Summary Report on Universities' Compliance With Select Agent Regulations

EXECUTIVE SUMMARY:

This report summarizes the results of our reviews of 15 universities' compliance with select agent regulations. Due to the sensitivity of the issues we identified, we restricted the distribution of each report to the individual university and the CDC.  The objective of this review was to determine whether each of the 15 universities had established controls over select agents in compliance with Federal regulations. 

As required, each of the 15 universities had appointed a 'Responsible Official' to provide management oversight of its select agent program.  However, at 11 of the 15 universities, certain other controls did not comply with Federal regulations.  The 11 universities had weaknesses in at least 1 control area that could have compromised the ability to safeguard select agents from accidental or intentional loss, including:  (1) weaknesses in inventory and/or access records; (2) weaknesses in access controls; (3) weaknesses in security plans; (4) not providing training to individuals with access to select agents or not documenting the means used to verify that individuals understood the training; and (5) not addressing required areas in emergency response plans.  Officials at the 11 universities generally agreed with our recommendations to strengthen their security controls.

We recommended that CDC resolve the recommendations in the 11 individual reports.  In written comments on our draft report, CDC stated that the results of our audits were generally consistent with the findings of its own inspections and that it was actively addressing the concerns raised in our draft report.