Rule2023-16929
Select Agent Determination Concerning Coxiella burnetii Phase II, Nine Mile Strain, Plaque Purified Clone 4 With Reversion to Wildtype cbu0533
Primary source
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Published
August 10, 2023
Effective
August 10, 2023
Issuing agencies
Health and Human Services Department
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.
Full Text
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<title>Federal Register, Volume 88 Issue 153 (Thursday, August 10, 2023)</title>
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[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Rules and Regulations]
[Page 54247]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16929]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
Select Agent Determination Concerning Coxiella burnetii Phase II,
Nine Mile Strain, Plaque Purified Clone 4 With Reversion to Wildtype
cbu0533
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Determination.
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SUMMARY: 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.
DATES: This determination is effective August 10, 2023.
FOR FURTHER INFORMATION CONTACT: Samuel S. Edwin Ph.D., Director,
Division of Select Agents and Toxins, Centers for Disease Control and
Prevention, 1600 Clifton Road NE, Mailstop H21-4, Atlanta, Georgia
30329, Telephone: (404) 718-2000.
SUPPLEMENTARY INFORMATION: Coxiella burnetti is a select agent that is
regulated pursuant to the HHS select agent and toxin regulations (42
CFR part 73). C. burnetii is a gram-negative intracellular bacterium
that causes Q Fever. Q Fever is a zoonotic disease that causes flu-like
symptoms in humans, including fever, chills, fatigue, and muscle pain.
Humans become infected when they are in close contact with infected
animal fluids and products.
The HHS select agent regulations (42 CFR part 73) established a
process by which an attenuated strain of a select biological agent that
does not have the potential to pose a severe threat to public health
and safety may be excluded from the requirements of the regulations. On
October 15, 2003, C. burnetii Phase II, Nine Mile Strain, plaque
purified clone 4 was excluded from HHS select agent regulations as it
does not pose a significant threat to public health and safety (<a href="https://selectagents.gov/sat/exclusions/hhs.htm">https://selectagents.gov/sat/exclusions/hhs.htm</a>).
As set forth under 42 CFR 73.4(e)(2), if an excluded attenuated
strain is subjected to any manipulation that restores or enhances its
virulence, the resulting select agent will be subject to the
requirements of the regulations. On March 20, 2023, an entity informed
CDC of a reversion whereby C. burnetii Phase II, Nine Mile Strain,
plaque purified clone 4 spontaneously mutated. The C. burnetii Phase
II, Nine Mile Strain, plaque purified clone 4 with reversion to
wildtype cbu0533 displayed increased pathogenicity and virulence. The
entity stated that after the excluded strain was injected into guinea
pigs, a spontaneous reversion occurred that resulted in a mutant strain
of the agent and the guinea pigs subsequently exhibited elevated fever
and weight loss. The genetic mutation that led to the mutant strain was
the reversion and restoration of a deletion in the cbu0533 gene. CDC
subject matter experts have determined that this reversion in cbu0533
restored virulence and pathogenicity. Therefore, C. burnetii Phase II,
Nine Mile Strain, plaque purified clone 4 with reversion to wildtype
cbu0533 is determined to be a select agent and subject to 42 CFR part
73.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-16929 Filed 8-9-23; 8:45 am]
BILLING CODE 4163-18-P
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