Suitability Assessment Program Guidance

Changes and Highlights

Revisions: This is a living document subject to on-going improvement. Feedback or suggestions for improvement are welcomed. Comments may be submitted to the Federal Select Agent Program at:

CDC: LRSAT@cdc.gov
APHIS: AgSAS@aphis.usda.gov

Revision History:

October 12, 2012: Initial posting
June 24, 2013 (Revision 1): The revisions are primarily changes to correct editorial errors from the previous version.
March 21, 2017 (Revision 2): The revisions reduce the document to essential regulatory guidance and correct editorial errors from the previous version.

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Introduction

The purpose of this guidance document is to assist entities in the development of a site-specific suitability assessment program for individuals with access to Tier 1 select agents and toxins (BSAT), according to section 11(f) of the select agent regulations (42 CFR § 73.11, 7 CFR § 331.11, and 9 CFR § 121.11). This guidance provides recommendations for meeting this requirement; however, the entity should develop the suitability assessment plan according to the specific conditions of their registered space.
Those sections of the select agent regulations which require an entity to include in its written security plan a pre-access suitability assessment and an on-going assessment of individuals with access to Tier 1 BSAT do not preempt federal, state, or local employment or privacy laws. An entity must ensure that it is compliant with all federal, state and local employment and privacy laws in the development of all suitability assessment plans.

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