108th Congress

Cloning

H.R. 234, H.R. 534, H.R. 801, H.R. 916, H.R. 938, S. 245, S. 303

Background

The controversial issue of human cloning continues to attract considerable congressional and media interest. On December 27, 2002, Clonaid, a company affiliated with the pro-cloning Raelian movement, announced that they had succeeded in cloning the first human baby. This announcement, while generating considerable skepticism, led several Members of Congress to introduce cloning bills soon after the 108th Congress convened. On February 27, 2003, H.R. 534 passed the House of Representatives by a vote of 241 to 155. The bill would prohibit both human reproductive and 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 in which stem cells (master cells that can differentiate into most cells of the body) are derived from a cloned embryo. SCNT is generally defined as transferring the nucleus of a human somatic cell (any cell other than an egg cell) into an egg cell (oocyte) 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 system 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.

Since the beginning of the 108th Congress, five bills have been introduced in the House and two in the Senate. The House has not held any hearings, although as described above, the House passed H.R. 534 by a wide margin on February 27, 2003. The Senate has held three hearings on cloning; two were held by the Senate Commerce, Science and Transportation Subcommittee on Science, Technology and Space (Senator Sam Brownback [R-KS], Chair) on January 29 and March 27, and one was held by the Senate Committee on the Judiciary (Senator Orrin G. Hatch [R-UT], Chair) on March 19. Adding a slightly different perspective, the March 27 hearing focused on the impact of human cloning on women's health. Witnesses argued that women would be coerced into donating eggs for research and that drugs used to obtain the eggs have serious side effects.

Provisions of the Legislation/Impact on NIH

H.R. 234/534—Human Cloning Prohibition Act of 2003

The bills, introduced by Representative Dave Weldon (R-FL), would:

• Prohibit reproductive and therapeutic human cloning.
• Prohibit 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. (Note: Unlike H.R. 234, H.R. 534 would prohibit any person from shipping or receiving any product derived from a cloned embryo.)
• Permit 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
• Require the General Accounting Office (GAO) 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
• Impose civil and criminal penalties for violation of the provisions of the bill

H.R. 801—Cloning Prohibition Act of 2003

The bill, introduced by Representative Jim Greenwood (R-PA), would:

• Prohibit the use of cloning technology to initiate a pregnancy or the shipment of a product of cloning technology with the knowledge that the product is intended to be used to initiate a pregnancy
• Not prohibit 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, 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
• Require a person engaging in SCNT to register with the Secretary of Health and Human Services and provide an attestation that the individual is aware of and would not violate the provisions of the bill
• Sunset in 10 years
• Impose civil and criminal penalties for violation of the provisions of the bill

H.R. 916—Human Cloning Research Prohibition Act

The bill, introduced by Representative Cliff Stearns (R-FL), would:

• Prohibit the expenditure of any Federal funds to conduct or support any research project that includes the use of human SCNT.
• Require the National Science Foundation to contract with the National Research Council to assess the impact that the implementation of the law would have on research.

H.R. 938—Human Cloning Prevention Act of 2003

The bill, introduced by Representative Ron E. Paul (R-TX), would:

• Prohibit any Federal agency from making any grant, contract, or other payment to any entity that has engaged in human SCNT within the past year.

S. 245—Human Cloning Prohibition Act of 2003

The bill, introduced by Senator Brownback, would:

• Prohibit both reproductive and therapeutic cloning. This bill is largely similar to H.R. 534.
• Prohibit 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 an embryo
• Permit 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
• Require GAO 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
• Impose civil and criminal penalties for violation of the provisions of the bill

S. 303—Human Cloning Ban and Stem Cell Research Protection Act of 2003

The bill, introduced by Senator Hatch, would:

• Prohibit reproductive cloning only.
• Make it unlawful to 1) conduct or attempt to conduct human cloning, 2) ship the product of nuclear transplantation (generally considered another term for SCNT) in interstate or foreign commerce for the purpose of human cloning in the United States or elsewhere, or 3) export to a foreign country an unfertilized blastocyst (early embryo) if the country does not prohibit human cloning.
• Require that all research involving nuclear transplantation be conducted in accordance with subparts A and B of 45 CFR 46. These provisions would require, in part, review by an institutional review board and appropriate informed consent.
• Require GAO to review (within 1 year) the Attorney General's enforcement record regarding the provisions of this bill, as well as the manner in which the U.S. Department of Justice is coordinating the efforts of State Attorneys General and local law enforcement in enforcing similar State prohibitions. GAO would also be required to provide a report on laws adopted by foreign countries and the actions taken by those countries to enforce such laws.
• Prohibit the maintenance of an unfertilized blastocyst for more than 14 days from its first cell division, not counting any time during which it is frozen
• Prohibit the selling or receiving of human oocytes or unfertilized blastocysts for valuable consideration. Valuable consideration does not include reasonable payments to compensate the donor for the time and inconvenience associated with the donation.
• Prohibit nuclear transplantation from being conducted in a laboratory in which human oocytes are subject to assisted reproductive technology treatments or procedures
• Impose civil and criminal penalties for violation of the provisions of the bill

Status and Outlook

H.R. 234 was introduced by Representative Weldon on January 8, 2003, and was referred to the House Committees on the Judiciary and on Energy and Commerce.

H.R. 534 was introduced by Representative Weldon on February 5, 2003, and was referred to the House Committee on the Judiciary. It was reported favorably by that Committee on February 25. H.R. 534 passed the House of Representatives on February 27 by a vote of 241 to 155. It is unclear whether there are sufficient votes in the Senate to pass H.R. 534 or its companion, S. 245.

H.R. 801 was introduced on February 13, 2003, by Representative Greenwood and was referred to the House Committee on Energy and Commerce. H.R. 801 was offered as a substitute amendment when H.R. 534 was being considered on the House Floor. That amendment failed by a vote of 164 to 237.

H.R. 916 was introduced on February 25, 2003, by Representative Stearns and was referred to the House Committees on Energy and Commerce and on Science.

H.R. 938 was introduced on February 26, 2003, by Representative Paul and was referred to the House Committee on Energy and Commerce.

S. 245 was introduced by Senator Brownback on January 29, 2003, and was referred to the Senate Committee on Health, Education, Labor and Pensions.

S. 303 was introduced by Senator Hatch on February 5, 2003, and was referred to the Senate Committee on the Judiciary.