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Security plan guidance (42 CFR § 73.11, 7 CFR § 331.11, and 9 CFR § 121.11)
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March 2017
[PDF-469.85 KB]
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Description: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:
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.
The purpose of this guidance document is to assist an entity in developing and implementing its site-specific security plan. Extra requirements for entities registered to use or possess Tier 1 biological select agents and toxins (BSAT) can be found in the Tier 1 guidance document. 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.” Implementation is performance-based and entities may find other ways to meet a regulatory requirement.
This document addresses the select agent regulations with regard to security with one exception: Entities with Tier 1 BSAT have pre-access suitably and ongoing suitability assessment requirements which are addressed in the Guidance for Suitability Assessments.
https://www.selectagents.gov/resources/Security_Plan_Guidance.pdf
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