104886 Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Rules and Regulations 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 2. In § 52.1170, the table in paragraph 

(e) is amended by adding an entry for 

‘‘2010 Sulfur Dioxide Determination of 

Attainment by the Attainment Date’’ 

before the entry for ‘‘Determination of 

failure to attain the 2010 SO2 standard’’ 

to read as follows: 

§ 52.1170 Identification of plan. 

* * * * * 

(e) * * * 

EPA-APPROVED MICHIGAN NONREGULATORY AND QUASI-REGULATORY PROVISIONS

Name of nonregulatory SIP provision 

Applicable 

geographic 

or nonattainment 

area 

State 

submittal 

date 

EPA Approval date Comments 

*******

2010 Sulfur Dioxide Determination of Attainment 

by the Attainment Date.

St. Clair 

County 

(part).

.................... 12/26/2024, [INSERT FIRST PAGE OF Federal 

Register CITATION].

....................

* * * * * * * 

* * * * * 

[FR Doc. 2024–30583 Filed 12–23–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2024–0563; FRL–12442– 

03–R9] 

Determination To Defer Sanctions; 

California; Mojave Desert Air Quality 

Management District 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Interim final determination. 

SUMMARY: The Environmental Protection 

Agency (EPA) is making an interim final 

determination that the California Air 

Resources Board (CARB) has submitted 

a rule and other materials on behalf of 

the Mojave Desert Air Quality 

Management District (MDAQMD) that 

corrects deficiencies in its Clean Air Act 

(CAA or ‘‘Act’’) State Implementation 

Plan (SIP) concerning reasonably 

available control technology (RACT) 

ozone nonattainment requirements for 

controlling emissions of oxides of 

nitrogen (NOX) from industrial, 

institutional, and commercial boilers, 

steam generators, and process heaters. 

This determination is based on a 

proposed approval, published elsewhere 

in this issue of the Federal Register, of 

MDAQMD Rule 1157, which regulates 

this source category. The effect of this 

interim final determination is that the 

imposition of sanctions that were 

triggered by a previous limited 

disapproval by the EPA in 2023 is now 

deferred. If the EPA finalizes its 

approval of MDAQMD’s submission, 

relief from these sanctions will become 

permanent. 

DATES: This interim final determination 

is effective December 26, 2024. 

However, comments will be accepted on 

or before January 27, 2025. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R09– 

OAR–2024–0563 at https://

www.regulations.gov. For comments 

submitted at Regulations.gov, follow the 

online instructions for submitting 

comments. Once submitted, comments 

cannot be edited or removed from 

Regulations.gov. The EPA may publish 

any comment received to its public 

docket. Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e., on the web, cloud, or 

other file sharing system). For 

additional submission methods, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

For the full EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

https://www.epa.gov/dockets/ 

commenting-epa-dockets. If you need 

assistance in a language other than 

English or if you are a person with a 

disability who needs a reasonable 

accommodation at no cost to you, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: La 

Kenya Evans-Hopper, EPA Region IX, 75 

Hawthorne St., San Francisco, CA 

94105; phone: (415) 972–3245; email 

evanshopper.lakenya@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us,’’ 

and ‘‘our’’ refer to the EPA. 

Table of Contents 

I. Background 

II. The EPA’s Evaluation and Action 

III. Statutory and Executive Order Reviews 

I. Background 

On June 16, 2023, the EPA issued a 

final rule (88 FR 39366, the ‘‘2023 final 

rule’’) promulgating a limited approval 

and limited disapproval for the 

MDAQMD rule listed in Table 1, which 

was submitted by the California Air 

Resources Board (CARB) to the EPA for 

inclusion into the California SIP. 

TABLE 1—DISTRICT RULE WITH PREVIOUS EPA ACTION

Rule No. Rule title Amended Submitted EPA action in 2023 

1157 .................. Boilers and Process Heaters 01/22/2018 05/23/2018 Limited Approval and Limited Disapproval. 


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Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Rules and Regulations 104887 

Areas classified as ‘‘Moderate’’ or 

above nonattainment for an ozone 

standard must implement RACT for 

each category of sources covered by a 

Control Techniques Guidelines (CTG) 

document as well as each major source 

of NOX (see CAA section 182(b)(2), (f)). 

The MDAQMD contains parts of the 

West Mojave Desert ozone 

nonattainment area, which is classified 

as ‘‘Severe’’ nonattainment for the 1997, 

2008, and 2015 8-hour ozone National 

Ambient Air Quality Standards 

(NAAQS), as well as part of the 

Southeast Desert Modified Air Quality 

Management Area, which is classified as 

‘‘Severe’’ nonattainment for the 1979 1- 

hour ozone NAAQS (see 40 CFR 

81.305). 

In the 2023 final rule, we determined 

that although the MDAQMD rule 

strengthened the SIP and was largely 

consistent with the requirements of the 

CAA, the submitted rule included a 

deficiency that precluded our full 

approval of the rule into the SIP. The 

MDAQMD’s previously submitted Rule 

1157 stated, ‘‘[n]o compliance 

determination shall be established based 

on data obtained from compliance 

testing, including integrated sampling 

methods, during a start-up period or 

shut-down period.’’ This provision 

prohibits the use of data gathered during 

periods of startup and shutdown from 

being used for determining compliance 

with the applicable limit. 

The EPA found that the provision was 

not consistent with the EPA’s SSM 

policy and Credible Evidence Rule 

because it forbids the use of credible 

evidence (compliance testing data 

generated during startup and shutdown 

periods) in establishing violations of the 

applicable emissions limit. In addition, 

the previously submitted Rule 1157 

removed the definitions of ‘‘start-up 

period’’ and ‘‘shut-down period,’’ 

making the scope of this provision 

unclear. 

Pursuant to section 179 of the CAA 

and our regulations at 40 CFR part 52, 

the disapproval action on Rule 1157 

under title I, part D started a sanctions 

clock for imposition of offset sanctions 

18 months after the action’s effective 

date of July 17, 2023, and highway 

sanctions six months later. 

On September 25, 2023, the 

MDAQMD revised Rule 1157, and on 

January 10, 2024, CARB submitted it to 

the EPA for approval into the California 

SIP, as shown in Table 2 below. 

TABLE 2—SUBMITTED RULE

Local agency Rule No. Rule title Amended Submitted 

MDAQMD ................................ 1157 Boilers and Process Heaters ................................................. 09/25/23 01/10/24 

On July 10, 2024, the submittal for 

MDAQMD Rule 1157 was deemed by 

operation of law to meet the 

completeness criteria in 40 CFR part 51 

appendix V. 

The revised MDAQMD Rule 1157 in 

Table 2 of this document is intended to 

address the disapproval issues in our 

June 16, 2023 final rule. In the Proposed 

Rules section of this Federal Register, 

we have proposed approval of the 

revised MDAQMD Rule 1157. Based on 

the proposed action approving Rule 

1157 into the California SIP, we are also 

making this interim final determination, 

effective on publication, to defer 

imposition of the offset sanctions and 

highway sanctions that were triggered 

by our 2023 final rule on Rule 1157, 

because we believe that the submittal 

corrects the deficiencies that triggered 

such sanctions. 

The EPA is providing the public with 

an opportunity to comment on this 

deferral of sanctions. If comments are 

submitted that change our assessment 

described in this interim final 

determination and the proposed 

approval of MDAQMD Rule 1157, we 

would take final action to lift this 

deferral of sanctions under 40 CFR 

52.31. If no comments are submitted 

that change our assessment, then all 

sanctions and any sanction clocks 

triggered by our June 16, 2023 final rule 

would be permanently terminated on 

the effective date of our final approval 

of Rule 1157. 

II. The EPA’s Evaluation and Action 

We are making an interim final 

determination to defer CAA section 179 

sanctions associated with our limited 

disapproval action on June 16, 2023, of 

MDAQMD Rule 1157 with respect to the 

requirements of part D of title I of the 

CAA. This determination is based on 

our concurrent proposal to fully 

approve MDAQMD Rule 1157 which 

resolves the deficiencies that triggered 

sanctions under section 179 of the CAA. 

Because the EPA has preliminarily 

determined that MDAQMD Rule 1157, 

amended on September 25, 2023, 

addresses the limited disapproval issues 

under part D of title I of the CAA 

identified in our 2023 final rule and the 

amended rule is now fully approvable, 

relief from sanctions should be provided 

as quickly as possible. Therefore, the 

EPA is invoking the good cause 

exception under the Administrative 

Procedure Act (APA) in not providing 

an opportunity for comment before this 

action takes effect (5 U.S.C. 553(b)(3)). 

However, by this action, the EPA is 

providing the public with a chance to 

comment on the EPA’s determination 

after the effective date, and the EPA will 

consider any comments received in 

determining whether to reverse such 

action. 

The EPA believes that notice-andcomment rulemaking before the 

effective date of this action is 

impracticable and contrary to the public 

interest. The EPA has reviewed the 

State’s submittal and, through its 

proposed action, is indicating that it is 

more likely than not that the State has 

submitted a revision to the SIP that 

corrects deficiencies under part D of the 

Act that were the basis for the action 

that started the sanctions clocks. 

Therefore, it is not in the public interest 

to impose sanctions. The EPA believes 

that it is necessary to use the interim 

final rulemaking process to defer 

sanctions while the EPA completes its 

rulemaking process on the approvability 

of the State’s submittal. Moreover, with 

respect to the effective date of this 

action, the EPA is invoking the good 

cause exception to the 30-day notice 

requirement of the APA because the 

purpose of this notice is to relieve a 

restriction (5 U.S.C. 553(d)(1)). 

III. Statutory and Executive Order 

Reviews 

This action defers sanctions and 

imposes no additional requirements. For 

that reason, this action: 

• Is not a significant regulatory action 

subject to review by the Office of 

Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 14094 (88 FR 

21879, April 11, 2023); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 


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104888 Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Rules and Regulations 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not subject to Executive Order 

13045 (62 FR 19885, April 23, 1997) 

because it proposes to approve a State 

program; 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); and 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act. 

In addition, the SIP is not approved 

to apply on any Indian reservation land 

or in any other area where the EPA or 

an Indian Tribe has demonstrated that a 

Tribe has jurisdiction. In those areas of 

Indian country, the rule does not have 

Tribal implications and will not impose 

substantial direct costs on Tribal 

governments or preempt Tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

Executive Order 12898 (Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations, 59 FR 7629, 

February 16, 1994) directs Federal 

agencies to identify and address 

‘‘disproportionately high and adverse 

human health or environmental effects’’ 

of their actions on communities with 

environmental justice (EJ) concerns to 

the greatest extent practicable and 

permitted by law. Executive Order 

14096 (Revitalizing Our Nation’s 

Commitment to Environmental Justice 

for All, 88 FR 25251, April 26, 2023) 

builds on and supplements Executive 

Order 12898 and defines EJ as, among 

other things, ‘‘the just treatment and 

meaningful involvement of all people, 

regardless of income, race, color, 

national origin, Tribal affiliation, or 

disability, in agency decision-making 

and other Federal activities that affect 

human health and the environment.’’ 

The State did not evaluate EJ 

considerations as part of its SIP 

submittal; the CAA and applicable 

implementing regulations neither 

prohibit nor require such an evaluation. 

The EPA did not perform an EJ analysis 

and did not consider EJ in this action. 

Consideration of EJ is not required as 

part of this action, and there is no 

information in the record inconsistent 

with the stated goal of Executive Order 

12898 of achieving EJ for communities 

with EJ concerns. 

This action is subject to the 

Congressional Review Act (CRA), and 

the EPA will submit a rule report to 

each House of the Congress and to the 

Comptroller General of the United 

States. The CRA allows the issuing 

agency to make a rule effective sooner 

than otherwise provided by the CRA if 

the agency makes a good cause finding 

that notice and comment rulemaking 

procedures are impracticable, 

unnecessary, or contrary to the public 

interest (5 U.S.C. 808(2)). The EPA has 

made a good cause finding for this 

action as discussed in section II of this 

preamble, including the basis for that 

finding. 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by February 24, 2025. Filing a 

petition for reconsideration by the EPA 

Administrator of this action does not 

affect the finality of this action for the 

purpose of judicial review, nor does it 

extend the time within which petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements (see CAA 

section 307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Nitrogen 

oxides, Ozone, Particulate matter, 

Reporting and recordkeeping 

requirements. 

Dated: December 13, 2024. 

Martha Guzman Aceves, 

Regional Administrator, Region IX. 

[FR Doc. 2024–30409 Filed 12–23–24; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 73 

Select Agent: Modified Junı ́n Virus 

Vaccine Strain 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notification of determination. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS), has determined 

that a previously excluded attenuated 

strain, Junı ́n virus vaccine strain Candid 

No.1, has key attenuating mutations in 

the glycoprotein envelope at GP1 T168A 

and GP2 F427I. Revertants at either of 

these positions have increased 

pathogenicity and virulence. Therefore, 

Junı ́n virus vaccine strain Candid No. 1 

containing GP1 168T and/or GP2 427F 

is a select agent and is subject to the 

select agent and toxin regulations. 

DATES: This determination is applicable 

as of May 3, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Daniel A. Singer, MD, MPH, FACP, 

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) 718–2000. 

SUPPLEMENTARY INFORMATION: Junı ́n 

virus is a negative sense, double 

stranded RNA virus and is the causative 

agent of Argentine hemorrhagic fever. 

Junı ́n virus causes chronic infection in 

Calomys musculinus, the Drylands 

vesper mouse. Humans can become 

infected upon exposure to infected 

animals or infected animals’ waste. 

Human-to-human spread is rare but can 

occur upon contact with an infected 

person’s bodily fluids. 

In accordance with the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002 (Bioterrorism 

Response Act), HHS regulates 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)). The 

list of HHS select agents and toxins is 

provided in the HHS select agent and 

toxin regulations (42 CFR part 73) and 

Junı ́n virus, a South American 

hemorrhagic fever virus, is included as 

a select agent (42 CFR 73.3(b)). 

The HHS select agent and toxin 

regulations established a process by 

which an attenuated strain of a select 

biological agent that does not have the 

potential to pose a severe threat to 

public health and safety may be 

excluded from the requirements of the 

select agent and toxin regulations (42 

CFR 73.3(e)). On February 7, 2003, Junı ́n 

virus vaccine strain Candid No.1 was 

excluded from the regulations as it does 

not pose a significant threat to public 

health and safety (McKee KT Jr, Oro JG, 

Kuehne AI, Spisso JA, Mahlandt BG. 

‘‘Candid No. 1 Argentine hemorrhagic 

fever vaccine protects against lethal 

Junı ́n virus challenge in rhesus 

macaques’’ Intervirology. 1992: 

34(3):154–63). This exclusion was 

granted based on the historically safe 

use of this strain as a vaccine against 

Argentine hemorrhagic fever for 


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