Rule2022-18973
Select Agent: Determination That Vaccine Strain, TC-83(A3G) of Venezuelan Equine Encephalitis Virus (VEEV) Is a Regulated Strain of VEEV
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 1, 2022
Effective
September 1, 2022
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 a modification to the attenuated, excluded strain Venezuelan Equine Encephalitis Virus (VEEV) TC-83 has been shown to increase its virulence. The modified VEEV strain TC-83(A3G) demonstrated increased pathogenicity and lethality. Therefore, the modified VEEV strain TC-83(A3G) is not an excluded strain but is a select agent and is subject to regulation.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 169 (Thursday, September 1, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Rules and Regulations]
[Pages 53679-53680]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18973]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
Select Agent: Determination That Vaccine Strain, TC-83(A3G) of
Venezuelan Equine Encephalitis Virus (VEEV) Is a Regulated Strain of
VEEV
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Regulatory determination.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), has
determined that a modification to the attenuated, excluded strain
Venezuelan Equine Encephalitis Virus (VEEV) TC-83 has been shown to
increase its virulence. The modified VEEV strain TC-83(A3G)
demonstrated increased pathogenicity and lethality. Therefore, the
modified VEEV strain TC-83(A3G) is not an excluded strain but is a
select agent and is subject to regulation.
DATES: This action is effective September 1, 2022.
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: VEEV is a member of the genus Alphavirus in
the family Togaviridae, and is a small, enveloped virus with a genome
consisting of a single strand of positive-sense RNA. VEEV is a
mosquito-borne virus that causes encephalitis or encephalomyelitis in
all equine species and humans.
The select agent regulations (42 CFR part 73) established a process
by which
[[Page 53680]]
an attenuated strain of a select biological agent or toxin that does
not pose a severe threat to public health and safety may be excluded
from the requirements of the select agent regulations. On February 7,
2003, VEEV strain TC-83 was excluded from select agent regulations
because mice vaccinated subcutaneously with the VEEV strain TC-83
rapidly developed immunity to subcutaneous or airborne challenge with
virulent VEEV (<a href="https://www.selectagents.gov/sat/exclusions/overlap.htm">https://www.selectagents.gov/sat/exclusions/overlap.htm</a>). As such, CDC determined that the attenuated strain did
not have the potential to pose a severe threat to public health and
safety.
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. Based on review by subject matter
experts, CDC has determined that a modification to the excluded
attenuated VEEV vaccine strain TC-83 has been shown to increase its
virulence and pathogenicity. An adenine (A) at position 3 in TC-83 has
been shown to contribute to the attenuation of VEEV. In TC-83(A3G), the
A has been changed to a guanine (G), which is found in all wild-type
isolates of VEEV. The reversion of this nucleotide mutation to the
wildtype nucleotide resulted in increased lethality in mice when
compared to mice inoculated with the vaccine strain TC-83. Additional
data determined that the pathogenic effects of TC-83(A3G) are more
pronounced in young mice. As such, the modification of the excluded,
attenuated VEEV vaccine strain TC-83 to create VEEV strain TC-83(A3G)
restores the virus's virulence and therefore, VEEV strain TC-83(A3G) is
subject to 42 CFR part 73.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-18973 Filed 8-30-22; 4:15 pm]
BILLING CODE 4163-18-P
</pre></body>
</html>Indexed from Federal Register on September 1, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.