Expanding Approved Stem Cell Lines in Ethically Responsible Ways, 34591-34593 [07-3112]

Agencies

• Executive Office of the President
• Presidential Documents

[Federal Register Volume 72, Number 120 (Friday, June 22, 2007)]
[Presidential Documents]
[Pages 34591-34593]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-3112]



[[Page 34589]]

-----------------------------------------------------------------------

Part III





The President





-----------------------------------------------------------------------



Executive Order 13435--Expanding Approved Stem Cell Lines in Ethically 
Responsible Ways


                        Presidential Documents 



Federal Register / Vol. 72, No. 120 / Friday, June 22, 2007 / 
Presidential Documents

___________________________________________________________________

Title 3--
The President

[[Page 34591]]

                Executive Order 13435 of June 20, 2007

                
Expanding Approved Stem Cell Lines in Ethically 
                Responsible Ways

                By the authority vested in me as President by the 
                Constitution and the laws of the United States of 
                America, and to provide leadership with respect to 
                research on pluripotent stem cells derived by ethically 
                responsible techniques so that the potential of 
                pluripotent stem cells can be explored without 
                violating human dignity or demeaning human life, it is 
                hereby ordered as follows:

                Section 1. Research on Alternative Sources of 
                Pluripotent Stem Cells. (a) The Secretary of Health and 
                Human Services (Secretary) shall conduct and support 
                research on the isolation, derivation, production, and 
                testing of stem cells that are capable of producing all 
                or almost all of the cell types of the developing body 
                and may result in improved understanding of or 
                treatments for diseases and other adverse health 
                conditions, but are derived without creating a human 
                embryo for research purposes or destroying, discarding, 
                or subjecting to harm a human embryo or fetus.

                (b) Within 90 days of this order, the Secretary, after 
                such consultation with the Director of the National 
                Institutes of Health (Director), shall issue a plan, 
                including such mechanisms as requests for proposals, 
                requests for applications, program announcements and 
                other appropriate means, to implement subsection (a) of 
                this section, that:

(i) specifies and reflects a determination of the extent to which specific 
techniques may require additional basic or animal research to ensure that 
any research involving human cells using these techniques is clearly 
consistent with the standards established under this order and applicable 
law;

(ii) prioritizes research with the greatest potential for clinical benefit;

(iii) takes into account techniques outlined by the President's Council on 
Bioethics, and any other appropriate techniques and research, provided they 
clearly meet the standard set forth in subsection (a) of this section;

(iv) renames the ``Human Embryonic Stem Cell Registry'' the ``Human 
Pluripotent Stem Cell Registry;'' and

(v) adds to the registry new human pluripotent stem cell lines that clearly 
meet the standard set forth in subsection (a) of this section.

                (c) Not later than December 31 of each year, the 
                Secretary shall report to the President on the 
                activities carried out under this order during the past 
                fiscal year, including a description of the research 
                carried out or supported by the Department of Health 
                and Human Services, including the National Institutes 
                of Health, and other developments in the science of 
                pluripotent stem cells not derived from human embryos.

                Sec. 2. Policy. The activities undertaken and supported 
                by and under the direction of the Secretary shall be 
                clearly consistent with the following policies and 
                principles:

                (a) the purposes of this order are (i) to direct the 
                Department of Health and Human Services, including the 
                National Institutes of Health, to intensify peer 
                reviewed research that may result in improved 
                understanding of or treatments for diseases and other 
                adverse health conditions, and (ii) to promote the 
                derivation of human pluripotent stem cell lines from a 
                variety

[[Page 34592]]

                of alternative sources while clearly meeting the 
                standard set forth in section 1(a) of this order;

                (b) it is critical to establish moral and ethical 
                boundaries to allow the Nation to move forward 
                vigorously with medical research, while also 
                maintaining the highest ethical standards and 
                respecting human life and human dignity;

                (c) the destruction of nascent life for research 
                violates the principle that no life should be used as a 
                mere means for achieving the medical benefit of 
                another;

                (d) human embryos and fetuses, as living members of the 
                human species, are not raw materials to be exploited or 
                commodities to be bought and sold; and

                (e) the Federal Government has a duty to exercise 
                responsible stewardship of taxpayer funds, both 
                supporting important medical research and respecting 
                ethical and moral boundaries.

                Sec. 3. Interpretation of this Order. (a) For purposes 
                of this order, the term ``human embryo'' shall mean any 
                organism, not protected as a human subject under 45 CFR 
                46 as of the date of this order, that is derived by 
                fertilization, parthenogenesis, cloning, or any other 
                means from one or more human gametes or human diploid 
                cells.

                (b) For purposes of this order, the term ``subjecting 
                to harm a human embryo'' shall mean subjecting such an 
                embryo to risk of injury or death greater than that 
                allowed for research on fetuses in utero under 45 CFR 
                46.204(b) and section 498(b) of the Public Health 
                Service Act (42 U.S.C. 289g(b)) as of the date of this 
                order.

                (c) Nothing in this order shall be construed to affect 
                any policy, guideline, or regulation regarding 
                embryonic stem cell research, human cloning by somatic 
                cell nuclear transfer, or any other research not 
                specifically authorized by this order, or to forbid the 
                use of existing stem cell lines deemed eligible for 
                other federally funded research in accordance with the 
                presidential policy decision of August 9, 2001, for 
                research specifically authorized by this order.

                Sec. 4. General Provisions. (a) This order shall be 
                implemented consistent with applicable law and subject 
                to the availability of appropriations.

[[Page 34593]]

                (b) This order is not intended to, and does not, create 
                any right, benefit, or privilege, substantive or 
                procedural, enforceable at law or in equity, by any 
                party against the United States, its departments, 
                agencies, or entities, its officers, employees, or 
                agents, or any other person.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    June 20, 2007.

[FR Doc. 07-3112
Filed 6-21-07; 11:09 am]
Billing code 3195-01-P