Select Agent Determination Concerning Coxiella burnetii Phase II, Nine Mile Strain, Plaque Purified Clone 4 With Reversion to Wildtype cbu0533
public-health · Centers for Disease Control and Prevention · Rule · Published 2023-08-10 · Effective 2023-08-10 · 88 FR 54247
Document
Document number
2023-16929
Federal Register citation
88 FR 54247
CFR reference
42 CFR 73
Type
Rule
Action
Determination.
Category
public-health
Sub-agency
Centers for Disease Control and Prevention
Publication date
2023-08-10
Effective date
2023-08-10
Abstract
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), has determined that an excluded attenuated strain, Coxiella burnetii Phase II, Nine Mile Strain, plaque purified clone 4, has, in one instance, been shown to spontaneously mutate when passaged in vivo. The resulting mutant, C. burnetii Phase II, Nine Mile Strain, plaque purified clone 4 with reversion to wildtype cbu0533, has enhanced pathogenicity and virulence. Therefore, C. burnetii Phase II, Nine Mile Strain, plaque purified clone 4 with reversion to wildtype cbu0533 is not an excluded strain but is a select agent and subject to the HHS select agent and toxin regulations.