Suitability Assessment Program Guidance: Ongoing Suitability Assessments

Section 11(f)(3) of the select agent regulations require the entity to ensure that individuals granted access to Tier 1 BSAT continue to merit access through an ongoing suitability assessment program.
The ongoing suitability assessment program requirements that must be implemented by entities registered for Tier 1 BSAT are covered under section 11(f)(3) of the select agent regulations. Requirements addressed in this section include:

• Mechanisms for self and peer-reporting of behaviors of concern. Specifically, incidents or conditions that could affect an individual’s ability to have access to, or work safety with, Tier 1 BSAT or to safeguard Tier 1 BSAT from theft, loss, or release.
• Ongoing monitoring of suitability for individuals with access to Tier 1 BSAT.
• Training on entity policies and procedures for reporting, evaluations, and corrective actions concerning the assessment of personnel suitability for employees with access to Tier 1 BSAT.

The regulations require an ongoing assessment of individuals with access to Tier 1 BSAT to ensure that he or she continues to merit access. Entities must remain engaged and regularly update information pertaining to an individual’s suitability for continued access to Tier 1 BSAT.

The entity should establish procedures for ongoing suitability assessments, and implement these procedures to leverage other institutional resources (e.g., legal counsel, administration, security, HR¸ etc.). If possible, use a committee approach to an ongoing suitability assessment program development effort to aid the RO in making sound access decisions to ensure the safety and security of Tier 1 BSAT.

If an entity identifies one of the statutory prohibitors of a restricted person listed below during an ongoing suitability assessment, the RO must immediately remove the individual’s access to select agents or toxins and notify FSAP in accordance with the regulations.

A “restricted person” is an individual who falls under one or more of the following categories:

• Is under indictment for a crime punishable by imprisonment for a term exceeding 1 year.
• Has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year.
• Is a fugitive from justice.
• Is an unlawful user of any controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)).
• Is an alien illegally or unlawfully in the United States.
• Has been adjudicated as a mental defective or has been committed to any mental institution.
• (i)Is an alien (other than an alien lawfully admitted for permanent residence) who is a national of a country as to which the Secretary of State, pursuant to section 6(j) of the Export Administration Act of 1979 (50 U.S.C. App. 2405(j)), section 620A of chapter 1 of part M of the Foreign Assistance Act of 1961 (22 U.S.C. 2371), or section 40(d) of chapter 3 of the Arms Export Control Act (22 U.S.C. 2780(d)), has made a determination (that remains in effect) that such country has repeatedly provided support for acts of international terrorism; or (ii) acts for or on behalf of, or operates subject to the direction or control of, a government or official of a country described in this subparagraph.
• Has been discharged from the Armed Services of the United States under dishonorable conditions.
• Is a member of, acts for or on behalf of, operates subject to the direction or control of, a terrorist organization as defined in section 212(a)(3)(B)(vi) of the Immigration and Nationality Act (8 USC 1182(a)(3)(B((iv).

Self-and Peer-Reporting – Section 11(f)(3)(i)

The ongoing assessment procedures described in the entity’s security plan must include self- and peer-reporting concerning incidents or conditions that could affect an individual’s ability to have access to or work safety with select agents or toxins, or safeguard select agents or toxins from theft.

Ongoing Monitoring

Section 11(f)(3)(iii) require that the ongoing assessment procedures described in the entity’s security plan must include procedures for the ongoing suitability monitoring of individuals with access to Tier 1 BSAT.
Multiple methods can be used to set up an ongoing assessment procedure, using currently available resources, including but not limited to:

• Annual technical, biosafety, and security performance evaluations of personnel having access to Tier 1 BSAT.
• Periodic review of Tier 1 BSAT access requirements, as determined by users’ duties and responsibilities.
• Annual evaluations as part of an occupational health program or independent evaluation.
• Periodic review of criminal records and visa status.