Optimizing the Security of Biological Select Agents and Toxins in the United States

This executive order directs a risk-based overhaul of how the U.S. regulates dangerous biological agents and toxins (BSAT). It mandates creating a highest-risk "Tier 1" subset of pathogens, revising security regulations, coordinating federal oversight across multiple agencies, and establishing an advisory panel to guide implementation.

Federal Register Open PDF 75 FR 39439

Impact dates

Date TBD
Agencies review inconsistent requirements (6 months after final rules)
Date TBD
Annual review of inconsistent requirements thereafter
Date TBD
Biennial review by National Security Staff
Jul 2, 2014
Panel charter expires (4 years, renewable)
Oct 2, 2012
Final rules and guidance for Tier 1 due
Dec 2, 2011
Tier 1 designation and graded protection options due
Oct 2, 2011
Proposed amendments to SAR for Tier 1 due
Jan 2, 2011
Coordinated BSAT security oversight plan due
Jan 2, 2011
SAP information-sharing process and criteria due
Nov 2, 2010
Panel consensus recommendations due

Key directives

Establish Federal Experts Security Advisory Panel with 16+ agency representatives (HHS and USDA as Co-Chairs)
Panel to provide consensus recommendations within 4 months on Tier 1 designation, list reduction, personnel reliability practices, physical/cyber security standards
DHS to chair Working Group on laboratory critical infrastructure security standards
HHS and USDA Secretaries to designate Tier 1 agents within 18 months and explore graded protection options
HHS and USDA to propose Tier 1-specific security regulation amendments within 15 months
HHS and USDA to promulgate final Tier 1 rules and guidance within 27 months
Agency heads to develop coordinated inspection and oversight plan within 6 months
Agencies to review and eliminate inconsistent requirements within 6 months of final rules, annually thereafter
HHS, USDA, and DOJ to develop SAP information-sharing process within 6 months
National Security Staff to conduct biennial implementation reviews

Who is ordered

Timeline

Immediate

Establishment of Federal Experts Security Advisory Panel within HHS
Panel must provide consensus recommendations within 4 months

Near term (90d)

Panel consensus recommendations due on Tier 1 designation, list reduction, personnel reliability, physical/cyber security (by 2010-11-02)
Federal agencies must develop coordinated BSAT security oversight plan within 6 months (by 2011-01-02)
SAP information-sharing process and criteria due within 6 months (by 2011-01-02)

Long term

Tier 1 designation and graded protection options due within 18 months (by 2011-12-02)
Proposed amendments to Select Agent Regulations for Tier 1 due within 15 months (by 2011-10-02)
Final rules and guidance for Tier 1 security due within 27 months (by 2012-10-02)
Agencies must review and rescind inconsistent requirements within 6 months of final rules, then annually
Biennial review of EO implementation by National Security Staff
Panel chartered for 4 years with renewal option

Risks & tensions

Vague enforcement mechanism: EO uses 'request' language in Section 5 rather than mandatory directive for rulemaking
Potential interagency friction: 16 agencies on Panel with consensus requirement; unresolved issues escalated through NSS process
Balancing act between security and research productivity explicitly acknowledged as policy tension
Personnel reliability standards for Tier 1 could raise civil liberties concerns if not carefully scoped
Information-sharing mandate (Section 8) creates tension with Privacy Act protections explicitly noted
Panel's 4-year charter with renewal uncertainty may create discontinuity in technical expertise