Government operations and workforce

Executive Order 13546: Optimizing the Security of Biological Select Agents and Toxins in the United States

President: Barack Obama

Directed agencies to strengthen and harmonize security for dangerous biological agents while preserving legitimate research and diagnostics.

Status: In effect. Is Executive Order 13546 still in effect? Yes. Executive Order 13546 remains an unrevoked select-agent security and oversight directive. The current Federal Register disposition table lists no revocation, and the Federal Select Agent Program identifies its continuing interagency inspection and information-sharing framework alongside the regulations implementing its Tier 1 security requirements. Sources: Current Federal Register executive order disposition table: 2010; Executive Order 13546: signed Federal Register text; Federal Select Agent Program: Executive Order 13546 implementation.

What does Executive Order 13546 do?

EO 13546 created a federal working group to review the Select Agent Program, tier agents by risk, improve personnel reliability, inspections and information sharing and avoid unnecessary burdens on lower-risk work. HHS and Agriculture incorporated risk-tiering and security changes into regulations.

Administration position: The order tightened custody and access controls; it did not ban lawful research with every listed organism.
SignedJuly 2, 2010
Lead departmentsHHS and Agriculture
Review deadlineFour months

Before and after

Before the order

Select-agent rules used less differentiated security requirements across diverse biological risks.

After the order

A Tier 1 category and enhanced security, reliability and inspection measures targeted the highest-risk agents.

Who had to do what

Agency / officeActionTiming / position
Federal working groupReview and recommend reformsCompleted
HHS and AgricultureRegulate and inspect registered entitiesContinuing
LaboratoriesMeet registration access biosafety and security dutiesContinuing

What happened next

EO 13546 signed.

The Federal Select Agent Program published the final rule implementing Tier 1 agents, personnel suitability and security requirements recommended under Executive Order 13546. Official source.