107th Congress

Cloning

H.R. 1260, H.R. 1372, H.R. 1608, H.R. 1644/S. 790, H.R. 2172, H.R. 2505/S. 1899, H.R. 2608, S. 704, S. 1758, S. 1893, S. 2076, and S. 2439

Background

The controversial issue of human cloning attracted considerable congressional and media interest during the 107th Congress. Although the House passed a broad ban on all forms of human cloning, the Senate failed to act, leaving the matter to the 108th Congress to resolve. Interest in the issue began almost immediately at the beginning of the 107th Congress, with independent announcements by two scientists and a religious cult leader that they were working on the technology to clone humans. In addition, efforts reported later by a small biotechnology company, Advanced Cell Technology (ACT), to clone embryos from which to derive stem cells, galvanized opposition to cloning technology and led to the House passage of a measure that would criminalize both reproductive and therapeutic cloning. The debate centered on whether to legislatively ban reproductive cloning and/or therapeutic cloning.

Reproductive cloning is generally defined as the use of cloning technology, otherwise called somatic cell nuclear transfer (SCNT), for initiating a pregnancy; therapeutic cloning is generally defined as the use of SCNT for conducting research. SCNT is generally defined as transferring the nucleus of a human somatic cell (any cell other than an egg cell) into an egg cell from which the nucleus has been removed or rendered inert. Although most advocates and Members of Congress are opposed to reproductive cloning, there is considerable disagreement regarding therapeutic cloning. Proponents of therapeutic cloning argue that it may be one way of minimizing the immune rejection problem that can result if the existing stem cell lines are used for clinical purposes. Therapeutic cloning would permit stem cells to be generated using a patient's own DNA. Opponents argue that the moral and ethical issues related to creating an embryo solely for research purposes and subsequently destroying it to extract stem cells justify a ban on this technology.

The House held four hearings on this issue: the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on March 28, 2001; the House Judiciary Subcommittee on Crime held a hearing on June 19; and the House Energy and Commerce Subcommittee on Health held a hearing on June 20. On July 31, with strong support from the Administration, the House passed H.R. 2505 (265 to 162), a bill that would criminalize both therapeutic and reproductive cloning. Although it had already passed a bill on this topic, the House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources (Representative Mark Souder [R-IN], Chairman) held a hearing on May 15, 2002.

Activity on this issue in the Senate lay dormant during the fall of 2001, eclipsed by action regarding the President's stem cell announcement on August 9, 2001. However, a November 25 announcement by ACT that it had succeeded in preliminary attempts to clone a human embryo to extract stem cells rekindled concerns related to human cloning. This culminated in an effort by Senator Sam Brownback (R-KS) to attach an amendment requiring a 6-month moratorium on all types of cloning to H.R. 10, the Comprehensive Retirement Security and Pension Reform Act of 2001. To avoid derailing debate on this legislation, the Senate Majority Leader promised to bring a freestanding cloning bill to the Senate Floor in spring 2002. The primary cloning bills pending in the Senate during the 107th Congress were S. 1899 (companion to the House-passed bill, H.R. 2505), introduced by Senator Brownback, to prohibit all forms of human cloning, and S. 2439, introduced by Senator Arlen Specter (R-PA), to prohibit reproductive cloning only.

On June 12, 2002, negotiations to bring such a bill to the floor collapsed when Senator Brownback rejected an offer by the Senate Majority Leader to consider cloning legislation without any amendments. Senator Brownback then attempted to attach an amendment to S. 2600, the Terrorism Risk Insurance Act of 2002, to prohibit the patenting of cloned human embryos or human cloning processes. The amendment would have precluded patents from being granted for 1) an organism of the human species at any stage of development, 2) a living organism made by human cloning, or 3) a process of human cloning. The Senate voted 65 to 31 to invoke cloture on S. 2600, thereby prohibiting consideration of nongermane amendments, including Senator Brownback's amendment.

Although the Senate failed to act on cloning legislation during the 107th Congress, it held several important hearings on this topic. On December 4, 2001, the Senate Appropriations Subcommittee on Labor, Health and Human Services (HHS) and Education (Senator Tom Harkin [D-IA], Chairman) held a hearing to discuss the announcement by ACT and the relationship between cloning and stem cell research. On February 5, 2002, the Senate Judiciary Committee (Senator Patrick J. Leahy [D-VT], Chairman) held a hearing on cloning. On March 5, the Senate Health, Education, Labor and Pensions Committee (Senator Edward M. Kennedy [D-MA], Chairman) held a hearing on cloning. On March 12, the Senate Appropriations Subcommittee on Labor, HHS and Education held a hearing on cloning.

While it may not influence legislative activities, it is important to note that the President's Council on Bioethics has issued recommendations on cloning. On January 17, 2002, the President's Council on Bioethics, chaired by Professor Leon Kass, met for the first time and agreed to consider cloning as its first order of business. On July 10, the Council presented its cloning report to the President. The Council was unanimous in recommending a permanent ban on reproductive cloning. It was split, however, in its recommendations regarding therapeutic cloning. Ten members of the Council recommended a 4-year moratorium on therapeutic cloning, allowing time for further review and "democratic deliberation" of the issue. Seven members of the Council recommended in favor of therapeutic cloning, as long as standards are developed for the regulation of such research.

Provisions of the Legislation/Impact on NIH

Twelve different cloning bills were introduced during the the 107th Congress. The bills contain similar definitions of cloning, but they differ in the scope of prohibited activities. Seven of the bills would have prohibited only reproductive cloning, and five of the bills would have prohibited both reproductive and therapeutic cloning. (Note: Deviations from the general definition of SCNT given earlier are noted below.)

H.R. 1260—Ban on Human Cloning Act

H.R. 1260 contains the following key provisions:

• Makes it unlawful for anyone to engage in reproductive cloning
• Defines "human cloning" as a procedure in which a person "transfers the nucleus of a human somatic cell into an egg cell from which the nucleus has been removed"
• Provides a criminal penalty for violation of the provisions of the bill

H.R. 1372—Human Cloning Research Prohibition Act

H.R. 1372 includes the following key provisions:

• Prevented the obligation or expenditure of Federal funds to conduct or support any project or research that includes the use of human SCNT technology to produce an oocyte undergoing cell division toward the development of a fetus.
• Allowed the use of SCNT or other cloning technologies to clone molecules, DNA, or cells other than human embryo cells or tissues, and the use of those techniques to create animals other than humans.
• Required the Director of the National Science Foundation to enter into an agreement with the National Research Council to develop a report within 5 years on the impact that implementation of the measure would have had on research.
• Expressed the Sense of Congress that other countries should establish substantially equivalent restrictions on human cloning.

H.R. 1608—Human Cloning Prohibition Act of 2001

H.R. 1608 contains the following key provisions:

• Prohibits knowingly replacing the nucleus of an oocyte with the nucleus of a human somatic cell; the prohibition would not apply if, before replacement of the nucleus of the oocyte, the nucleus of the human somatic cell had been modified so that the cell could not develop to completion
• Provides both criminal and civil penalties for violation of the provisions of the bill

H.R. 1644/S. 790—Human Cloning Prohibition Act of 2001

H.R. 1644/S. 790 contains the following key provisions:

• Prohibited both therapeutic and reproductive cloning
• Prohibited any person from 1) performing or attempting to perform human cloning, 2) participating in an attempt to perform human cloning, or 3) shipping or receiving the product of human cloning for any purpose.
• Allowed other areas of scientific research not specifically prohibited, including research in the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans.
• Provided both criminal and civil penalties for violation of the provisions of the bill

H.R. 2172—Cloning Prohibition Act of 2001

H.R. 2172 contains the following key provisions:

• Prohibited reproductive cloning. The prohibition would not have applied to the following: 1) the use of SCNT to clone molecules, DNA, cells, or tissues, 2) the use of mitochondrial, cytoplasmic, or gene therapy, 3) the use of in vitro fertilization (IVF), the administration of fertility-enhancing drugs, or the use of other medical procedures to assist a woman in becoming or remaining pregnant, 4) the use of SCNT to clone animals other than humans, and 5) any other activity (including biomedical, microbiological, or agricultural research or practices) not expressly prohibited.
• Required persons engaging in SCNT to register with the Secretary of HHS and provide an attestation that the individual is aware of and will not violate the provisions of the bill
• Preempts inconsistent State laws
• Provides a 10-year sunset provision
• Provides civil and criminal penalties for violation of the provisions of the bill
• Required the Secretary of HHS to enter into a contract with the Institute of Medicine to review and provide a report on the current state of knowledge of the biological properties of stem cells obtained from embryos, fetal tissue, and adult tissue.

H.R. 2505/S. 1899—Human Cloning Prohibition Act of 2001

H.R. 2505, which has almost identical provisions to H.R. 1644, contains the following key provisions:

• Prohibits both reproductive and therapeutic cloning.
• Prohibited any person from knowingly 1) performing or attempting to perform human cloning, 2) participating in an attempt to perform human cloning, or 3) shipping or receiving for any purpose an embryo produced by human cloning or any product derived from such embryo. (Note: This provision is slightly different from H.R. 1644 in that it contained a requirement that the violation must have occurred "knowingly." It also would have prohibited the shipping or receipt of any "product derived from" a cloned embryo.)
• Allowed other areas of scientific research, including research on the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans
• Required the General Accounting Office to conduct a study on the use of new medical developments using SCNT and current public attitudes and prevailing ethical views concerning the use of SCNT
• Provides civil and criminal penalties for violation of the provisions of the bill

H.R. 2608—Cloning Prohibition Act of 2001

H.R. 2608, which is almost identical to H.R. 2172, contains the following key provisions:

• Prohibited reproductive cloning. (Note: H.R. 2608 prohibited the "receipt" of the product of SCNT, with the knowledge that the product is intended to be used to initiate a pregnancy.) H.R. 2608 would have prohibited only the shipping and transport of such products, and the prohibition would not apply to the following: 1) the use of SCNT to clone molecules, DNA, cells, or tissues, 2) the use of mitochondrial, cytoplasmic, or gene therapy, 3) the use of IVF, the administration of fertility-enhancing drugs, or the use of other medical procedures to assist a woman in becoming or remaining pregnant, 4) the use of SCNT to clone animals other than humans, and 5) any other activity (including biomedical, microbiological, or agricultural research or practices) not expressly prohibited.
• Required persons engaging in SCNT to register with the Secretary of HHS and provide an attestation that the individual is aware of and would not violate the provisions of the bill
• Preempts inconsistent State laws
• Contains a 10-year sunset provision
• Provides civil and criminal penalties for violation of the provisions of the bill
• Required the Secretary of HHS to enter into a contract with the Institute of Medicine to review and provide a report on the current state of knowledge of the biological properties of stem cells obtained from embryos, fetal tissue, and adult tissue

S. 704—Human Cloning Prevention Act

S. 704 contains the following key provisions:

• Makes it unlawful for anyone to engage in reproductive cloning
• Defined human cloning as "the use of somatic cell nuclear transfer or any other cloning technique for the purpose of initiating or attempting to initiate a human pregnancy; or the implantation of a conceptus, blastocyst, or embryo created through somatic nuclear transfer into a mammalian uterus; or the creation of genetically identical siblings by dividing a conceptus, blastocyst, or embryo for the purpose of initiating or attempting to initiate a human pregnancy"
• Provides both criminal and civil penalties for violation of the provisions of the bill

S. 1758—Human Cloning Prohibition Act of 2001

S. 1758 contains the following key provisions:

• Prohibits only reproductive cloning
• Permits, specifically, cloning technology for producing human stem cells
• Provides civil and criminal penalties for violation of the provisions of the bill
• Would have added Section 498C to the Public Health Service Act to require that therapeutic cloning activities adhere to Federal regulations for the protection of human subjects in research, with civil monetary penalties authorized for violations of these regulations. The Secretary of HHS would have been responsible for enforcing this section.

S. 1893—Human Cloning Ban and Stem Cell Research Protection Act of 2001

S. 1893 contains the following key provisions:

• Prohibits only reproductive cloning
• Provides both civil and criminal penalties for violation of the bill
• Specifically permits somatic cell nuclear transfer to clone molecules, DNA, cells, and tissues

S. 2076—Human Cloning Prohibition Act

S. 2076 contains the following key provisions:

• Prohibits only reproductive cloning
• Provides both civil and criminal penalties for violation of the bill

S. 2439—Human Cloning Prohibition Act of 2002

S. 2439 contains the following key provisions:

• Prohibits only reproductive cloning
• Required that all research involving nuclear transplantation (generally considered another term for SCNT) be conducted in accordance with subparts A and B of 45 C.F.R. 46. These provisions would have required, in part, review by an institutional review board and appropriate informed consent.
• Provides both civil and criminal penalties for violation of the bill

Status and Outlook

H.R. 1260 was introduced by Representative Brian D. Kerns (R-IN) on March 28, 2001, and was referred to the House Committee on the Judiciary. On June 14, the bill was referred to the House Judiciary Subcommittee on Crime.

H.R. 1372 was introduced by Representative Cliff Stearns (R-FL) on April 3, 2001, and was referred to the House Committees on Energy and Commerce and on Science. On April 12, the bill was referred to the House Science Subcommittee on Research. On April 16, it was referred to the House Energy and Commerce Subcommittee on Health.

H.R. 1608 was introduced by Representative Vernon Ehlers (R-MI) on April 26, 2001, and was referred to the House Committee on the Judiciary. On June 14, the bill was referred to the House Judiciary Subcommittee on Crime.

H.R. 1644 was introduced by Representative Dave Weldon (R-FL) on April 26, 2001, and S. 790 was introduced by Senator Brownback on the same day. These bills were referred to the House Committees on Energy and Commerce and on the Judiciary and to the Senate Committee on the Judiciary, respectively. H.R. 1644 was referred to the House Energy and Commerce Subcommittee on Health on May 4 and the House Judiciary Subcommittee on Crime on June 19. The former held a hearing on this bill on June 20, and the latter on June 19.

H.R. 2172 was introduced by Representative Jim Greenwood (R-PA) on June 14, 2001, and was referred to the House Committee on Energy and Commerce. On June 25, the bill was referred to the House Energy and Commerce Subcommittee on Health.

H.R. 2505 was introduced by Representative Weldon on July 16, 2001, and was referred to the House Committee on the Judiciary. The House Judiciary Subcommittee on Crime held a markup session on July 19 and reported the bill to the full Committee. The House Committee on the Judiciary held a markup session on July 24 and reported the bill favorably by a vote of 18 to 11. The bill was passed by the House on July 31 by a vote of 265 to 162. S. 1899, the Senate companion bill to H.R. 2505, was introduced by Senator Brownback on January 28, 2002. The measure was referred to the Senate Committee on the Judiciary.

H.R. 2608 was introduced by Representative Greenwood on July 24, 2001, and was referred to the House Committee on Energy and Commerce. On July 31, the bill was referred to the House Energy and Commerce Subcommittee on Health.

S. 704 was introduced by Senator Ben Nighthorse Campbell (R-CO) on April 5, 2001, and was referred to the Senate Committee on Health, Education, Labor and Pensions.

S. 1758 was introduced by Senator Dianne Feinstein (D-CA) on December 3, 2001, and was referred to the Senate Committee on the Judiciary.

S. 1893 was introduced by Senator Harkin on January 24, 2002, and was referred to the Senate Committee on Health, Education, Labor and Pensions.

S. 2076 was introduced by Senator Byron L. Dorgan (D-ND) on April 9, 2002, and was referred to the Senate Committee on the Judiciary.

S. 2439 was introduced by Senator Specter on May 1, 2002, and was referred to the Senate Committee on the Judiciary. Key cosponsors included Senators Feinstein, Harkin, Kennedy, and Orrin G. Hatch (R-UT).

The Senate failed to act on any cloning legislation during the 107th Congress. Senators Brownback and Specter have publicly indicated that they will reintroduce their respective bills when the 108th Congress convenes. It is also possible that the issue could be debated on the Senate floor when, and if, the Senate considers the FY 2003 Senate Labor, HHS, and Education Appropriation bill early next year. Several Members of the Senate may introduce cloning amendments (both pro and con) to that bill.