Abstract
New regulations on the possession, transfer and use of biological agents and toxins have provided the regulatory premise to introduce institutional-level biosecurity practices at research laboratories handling Select Agents and other infectious materials. However, clinical and public health laboratories licensed under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that do diagnostic testing, verification, or proficiency testing are generally exempted from the regulations. Although a CLIA laboratory director is required to notify the Department of Health and Human Services immediately upon identifying specific Select Agents, a prevailing opinion is there is no reporting mechanism for diagnostic test results. CLIA Laboratories are required to adhere to established biosafety guidelines, but face fewer biosecurity-driven restrictions on their behavior, and are often more vulnerable compared to research laboratories to diversion of Select Agents and other agents of public health concern for malevolent uses. International laboratories involved in proficiency testing programs routinely receive agents of public health concern, and lack biosecurity status and reporting mechanism. This applies also to international shipping companies involving in transport of agents of public health concern under the proficiency testing programs. This paper reviews the emerging consensus on whether CLIA exemption fundamentally compromises on the biosecurity goals of the new regulations, and options for addressing biosecurity of Select Agents and other agents of public health concern for international CLIA Laboratories and shipping companies.