Possession, Use, and Transfer of Select Agents and Toxins; Regulation of an Attenuated Vaccine Strain of Venezuelan Equine Encephalitis Virus as a Select Agent, 53647 [2022-18990]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Rules and Regulations]
[Page 53647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18990]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

========================================================================


Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / 
Rules and Regulations

[[Page 53647]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 121

[Docket No. APHIS-2022-0034]


Possession, Use, and Transfer of Select Agents and Toxins; 
Regulation of an Attenuated Vaccine Strain of Venezuelan Equine 
Encephalitis Virus as a Select Agent

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Regulatory determination.

-----------------------------------------------------------------------

SUMMARY: We are notifying the public that the Animal and Plant Health 
Inspection Service (APHIS) has determined that the modified Venezuelan 
equine encephalitis virus (VEEV) strain TC-83(A3G), which is a 
modification to the attenuated strain VEEV TC-83, has demonstrated 
increased pathogenicity and lethality and that the strain has the 
potential to pose a severe threat to animal health or animal products. 
We are advising the public that VEEV strain TC-83(A3G) is therefore a 
select agent and subject to APHIS' select agent and toxin regulations.

DATES: Effective September 1, 2022.

FOR FURTHER INFORMATION CONTACT: Dr. Randy Capsel, Science Officer, 
Division of Agricultural Select Agents and Toxins, Emergency and 
Regulatory Compliance Services, Animal and Plant Health Inspection 
Service, 4700 River Road, Riverdale, MD 20737; Telephone: (301) 851-
3402; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Agricultural Bioterrorism Protection Act of 2002, as amended 
(the Act, 7 U.S.C. 8401) provides for the regulation of certain 
biological agents and toxins that have the potential to pose a severe 
threat to animal and plant health, or to animal and plant products. The 
Animal and Plant Health Inspection Service (APHIS) has the primary 
responsibility for implementing the provisions of the Act within the 
U.S. Department of Agriculture. The Act also provides authority for 
APHIS to jointly regulate with the U.S. Department of Health & Human 
Services' Centers for Disease Control and Prevention (CDC) biological 
agents and toxins that have the potential to pose a serve threat to 
both public health and safety and animal health or animal products.
    The regulations in 9 CFR part 121 (referred to below as the 
regulations) implement the provisions of the Act by setting forth the 
requirements for possession, use, and transfer of Veterinary Services 
select agents and toxins. In Sec.  121.4 of the regulations, paragraph 
(e) sets forth a process by which an attenuated strain of a select 
agent or toxin modified to be less potent or toxic may be excluded from 
the requirements of the select agent and toxin regulations in part 121 
based upon a determination by APHIS' Administrator that the attenuated 
strain or modified toxin does not pose a severe threat to public health 
and safety, animal health, or animal products. Under Sec.  121.4(e)(2), 
if an excluded attenuated strain is subjected to any manipulation that 
restores or enhances its virulence, resulting in a select agent that 
poses a severe threat to animal health or animal products, the 
resulting select agent will be subject to the requirements of the 
regulations in part 121.
    Venezuelan equine encephalitis virus (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. Because it can 
affect both animals and humans, VEEV is listed as an overlap select 
agent in Sec.  121.4(b) of the regulations and therefore is subject to 
regulation by both APHIS and CDC. On February 7, 2003, VEEV strain TC-
83 was excluded from the regulations because mice vaccinated 
subcutaneously with VEEV strain TC-83 rapidly developed immunity to 
subcutaneous or airborne challenge with virulent VEEV.\1\ Based on 
these findings, APHIS, in collaboration with CDC, determined that the 
attenuated strain did not have the potential to pose a severe threat to 
animal health or animal products.
---------------------------------------------------------------------------

    \1\ See https://www.selectagents.gov/sat/exclusions/overlap.htm.
---------------------------------------------------------------------------

    However, based on a recent review by subject matter experts, APHIS 
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 wild-type 
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 a result, the modification of the excluded, attenuated VEEV 
vaccine strain TC-83 to create VEEV strain TC-83(A3G) restores the 
virus's virulence and has the potential to pose severe threat to animal 
health or animal products. Therefore, VEEV strain TC-83(A3G) is subject 
to the regulations in part 121.

    Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 29th day of August 2022.
Anthony Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2022-18990 Filed 8-30-22; 11:15 am]
BILLING CODE 3410-34-P