`[Federal Register Volume 89, Number 242 (Tuesday, December 17, 2024)]
[Rules and Regulations]
[Pages 101837-101846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29567]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. APHIS-2019-0018]
RIN 0579-AE52


Agricultural Bioterrorism Protection Act of 2002; Biennial Review 
and Republication of the Select Agent and Toxin List

AGENCY: Animal and Plant Health Inspection Service, Department of 
Agriculture (USDA).

ACTION: Final rule.

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SUMMARY: In accordance with Title II, Subtitle B of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 (which 
is cited as the ``Agricultural Bioterrorism Protection Act of 2002'' 
and referred to as the Act), we are amending and republishing the list 
of select agents and toxins that have the potential to pose a severe 
threat to animal or plant health, or to animal or plant products. The 
Act requires the biennial review and republication of the list of 
select agents and toxins (the list) and the revision of the list as 
necessary. This action implements the findings from the biennial review 
of the list. The biennial review was initiated within 2 years of the 
completion of the previous biennial review. This final rule will focus 
solely on removing from the select agent list the following pathogens: 
Peronosclerospora philippinensis (Peronosclerospora sacchari) (Plant

[[Page 101838]]

Protection and Quarantine select agent), African horse sickness virus 
(Veterinary Services select agent), and Brucella abortus, Brucella 
suis, and Brucella melitensis (overlap select agents).

DATES: Effective January 16, 2025.

FOR FURTHER INFORMATION CONTACT: Dr. Jacek Taniewski, DVM, Director, 
Division of Agricultural Select Agents and Toxins, ERCS, APHIS, 4700 
River Road, Riverdale, MD 20737; (301) 851-3352; 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002, as amended (referred to below as the Bioterrorism 
Response Act or the Act) provides for the regulation of certain 
biological agents and toxins that have the potential to pose a severe 
threat to human, animal, and plant health, or to animal and plant 
products. The Animal and Plant Health Inspection Service (APHIS) has 
the responsibility for implementing the provisions of the Bioterrorism 
Response Act within the U.S. Department of Agriculture (USDA). 
Veterinary Services (VS) select agents and toxins, listed in 9 CFR 
121.3, are those that have been determined to have the potential to 
pose a severe threat to animal health or animal products. Plant 
Protection and Quarantine (PPQ) select agents and toxins, listed in 7 
CFR 331.3, are those that have been determined to have the potential to 
pose a severe threat to plant health or plant products. Overlap select 
agents and toxins, listed in 9 CFR 121.4, are those that have been 
determined to pose a severe threat to public health and safety, to 
animal health, or to animal products. Overlap select agents are subject 
to regulation by both APHIS and the Centers for Disease Control and 
Prevention (CDC), which has the primary responsibility for implementing 
the provisions of the Act for the U.S. Department of Health and Human 
Services (HHS). Together, APHIS and CDC comprise the Federal Select 
Agent Program (FSAP).
    Title II, Subtitle B of The Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, as amended, (which is cited as 
the ``Agricultural Bioterrorism Protection Act of 2002,'' and referred 
to below as the Act), section 212(a)(1)(A) (7 U.S.C. 8401(a)(1)(A)), 
provides, in part, that the Secretary of Agriculture (the Secretary) 
``shall by regulation establish and maintain a list of each biological 
agent and each toxin that the Secretary determines has the potential to 
pose a severe threat to animal or plant health, or to animal or plant 
products.''
    In determining whether to include an agent or toxin in the list, 
the Secretary shall consider the following criteria stated in the Act 
(7 U.S.C. 8401(a)(1)(B)):
     ``[T]he effect of exposure to the agent or toxin on animal 
or plant health, and on the production and marketability of animal or 
plant products;''
     ``[T]he pathogenicity of the agent or the toxicity of the 
toxin and the methods by which the agent or toxin is transferred to 
animals or plants;''
     ``[T]he availability and effectiveness of 
pharmacotherapies and prophylaxis to treat and prevent any illness 
caused by the agent or toxin;''
     ``[W]hether such inclusion would have a substantial 
negative impact on the research and development of solutions for the 
animal or plant disease caused by the agent or toxin; and whether the 
negative impact [on research and development] would substantially 
outweigh the risk posed by the agent or toxin to animal or plant health 
if it is not included on the list'' (added by the 2018 Farm Bill); and
     ``[A]ny other criteria that the Secretary considers 
appropriate to protect animal or plant health, or animal or plant 
products.''
    Paragraph (a)(2) of section 212 of the Act (7 U.S.C. 8401(a)(2)) 
requires the Secretary to review and republish the list of select 
agents and toxins every 2 years and to otherwise revise the list as 
necessary. To fulfill this statutory mandate, APHIS convenes separate 
interagency working groups in order to review the lists of PPQ and VS 
select agents and toxins, as well as any overlap select agents and 
toxins, and develop recommendations regarding possible changes to the 
list using the five criteria for listing, stated above, found in the 
Act. APHIS and CDC coordinate on the biennial review for overlap select 
agents and toxins that have been determined to pose a severe threat to 
human and animal health or animal products.
    On March 17, 2020, we published in the Federal Register (85 FR 
15078-01, Docket No. APHIS-2019-0018) an advance notice of proposed 
rulemaking (ANPR) \1\ and request for comments in which we solicited 
public comment on the possible delisting of one PPQ select agent, 
Peronosclerospora philippinensis (P. sacchari), one VS select agent, 
African horse sickness virus, and five overlap select agents, Bacillus 
anthracis (Pasteur strain), Brucella abortus, B. suis, and B. 
melitensis, and Venezuelan equine encephalitis virus. We discussed the 
comments received on the ANPR in the proposed rule that followed. On 
January 30, 2024, we published in the Federal Register (89 FR 5795-
5819, Docket No. APHIS-2019-0018) a proposal \2\ to amend and republish 
the list of select agents and toxins that have the potential to pose a 
severe threat to animal or plant health, or to animal or plant 
products. We proposed to delist P. philippinensis (sacchari), African 
horse sickness virus, B. abortus, B. suis, and B. melitensis.
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    \1\ To view the ANPR and the comments we received, go to 
www.regulations.gov. Enter APHIS-2019-0018 in the Search field.
    \2\ To view the proposed rule and the comments we received, go 
to www.regulations.gov. Enter APHIS-2019-0018 in the Search field.
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    In the proposed rule, we also proposed additional changes to the 
regulations beyond those discussed in the ANPR. Certain of these 
changes were, in our assessment, codifications of existing operational 
policy. These included provisions related to: Discovery of a select 
agent or toxin, disposal of select agent waste after conclusion of 
patient care, the exclusion of animals naturally infected with select 
agents from the requirements of the regulations, allowing individuals 
other than the responsible official (e.g., principal investigators) to 
revise inactivation procedure documentation, removal procedures, and 
the content of annual internal inspections.
    Other changes were intended as clarifications of existing 
provisions of the regulations. These included proposed definitions of 
loss, release, and theft, clarifying reporting requirements for 
``discovered'' select agents or toxins, a clarification regarding what 
constitutes an acceptable ``validated inactivation procedure,'' 
clarifications related to the existing reporting requirements, 
clarifying that certificates must accompany transfers of a select agent 
or toxin, including intra-entity transfers, clarifying that the 
documentation in the IT system for the FSAP program serves as official 
records required by the regulations, clarifying the documentation that 
may be needed for the issuance of a certificate of registration, 
clarifying that a responsible official cannot be approved as the 
responsible official at more than one registered entity and cannot be 
the sole alternate responsible official at another registered entity, 
clarifying requirements related to restricted experiments, clarifying 
the notification requirements for changes to the application for 
registration, and clarifying the scope of pre-access suitability 
assessments.

[[Page 101839]]

    Finally, certain proposed provisions would have been new, including 
provisions regarding effluent decontamination system, biosafety 
provisions for facility verification requirements for registered 
biosafety level 3 and animal biosafety level 3 laboratories, and a new 
requirement related to restricted experiments.
    We solicited comments concerning our proposal for 60 days, ending 
April 1, 2024. We received 69 comments by that date. The comments were 
from private citizens, research institutions, organizations 
representing research institutions, organizations representing the 
domestic cattle, bison, and equine industries, representatives from 
State fish and wildlife departments, and representatives from State 
departments of agriculture.
    While commenters largely supported our proposed amendments to the 
list of select agents and toxins, commenters raised legal, operational, 
and policy concerns about many of our proposed codifications, 
clarifications, and additions to the regulations.
    We proposed to delist P. philippinensis, African horse sickness 
virus, B. abortus, B. suis, and B. melitensis as select agents, and the 
comments we received regarding these select agents are discussed below.

P. philippinensis

    We received one comment specifically addressing P. philippinensis. 
The commenter supported delisting P. philippinensis, citing cultivation 
characteristics that would make propagation difficult and unlikely to 
produce a dangerous agent. We did not receive any comments stating an 
opposition to delisting. Accordingly, we are delisting P. 
philippinensis as proposed.

African Horse Sickness (AHS) Virus

    We received two comments specifically addressing AHS virus.
    One commenter agreed with delisting, citing limited communicability 
and the existence of countermeasures. Another commenter opposed 
delisting, citing the widespread presence of the disease's vectors in 
the United States, the high mortality rate for animals associated with 
the disease, and the absence of available vaccines for AHS virus within 
the United States. The commenter did acknowledge that vaccines were 
available internationally but stated that there were no guidelines for 
their use within the United States, nor did they think APHIS would 
authorize their use in the event of an outbreak. The commenter further 
stated that, even if APHIS were to authorize their use in the event of 
a domestic outbreak of AHS virus, the specific serotype would need to 
be identified, and a monovalent vaccine procured from a foreign source, 
which could take months.
    We agree that AHS virus causes a life-threatening, hemorrhagic, 
noncontagious, nonzoonotic, arthropod-borne viral disease of equines. 
However, the Act's aim is not solely to determine whether a pathogen 
causes deadly disease, but whether it is likely to be used as a 
bioterrorism agent, and if used, what the potential impacts would be. 
In that regard, in deciding whether an agent or toxin should be 
included on the select agent and toxin list, the Act requires us to 
take into consideration not only the pathogenicity of the agent, but 
also the methods by which it is disseminated, and the availability and 
effectiveness of prophylaxis as well as treatments, such as vaccines 
and pharmaceuticals.
    AHS virus must use arthropod vectors in order to be transmitted. 
While the commenter is correct that arthropod vectors for the disease 
do exist within the United States, both the AHS virus and its vector 
must be present in an environment for transmission to equines to occur, 
making the virus difficult to effectively disseminate in equine 
populations. Therefore, we concluded that the AHS virus will unlikely 
be used as a bioterrorism agent. Additionally, while the commenter is 
correct that currently there are no vaccines available in the United 
States for AHS, and, accordingly, no guidelines yet established for use 
of AHS vaccines within the United States, vaccines are available 
internationally and in the event of foreign animal disease outbreak, 
USDA can implement emergency response plans. USDA's manual for response 
to an introduction of a foreign animal diseases, such as AHS, is found 
at https://www.aphis.usda.gov/sites/default/files/fadprep_manual_1.pdf.
    The difficulty in disseminating and transmitting AHS virus and the 
availability of vaccines played a significant role in the Agricultural 
Interagency Select Agents and Toxins Technical Advisory Committee, or 
Ag-ISATTAC's, recommendation to delist AHS virus as a select agent.
    Based on the foregoing considerations, we are delisting AHS virus 
as a select agent, as proposed.

Brucella Species

    We received 44 comments supporting delisting of all three species 
of Brucella (B. abortus, B. suis, and B. melitensis). These commenters 
supported delisting for one or more of the following reasons:
     State animal health officials, researchers, and industry 
stakeholder groups stated that these species are unlikely to be 
intentionally used as an agent of bioterrorism. They commented that 
Brucella has a limited to negligible rate as a bioterrorism weapon and 
the benefits (e.g., research, testing, etc.) outweigh the risks. Also, 
they stated that these organisms are effectively contained within 
appropriate biosafety and biosecurity facilities, limiting access to 
unauthorized individuals.
     Private citizens and animal health groups stated that 
existing regulatory burden prevents ongoing research into vaccine 
development specifically in the areas of vaccine efficacy and vaccine 
delivery in wildlife. We agree regarding the burden to the research 
community, and that more robust studies can help limit the spread of 
disease.
     Private citizens commented that brucellosis in humans is 
rarely fatal and easily treatable in the early stages.
     Stakeholders and private citizens, also, said intervention 
strategies to reduce the disease in animal populations exist: There are 
already nationally recognized biosafety measures used by U.S. 
researchers in handling these agents. For instance, there are effective 
and well-established antibiotic treatment regimens for brucellosis due 
to infections with B. abortus, B. melitensis, or B. suis.
    We received an additional 11 comments that only addressed B. 
abortus and supported delisting it. In addition to the above 
considerations, these commenters supported delisting B. abortus to 
facilitate research and development of more effective vaccines for 
wildlife reservoirs of the agent.
    We received two comments opposing delisting of one or more of the 
Brucella spp. One commenter opposed delisting Brucella spp. pending 
vaccine development, citing an incident where the commenter claimed 
more than 300 veterinary medical professionals in a foreign country 
were exposed to B. abortus while vaccinating cattle, with multiple 
mortalities.
    While human health considerations generally fall outside of APHIS' 
administration of the Act, and are instead under the purview of CDC, 
because the commenter raised concerns related to transmissibility due 
to human interaction with livestock, we wish to provide context for the 
incident cited by the commenter and respond to the stated concerns.
    The above-cited incident did not occur in the United States. While 
misuse of vaccines, and improper vaccination protocols have, on rare 
occasion, resulted in transmission of the

[[Page 101840]]

vaccine strain of B. abortus to humans domestically, antibiotics are 
widely available within the United States to treat incidents of 
brucellosis in humans, and mortality is rare. The Act also directs us 
to consider not only the availability of prophylaxis, such as vaccines, 
but also pharmacotherapies, such as antibiotics. For these reasons, we 
disagree with the commenter that B. abortus should not be delisted 
pending vaccine development. The commenter also did not contest our 
reasons in the proposed rule for delisting B. abortus: The agent is 
unlikely to be used as an agent of bioterrorism for a large-scale 
population introduction due to the high concentration of the agent 
necessary to produce disease as well as modern cattle production 
processes that limit animal-to-animal transmission routes; there is an 
efficacious vaccine; there is moderate immunity status within 
vulnerable populations; there is limited farm-to-farm transmission 
risk; and there are effective quarantine procedures. In this regard, we 
note that several of the commenters who supported delisting B. abortus 
provided scientific research or articles that buttressed these 
considerations.
    Another commenter claimed, without evidence, that B. abortus was 
not a real disease, and being used as a pretext to kill bison.
    The commenter is incorrect. B. abortus is a documented disease of 
cattle and bison.
    Multiple commenters supportive of delisting Brucella spp. stated 
that B. abortus is a serious human health risk, and supported delisting 
insofar as it would, among other things, facilitate vaccine development 
in cattle and bison that could reduce rancher exposure to the disease.
    As we noted above, human health considerations generally fall 
outside of APHIS' administration of the Act. However, we disagree with 
the commenters' characterization of the human health risk presented by 
brucellosis. While it can be fatal, the case fatality rate and person-
to-person transmission for B. abortus continues to be very low. In 
addition, the human illnesses caused by B. abortus are readily 
recognized and can be treated with widely available antibiotics.
    One commenter requested clarification that the diseases would still 
be reportable, even if delisted as select agents, and that the domestic 
brucellosis eradication program would still remain.
    Brucellosis is a livestock disease that is reportable to State and 
Federal animal health authorities in the United States when an outbreak 
occurs. Our domestic brucellosis eradication program is administered by 
APHIS and State animal health authorities under a different statute, 
the Animal Health Protection Act (7 U.S.C. 8301-8317), and will remain 
in effect.\3\
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    \3\ 9 CFR part 78 (Brucellosis; Domestic Brucellosis 
Regulations).
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    One commenter stated that it was the commenter's understanding that 
CDC biosafety level 3 (BSL 3) requirements will still be in effect for 
Brucella spp. even if all three agents are delisted.
    Delisting of an agent neither reduces nor affects the recommended 
biosafety level for laboratory work. BSL 3 laboratory safety and 
containment is currently recommended for laboratory work with Brucella 
spp. The current BSL 3 laboratory safety and containment 
recommendations for Brucella spp. are outlined in the Biosafety in 
Microbiological and Biomedical Laboratories (BMBL), available at: 
https://www.cdc.gov/labs/bmbl/index.html.
    Finally, several commenters stated that research facilities 
registered with FSAP and currently conducting ongoing research on 
Brucella spp. will need guidance regarding the impacts of delisting on 
their work. FSAP will provide such guidance.
    Accordingly, we are delisting B. abortus, B. melitensis, and B. 
suis as select agents, as proposed.

CDC Agents

    Finally, we received a few comments on CDC's list of select agents 
and toxins. These comments are outside of the scope of this rulemaking, 
and APHIS has routed them to CDC for consideration.

Nipah Virus

    In its January 30, 2024, proposed rule (89 FR 5823-1), CDC proposed 
designating Nipah virus, an overlap select agent, as a Tier 1 select 
agent because of its human transmissibility, high case fatality rate, 
high severity of illness, and severe long-term effects. However, due to 
an inadvertent oversight in our proposed rule, APHIS did not propose 
parallel changes. In its final rule published elsewhere in this issue 
of the Federal Register, CDC is designating Nipah virus as a Tier 1 
select agent as proposed based on consideration of the comments 
received. As a result of CDC's decision, because Nipah virus is an 
overlap select agent, in this final rule, we are amending 9 CFR 
121.3(b) to add an asterisk before ``Nipah virus,'' thus indicating its 
designation as a Tier 1 select agent. We are doing this to ensure 
harmonization between our regulations and CDC's regulations regarding 
this designation.
    Therefore, for the reasons given, we are adopting the proposed 
revisions to the lists of select agents and toxin set forth in 7 CFR 
331.3(b) and 9 CFR 121.3(b) and (b) that arose out of the biennial 
review of the list as final, with the change discussed immediately 
above. Executive Orders 12866 and 13563 and Regulatory Flexibility Act
    This final rule has been determined to be significant for the 
purposes of Executive Order 12866 as amended by Executive Order 14094, 
``Modernizing Regulatory Review,'' and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this final rule. The 
economic analysis provides a cost-benefit analysis, as required by 
Executive Orders 12866 and 13563, which direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and equity). Executive Order 13563 
emphasizes the importance of quantifying both costs and benefits, of 
reducing costs, of harmonizing rules, and of promoting flexibility. The 
economic analysis also examines the potential economic effects of this 
rulemaking on small entities, as required by the Regulatory Flexibility 
Act.
Summary
    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (Pub. L. 107-188), as amended (referred to below 
as the Bioterrorism Response Act), provides for the regulation of 
certain biological agents and toxins that have the potential to pose a 
severe threat to human, animal, or plant health, or to animal or plant 
products. APHIS, Emergency & Regulatory Compliance Services (ERCS), and 
the Division of Agricultural Select Agents and Toxins (DASAT) have the 
primary responsibility for implementing the provisions of the 
Bioterrorism Response Act with the USDA. Within APHIS, VS select agents 
and toxins, listed in 9 CFR 121.3, are those that have been determined 
to have the potential to pose a severe threat to animal health or 
animal products, and PPQ select agents and toxins, listed in 7 CFR 
331.3, are those that have been determined to have the potential to 
pose a severe threat to plant health or plant products. Overlap select 
agents and toxins, listed in 9 CFR 121.4, are those

[[Page 101841]]

that have been determined to pose a severe threat to public health and 
safety, to animal health, or to animal products. Overlap select agents 
and toxins are subject to regulation by both APHIS, ERCS, DASAT, and 
the CDC's Division of Regulatory Science and Compliance (DRSC), which 
has the primary responsibility for implementing the provisions of the 
Bioterrorism Response Act for the U.S. Department of Health and Human 
Services (HHS). Together, APHIS, ERCS, DASAT, and CDC's DRSC comprise 
the Federal Select Agent Program (FSAP).
    Title II, Subtitle B of the Bioterrorism Response Act (which is 
cited as the ``Agricultural Bioterrorism Protection Act of 2002,'' as 
amended, and referred to below as the Act), section 212(a)(1) (7 U.S.C. 
8401(a)(1)), provides, in part, that the Secretary of Agriculture (the 
Secretary) must establish and maintain, by regulation, a list of each 
biological agent and each toxin that the Secretary determines has the 
potential to pose a severe threat to animal or plant health, or to 
animal or plant products. Paragraph (a)(2) of section 212 of the Act (7 
U.S.C. 8401(a)(2)) requires the Secretary to review and republish the 
list of select agents and toxins every two years and to otherwise 
revise the list as necessary. To fulfill this statutory mandate, APHIS 
convenes separate interagency working groups to review the list of PPQ 
and VS select agents and toxins, as well as any overlap select agents 
and toxins, and develop recommendations regarding possible changes to 
the list using the five criteria for listing found in the Act. APHIS 
and CDC coordinate on the biennial review for overlap select agents and 
toxins that have been determined to pose a severe threat to human and 
animal health or animal products.
    APHIS is delisting three overlap select agents: Brucella abortus, 
Brucella suis, and Brucella melitensis. CDC has made parallel 
regulatory changes with respect to these Brucella spp. APHIS is also 
delisting one PPQ select agent, Peronosclerospora philippinensis 
(Peronosclerospora sacchari), and one VS select agent, African horse 
sickness (AHS) virus. These delisting changes will economically benefit 
producers, research and reference laboratories, and State and Federal 
oversight agencies, while also maintaining adequate program oversight 
of delisted select agents and toxins through HHS CDC and National 
Institutes of Health guidelines along with USDA-APHIS permits for 
movement.
    Previous regulatory restrictions had effectively prohibited vaccine 
trials using natural transmission models, limited the opportunity for 
large animal studies, inhibited available surveillance, and prohibited 
studies that would evaluate vaccine or diagnostic product efficacy 
through comingling vaccinated and naturally infected animals. Delisting 
these five agents could decrease disease management costs for State and 
Federal governments as well as livestock producers. Additionally, 
delisting will remove restrictions that limited courier availability 
for these five agents, a factor that previously resulted in prohibitive 
shipment costs for many laboratories. Previous shipment costs had 
inhibited isolate sharing between reference and research laboratories, 
thus leading to decreased advancements from researchers and 
laboratories involved in diagnostic improvements and disease 
eradication efforts. Delisting the three Brucella agents (B. abortus, 
B. suis, and B. melitensis) as overlap select agents and one VS agent, 
AHS virus, along with one plant agent, Peronosclerospora 
philippinensis, from the list of select agents and toxins will 
economically benefit producers, research and reference laboratories, 
and State and Federal oversight agencies.
    B. abortus presents little economic or animal health risk as a 
bioterrorism agent as it is unlikely to result in large-scale 
population introduction due to the high concentration of the agent 
necessary to produce disease as well as modern cattle production 
processes that limit animal-to-animal transmission routes. There is an 
efficacious vaccine, moderate immunity status within vulnerable 
populations, limited farm-to-farm transmission risk, and effective 
quarantine procedures. (Center for Food Security and Public Health, 
2009; Moreno, E., 2014; Olsen, S.C., 2011.) B. melitensis primarily 
affects goats and sheep and is of lesser concern because the low farm-
to-farm transmission risk due to modern production practices limits the 
chance of introduction on a scale large enough to impact domestic 
production. (The Center for Food Security and Public Health, 2009; 
Moreno, E., 2014; Olsen, S.C., 2011.) B. suis also presents a low to 
moderate animal health risk due to limited farm-to-farm transmission 
risk because of modern production practices, which reduce the risk of a 
large-scale introduction. (The Center for Food Security and Public 
Health, 2009; Stoffregen, W.C., 2006; World Organizsation for Animal 
Health (OIE), 2017; Zhu, L., et al., 2016.) For these reasons and due 
to the overwhelming public support, APHIS, in conjunction with CDC, is 
delisting these three Brucella species.
    Peronosclerospora philippinensis (Peronosclerospora sacchari) is 
only able to survive and reproduce in the host plant and requires 
specific environmental conditions to become infectious, for which 
mitigations exist. The production characteristics for large volume 
production and subsequent dissemination require extensive 
specialization and reflect high degree of difficulty for dissemination 
of the agent. Thus, the economic impact of possible misuse of this 
agent was deemed a low impact. We are delisting the agent based upon 
affirmative responses to proposed delisting.
    AHS virus causes a life-threatening, hemorrhagic, noncontagious, 
nonzoonotic, arthropod-borne viral disease of equines. However, the 
Act's aim is not solely to determine whether a pathogen causes deadly 
disease, but whether it is likely to be used as a bioterrorism agent, 
and if used, what the potential impacts would be. In that regard, in 
deciding whether an agent or toxin should be included on the select 
agent and toxin list, the Act requires us to take into consideration 
not only the pathogenicity of the agent, but also the methods by which 
it is disseminated, and the availability and effectiveness of 
prophylaxis as well as treatments, such as vaccines and 
pharmaceuticals. AHS is an arthropod-borne illness that must be 
vectored to be transmitted. Because both the disease and its vector 
must be present in an environment for transmission to equines to occur, 
we considered AHS unlikely to be used as an agent of bioterrorism. 
Vaccines are also available internationally and in the event of foreign 
animal disease outbreak, we can implement emergency response plans. 
Based on the foregoing considerations, we are delisting AHS virus as a 
select agent.
    Currently, there are 236 entities registered with APHIS and CDC. Of 
these entities, 13 are private entities, 30 are Federal entities, 42 
are commercial entities, 84 are academic entities, and 67 are State 
entities. Less than 32 percent of all firms operating within these 
North American Industry Classification (NAICS) categories are 
considered to be small entities.
    This document provides a cost-benefit analysis, as required by 
Executive Orders 12866, 13563, and 14094 which direct Federal agencies 
to assess all costs and benefits of available regulatory alternatives 
and, if regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety effects, and equity). Executive Order 13563 
emphasizes the importance of

[[Page 101842]]

quantifying both costs and benefits, of reducing costs, of harmonizing 
rules, and of promoting flexibility. This document also examines the 
potential economic effects of this rulemaking on small entities, as 
required by the Regulatory Flexibility Act.
Description of Final Rule
    Pursuant to the Agricultural Bioterrorism Protection Act of 2002, 
as amended (7 U.S.C. 8401(a)(2)) (Act), APHIS has completed its 
required biennial review of the current list of select agents and 
toxins in 7 CFR 331.3 (PPQ select agents) and 9 CFR 121.3 (VS select 
agents) and 121.4 (overlap select agents overseen jointly with CDC). 
This final rule implements the recommendations of the interagency 
working groups with respect to the list of select agents and toxins. 
APHIS, in conjunction with CDC, is removing the following overlap 
select agents from the list of select agents and toxins: Brucella 
abortus, Brucella suis, and Brucella melitensis. Public response showed 
overwhelming support for delisting all three Brucella species. 
Therefore, we consider it appropriate to delist these three Brucella 
spp.
    We are also delisting Peronosclerospora philippinensis 
(Peronosclerospora sacchari). We received only supportive comments for 
this proposed delisting.
    Finally, we are delisting AHS virus. While we received a comment 
opposed to this delisting, it did not call into question our 
considerations in proposing delisting.
Overview of the Action and Affected Entities
    As previously discussed, there are 236 entities registered with 
APHIS and CDC. Of these entities,13 are private entities, 30 are 
Federal entities, 42 are commercial entities, 84 are academic entities, 
and 67 are State entities. Of these, less than 32 percent of all 
entities within these NAICS categories are considered to be small 
entities. The delisting of B. abortus, B. suis, and B. melitensis is 
anticipated to economically benefit producers, research and reference 
laboratories, and State and Federal oversight agencies, while also 
maintaining adequate program oversight of delisted select agents and 
toxins through HHS CDC and National Institutes of Health guidelines 
along with USDA-APHIS permits for movement. Below we provide a cost-
benefit analysis, as required by Executive Orders 12866, 13563, and 
14094 to examine the potential economic effects of delisting B. 
abortus, B. suis, B. melitensis, Peronosclerospora philippinensis 
(Peronosclerospora sacchari), and AHS virus on small entities.
Expected Costs and Benefits of the Final Rule
    There are currently costs associated with registration of the 
select agents that we are delisting. There are no direct costs for 
regulated entities associated with the delisting of Brucella species, 
only benefits to facilities to participate in Brucella research. If 
Brucella species are delisted, APHIS regulations requiring permits for 
their movement pursuant to 9 CFR part 122 will be operative, however; 
new permits cost $150 and permitting information is found here: https://www.aphis.usda.gov/animal-product-import/organisms-vectors. Many 
entities have been requesting the delisting of the Brucella spp. for 
years. State Veterinarians have expressed concern regarding the 
limitation on brucellosis research because of the designation of 
Brucella as a select agent.\4\
---------------------------------------------------------------------------

    \4\ State Veterinarian Notes, March 2020: Limitations on 
brucellosis research due to being listed as a select agent. (https://liv.mt.gov/_docs/Animal-Health/Newsletters/1st%20%20Quarter%20Newsletter%20Vol%2013%20Iss%201%20C%20Final.pdf).
---------------------------------------------------------------------------

    Livestock producer organizations and the United States Animal 
Health Association have voiced their support and the need for the 
development of a B. suis vaccine, as well as improved diagnostics for 
Brucella spp.\5\ Similarly, Peronosclerospora philippinensis 
(Peronosclerospora sacchari) has received public support for delisting 
as the agent is only able to survive and reproduce in the host plant, 
and AHS, while a life-threatening viral disease of equines, is unlikely 
to be used as a bioterrorism agent. Previous regulatory restrictions 
had effectively prohibited vaccine trials using natural transmission 
models, limited the opportunity for large animal studies, inhibited 
available surveillance, and prohibited studies that would evaluate 
vaccine or diagnostic product efficacy through comingling vaccinated 
and naturally infected animals. These limitations increase disease 
management costs for State and Federal governments as well as livestock 
producers.
---------------------------------------------------------------------------

    \5\ United States Animal Health Association (USAHA) Committee on 
Cattle and Bison, 2020, page 8: AgSAS Delisting Update: https://www.usaha.org/upload/Committee/2020Reports/Cattle_Bison_Report_2020.pdf.
---------------------------------------------------------------------------

    One previous example of the public requesting delisting of a select 
agent for research purposes was Valley Fever or Coccidiodes spp. Until 
October 2012, Valley Fever or Coccidiodes spp. had been listed as a 
select agent by both APHIS and CDC. Since delisting, additional 
research has taken place, resulting in enhanced outreach to inform 
potential infected citizens. Doctors and medical personnel also are 
more familiar with it and understand that climate change is 
contributing to this disease in California. Like Valley Fever, the high 
cost to work with Brucella spp. has prevented appropriate research and 
field studies to take place, thus hampering new information and 
research to limit or stop the spread of the disease or at least inform 
the public of its method of infection. Very few laboratories currently 
have the resources or ability to do Brucella spp. research due to the 
facility needs required by its current listing as a select agent under 
the regulations.
    Due to the stringent transfer requirements in 9 CFR 121.16 for 
select agents, currently, there is limited courier availability for 
Brucella spp., Peronosclerospora philippinensis (Peronosclerospora 
sacchari), and AHS virus shipments. The lack of available couriers has 
resulted in prohibitive shipment costs for many laboratories. The 
increased shipment costs have inhibited isolate sharing between 
reference and research laboratories, thus leading to decreased 
advancements from researchers and laboratories involved in diagnostic 
improvements and disease eradication efforts. Removing the three 
Brucella species (B. abortus, B. suis, and B. melitensis) as overlap 
select agents and one VS agent, AHS virus, along with one plant agent, 
Peronosclerospora philippinensis, from the list of select agents and 
toxins will thus economically benefit producers, research and reference 
laboratories, and, for Brucella abortus delisting, State and Federal 
oversight agencies.
    As described, any impacts of delisting these agents from the list 
of select agents and toxins are expected to be beneficial for the 
affected industries.
Small-Entity Prevalence
    Entities that possess, use, or transfer B. abortus, B. suis, and B. 
melitensis along with Peronosclerospora philippinensis 
(Peronosclerospora sacchari) and AHS virus would either benefit or be 
unaffected by this final rule. Potentially affected entities include 
laboratories, other research institutions, and related entities in 
possession of the Brucella spp. Affected entities (other than Federal 
and State governmental entities) are likely found within the following 
NAICS categories:
     541714, Research and Development in Biotechnology;

[[Page 101843]]

     541715, Research and Development in the Physical, 
Engineering, and Life Sciences (except Biotechnology);
     325412, Pharmaceutical Preparation Manufacturing;
     325413, In-Vitro Diagnostic Substance Manufacturing;
     325414, Biological Product (except Diagnostic) 
Manufacturing;
     541940, Veterinary Services;
     611310, Colleges, Universities and Professional Schools;
     621511, Medical Laboratories;
     622110, General Medical and Surgical Hospitals.
    The Small Business Administration (SBA) has established small-
entity size standards based on the NAICS categories. An entity 
classified within NAICS 541714 and NAICS 541715 is considered small 
with 1,000 or fewer employees, and one within NAICS, 325413, and 325414 
is considered small with 1,250 or fewer employees and one with NAICS 
325124 is considered small with 1,300 or fewer employees. An entity 
within NAICS 541940 is considered small with annual receipts of $10 
million or less, and an entity within NAICS 611310 is considered small 
with annual receipts of not more than $34.5 million. Entities 
classified within NAICS 621511 are considered to be small if they have 
annual receipts of not more than $41.5 million. An entity classified 
within NAICS 622110 is considered to be small with annual receipts of 
not more than $47 million.
Potential Impact on Small Entities
    As described above, entities that possess, use, or transfer the 
delisted agents are not expected to be significantly affected by this 
final rule and will benefit from the enhanced ability to further 
perform research on the relevant agent.
    Currently, there are 236 entities registered with APHIS and CDC. Of 
these entities, 13 are private entities, 30 are Federal entities, 42 
are commercial entities, 84 are academic entities, and 67 are State 
entities. Approximately 32 percent of all entities within these NAICS 
categories of laboratories are considered to be small entities and 68 
percent are considered large entities.
    Of these 236 registered entities, potentially affected entities 
include laboratories, other research institutions, and related entities 
in possession of select agents. Potentially affected entities (other 
than Federal and State governmental entities) are likely found within 
the following NAICS categories:
     541714, Research and Development in Biotechnology;
     541715, Research and Development in the Physical, 
Engineering, and Life Sciences (except Biotechnology);
     325412, Pharmaceutical Preparation Manufacturing;
     325413, In-Vitro Diagnostic Substance Manufacturing;
     325414, Biological Product (except Diagnostic) 
Manufacturing;
     541940, Veterinary Services;
     611310, Colleges, Universities and Professional Schools;
     621511, Medical Laboratories; or
     622110, General Medical and Surgical Hospitals.
    The SBA has established small-entity size standards based on the 
NAICS categories. An entity classified within NAICS 541714 and NAICS 
541715 is considered small with 1,000 or less employees, and an entity 
classified within NAICS 325412 is considered small with 1,300 or less 
employees, 325413, and 325414 is considered small with 1,250 or less 
employees. An entity in NAICS 541940 is considered small with annual 
receipts of $10 million or less, and an entity in NAICS 611310 is 
considered small with annual receipts of not more than $34.5 million. 
Entities classified within NAICS 621511 are considered to be small if 
they have annual receipts of not more than $41.5 million. An entity 
classified within NAICS 622110 is considered to be small with annual 
receipts of not more than $47 million.
    While the breakdown of the size of the entities, as reported by the 
2017 Economic Census (updated subset of 2021 County Business Patterns 
released on July 3, 2024), does not precisely fit the SBA guidelines, 
the data indicates that the majority (68 percent) of the entities in 
industries potentially affected by this final rule, other than post-
secondary institutions, can be considered large entities. In other 
words, over 68 percent of all entities included in the above mentioned 
NAICS codes are large entities meaning only approximately 32 percent of 
these entities are small entities \6\ (see table 1 below). According to 
the 2017 Economic Census and 2021 subset, the most recent census data 
available for all entities, 98 percent of entities in NAICS 541714 and 
96 percent 541715, 93 percent of entities in NAICS 325412, 86 percent 
of entities in NAICS 325413, 86 percent of entities in NAICS 325414, 0 
percent of entities in NAICS 541940, 13 percent of entities in NAICS 
621511, 7 percent of entities in NAICS 611310, and 3 percent of 
entities in NAICS 622110 can be classified as small entities.\7\
---------------------------------------------------------------------------

    \6\ NAICS codes included for all firms totaled 50,281. Of that 
total, 16,149 were considered small and 34,132 were considered 
large. Overall percent was 32 percent small firms and 68 percent 
large firms.
    \7\ Based on the small business size standards matched to 
industries described in NAICS, as modified by the Office of 
Management and Budget in 2017, and reported in the SBA's Small 
Business Size regulations contained in 13 CFR part 121 (https://www.ecfr.gov/current/title-13/chapter-I/part-121) and data by 
enterprise receipt size (https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html) and also when not available in sub 
2021 (https://www.census.gov/data/tables/2017/econ/susb/2017-susb-annual.html).

                     Table 1--Prevalence of Small/Large Entities Within Affected Industries
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
NAICS code                                        Number of firms in each SBA size class           Percentage of
                                                                                                     small firms
----------------------------------------------------------------------------------------------------------------
SBA Small-entity Standard based on        <1,000 Employees small      1,000 + Employees large
 Employment.                               entities.                   entities.
541714 Research and Development (R&D) in  4,638.....................  76........................              98
 Biotechnology (commercial and non-
 profit) 4,714 firms.
541715 R&D in the Life Sciences           9,399.....................  425.......................              96
 (commercial and non-profit) 9,824 firms.
                                          <1,250 Employees small      1,250 + Employees large
                                           entities.                   entities.
325413 In-vitro Diagnostic Substance 194  167.......................  27........................              86
 firms.
325414 Biological Product (except         247.......................  41........................              86
 Diagnostic) 288 firms.
                                          <1,300 Employees..........  1,300 + Employees large
                                                                       entities.
325412 Pharmaceutical Preparation 1,172   1,092.....................  80........................              93
 firms.
SBA Small-entity Standard based on        <$10 million in Receipts    $10 million + in Receipts
 Annual Receipts.                          small firms.                large firms.


[[Page 101844]]


                Table 1--Prevalence of Small/Large Entities Within Affected Industries--Continued
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
NAICS code                                        Number of firms in each SBA size class           Percentage of
                                                                                                     small firms
----------------------------------------------------------------------------------------------------------------
541940 Veterinary Services 42 b receipts  0.........................  28,291....................               0
 28,291 firms.
SBA Small-entity Standard based on        <$34.5 million in Receipts  $34.5 million + in
 Annual Receipts.                          small firms.                Receipts large firms.
611310 Colleges, Universities, and        168.......................  2,265.....................               7
 Professional Schools 2,433 firms.
SBA Small-entity Standard based on        <$41.5 million in Receipts  $41.5 million + in
 Annual Receipts.                          small firms.                Receipts large firms.
621511 Medical Laboratories 3,365 firms.  438.......................  2,927.....................              13
SBA Small-entity Standard based on        <$47 million in Receipts    $47 million + in Receipts
 Annual Receipts.                          small firms.                large firms.
622110 General Medical and Surgical       65........................  2,495.....................               3
 Hospitals 2,560.
----------------------------------------------------------------------------------------------------------------

    The analysis above shows the potential costs of the final rule to 
be slight as permits would be required for movement. While an 
interstate transport permit of organisms and vectors will be required, 
delisted agents will incur less cost than prior to delisting. Prior to 
delisting, entities had to pay a few thousand dollars in shipping costs 
alone to move select agent's interstate, due to heightened security 
measures to move select agent's interstate. The organism and vector 
permit will cost $150 to move these delisted agents interstate, which 
is significantly less than the thousands of dollars required to ship 
select agents interstate. The benefits of the final rule will accrue to 
all firms conducting research with Brucella spp., Peronosclerospora 
philippinensis (Peronosclerospora sacchari), and AHS as most of which 
(68 percent) included in the above mentioned NAICS codes are large 
entities, meaning only approximately 32 percent of these firms are 
small entities. Following delisting, they will have the option to 
purchase a permit for movement only if they decide the benefits of the 
permit outweigh the cost of $150 per permit. Receipts are in the 
millions to billions of dollars for these entities; the cost of the 
permit will be insignificant based upon receipts shown in the Census of 
Agriculture data. In addition, this is a significant reduction in the 
cost of shipping select agents interstate which is in the magnitude of 
a few thousand dollars to move a single select agent interstate. 
Finally, these entities as mentioned above have already been incurring 
these shipping costs for interstate movement of delisted and select 
agents.
Alternatives to the Final Rule
    APHIS convenes separate interagency working groups in order to 
review the list of PPQ and VS select agents and toxins, as well as any 
overlap select agents and toxins, and develop recommendations regarding 
possible changes to the list using the five criteria for listing found 
in the Act. APHIS and CDC coordinate on the biennial review for overlap 
select agents and toxins that have been determined to pose a severe 
threat to human and animal health or animal products. The delisting of 
the three Brucella spp., AHS virus, and P. philippinensis (P. sacchari) 
is based on the recommendations of the interagency working groups.
    The most significant impact of this final rule is the delisting of 
Brucella spp., AHS virus, and P. philippinensis (P. sacchari), and 
APHIS and HHS/CDC has carefully considered the alternative of delisting 
the agents, which would be retaining the agents on the list and 
continuing regulating these agents.
    Retaining the Brucella species on the list has several economic, 
agricultural, and economic effects with little biosecurity benefit. 
Most notably, retaining Brucella species on the list prevents 
researchers from progressing advancement of science with regards to 
study of the agents and development of countermeasures for this agent 
by subjecting these laboratories to Federal Select Agent regulatory 
authority.
    Continuing regulation of Brucella melitensis, suis, and abortus has 
a one-time cost of approximately $29,000 to an entity that wishes to 
register with FSAP for work with these agents. This cost to the 
regulated community represents a regulatory burden to entities that 
wish to advance understanding of the agent and research medical 
countermeasures.
    An alternative to the final rule is to not delist these select 
agents. Retaining Brucella spp., AHS virus, and P. philippinensis (P. 
sacchari) would maintain the current status quo; it does not consider 
that these agents no longer pose a severe threat to public health and 
safety, does not promote better research and vaccine development, and 
does not align with USDA's decision to delist these agents. In 
addition, this option is not consistent with the public comment 
received to support amending the select agent list.
    Maintaining the status quo would mean foregoing continued research 
on an improved B. abortus vaccine and development of a B. suis vaccine, 
as well as improved diagnostics for both agents. Similarly, 
Peronosclerospora philippinensis (Peronosclerospora sacchari) has 
received public support for delisting as the agent is only able to 
survive and reproduce in the host plant, and AHS, while a life-
threatening viral disease of equines, is unlikely to be used as a 
bioterrorism agent. Previous regulatory restrictions had effectively 
prohibited vaccine trials using natural transmission models, limited 
the opportunity for large animal studies, inhibited available 
surveillance, and prohibited studies that would evaluate vaccine or 
diagnostic product efficacy through comingling vaccinated and naturally 
infected animals. These limitations also increase disease management 
costs for State and Federal governments as well as livestock producers.
    After carefully considering the technical input of subject matter 
experts, both within the Federal Government and from public comments, 
and recommendations from Federal advisory groups, APHIS and HHS/CDC is 
finalizing the changes to delist agents.

[[Page 101845]]

Reasons Action Is Being Considered
    APHIS and CDC are delisting B. abortus, B. suis, and B. melitensis 
from the select agents and toxins list to reduce costs and enhance 
opportunities for research on B. abortus vaccine and development of a 
B. suis vaccine, as well as improved diagnostics for both agents. The 
delisting of Brucella spp., AHS virus, and P. philippinensis (P. 
sacchari) is also based on the recommendations of interagency working 
groups. P. philippinensis (P. sacchari) is only able to survive and 
reproduce in the host plant and requires specific environmental 
conditions to become infectious, for which mitigations exist. Thus, the 
economic impact of possible misuse of this agent was deemed a low 
impact. We are delisting this agent based upon affirmative responses to 
proposed delisting. With regard to AHS, because both the disease and 
its vector must be present in an environment for transmission to 
equines to occur, we considered AHS unlikely to be used as an agent of 
bioterrorism. Vaccines are available internationally and in the event 
of foreign animal disease outbreak, we can implement emergency response 
plans. Based on the foregoing considerations, we are delisting AHS 
virus as a select agent.
Objectives of and Legal Basis for the Final Rule
    Pursuant to the Agricultural Bioterrorism Protection Act of 2002, 
as amended (7 U.S.C. 8401(a)(2)), APHIS has completed its required 
biennial review of the current list of select agents and toxins in 7 
CFR 331.3 (PPQ select agents) and 9 CFR 121.3 (VS select agents) and 
121.4 (overlap select agents overseen jointly with CDC). This final 
rule will implement the recommendations of the interagency working 
groups with respect to the list of select agents and toxins. APHIS, in 
conjunction with CDC, is removing the following overlap select agents: 
B. abortus, B. suis, and B. melitensis. APHIS is also removing one VS 
select agent, AHS virus. APHIS is also removing one PPQ select agent, 
P. philippinensis (P. sacchari).
Projected Reporting, Recordkeeping, and Other Compliance Requirements
    Delisting Brucella spp., AHS virus, and P. philippinensis (P. 
sacchari) will not result in additional reporting, recordkeeping, or 
other compliance requirements.
Duplication, Overlap, or Conflict With Existing Rules and Regulations
    APHIS has not identified any duplication, overlap, or conflict of 
the final rule with other Federal rules or regulations.
Executive Order 13175
    This final rule has been reviewed in accordance with the 
requirements of Executive Order 13175, ``Consultation and Coordination 
with Indian Tribal Governments.'' Executive Order 13175 requires 
Federal agencies to consult and coordinate with Tribes on a government-
to-government basis on policies that have Tribal implications, 
including regulations, legislative comments or legislation, and other 
policy statements or actions that have substantial direct effects on 
one or more Indian Tribes, on the relationship between the Federal 
Government and Indian Tribes or on the distribution of power and 
responsibilities between the Federal Government and Indian Tribes. What 
follows is a summary of such coordination to date. APHIS has assessed 
the impact of this rulemaking on Indian Tribes by soliciting Tribal 
feedback on its provisions. On April 8, 2022, APHIS sent Tribal nations 
a letter outlining the provisions of the proposed rule and soliciting 
their feedback. On May 5, 2022, the Sac and Fox Tribe of the 
Mississippi in Iowa submitted a response expressing concerns regarding 
whether possible Brucella abortus delisting would materially adversely 
impact APHIS' domestic quarantine program for the control and 
eradication of brucellosis in cattle and bison. In response, APHIS 
clarified that the two issues were distinct, and no adverse operational 
impacts were anticipated. On June 6, 2022, the Tribe indicated that 
they have no further comments or concerns. To date, no other Tribes 
have expressed concerns regarding this rulemaking, nor did Tribes 
submit comments on the proposed rule during its comment period. 
Therefore, the Agency has determined that this final rule does not, to 
our knowledge, have Tribal implications that require formal Tribal 
consultation under Executive Order 13175.
    If a Tribe requests consultation, the Animal and Plant Health 
Inspection Service will work with the Office of Tribal Relations to 
ensure meaningful consultation is provided where changes, additions, 
and modifications identified herein are not expressly mandated by 
Congress.
Executive Order 12988
    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule (1) preempts all State and local laws 
and regulations that are in conflict with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
    This final rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

List of Subjects

7 CFR Part 331

    Agricultural research, Laboratories, Plant diseases and pests, 
Reporting and recordkeeping requirements.

9 CFR Part 121

    Agricultural research, Animal diseases, Laboratories, Medical 
research, Reporting and recordkeeping requirements.

    Accordingly, we are amending 7 CFR part 331 and 9 CFR part 121 as 
follows:

Title 7--Agriculture

PART 331--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS

0
1. The authority citation for part 331 continues to read as follows:

    Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.3.


0
2. Amend Sec.  331.3 by revising paragraph (b) to read as follows:


Sec.  331.3  PPQ select agents and toxins.

* * * * *
    (b) PPQ select agents and toxins are:
    (1) Coniothyrium glycines, (formerly Phoma glycinicola, 
Pyrenochaeta glycines);
    (2) Ralstonia solanacearum;
    (3) Rathayibacter toxicus;
    (4) Sclerophthora rayssiae;
    (5) Synchytrium endobioticum; and
    (6) Xanthomonas oryzae.
* * * * *

Title 9--Animals and Animal Products

PART 121--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS

0
3. The authority citation for part 121 continues to read as follows:

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


[[Page 101846]]



0
4. Amend Sec.  121.3 by revising paragraph (b) to read as follows:


Sec.  121.3  VS select agents and toxins.

* * * * *
    (b) VS select agents and toxins are:
    (1) African swine fever virus;
    (2) Avian influenza virus;
    (3) Classical swine fever virus;
    (4) * Foot-and-mouth disease virus;
    (5) Goat pox virus;
    (6) Lumpy skin disease virus;
    (7) Mycoplasma capricolum;
    (8) Mycoplasma mycoides;
    (9) Newcastle disease virus; \1\
    (10) Peste des petits ruminants virus;
    (11) * Rinderpest virus;
    (12) Sheep pox virus; and
    (13) Swine vesicular disease virus.
* * * * *
    \1\ A virulent Newcastle disease virus (avian paramyxovirus type 1) 
has an intracerebral pathogenicity index in day-old chicks (Gallus 
gallus) of 0.7 or greater, or has an amino acid sequence at the fusion 
(F) protein cleavage that is consistent with virulent strains of 
Newcastle disease virus and phenylalanine at residue 117 of the F1 
protein N-terminus, except for genotype VI viruses from columbid birds.

0
5. Amend Sec.  121.4 by revising paragraph (b) to read as follows:


Sec.  121.4  Overlap select agents and toxins.

* * * * *
    (b) Overlap select agents and toxins are:
    (1) * Bacillus anthracis;
    (2) Bacillus anthracis (Pasteur strain);
    (3) * Burkholderia mallei;
    (4) * Burkholderia pseudomallei;
    (5) Hendra virus;
    (6) * Nipah virus;
    (7) Rift Valley fever virus; and
    (8) Venezuelan equine encephalitis virus.
* * * * *

    Done in Washington, DC.
Jennifer Moffitt,
Undersecretary, Marketing and Regulatory Programs, USDA.
[FR Doc. 2024-29567 Filed 12-16-24; 8:45 am]
BILLING CODE 3410-34-P`