This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

101837 

Vol. 89, No. 242 

Tuesday, December 17, 2024 

ELECTION ASSISTANCE COMMISSION 

2 CFR Part 5801 

Adoption of Uniform Administrative 

Requirements, Cost Principles, and 

Audit Requirements for Federal 

Awards 

AGENCY: Election Assistance 

Commission. 

ACTION: Final rule. 

SUMMARY: The U.S. Election Assistance 

Commission (EAC) is publishing this 

final rule to formally adopt the Office of 

Management & Budget’s Uniform 

Administrative Requirements, Cost 

Principles, and Audit Requirements for 

Federal Awards regulations for EAC 

grants management, which is already 

included in the EAC’s agreements with 

its grant recipients. 

DATES: This final rule is effective 

December 20, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Camden Kelliher, EAC General Counsel. 

Phone: 202–360–3160, email: ckelliher@

eac.gov. 

SUPPLEMENTARY INFORMATION: Through 

its terms and conditions of its grant 

awards, the EAC requires grant award 

recipients and sub-recipients to abide by 

all federal financial assistance 

requirements, including 2 CFR part 200. 

The EAC already has regulations 

adopting 2 CFR part 180, which can be 

found at 2 CFR part 5800. 

On April 4, 2024, the Office of 

Management & Budget (OMB) issued 

memorandum M–24–11, Reducing 

Burden in the Administration of Federal 

Financial Assistance in effort to provide 

government-wide direction to federal 

agencies on improving the management 

of federal financial assistance and to 

ensure the consistent management of 

such assistance. On April 22, 2024, 

OMB issued a final rule officially 

revising its regulations pertaining to 

federal financial assistance management 

in title 2 of the CFR and requiring 

agencies to implement the newly 

revised regulations as quickly as 

possible by taking appropriate steps to 

ensure the regulations apply to all 

federal financial awards issued on or 

after October 1, 2024. 

The Help America Vote Act of 2002 

limits the EAC’s rulemaking authority to 

only to the extent permitted under 

Section 9(a) of the National Voter 

Registration Act. However, the EAC in 

this instance is ‘‘adopting’’ 2 CFR part 

200—the EAC is not ‘‘making’’ rules. 

Furthermore, 2 CFR 200.106 states 

agencies awarding federal funds must 

implement the OMB guidance in 2 CFR 

in codified regulations. 

Waiver of Proposed Rulemaking 

The rule issued by the EAC concerns 

matters relating to ‘‘grants, benefits, or 

contracts,’’ 5 U.S.C. 553(a)(2), and is 

therefore exempt from the requirement 

of prior notice and comment. 

Waiver of Delayed Effective Date 

Under 5 U.S.C. 553(d), agencies may 

waive the delayed effective date 

requirement if they find good cause and 

explain the basis for the waiver in the 

final rulemaking document or if the 

regulations grant or recognize an 

exemption or relieve a restriction. 

OMB informed the public on April 4, 

2024, that agencies would be required to 

adopt the Uniform Guidance and make 

it effective by October 1, 2024. The 

public has had significant time to 

prepare for the promulgation of these 

final regulations. As such, the EAC has 

determined there is good cause to waive 

the delayed effective date. 

List of Subjects in 2 CFR Part 5081 

Accounting, administrative practice 

and procedure, federal financial 

assistance, grant programs, grants 

administration, state and local 

governments, state-federal relations. 

■ For the reasons stated, Part 5801 is 

established in Chapter LVIII of Title 2 of 

the Code of Federal Regulations to read 

as follows: 

PART 5801—UNIFORM 

ADMINISTRATIVE REQUIREMENTS, 

COST PRINCIPLES, AND AUDIT 

REQUIREMENTS FOR FEDERAL 

AWARDS 

Sec. 

5801.10 Adoption of 2 CFR part 200 

5801.20 through 5801.99 [Reserved]. 

Authority: 2 CFR part 200. 

§ 5801.10 Adoption of 2 CFR Part 200. 

The U.S. Election Assistance 

Commission adopts the Office of 

Management and Budget (OMB) 

Guidance in 2 CFR part 200. Thus, this 

part gives regulatory effect to the OMB 

guidance. 

§§ 5801.20 through 5801.99 [Reserved]. 

Camden Kelliher, 

General Counsel, U.S. Election Assistance 

Commission. 

[FR Doc. 2024–29685 Filed 12–16–24; 8:45 am] 

BILLING CODE 4810–71–P 

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. 

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 


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101838 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

1To view the ANPR and the comments we 

received, go to www.regulations.gov. Enter APHIS– 

2019–0018 in the Search field. 

2To view the proposed rule and the comments 

we received, go to www.regulations.gov. Enter 

APHIS–2019–0018 in the Search field. 

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; jacek.taniewski@usda.gov. 

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. 

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 intraentity 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. 


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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 lifethreatening, hemorrhagic, 

noncontagious, nonzoonotic, arthropodborne 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 AgISATTAC’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 


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101840 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

3 9 CFR part 78 (Brucellosis; Domestic Brucellosis 

Regulations). 

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

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 costbenefit 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 


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Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 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 largescale 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-tofarm 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 farmto-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 


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101842 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

4State 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). 

5United 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. 

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 costbenefit 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-productimport/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

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. 

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; 


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6NAICS 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. 

7Based 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-susbannual.html). 

• 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 postsecondary 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

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 Employment ........................................... <1,000 Employees 

small entities.

1,000 + Employees 

large entities.

541714 Research and Development (R&D) in Biotechnology (commercial 

and non-profit) 4,714 firms.

4,638 .......................... 76 ............................... 98 

541715 R&D in the Life Sciences (commercial and non-profit) 9,824 firms ..... 9,399 .......................... 425 ............................. 96 

<1,250 Employees 

small entities.

1,250 + Employees 

large entities.

325413 In-vitro Diagnostic Substance 194 firms ............................................... 167 ............................. 27 ............................... 86 

325414 Biological Product (except Diagnostic) 288 firms ................................. 247 ............................. 41 ............................... 86 

<1,300 Employees ..... 1,300 + Employees 

large entities.

325412 Pharmaceutical Preparation 1,172 firms .............................................. 1,092 .......................... 80 ............................... 93 

SBA Small-entity Standard based on Annual Receipts .................................... <$10 million in Receipts small firms.$10 million + in Receipts large firms.


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101844 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

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 28,291 firms ................................... 0 ................................. 28,291 ........................ 0 

SBA Small-entity Standard based on Annual Receipts .................................... <$34.5 million in Receipts small firms.$34.5 million + in Receipts large firms.

611310 Colleges, Universities, and Professional Schools 2,433 firms ............. 168 ............................. 2,265 .......................... 7 

SBA Small-entity Standard based on Annual Receipts .................................... <$41.5 million in Receipts small firms.$41.5 million + in Receipts large firms.

621511 Medical Laboratories 3,365 firms ......................................................... 438 ............................. 2,927 .......................... 13 

SBA Small-entity Standard based on Annual Receipts .................................... <$47 million in Receipts small firms.$47 million + in Receipts large firms.

622110 General Medical and Surgical Hospitals 2,560 .................................... 65 ............................... 2,495 .......................... 3 

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 onetime 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. 


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Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 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 

■ 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. 

■ 2. Amend § 331.3 by revising 

paragraph (b) to read as follows: 

§ 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 

■ 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. 


ddrumheller on DSK120RN23PROD with RULES1
101846 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

■ 4. Amend § 121.3 by revising 

paragraph (b) to read as follows: 

§ 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. 

* * * * * 1A 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. 

■ 5. Amend § 121.4 by revising 

paragraph (b) to read as follows: 

§ 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 

DEPARTMENT OF ENERGY 

10 CFR Part 1008 

[DOE–HQ–2024–0085] 

RIN 1903–AA18 

Privacy Act of 1974: Implementation of 

Exemptions 

AGENCY: U.S. Department of Energy. 

ACTION: Final rule. 

SUMMARY: The Department of Energy 

(DOE or Department) is revising its 

regulations to exempt certain records 

maintained under a newly established 

system of records—DOE–85, Research, 

Technology, and Economic Security 

Due Diligence Review Records—from 

the notification and access provisions of 

the Privacy Act of 1974. The 

Department is exempting portions of 

this system of records from these 

subsections of the Privacy Act because 

of requirements related to classified 

information. 

DATES: This final rule is effective on 

January 16, 2025. 

FOR FURTHER INFORMATION CONTACT: Kyle 

David, U.S. Department of Energy, 1000 

Independence Avenue SW, Office 8H– 

085, Washington, DC, 20585; facsimile: 

(202) 586–8151; email: kyle.david@

hq.doe.gov, telephone: (240) 686–9485. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Authority and Background 

A. Authority 

B. Background 

II. Discussion 

III. Summary of Public Comments 

IV. Section 1008.12 Analysis 

V. Procedural Issues and Regulatory Review 

A. Review Under Executive Orders 12866, 

13563, and 14094 

B. Review Under the Regulatory Flexibility 

Act 

C. Review Under the Paperwork Reduction 

Act of 1995 

D. Review Under the National 

Environmental Policy Act of 1969 

E. Review Under Executive Order 12988 

F. Review Under Executive Order 13132 

G. Review Under Executive Order 13175 

H. Review Under the Unfunded Mandates 

Reform Act of 1995 

I. Review Under Executive Order 12360 

J. Review Under Executive Order 13211 

K. Review Under the Treasury and General 

Government Appropriations Act, 1999 

L. Review Under the Treasury and General 

Government Appropriations Act, 2001 

M. Congressional Notification 

VI. Approval by the Office of the Secretary 

of Energy 

I. Authority and Background 

A. Authority 

DOE has broad authority to manage 

the agency’s collection, use, processing, 

maintenance, storage, and disclosure of 

Personally Identifiable Information (PII) 

pursuant to the following authorities: 42 

United States Code (U.S.C.) 7101 et seq., 

50 U.S.C. 2401 et seq., 5 U.S.C. 1104, 5 

U.S.C. 552, 5 U.S.C. 552a, 42 U.S.C. 

7254, 5 U.S.C. 301, and 42 U.S.C. 405 

note. 

B. Background 

The Privacy Act of 1974 (the Act) (5 

U.S.C. 552a) embodies fair information 

practice principles in a statutory 

framework governing the means by 

which the U.S. Government collects, 

maintains, uses, and disseminates 

personally identifiable information. The 

Privacy Act applies to information that 

is maintained in a ‘‘system of records.’’ 

A ‘‘system of records’’ is a group of any 

records under the control of an agency 

from which information is retrieved by 

the name of the individual or by some 

identifying number, symbol, or other 

identifying particular assigned to the 

individual. In the Privacy Act, an 

individual is defined to encompass U.S. 

citizens and lawful permanent 

residents. 

The Privacy Act includes two sets of 

provisions that allow agencies to claim 

exemptions from certain requirements 

in the statute. These provisions allow 

agencies in certain circumstances to 

promulgate rules to exempt a system of 

records from certain provisions of the 

Privacy Act. For this system of records, 

pursuant to 5 U.S.C. 552a(k)(1), the 

Department exempts this system of 

records from subsections (c)(3); (d); 

(e)(1), (e)(4)(G), (4)(H), and (4)(I); and (f) 

of the Privacy Act. This exemption is 

needed to protect information relating to 

DOE activities from disclosure to 

subjects or others related to these 

activities. Specifically, the exemption is 

required to safeguard classified 

information. Pursuant to the Privacy Act 

and Office of Management and Budget 

(OMB) Circular A–108, Federal Agency 

Responsibilities for Review, Reporting, 

and Publication under the Privacy Act, 

DOE is issuing this Rule to make clear 

to the public the reasons why this 

particular exemption is being applied. 

II. Discussion 

The Department is exempting 

portions of a newly established system 

of records—DOE–85, Research, 

Technology, and Economic Security 

Due Diligence Review Records—from 

subsections (c)(3); (d); (e)(1), (e)(4)(G), 

(4)(H), and (4)(I); and (f) of the Privacy 

Act of 1974. To claim this exemption, 

DOE is amending 10 CFR 1008.12 by 

adding a new paragraph, (b)(1)(ii)(N). 

The Department exempts portions of 

this system of records from these 

subsections of the Privacy Act because 

of requirements related to classified 

information. 

The purpose of this system is to 

enhance DOE’s capabilities to aggregate, 

link, analyze, and maintain information 

used by the Department to assess 

research, technology, and economic 

security (RTES) risk. RTES risks may 

include risk of foreign government 

interference and exploitation, 

intellectual property (IP) loss, national 


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