II

Calendar No. 305

105TH CONGRESS

2D SESSION S. 1611

To amend the Public Health Service Act to prohibit any attempt to clone

a human being using somatic cell nuclear transfer and to prohibit the

use of Federal funds for such purposes, to provide for further review

of the ethical and scientific issues associated with the use of somatic

cell nuclear transfer in human beings, and for other purposes.

IN THE SENATE OF THE UNITED STATES

FEBRUARY 4, 1998

Mrs. FEINSTEIN (for herself and Mr. KENNEDY) introduced the following bill;

which was read the first time

FEBRUARY 5, 1998

Read the second time and placed on the calendar

A BILL

To amend the Public Health Service Act to prohibit any

attempt to clone a human being using somatic cell nuclear transfer and to prohibit the use of Federal funds

for such purposes, to provide for further review of the

ethical and scientific issues associated with the use of

somatic cell nuclear transfer in human beings, 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,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Prohibition on Cloning

3 of Human Beings Act of 1998’’.

4 SEC. 2. FINDINGS.

5 Congress finds that—

6 (1) it has been reported that an adult sheep has

7 been cloned using a technique called somatic cell nu8 clear transfer;

9 (2) the National Bioethics Advisory Commission

10 (referred to in this Act as the ‘‘NBAC’’) has re11 viewed the scientific and ethical implications of the

12 potential use of such technology to clone human

13 beings;

14 (3) the NBAC has determined that—

15 (A) somatic cell nuclear transfer tech16 nology may have many applications for bio17 technology, livestock productions, and new med18 ical approaches including the production of

19 pharmaceutical proteins and prospects for re20 pair, regeneration, or transplant of human tis21 sues or organs; and

22 (B) the possibility of using somatic cell nu23 clear transfer for the purposes of creating a

24 child entails significant scientific uncertainty

25 and medical risk, which could result in harm to

26 a child;
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1 (4) the NBAC concluded unanimously that at

2 this time it is morally unacceptable for anyone in the

3 public or private sector, whether in a research or

4 clinical setting, to attempt to create a child using so5 matic cell nuclear transfer-cloning;

6 (5) the consensus of the NBAC is based on cur7 rent scientific information indicating that this tech8 nique is not safe to use in humans at this time;

9 (6) in addition to issues of safety, the NBAC

10 identified many additional serious ethical concerns

11 which they agreed require a great deal more wide12 spread and careful public deliberation before this

13 technology may be used;

14 (7) the NBAC recommended a continuation of

15 the current moratorium on the use of Federal funds

16 to support any attempt to create a child by somatic

17 cell nuclear transfer, and an immediate request to

18 all firms, clinicians, investigators, and professional

19 societies to comply voluntarily with the intent of the

20 Federal moratorium;

21 (8) the NBAC further recommended that Fed22 eral legislation be enacted to prohibit anyone from

23 attempting, whether in a research or clinical setting,

24 to create a child through somatic cell nuclear trans25 fer cloning;
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1 (9) the NBAC also recommended that the

2 United States cooperate with other countries to en3 force mutually supported restrictions on this activity;

4 (10) the NBAC specified that such Federal leg5 islation should include a sunset provision and that,

6 prior to the sunset date, an oversight body should

7 review and report on the status of somatic cell nu8 clear transfer technology and the ethical and social

9 issues associated with its use and recommend wheth10 er the prohibition should be continued;

11 (11) the NBAC concluded that any regulatory

12 or legislative actions undertaken to effect the fore13 going prohibition should be carefully written so as

14 not to interfere with other important areas of re15 search, such as the cloning of human DNA se16 quences and cells, which raise neither the scientific

17 nor the ethical issues that arise from the possible

18 creation of children through somatic cell nuclear

19 transfer techniques;

20 (12) the NBAC also found that cloning animals

21 by somatic cell nuclear transfer does not raise the

22 same issues implicated in attempting to use the

23 technique to create a child, and its continuation

24 should only be subject to existing regulations regard25 ing the humane use of animals; and
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1 (13)(A) biomedical research facilities, including

2 those conducting cloning, and reproductive services

3 facilities engage in and affect interstate commerce;

4 (B) the products of biomedical research, includ5 ing cloning, and the services provided by reproduc6 tive services facilities move in interstate commerce;

7 (C) patients travel regularly across State lines

8 in order to access reproductive services facilities; and

9 (D) biomedical research facilities, including

10 those conducting cloning, and reproductive services

11 facilities engage scientists, doctors, and other staff

12 in an interstate market, and contract for research

13 and purchase medical and other supplies in an inter14 state market.

15 SEC. 3. PURPOSES.

16 It is the purpose of this Act to—

17 (1) prohibit any attempt, in this country or

18 elsewhere, to clone a human being, that is, to use

19 the product of somatic cell nuclear transfer to create

20 a human being genetically identical to an existing or

21 deceased human being;

22 (2) prohibit the use of Federal funds for any of

23 the activities described in paragraph (1); and
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1 (3) provide for further review of the ethical and

2 scientific issues associated with the use of somatic

3 cell nuclear transfer in humans.

4 SEC. 4. AMENDMENT TO THE PUBLIC HEALTH SERVICE

5 ACT.

6 Part H of title IV of the Public Health Service Act

7 (42 U.S.C. 289 et seq.) is amended by adding at the end

8 the following:

9 ‘‘SEC. 498C. PROHIBITION ON CLONING.

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

11 ‘‘(1) CLONING.—The term ‘cloning’ means the

12 production of a precise genetic copy of a molecule

13 (including DNA), cell, tissue, organ, plant, animal,

14 or human.

15 ‘‘(2) NUCLEUS.—The term ‘nucleus’ means the

16 cell structure that houses the chromosomes, and

17 thus the genes.

18 ‘‘(3) OOCYTE.—The term ‘oocyte’ means the fe19 male germ cell, the egg.

20 ‘‘(4) SOMATIC CELL.—The term ‘somatic cell’

21 means a mature, diploid cell.

22 ‘‘(5) SOMATIC CELL NUCLEAR TRANSFER.—The

23 term ‘somatic cell nuclear transfer’ means transfer24 ring the nucleus of a somatic cell of an existing or

25 deceased human child or adult into an oocyte from
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1 which the nucleus or all chromosomes have been or

2 will be removed or rendered inert.

3 ‘‘(b) PROHIBITIONS.—It shall be unlawful for any

4 person or other legal entity, public or private—

5 ‘‘(1) to implant or attempt to implant the prod6 uct of somatic cell nuclear transfer into a woman’s

7 uterus;

8 ‘‘(2) to ship the product of somatic cell nuclear

9 transfer in interstate or foreign commerce for the

10 purpose of implanting the product of somatic cell

11 nuclear transfer into a woman’s uterus, in the

12 United States or elsewhere; or

13 ‘‘(3) to use funds made available under this

14 Act, or any other Act, for an activity prohibited

15 under paragraph (1) or (2).

16 ‘‘(c) PROTECTED RESEARCH AND PRACTICES.—

17 Nothing in this section shall be construed to restrict areas

18 of biomedical and agricultural research or practices not

19 expressly prohibited in this section, including research or

20 practices that involve the use of—

21 ‘‘(1) somatic cell nuclear transfer or other

22 cloning technologies to clone molecules, DNA, cells,

23 and tissues;

24 ‘‘(2) mitochondrial, cytoplasmic or gene ther25 apy; or
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1 ‘‘(3) somatic cell nuclear transfer techniques to

2 create nonhuman animals.

3 ‘‘(d) NATIONAL BIOETHICS ADVISORY COMMISSION

4 REPORT.—

‘‘(1) IN GENERAL.—Not later than 41 5 ⁄2 years,

and subsequently, 91 6 ⁄2 years, after the date of enact7 ment of this section, the National Bioethics Advisory

8 Commission shall prepare and submit to the Presi9 dent and Congress a report concerning—

10 ‘‘(A) the state of the science of cloning and

11 relevant developments in cell biology;

12 ‘‘(B) the ethical and social issues associ13 ated with the potential use of this technology in

14 humans; and

15 ‘‘(C) the advisability of continuing the pro16 hibition established under this section.

17 ‘‘(2) OTHER REPORTS.—The National Bioethics

18 Advisory Commission may produce reports in addi19 tion to the reports required under paragraph (1) if

20 the Commission determines that such reports are

21 useful to clarify any of the topics described in para22 graph (1), address changes in the state of science or

23 society, or modify or clarify the recommendations of

24 the Commission.
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1 ‘‘(3) CONTINUATION OF COMMISSION.—The

2 National Bioethics Advisory Commission is author3 ized to continue for the 10-year period described in

4 subsection (i) to prepare reports under this section

5 and for other purposes as established in Executive

6 Order 12975 and subsequent amendments to such

7 Order. This paragraph shall be construed to super8 sede the termination and chartering provisions of

9 section 14 of the Federal Advisory Committee Act

10 (5 U.S.C. App 2).

11 ‘‘(e) PENALTIES.—

12 ‘‘(1) IN GENERAL.—Any person who inten13 tionally violates the provisions of subsection (b) shall

14 be fined the greater of $1,000,000 or 3 times the

15 gross pecuniary gain or loss resulting from the viola16 tion.

17 ‘‘(2) CIVIL ACTIONS.—If a person is violating

18 or about to violate the provisions of subsection (b),

19 the Attorney General may commence a civil action in

20 an appropriate Federal district court to enjoin such

21 violation.

22 ‘‘(3) FORFEITURE.—Any property, real or per23 sonal, derived from or used to commit a violation or

24 attempted violation of the provisions of subsection

25 (b), or any property traceable to such property, shall
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1 be subject to forfeiture to the United States in ac2 cordance with the procedures set forth in chapter 46

3 of title 18, United States Code.

4 ‘‘(4) AUTHORITY.—The Attorney General shall

5 have exclusive, nondelegable enforcement authority

6 under this section.

7 ‘‘(5) ADVISORY OPINIONS.—The Attorney Gen8 eral shall, upon request, render binding advisory

9 opinions regarding the scope, applicability, interpre10 tation, and enforcement of this section with regard

11 to specific research projects or practices.

12 ‘‘(f) COOPERATION WITH FOREIGN COUNTRIES.—It

13 is the sense of Congress that the President should cooper14 ate with foreign countries to enforce mutually supported

15 restrictions on the activities prohibited under subsection

16 (b).

17 ‘‘(g) RIGHT OF ACTION.—Nothing in this section

18 shall be construed to give any individual or person a pri19 vate right of action.

20 ‘‘(h) PREEMPTION OF STATE LAW.—The provisions

21 of this section shall preempt any State or local law that

22 prohibits or restricts research regarding, or practices con23 stituting, somatic cell nuclear transfer, mitochondrial or

24 cytoplasmic therapy, or the cloning of molecules, DNA,

25 cells, tissues, organs, plants, animals, or humans.
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1 ‘‘(i) EFFECTIVE DATE.—This section shall be effec2 tive for the 10-year period beginning on the date of enact3 ment of this section. The prohibitions contained in this

4 section shall terminate at the expiration of such 10-year

5 period.’’.
Calendar No. 305

105TH CONGRESS

2D SESSION S. 1611

A BILL

To amend the Public Health Service Act to prohibit

other purposes.cell nuclear transfer in human beings, and forentific issues associated with the use of somaticvide for further review of the ethical and sciuse of Federal funds for such purposes, to promatic cell nuclear transfer and to prohibit theany attempt to clone a human being using soFEBRUARY 5, 1998

Read the second time and placed on the calendar