Toxin in the United States

Executive Order 13546

Executive Order in relation with Optimizing the Security of Biological Select Agents and Toxins in the United States (July 02, 2010):

“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;

(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;

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.”

Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction

ENTRY INTO FORCE: 26 March 1975

The States Parties to this Convention,

Determine to act with a view to achieving effective progress toward general
and complete disarmament, including the prohibition and elimination of all
types of weapons of mass destruction, and convinced that the prohibition of
the development, production and stockpiling of chemical and bacteriological
(biological) weapons and their elimination, through effective measures,
will facilitate the achievement of general and complete disarmament under
strict and effective control,

Recognizing the important significance of the Protocol for the Prohibition
of the Use in War of Asphyxiating, Poisonous or Other Gases, and of
Bacteriological Methods of Warfare, signed at Geneva on June 17, 1925, and
conscious also of the contribution which the said Protocol has already made
and continues to make, to mitigating the horrors of war,

Reaffirming their adherence to the principles and objectives of that
Protocol and calling upon all States to comply strictly with them,

Recalling that the General Assembly of the United Nations has repeatedly
condemned all actions contrary to the principles and objectives of the
Geneva Protocol of June 17, 1925,

Desiring to contribute to the strengthening of confidence between peoples
and the general improvement of the international atmosphere,

Desiring also to contribute to the realization of the purposes and
principles of the Charter of the United Nations,

Convinced of the importance and urgency of eliminating from the arsenals of
States, through effective measures, such dangerous weapons of mass
destruction as those using chemical or bacteriological (biological) agents,

Recognizing that an agreement on the prohibition of bacteriological
(biological) and toxin weapons represents a first possible step towards the
achievement of agreement on effective measures also for the prohibition of
the development, production and stockpiling of chemical weapons, and
determined to continue negotiations to that end,

Determined, for the sake of all mankind, to exclude completely the
possibility of bacteriological (biological) agents and toxins being used as
weapons,

Convinced that such use would be repugnant to the conscience of mankind and
that no effort should be spared to minimize this risk,

Have agreed as follows:

ARTICLE I

Each State Party to this Convention undertakes never in any circumstance to
develop, produce, stockpile or otherwise acquire or retain:

(1) Microbial or other biological agents, or toxins whatever their origin
or method of production, of types and in quantities that have no
justification for prophylactic, protective or other peaceful purposes;

(2) Weapons, equipment or means of delivery designed to use such agents or
toxins for hostile purposes or in armed conflict.

ARTICLE II

Each State Party to this Convention undertakes to destroy, or to divert to
peaceful purposes, as soon as possible but not later than nine months after
the entry into force of the Convention, all agents, toxins, weapons,
equipment and means of delivery specified in article I of the Convention,
which are in its possession or under its jurisdiction or control. In
implementing the provisions of this article all necessary safety
precautions shall be observed to protect populations and the environment.

ARTICLE III

Each State Party to this Convention undertakes not to transfer to any
recipient whatsoever, directly or indirectly, and not in any way to assist,
encourage, or induce any State, group of States or international
organizations to manufacture or otherwise acquire any of the agents,
toxins, weapons, equipment or means of delivery specified in article I of
the Convention.

ARTICLE IV

Each State Party to this Convention shall, in accordance with its
constitutional processes, takes any necessary measures to prohibit and
prevent the development, production, stockpiling, acquisition or retention
of the agents, toxins, weapons, equipment and means of delivery specified
in article I of the Convention, within the territory of such State, under
its jurisdiction or under its control anywhere.

ARTICLE V

The States Parties to this Convention undertake to consult one another and
to cooperate in solving any problems which may arise in relation to the
objective of, or in the application of the provisions of, the Convention.
Consultation and cooperation pursuant to this article may also be
undertaken through appropriate international procedures within the
framework of the United Nations and in accordance with its Charter.

ARTICLE VI

(1) Any State Party to this Convention which finds that any other State
Party is acting in breach of obligations deriving from the provisions of
the Convention may lodge a complaint with the Security Council of the
United Nations. Such a complaint should include all possible evidence
confirming its validity, as well as a request for its consideration by the
Security Council.

(2) Each State Party to this Convention undertakes to cooperate in carrying
out any investigation which the Security Council may initiate, in
accordance with the provisions of the Charter of the United Nations, on the
basis of the complaint received by the Council. The Security Council shall
inform the States Parties to the Convention of the results of the
investigation.

ARTICLE VII

Each State Party to this Convention undertakes to provide or support
assistance, in accordance with the United Nations Charter, to any Party to
the Convention which so requests, if the Security Council decides that such
Party has been exposed to danger as a result of violation of the
Convention.

ARTICLE VIII

Nothing in this Convention shall be interpreted as in any way limiting or
detracting from the obligations assumed by any State under the Protocol for
the Prohibition of the Use in War of Asphyxiating, Poisonous or Other
Gases, and of Bacteriological Methods of Warfare, signed at Geneva on June
17, 1925.

ARTICLE IX

Each State Party to this Convention affirms the recognized objective of
effective prohibition of chemical weapons and, to this end, undertakes to
continue negotiations in good faith with a view to reaching early agreement
on effective measures for the prohibition of their development, production
and stockpiling and for their destruction, and on appropriate measures
concerning equipment and means of delivery specifically designed for the
production or use of chemical agents for weapons purposes.

ARTICLE X

(1) The States Parties to this Convention undertake to facilitate, and have
the right to participate in, the fullest possible exchange of equipment,
materials and scientific and technological information for the use of
bacteriological (biological) agents and toxins for peaceful purposes.
Parties to the Convention in a position to do so shall also cooperate in
contributing individually or together with other States or international
organizations to the further development and application of scientific
discoveries in the field of bacteriology (biology) for prevention of
disease, or for other peaceful purposes.

(2) This Convention shall be implemented in a manner designed to avoid
hampering the economic or technological development of States Parties to
the Convention or international cooperation in the field of peaceful
bacteriological (biological) activities, including the international
exchange of bacteriological (biological) agents and toxins and equipment
for the processing, use or production of bacteriological (biological)
agents and toxins for peaceful purposes in accordance with the provisions
of the Convention.

ARTICLE XI

Any State Party may propose amendments to this Convention. Amendments shall
enter into force for each State Party accepting the amendments upon their
acceptance by a majority of the States Parties to the Convention and
thereafter for each remaining State Party on the date of acceptance by it.

ARTICLE XII

Five years after the entry into force of this Convention, or earlier if it
is requested by a majority of the Parties to the Convention by submitting a
proposal to this effect to the Depositary Governments, a conference of
States Parties to the Convention shall be held at Geneva, Switzerland, to
review the operation of the Convention, with a view to assuring that the
purposes of the preamble and the provisions of the Convention, including
the provisions concerning negotiations on chemical weapons, are being
realized. Such review shall take into account any new scientific and
technological developments relevant to the Convention.

ARTICLE XIII

(1) This Convention shall be of unlimited duration.

(2) Each State Party to this Convention shall in exercising its natural
sovereignty have the right to withdraw from the Convention if it decides
that extraordinary events, related to the subject matter of the Convention,
have jeopardized the supreme interests of its country. It shall give notice
of such withdrawal to all other States Parties to the Convention and to the
United Nations Security Council three months in advance. Such notice shall
include a statement of the extraordinary events it regards as having
jeopardized its supreme interests.

ARTICLE XIV

(1) This Convention shall be open to all States for signature. Any State
which does not sign the Convention before its entry into force in
accordance with paragraph (3) of this Article may accede to it at any time.

(2) This Convention shall be subject to ratification by signatory States.
Instruments of ratification and instruments of accession shall be deposited
with the Governments of the United States of America, the United Kingdom of
Great Britain and Northern Ireland and the Union of Soviet Socialist
Republics, which are hereby designated the Depositary Governments.

(3) This Convention shall enter into force after the deposit of instruments
of ratification by twenty-two Governments, including the Governments
designated as Depositaries of the Convention.

(4) For States whose instruments of ratification or accession are deposited
subsequent to the entry into force of this Convention, it shall enter into
force on the date of the deposit of their instrument of ratification or
accession.

(5) The Depositary Governments shall promptly inform all signatory and
acceding States of the date of each signature, the date of deposit of each
instrument of ratification or of accession and the date of the entry into
force of this Convention, and of the receipt of other notices.

(6) This Convention shall be registered by the Depositary Governments
pursuant to Article 102 of the Charter of the United Nations.

ARTICLE XV

This Convention, the English, Russian, French, Spanish and Chinese texts of
which are equally authentic, shall be deposited in the archives of the
Depositary Governments. Duly certified copies of the Convention shall be
transmitted by the Depositary Governments of the signatory and acceding
States.