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

President: George W. Bush

Directed HHS to support pluripotent stem-cell research using methods that did not create embryos for research or destroy, discard or harm embryos or fetuses.

Status: Revoked.

Is Executive Order 13435 still in effect? No. EO 13505 expressly revoked it in section 5(b) on March 9, 2009 and directed a new NIH guidance process, subject to law and appropriations. EO 13505, sections 2–5.

What does Executive Order 13435 do?

In 2007, the order directed HHS to conduct and support pluripotent stem-cell research using techniques that avoided creating embryos for research or destroying, discarding or harming embryos or fetuses. It sought alternative ways to obtain cells capable of developing into different tissue types while maintaining the administration’s embryo-related limits. It did not simply open federal funding to additional embryo-derived lines. Signed order, sections 1–3.

HHS was to prioritize likely clinical benefit while assessing needed basic and animal research, consider techniques discussed by the President’s Council on Bioethics, and rename and expand the registry with qualifying lines. NIH’s December 13, 2007 funding announcement sought non-embryonic pluripotent-cell research, including reprogrammed somatic cells and amniotic-fluid cells. An invitation for applications documents an agency step, not a resulting grant award or effective treatment. Historical NIH announcement PA-08-043.

EO 13505 expressly revoked EO 13435 in March 2009 and directed a new NIH policy process for human stem-cell research.

Administration position: The later order changed executive research direction subject to law and appropriations; it did not itself authorize all stem-cell research.
SignedJune 20, 2007
Original directionDirected HHS to support pluripotent stem-cell research using methods that did not create embryos for research or destroy, discard or harm embryos or fetuses.
Later evidenceEO 13505 expressly revoked EO 13435 in March 2009 and directed a new NIH policy process for human stem-cell research.
Review dateSeptember 26, 2026

Before and after

Before the order

Earlier executive policy limited federal funding to eligible stem-cell lines.

After the order

The immediate 2007 change was a federal research initiative for qualifying alternative-source cells, with a 90-day HHS plan and annual reporting. Section 3(c) left the August 9, 2001 policy on embryonic research intact. EO 13435, sections 1 and 3.

EO 13505 expressly revoked EO 13435 in March 2009 and directed a new NIH policy process for human stem-cell research.

The later order changed executive research direction subject to law and appropriations; it did not itself authorize all stem-cell research.

Who had to do what

Source: Signed Federal Register text.
Agency / officeActionTiming / position
Secretary of Health and Human ServicesConduct and support research on pluripotent stem cells obtained without creating embryos for research or destroying, discarding, or harming an embryo or fetus; issue an implementation plan after consulting the NIH Director, prioritize clinical benefit, rename the registry, and add qualifying lines. Report activities to the President.Plan within 90 days of June 20, 2007; report by December 31 each year on the preceding fiscal year.
Director of the National Institutes of HealthServe as the HHS Secretary’s consultation partner for the research implementation plan; NIH research falls within the Secretary’s program and annual report.Consultation for the plan due within 90 days; no separate NIH deadline.

The HHS and NIH directions are in sections 1–2. The President’s Council on Bioethics was a source of techniques HHS had to consider, not the recipient of a new dated deliverable. Signed sections 1–2.

What happened next

EO 13435 was signed with a 90-day implementation-plan requirement and December 31 annual-report deadline. Official source.

NIH issued PA-08-043 inviting non-embryonic human pluripotent stem-cell research applications under the order. Official source.

NIH announced a historical one-year administrative-revision opportunity for existing grantees, with an April 1, 2008 receipt deadline. Official source.

EO 13505 section 5(b) revoked EO 13435 and required new NIH guidance within 120 days. Official source.

NIH guidelines under the successor order took effect; the release notice was dated July 6. Official source.

NIH announced a pause on reviewing and approving new embryonic stem-cell registry lines during an assessment. The notice allowed previously approved lines to remain usable in NIH-funded research; it did not revive EO 13435. Official source.