Rule2024-29567
Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
Primary source
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Published
December 17, 2024
Effective
January 16, 2025
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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 Protection and Quarantine select agent), African horse sickness virus (Veterinary Services select agent), and Brucella abortus, Brucella suis, and Brucella melitensis (overlap select agents).
Full Text
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<title>Federal Register, Volume 89 Issue 242 (Tuesday, December 17, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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;
<a href="/cdn-cgi/l/email-protection#d0bab1b3b5bbfea4b1beb9b5a7a3bbb990a5a3b4b1feb7bfa6"><span class="__cf_email__" data-cfemail="761c1715131d580217181f1301051d1f360305121758111900">[email protected]</span></a>.
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)):
<bullet> ``[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;''
<bullet> ``[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;''
<bullet> ``[T]he availability and effectiveness of
pharmacotherapies and prophylaxis to treat and prevent any illness
caused by the agent or toxin;''
<bullet> ``[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
<bullet> ``[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
<a href="http://www.regulations.gov">www.regulations.gov</a>. Enter APHIS-2019-0018 in the Search field.
\2\ To view the proposed rule and the comments we received, go
to <a href="http://www.regulations.gov">www.regulations.gov</a>. 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 <a href="https://www.aphis.usda.gov/sites/default/files/fadprep_manual_1.pdf">https://www.aphis.usda.gov/sites/default/files/fadprep_manual_1.pdf</a>.
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:
<bullet> 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.
<bullet> 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.
<bullet> Private citizens commented that brucellosis in humans is
rarely fatal and easily treatable in the early stages.
<bullet> 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:
<a href="https://www.cdc.gov/labs/bmbl/index.html">https://www.cdc.gov/labs/bmbl/index.html</a>.
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: <a href="https://www.aphis.usda.gov/animal-product-import/organisms-vectors">https://www.aphis.usda.gov/animal-product-import/organisms-vectors</a>. 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. (<a href="https://liv.mt.gov/_docs/Animal-Health/Newsletters/1st%20%20Quarter%20Newsletter%20Vol%2013%20Iss%201%20C%20Final.pdf">https://liv.mt.gov/_docs/Animal-Health/Newsletters/1st%20%20Quarter%20Newsletter%20Vol%2013%20Iss%201%20C%20Final.pdf</a>).
---------------------------------------------------------------------------
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: <a href="https://www.usaha.org/upload/Committee/2020Reports/Cattle_Bison_Report_2020.pdf">https://www.usaha.org/upload/Committee/2020Reports/Cattle_Bison_Report_2020.pdf</a>.
---------------------------------------------------------------------------
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:
<bullet> 541714, Research and Development in Biotechnology;
[[Page 101843]]
<bullet> 541715, Research and Development in the Physical,
Engineering, and Life Sciences (except Biotechnology);
<bullet> 325412, Pharmaceutical Preparation Manufacturing;
<bullet> 325413, In-Vitro Diagnostic Substance Manufacturing;
<bullet> 325414, Biological Product (except Diagnostic)
Manufacturing;
<bullet> 541940, Veterinary Services;
<bullet> 611310, Colleges, Universities and Professional Schools;
<bullet> 621511, Medical Laboratories;
<bullet> 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:
<bullet> 541714, Research and Development in Biotechnology;
<bullet> 541715, Research and Development in the Physical,
Engineering, and Life Sciences (except Biotechnology);
<bullet> 325412, Pharmaceutical Preparation Manufacturing;
<bullet> 325413, In-Vitro Diagnostic Substance Manufacturing;
<bullet> 325414, Biological Product (except Diagnostic)
Manufacturing;
<bullet> 541940, Veterinary Services;
<bullet> 611310, Colleges, Universities and Professional Schools;
<bullet> 621511, Medical Laboratories; or
<bullet> 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 (<a href="https://www.ecfr.gov/current/title-13/chapter-I/part-121">https://www.ecfr.gov/current/title-13/chapter-I/part-121</a>) and data by
enterprise receipt size (<a href="https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html">https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html</a>) and also when not available in sub
2021 (<a href="https://www.census.gov/data/tables/2017/econ/susb/2017-susb-annual.html">https://www.census.gov/data/tables/2017/econ/susb/2017-susb-annual.html</a>).
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
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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.