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Entities Generally Met Federal Select Agent Program Internal Inspection Requirements But CDC Could Do More To Improve Effectiveness


Select agents and toxins are potential bioweapons that can cause significant loss of life and economic damage. Incidents of mishandling select agents and toxins by some entities registered with the Federal Select Agents Program (FSAP) have raised questions about CDC's Division of Select Agents and Toxin's (DSAT) ability to oversee entities' responsible handling of select agents and toxins. Entities' internal inspections are one critical safeguard to help protect public health and safety. In this review, OIG examines entities' and DSAT's roles in implementing and overseeing these internal inspections. This builds on a companion review in which OIG examined DSAT's inspections of entities.


We reviewed DSAT data, survey data, and documentation from a purposive sample of 24 DSAT inspectors and 21 entities registered with the FSAP from 2013 through 2015. We determined whether entities reported conducting internal inspections during this timeframe and whether DSAT cited those entities that did not conduct them. We asked DSAT inspectors about their challenges in overseeing entities' compliance with the internal inspection requirement and asked entities about their challenges in conducting internal inspections.


Most entities in our review reported to us that they conducted internal inspections as required. In nearly all cases, CDC identified and cited those few entities that reported to us they did not conduct these inspections as required. These inspections are important tools for protecting public health and safety, and many of them identified potential noncompliance with biosafety and security requirements. This is consistent with the types of observations that DSAT most commonly found in its inspections, according to a previous HHS OIG report. However, these inspections may not always be as thorough and well documented as they should be. Unclear inspection requirements and insufficient training may challenge both DSAT's ability to oversee entities' internal inspections and entities' ability to conduct them and may partially explain why entities' internal inspections are not always sufficiently thorough or sufficiently documented.


CDC should take steps to strengthen the effectiveness of entity internal inspections by clarifying the FSAP internal inspection requirements and the procedures for assessing entity compliance, and by developing and providing additional training to both DSAT inspectors and entities on these requirements and procedures. CDC concurred with all our recommendations.

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Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201