[Weekly Compilation of Presidential Documents Volume 43, Number 25 (Monday, June 25, 2007)]
[Pages 834-835]
[Online from the Government Publishing Office, www.gpo.gov]

<R04>
Executive Order 13435--Expanding Approved Stem Cell Lines in Ethically 
Responsible Ways

June 20, 2007

    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

[[Page 835]]

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 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.
    (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.
                                                George W. Bush
 The White House,
 June 20, 2007.

 [Filed with the Office of the Federal Register, 11:09 a.m., June 21, 
2007]

Note: This Executive order was published in the Federal Register on June 
22.