Excerpt from the Committee Report.
Passed the House of Representatives July 31, 2001
HR 2505 EH
H. R. 2505
To amend title 18, United States Code, to prohibit human cloning.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the 'Human Cloning Prohibition Act of 2001'.
SEC. 2. PROHIBITION ON HUMAN CLONING.
(a) IN GENERAL- Title 18, United
States Code, is amended by inserting after
chapter 15, the following:
'CHAPTER 16--HUMAN CLONING
'302. Prohibition on human cloning.
'Sec. 301. Definitions
'In this chapter:
'(1) HUMAN CLONING - The term 'human cloning' means human asexual reproduction, accomplished by introducing nuclear material from one or more human somatic cells into a fertilized or unfertilized oocyte whose nuclear material has been removed or inactivated so as to produce a living organism (at any stage of development) that is genetically virtually identical to an existing or previously existing human organism.
'(2) ASEXUAL REPRODUCTION - The term 'asexual reproduction' means reproduction not initiated by the union of oocyte and sperm.
'(3) SOMATIC CELL - The term 'somatic cell' means a diploid cell (having a complete set of chromosomes) obtained or derived from a living or deceased human body at any stage of development.
'Sec. 302. Prohibition on human cloning
'(a) IN GENERAL - It shall be unlawful for any person or entity, public or private, in or affecting interstate commerce, knowingly--
'(1) to perform or attempt to perform human cloning;
'(2) to participate in an attempt to perform human cloning; or
'(3) to ship or receive for any purpose an embryo produced by human cloning or any product derived from such embryo.
'(b) IMPORTATION- It shall be unlawful for any person or entity, public or private, knowingly to import for any purpose an embryo produced by human cloning, or any product derived from such embryo.
'(c) PENALTIES -
'(1) CRIMINAL PENALTY - Any person or entity that violates this section shall be fined under this title or imprisoned not more than 10 years, or both.
'(2) CIVIL PENALTY - Any person or entity that violates any provision of this section shall be subject to, in the case of a violation that involves the derivation of a pecuniary gain, a civil penalty of not less than $1,000,000 and not more than an amount equal to the amount of the gross gain multiplied by 2, if that amount is greater than $1,000,000.
'(d) SCIENTIFIC RESEARCH - Nothing in this section restricts areas of scientific research not specifically prohibited by this section, 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.'.
(b) CLERICAL AMENDMENT - The table of chapters for part I of title 18, United States Code, is amended by inserting after the item relating to chapter 15 the following: 301'.
SEC. 3. STUDY BY 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
(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 4 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 it considers appropriate. Passed the House of Representatives July 31, 2001.
BACKGROUND AND NEED FOR THE LEGISLATION
Cloning, which literally means to make a copy, is the asexual reproduction of a precise genetic copy of a molecule, cell, tissue, plant, or animal. The word 'cloning' can be used as a generic term to describe several different techniques of cloning. Molecular cloning refers to the copying of DNA fragments. For example, the human gene for insulin has been cloned into bacteria to produce insulin for the treatment of diabetes. In addition, human cells are routinely cloned to study cancer or genetic diseases.
The cloning technique that could possibly allow for the production of individuals who are genetically identical to an already existing individual is known as 'somatic cell nuclear transfer.' This is the procedure that was used to clone Dolly the sheep in 1996, the first mammal ever to be cloned from an adult cell. Somatic cell nuclear transfer involves taking a mature but unfertilized egg, removing or deactivating its nucleus, and introducing a nucleus obtained from a specialized (somatic) cell of another adult organism. The egg is chemically treated so that it begins to behave as if fertilization has occurred. Once the egg begins to divide, the embryo is transferred to a female's uterus to initiate pregnancy. Since almost all the hereditary material of a cell is contained within its nucleus, the re-nucleated egg and the individual into which it develops are genetically identical to the organism that was the source of the transferred nucleus.
The announcement of the birth of Dolly brought into sharp focus the future possibility of cloning human beings along with all its inherent moral, ethical, and legal implications. The National Bioethics Advisory Commission (NBAC) was ordered to review the legal and ethical issues involved in the cloning of human beings and delivered its recommendations in June 1997. The NBAC agreed that the creation of a child by somatic cell nuclear transfer is scientifically and ethically objectionable because: 1) the efficiency of nuclear transfer is so low and the chance of abnormal offspring is so high that experimentation of this sort in humans was premature; and 2) the cloning of an already existing human being may have a negative impact on issues of personal and social well being such as family relationships, identity and individuality, religious beliefs, and expectations of sameness.
Currently, no clear regulations exist in the United States that would prevent a private group from attempting to clone a human being. The Food and Drug Administration (FDA) has announced that it has the authority to regulate human cloning, but that authority has been questioned by many experts and remains unclear today. According to the FDA, that authority comes in part from the Public Health Service (PHS) Act, which gives FDA the power to regulate 'biological products' that are used to treat medical conditions. The FDA asserts that a human somatic cell clone (a cloned human embryo) is a 'biological product' intended to treat a medical condition, that condition being infertility.
The FDA also says it can regulate human cloning under the Food, Drug and Cosmetic (FD&C) Act because human somatic cell clones fall under the definition of 'drugs.' That act defines drugs as 'articles (other than food) intended to affect the structure or any function of the body.' According to the FDA, a human somatic cell clone is an 'article' that affects the structure and function of a woman's body by making her pregnant and would be subject to investigational new drug application requirements under the FD&C Act.
With recent reports that otherwise reputable scientists and physicians plan to produce the first human clone and no clear regulations in place, it has become imperative that Congress act to prevent this ethically and morally objectionable procedure.
Several other nations and international organizations have also enacted laws or issued policy statements prohibiting the cloning of human beings. Argentina, Australia, Belgium, Canada, China, Denmark, France, Germany, Israel, Japan, Norway, Peru, Slovakia, South Korea, Spain, Sweden, Switzerland, and the United Kingdom already have laws or have announced plans to pass laws prohibiting the cloning of human beings. In addition, the Denver Summit of Eight, the Council of Europe, the World Health Organization, UNESCO's International Bioethics Committee, the European Commission, and the Human Genome Organization have called for a worldwide ban on the cloning of human beings.
The possible production of a human clone raises a host of ethical questions. Cloning entails producing a person with a particular genetic code because of the attractiveness or usefulness of a person with that code. In this sense, by allowing human cloning, we are possibly legitimizing in principle the entire enterprise of designing children to suit parental or social purposes.
It must also be recognized that any attempt at cloning a human being would be experimentation on the resulting child-to-be. Each experiment runs a high risk of failure. In all the animal experiments, fewer than 2 to 3 percent of all cloning attempts succeeded. Not only are there fetal deaths and stillborn infants, but many of the so-called 'successes' are in fact failures. As has only recently become clear, there is a very high incidence of major disabilities and deformities in cloned animals that attain live birth. Attempts to clone human beings carry massive risks of producing unhealthy, abnormal, and malformed children.
It is well within Congress' power and perogative to restrict or prohibit the means used by researchers that threaten interests in which the citizens of this country have a legitimate concern. As the National Bioethics Advisory Commission 1997 report pointed out, '(b)ecause science is both a public and social enterprise and its application can have a profound impact, society recognizes that the freedom of scientific inquiry is not an absolute right. . . .'
Some opponents of the bill would rather see a ban that would only prohibit cloning when there was an intent to initiate a pregnancy and would still allow scientists to clone human embryos for experimental purposes. This approach to prohibiting cloning would be much less effective and would inevitably turn out to be unenforceable. Once cloned embryos were produced and available in laboratories, it would be virtually impossible to control what was done with them. Stockpiles of cloned human embryos could be produced, bought and sold without anyone knowing it. Implantation of cloned embryos, a relatively easy procedure, would take place out of sight. At that point, governmental attempts to enforce a cloning ban would prove impossible to police or regulate. Creating cloned human children necessarily begins by producing cloned human embryos. The only effective way to prevent this is to prohibit all human cloning.
Opponents of a complete ban on human cloning also argue that H.R. 2505 would have a negative impact in the field of stem cell research. Testimony given before the Committee does not support this argument. Cloning human embryos for the sole purpose of destroying them for their stem cells is unnecessary because of the successes that scientists have had with adult stem cells. Adult stem cells are already being used successfully for therapeutic benefit in humans. This includes treatments associated with various types of cancer, to relieve systemic lupus, multiple sclerosis, rheumatoid arthritis, anemias, immunodeficiency diseases, and restoration of sight through regeneration of corneas. Furthermore, initial clinical trials have begun to repair heart damage using the patient's own adult stem cells. Adult stem cells are making good on what are only promises of embryonic stem cells.
Few issues have ever created such a unified public opposition as the possibility of producing human beings who are genetically identical to an already existing individual. Cloning experiments produced 277 stillborn, miscarried or dead sheep before Dolly was successfully cloned. That failure rate, which has remained steady since 1997, is not acceptable for human beings. H.R. 2505, by banning human cloning at any stage of development, provides the most effective protection from the dangers of abuse inherent in this rapidly developing field. By preventing the cloning of human embryos, there can be no possibility of cloning a human being.