion by: Mrs. Slaughter. 

Summary of motion: To make in order the amendment offered by 

Representative Scott to provide an exemption to allow the shipping, 

receipt, or importation for use in medical treatment of any product 

derived from an embryo (including pluripotent stem cells) if such 

product is unable to develop into a full human being. 

Results: Defeated 3 to 7. 

Vote by Members: Goss—Nay; Pryce—Nay; Hastings (WA)—Nay; 

Myrick—Nay; Sessions—Nay; Reynolds—Nay; Frost—Yea; Slaughter—Yea; McGovern—Yea; Dreier—Nay. 

Rules Committee record vote No. 5

Date: February 26, 2003. 

Measure: H.R. 534. 

Motion by: Mr. McGovern. 

Summary of motion: To make in order the amendment offered by 

Representatives Jackson-Lee and Nadler to provide an exemption 

to allow for the transfer of nuclei from somatic cells into 

unfertilized eggs to derive embryonic stem cells for the purpose of 

creating genetically diverse embryonic stem cell lines. 

Results: Defeated 3 to 7. 

Vote by Members: Goss—Nay; Pryce—Nay; Hastings (WA)—Nay; 

Myrick—Nay; Sessions—Nay; Reynolds—Nay; Frost—Yea; Slaughter—Yea; McGovern—Yea; Dreier—Nay.

Rules Committee record vote No. 6

Date: February 26, 2003. 

Measure: H.R. 534. 

Motion by: Mr. McGovern. 

Summary of motion: To make in order the amendment offered by 

Representative Wu to repeal the ban on human cloning five years 

after its enactment. 

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Results: Defeated 3 to 7. 

Vote by Members: Goss—Nay; Pryce—Nay; Hastings (WA)—Nay; 

Myrick—Nay; Sessions—Nay; Reynolds—Nay; Frost—Yea; Slaughter—Yea; McGovern—Yea; Dreier—Nay. 

SUMMARY OF AMENDMENTS MADE IN ORDER UNDER THE RULE

(Summaries derived from information provided by sponsors.) 

1. Scott—Provides for a study by the General Accounting Office 

(GAO) to assess the need (if any) for amendment of the prohibition 

on human cloning. GAO must report its finding to Congress within 

2 years. (10 minutes) 

2. Stearns—Expresses the Sense of the Congress that other nations should establish equivalent prohibitions on cloning. (10 minutes) 

3. Greenwood/Deutsch/DeGette/Kirk/Eshoo/Schiff—Substitute. 

Defines human somatic cell nuclear transfer with the intent to initiate a pregnancy as a criminal act subject to criminal and civil 

penalties. Makes it illegal to ship or transport the products of 

human somatic cell nuclear transfer if the products will be used to 

initiate a pregnancy. Criminal penalties include imprisonment of 

up to 10 years. Civil penalties include fines up to $10,000,000 or 

2 times the pecuniary gain from cloning. Provides for forfeiture of 

equipment, other property and any monetary gains from human 

cloning. Requires all individuals or companies who plan to perform 

human somatic cell nuclear transfer to register with the Food and 

Drug Administration. Requires all research be conducted with Institutional Review Board oversight and with informed consent of 

the donors of the cells to be used. Protects other uses of somatic 

cell nuclear transfer (including cloning of molecules, DNA, cells, or 

tissues). Protects 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. Requires a study 

by the Institute of Medicine on the properties of embryonic, fetal 

and adult stem cells. Preempts future state laws that are different 

from the federal cloning law or prohibit protected types of research. 

Sunsets 10 years after enactment. (60 minutes) 

TEXT OF AMENDMENTS MADE IN ORDER UNDER THE RULE

1. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE SCOTT OF

VIRGINIA, OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES

Add at the end of the bill the following:

SEC. 3. STUDY BY THE GENERAL ACCOUNTING OFFICE. 

(a) IN GENERAL.—The General Accounting Office shall conduct a 

study to assess the need (if any) for amendment of the prohibition 

on human cloning, as defined in section 301 of title 18, United 

States Code, as added by this Act, which study should include—

(1) a discussion of new developments in medical technology 

concerning human cloning and somatic cell nuclear transfer, 

the need (if any) for somatic cell nuclear transfer to produce 

medical advances, current public attitudes and prevailing ethical views concerning the use of somatic cell nuclear transfer, 

and potential legal implications of research in somatic cell nuclear transfer; and 

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(2) a review of any technological developments that may require that technical changes be made to section 2 of this Act. 

(b) REPORT.—The General Accounting Office shall transmit to the 

Congress, within 2 years after the date of enactment of this Act, 

a report containing the findings and conclusions of its study, together with recommendations for any legislation or administrative 

actions which in considers appropriate. 

2. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE STEARNS

OF FLORIDA, OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES

Add at the end the following: 

SEC. . SENSE OF CONGRESS. 

It is the sense of the Congress that each foreign country should 

establish a prohibition substantially equivalent to the prohibition 

established by the amendments made by this Act. 

3. AN AMENDMENT IN THE NATURE OF A SUBSTITUTE TO BE OFFERED BY REPRESENTATIVE GREENWOOD OF PENNSYLVANIA, OR

HIS DESIGNEE, DEBATABLE FOR 60 MINUTES

Strike all after the enacting clause and insert the following:

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Cloning Prohibition Act of 2003’’. 

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, or the product of such technology, to 

initiate a pregnancy or with the intent to initiate a pregnancy; or ‘‘(B) to ship, mail, transport, or receive the product of 

such 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 nuclear material of a human somatic cell into an 

egg cell from which the nuclear material 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 (excluding those using human somatic cell nuclear transVerDate Dec 13 2002 05:04 Feb 27, 2003 Jkt 019008 PO 00000 Frm 00004 Fmt 6659 Sfmt 6602 E:\HR\OC\HR021.XXX HR021
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fer or the product thereof) 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). 

‘‘(c) REGISTRATION.—

‘‘(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 2003, 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 BY RESEARCHER.—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) APPLICABILITY OF HUMAN SUBJECT PROTECTION STANDARDS.—

‘‘(1) IN GENERAL.—Research involving human somatic cell 

nuclear transfer technology shall be conducted in accordance 

with parts 50 and 56 of title 21, Code of Federal Regulations, 

subject to paragraph (2). Individuals whose cells are used for 

such research shall be considered human subjects for purposes 

of such parts. 

‘‘(2) INFORMED CONSENT.—

‘‘(A) DONOR OF HUMAN CELLS.—In research involving 

human somatic cell nuclear transfer technology, human 

cells may be used only if, in addition to requirements that 

apply under parts 50 and 56 of title 21, Code of Federal 

Regulations, the individual who provides the cells makes 

a statement in writing, which is signed by the individual, 

declaring that—

‘‘(i) the individual donates the cells for purposes of 

such research; 

‘‘(ii) the individual understands that Federal law 

regulates such technology and establishes a crime relating to the use of the technology to initiate a pregnancy; and 

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‘‘(iii) the individual does not intend for the cells to 

be used to initiate a pregnancy. 

‘‘(B) ATTESTATION BY RESEARCHERS.—In research involving human somatic cell nuclear transfer technology, 

human cells may be used only if, in addition to requirements that apply under parts 50 and 56 of title 21, Code 

of Federal Regulations, the individual with the principal 

responsibility for conducting the research makes a statement in writing, which is signed by the individual, declaring that the consent of the donor of the cells for the cells 

to be used in such research was obtained in accordance 

with this subsection. 

‘‘(e) 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 2003. 

‘‘(f) RIGHT OF ACTION.—This section may not be construed as establishing any private right of action. 

‘‘(g) DEFINITION.—For purposes of this section, the term ‘person’

includes governmental entities. 

‘‘(h) SUNSET.—This section and section 301(hh) 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 2003.’’. 

(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 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(hh) shall be imprisoned not more than 10 years or fined 

in accordance with title 18, United States Code, or both.’’. 

(3) CIVIL PENALTIES.—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(hh) or section 1001(d) 

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 

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‘‘(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 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 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(hh), 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.

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