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Security guidance for select agent or toxin facilities : 7 CFR Part 331, 9 CFR Part 121, 42 CFR Part 73
  • Published Date:
    5 July, 2013
  • Status:
    current
  • Language:
    English
Filetype[PDF - 1.72 MB]


Details:
  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S). Office of Public Health Preparedness and Response. Division of Select Agents and Toxins. ; United States. Animal and Plant Health Inspection Service. Agriculture Select Agent Program. ;
  • Description:
    Considerations when performing a risk assessment and developing a site specific security plan -- Security Program Development and Management (Section 11) -- Physical Security ((Section 11(c)(1) and 11(d)(3)) -- Personnel Security (Section 10) -- Operational Security (Section 11(d)(3)) -- Inventory Control Measures (Sections 11(c)(1) and(2) and 17) -- Understanding and Complying with Security Procedures/Training (Sections 15, 11(f) and 11(d)(7)) -- Inspection of Suspicious Packages (Section 11(d)(4)) -- Shipping (Section 11(c)(10)) -- Intra-entity Transfers (Section 11(d)(5)) -- Reporting requirements (Section 11(c)(8) and 11(d)(7)) -- References -- Appendix I: Sample Scenario Diagram -- Appendix II: Risk Assessment Methods -- Appendix III: Comparison of Access Control Devices and Systems -- Appendix IV: Tier 1 Barrier Scenarios -- Appendix V: Intrusion Detection Systems -- Appendix VI: Example of a Select Agent Inventory Form that Captures the Requirements -- Appendix VII: Example of a Toxin Inventory Form that Captures the Requirements -- Appendix VIII: Suspicious Package -- Appendix IX: Example of an Intra-Entity Transfer Form that Captures the Requirements -- Appendix X: SharedareaswhereTier1BSATareusedorstored – Appendix XI: Access and Barrier Scenarios.

    Section 201 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107- 188)(the Act) requires the Secretary of the Department of Health and Human Services (HHS) to, by regulation, provide for “the appropriate safeguard and security requirements for persons possessing, using, or transferring a listed agent or toxin commensurate with the risk such agent or toxin poses to public health and safety(including the risk of use in domestic or international terrorism).” Section 212 of the Act requires the Secretary of the Department of Agriculture (USDA) to, by regulation, provide for “the appropriate safeguard and security requirements for persons possessing, using, or transferring a listed agent or toxin commensurate with the risk such agent or toxin pose to animal and plant health, and animal and plant products (including the risk of use in domestic or international terrorism).”

    The select agent regulations require a registered entity to develop and implement a written security plan that is (1) sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release; and (2) designed according to a site-specific risk assessment, providing graded protection (See section 11 (Security) of the select agent regulations).

    The purpose of this document is to assist the entity in developing and implementing its site-specific security plan. This document is organized by security function/system with the regulatory citation at the end of the section heading. We have addressed any additional Tier 1 BSAT specific requirements at the end of the section. As used in this document, the word “must” means a regulatory requirement. The use of the word “should” or “consider” is a suggested method to meet that requirement based on generally recognized security “best practices.” We recognize that implementation is performance based and that an entity may find other ways to meet the regulatory requirement.

    This document addresses the amendments to the select agent regulations with regard to security with one exception. Entities with Tier 1 BSAT have additional pre-access suitably and ongoing suitability assessment requirements which are addressed in the “Guidance for Suitability Assessments” available at www.selectagents.gov.

    Revision History: October 12, 2012: Initial posting; April 11, 2013 (Revision 1): The revisions are primarily changes to correct editorial errors from previous version; July 3, 2013 (Revision 2): Appendix added to document.

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