39-006

1st Session

Part 1
HUMAN CLONING RESEARCH PROHIBITION ACT

The Committee on Science, to whom was referred the bill (H.R. 922) to prohibit the expenditure of Federal funds to conduct or support research on the cloning of humans, having considered the same, report favorably thereon with an amendment and recommend that the bill as amended do pass.

The amendment is as follows:

Strike out all after the enacting clause and insert in lieu thereof the following:

SECTION 1. SHORT TITLE.

This Act may be cited as the `Human Cloning Research Prohibition Act'.

SEC. 2. PROHIBITION AGAINST EXPENDITURE OF FEDERAL FUNDS FOR RESEARCH ON CLONING HUMANS.

(a) PROHIBITION- None of the funds made available in any Federal law may be obligated or expended to conduct or support any project of research that includes the use of human somatic cell nuclear transfer technology to produce an embryo.

(b) DEFINITIONS- For purposes of this section--

(1) the term `human somatic cell nuclear transfer' means transferring the nucleus of a human somatic cell into an oocyte from which the nucleus has been removed or rendered inert; and

(2) the term `somatic cell' means a cell of an embryo, fetus, child, or adult which is not and will not become a sperm or egg cell.

SEC. 3. REVIEW.

The Director of the National Science Foundation shall enter into an agreement with the National Research Council for a review of the implementation of this Act. Not later than 5 years after the date of the enactment of this Act, the Director shall transmit to the Congress a report containing the results of that review, including the conclusions of the National Research Council on--

(1) the impact that the implementation of this Act has had on research; and

(2) recommendations for any appropriate changes to this Act.

SEC. 4. PROTECTED SCIENTIFIC RESEARCH.

Nothing in this Act shall restrict other areas of scientific research not specifically prohibited by this Act, including important and promising work that involves--

(1) the use of somatic cell nuclear transfer or other cloning technologies to clone molecules, DNA, cells other than human embryo cells, or tissues; or

(2) the use of somatic cell nuclear transfer techniques to create animals other than humans.

I. PURPOSE OF THE BILL

The purpose of the bill is to prohibit the expenditure of Federal funds to conduct or support research which includes the cloning of humans.

II. BACKGROUND AND NEED FOR THE LEGISLATION

On February 23, 1997, The Observer broke the international news that embryologist Dr. Ian Wilmut and his colleagues from Edinburgh, Scotland's Roslin Institute, were about to announce the successful cloning of an adult sheep by using a new cloning technique which had never before been fully successful in mammals. This announcement of the creation of `Dolly' represented a remarkable scientific breakthrough.

While these advances in cloning technology offer great potential in areas such as medical research and agriculture, the sheep cloning raised the prospect of a similar procedure for humans. Although major hurdles still exist before human cloning can become a reality, this theoretical ability to clone humans has raised strong objections and profound moral, ethical, religious, and psychological concerns throughout the world.

In February 1997, following the announcement of Dolly's cloning, the President issued an executive order to all Federal agencies that `no [F]ederal funds shall be allocated for cloning of human beings.' Additionally, among other recommendations, the National Bioethics Advisory Commission's June, 1997 report, `Cloning Human Beings,' endorsed the continuation of the current moratorium on the use of Federal funding in support of any attempt to use somatic cell nuclear transfer to produce a product with the intent of introducing the product into a woman's womb.

There is also an annual statutory prohibition of Federal funding for research which creates or destroys human embryos by agencies funded through the Labor, Health and Human Services, and Education Appropriations bill. This ban must be enacted annually. Currently, there is no permanent statutory prohibition on the use of Federal research funds to produce human embryos through the use of somatic cell nuclear transfer.

Internationally, the European Union and several countries, including Germany, Denmark, Australia, Spain, and the United Kingdom, already have laws or are preparing laws to forbid human cloning. France, Argentina, China, and Japan have also indicated an intention to deter efforts to clone humans, as well as the Council of Europe and the World Health Organization. At the June 1997, G7 Summit of Economic Countries in Denver, Colorado, the heads of state for the United States, Japan, Germany, England, France, Italy, and Canada, all endorsed a worldwide ban on human cloning.

In order to address the lack of a permanent statutory ban on the use of Federal research funds to produce human clones, Congressman Vern Ehlers of Michigan introduced H.R. 922 on March 5, 1997. H.R. 922 was referred to the Committee on Science and the Committee on Commerce.

III. SUMMARY OF HEARINGS

In the wake of the announcement that scientists in Scotland apparently had succeeded in cloning an adult sheep, the Science Committee held a series of three hearings, over five months, on human cloning. The Committee examined the legal and ethical issues associated with the use of cloning technology, reviewed the National Bioethics Advisory Commission's report, `Cloning Human Beings,' and discussed the parameters for Federal funding of human cloning research.

March 5, 1997; `Biotechnology and the Ethics of Cloning: How Far Should We Go?'

On Wednesday, March 5, 1997, the Technology Subcommittee held the first Congressional hearing on the subject of cloning, entitled `Biotechnology and the Ethics of Cloning: How Far Should We Go?' Testifying before the Subcommittee were Dr. Harold E. Varmus, Director, National Institutes of Health, Bethesda, Maryland; Dr. Caird E. Rexroad, Jr., Supervisory Research Physiologist, Agriculture Research Service, Gene Evaluation and Mapping Laboratory, Livestock and Poultry Sciences Institute, United States Department of Agriculture, Beltsville, Maryland; Dr. M. Susan Smith, Director, Oregon Regional Primate Research Center, Oregon Health Sciences University, Beaverton, Oregon; Dr. Thomas M. Murray, Chairman, Genetics Testing Subcommittee, National Bioethics Advisory Commission and Professor and Director, Center for Biomedical Ethics, Case Western University, School of Medicine, Cleveland, Ohio; and, Mr. James Geraghty, President and Chief Executive Officer, Genzyme Transgenics, Farmingham, Massachusetts.

Dr. Varmus began his testimony with a historical perspective of the development of genetic research in areas similar to the topic of interest. Dr. Varmus then presented six areas of focus and/or implementation which have arisen as a result of advancements in genetic cloning techniques. These advancements included: Traditional Husbandry (to generate optimal forms of plants or animals for feeding the human populations); Non-traditional Husbandry (to produce medically useful products or organs that may be useful for human transplantation); Research of Human Disease (the use of animals to simulate diseases in humans); Fundamental Biological Principles Research (analyzing the process by which genes are activated and deactivated to better understand genetic disease and the developmental process); Reprogramming of Human Cells (to treat certain diseases); and creation of Human Clones.

The final research effort, though not having been successfully accomplished to date, is the subject of the moral and ethical debate that has infiltrated practically every sector of society. This effort, Dr. Varmus contends, is an offensive idea that is not scientifically necessary. Scientific genetic studies can be conducted on animals, while social studies can be (and could always have been) conducted on identical twins. Dr. Varmus opens a forum of debate, searching for situations whereby cloning might be socially acceptable. He applauds the President's decision to refer the issue to NBAC, and supports the extension of the ban on cloning research.

Dr. Rexroad, though stressing that scientists at the United States Department of Agriculture have not been participating in research efforts similar to that done in Scotland at the Roslin Institute, highlighted many of the significant genetic research projects currently underway at USDA laboratories and the societal benefit he hopes such research will generate. Dr. Rexroad was very careful to note precise similarities and differences between work done at the Roslin Institute and work done by the Department of Agriculture. He also mentioned many possible advancements in livestock populations that could possibly be derived from recent findings in genetic research. In closing, Dr. Rexroad stressed that the cloning of animals `from adult or fetal cells is seen by the ARS [Agricultural Research Service] to be a primary tool for research that could lead to important advances in biotechnology . . . [that could] provide a powerful approach to improving the availability, affordability and the quality of food . . .'

Dr. Smith presented a very comprehensive survey of the work and efforts that are being conducted at the Oregon Regional Primate Research Center. Stressing that the primary (and solitary) purpose of the work is to produce identical sets of twin rhesus monkeys by means of a process whereby monkey embryos are inserted (in vitro) into host mothers, Dr. Smith listed the numerous benefits to science that these processes might add. While focusing on the use of embryonic cells to produce genetically identical offspring, the Primate Center has no plans or rationale for the cloning of adult monkeys. Reiterating the potential of the research conducted at her center, Dr. Smith cautioned against the prevention of valuable research by an act of Congress or the Administration.

Dr. Murray spoke of the many issues and concerns that the National Bioethics Advisory Commission, Genetic Subcommittee will consider over its ninety day study. He touched upon many of the societal factors that will be addressed, including religious concerns of many types, the concern over the sanctity and the power of creation, and the debate between genetic and environmental determinism. Faced with the strong sentiment possessed by much of the public, the NBAC has a extensive task of weighing the concerns of an extremely diverse population, while protecting the valuable research alluded to by the previous witnesses.

Mr. Geraghty, though not formally representing the biotechnology industry, believes that the remarks he presented would depict a consensus throughout the industry. He contended that an overwhelming majority agrees that `there is no place for the cloning of human beings in our society and recognizes that we must work within acceptable social limits.' His purpose in testifying was to discuss the potential impact and possible benefits that recent advances in cloning research have made possible. He touched upon the techniques (and subsequent benefits) made possible by the Dolly experiment. He concluded by noting that the widespread public knowledge of the results of the cloning of Dolly could be a great opportunity to educate the public in the advances in the biopharmaceutical field which have already enhanced the lives of many.

June 12, 1997; `Review of the Recommendations on Cloning by the President's Commission'

The second hearing in the series was held on June 12, 1997, three days following the publication of the report, `Cloning Human Beings,' submitted by the National Bioethics Advisory Commission (NBAC) to the President. The President had requested the NBAC to perform a ninety day study to examine the scientific, ethical, and legal aspects of the cloning issue. The hearing, entitled `Review of the Recommendations on Cloning by the President's Commission,' provided the first Congressional forum for discussion on the findings of the Commission.

Testifying before the Technology Subcommittee were three NBAC members, including its Chairman and the Chairman of the relevant subcommittee, as well as the Director of the National Institutes of Health. The witnesses were: Dr. Harold E. Varmus, Director, National Institutes of Health, Bethesda, Maryland; Dr. Harold T. Shapiro, Chairman, National Bioethics Advisory Commission, and President, Princeton University, Princeton, New Jersey; Dr. Thomas M. Murray, Chairman, Genetics Testing Subcommittee, National Bioethics Advisory Commission, Professor and Director, Center for Biomedical Ethics, Case Western University, School of Medicine, Cleveland, Ohio; and, David R. Cox, M.D., Ph.D., Professor of Genetics and Pediatrics, Department of Genetics, Stanford University School of Medicine, Stanford, California.

Dr. Varmus briefly summarized the legislative activity (the House Committee on Science, Subcommittee on Technology hearing on March 5, 1997 and the Senate Committee on Labor and Human Resources, Subcommittee on Public Health and Safety hearing on March 12, 1997) that had transpired.

Dr. Shapiro broadly summarized some of the major conclusions of NBAC. He began by presenting some of the scientific uncertainties that currently obstruct the successful cloning of a human being, and thus, the successful scripting of public policy analysis in this area. He stated that the Commission's report cited current deficiencies in technology for the safe cloning of a human, and that the current state would expose the fetus and developing child to unacceptable risks. This deficiency was coupled with far-reaching concern that human cloning is not deemed morally acceptable by society as a whole.

He explained the Commission's approach to the study, claiming that ethicists, theologians, scientists, scientific societies, physicians, and others were all given the opportunity to present their opinions. He noted that NBAC's focus was on the issues pertaining to cloning technologies that would be used to create an embryo which would be implanted into a woman's uterus. He concluded by suggesting that a specific period of time be set aside, during which no attempts at human somatic cell nuclear transfer would be attempted, and that the debate be revisited after scientific, moral, and ethical data can be collected and better evaluated.

Dr. Murray gave testimony discussing mainly the religious and ethical issues analyzed by the Commission. After outlining the process taken by the NBAC, he presented the major findings in regard to ethical and religious debate. Dr. Murray raised the issue of the responsible dominion over nature by humankind. He also discussed religious teaching on procreation in an effort to better understand the differences between begetting and making. NBAC also gave testimony that the potential cloning of humans would disrupt the relationship among generations. The Commission also focused on concerns over hubris, domination and oppression of made people, and concern over objectification. With regard to ethics, the findings were almost unanimous in their concern that undue harm was posed to a child conceived by current cloning technology. The Commission also noted that extreme caution must be exhibited whenever humans are used as the subject of scientific experimentation. NBAC found there is sufficient cause to warrant legislation because a developing child would be subject to undue harm as a result of current `unscientifically plausible technology.'

Dr. Cox testified about the remarkable nature of the scientific discovery and the opportunity for great advancements in basic science. Dr. Cox was careful to mention the scope of the NBAC study. He explained that the cloning technique in question, somatic cell nuclear transfer, cannot be done without the transfer of genetic information to an egg. When division of the egg takes place, by definition, an embryo is produced. He stated that it was not in the scope of the study to revisit the embryonic debate. He concluded by stating that NBAC recommended legislation aimed at controlling science, despite the fact that, above all, `scientists value scientific freedom.'

July 22, 1997; `Legislative Hearing on the Prohibition of Federal Funding for Human Cloning Research'

The final hearing in the series, held on July 22, 1997, was entitled `Legislative Hearing on the Prohibition of Federal Funding for Human Cloning Research.' The hearing discussed the parameters for legislating Federal funding for human cloning research and reviewed H.R. 922, `The Human Cloning Research Prohibition Act,' introduced by Congressman Vern Ehlers of Michigan.

The hearing featured testimony from Dr. Hessel Bouma, III, Professor of Biology, Calvin College Biology Department, Grand Rapids, Michigan; Fr. Kevin Wildes, Associate Director, Kennedy Institute of Ethics, Georgetown University, Washington, DC; Dr. Arthur F. Haney, M.D., President-elect, American Society of Reproductive Medicine (ASRM) and Director, Department of Endocrinology and Infertility, Duke University Medical Center, Durham, North Carolina; Dr. Alison Taunton-Rigby, Member of the Board of Directors of the Biotechnology Industry Organization (BIO) and President and Chief Executive Officer, Aquila Biopharmaceuticals, Worcester, Massachusetts; and, Dr. Lester M. Crawford, Vice Chairman, National Association for Biomedical Research (NABR) and Director, Center for Food and Nutrition Policy, Georgetown University, Washington, DC.

Dr. Bouma testified in strong opposition to the cloning of humans, and presented provisions that the legislation must include, as well as recommendations for the need to ban additional activities. He stressed the uniqueness, freedom, and respect intrinsic to human life. Cloning, Dr. Bouma testified, is in direct violation of all three, and therefore should be prohibited by law. Dr. Bouma, while he supports Congressman Ehlers efforts to restrict Federal funding, believes that legislation to ban privately funded research should be enacted as well. He cautioned that legislation must be crafted carefully, and not infringe upon the genetic research in farming or agriculture for purposes of enhancing food or drug supplies, nor should it inhibit research aimed at developing human tissues or organs for implantation.

Dr. Wildes stated that he supported the conclusions of the National Bioethics Advisory Commission study that legislation to prevent human cloning was necessary. He notes, with the history of the past century containing many prime examples, that science does not exist in a vacuum. He cites chilling reminders of the consequences that arise when science and medicine move outside of the moral fabric of any given society. He called for a built-in review mechanism for any legislation, mentioning that ethical issues in science and medicine change extremely rapidly, and certain obscure topics often come to the forefront of public attention.

Testifying on behalf of the American Society for Reproductive Medicine (ASRM), Dr. Haney stated that the ASRM believes human cloning to be totally unjustifiable. Dr. Haney called for meticulous care to be taken in the drafting of legislative measures, in an effort to assure proper definitions of cloning. The ASRM offered a definition of cloning it approved for legislation. The ASRM also supported an initiative that would include a sunset clause in the bill language. Finally, the ASRM endorsed preempting state laws on cloning to ensure uniformity across the Nation.

Dr. Alison Taunton-Rigby represented the Biotechnology Industry Organization (BIO), representing 730 biotechnology companies and others engaged in biotechnology research on medicines and diagnostics, agriculture, pollution control, and industrial applications. BIO agrees that it is unacceptable for anyone in the public or private sector to clone humans. BIO believes that legislation on the subject of cloning human beings that must not be enacted. In lieu of legislation, BIO recommends that the current moratorium be continued indefinitely. If legislation must be enacted,

BIO recommends: (1) it should focus only on research funded by the Federal Government; (2) it should include a sunset provision; (3) a preemption provision; (4) a findings section; (5) a section defining protected research; (6) a prohibition on private rights of action; and (7) an effective date.

Dr. Crawford represented the National Association of Biomedical Research (NABR), which is dedicated exclusively to advocating sound public policy regarding the humane and necessary use of animals in biomedical research, education and testing. NABR represents over 360 member institutions including the nation's largest university, the majority of U.S. medical and veterinary schools, academic and professional societies, voluntary health organizations as well as pharmaceutical and biotechnology companies. NABR agrees with and supports the conclusions and recommendations made by the National Bioethics Advisory Commission. NABR recommendations are: (1) science will not pursue research results which society is morally and ethically unwilling to accept; (2) safeguards are in place to protect humans and animals in experimentation; and (3) existing laws and regulations are being followed and should be periodically reviewed to keep pace with new technologies.

IV. COMMITTEE ACTIONS

The Science Committee met to mark up H.R. 922 on July 29, 1997. Three amendments were offered during the Committee's consideration of the bill. One was rejected and two were adopted by voice vote.

1. Amendment in the Nature of a Substitute, offered by Mr. Ehlers of Michigan, was adopted, as amended, by a voice vote. The Amendment in the Nature of a Substitute to H.R. 922 struck all after the enacting clause and inserted in lieu thereof a short title, a redefined prohibition against expenditure of Federal funds for research including the creation of a human clone, and a review by the National Research Council on the impact of the Act on research, to be conducted five years after the date of enactment of the Act.

2. En Bloc Amendment to the Ehlers Amendment in the Nature of a Substitute to H.R. 922, offered by Ms. Rivers of Michigan, was rejected by a voice vote. The Rivers En Bloc Amendment would have changed the definitions of the prohibition against expenditure of Federal research funds for cloning humans.

3. Amendment to the Ehlers Amendment in the Nature of a Substitute to H.R. 922, offered by Ms. Rivers of Michigan, was adopted, as modified, by a voice vote. The Rivers Amendment inserted a new Section 4 to the bill, entitled `Protected Scientific Research.'

With a quorum present, Mr. Brown moved H.R. 922, as amended, be reported. The motion was adopted by voice vote.

V. SUMMARY OF MAJOR PROVISIONS OF THE BILL

Provides a prohibition against expenditure of Federal funds for research which includes the creation of a human clone.

Provides a review by the National Research Council of the impact of this Act upon research, to be completed five years after the date of the enactment of the Act.

VI. SECTION-BY-SECTION ANALYSIS

Section 1. Short title

This Act is titled the `Human Cloning Research Prohibition Act.'

Section 2. Prohibition against expenditure of federal funds for research on cloning humans

The Act prohibits the use of Federal funds to conduct or support any project of research that includes the use of human somatic cell nuclear transfer technology to produce an embryo. The bill defines `human somatic cell nuclear transfer' and `somatic cell.'

Section 3. Review

The Director of the National Science Foundation shall enter into an agreement with the National Research Council to conduct a review of the impact of the Act on research. The report, its conclusions, and any recommendations for appropriate changes to the Act shall be transmitted to Congress no later than five years after the date of enactment of this Act.

Section 4. Protected scientific research

The Act shall not restrict the important and promising work not specifically prohibited by the Act including the use of somatic cell nuclear transfer or other cloning technologies to clone molecules, DNA, cells other than human embryo cells, or tissues or the use of somatic cell nuclear transfer techniques to create animals other than humans.

VII. COMMITTEE VIEWS

The Science Committee is charged with overseeing Federal funding of civilian science research and development. It has been the Committee's intent to craft legislation that will address the moral and ethical issues associated with human cloning while ensuring that Federal agencies retain their ability to pursue important scientific research.

The Committee believes it is extremely important to make a statement to society that human cloning is not acceptable in the United States and that Federal funding should not be used for research that includes human cloning. The Committee believes that attempting to clone a human being is unacceptably dangerous to the child and morally and ethically unacceptable to our society. This appears to reflect a national, if not a worldwide, consensus on the issue.

The Committee, however, recognizes the complexity of legislating a prohibition on Federal funding for human cloning research that does not adversely impact other scientifically important forms of research. While banning the use of Federal research funding for human cloning, the Committee seeks to preserve Federal funding for genetic research and animal cloning technologies that could substantially improve our quality of life and provide us with life-saving cures for diseases.

VIII. COST ESTIMATE

Clause 7(a) of Rule XIII of the Rules of the House of Representatives requires each committee report accompanying each bill or joint resolution of a public character to contain: (1) an estimate, made by such committee, of the costs which would be incurred in carrying out such bill or joint resolution in the fiscal year in which it is reported, and in each of the five fiscal years following such fiscal year (or for the authorized duration of any program authorized by such bill or joint resolution, if less than five years); (2) a comparison of the estimate of costs described in subparagraph (1) of this paragraph made by such committee with an estimate of such costs made by any Government agency and submitted to such committee; and (3) when practicable, a comparison of the total estimated funding level for the relevant program (or programs) with the appropriate levels under current law. However, clause 7(d) of that Rule provides that this requirement does not apply when a cost estimate and comparison prepared by the Director of the Congressional Budget Office under section 403 of the Congressional Budget Act of 1974 has been timely submitted prior to the filing of the report and included in the report pursuant to clause 2(l)(3)(C) of rule XI. A cost estimate and comparison prepared by the Director of the Congressional Budget Office under section 403 of the Congressional Budget Act of 1974 has been timely submitted prior to the filing of this report and included in Section IX of this report pursuant to clause 2(l)(3)(C) of rule XI.

Clause 2(l)(3)(B) of Rule XI of the Rules of the House of Representatives requires each committee report that accompanies a measure providing new budget authority (other than continuing appropriations), new spending authority, or new credit authority, or changes in revenues or tax expenditures to contain a cost estimate, as required by section 308(a)(1) of the Congressional Budget Act of 1974 and, when practicable with respect to estimates of new budget authority, a comparison of the total estimated funding level for the relevant program (or programs) to the appropriate levels under current law. H.R. 922 does not contain any new budget authority, credit authority, or changes in revenues or tax expenditures. H.R. 922 does not specifically authorize additional discretionary spending. H.R. 922 does include a National Research Council review requirement which will impact discretionary spending as described in the Congressional Budget Office report on the bill, which is contained in Section IX of this report.

IX. CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

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X. COMPLIANCE WITH PUBLIC LAW 104-4

H.R 922 contains no unfunded mandates.

XI. COMMITTEE OVERSIGHT FINDINGS AND RECOMMENDATIONS

Clause 2(l)(3)(A) of Rule XI of the Rules of the House of Representatives requires each committee report to include oversight findings and recommendations required pursuant to clause 2(b)(1) of Rule X. The Committee has no oversight findings.

XII. OVERSIGHT FINDINGS AND RECOMMENDATIONS BY THE COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT

Clause 2(l)(3)(D) of Rule XI of the Rules of the House of Representatives requires each committee report to contain a summary of the oversight findings and recommendations made by the House Government Reform and Oversight Committee pursuant to clause 4(c)(2) of Rule X, whenever such findings and recommendations have been submitted to the Committee in a timely fashion. The Committee on Science has received no such findings or recommendations from the Committee on Government Reform and Oversight.

XIII. CONSTITUTIONAL AUTHORITY STATEMENT

Clause 2(l)(4) of Rule XI of the Rules of the House of Representatives requires each report of a committee on a bill or joint resolution of a public character to include a statement citing the specific powers granted to the Congress in the Constitution to enact the law proposed by the bill or joint resolution. Article I, section 8 of the Constitution of the United States grants Congress the authority to enact H.R. 922.

XIV. FEDERAL ADVISORY COMMITTEE STATEMENT

H.R. 922 does not authorizes any work to be performed by a Federal Advisory Committee.

XV. CONGRESSIONAL ACCOUNTABILITY ACT

The Committee finds that H.R. 922 does not relate to the terms and conditions of employment or access to public services or accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act (Public Law 104-1).

XVI. COMMITTEE RECOMMENDATIONS

On July 29, 1997, a quorum being present, the Committee favorably reported the Human Cloning Research Prohibition Act, by a voice vote, and recommends its enactment.

XVII. PROCEEDINGS OF THE FULL COMMITTEE MARKUP

U.S. House of Representatives,

Committee on Science,

--Washington, DC.

The Committee met at 1:19 p.m., in room 2318 of the Rayburn House Office Building, Hon. F. James Sensenbrenner, Jr., Chairman of the Committee, presiding.

Chairman SENSENBRENNER. Finally, the last item on the agenda is H.R. 922, the Human Cloning Research Prohibition Act.

Without objection, opening statements by all members will be placed in the record at this point.

[The text of the bill, supporting materials, and the opening statement of Chairman Sensenbrenner follow:]

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Chairman SENSENBRENNER. The Chair recognizes the gentlewoman from Maryland, Mrs. Morella, the Subcommittee Chair.

Mrs. MORELLA. Thank you, Mr. Chairman.

I appreciate your leadership on this issue, for it is appropriate and right for the Science Committee to exercise our voice in the shaping of our Nation's human cloning policy and the federal funding for such research.

The Technology Subcommittee held the first Congressional hearings on cloning after the announcement of the landmark breakthrough technology that created Dolly the Sheep, and after the National Bioethics Advisory Committee submitted its report, `Cloning Human Beings,' to the President.

In the course of our series of hearings, we have received input from leading scientists, biomedical researchers, members of industry, bioethicists, religious organizations, and the general public.

From many opinions and beliefs, two sets of unanimous conclusions have emerged. The fact is that attempting to clone a human being is unacceptably dangerous to the child, and morally unacceptable to our society.

There should be legislation prohibiting the federal funding of attempts to create a child using the somatic cell nuclear transfer cloning techniques that made possible the creation of Dolly.

This appears to reflect a national, if not a worldwide, consensus on the issue.

The second conclusion reached at our hearing is that in achieving the legislative goal of prohibiting federal funding for human cloning research, it is imperative that we proceed carefully and prudently.

We must be extremely careful in crafting language which does not result in over-restrictive legislation that could impede new avenues of research.

By taking a cautioned and judicious approach to prohibit the federal funding for human cloning research, we can prevent the misuse of cloning technology on humans while also preserving the potential for future biomedical breakthroughs using that technology.

As we all know, the promise of cloning technology holds tremendous agricultural and medical benefits which could substantially improve our quality of life. These include revolutionary medical treatments and life-saving cures for diseases such as cancer, hemophilia, cystic fibrosis, sickle cell anemia, and emphysema, as well as better crops and stronger livestock.

Additionally, cloning technology furthers our knowledge about developmental biology that may one day lead to such advances as the repair and regeneration of human tissue in severe burns and spinal cord injuries, and bone barrow regeneration for patients undergoing cancer chemotherapy.

We must not inhibit the potential for this research and development by any legislative actions we undertake. So much is at stake: the health of patients with unmet medical needs and the well-being of their families.

It has become clear, as we have engaged in the process of legislating a prohibition on federal funding for human cloning research, that what may outwardly appear to be simple is in fact actually highly complex.

We all want to prohibit the federal funding of human cloning, but how can we legislate its ban without inadvertently hindering biomedical research and imperil our progress against disease?

Today we are considering one such attempt to do just that.

While I commend my good friend from Michigan, Mr. Ehlers, for his sincere efforts to ban the federal funding of human cloning research while protecting scientific development, and I appreciate the courtesies that he has extended to me in his efforts to reach an agreement with the biotechnology, pharmaceutical, and biomedical research organizations, I regret that I cannot support this bill.

Mr. Chairman, there is deep concern within all the scientific organizations that could potentially be impacted by federal legislation to ban human cloning, including the biotechnology industry of which I represent the third largest concentration in the country, but H.R. 922 is drafted imprecisely and could harm continued genetic research and biomedical innovation.

I share their concerns. Among the biotechnology, pharmaceutical and biomedical research organizations, there is no disagreement that human cloning should be banned. Yet, not one scientific organization can endorse H.R. 922.

I just think, Mr. Chairman, that perhaps with more time for greater deliberation, a consensus bill can be worked out between the scientific research organizations and all interested parties.

However, I believe H.R. 922 in its current form may have unintended adverse consequences on future biomedical advances, and I regretfully will be voting against its passage. I yield back.

Chairman SENSENBRENNER. The gentleman from Tennessee? As the Ranking Member of the Subcommittee, do you have anything you wish to add? Or, without objection----

Mr. GORDON. Without object, I will again follow the Chairman's earlier request and put my remarks in the record.

Chairman SENSENBRENNER. Without objection, so ordered.

[No response.]

Chairman SENSENBRENNER. We now are to the point of amendments.

The amendment on the roster is one offered by the gentleman from Michigan, Mr. Ehlers. The Chair recognizes the gentleman from Michigan.

Mr. EHLERS. Thank you, Mr. Chairman. I am pleased to offer this amendment in the nature of a substitute to the bill. I will keep in mind the time limits----

Chairman SENSENBRENNER. Without objection, the amendment is considered as read and open for amendment at any point.

[The amendment roster and the text of the amendment follow:]

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Chairman SENSENBRENNER. The gentleman from Michigan is recognized for a quick 5 minutes.

Mr. EHLERS. Thank you. And I will try to make it a quick 5 minutes.

I am disappointed that the President has not invited me to the White House, as well, since we not only agree on the balanced budget bill, but also on the issue of human cloning and think that it is unacceptable, particularly from the moral standpoint.

The President has imposed a moratorium, and this bill was introduced for the purpose of making the moratorium permanent.

As we considered the issue in the Technology Subcommittee, or the entire panoply of issues surrounding cloning, it became clear that the initial bill was not specific enough. That point was raised by a number of individuals both in the biotechnology industry, but also those who were interested in the general issue of the moral ethics and other aspects of that relating to human cloning.

In particular the issues was raised regarding embryo research. In an attempt to allay those fears--and also, if I may emphasize, the purpose of this bill is not just to prohibit human cloning, but to ensure that the industry is allowed to continue cloning of animals, cloning of plants, cloning of molecules, DNA, various cells, et cetera.

It is very important to continue that research because it does promise major medical advances in the future.

But the issue of embryo research is a very difficult issue. I decided the best way out of this was simply to use the language that has been used before by the Congress, that was passed by the Congress and signed into law by the President in the annual appropriations bills of Labor/HHS.

And so they say that language was used in the bill, or in the substitute which is before you. We address the issue of cloning simply by using the language of the HHS Act: `None of the funds made available in the Act may be used for the creation of an embryo.'

That follows exactly the language that has been used for a number of years and has been approved by the Congress in the past.

I had hoped that this would allay any controversy. There are still some individuals that are concerned about that and think that this closes the door on research.

It is not my intent to close any doors, other than those involving the morality and ethics of the research in question.

As a scientist, certainly I want to continue whatever research is permissible. I believe that under this bill virtually all the research that the industry wants to do can continue.

However, when one is talking about creating life, there are many additional questions that arise. Many different segments of society feel differently about the issue, and this bill is an honest attempt to use the language that has survived the legislative process in the past, and I believe is acceptable to the Majority in the House and the Senate, has been signed into law by the President, and is acceptable to the majority of the people in the United States.

Therefore, I am pleased to offer this amendment and urge the support of this Committee for that amendment.

Ms. RIVERS. Mr. Chairman?

Chairman SENSENBRENNER. The gentleman's time has expired.

The gentlewoman from Michigan, Ms. Rivers.

Ms. RIVERS. I have amendments to the amendment at the desk.

Chairman SENSENBRENNER. The Clerk will report the amendments to the amendment, and also distribute it to the members.

Ms. SCHWARTZ. Ms. Rivers' En Bloc Amendment to Ehlers Amendment in the Nature of a Substitute to H.R. 922.

`On page----

Ms. RIVERS. Could we consider it as read, sir?

Chairman SENSENBRENNER. Without objection, the amendment will be considered as read.

Does any member wish to reserve a point of order on the amendments?

Mr. EHLERS. Could we have a clarification, Mr. Chairman, as to which amendment we are considering?

Chairman SENSENBRENNER. The one that is being passed out. I am going to ask unanimous consent that the Rivers' Amendments be considered en bloc.

[No response.]

Chairman SENSENBRENNER. Without objection, the Rivers' Amendments are considered en bloc.

Before recognizing the gentlewoman from Michigan, does anybody wish to reserve a point of order on them, on the amendments en bloc as----

Mr. WELDON of Florida. Parliamentary inquiry, Mr. Chairman.

Chairman SENSENBRENNER. The gentleman from Florida will state his inquiry.

Mr. WELDON of Florida. Is this amendment en bloc in violation of the rules or procedures of the Committee or of the House?

Chairman SENSENBRENNER. Well, the Chair would have to rule on that as a part of a point of order. In a parliamentary inquiry it is not proper for the Chair to give advisory opinions in the form of a parliamentary inquiry.

Ms. RIVERS. Parliamentary inquiry, Mr. Chair?

Chairman SENSENBRENNER. The gentlewoman from Michigan will state the parliamentary inquiry.

Ms. RIVERS. I am making certain--I am requesting information on whether or not we are dealing with the single page of paper with two proposals on it marked `Rivers En Bloc.'

Chairman SENSENBRENNER. That is correct.

Ms. RIVERS. Not the second sheet.

Chairman SENSENBRENNER. The second page of paper, which deletes Section 3 and inserts a new Section 3, was not offered, unless you wish to include that in your en----

Ms. RIVERS. No. All I wish to include at this point is the single page labeled Rivers En Bloc.

Chairman SENSENBRENNER. Okay. Does anybody wish to reserve or make a point of order on the single page of paper as described by the gentlewoman from Michigan?

Mrs. MORELLA. Mr. Chairman?

Chairman SENSENBRENNER. Yes?

Mrs. MORELLA. I do not know whether this is in order. I guess it is a point of clarification addressed to the offeror of the amendment to the amendment----

Chairman SENSENBRENNER. Well, if there are no points of order, the Chair will recognize the gentlewoman from Michigan, Mrs. Rivers, for 5 minutes. And the gentlewoman from Maryland, or any other member of the Committee, can seek whatever clarifications they might desire as a part of the debate on the Rivers' Amendment.

We are only dealing with the first page of paper that was passed out.

[The text of the amendment follows:]

Insert offset folio 35

001

Ms. RIVERS. Right. That is the first amendment.

Chairman SENSENBRENNER. There are two other Rivers' amendments that are not before the Committee at this time.

The gentlewoman is recognized for 5 minutes.

Ms. RIVERS. Thank you, Mr. Chairman.

I bring this amendment before the Committee today for several reasons. The first is because I am concerned that we use precise language in all of the work that we do here.

Concerns have been raised first by the Biotechnology Industry Organization, as well as members of NBAC, about the language that we have chosen to use in this particular vehicle.

I will speak specifically from a letter addressed to me from the Biotechnology Industry Organization, which I would also ask unanimous consent to enter into the record.

Chairman SENSENBRENNER. Without objection.

[The letter referred to follows:]

Insert offset folio 37

001

Ms. RIVERS. This says that they are concerned that the terms used in the Ehlers proposal are not correct from a scientific viewpoint, or at least open to a wide-ranging and troublesome interpretation.

We would think that the science community would want to demonstrate its expertise on issues of science and not use terms which are not correct from a scientific point of view.

They follow by saying: My proposed prohibition is technically correct and focused on the cloning issue. Several individuals have raised questions about the definitions that I have put forward, and I need to be very clear that those definitions come from recognized sources, from the National Bioethics Advisory Committee, from the Biotechnology Industrial Organization, from the American Society of Reproductive Medicine, both of which have endorsed this proposal, as well as from the Bantam Medical Dictionary.

I feel very comfortable that this is language that is widely understood and widely respected.

Secondly, I think it is important that, as we heard from the Biotechnology Advisory Committee, it is important that we listen to what they have to say.

It is, unfortunately, a real problem in public life these days that Committees are continually seated only to be ignored after they have done their work and made their reports.

The National Bioethics Advisory Committee was very clear in what they were suggesting about what they thought should be done, and frankly they did not address the issue of embryonic research that the maker of the proposal is so interested in.

I am particularly concerned that the Ehlers' bill unnecessarily embroils the Committee in the controversy around human embryo research.

As I said, NBAC did not deal with the issue. They consciously avoided reopening the debate on the embryo research.

The maker of the proposal mentioned the President a few minutes ago, but the President did not speak to embryonic research in his cloning bill; he also left that for another time.

I am also concerned that the Ehlers' language creates conflict in that it is different language than is currently contained in the law or the legislative ban.

Secondly, the Biotechnology Industry Association has characterized the Ehlers amendment as overbroad, inconsistent with the recommendations of the National Bioethics Advisory Committee, and jeopardizing to vital biomedical research.

The Ehlers' ban on federally funded human embryo research is a permanent ban, as opposed to the year-by-year ban currently contained in the Labor/HHS appropriations bill.

It is inappropriate to enact a permanent ban, given the rapid and unpredictable pace of biomedical research.

In all, this amendment would make clear scientific definitions for the terms used within the bill. It would be respectful of the proposals that have come back to us from the National Bioethics Advisory Committee work.

It would allow the existing legislative ban on embryonic research to continue without being complicated by a second standard being created by a different Committee, and it would allow the scientific

research to go on as I believe NBAC and other organizations have urged us.

I would urge people to recognize that this does not create the ability for scientists today to do embryonic research. That ban is still in legislative existence. It simply clarifies scope of the Science Committee's recommendations on this issue.

Thank you.

[The voting bells ring.]

Chairman SENSENBRENNER. What would the gentleman from California like us to do relating to a recess?

Mr. BROWN of California. I think we should recess now and come back. We might have time to finish the bill if we come back.

Chairman SENSENBRENNER. Okay. I have conferred with the gentleman from California. The Chair is about ready to declare the Committee in recess.

I would ask all members to come back very promptly after this vote so that we can finish the bill before half of the Committee goes to celebrate.

So without objection, the Committee is in recess. I would ask members to really make an effort to come back promptly.

[Brief recess.]

Chairman SENSENBRENNER. The Committee will be in order.

Pending at the time of the recess were the Rivers' En Bloc Amendments to the Ehlers' Amendment in the nature of a substitute.

Does anybody else seek recognition?

The gentleman from Maryland, Mr. Bartlett.

Mr. BARTLETT. Thank you very much, Mr. Chairman.

We had a series of hearings on this subject and witnesses from a wide spectrum of interests. I think that there was near consensus on three issues.

One was that we have had a long debate on embryo research and there is existing legislation which prohibits the use of federal funds in embryo research.

The second consensus was that the President's moratorium on using federal funds for cloning humans is working.

And the third consensus was that this is a very important area that we need an expanded dialogue in so that when we pass legislation we are very sure that we have carefully crafted legislation that will do what we want to do and will not do some things that are not intended.

I think from the discussion today it is obvious that there is not unanimity on what the appropriate language is.

I really regret that we have this bill before us now because I think that it is so important that we should have had more of a public dialogue and more opportunity for input before we bring a bill to a vote.

I am debating whether or not I can support the bill in its final form, not because I do not support the intent of the bill, but because I am concerned that we have not had time for adequate dialogue so that we can carefully draft the language so that we will accomplish just what we want to accomplish and nothing more.

Thank you very much, Mr. Chairman.

Chairman SENSENBRENNER. The gentleman's time has expired.

The gentleman from Michigan, Mr. Ehlers.

Mr. EHLERS. Thank you, Mr. Chairman.

I wish to respond to the two previous speakers.

Chairman SENSENBRENNER. The gentleman is recognized for 5 minutes.

Mr. EHLERS. First, I would simply comment on the matter of discussions and hearings.

The gentlewoman from Maryland, Mrs. Morella, Chairwoman of the Technology Subcommittee, has been very conscientious on this point and has held three hearings on the topic, all of which went on at some length.

We examined the issues thoroughly. We had one hearing shortly after the announcement of the birth of Dolly; another hearings after the National Bioethics Advisory Commission Report, and another hearing on this bill itself. So there has been a good deal of discussion.

In addition to that, Mrs. Morella has met with many individuals interested in this issue, and so have I had many individual conferences and talked to individuals about it. So there has been both public discussion of it and private discussions.

In response to the amendment proposed by the gentlewoman from Michigan, a colleague of mine from Ann Arbor, I have to oppose her amendment.

These definitions are not new. I have looked at them before. The biotech industry had proposed them to me earlier.

I tried preparing a bill incorporating them and ran into a number of snags after discussing them with other members and other interested parties.

For example, it goes far beyond the stated intent of simply not mentioning embryos. It basically says that nothing is prohibited except cloning a human being and implanting the resulting product for gestation and subsequent birth.

That is a very broad-based definition. That provides the greatest amount of latitude. Is the PA system working, by the way? It does not sound like it.

Testing? Good.

The biotech industry of course wants the widest possible latitude, and this definition would give them the widest possible latitude. I believe it is important not just to respond to industry concerns but the concerns of society as a whole, as well. Therefore I oppose this amendment.

I believe it would allow considerable experimentation on embryos, and one could even read into it that there could be experimentation after implanting because of the words `its implantation of the resulting product for gestation and subsequent birth.'

I would also like to address the comments made by the gentlewoman from Ann Arbor about the NBAC report, the National Bioethics Advisory Commission, saying that they did not say anything about embryos and therefore we should not, either.

In fact, when we had the hearing and the members of NBAC who were present presented the recommendations of the Commission to us, they were specifically asked that question by a member of the

Committee--not myself--and their response was, they did not enter into the discussion----

We seem to have lost our sound again.

We did not enter into a discussion--or they did not enter into a discussion of embryos for two reasons. First of all, they did not have the time to do so. They were on a very short schedule for 90 days and they had a great deal to do, and they decided not to address that issue.

The second reason was, they felt the issue was already resolved by the legislation that is in place in the appropriations bills of Labor/HHS, and therefore that was the law of the land and that the industry would have to work within the law of the land.

That is one of the major reasons I decided to simply use that language in addressing the concern of individuals about cloning of embryos.

So I would urge the Committee to reject the Rivers' amendment and to stick with the language that is in the substitute that I have offered.

Thank you, Mr. Chairman.

Chairman SENSENBRENNER. The question is on the Rivers' Amendments en block to the Ehlers Amendment in the nature of a substitute.

Those in favor of the Rivers' Amendment will signify by saying, aye.

[Chorus of ayes.]

Chairman SENSENBRENNER. Opposed, no.

[Chorus of nays.]

Chairman SENSENBRENNER. The noes appear to have it. The noes have it, and the amendment is not agreed to.

Are there further amendments?

The gentlewoman from Michigan, Ms. Rivers.

Ms. RIVERS. Thank you, Mr. Chair.

First, I would like unanimous consent to withdraw amendments number two and number four----

Chairman SENSENBRENNER. The gentlewoman does not need that consent because she has not offered them yet.

Ms. RIVERS. Thank you, Mr. Chair.

Then I would like to offer Amendment No. 3----

Chairman SENSENBRENNER. The Clerk will report the amendment.

Ms. SCHWARTZ. `Rivers Amendment to the Ehlers Amendment In The Nature of A Substitute'----

Ms. RIVERS. I would ask that it be treated as read.

Chairman SENSENBRENNER. Well, let the Clerk read to make sure that the Clerk has got the right amendment.

Ms. SCHWARTZ (continuing). `to H.R. 922. At the end of the amendment, insert the following:

`SEC. 4. PROTECTED SCIENTIFIC RESEARCH. Nothing in this Act shall restrict other areas'----

I would ask that it be considered as read.

Chairman SENSENBRENNER. Without objection, the amendment will be considered as read, and the gentlewoman from Michigan is recognized for 5 minutes.

[The text of the amendment follows:]

Insert offset folio 42

001

Ms. RIVERS. I need only a moment, Mr. Chair, to say that I would ask unanimous consent to change this amendment in a single fashion, which is, under Subsection [1] under SECTION 4., the use of somatic cell nuclear transfer or other cloning technologies to clone molecules, DNA or human embryo cells.

Mr. EHLERS. You mean cells other than human embryo cells?

Ms. RIVERS. Cells other than human embryo.

Chairman SENSENBRENNER. Without objection, the amendment is modified as described.

[No response.]

Chairman SENSENBRENNER. Hearing none, so ordered and the gentlewoman from Michigan is recognize.

Ms. RIVERS. Thank you. This is to make clear that, while there are prohibitions within the larger part of the bill, this is to make clear that this specific scientific inquiry and research is specifically protected under the bill.

It makes a clear statement about activities that are going on and our desire to see them continue and to make clear that they are not prohibited in any way by this provision.

Thank you.

Chairman SENSENBRENNER. The gentlewoman yields back the balance of her time.

The gentleman from Michigan, Mr. Ehlers----

Mr. EHLERS. Thank you, Mr. Chairman. In the interests of time----

Chairman SENSENBRENNER (continuing). Is recognized for 5 minutes.

Mr. EHLERS. Thank you. In the interests of time, and in view of the fact that I previously offered something along this line to the industry, in view of my stated objective of making clear that research other than human cloning would be permitted, I believe I can accept this amendment.

I do have some question about the precise wording, and if the author or sponsor of the amendment will recognize that I do have some concerns about the precise working and may want to reword it as it goes through the process of first the Commerce Committee and then to the Floor, I am willing to accept the amendment and say I am accepting the intent and we may have to deal with some wording changes later on.

Chairman SENSENBRENNER. The gentleman yields back.

The question is on--the gentleman from Florida, Mr. Weldon?

Mr. WELDON of Florida. Mr. Chairman, if I could be recognized for a question?

Chairman SENSENBRENNER. The gentleman is recognized for 5 minutes.

Mr. WELDON of Florida. Is the intent here to allow research to cultivate skin cells and that sort of thing? Is that the purpose or intent of this amendment? If the lady would respond?

Ms. RIVERS. Thank you. Yes. The Ehlers amendment is written in the form of a prohibition of certain kinds of activities are not to be pursued. This is to make clear that certain other kinds of activities are specifically protected.

That is, to protect all of the nonembryonic research that is going on. So non-embryonic cells, nonreproductive cell work that may be going on is still protected and still encouraged.

Mr. WELDON of Florida. I thank the lady.

Chairman SENSENBRENNER. The question is on the Rivers' amendment to the Ehlers amendment in the nature of a substitute.

Those in favor will signify by saying, aye.

[Chorus of ayes.]

Chairman SENSENBRENNER. Opposed, no?

[No response.]

Chairman SENSENBRENNER. The ayes have it, and the amendment is agreed to.

Are there further amendments to the bill?

[No response.]

Chairman SENSENBRENNER. The question is on the Ehlers amendment in the nature of a substitute. Those in favor will signify by saying, aye.

[Chorus of ayes.]

Chairman SENSENBRENNER. Opposed, no?

[Chorus of nays.]

Chairman SENSENBRENNER. The ayes appear to have it. The ayes have it, and the amendment in the nature of a substitute as amended is agreed to.

Are there further amendments to the bill?

[No response.]

Chairman SENSENBRENNER. If not, the Chair will recognize a Member for a motion to report.

The gentleman from California, Mr. Brown.

Mr. BROWN of California. I move the Committee report the bill H.R. 922, Human Cloning Research Prohibition Act As Amended. Furthermore, I move to instruct the staff to prepare the legislative report, to make technical and conforming amendments, and that the Chairman take all necessary steps to bring the bill before the House for consideration.

Chairman SENSENBRENNER. The question is on the motion. The Chair notes the presence of a reporting quorum, barely. Those in favor will signify by saying, aye.

[Chorus of ayes.]

Chairman SENSENBRENNER. Opposed, no?

[Chorus of nays.]

Chairman SENSENBRENNER. The ayes appear to have it. The ayes have it, and the bill is reported.

Without objection, the motion to reconsider is laid upon the table.

Without objection, the members will have 2 subsequent calendar days in which to submit Supplemental, Minority or Additional views on the measure.

Without objection, pursuant to Clause 1 of Rule 20 of the Rules of the House of Representatives, the Committee authorizes the Chairman to offer such motions as may be necessary in the House to go to Conference with the Senate on the bill.

Are there any objections to any of these unanimous consent requests?

[No response.]

Chairman SENSENBRENNER. Hearing none, so ordered.

The Chair would like to thank all members for their cooperation in getting the business completed expeditiously. Democrats, have fun. This Committee is in recess.

[Whereupon, at 2:10 p.m., Tuesday, July 29, 1997, the Committee was recessed, to reconvene at 10:00 a.m., July 30, 1997.]