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Clinical laboratories, the select agent program, and biological surety (biosurety)
Ross H Pastel1, Gretchen Demmin, Grant Severson
1United States Army Medical Research Institute of Infectious Diseases (USAMRIID), 1425 Porter Street, Fort Detrick, MD 21702, USA. ross.pastel@amedd.army.mil
Clinics in Laboratory Medicine
|July 4, 2006
Summary
Federal regulations, including CDC
Area of Science:
- Public Health
- Biosecurity
- Regulatory Science
Background:
- Bioterrorism threats necessitate strict control over biological select agents and toxins (BSAT).
- Federal laws have led to regulations by the CDC and USDA to manage BSAT.
- CDC's 42 CFR 73 impacts clinical labs identifying BSAT.
Purpose of the Study:
- To outline the regulatory framework for biological select agents and toxins (BSAT).
- To explain the relationship between CDC regulations and Department of Defense biosurety requirements.
- To detail the foundational elements of biosurety regulations.
Main Methods:
- Analysis of federal laws and regulations (42 CFR 73).
- Examination of Department of Defense biological surety (biosurety) requirements.
- Deconstruction of the structural components of biosurety regulations.
Main Results:
- CDC's 42 CFR 73 is a component within the broader biosurety framework.
- Both CDC and biosurety regulations share four core pillars: safety, physical security, agent accountability, and personnel reliability.
- Training and management form the essential foundation and oversight for these regulations.
Conclusions:
- Understanding these regulations is crucial for clinical and military laboratories handling BSAT.
- The layered regulatory approach ensures comprehensive management of dangerous biological agents.
- Biosurety provides a robust structure for managing biological risks.