Regulatory Guidance (continued)
•
VEE is a
BSL3 Agent
•
TC‐83 is not a select agent, can be manipulated at
BSL2
•
If aerosols of TC‐83 are generated, it
reverts to BSL3
due to infectious nature for humans
•
Human vaccination is limited to administration by
the military as part of the
Special Immunization Program /
Investigational New Drug Authority
–
Military personnel, laboratory workers
Standard Method Performance
Requirements ‐ Goal
Development of Standard Method Performance
Requirements (SMPR) for Venezuelan Equine
Encephalitis virus by PCR method, with the
possibility of developing a single SMPR for a
combination of Venezuelan Equine Encephalitis
virus, Western Equine Encephalitis virus, and
Eastern Equine Encephalitis virus
