In the United States there is no federal legislation prohibiting cloning for either reproductive and therapeutic purposes. However, under the 1996 Dickey-Wicker Amendment it is illegal to use federal funds to support research “in which human embryos are created, destroyed, discarded, or knowingly be subjected to risk of injury or death greater than allowed for research on fetuses in utero under 45 CFR 46.204 and 46.207, and subsection 498(b) of the Public Health Service Act.” Moreover, the Dickey-Wicker Amendment defines a human embryo as “any organism, not protected as a human subject under 45 CFR 46 as of the date of enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.”
The Food and Drug Administration (FDA) has asserted jurisdiction over clinical research using cloning technology to create a human being. According to FDA, clinical research using cloning technology to create a human being is subject to FDA regulation under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. This authority is based on the agency’s oversight authority over all products intended to treat or prevent disease. Furthermore, FDA has indirect oversight authority over research cloning, as data obtained from such research may be used to support an application for new therapy procedures. The agency has further indirect oversight authority over the laboratory procedures that would be used to create cloned embryos “as part of a determination of the safety and effectiveness of the end product” (Javitt G, Suthers K, and K Hudson. Cloning: A Policy Analysis. Washington, DC: Genetics and Public Policy Center, 2005). It is important to note that the FDA has explicitly stated that it would not permit the use of cloning technology to create a human being due to “major unresolved safety questions” pertaining to the use of such technology.
President Bush announced in August 2001 that for the first time federal funds would be used to support research on human embryonic stem cells, while stating his strong opposition to “human cloning.” Although not mentioned specifically in his speech, a fact sheet on the White House Web site states that federal funds will not be used for “the cloning of human embryos for any purpose.” However, it is important to note that there is no current federal legislation prohibitions or restrictions on the use of private funds for either reproductive and therapeutic cloning research.
Following the president’s announcement, in July of 2002 the President's Council on Bioethics released its report Human Cloning and Human Dignity, in which the council unanimously recommended a ban on reproductive cloning, and, by a vote of 10 to 7, a four-year moratorium on cloning for medical research purposes.
The current U.S. administration supports a comprehensive cloning ban; however, its efforts to adopt federal legislation on the subject have yet to be successful. In the past years the U.S. Congress, which remains polarized on the issue of cloning, has considered numerous bills – including one supported by a bipartisan majority – also without success.
In the 2002 report Scientific and Medical Aspects of Human Reproductive Cloning, the National Academy of Sciences recommended that “human reproductive cloning should not now be practiced. It is dangerous and likely to fail.” The NAS also recommended that an enforceable ban, subject to a sunset clause of five years, be adopted by the federal government. Regarding cloning for therapeutic or research purposes, the NAS recommended that cloning to produce stem cells should be permitted because of the potential for developing new therapies and advancing biomedical knowledge. While the NAS’s 2005 Guidelines for Human Embryonic Stem Cell Research do not specifically address human reproductive cloning or apply to reproductive uses of nuclear transfer, the NAS continues to support the view that research aimed at human reproductive cloning should not be conducted at this time.
State human cloning laws
States with statutes specifically banning human reproductive and therapeutic cloning:
- Arkansas, [2003 SB 185]; Ark. Code § 20- 16-1001 et. seq. (2004)
- Indiana, Ind. Code § 16-18-2-5.5. -56.5, -128.5, -183.5 (2005)
- Iowa, Iowa Code §§ 707B.1-.4 (2004)
- Michigan, Mich. Comp. Laws §§ 333.26401-06, 333.16274, 16275, 20197, 750.430a (2004)
- North Dakota, [2003 HB 1424]; N.D. Cent. Code §§ 12.1-39-01, 12.1-39-02 (2004)
- South Dakota, 2004 SB 184
- Virginia, Va. Code Ann. §§ 32.1-162.21- .22 (2004) (unclear whether therapeutic cloning is included in the ban)
States with statutes specifically banning human reproductive cloning:
- Maryland, 2006 SB 144
States banning the use of public monies for reproductive and/or therapeutic cloning:
- Arizona, HB 2221 (2005) (human reproductive and therapeutic cloning)
- Missouri, Mo. Rev. Stat. § 1.217 (2004) (human reproductive cloning)
States with statutes specifically allowing therapeutic cloning:
- California, Cal. Bus. & Prof. §§ 16004, 16105; Cal. Health & Safety §§24185-24187 (2004)
- Missouri, Mo. Rev. Stat. § 1.217 (2004)
- New Jersey, [2003 SB 1909/2003 AB 2840]; N.J. Stat. § 2C:11A-1 (2004)
- Rhode Island, R.I. Gen. Laws §§ 23-16.4-1 - .4-4 (2004) (Sunset provision: July 7, 2010)
- Connecticut, Public Act 05-149 (2005)
For more information, see National Conference on State Legislatures, State Human Cloning Laws (updated April 2006) http://www.ncsl.org/programs/health/Genetics/rt-shcl.htm
- Balanced Budget Downpayment Act, I, Pub. L. No. 104-199, § 128, 1.10 Stat. 34 (first enactment of Dickey-Wicker amendment), (1996).
- Federal Food, Drug & Cosmetic Act, Title 21 § 201 et. seq.
- Public Health Service Act, Title 42 § 201 et. seq.
- Department of Health and Human Services, Food and Drug Administration, Letter to Institutional Review Boards, (October 1998),
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- President Bush’s position on stem cell research, (August 2001), http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html
- National Academy of Sciences, Scientific and Medical Aspects of Human Reproductive Cloning, (2002).
- The President’s Council on Bioethics, Human Cloning and Human Dignity: An Ethical Inquiry, (2002).
- The President’s Council on Bioethics, Reproduction and responsibility: the regulation of new biotechnologies, (2004), http://www.bioethics.gov/reports/reproductionandresponsibility/index.html
- The President's Council on Bioethics, Monitoring Stem Cell Research, (January 2004), http://www.bioethics.gov/reports/stemcell/pcbe_final_version_monitoring_stem_cell_research.pdf
- National Academy of Sciences, Guidelines for Human Embryonic Stem Cell Research, (April 2005), http://newton.nap.edu/catalog/11278.html
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