Expanding Approved Stem Cell Lines in Ethically Responsible Ways

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

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.

    (Presidential Sig.)

THE WHITE HOUSE,

    June 20, 2007.