Comment from Larry Sater

Our staff has reviewed the proposed changes and we support the revised list of select agents and toxins, including the new tiers. We also support the personal accountability of staff as described in the documents. We have a comment with questions regarding the following: RO and ARO’s must prove competency in select agents to be qualified. More details of this process are needed. For instance, is in-house training & testing sufficient if they have passing grades? Does the Select Agent Program (SAP) have its own test to administer? Specific, objective criteria for assessing competency must be provided to all entities in advance of adoption and be open to review and comment. For instance, who at the Select Agent Program develops competency criteria and evaluates all RO’s and ARO’s? How often would competency assessments be conducted? If staff fail a competency assessment, what kind of remediation (training, retesting) will be offered? If specific minimum requirements/criteria are not provided to entities in advance of adopting this proposal, approval or rejection of staff would be subjective. If these points can be satisfactorily addressed in the proposed documents, we would support the other proposed changes. Please contact us if you have questions or clarifications to the above questions.