Challenges and Practices in Building and Implementing Biosafety and Biosecurity Programs to Enable Basic and...

Area of Science:

• * Life Sciences
• * Public Health
• * Biodefense

Background:

• * Select agent research in the U.S. is governed by federal biological surety guidelines.
• * These guidelines encompass biosecurity (safeguarding agents) and biosafety (safe operations).
• * Biological surety programs address high-risk agents with potential for adverse medical or agricultural consequences.

Purpose of the Study:

• * To provide a simplified yet comprehensive review of select agent research requirements.
• * To discuss implemented activities by U.S. Regional and National Biocontainment Laboratories (RBL, NBL).
• * To highlight how RBL/NBL programs meet federal metrics for biological surety.

Main Methods:

• * Review of federally-mandated biological surety guidelines and regulations.
• * Analysis of programs developed by U.S. RBL/NBL facilities.
• * Examination of implemented activities to achieve compliance metrics.

Main Results:

• * Established biosecurity and biosafety protocols are essential for select agent research.
• * RBL/NBL facilities are actively developing and implementing programs to meet federal requirements.
• * Ongoing adaptation to new guidelines and regulations is critical for these facilities.

Conclusions:

• * Compliance with biological surety guidelines is mandatory for select agent research in the U.S.
• * RBL/NBL programs play a crucial role in ensuring the safe and secure handling of high-risk biological agents.
• * Continuous development and implementation of robust programs are necessary to meet evolving federal standards.