Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 101941 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the exemptions from the requirement of 

a tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal governments, on the 

relationship between the National 

Government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999), and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

V. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 4, 2024. 

Edward Messina, 

Director, Office of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 174—PROCEDURES AND 

REQUIREMENTS FOR PLANTINCORPORATED PROTECTANTS 

■ 1. The authority citation for part 174 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y; 21 U.S.C. 

321(q), 346a and 371. 

■ 2. Add §§ 174.551 and 174.552 to 

subpart W to read as follows: 

Subpart W—Tolerances and Tolerance 

Exemptions 

* * * * * 

§ 174.551 Brevibacillus laterosporus 

Mpp75Aa1.1 protein; exemption from the 

requirement of a tolerance. 

Residues of Brevibacillus laterosporus 

Mpp75Aa1.1 protein in or on the food 

and feed commodities of corn: corn, 

field; corn, sweet; and corn, pop are 

exempt from the requirement of a 

tolerance when used as a plantincorporated protectant in corn. 

§ 174.552 Bacillus thuringiensis Vpb4Da2 

protein; exemption from the requirement of 

a tolerance. 

Residues of Bacillus thuringiensis 

Vpb4Da2 protein in or on the food and 

feed commodities of corn: corn, field; 

corn, sweet; and corn, pop are exempt 

from the requirement of a tolerance 

when used as a plant-incorporated 

protectant in corn. 

[FR Doc. 2024–29133 Filed 12–16–24; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 73 

[Docket No. CDC–2020–0024] 

RIN 0920–AA71 

Possession, Use, and Transfer of 

Select Agents and Toxins; Biennial 

Review of the List of Select Agents and 

Toxins 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: This rule finalizes updates to 

the HHS list of select agents and toxins 

that could pose a severe threat to public 

health and safety. These updates were 

proposed along with other changes to 

the select agent and toxin regulations, 

which will be addressed in a separate 

regulatory action. In a companion 

document published in this issue of the 

Federal Register, the U.S. Department of 

Agriculture (USDA) is making parallel 

regulatory changes. 

DATES: This final rule is effective 

January 16, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Daniel A. Singer, MD, Acting Director, 

Division of Regulatory Science and 

Compliance, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE, 

Mailstop H21–4, Atlanta, Georgia 30329. 

Telephone: (404) 553–8266. 

SUPPLEMENTARY INFORMATION: The final 

rule is organized as follows: 

I. Background 

A. Legal Authority 

B. 2024 Proposed Rule 

II. Responses to Comments and Provisions of 

the Proposed Rule 

A. Removal of Brucella abortus, Brucella 

melitensis, and Brucella suis 

B. Nomenclature and Other Changes in the 

Select Agent and Toxin List 

C. Additional Comments Received 

D. Retaining Tier 1 Designation of 

Botulinum Neurotoxin Producing 

Species of Clostridium 

E. No Addition of Hantaviruses 

F. Toxin Review: Changes to Exclusion 

Limits for Short, Paralytic Alpha 

Conotoxins 

G. Designation of Nipah Virus as a Tier 1 

Select Agent 

H. Addition of a Footnote to the HHS 

Select Agent and Overlap Select Agent 

List 

I. Summary of Final Rule Provisions 

III. Alternatives Considered 

IV. Required Regulatory Analyses 

A. Executive Orders 12866, 13563, and 

14094 

B. The Regulatory Flexibility Act (RFA), as 

Amended by the Small Business 

Regulatory Enforcement Fairness Act 

(SBREFA) 


ddrumheller on DSK120RN23PROD with RULES1
101942 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

C. Paperwork Reduction Act of 1995 

D. E.O. 12988: Civil Justice Reform 

E. E.O. 13132: Federalism 

F. Plain Language Act of 2010 

V. References 

I. Background 

A. Legal Authority 

Under the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (Bioterrorism 

Response Act), the HHS Secretary must, 

by regulation, establish and maintain a 

list of biological agents and toxins that 

have the potential to pose a severe 

threat to public health and safety (42 

U.S.C. 262a(a)(1)). In determining 

whether to include a biological agent or 

toxin on the list, the Bioterrorism 

Response Act requires that the HHS 

Secretary consider the following 

criteria: 

• the effect on human health of 

exposure to an agent or toxin; 

• the degree of contagiousness of the 

agent and the methods by which the 

agent or toxin is transferred to humans; 

• the availability and effectiveness of 

pharmacotherapies and immunizations 

to treat and prevent illnesses resulting 

from an agent or toxin; and 

• any other criteria, including the 

needs of children and other vulnerable 

populations, that the HHS Secretary 

considers appropriate (42 U.S.C. 

262a(a)(1)(B)). 

Under 42 U.S.C. 262a(a)(2), the HHS 

Secretary must review and republish the 

list of HHS select agents and toxins at 

least biennially. 

In the preparation of this rulemaking, 

HHS/CDC considered the statutory 

criteria and evaluated each agent and 

toxin based on the following: 

• Effect on human health: 

Æ the degree of pathogenicity (ability 

of an organism to cause disease); 

Æ long-term health effects; 

Æ severity of illness; 

Æ case fatality rate; 

Æ status of host immunity (e.g., 

whether an individual has already been 

exposed to the agent and generated an 

immune response); 

Æ vulnerability of special 

populations; 

• Degree of contagiousness: 

Æ dissemination efficacy; 

Æ aerosol stability; 

Æ rate of transmission; 

• Availability and effectiveness of 

pharmacotherapies: 

Æ available treatment; 

• Other Criteria: 

Æ decontamination and restoration 

(the extent remediation efforts are 

needed due to agent persistence in the 

environment and population); 

Æ matrix stability; 

Æ ease of production; 

Æ ability to genetically manipulate or 

alter; 

Æ the burden or impact on the health 

care system. 

The Federal Select Agent Program 

(FSAP) is the collaboration of the CDC, 

Division of Regulatory Science and 

Compliance (previously known as the 

Division of Select Agents and Toxins), 

and the USDA Animal and Plant Health 

Inspection Service (APHIS), Division of 

Agricultural Select Agents and Toxins. 

These two agencies administer the HHS 

and USDA select agent and toxin 

regulations and coordinate Federal 

oversight of select agents and toxins in 

a manner to minimize the 

administrative burden on the regulated 

community. 

The list of HHS select agents and 

toxins is divided into two sections— 

agents and toxins regulated solely by 

HHS and agents that are regulated by 

both HHS and USDA. The biological 

agents and toxins listed in 42 CFR 73.3 

(HHS select agents and toxins) have the 

potential to pose a severe threat to 

human health and safety and are 

regulated only by HHS. The biological 

agents listed in § 73.4 (overlap select 

agents and toxins) have the potential to 

pose a severe threat to human health 

and safety, as determined by HHS, and 

a severe threat to animals and animal 

products, as determined by the USDA, 

pursuant to USDA’s authority under the 

Agriculture Bioterrorism Protection Act 

of 2002 (7 U.S.C. 8401). Accordingly, 

these biological agents are jointly 

regulated by HHS and USDA as 

‘‘overlap’’ select agents. The 

Bioterrorism Response Act defines the 

term ‘‘overlap agents and toxins’’ to 

mean biological agents and toxins that 

are listed pursuant to 42 U.S.C. 

262a(a)(1) and listed pursuant to 7 

U.S.C. 8401(a)(1). If HHS/CDC removes 

any overlap select agents from its list, 

these agents might still be regulated as 

USDA select agents dependent on the 

outcome of the USDA biennial review. 

B. 2024 Proposed Rule 

On March 17, 2020, CDC published an 

advance notice of proposed rulemaking 

(ANPRM) (85 FR 15087) seeking public 

comments on potential changes to the 

current list of HHS and overlap select 

agents and toxins that are regulated by 

both HHS and USDA. The received 

comments broadly supported removal of 

the Brucella species—of the 335 

comments received, 325 supported 

removal of one or more species of 

Brucella. Only two commenters were in 

favor of retaining the Brucella species. 

HHS/CDC engaged the 

Intragovernmental Select Agents and 

Toxins Technical Advisory Committee 

(ISATTAC) to review and consider the 

public comments. The committee 

reviewed the public comments over a 

series of seven meetings held between 

June 12, 2020, and December 11, 2020. 

Other Federal subject-matter experts 

were invited to the meetings to address 

questions from the committee. The 

ANPRM also requested input on 

removal of other agents from the list 

(e.g., Coxiella burnetii, Rickettsia 

prowazekii, Bacillus anthracis [Pasteur 

strain]). After considering public 

comments, ISATTAC advisory input, 

and Federal subject-matter experts’ 

input, CDC proposed changes to the 

select agent and toxin list and removal 

of three species of Brucella. 

On January 30, 2024, HHS issued a 

proposed rule entitled ‘‘Possession, Use, 

and Transfer of Select Agents and 

Toxins; Biennial Review of the List of 

Select Agents and Toxins’’ (89 FR 5823). 

The proposed rule included two sets of 

proposals: (1) regulatory changes related 

to the select agents and toxins on the list 

(i.e., remove three species of Brucella 

from the list of overlap select agents and 

toxins, raise one toxin’s exclusion 

amounts, rename three viruses, 

designate a current agent as a Tier 1 

agent, and remove the designation of 

Tier 1 status from one agent), and (2) 

regulatory changes related to the 

administration of FSAP. This second set 

of proposals included adding 

definitions and provisions to clarify 

inactivation of select agents, adding 

requirements to report discoveries of 

select agents and toxins, and codifying 

policies regarding effluent 

decontamination systems and biosafety 

provisions for facility verification 

requirements for registered biosafety 

level 3 and animal biosafety level 3 

laboratories. 

HHS/CDC has elected to finalize the 

January 30, 2024, proposed rule in two 

separate rulemakings—one final rule 

focused on changes to the select agents 

and toxins list (this final rule), and a 

second final rule focused on regulatory 

changes to the administration of the 

FSAP discussed above. This final rule 

will focus solely on removing three 

select agents, raising one toxin’s 

exclusion limit, updating nomenclature, 

and designating an agent as Tier 1. 

HHS/CDC is proceeding with two final 

rules for clarity and to avoid any 

unnecessary delay in finalizing the 

revised select agents and toxins list. 

HHS/CDC will publish another 

regulatory action focused on the 

proposed rule’s administrative and 

programmatic changes at a later date. 

Like HHS/CDC, USDA/APHIS is also 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 101943 

proceeding with two separate final rules 

for this rulemaking. 

Interested persons or organizations 

were invited to participate by 

submitting written views, 

recommendations, and data. HHS/CDC 

invited general comments as to whether 

there are additional biological agents or 

toxins that should be added or removed 

from the HHS list of select agents and 

toxins based on the following criteria 

outlined under 42 U.S.C. 262a(a)(1)(B): 

(1) ‘‘the effect on human health of 

exposure to the agent or toxin;’’ 

(2) ‘‘the degree of contagiousness of 

the agent or toxin and the methods by 

which the agent or toxin is transferred 

to humans;’’ 

(3) ‘‘the availability and effectiveness 

of pharmacotherapies and 

immunizations to treat and prevent any 

illness resulting from infection by the 

agent or toxin;’’ and 

(4) ‘‘any other criteria, including the 

needs of children and other vulnerable 

populations, that the Secretary 

considers appropriate’’. 

Comments were also requested on the 

following specific proposed changes to 

the list of HHS select agents and toxins: 

• Removal of Brucella abortus, 

Brucella melitensis, and Brucella suis: 

Proposal to remove Brucella abortus, 

Brucella melitensis, and Brucella suis 

from the select agent list. 

• Updates to nomenclature of select 

agents: To change ‘‘SARS coronavirus 

(SARS–CoV)’’ to ‘‘Severe acute 

respiratory syndrome coronavirus 

(SARS–CoV)’’ to correct the 

nomenclature; to remove the exclusion 

regarding South American genotype of 

Eastern Equine Encephalitis virus as 

this terminology is no longer the correct 

nomenclature; and to rename Ebola 

virus to Ebolavirus in accordance with 

the recent taxonomic change by the 

International Committee on Taxonomy 

of Viruses (ICTV) (this was initially 

included as its own section in the 

proposed rule but moved under this 

section for nomenclature changes). 

• Updates to nomenclature of 

monkeypox virus: Proposal to update 

the terminology of ‘‘monkeypox virus,’’ 

which was initially proposed to be 

updated to ‘‘Mpox Clade I.’’ 

• Removal of the Designation of 

Botulinum neurotoxin producing 

species of Clostridium as a Tier 1 Agent: 

Proposal to retain botulinum neurotoxin 

producing species of Clostridium as an 

HHS select agent, but no longer list it as 

a Tier 1 agent. 

• No Addition of Hantaviruses: 

Proposal to not add Sin Nombre virus 

(SNV), Andes virus (ANDV), Hantaan 

virus (HTNV), and Dobrava virus 

(DOBV) to the select agent list. 

• Toxin Review: Changes to 

Exclusion Limits for Short, Paralytic 

Alpha Conotoxins: Proposal to increase 

the exclusion amount for short, 

paralytic alpha conotoxins from 100 mg 

to 200 mg. 

• Designation of Nipah virus as a Tier 

1 Select Agent: Proposal to designate 

Nipah virus as a Tier 1 select agent. 

• Addition of a Footnote to the HHS 

Select Agent List on the FSAP website: 

Proposal to add a footnote to the list for 

HHS and Overlap select agents 

indicating that the current nomenclature 

will be available on the FSAP website 

(https://www.selectagents.gov) to 

harmonize the list of select agent viruses 

with ICTV nomenclature. 

The public comment period for the 

proposed rule ended on April 1, 2024. 

HHS/CDC received 44 unique comments 

from individuals, stakeholders, and 

groups and carefully reviewed and 

considered the comments in this 

preparation of the final rule. Of these 44 

comments, 37 include discussion of the 

list of select agents discussed in this 

final rule. A summary of the comments 

relevant to the content of this final rule 

and responses to those comments are 

found at section II, below. Public 

comments addressing other topics from 

the proposed rule will be addressed in 

a separate regulatory action. 

II. Responses to Comments and 

Provisions of the Proposed Rule 

The following is a section-by-section 

discussion of the changes HHS/CDC is 

making to the list of select agents and 

toxins in 42 CFR 73.3 and 73.4 after 

consideration of public comments. As 

previously stated, the changes proposed 

in the proposed rule will be finalized in 

two separate rules. This final rule 

addresses changes to the list of select 

agents and toxins in 42 CFR 73.3 and 

73.4. All other revisions to definitions, 

policies, and regulatory requirements 

addressed in the proposed rule will be 

addressed in a separate final rule. 

A. Removal of Brucella abortus, 

Brucella melitensis, and Brucella suis 

Regarding the request for comment on 

whether to remove three species of 

Brucella (B. abortus, B. melitensis, and 

B. suis) from the select agent and toxins 

list, HHS/CDC received 37 comments 

from individuals, animal health groups, 

regulated entities, and public health 

associations that fully supported 

removing the three agents. No public 

comments proposed maintaining these 

agents on the select agent and toxins 

list. 

Individuals and animal health groups 

stated that they support removing B. 

abortus, B. melitensis, and B. suis to 

allow for more robust studies on 

alternative methods of surveillance, 

effective delivery mechanisms for 

wildlife vaccination, and techniques to 

limit disease spread, such as 

contraception and novel sustainedrelease antibiotics in conjunction with 

immuno-contraception. Commenters 

stated the etiology and pathophysiology 

of the Brucella species make it poorly 

suited to cause a severe threat to human 

health. Commenters further noted that 

the disease is extremely rare in North 

America and has limited capacity for 

human-to-human transmission. The 

same commenters stated maintaining 

the Brucella species as select agents 

causes considerable burden to the 

research community, impairing 

necessary scientific developments of 

diagnostic tools and vaccine delivery 

methods. Regulatory constraints on 

Brucella species were further correlated 

to fewer individuals entering the field of 

Brucella research. The commenters 

agreed removal of these agents would 

not affect the nationally recognized 

biosafety measures used by U.S. 

researchers in handling these agents. 

Commenters also noted that, regardless 

of the FSAP’s regulation of these agents, 

Brucella species remain endemic 

worldwide. This change would, 

however, enhance proactive measures 

for research and diagnostics. 

State veterinarians, state agriculture 

departments, and livestock associations 

also support the removal of the Brucella 

species and believe delisting these 

agents will allow for faster production 

of improved diagnostics. These groups 

believe delisting ultimately will reduce 

the cost for ranching families and other 

taxpayers when performing the required 

testing on domestic livestock. These 

groups stated that current tests often 

cross-react or result in false positives 

that threaten animal agribusinesses; the 

benefits to delist the Brucella species 

are numerous; and the perceived risk to 

national security is not supported by 

peer-reviewed science. One group stated 

removal of these agents is a step toward 

using a modernized risk-based approach 

for biosafety and security. 

Regulated entities (i.e., entities 

registered with FSAP under 42 CFR 

73.7) reported similar support for 

removing B. abortus, B. melitensis, and 

B. suis and included that they have no 

concerns with maintaining work using 

BSL–3/ABSL–3 practices. Commenters 

stated that guidance will be needed for 

the regulated community currently 

registered for these agents on how to 

remove registered space and/or removal 

of Brucella species from registration 

while active work is ongoing with 

Brucella. 


ddrumheller on DSK120RN23PROD with RULES1
101944 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

Public health associations commented 

that B. abortus, B. melitensis, and B. suis 

should be removed because of the low 

mortality rate and because current 

molecular and diagnostic methods allow 

for the effective detection of the agents. 

Comments stated delisting these agents 

will remove substantial regulatory 

requirements on individuals, 

specifically the Responsible Official and 

Alternate Responsible Official, and 

allow for an expanded work staff to 

contribute to testing. Further, antibiotic 

treatment regimens are effective and 

well-established for treating brucellosis 

due to infections with B. abortus, B. 

melitensis, or B. suis. 

In accordance with the proposed rule 

and public comments, HHS/CDC is 

removing B. abortus, B. melitensis, and 

B. suis from the select agent and toxins 

list upon publication of the final rule. 

This decision is based on the criteria 

and considerations outlined in 42 U.S.C. 

262a, including the low mortality rate, 

rare human-to-human transmission, and 

availability of therapeutics, and is 

supported by the strong and unanimous 

support received through public 

comments in favor of removing these 

agents (Olsen et al., 2018). Please note 

that all entities currently working with 

B. abortus, B. melitensis, or B. suis will 

need to remove these agents from their 

APHIS/CDC Form 1 (registration), 

including Sections 3, 7A/C (and 

associated attachments), and 7B. FSAP 

will be reaching out to affected entities 

upon publication of this final rule. 

Further guidance can be found at 

https://www.selectagents.gov/efsap/ 

using/form1/docs/eFSAP_Form_1_

Amendments_Guidance_508.pdf. 

For brucellosis case reporting and 

national notification, please visit 

https://www.cdc.gov/brucellosis/hcp/ 

surveillance/index.html. 

Additionally, BSL–3/ABSL–3 

laboratory safety and containment 

recommendations for Brucella species 

are outlined in the Biosafety in 

Microbiological and Biomedical 

Laboratories (BMBL) found at https://

www.cdc.gov/labs/bmbl/index.html. 

B. Nomenclature and Other Changes in 

the Select Agent and Toxin List 

HHS/CDC proposed to amend the 

select agent list by updating 

‘‘monkeypox virus’’ to the regulated 

virus variant ‘‘Mpox virus (clade I).’’ 

Initially, HHS/CDC based this change on 

the World Health Organization (WHO) 

recommendation to adopt a new disease 

name from monkeypox to mpox (https:// 

www.who.int/news/item/28-11-2022- 

who-recommends-new-name-formonkeypox-disease). This was updated 

in the International Classification of 

Diseases (ICD) system (https://

icd.who.int/browse/2024-01/mms/ 

en#160886685). 

Global experts, including the 

International Committee on the 

Taxonomy of Viruses, assigned new 

names to the monkeypox virus variants 

but not to the virus itself. The virus 

variants became known as monkeypox 

virus Clade I (formerly Congo Basin, 

Central African clade) and Clade II 

(formerly West African Clade) (https://

www.who.int/news/item/12-08-2022- 

monkeypox--experts-give-virus-variantsnew-names). These efforts were in part 

to align the disease name and virus 

variants with current best naming 

practices. 

FSAP issued guidance during the 

2022 mpox outbreak to assist 

individuals and entities to comply with 

select agent and toxin regulations after 

they identified monkeypox virus in 

diagnostic samples. The guidance 

clarified that when materials are 

identified as being or containing 

monkeypox virus, and the clade is 

unknown, the materials are considered 

select agents. The guidance also 

explained when regulatory exemptions 

and exclusions would apply. This 

guidance was issued based on current 

diagnostic assays not being specific to 

the monkeypox virus clade. 

Based on these considerations and 

recognition that this change would have 

implications beyond a change in 

nomenclature, HHS/CDC will not 

change the listed agent from 

‘‘monkeypox virus’’ to ‘‘Mpox virus 

(clade I).’’ The decision to retain the 

existing listing is to ensure consistency 

in nomenclature and the regulation of 

select agent material. FSAP does not 

include clade-specific designations for 

other select agents, but the regulations 

provide exclusions when appropriate. 

This ensures select agent material is 

possessed, used, and transferred in 

accordance with the regulations, which 

is critically important when cladespecific assays are generally used. 

Therefore, HHS/CDC is retaining the 

current listing and monkeypox virus, 

meaning monkeypox virus with clade 

unknown is a select agent. Likewise, 

monkeypox virus identified as clade I is 

a select agent. The decision to retain the 

current listing means no changes are 

made to the regulation of this select 

agent or the applicable exclusions and 

exemptions. 

As mentioned above, monkeypox 

virus contains two virus variants, or 

clades. In 2012, HHS/CDC excluded the 

West African Clade of monkeypox virus 

from the select agent regulatory 

requirements (https://

www.selectagents.gov/sat/exclusions/ 

hhs.htm). Excluded select agents have 

been determined to not pose a severe 

threat to public health and safety and 

are not regulated as select agents. 

Though not explicitly proposed in the 

proposed rule, HHS/CDC has decided to 

rename the excluded West African 

Clade monkeypox virus to clade II 

monkeypox virus. This nomenclature 

change aligns with WHO 

recommendations (Ulaeto et al., 2023, 

https://www.who.int/news/item/28-11- 

2022-who-recommends-new-name-formonkeypox-disease). This change 

promotes consistent terminology in 

global and public health and will not 

impact regulated entities. 

Additionally, HHS/CDC proposed to 

change SARS coronavirus (SARS–CoV) 

to ‘‘Severe acute respiratory syndrome 

coronavirus (SARS–CoV),’’ which is the 

correct nomenclature. This 

nomenclature change was also 

supported by two comments and is 

finalized as proposed. 

Though ‘‘Eastern equine encephalitis 

virus’’ is an HHS select agent, the 

regulations exclude any South 

American genotype of Eastern Equine 

Encephalitis Virus from the 

requirements. HHS/CDC proposed to 

remove the exclusion regarding South 

American genotype of Eastern Equine 

Encephalitis virus as this no longer 

reflected the appropriate nomenclature, 

but did not provide the updated virus 

name. The updated nomenclature of the 

South American genotype of Eastern 

Equine Encephalitis virus is ‘‘Madariaga 

virus.’’ HHS/CDC received two 

comments requesting clarification on 

whether Madariaga virus would be 

excluded from regulatory requirements 

and one comment in favor of this 

exclusion. The nomenclature of the 

excluded South American genotype of 

Eastern Equine Encephalitis virus is 

finalized as ‘‘Madariaga virus.’’ For 

clarity, 42 CFR 73.3(d)(12) will now 

read as excluding ‘‘Madariaga virus’’ 

from the regulatory requirements. 

Lastly, HHS/CDC proposed the 

renaming of Ebola virus to the genus 

Ebolavirus. HHS/CDC received 10 

public comments that supported 

renaming Ebola virus to the genus 

Ebolavirus to align with the 

International Committee on Taxonomy 

of Viruses (ICTV). None of the 

commenters provided evidence or 

rationale for their support of this 

change. One commenter stated that 

HHS/CDC should also make it clear that 

any strain that is similar enough to this 

genus, whether naturally discovered or 

artificially derived, should be regarded 

as a select agent. HHS/CDC will not 

make any changes based on this 

comment but does note that any virus 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 101945 

(including separate strains or species) 

that is classified as being a member of 

the genus Ebolavirus would be subject 

to the requirements of this part. The 

renaming of Ebolavirus is finalized as 

proposed. 

C. Additional Comments Received 

HHS/CDC also received three public 

comments recommending the removal 

of monkeypox virus (clade I) from the 

HHS list of select agents and toxins. One 

commenter stated that given the 

virulence and transmission patterns of 

circulating strains of clade I combined 

with the similarity of prophylaxis and 

treatment measures for both clade I and 

II, they did not feel it should be 

regarded as a select agent any longer. 

Another commenter stated that the risk 

of a severe monkeypox virus (clade I) 

outbreak in the United States is likely 

minimal, given the low risk of casual 

human-to-human transmission; mild 

clinical symptoms for 

immunocompetent people; low 

mortality rate; an FDA-approved, 

effective vaccine; availability of 

pharmacotherapy treatment; and a 

robust healthcare infrastructure and 

public health response. The final 

commenter recommended removal of 

monkeypox virus (clade I), as its status 

as a select agent could potentially 

restrict early detection via wastewater 

surveillance and may lead to 

unnecessary burdens on healthcare 

facilities, particularly in underresourced communities. This 

commenter stated that removing 

monkeypox virus (clade I) from the 

select agent list would remove barriers 

to rapid diagnosis, ensure equitable 

access to care, and streamline public 

health response efforts by increasing 

accessibility to testing in the event 

monkeypox virus (clade I) begins to 

circulate in the United States. The select 

agent regulations include provisions 

that exempt diagnostic laboratories from 

the requirements, as long as these 

laboratories secure, destroy, and report 

positive samples. This exemption 

allows for continued rapid diagnosis, 

equitable access to care, and a robust 

public health response effort. As new 

data from current outbreaks are 

collected and analyzed, HHS/CDC will 

take these comments along with future 

data into consideration during the next 

biennial review. The review process 

considers how the agent affects human 

health, the degree of transmissibility, if 

there are effective medical 

countermeasures available, and the 

needs of vulnerable populations. 

Appropriate departments and agencies 

with scientific experts will also be 

consulted. At present, more data would 

be needed to support the removal of 

monkeypox virus from the select agent 

list, so monkeypox virus will remain on 

the list as an HHS-only select agent, and 

monkeypox virus (clade I) will remain 

a regulated variant. 

Additionally, one commenter stated 

that they do not support the addition of 

SARS–CoV/SARS–CoV–2 chimeric 

viruses, which were previously added 

as a select agent on November 17, 2021. 

HHS/CDC is not making changes to the 

final rule based on this comment. A 

final rule published on March 3, 2023 

(88 FR 13322), outlines the basis for 

adding SARS–CoV/SARS–CoV–2 

chimeric viruses resulting from any 

deliberate manipulation of SARS–CoV– 

2 to incorporate nucleic acids coding for 

SARS–CoV virulence factors as an HHS 

select agent. 

One commenter inquired why H2N2 

(a subtype of Influenza A virus) was not 

considered a select agent, especially 

since NIAID’s Laboratory of Infectious 

Diseases published that the 1957 

pandemic strain of H2N2 would most 

likely cause a pandemic. As mentioned 

above, changes to the list of select 

agents and toxins are carefully 

considered using specific criteria and in 

consultation with appropriate 

departments, agencies, and scientific 

experts. This review also takes into 

account current data to support changes 

to the list. FSAP will continue assessing 

changes to the select agent and toxin list 

as part of its ongoing biennial review 

process, but HHS/CDC is not making 

any changes based on this comment at 

this time. 

Another commenter stated that, given 

the further development of reverse 

genetics systems, FSAP should consider 

oversight of the nucleic acids, in part or 

in whole, that could be used to create 

select agents. HHS/CDC is not making 

any changes based on this comment but 

does understand that the ability to 

synthetically create agents capable of 

posing a severe threat to public health 

and safety is becoming less difficult 

because of newer technologies. HHS/ 

CDC will further review the risks posed 

by these technologies. 

One additional public commenter 

thanked the Federal Government for 

transparency regarding the criteria for 

adding/delisting agents and toxins and 

strongly supported the continued use of 

these criteria and processes. Another 

commenter stated that a list-based 

approach no longer adequately 

addresses the current biological threat 

landscape, which includes unknown, 

accidental, engineered, and naturally 

occurring hazardous biological agents 

and toxins. To address the current 

biological threat landscape, the 

commenter stated that FSAP should 

take into account transmissibility, not 

just pathogenicity, and should move 

toward a ‘‘tiered, risk-based program’’ 

and away from a ‘‘list-based program.’’ 

HHS/CDC thanks these commenters for 

their thoughts. HHS/CDC does evaluate 

transmissibility in the assessments of 

whether to include an agent in our list, 

specifically under the direction of the 

statute that includes contagiousness as a 

criterion for inclusion. Also, FSAP 

derives its regulatory authority from 

section 351A(a)(1) of the Public Health 

Service Act (42 U.S.C. 262a(a)(1)), 

which states that HHS/CDC must 

maintain a list of select agents and 

toxins. HHS/CDC may consider 

additional tiering to the list of select 

agents and toxins at the next biennial 

review. 

D. Retaining Tier 1 Designation of 

Botulinum Neurotoxin Producing 

Species of Clostridium 

Botulinum neurotoxin, which causes 

botulism, is a Tier 1 select toxin, and 

botulinum neurotoxin producing 

species of Clostridium are a Tier 1 select 

agent, regulated by HHS/CDC. In the 

2024 proposed rule, HHS/CDC 

requested comment on the proposal to 

retain botulinum neurotoxin producing 

species of Clostridium as an HHS select 

agent, but no longer designate it as a 

Tier 1 agent because the organism itself 

does not normally cause disease. 

Botulinum neurotoxin would still be 

designated as a Tier 1 toxin. HHS/CDC 

received mixed reactions and a total of 

14 comments on whether to downgrade 

botulinum neurotoxin producing 

species of Clostridium from a Tier 1 

agent, while keeping it as an HHS select 

agent. 

Nine commenters supported 

downgrading the agent from Tier 1, 

three opposed the change, and two 

comments requested clarification of 

when nucleic acids that encode for toxic 

forms of botulinum neurotoxin would 

be considered Tier 1 or non-Tier 1. One 

commenter stated the most compelling 

rationale for no longer designating the 

agent as Tier 1 is that public health 

outbreaks with this organism are not 

likely or projected to be particularly 

disruptive. 

Three commenters did not support 

the change. They stated that no longer 

designating botulinum neurotoxin 

producing species of Clostridium as a 

Tier 1 select agent—while keeping 

botulinum neurotoxin as a Tier 1 

toxin—would introduce ambiguity to 

procedures related to storage, 

possession, use, and in the event of an 

accidental release. One commenter 

stated that if the neurotoxin remains as 


ddrumheller on DSK120RN23PROD with RULES1
101946 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

a Tier 1 agent and regulatory 

requirements are only reduced for the 

organism, it could potentially cause 

violations relating to an entity 

producing the toxin in an unregulated 

manner. 

One commenter recommended that if 

botulinum neurotoxin remains a Tier 1 

agent, then botulinum neurotoxin 

producing species of Clostridium should 

also remain as Tier 1. Another 

commenter pointed out that HHS/CDC 

would need to provide extensive 

guidance regarding differentiating 

between experiments or steps in 

experiments that include both the agent 

and toxin that require Tier 1 personnel 

and practices versus non-Tier 1 

personnel and practices if this change 

were to take effect. Both commenters 

recommended that the agent, toxin, and 

regulated nucleic acids all be regulated 

as either non-Tier 1 or Tier 1 because 

regulating the related materials 

differently would create a substantial 

administrative burden to registered 

entities. 

HHS/CDC agrees that public health 

outbreaks are unlikely to occur with 

botulinum neurotoxin producing 

species of Clostridium. Per Executive 

Order 13546, ‘‘Optimizing the Security 

of Biological Select Agents and Toxins 

in the United States,’’ botulinum 

neurotoxin producing species of 

Clostridium do not pose a great risk of 

deliberate misuse with the most 

significant potential for mass casualties, 

and therefore do not meet the standard 

of Tier 1. However, in accordance with 

several other comments, HHS/CDC 

agrees that downgrading the agent (or 

nucleic acids encoding for toxic forms 

of botulinum neurotoxin) from Tier 1, 

while continuing to regulate botulinum 

neurotoxin as a Tier 1 toxin would 

require registered entities to 

differentiate between the applicable 

regulatory requirements, which may 

cause confusion. Likewise, establishing 

different regulatory standards for the 

select agent and related toxin would 

create challenges for HHS/CDC in 

assessing compliance. The agent has the 

inherent ability to produce Tier 1 toxin. 

In consideration of the logistical 

challenges raised in the comments 

referenced above, HHS/CDC will 

continue to regulate botulinum 

neurotoxin producing species of 

Clostridium as a Tier 1 select agent. 

E. No Addition of Hantaviruses 

In response to the 2024 proposed rule, 

HHS/CDC received nine public 

comments that unanimously supported 

the proposal to not add Hantaviruses 

[Sin Nombre virus (SNV), Andes virus 

(ANDV), Hantaan virus (HTNV), and 

Dobrava virus (DOBV)] to the select 

agent and toxins list. Eight commenters 

did not offer a rationale or evidence for 

their stance; however, one commenter 

stated that because there is no evidence 

of sustained person-to-person 

transmission of SNV, ANDV, HTNV, or 

DOBV, they concurred with the 

proposal not to add these viruses to the 

select agent list. Given the limited direct 

person-to-person transmission and 

difficulty propagating in a laboratory 

setting, it is unclear whether 

Hantaviruses would pose a severe threat 

to public health and safety. In 

accordance with the criteria and 

considerations for determining whether 

to include an agent or toxin on the list 

as articulated in 42 U.S.C. 262a, as 

proposed and in addition to the 

unanimous support for not adding these 

agents via public comment, HHS/CDC 

will not be adding SNV, ANDV, HTNV, 

and DOBV as HHS select agents. 

F. Toxin Review: Changes to Exclusion 

Limits for Short, Paralytic Alpha 

Conotoxins 

In response to the 2024 proposed rule, 

HHS/CDC received eight public 

comments that unanimously supported 

the proposal to increase the exclusion 

amount for short, paralytic alpha 

conotoxins from 100 mg to 200 mg. 

HHS/CDC proposed this change based 

on assessments of lethal doses of 

conotoxin compared to other regulated 

toxins and the amount of the toxin that 

would be needed if a bad actor sought 

to weaponize it. To assess the amount 

necessary to weaponize a biological 

toxin, the Department of Homeland 

Security (DHS) developed toxin 

parameters and attack scenarios for 

potential inhalation and ingestion 

exposures to select toxins. The DHS 

models determined the impact of the 

dissemination of varying concentrations 

of toxins on public health. HHS/CDC 

reviewed the DHS models, and the 

lethal doses of conotoxins are 

comparable to other regulated toxins 

with a much higher permissible amount. 

Based on the DHS model and the public 

comments mentioned above, HHS/CDC 

is raising the exclusion limit for 

conotoxin from 100 mg to 200 mg as 

proposed. 

G. Designation of Nipah virus as a Tier 

1 Select Agent 

In the 2024 proposed rule, HHS/CDC 

sought public comment on whether 

Nipah virus should be identified as a 

Tier 1 select agent because of its human 

transmissibility, high case fatality rate, 

low infectious dose, high severity of 

illness, and severity of long-term effects. 

HHS/CDC received a total of 10 

comments on this proposal. One 

commenter was in favor of designating 

Nipah virus as a Tier 1 select agent, 

especially given the known person-toperson transmissibility of the virus. 

There were nine commenters against 

this change. Eight of these commenters 

stated the justification is not sufficient 

support for designating Nipah virus as 

a Tier 1 select agent over other agents 

on the select agent list that are Risk 

Group 4 pathogens. One commenter 

thought it was unclear what value the 

Tier 1 designation would have for Nipah 

virus. 

CDC disagrees with these 

commenters. Executive Order 13546, 

‘‘Optimizing the Security of Biological 

Select Agents and Toxins in the United 

States,’’ directs the HHS Secretary to 

designate a subset of select agents and 

toxins as Tier 1 that present the greatest 

risk of deliberate misuse with the most 

significant potential for mass casualties 

or devastating effects to the economy, 

critical infrastructure, or public 

confidence. Nipah virus has high 

human transmissibility; a high case 

fatality rate (estimated between 40– 

100%); a low infectious dose (ranging 

from 101¥107 plaque forming units 

depending on route of infection); high 

severity of illness; and severe long-term 

effects, including neurological 

complications including 

encephalopathy, cranial nerve palsies, 

and dystonia (Sejvar et al., 2007 and Lo 

et al., 2008). 

For these reasons, HHS/CDC is 

designating Nipah virus as a Tier 1 

select agent. 

H. Addition of a Footnote to the HHS 

Select Agent and Overlap Select Agent 

List 

In the 2024 proposed rule, HHS/CDC 

received one public comment that 

supported the proposal to add a footnote 

to the list of HHS and Overlap select 

agents indicating that the current ICTV 

nomenclature for select agent viruses, if 

different from that published in the 

HHS regulations, will be available on 

the FSAP website (https://

www.selectagents.gov). This commenter 

stated that the FSAP website is a good 

place to provide this information. As 

proposed, HHS/CDC will proceed with 

adding a footnote to the list for HHS and 

Overlap select agents for this purpose. 

I. Summary of Final Rule Provisions 

In summary of the discussions in 

section II. of this rule, HHS/CDC is 

finalizing these revisions to the Federal 

Select Agent Program at 42 CFR part 73: 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 101947 

• Remove Brucella abortus, Brucella 

melitensis, and Brucella suis from the 

select agent list. 

• Update the nomenclature of select 

agents: 

Æ Change ‘‘SARS coronavirus (SARS– 

CoV)’’ to ‘‘Severe acute respiratory 

syndrome coronavirus (SARS–CoV)’’ to 

correct the nomenclature; 

Æ Rename the exclusion of ‘‘South 

American genotype of Eastern Equine 

Encephalitis virus’’ to ‘‘Madariaga 

virus’’; 

Æ Rename the exclusion of ‘‘West 

African Clade of Monkeypox virus’’ to 

‘‘clade II monkeypox virus’’; 

Æ Rename Ebola virus to Ebolavirus 

in accordance with the recent 

taxonomic change by the International 

Committee on Taxonomy of Viruses 

(ICTV); 

• Retain nomenclature of monkeypox 

virus; 

• Retain designation of botulinum 

neurotoxin producing species of 

Clostridium as a Tier 1 agent; 

• No addition of Hantaviruses: 

specifically not adding Sin Nombre 

virus (SNV), Andes virus (ANDV), 

Hantaan virus (HTNV), and Dobrava 

virus (DOBV) to the select agent list; 

• Increase the exclusion amount for 

short, paralytic alpha conotoxins from 

100 mg to 200 mg; 

• Designate Nipah virus as a Tier 1 

Select agent; 

• Add a footnote to the list for HHS 

and Overlap select agents indicating 

that the current nomenclature will be 

available on the FSAP website (https:// 

www.selectagents.gov). 

III. Alternatives Considered 

Under 42 U.S.C. 262a(a)(2), the HHS 

Secretary must review and republish the 

list of HHS select agents and toxins at 

least biennially. This ensures scientific 

advancements and gained knowledge 

are applied to each agent and toxin on 

the list. 

Below are reasonable regulatory 

alternatives considered regarding key 

individual provisions listed in this final 

rule. 

This final rule contains several 

updates to outdated nomenclature of 

agents, including monkeypox virus, 

Severe acute respiratory syndrome 

coronavirus (SARS–CoV), and 

Ebolavirus. Retaining outdated 

nomenclature is not scientifically 

accurate and causes confusion when 

organizations seek to be in compliance 

with the regulations. Retaining outdated 

nomenclature can also cause 

discrepancies between HHS/CDC and 

other global health organizations. There 

is a low, one-time cost associated with 

updating nomenclature. The alternative 

of finalizing the rule without the 

proposed changes, i.e., retaining 

outdated nomenclature, is not feasible 

or accurate. 

Several changes in this final rule also 

ensure continued compliance with E.O. 

13546. 

If HHS/CDC were to retain Nipah 

virus without a Tier 1 designation, the 

select agent and toxin list would have 

an agent that has a great risk of 

deliberate misuse with the potential for 

mass casualties, like other Tier 1 select 

agents, but without the additional 

provisions outlined for Tier 1 select 

agents and toxins. These additional 

provisions include advanced security 

even compared to non-Tier 1 agents, 

laboratory personnel enrollment in an 

entity-specific Occupational Health 

Program, and that entity-specific risk 

assessments include Nipah virus as a 

Tier 1 agent. Not having Nipah virus 

designated as Tier 1 select agent could 

potentially result in entities or 

personnel handling the agent 

incorrectly, causing public health, 

biosafety, and biosecurity concerns. It 

also would not enable FSAP to ensure 

and require compliance with the 

enhanced Tier 1 biosafety and 

biosecurity requirements provided for in 

the regulations. 

All entities currently registered with 

FSAP for Nipah virus are also registered 

for other Tier 1 select agents and toxins. 

Therefore, these entities have Tier 1 

provisions in place already that can be 

applied to Nipah virus. If HHS/CDC 

were to retain Nipah virus as a select 

agent without Tier 1 designation, the 

department and agency would be out of 

compliance with E.O. 13546. It could 

also potentially cause public health and 

biosecurity concerns in that the agent is 

not handled appropriately. Nipah virus 

has high human transmissibility; a high 

case fatality rate (estimated between 40– 

100%); a low infectious dose; high 

severity of illness; and severe long-term 

effects. 

Along similar reasoning, new models 

from DHS illustrate the lethal doses of 

conotoxins are comparable to other 

regulated toxins with a much higher 

permissible amount. The alternative to 

not raising the permissible toxin limit 

for short, paralytic alpha conotoxins 

would lead to irregularities of regulatory 

application as it pertains to select 

toxins. Keeping the permissible toxin 

limit at 100 mg for short, paralytic alpha 

conotoxins could prevent research and 

advancement of understanding the 

select toxin, with no advancement on 

biosafety and biosecurity. The raised 

permissible toxin limit of 200 mg will 

allow more research to occur with the 

select toxin with no effect on public 

health and safety. It is important that 

HHS/CDC considers new data while 

reviewing the select agent and toxin list 

to ensure the list is in accordance with 

criteria and considerations as 

articulated in 42 U.S.C. 262a. 

Similarly, the final rule does not 

include adding Hantaviruses (i.e., Sin 

Nombre virus (SNV), Andes virus 

(ANDV), Hantaan virus (HTNV), and 

Dobrava virus (DOBV)) to the list as was 

initially proposed in the ANPRM. 

Adding Hantaviruses to the list would 

lead to the agency regulating agents that 

are not proven to pose a severe threat to 

public health and safety. Hantaviruses 

have limited direct person-to-person 

transmission and are difficult to 

propagate in a laboratory setting. At this 

time, research shows it is not certain 

that Hantaviruses require any regulation 

in accordance with the criteria and 

considerations as articulated in 42 

U.S.C. 262a. If FSAP were to begin 

regulating Hantaviruses, there would be 

costs associated with onboarding, 

inspecting, and managing those entities 

that would be required to register with 

FSAP, with no current need to regulate 

the agents. 

The most significant impact of this 

rule is the delisting of Brucella species, 

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 FSAP’s 

regulatory authority. These agents are 

designated as Risk Group 3 agents, 

meaning entities and organizations will 

continue working with these agents at 

the appropriate biosafety level 

(Biosafety Level 3), as outlined in the 

national standard Biosafety in 

Microbiological and Biomedical 

Laboratories, 6th edition. 

Continuing regulation of Brucella 

melitensis, suis, and abortus has a onetime cost of approximately $29k to an 

entity that wishes to register with FSAP 

for work with these agents. This cost to 

the regulated community, due to the 

reasons listed above, does not enhance 

biosafety and biosecurity, and may be a 

regulatory burden to entities that wish 

to advance understanding of the agent 

and research medical countermeasures. 

There is no alternative to foregoing 

review of the select agent and toxin list. 


ddrumheller on DSK120RN23PROD with RULES1
101948 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

This rulemaking is intended to meet the 

regulatory mandate under 42 U.S.C. 

262a(a)(2) where the HHS Secretary 

must review and republish the list of 

HHS select agents and toxins at least 

biennially. CDC conducts the biennial 

review in consultation with CDC’s 

Intragovernmental Select Agents and 

Toxins Technical Advisory Committee 

(ISATTAC). An alternative to the rule 

was to not delist three select agents, not 

raise the exclusion amount of a 

regulated toxin, not update 

nomenclature, and not add the Tier 1 

designation to a select agent. Retaining 

the Brucella species 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 the Brucella 

agents. Additionally, the alternative to 

not amend the select agent list is 

inconsistent with USDA’s rule, creating 

regulatory conflict. In addition, this 

option is not consistent with the public 

comment received to support amending 

the select agent list. 

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, HHS/CDC is finalizing 

the changes listed in section II, part I 

(Summary of Final Rule Provisions) 

above to the list of select agents and 

toxins. 

IV. Required Regulatory Analyses 

The HHS/CDC modifications to the 

list of select agents and toxins addressed 

in this rule will benefit producers, 

research and reference laboratories, and 

state and Federal oversight agencies, 

while also maintaining adequate 

program oversight of select agents and 

toxins. Specifically, HHS/CDC is 

removing Brucella abortus, Brucella 

melitensis, and Brucella suis from the 

select agent and toxin list; updating the 

nomenclature for several select agents 

(‘‘SARS coronavirus (SARS–CoV),’’ 

removing the exclusion regarding 

‘‘South American genotype of Eastern 

Equine Encephalitis virus,’’ renaming 

the exclusion regarding ‘‘West African 

Clade of Monkeypox virus,’’ and ‘‘Ebola 

virus’’); retaining the nomenclature of 

Monkeypox virus; retain the Tier 1 

designation of Botulinum neurotoxin 

producing species of Clostridium; no 

addition of Hantaviruses to the current 

select agent and toxin list; increase the 

exclusion amount for short, paralytic 

alpha conotoxins from 100 mg to 200 

mg; and designating Nipah virus as a 

Tier 1 Select Agent. HHS/CDC is also 

adding a footnote to the list for HHS and 

Overlap select agents indicating that the 

current nomenclature will be available 

on the website (www.selectagents.gov). 

Currently, 236 entities are registered 

with the Federal Select Agent Program 

(FSAP). Of these entities, there are 13 

private entities, 30 Federal entities, 42 

commercial entities, 84 academic 

entities, and 67 state entities (registered 

with either APHIS or CDC, depending 

on the select agents and toxins they 

work with). Less than 4 percent of all 

firms operating within these North 

American Industry Classification 

categories are considered to be small 

entities. This final rule will not have a 

significant economic impact on a 

substantial number of small entities. 

The benefits of strengthened 

safeguards against the unintentional or 

deliberate release of a select agent or 

toxin greatly exceed the costs of 

complying with the regulatory 

requirements. As an example of losses 

that can occur due to a select agent 

release, the October 2001 anthrax 

attacks caused 5 fatalities and 17 

illnesses, disrupted business and 

government activities (including $2 

billion in lost revenues for the U.S. 

Postal Service) and required more than 

$23 million to decontaminate one 

Senate office building and $3 billion to 

decontaminate postal facilities and 

procure mail-sanitizing equipment. 

Deliberate introduction greatly increases 

the probability of a select agent 

becoming established and causing wideranging and devastating impacts to the 

economy, other disruptions to society, 

and diminished confidence in public 

and private institutions. 

HHS has examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011), Executive Order 14094, entitled 

‘‘Modernizing Regulatory Review’’ 

(April 6, 2023), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, section 202 of 

the Unfunded Mandates Reform Act of 

1995 (March 22, 1995; Pub. L. 104–4), 

and Executive Order 13132 on 

Federalism (August 4, 1999). This final 

rule does not meet the criteria set forth 

in 5 U.S.C. 804(2) under the 

Congressional Review Act. 

A. Executive Orders 12866, 13563, and 

14094 

Executive Orders 12866 and 13563 

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, distributive impacts, and 

equity). Executive Order 14094 (the 

Modernizing E.O.) amends section 3(f) 

of Executive Order 12866 (Regulatory 

Planning and Review). The amended 

section 3(f) of Executive Order 12866 

defines a ‘‘significant regulatory action’’ 

as an action that is likely to result in a 

rule: (1) having an annual effect on the 

economy of $200 million or more in any 

1 year (adjusted every 3 years by the 

Administrator of Office of Information 

and Regulatory Affairs (OIRA) for 

changes in gross domestic product), or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, territorial, or Tribal 

governments or communities; (2) 

creating a serious inconsistency or 

otherwise interfering with an action 

taken or planned by another agency; (3) 

materially altering the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or (4) 

raise legal or policy issues for which 

centralized review would meaningfully 

further the President’s priorities or the 

principles set forth in this Executive 

order, as specifically authorized in a 

timely manner by the Administrator of 

OIRA in each case. OIRA has 

determined that this rule is significant. 

Statement of Need 

As discussed above, HHS/CDC is 

removing Brucella abortus, Brucella 

melitensis, and Brucella suis from the 

select agent list; updating the 

nomenclature for several select agents 

(‘‘SARS coronavirus (SARS–CoV),’’ the 

exclusion regarding ‘‘South American 

genotype of Eastern Equine Encephalitis 

virus,’’ the exclusion regarding ‘‘West 

African Clade of Monkeypox virus,’’ and 

‘‘Ebola virus’’); retaining the 

nomenclature of Monkeypox virus; 

retaining the Tier 1 designation of 

Botulinum neurotoxin producing 

species of Clostridium; not adding 

Hantaviruses to the current select agent 

list; increasing the exclusion amount for 

short, paralytic alpha conotoxins from 

100 mg to 200 mg; and designating 

Nipah virus as a Tier 1 Select Agent. 

HHS/CDC is also adding a footnote to 

the list for HHS and Overlap select 

agents indicating that the current 

nomenclature will be available on the 

website (www.selectagents.gov). 

Some of the regulatory changes 

described in the preamble and reported 

below are a minor in nature, and as 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 101949 

1U.S. Office of Personnel and Management. 

https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2024/general-schedule-gssalary-calculator/ accessed on September 4, 2024. 

2U S Office of Personnel Management: General 

Schedule (opm.gov). 

3Pappas, G., Panagopoulou, P., Christou, L., & 

Akritidis, N. (2006). Biological weapons: Brucella as 

a biological weapon. Cellular and molecular life 

sciences CMLS, 63, 2229–2236. 

such, are expected to have minimal 

impact on the costs and benefits of 

current regulations, except for the onetime costs of updating official 

documents for CDC. These regulatory 

changes are the updates to the 

nomenclature for several select agents 

(‘‘SARS coronavirus [SARS–CoV],’’ the 

exclusion regarding ‘‘South American 

genotype of Eastern Equine Encephalitis 

virus,’’ the exclusion regarding ‘‘West 

African Clade of Monkeypox virus.’’ and 

‘‘Ebola virus); retaining the 

nomenclature of Monkeypox virus, 

retaining the Tier 1 designation of 

Botulinum neurotoxin producing 

species of Clostridium; no addition of 

Hantaviruses to the current select agent 

list; increasing the exclusion amount for 

short, paralytic alpha conotoxins from 

100 mg to 200 mg; and designating 

Nipah virus as a Tier 1 Select Agent. 

This final rule changes the regulatory 

baseline by removing Brucella abortus, 

Brucella melitensis, and Brucella suis 

from the select agent list. As of July 

2024, of the 236 registered entities with 

FSAP, 112 were registered for select 

agents and toxins including Brucella 

abortus, melitensis, and/or suis, and 

three of those entities were registered 

for only Brucella species. CDC expects 

the three entities registered for only 

Brucella species will deregister from 

FSAP, which HHS/CDC expects will 

cause minimal savings for these 

laboratories, as well as CDC. The 

remaining 109 entities will likely 

submit amendments to their 

registrations to remove the delisted 

agents while maintaining the rest of 

their registration. Therefore, HHS/CDC 

expects no change in the costs for these 

entities; there is no cost to deregister 

with FSAP. Because of the small 

number of entities that will deregister 

due to the delisting of Brucella species, 

the cost-savings to the government will 

be minimal, roughly a net value 

(benefits-costs) of $8,795.78 in one-time 

cost savings. 

Costs 

This final rule does not impose any 

mandatory costs on the public and 

benefits laboratories who choose to 

develop research using Brucella abortus, 

Brucella melitensis, and Brucella suis. 

Nonetheless, the changes in this rule 

will have a minimal economic impact 

on CDC due to the process of updating 

official documentation for the 

implementation of the changes listed in 

this final rule. 

To estimate the cost to CDC of 

including the changes listed in this final 

rule in official documents, HHS/CDC 

assumed that 1 GS–14, step 5 employee 

and one GS–15, step 5 employee each 

spend 40 hours (i.e., 80 hours in total) 

for any updates to cite the language in 

this final rule. The hourly wage rates for 

two employees based in WashingtonBaltimore-Arlington, DC-MD-VA-WVPA are $75.70 (GS–14) and $89.03 (GS– 

15).1 To account for the non-wage 

benefits, we multiplied the wage cost by 

two to result in a total cost estimate of 

$13,178 (table 1). 

TABLE 1—SUMMARY OF THE ONE-TIME COSTS IN 2024 USD TO UPDATE OFFICIAL DOCUMENTS FOR DEPARTMENT OF

STATE (DOS), CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) COSTS FROM UPDATING OFFICIAL DOCUMENTS WITH THE CHANGES IN THIS FINAL RULE

Agency Cost components Hourly wage 

rate 2

Multiplier nonwage benefits 

and overhead 

Total 

CDC ........................................ 80 hours split between GS–14, step 5, and GS–15, step 5 

levels.

$82.4 2 $13,178 

Total ................................. ................................................................................................. ........................ ........................ 13,178 

The changes in this final rule that are 

minor in nature and should not result in 

an additional regulatory burden to 

regulated entities. Instead, they should 

help reduce costs by reducing confusion 

regarding the requirements for the 

possession, use, and transfer of 

biological select agents and toxins. 

The elimination of Brucella abortus, 

Brucella melitensis, and Brucella suis 

from the select agents and toxins list 

should not result in additional 

regulatory burden for CDC or regulated 

entities as this change would imply less 

regulatory burden. However, one 

concern about this reduction in 

regulatory burden is that it could cause 

costs or losses to the general public by 

increasing the risk of Brucella abortus, 

Brucella melitensis, and Brucella suis 

being accessed without authorization, 

stolen, lost, or released. Although this 

cost cannot be measured until after the 

regulation has been applied, HHS/CDC 

expects that the risk of Brucella abortus, 

Brucella melitensis, and Brucella suis 

being accessed without authorization, 

stolen, lost, or released would be 

minimal as the current recommended 

best practices in place to mitigate these 

biosafety and biosecurity risks 

(Biosafety in Microbiological and 

Biomedical Laboratories) will remain in 

place. USDA’s prevention and 

eradication efforts against Brucellosis 

from livestock in the United States 

through the National Bovine Brucellosis 

Surveillance Plan and the National 

Brucellosis Eradication program will 

continue even with the changes in this 

rule. 

Another concern linked to the 

reduction in regulatory burden to 

agencies and laboratories is that it could 

increase cost to the general public by 

increasing the risk of Brucella abortus, 

Brucella melitensis, and Brucella suis 

becoming an agent of interest to be used 

as a bioweapon. Although this risk 

cannot be measured by HHS/CDC 

currently, HHS/CDC expects this risk to 

be minimal as recent literature indicates 

that Brucella’s ‘‘minimal mortality, 

availability of treatment options, 

protracted inoculation period and the 

emergence of new, more virulent 

potential weapons means that its 

inclusion among agents of bioterrorism 

is nowadays mainly of historical 

significance.’’ 3

Increasing the exclusion limits for 

short paralytic alpha conotoxins will 

have a negligible impact on costs for 

regulated entities. There are only four 

registered entities currently working 

with these conotoxins, and increasing 


ddrumheller on DSK120RN23PROD with RULES1
101950 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

4U.S. Office of Personnel Management: General 

Schedule (opm.gov). 

5Bureau of Transportation Statistics: Air Fares √ 

Bureau of Transportation Statistics (bts.gov). 

6FY 2024 Federal Per Diem Rates: FY 2024 

Federal Per Diem Rates (federalpay.org). 

the exclusion limit will allow for 

additional research and testing without 

the additional burden of select agent 

and toxin regulatory requirements. 

Change to the designation of Nipah 

virus as a Tier 1 select agent will have 

a negligible impact on costs for 

regulated entities. All eight of the 

entities that are currently registered for 

Nipah virus are already registered for 

other Tier 1 select agents; therefore they 

are already complying with the 

additional Tier 1 requirements and will 

not incur additional costs with this 

change. 

Benefits 

HHS found the benefits of this 

rulemaking to outweigh the costs to 

regulated entities as all the changes 

described in this final rule have a zero 

cost to regulated entities. Furthermore, 

these changes are likely to reduce 

regulated entities’ costs by simplifying 

their processes and reducing some of 

the regulatory burden. HHS/CDC is 

unable to quantify the cost reductions to 

regulated entities due to the minor 

changes but expects this final rule will 

potentially simplify processes for them. 

Nonetheless, at a minimum, costs of 

these changes are zero for regulated 

entities, thus any simplification of 

processes coming out of this change 

implies a gain. 

As of July 2024, of the 236 registered 

entities with APHIS and CDC, 112 were 

registered for select agents and toxins 

including Brucella abortus, melitensis, 

and/or suis, and three of those entities 

are registered for only Brucella species. 

CDC expects the three entities registered 

for only Brucella species will deregister 

from FSAP, which HHS/CDC expects to 

cause small savings for these entities. 

Although FSAP registration does not 

have a direct cost for regulated entities, 

HHS/CDC estimates that it takes 12 

hours of labor a week for eight months 

to perform the registration processes 

required to get an FSAP registration. 

These activities are usually performed 

by a Responsible Official/Biosafety 

Officer or an Alternate Responsible 

Official/Biosafety Officer. The GS scale 

for these professionals typically ranges 

from GS–9 to GS–14. Assuming a GS– 

14 scale, the hourly wage rate based in 

Washington-Baltimore-Arlington, DCMD-VA-WV-PA is $75.70. Thus, the 

estimated one-time cost of registration 

with FSAP for an entity is $29,069. This 

estimated one-time cost savings will 

apply to any entities not registered with 

FSAP that wish to work with Brucella 

species. Renewal of registration with 

FSAP is a negligible cost as the process 

takes less than 10 minutes. Because 

three entities are currently registered 

solely for Brucella species, the 

exclusion of Brucella abortus, Brucella 

melitensis, and Brucella suis from the 

select agent list means they will not 

need to participate in the registration 

renewal process, which is a negligible 

cost. 

HHS/CDC expects that the 

deregistration of the three entities 

registered only for Brucella species with 

FSAP will also cause small one-time 

cost-savings to CDC, as CDC personnel 

will no longer follow these entities 

throughout the registration process. 

HHS/CDC estimates that CDC personnel 

spend about three hours a week for six 

months reviewing laboratories’ Standard 

Operating Procedures (SOPs) for entity’s 

registration applications to FSAP. 

Assuming that the CDC staff reviewing 

SOPs is GS–13 step 5, the hourly salary 

in 2024 dollars would be $64.06, thus 

the one-time cost savings to CDC of 

reviewing the SOPs required for one 

entity’s registration is $1,153.08, and 

this implies a total of $3,459.24 in cost 

savings for CDC of not going through the 

registration process of the three entities 

that would deregister after the 

publication of this rule. 

In addition to these cost savings CDC 

will also have cost savings from not 

having to perform inspections on the 

three entities that are ending their FSAP 

registrations as a result of the exclusion 

of Brucella abortus, Brucella melitensis, 

and Brucella suis from the select agent 

list. Assuming that the personnel 

performing the inspections are a GS–12 

step 5, and a GS–13 step 5 inspectors, 

the hourly wage is $53.87, and $64.06, 

respectively. Using an overhead 

multiplier of 2 to take into account nonwage benefits, and considering the 

travel costs of inspections, HHS/CDC 

estimates one-time costs savings of 

$10,564.18 per inspection not 

performed per entity (table 2). Since 

each entity goes through at least one 

inspection during registration, HHS/ 

CDC estimates CDC will have a cost 

savings of at least $31,692.54 due to 

inspections not performed for the three 

entities deregistering from FSAP. 

TABLE 2—ESTIMATED ANNUAL CDC COST-SAVINGS IN 2024 USD FOR INSPECTION OF EACH FACILITY ONLY WORKING

WITH BRUCELLA

Type of CDC staff Number of 

staff 

Number of inspections 

per year 

Number of hours spent 

per inspection 

Average 

hourly 

wage rate 4

Overhead 

multiplier 

One-time 

annual 

benefit 

GS–12 (step 5) ............. 1 ................ 0.5 ................................. 40 .................................. $53.87 2 $4,309.6 

GS–13 (step 5) ............. 1 ................ 0.5 ................................. 40 .................................. 64.06 2 5,124.8 

Total ....................... ................... ....................................... ....................................... ........................ ........................ 9,438.4 

Travel costs ................... Airfare 5 ...... 417.79/per person ......... Hotel, food, lodging 6 ..... 145.10/per person 1125.78 

Total (Personnel + 

Travel).

................... ....................................... ....................................... ........................ ........................ 10,564.18 

Executive Order 14094 reaffirms the 

principles of E.O. 12866 and E.O. 13563 

and states that regulatory analysis 

should facilitate agency efforts to 

develop regulations that serve the 

public interest, advance statutory 

objectives, and are consistent with E.O. 

12866, E.O. 13563, and the Presidential 

Memorandum of January 20, 2021 

(Modernizing Regulatory Review). 

Regulatory analysis, as practicable and 

appropriate, should recognize 

distributive impacts and equity, to the 

extent permitted by law. HHS/CDC 

developed this final rule in a manner 

consistent with these requirements. E.O. 

13563 emphasizes further that 

regulations must be based on the best 

available science and that the 

rulemaking process must allow for 

public participation and an open 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 101951 

exchange of ideas. HHS/CDC developed 

this final rule in a manner consistent 

with these requirements. In 

administering FSAP, HHS, along with 

USDA, regularly interact with the 

affected registered entities via email, 

phone, online webinars, through the 

eFSAP information system, and through 

designated points of contact at 

registered entities. All changes result 

from entity questions received or 

interaction with registered entities who 

have contacted FSAP when they had 

questions or regulatory interpretation 

requests. Therefore, HHS/CDC believes 

this final rule serves the public interest. 

Additionally, HHS/CDC encouraged 

public participation and informed 

registered entities of the proposed rule 

via a Select Agent (SA) Gram and a 

GovD message to ensure they were 

aware and had a chance to provide 

public comments. The FSAP website 

(www.selectagents.gov) was updated to 

share the proposed changes and 

provided a link to web visitors so that 

they could review and provide 

comments on the proposed rule. Lastly, 

HHS/CDC emailed outreach notes 

summarizing the proposed rule directly 

to national partner organizations (e.g., 

the Association of Public Health 

Laboratories, American Society for 

Microbiology, American Biological 

Safety Association) so that they could 

share among their constituents. As 

discussed above, HHS/CDC carefully 

reviewed and considered public 

comments in the development of this 

final rule. 

B. The Regulatory Flexibility Act (RFA), 

as Amended by the Small Business 

Regulatory Enforcement Fairness Act 

(SBREFA) 

HHS/CDC examined the impacts of 

this final rule under the Regulatory 

Flexibility Act (5 U.S.C. 601–612). 

Unless HHS/CDC certifies that the final 

rule is not expected to have a significant 

economic impact on a substantial 

number of small entities, the RFA, as 

amended by SBREFA, requires agencies 

to analyze regulatory options that would 

minimize any significant economic 

impact of a rule on small entities. 

Currently, 236 entities are registered 

with FSAP. Of these entities, there are 

13 private entities, 30 Federal entities, 

42 commercial entities, 84 academic 

entities, and 67 state entities (registered 

with either APHIS or CDC, depending 

on the select agents and toxins they 

work with). Less than 4 percent of all 

firms operating within these North 

American Industry Classification 

System (NAICS) categories are 

considered to be small entities. HHS/ 

CDC estimates that 13 entities will be 

impacted by the changes in this rule. Of 

these 13 entities, which are not 

considered small, 4 are associated with 

colleges, universities, and professional 

schools; 2 are categorized as research 

and development in biotechnology; and 

7 are part of research and development 

in the physical, engineering, and life 

sciences. Applying NAICS’ estimation 

of less than 4 percent of entities 

classified as small, we find that not even 

one small entity will be affected by the 

changes in this rule. Based on our 

analysis as described above, we certify 

that this final rule will not have a 

significant economic impact on a 

substantial number of small entities 

within the meaning of the RFA. In 

addition, no public comments were 

received from any small entities on the 

RFA section. 

Based on the information above, this 

regulatory action is not a major rule as 

defined by sec. 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996. This final rule will 

not result in an annual effect on the 

economy of $100,000,000 or more; a 

major increase in cost or prices; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of U.S.-based companies to 

compete with foreign-based companies 

in domestic and export markets. 

C. Paperwork Reduction Act of 1995 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), HHS/CDC 

determined that the Paperwork 

Reduction Act does apply to 

information collection and 

recordkeeping requirements included in 

this rule. This final rule focuses on the 

select agent and toxins list. Any changes 

to burden hours caused by the removal 

of Brucella abortus, Brucella suis, and 

Brucella melitensis from the list of 

select agents and toxins will be 

submitted for consideration by OMB 

under the existing approved PRA 

package (Possession, Use, and Transfer 

of Select Agents and Toxins (42 CFR 

part 73)). Other changes put forth in this 

final rule, i.e., updating entity 

registrations to reflect the nomenclature 

updates to the list, will be instituted by 

FSAP, resulting in no additional 

paperwork for the regulated community. 

D. E.O. 12988: Civil Justice Reform 

This rule has been reviewed under 

E.O. 12988, Civil Justice Reform. Once 

the final rule is in effect, HHS/CDC 

notes that (1) All state and local laws 

and regulations that are inconsistent 

with this rule will be preempted; (2) no 

retroactive effect will be given to this 

rule; and (3) administrative proceedings 

will not be required before parties may 

file suit in court challenging this rule. 

E. E.O. 13132: Federalism 

HHS/CDC reviewed this final rule in 

accordance with Executive Order 13132 

regarding federalism and determined 

that it does not have federalism 

implications. The rule does not ‘‘have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ 

In accordance with section 361(e) of 

the PHSA [42 U.S.C. 264(e)], nothing in 

this rule would supersede any 

provisions of state or local law except to 

the extent that such a provision 

conflicts with this rule. 

F. Plain Language Act of 2010 

Under the Plain Language Act of 2010 

(Pub. L. 111–274, October 13, 2010), 

executive departments and agencies are 

required to use plain language in 

documents that explain to the public 

how to comply with a requirement the 

Federal Government administers or 

enforces. HHS/CDC has attempted to 

use plain language in issuing this rule 

consistent with the Federal Plain 

Writing Act guidelines. 

V. References 

Government Accountability Office. 2023. 

Public Health Preparedness: HHS Could 

Improve Oversight of Research Involving 

Enhanced Potential Pandemic Pathogens 

(GAO–23–105455). https://www.gao.gov/ 

products/gao-23-105455 

Lo, M., et al. The Emergence of Nipah virus, 

a Highly Pathogenic Paramyxovirus. J 

Clin Virol, 2008. 43(4): p. 396–400. 

Olsen, S., et al. Biosafety Concerns Related to 

Brucella and its Potential Use as a 

Bioweapon. Applied Biosafety, 2018. 

23(2): p. 77–90. Biosafety Concerns 

Related to Brucella and Its Potential Use 

as a Bioweapon | Applied Biosafety 

(liebertpub.com). 

Sejvar, J., et al. Long-term Neurological and 

Functional Outcome in Nipah virus 

Infection. Ann Neurol. 2007 Sep;62(3): p. 

235–42. 

Ulaeto, D., et al. New Nomenclature for mpox 

(monkeypox) and Monkeypox Virus 

Clades. The Lancet: Infectious Diseases, 

2023. 23(3): pg 273–275. https://

www.thelancet.com/journals/laninf/ 

article/PIIS1473-3099(23)00055-5/ 

fulltext. 

List of Subjects in 42 CFR Part 73 

Biologics, Packaging and containers, 

Penalties, Reporting and recordkeeping 

requirements, Transportation. 

For the reasons discussed in the 

preamble, HHS amends 42 CFR part 73 

as follows: 


ddrumheller on DSK120RN23PROD with RULES1
101952 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

PART 73—SELECT AGENTS AND 

TOXINS 

■ 1. The authority citation for part 73 is 

revised to read as follows: 

Authority: 42 U.S.C. 262a. 

■ 2. Section 73.3 is amended by: 

■ a. Revising paragraph (b); 

■ b. In paragraph (d)(7), removing the 

text ‘‘100 mg of Conotoxins’’ and adding 

in its place the text ‘‘200 mg of 

Conotoxins’’; and 

■ c. Revising paragraph (d)(12). 

The revisions read as follows: 

§ 73.3 HHS select agents and toxins. 

* * * * * 

(b) HHS select agents and toxins 1 are: 

(1) Abrin. 

(2) Bacillus cereus Biovar anthracis.* 

(3) Botulinum neurotoxins.* 

(4) Botulinum neurotoxin producing 

species of Clostridium.* 

(5) Conotoxins (Short, paralytic alpha 

conotoxins containing the following 

amino acid sequence 

X1CCX2PACGX3X4X5X6CX7).2

(6) Coxiella burnetii. 

(7) Crimean-Congo hemorrhagic fever 

virus. 

(8) Diacetoxyscirpenol. 

(9) Eastern equine encephalitis virus. 

(10) Ebolavirus * 

(11) Francisella tularensis.* 

(12) Lassa fever virus. 

(13) Lujo virus. 

(14) Marburg virus.* 

(15) Monkeypox virus. 

(16) Reconstructed replication 

competent forms of the 1918 pandemic 

influenza A virus containing any 

portion of the coding regions of all eight 

gene segments (Reconstructed 1918 

influenza A virus). 

(17) Ricin. 

(18) Rickettsia prowazekii. 

(19) Severe acute respiratory 

syndrome coronavirus (SARS–CoV). 

(20) SARS–CoV/SARS–CoV–2 

chimeric viruses resulting from any 

deliberate manipulation of SARS–CoV– 

2 to incorporate nucleic acids coding for 

SARS–CoV virulence factors. 

(21) Saxitoxin. 

(22) South American hemorrhagic 

fever virus: Chapare. 

(23) South American hemorrhagic 

fever virus: Guanarito. 

(24) South American hemorrhagic 

fever virus: Junin. 

(25) South American hemorrhagic 

fever virus: Machupo. 

(26) South American hemorrhagic 

fever virus: Sabia. 

(27) Staphylococcal enterotoxins 

(subtypes A,B,C,D,E). 

(28) T–2 toxin. 

(29) Tetrodotoxin. 

(30) Tick-borne encephalitis virus: Far 

Eastern subtype. 

(31) Tick-borne encephalitis virus: 

Siberian subtype. 

(32) Kyasanur Forest disease virus. 

(33) Omsk haemorrhagic fever virus. 

(34) Variola major virus (Smallpox 

virus).* 

(35) Variola minor virus (Alastrim).* 

(36) Yersinia pestis.* 1Please refer to https://

www.selectagents.gov for current 

information on historical or proposed 

nomenclature for the HHS select agents 

on the list. 2C = Cysteine residues are all present 

as disulfides, with the 1st and 3rd 

Cysteine, and the 2nd and 4th Cysteine 

forming specific disulfide bridges; The 

consensus sequence includes known 

toxins a-MI and a-GI (shown above) as 

well as a-GIA, Ac1.1a, a-CnIA, a-CnIB; 

X1 = any amino acid(s) or Des-X; X2 = 

Asparagine or Histidine; P = Proline; A 

= Alanine; G = Glycine; X3 = Arginine 

or Lysine; X4 = Asparagine, Histidine, 

Lysine, Arginine, Tyrosine, 

Phenylalanine or Tryptophan; X5 = 

Tyrosine, Phenylalanine, or 

Tryptophan; X6 = Serine, Threonine, 

Glutamate, Aspartate, Glutamine, or 

Asparagine; X7 = Any amino acid(s) or 

Des X and; ‘‘Des X’’ = ‘‘an amino acid 

does not have to be present at this 

position.’’ For example, if a peptide 

sequence were XCCHPA then the 

related peptide CCHPA would be 

designated as Des-X. 

* * * * * 

(d) * * * 

(12) Madariaga virus and any Clade II 

Monkeypox provided that the 

individual or entity can identify that the 

agent is within the exclusion category. 

* * * * * 

■ 3. Section 73.4 is amended by revising 

paragraph (b) to read as follows: 

§ 73.4 Overlap select agents and toxins. 

* * * * * 

(b) Overlap select agents and toxins 1

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. 

(8) Venezuelan equine encephalitis 

virus. 1Please refer to https://

www.selectagents.gov for current 

information on historical or proposed 

nomenclature for the Overlap select 

agents on the list. 

* * * * * 

Dated: December 11, 2024. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2024–29583 Filed 12–16–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 513 

[Docket No. NHTSA–2023–0014] 

RIN 2127–AL85 

Implementing the Whistleblower 

Provisions of the Vehicle Safety Act 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This final rule addresses an 

important source of motor vehicle safety 

information and fulfills a requirement in 

the Motor Vehicle Safety Whistleblower 

Act (Whistleblower Act) that NHTSA 

promulgate regulations on the 

requirements of the Act, in complement 

to NHTSA’s existing whistleblower 

program. The Whistleblower Act 

authorizes the Secretary of 

Transportation to pay an award, subject 

to certain limitations, to eligible 

whistleblowers who voluntarily provide 

original information relating to any 

motor vehicle defect, noncompliance, or 

any violation or alleged violation of any 

notification or reporting requirement, 

which is likely to cause unreasonable 

risk of death or serious physical injury, 

if the information provided leads to the 

successful resolution of a covered 

action. This final rule defines certain 

terms important to the operation of the 

whistleblower program, outlines the 

procedures for submitting original 

information to NHTSA and applying for 

awards, discusses NHTSA’s procedures 

for making decisions on award 

applications, and generally explains the 

scope of the whistleblower program to 

the public and potential whistleblowers. 

DATES: 

Effective date: This rule is effective 

January 16, 2025. 

Petitions for Reconsideration: If you 

wish to submit a petition for 

reconsideration of this rule, your 

petition must be received by January 31, 

2025. 

ADDRESSES: Any petitions for 

reconsideration should refer to the 

docket number set forth above (NHTSA– 

2023–0014) and be submitted to the 


ddrumheller on DSK120RN23PROD with RULES1