Summary Report on State, Local, Private, and Commercial Laboratories' Compliance With Select Agent Regulations

The audit objectives were to (1) summarize the findings in our eight individual reports and (2) determine whether CDC had resolved the audit recommendations in those reports in a timely manner.

The individual audits found that each of the eight entities had appointed a Responsible Official to provide management oversight of its select agent program.  However, certain other controls at all eight entities did not comply with Federal regulations and each entity had weaknesses in at least one control area that could have compromised their ability to safeguard select agents from accidental or intentional loss.

In responding to our draft report, CDC stated that it had resolved our recommendations at five of the eight entities and that the remaining three entities had withdrawn their certificates of registration and no longer possessed select agents.  CDC attached audit clearance documents resolving the recommendations in our reports to all eight entities.  Therefore, this final report contains no recommendation.