Presidential DocumentExecutive Order 135462010-16864
Optimizing the Security of Biological Select Agents and Toxins in the United States
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Published
July 8, 2010
Signed
July 2, 2010
Issuing agencies
Executive Office of the President
Full Text
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<title>Federal Register, Volume 75 Issue 130 (Thursday, July 8, 2010)</title>
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[Federal Register Volume 75, Number 130 (Thursday, July 8, 2010)]
[Presidential Documents]
[Pages 39439-39442]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2010-16864]
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Part VII
The President
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Executive Order 13546--Optimizing the Security of Biological Select
Agents and Toxins in the United States
Presidential Documents
Federal Register / Vol. 75, No. 130 / Thursday, July 8, 2010 /
Presidential Documents
___________________________________________________________________
Title 3--
The President
[[Page 39439]]
Executive Order 13546 of July 2, 2010
Optimizing the Security of Biological Select
Agents and Toxins in the United States
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:
Section 1. Policy. It is the policy of the United
States that:
(a) A robust and productive scientific enterprise
that utilizes biological select agents and toxins
(BSAT) is essential to national security;
(b) BSAT shall be secured in a manner appropriate
to their risk of misuse, theft, loss, and accidental
release; and
(c) Security measures shall be taken in a
coordinated manner that balances their efficacy with
the need to minimize the adverse impact on the
legitimate use of BSAT.
Sec. 2. Definitions. (a) ``Select Agent Program'' (SAP)
means the regulatory oversight and administrative
activities conducted by the Secretaries of Health and
Human Services and Agriculture and the Attorney General
to implement the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 and
the Agricultural Bioterrorism Protection Act of 2002.
(b) ``Select Agent Regulations'' (SAR) means the
Federal regulations found in Part 73 of Title 42 of the
Code of Federal Regulations, Part 331 of Title 7 of the
Code of Federal Regulations, and Part 121 of Title 9 of
the Code of Federal Regulations.
(c) ``Biological Select Agents and Toxins'' means
biological agents and toxins with the potential to pose
a severe threat to public health and safety, animal and
plant health, or animal and plant products and whose
possession, use, and transfer are regulated by the
Department of Health and Human Services and the
Department of Agriculture under the SAR.
Sec. 3. Findings. (a) The use of BSAT presents the risk
that BSAT might be lost, stolen, or diverted for
malicious purpose. The SAP exists to provide effective
regulatory oversight of the possession, use, and
transfer of BSAT that reduces the risk of their misuse
or mishandling. The absence of clearly defined, risk-
based security measures in the SAR/SAP has raised
concern about the need for optimized security and for
risk management.
(b) In addition, variations in, and limited
coordination of, individual executive departments' and
agencies' oversight, security practices, and
inspections have raised concerns that the cost and
complexity of compliance for those who are registered
to work with BSAT could discourage research or other
legitimate activities.
(c) Understanding that research and laboratory work
on BSAT is essential to both public health and national
security, it is in the interest of the United States to
address these issues.
Sec. 4. Risk-based Tiering of the Select Agent List. To
help ensure that BSAT are secured according to level of
risk, the Secretaries of Health and Human Services and
Agriculture shall, through their ongoing review of the
biological Select Agents and Toxins List (``Select
Agent List'') contained in regulations, and no later
than 18 months from the date of this order:
(a) designate a subset of the Select Agent List
(Tier 1) that presents the greatest risk of deliberate
misuse with most significant potential for mass
casualties or devastating effects to the economy,
critical infrastructure, or public confidence;
[[Page 39440]]
(b) explore options for graded protection of Tier 1
agents and toxins as described in subsection (a) of
this section to permit tailored risk management
practices based upon relevant contextual factors; and
(c) consider reducing the overall number of agents
and toxins on the Select Agent List.
Sec. 5. Revision of Regulations, Rules, and Guidance to
Accommodate a Tiered Select Agent List. Consistent with
section 4 of this order, I request that:
(a) The Secretaries of Health and Human Services
and Agriculture, no later than 15 months from the date
of this order, propose amendments to their respective
parts of the SAR that would establish security
standards specific to Tier 1 agents and toxins.
(b) The Secretaries of Health and Human Services
and Agriculture each, no later than 27 months from the
date of this order, promulgate final rules and guidance
that clearly articulate security actions for
registrants who possess, use, or transfer Tier 1 agents
and toxins.
Sec. 6. Coordination of Federal Oversight for BSAT
Security. To ensure that the policies and practices
used to secure BSAT are harmonized and that the related
oversight activities of the Federal Government are
coordinated, the heads of executive departments and
agencies identified in section 7(a)(ii) of this order
shall:
(a) no later than 6 months from the date of this
order, develop and implement a plan for the
coordination of BSAT security oversight that:
(i) articulates a mechanism for coordinated and reciprocal inspection of
and harmonized administrative practices for facilities registered with the
SAP;
(ii) ensures consistent and timely identification and resolution of BSAT
security and compliance issues;
(iii) facilitates information sharing among departments and agencies
regarding ongoing oversight and inspection activities; and
(iv) provides for comprehensive and effective Federal oversight of BSAT
security; and
(b) no later than 6 months from the issuance of
final rules and guidance as described in section 5 of
this order, and annually thereafter, review for
inconsistent requirements and revise or rescind, as
appropriate, any regulations, directives, guidance, or
policies regarding BSAT security within their
department or agency that exceed those in the updated
SAR and guidance as described in section 5 of this
order.
Sec. 7. Implementation. (a) Establishment, Operation,
and Functions of the Federal Experts Security Advisory
Panel.
(i) There is hereby established, within the Department of Health and Human
Services for administrative purposes only, the Federal Experts Security
Advisory Panel (Panel), which shall make technical and substantive
recommendations on BSAT security concerning the SAP.
(ii) The Panel shall consist of representatives from the following, who may
consult with additional experts from their department or agency as
required:
1. the Department of State;
2. the Department of Defense;
3. the Department of Justice;
4. the Department of Agriculture (Co-Chair);
5. the Department of Commerce;
6. the Department of Health and Human Services (Co-Chair);
7. the Department of Transportation;
8. the Department of Labor;
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9. the Department of Energy;
10. the Department of Veterans Affairs;
11. the Department of Homeland Security;
12. the Environmental Protection Agency;
13. the Office of the Director of National Intelligence;
14. the Office of Science and Technology Policy;
15. the Joint Chiefs of Staff; and
16. any other department or agency designated by the Co-Chairs.
(iii) To assist the Secretaries of Health and Human Services and
Agriculture and the Attorney General in implementing the policies set forth
in sections 1, 4, 5, and 6 of this order, the Panel shall, no later than 4
months from the date of this order, provide consensus recommendations
concerning the SAP on:
1. the designation of Tier 1 agents and toxins;
2. reduction in the number of agents on the Select Agent List;
3. the establishment of appropriate practices to ensure reliability of
personnel with access to Tier 1 agents and toxins at registered facilities;
4. the establishment of appropriate practices for physical security and
cyber security for facilities that possess Tier 1 agents. The Department of
Homeland Security shall Chair a Working Group of the Panel that develops
recommended laboratory critical infrastructure security standards in these
areas; and
5. other emerging policy issues relevant to the security of BSAT.
Thereafter, the Panel shall continue to provide technical advice concerning
the SAP on request.
(iv) If the Panel is unable to reach consensus on recommendations for an
issue within its charge, the matter shall be resolved through the
interagency policy committee process led by the National Security Staff.
(v) The Secretaries of Health and Human Services and Agriculture and the
Attorney General shall report to the Assistant to the President for
Homeland Security and Counterterrorism on the consideration and
implementation of Panel recommendations concerning the SAP, including a
rationale for failure to implement any recommendations.
(vi) The Panel shall be chartered for a period of 4 years subject to
renewal through the interagency policy committee process led by the
National Security Staff.
(b) To further assist the Secretaries of Health and
Human Services and Agriculture and the Attorney General
in implementing the policy set forth in sections 1, 4,
5, and 6 of this order, the National Science Advisory
Board for Biosecurity shall provide technical advice
and serve as a conduit for public consultation, as
needed, on topics of relevance to the SAP.
Sec. 8. Sharing of Select Agent Program Information.
(a) Consistent with applicable laws and regulations,
the Secretaries of Health and Human Services and
Agriculture and the Attorney General shall, no later
than 6 months from the date of this order, develop a
process and the criteria for making SAP information
available to executive departments and agencies when
such information is necessary for furthering a public
health, safety, security, law enforcement, or national
security mission.
(b) SAP information shall continue to be
safeguarded properly and handled securely to minimize
the risk of disclosing sensitive, personal, and other
information protected by the Privacy Act, 5 U.S.C.
552a.
Sec. 9. General Provisions. (a) The National Security
Staff shall, on a biennial basis, review the
implementation and effectiveness of this order and
refer to the interagency policy committee process any
issues that require further deliberation or
adjudication.
[[Page 39442]]
(b) Nothing in this order shall be construed to
impair or otherwise affect the authority granted by law
to a department or agency, or the head thereof, or
functions of the Director of the Office of Management
and Budget relating to budgetary, administrative, or
legislative proposals.
(c) This order shall be implemented consistent with
applicable law and subject to the availability of
appropriations.
(d) This order is not intended to, and does not,
create any right or benefit, 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.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
(Presidential Sig.)
THE WHITE HOUSE,
July 2, 2010.
[FR Doc. 2010-16864
Filed 7-7-10; 11:15 am]
Billing code 3195-W0-P
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</html>Indexed from Federal Register on July 8, 2010.
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