The Select Agent Regulations: Structure and Stricture

Abstract

Since their inception in 1996, the select agent regulations have shaped the direction of research on high-risk biological agents in the United States. Implemented in response to an increased concern about nefarious use of biological agents, the overarching aim of the regulations is to protect the public health of the United States through both security and safety infrastructure. However, while there does exist an evident need for effective regulations surrounding certain pathogens and toxins, the bureaucratic and inordinate nature of the existing regulations has created significant regulatory and financial burdens in conducting select agent research. Specifically, impediments to this research have arisen from complicated bureaucratic procedures, the impractical financial burden associated with adhering to facility standards, and confusion about research surrounding species-level designation of listed microorganisms. While intended to protect public health, the ineffectual and overly stringent nature of these regulatory policies continues to hinder essential scientific research and, in turn, may paradoxically lead to safety and security vulnerabilities now and in the future.