[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 [www.gpo.gov]
[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
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                         Presidential Documents 
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  Federal Register / Vol. 75, No. 130 / Thursday, July 8, 2010 / 
Presidential Documents  

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 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.

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                    (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.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    July 2, 2010.

[FR Doc. 2010-16864
Filed 7-7-10; 11:15 am]
Billing code 3195-W0-P