Transcription of Security Plan Guidance - Select Agents
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Security Plan Guidance - Select Agents
P a g e | 1 Security plan Guidance Document Contents Changes and Highlights .. 2 Introduction .. 3 Section 11(a) Creating a Site-Specific Written Security plan .. 4 Section 11(b) Site-Specific Risk Assessment .. 7 Section 11(c) Planning 10 Access Control .. 10 Unauthorized or Suspicious Persons .. 13 Access Approval .. 13 RO Reporting .. 14 Information Systems Security Controls .. 15 Shipping and Transfers .. 15 Section 11(d) Security Requirements .. 17 17 Section 11(e) Inventory Audits .. 17 Tier 1 Security Section 11(f).. 18 Section 11(h) Review and Revision .. 23 Appendix I: Risk Assessment Methods .. 24 Appendix II: Access Control Devices .. 26 Appendix III: Intrusion Detection Systems .. 27 Appendix IV: Example Intra-Entity Transfer Form that Captures the Section 17 Requirements .. 28 Appendix V: Scenarios (Non-Tier 1 Barriers and Access Controls): .. 29 P a g e | 2 Security plan Guidance Document Changes and Highlights Revisions: This is a living document subject to ongoing improvement.
P a g e | 3 Security Plan Guidance Document Introduction Section 11 of the select agent regulations (42 CFR § 73.11, 7 CFR § 331.11, and 9 CFR § 121.11) requires a registered entity to develop and implement a written security plan that is:
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Bachelor of Library and Information Science, SCIENCE, Political Science, State Board of Mortuary Science, New Jersey Division of Consumer Affairs www.NJConsumerAffairs.gov State Board of Mortuary Science, CHAPTER 10 Curriculum Development and, Committee, Code of FairTesting Practices, Code of Fair Testing Practices