[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Page 65023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23446]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
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  Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / 
Notices  

[[Page 65023]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2022-0016]


Notice of Withdrawal of Select Agent Regulatory Exclusions for 
Two Strains of African Swine Fever Virus

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of withdrawal of select agent regulatory exclusions.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) has withdrawn the select agent regulatory 
exclusions for two African swine fever virus strains, ASFV-G-[Delta]MGF 
and ASFV-G-[Delta]9GL/[Delta]MGF. Possession, use, and transfer of 
these strains must now comply with APHIS' select agent and toxin 
regulations. APHIS withdrew the select agent regulatory exclusions for 
these strains because it has evaluated new information and determined 
that they have the potential to pose a severe threat to animal health 
or animal products.

DATES: As of January 7, 2022, the subject select agent exclusions were 
withdrawn.

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, Maryland 20737; Telephone: (301) 
851-3402; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 
8401, referred to below as the Act) 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.
    In accordance with the Act, APHIS promulgated the select agent and 
toxin regulations found in 7 CFR part 331 and 9 CFR part 121. Paragraph 
(e) in Sec.  121.3 states that an attenuated strain of a select agent 
or a select toxin modified to be less potent or toxic may be excluded 
from the requirements of this part based upon a determination by the 
Administrator that the attenuated strain or modified toxin does not 
pose a severe threat to animal health or animal products.
    African swine fever virus (ASFV) is listed as a select agent in 
Sec.  121.3(b) of the select agent and toxin regulations. APHIS 
approved the initial select agent regulatory exclusions of two ASFV 
strains, ASFV-G-[Delta]MGF and ASFV-G-[Delta]9GL/[Delta]MGF, based on 
applications submitted in accordance with the select agent and toxin 
regulations and with review and recommendations from the Agriculture 
Interagency Select Agents and Toxins Technical Advisory Committee (Ag-
ISATTAC) at meetings on January 27, 2020, and April 8, 2021. Pursuant 
to Sec.  121.3(e)(1), APHIS listed the exclusions on the National 
Select Agent Registry website at https://www.selectagents.gov.
    On January 7, 2022, APHIS withdrew the previously approved select 
agent regulatory exclusions for the ASFV-G-[Delta]MGF and ASFV-G-
[Delta]9GL/[Delta]MGF strains and removed them from the list on the 
National Select Agent Registry website. In addition, APHIS notified all 
entities that were known to have the previously excluded ASFV strains 
that possession, use, and transfer of these ASFV strains must now 
comply with the select agent and toxin regulations in part 121. APHIS 
based the decision to withdraw the exclusions on newly acquired 
information regarding safety and genome instability potentially leading 
to reversion of virulence that was either unavailable or not provided 
to either APHIS or Ag-ISATTAC during either the January 2020 or April 
2021 discussions for regulatory exclusion. More specifically, among 
other sources, two journal articles published in 2020 and 2021 from 
China's Harbin Veterinary Research Institute identified instability 
within the MGF genome segments.
    With the publication of this notice, we are informing the public 
that we withdrew the previously approved select agent regulatory 
exclusions for the ASFV-G-[Delta]MGF and ASFV-G-[Delta]9GL/[Delta]MGF 
strains, effective on January 7, 2022, and that the possession, use, 
and transfer of these ASFV strains must now comply with the select 
agent and toxin regulations in part 121. This notice serves as an 
official record and public notification of these actions.

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this action 
as not a major rule, as defined by 5 U.S.C. 804(2).
    Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 13th day of October 2022.
Anthony Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2022-23446 Filed 10-26-22; 8:45 am]
BILLING CODE 3410-34-P