Suitability Assessment Program Guidance - Change/Highlight Section

Sep 18, 2026

Guidance document for entities developing a site-specific suitability assessment program for individuals with access to Tier 1 select agents and toxins (BSAT). It outlines recommendations tied to the select agent regulations, including pre-access suitability assessments and on-going suitability monitoring. The document specifies program leadership expectations, interview and reporting structures, training requirements, risk and threat reporting mechanisms, and handling of denial, termination, suspension, appeals, and voluntary access removal. It also addresses short-term visitor training access and provides references and appendices.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages21

Reading Time53 min

AccessFree to download

Change/Highlight Section

Introduction

Suitability Assessments

Suitability Assessment Program Leadership Requirements

Pre-Access Suitability Assessments

Ongoing Suitability Assessments

Training (Section 11(f)(3)(ii))

Denial, Termination or Suspension of Tier 1 BSAT Access

Appeal Consideration

Voluntary Removal from Access to Tier 1 BSAT

Visitors for short term training with Tier 1 BSAT

References

Appendices

SUITABILITY ASSESSMENT PROGRAM GUIDANCE 42 CFR § 73.11, 7 CFR § 331.11, and 9 CFR § 121.11 JUNE 2022 Change/Highlight Section 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](LRSAT@cdc.gov) [APHIS:](APHIS: DASAT@usda.gov)[ DASAT@usda.gov](APHIS: DASAT@usda.gov) [Revision History:](Revision History:) October 12, 2012: Initial posting June 24, 2013: The revisions are primarily changes to correct editorial errors from the previous version. March 2017): The revisions reduce the document to essential regulatory guidance and correct editorial errors from the previous version. June 2022: Updated training section to clarify requirements of insider threat awareness briefings. 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. Contents Change/Highlight Section ....................................................................................................................................................2 Introduction .........................................................................................................................................................................2 Suitability Assessments ........................................................................................................................................................4 Suitability Assessment Program Leadership Requirements ..................................................................................................4 Pre-Access Suitability Assessments .......................................................................................................................................5 Pre-Access Suitability Assessment: ...................................................................................................................................5 Additional Information Requested for Individuals in a Supervisory Role..........................................................................7 Applicant Interview ..........................................................................................................................................................7 Ongoing Suitability Assessments ..........................................................................................................................................8 Self-and Peer-Reporting – Section 11(f)(3)(i) ....................................................................................................................9 Ongoing Monitoring .........................................................................................................................................................9 Development of a Risk and Threat Reporting Mechanism ....................................................................................................9 Examples of Reportable Conditions, Behaviors, or Other Information ........................................

FAQs

What is the purpose of this suitability assessment guidance document?

It assists entities in developing a site-specific suitability assessment program for individuals with access to Tier 1 select agents and toxins (BSAT) under section 11(f) of the select agent regulations.

What assessments are covered by the program guidance?

The guidance covers pre-access suitability assessments and on-going suitability assessments, including self- and peer-reporting and ongoing monitoring.

How does the document address access changes such as denial, termination, or suspension?

It explains processes for denial, termination, or suspension of Tier 1 BSAT access, includes appeal consideration, and describes voluntary removal from access, along with related access scenarios such as short-term training visitors.

Sep 18, 2026

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