Federal Register / Vol. 89, No. 210 / Wednesday, October 30, 2024 / Proposed Rules 86305 

409(c)(5) of the FD&C Act, FDA is to 

‘‘consider among other relevant factors’’ 

the following: (1) probable consumption 

of the additive; (2) cumulative effect of 

such additive ‘‘in the diet of man or 

animals, taking into account any 

chemically or pharmacologically related 

substance or substances in such diet;’’ 

and (3) safety factors ‘‘generally 

recognized’’ by qualified experts ‘‘as 

appropriate for the use of animal 

experimentation data.’’ 

Section 409(c)(5) of the FD&C Act 

does not impose a ‘‘legal obligation’’ for 

FDA to consider exposure from nondietary sources in determining safety. 

Rather, section 409(c)(5) of the FD&C 

Act makes clear that FDA has discretion 

to review a number of factors to 

determine whether a food additive is 

safe. Besides the factors enumerated in 

subparagraphs (A), (B), and (C), section 

409(c)(5) of the FD&C Act gives us 

discretion to decide, in our scientific 

expertise, whether there are other 

factors that are ‘‘relevant’’ to the safety 

of a food additive in the context of a 

particular petition. Moreover, the text of 

subparagraphs (A) and (B), which 

contemplate FDA considering foodrelated uses in assessing safety, 

provides additional support that it is not 

required for FDA to consider exposure 

from non-dietary sources as a relevant 

factor. Specifically, subparagraph (A) 

states that in determining safety, the 

Secretary shall consider ‘‘the probable 

consumption of the additive and of any 

substance formed in or on food because 

of the use of the additive,’’ and 

subparagraph (B) refers to the diet of 

man or animals’’ (emphasis added). 

Subparagraph 409(c)(5)(C) of the FD&C 

Act, which directs FDA to consider 

safety factors that ‘‘are generally 

recognized as appropriate for the use of 

animal experimentation data,’’ does not 

suggest that FDA must consider 

exposure from non-dietary sources. 

Therefore, the objectors’ argument that 

non-dietary exposure must be part of the 

safety analysis under section 409(c)(5) 

of the FD&C Act is incorrect. While the 

objectors state that other federal 

agencies ‘‘frequently consider 

background exposures when evaluating 

and regulating harmful chemicals,’’ we 

administer the FD&C Act and not 

authorities that are applicable to other 

Federal agencies. 

V. Summary and Conclusions 

After evaluating the objections, we 

conclude that the submission does not 

provide a basis to support modifying or 

revoking the denial of FAP 6B4815. 

Therefore, we are overruling the 

objections and denying the requests for 

a public hearing. 

VI. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff, (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852, 240–402–7500 and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

1. * FDA Memorandum from J. Urbelis to 

Administrative File for Food Additive 

Petition (FAP) 6B4815, May 11, 2022. 

2. * FDA, Guidance for Industry, 

‘‘Toxicological Principles for the Safety 

Assessment of Food Ingredients: 

Redbook 2000,’’ July 2007 (available at 

https://www.fda.gov/media/79074/ 

download). 

3. * FDA Chemistry Memorandum from R. 

Brinas to J. Urbelis, May 11, 2022. 

4. * FDA Toxicology Memorandum from T– 

F. Cheng to J. Urbelis, May 11, 2022. 

5. * Agency for Toxic Substances and Disease 

Registry (ATSDR) ‘‘Toxicological Profile 

for Di(2-ethylhexyl) Phthalate (DEHP),’’ 

January 2022. 

6. * ‘‘NTP Technical Report on the 

Toxicology and Carcinogenesis Studies 

of Di(2-ethylhexyl) Phthalate 

Administered in Feed to Sprague Dawley 

Rats,’’ December 2021. 

7. European Food Safety Authority Panel on 

Food Contact Materials, Enzymes and 

Processing Aids, ‘‘Update of the Risk 

Assessment of Di-Butylphthalate (DBP), 

Butyl-Benzyl-Phthalate (BBP), Bis(2- 

ethylhexyl)Phthalate (DEHP), DiIsononylphthalate (DINP) and DiIsodecylphthalate (DIDP) for Use in Food 

Contact Materials,’’ European Food 

Safety Authority Journal, 17(12):5838, 

2019. 

8. Conley, J., C.S. Lambright, N. Evans, et. al., 

‘‘A Mixture of 15 Phthalates and 

Pesticides Below Individual Chemical 

No Observed Adverse Effects Levels 

(NOAELs) Produces Reproductive Tract 

Malformations in the Male Rat,’’ 

Environment International, 156:106615, 

2021. 

9. ** 2014 Organization for Economic 

Cooperation and Development (OECD) 

Guidance on Grouping of Chemicals. 

10. ** 2014 Chronic Hazard Advisory Panel 

(CHAP) on Phthalates and Phthalate 

Alternatives Final Report. 

11. Howdeshell, K., A.K. Hotchkiss, L.E. Gray 

Jr., et al., ‘‘Cumulative Effects of 

Antiandrogenic Chemical Mixtures and 

Their Relevance to Human Health Risk 

Assessment,’’ International Journal of 

Hygiene and Environmental Health 220 

(2Pt A):179, 2017. 

12. Conley, J., C.S. Lambright, N. Evans, et. 

al., ‘‘Mixed Antiandrogenic Chemicals at 

Low Individual Doses Produce 

Reproductive Tract Malformations in the 

Male Rat,’’ Toxicological Sciences 

164(1):166, 2018. 

Dated: October 22, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–25120 Filed 10–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R08–OAR–2024–0207; FRL–12341– 

01–R8] 

Air Plan Approval; Revisions to 

Colorado Common Provisions 

Regulation 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

revisions to the Common Provisions 

Regulation of the Colorado State 

Implementation Plan (SIP). These 

revisions were submitted by the State of 

Colorado in response to the EPA’s June 

12, 2015, Findings of Substantial 

Inadequacy and ‘‘SIP call’’ for certain 

provisions in the SIP related to 

affirmative defenses applicable to excess 

emissions during startup, shutdown, 

and malfunction (SSM) events. The EPA 

is proposing approval of these SIP 

revisions because the Agency has 

determined that they are in accordance 

with the requirements for SIP provisions 

under the Clean Air Act (CAA or the 

Act). 

DATES: Written comments must be 

received on or before November 29, 

2024. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R08– 

OAR–2024–0207, to the Federal 

Rulemaking Portal: https://

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Once submitted, comments cannot be 

edited or removed from https://

www.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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
86306 Federal Register / Vol. 89, No. 210 / Wednesday, October 30, 2024 / Proposed Rules 

1 ‘‘State Implementation Plans: Response to 

Petition for Rulemaking; Restatement and Update of 

EPA’s SSM Policy Applicable to SIPs; Findings of 

Substantial Inadequacy; and SIP Calls to Amend 

Provisions Applying to Excess Emissions During 

Periods of Startup, Shutdown and Malfunction.’’ 80 

FR 33840, June 12, 2015. 

2Memorandum to Regional Administrators, 

Region I–X; From: Kathleen M. Bennett, Assistant 

Administrator for Air, Noise and Radiation; Subject: 

Policy on Excess Emissions During Startup, 

Shutdown, Maintenance, and Malfunctions. 

September 28, 1982. 

3Memorandum to Regional Administrators, 

Regions I–X; From: Kathleen M. Bennett, Assistant 

Administrator for Air, Noise and Radiation; Subject: 

Policy on Excess Emissions During Startup, 

Shutdown, Maintenance, and Malfunctions. 

February 15, 1983. 

4Memorandum to Regional Administrators, 

Regions I–X; From: Steven A. Herman, Assistant 

Administrator for Enforcement and Compliance 

Assurance, and Bob Perciasepe, Assistant 

Administrator for Air and Radiation; Subject: Policy 

on Excess Emissions During Malfunctions, Startup, 

and Shutdown. September 20, 1999. 

5 79 FR 55923 (September 17, 2014). 

6 1999 SSM Guidance. 

7The Common Provisions Regulation is codified 

at 5 Colorado Code of Regulations (CCR) 1001–2 of 

the Colorado SIP. 

8 71 FR 8958 (February 22, 2006) and 73 FR 45880 

(August 7, 2008). 

9Court decisions confirmed that this requirement 

for continuous compliance prohibits exemptions for 

excess emissions during SSM events. See, e.g., 

Sierra Club v. EPA, 551 F.3d 1019, 1021 (D.C. Cir. 

2008); US Magnesium, LLC v. EPA, 690 F.3d 1157, 

1170 (10th Cir. 2012). 

10 78 FR 12480. 

11 78 FR 12480. 

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, the full 

EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

https://www2.epa.gov/dockets/ 

commenting-epa-dockets. 

Docket: All documents in the docket 

are listed in the https://

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically in 

https://www.regulations.gov. Please 

email or call the person listed in the FOR

FURTHER INFORMATION CONTACT section if 

you need to make alternative 

arrangements for access to the docket. 

FOR FURTHER INFORMATION CONTACT: 

Adam Clark, Air and Radiation 

Division, EPA, Region 8, Mailcode 

8ARD–AQ, 1595 Wynkoop Street, 

Denver, Colorado 80202–1129, 

telephone number: (303) 312–7104, 

email address: clark.adam@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

the EPA. 

I. Background 

Prior to the EPA’s 2015 SSM SIP 

Action,1 which is discussed later in this 

section, the Agency had a longstanding 

interpretation of the CAA with respect 

to the treatment of excess emissions 

during periods of SSM in SIPs. This 

statutory interpretation had been 

expressed, reiterated, and elaborated 

upon in a series of guidance documents 

issued in 1982, 1983, and 1999 

described below. 

In the 1982 SSM Guidance, the EPA 

recommended the exercise of 

enforcement discretion to address 

periods of excess emissions occurring 

during SSM events.2 Subsequently, in 

the 1983 SSM Guidance, the EPA 

expanded on this approach by 

recommending that a State could elect 

to adopt SIP provisions providing 

parameters for the exercise of 

enforcement discretion by the State’s 

personnel.3 In our 1999 SSM Guidance, 

the EPA interpreted that States could 

elect to create ‘‘affirmative defense’’ 

provisions applicable to SSM events in 

their SIPs.4 The EPA has defined the 

term affirmative defense provision as a 

State law provision in a SIP that 

specifies particular criteria or 

preconditions that, if met, would 

purport to preclude a court from 

imposing monetary penalties or other 

forms of relief for violations of SIP 

requirements in accordance with CAA 

section 113 or CAA section 304.5 Also 

in the 1999 Guidance, the EPA 

established parameters that should be 

included as part of such an affirmative 

defense in order to ensure that it would 

be available only in certain narrow 

circumstances.6 Both of the provisions 

being addressed in today’s action, 

Colorado Common Provisions 

Regulation 7 sections II.E. (applicable to 

qualifying sources during malfunctions), 

and II.J. (applicable to qualifying 

sources during periods of startup and 

shutdown) were approved by the EPA 

based on our finding that they were 

consistent with the recommendations of 

the 1999 Guidance.8

On February 22, 2013, the EPA 

proposed to take action on a petition for 

rulemaking that the Sierra Club filed 

with the EPA Administrator on June 30, 

2011 (78 FR 12460). In that action, the 

EPA proposed to grant the Petitioner’s 

claim in part. The EPA proposed to 

revise its SSM policy with respect to 

affirmative defenses for violations due 

to excess emissions that occur during 

startup and shutdown, thus rescinding 

our prior interpretation that the SSM 

policy allows for those types of 

affirmative defenses in SIPs. This was a 

change from the EPA’s interpretation of 

the CAA in the 1999 SSM Guidance, in 

which the EPA had interpreted that 

States could elect to create such 

affirmative defense provisions for 

startup and shutdown events, so long as 

the provisions were narrowly drawn 

and consistent with the established 

criteria to assure that they met CAA 

requirements. The EPA’s evaluation of 

the petition and the statutory basis for 

affirmative defense provisions initiated 

a review of the appropriateness of 

affirmative defense provisions 

applicable during startup and 

shutdown, which are ordinary modes of 

operation that are generally predictable 

and within the control of the source. As 

explained in more detail in the February 

22, 2013, proposal document, the EPA’s 

evaluation of the Sierra Club Petition in 

light of then-recent case law 9 caused 

the EPA to alter its view on the 

appropriateness of affirmative defenses 

applicable to planned events such as 

startup and shutdown. Specifically, the 

EPA stated that ‘‘because these events 

are modes of normal operation, the EPA 

believes that sources should be expected 

to comply with applicable emission 

limitations during such events.’’ 10

The EPA distinguished between 

affirmative defense provisions for 

startup and shutdown and those for 

malfunctions, stating ‘‘the distinction 

that makes affirmative defenses 

appropriate for malfunctions is that by 

definition those events are unforeseen 

and could not have been avoided by the 

owner or operator of the source, and the 

owner or operator of the source will 

have taken steps to prevent the violation 

and to minimize the effects of the 

violation after it occurs.’’ 11 Because of 

this distinction, in the February 22, 

2013 proposal, the EPA proposed to 

grant the Sierra Club’s petition with 

respect to Colorado Common Provisions 

section II.J., ‘‘Affirmative Defense 

Provision for Excess Emissions During 

Startup and Shutdown,’’ but to deny the 

Sierra Club’s petition with respect to 

Common Provisions section II.E., 

‘‘Affirmative Defense Provision for 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 210 / Wednesday, October 30, 2024 / Proposed Rules 86307 

12 78 FR 12530. 13NRDC v. EPA, 749 F.3d 1055 (D.C. Cir. 2014). 14 ‘‘State Implementation Plans: Response to 

Petition for Rulemaking; Findings of Substantial 

Inadequacy; and SIP Calls To Amend Provisions 

Applying to Excess Emissions During Periods of 

Startup, Shutdown and Malfunction; Supplemental 

Proposal To Address Affirmative Defense 

Provisions in States Included in the Petition for 

Rulemaking and in Additional States.’’ 79 FR 

55920, September 17, 2014. 

15Sierra Club et al. v. Regan, No. 21–cv–6956 

(N.D. Cal, September 8, 2021). 

16 87 FR 21118 (April 11, 2022). 

17October 9, 2020 memorandum ‘‘Inclusion of 

Provisions Governing Periods of Startup, 

Shutdown, and Malfunctions in State 

Implementation Plans,’’ from Andrew R. Wheeler, 

Administrator. The 2020 Memorandum stated that 

it ‘‘did not alter in any way the determinations 

made in the 2015 SSM SIP Action that identified 

specific State SIP provisions that were substantially 

inadequate to meet the requirements of the Act.’’ 

Accordingly, the 2020 Memorandum had no direct 

impact on the SIP call issued in 2015. 

18September 30, 2021, memorandum 

‘‘Withdrawal of the October 9, 2020, Memorandum 

Addressing Startup, Shutdown, and Malfunctions 

in State Implementation Plans and Implementation 

of the Prior Policy,’’ from Janet McCabe, Deputy 

Administrator. 

19See Environ. Comm. Fl. Elec. Power v. EPA, 94 

F.4th 77, 115 (D.C. Cir. 2024). 

20See 40 CFR 52.1392(i)(1). 

Excess Emissions During 

Malfunctions.’’ 12

Subsequent to the EPA’s issuance of 

the February 22, 2013 proposal, on 

April 18, 2014, the U.S. Court of 

Appeals for the District of Columbia 

Circuit ruled that CAA sections 113 and 

304 preclude the EPA the authority to 

create affirmative defense provisions in 

the Agency’s own regulations imposing 

emission limits on sources, because 

such provisions purport to alter the 

jurisdiction of Federal courts to assess 

liability and impose penalties for 

violations of those limits in private civil 

enforcement cases.13 In light of this 

decision, on September 17, 2014, the 

EPA issued a supplemental proposed 

rulemaking which outlined our updated 

policy that affirmative defense SIP 

provisions, even if they are narrowly 

tailored and applicable only to 

malfunctions, are not consistent with 

CAA requirements. Accordingly, the 

EPA proposed to grant the portion of the 

Sierra Club’s petition with regard to 

affirmative defenses in the case of 

malfunctions that it had previously 

proposed to deny, including Colorado 

Common Provisions section II.E.14 In 

that supplemental proposal, the EPA 

stated that the reasoning of the court in 

that decision indicates that the States, 

like the EPA, have no authority in SIP 

provisions to alter the statutory 

jurisdiction of Federal courts under 

CAA section 113 and 304 to assess 

penalties for violations of CAA 

requirements through affirmative 

defense provisions. We additionally 

noted that if States lack authority under 

the CAA to alter the jurisdiction of the 

Federal courts through affirmative 

defense provisions in SIPs, then the 

EPA also lacks authority to approve any 

such provision in a SIP. (Id. at 79 FR 

55929). 

On June 12, 2015, pursuant to CAA 

section 110(k)(5), the EPA finalized 

‘‘State Implementation Plans: Response 

to Petition for Rulemaking; Restatement 

and Update of EPA’s SSM Policy 

Applicable to SIPs; Findings of 

Substantial Inadequacy; and SIP Calls to 

Amend Provisions Applying to Excess 

Emissions During Periods of Startup, 

Shutdown and Malfunction,’’ (80 FR 

33839, June 12, 2015), hereafter referred 

to as the ‘‘2015 SSM SIP Action.’’ The 

2015 SSM SIP Action clarified, restated, 

and updated the EPA’s interpretation 

that SSM exemptions and affirmative 

defense SIP provisions are inconsistent 

with CAA requirements. The 2015 SSM 

SIP Action found that certain SIP 

provisions in 36 States, including 

Colorado, were substantially inadequate 

to meet CAA requirements and issued a 

SIP call to those States to submit SIP 

revisions to address these inadequacies. 

The EPA established an 18-month 

deadline by which the affected States 

had to submit such SIP revisions. With 

regard to the Colorado SIP, in the 2015 

SSM SIP Action, the EPA determined 

that two affirmative defense provisions 

in the Colorado SIP (Common 

Provisions Regulation sections II.E. and 

II.J.) were substantially inadequate to 

meet CAA requirements (80 FR 33840, 

33970). 

On November 21, 2016, Colorado 

submitted SIP revisions to Common 

Provisions Regulation sections II.E. and 

II.J. in response to the SIP call issued in 

the 2015 SSM SIP Action, which did not 

include removal of the affirmative 

defense provisions. On September 8, 

2021, Plaintiffs Sierra Club, 

Environmental Integrity Project, and 

Natural Resources Defense Council 

(collectively, Plaintiffs) filed a 

complaint in the United States District 

Court for the Northern District of 

California, Oakland Division, alleging 

that the EPA had failed to, among other 

things, take final rulemaking action on 

Colorado’s November 21, 2016 SIP 

submission.15 The EPA established a 

consent decree with the Plaintiffs which 

required the EPA to take final action on 

the Colorado November 21, 2016 

submission by May 31, 2023, unless 

Colorado withdrew the submission.16

On May 31, 2023, Colorado withdrew 

the November 21, 2016, submission. As 

discussed further below, Colorado 

submitted new revisions to Common 

Provisions Regulation sections II.E. and 

II.J. on June 26, 2023. 

The EPA issued a Memorandum in 

October 2020 (2020 Memorandum), 

which stated that certain provisions 

governing SSM periods in SIPs, 

including affirmative defense 

provisions, could be viewed as 

consistent with CAA requirements.17

However, on September 30, 2021, the 

EPA’s Deputy Administrator withdrew 

the 2020 Memorandum and announced 

the EPA’s return to the policy 

articulated in the 2015 SSM SIP Action 

(2021 Memorandum).18 As articulated 

in the 2021 Memorandum, SIP 

provisions that contain exemptions or 

affirmative defense provisions are not 

consistent with CAA requirements and, 

therefore, generally are not approvable if 

contained in a SIP submission. 

On March 1, 2024, the D.C. Circuit 

Court of Appeals issued a decision in 

Environ. Comm. Fl. Elec. Power v. EPA, 

94 F.4th 77, 115 (D.C. Cir. 2024). The 

case was a consolidated set of petitions 

for review of the 2015 SSM SIP Action. 

The Court granted the petitions in part, 

vacating the SIP call with respect to SIP 

provisions that the EPA identified as 

automatic exemptions, director’s 

discretion provisions, and affirmative 

defenses that are functionally 

exemptions; and denied the petitions in 

part as to other provisions that the EPA 

identified as overbroad enforcement 

discretion provisions or affirmative 

defense provisions that would preclude 

or limit a court from imposing relief in 

the case of violations, which the Court 

also refers to as ‘‘specific relief.’’ This is 

juxtaposed against the Court’s granting 

of the petition as to affirmative defenses 

that are functionally exemptions 

because they ‘‘create an exemption from 

the normal emission rule.’’ 19 The EPA 

finds that the affirmative defense 

provision in the 2008 Billings/Laurel 

SO2 FIP to be ‘‘specific relief’’ as 

interpreted by the Court, as the 

provision specifically states that an 

owner or operator ‘‘may assert an 

affirmative defense to a claim for civil 

penalties for exceedances of such limits 

during periods of malfunction, startup, 

or shutdown,’’ and ‘‘to establish the 

affirmative defense and to be relieved of 

a civil penalty in any action to enforce 

such a limit, the owner or operator of 

the facility must meet the notification 

requirements of paragraph (i)(2) of this 

section in a timely manner and prove by 

a preponderance of evidence. . .’’ 20

The EPA has assessed the impact of the 

decision with respect to our proposed 

approval of Colorado’s removal of the 

specific affirmative defense provisions 


ddrumheller on DSK120RN23PROD with PROPOSALS1
86308 Federal Register / Vol. 89, No. 210 / Wednesday, October 30, 2024 / Proposed Rules 

21 80 FR 33840, 33970 (June 12, 2015) and 79 FR 

55920, 55946 (September 17, 2014). 

22Environ. Comm. Fl. Elec. Power v. EPA, 94 

F.4th 77, 114–115 (D.C. Cir. 2024). 

at issue in the State’s June 26, 2023, 

submission. We have concluded that the 

previously stated reasons for the 

inappropriateness of affirmative defense 

provisions like Common Provisions 

sections II.E. and II.J., as articulated in 

the 2015 SSM SIP Action and 2021 

Memorandum, are consistent with the 

recent D.C. Circuit decision, as these are 

affirmative defense provisions against 

specific relief.21 The Court upheld the 

EPA’s 2015 SSM SIP Action with regard 

to affirmative defenses against specific 

relief, finding that because CAA 304(a) 

and 113(b) authorize citizens and the 

EPA to seek injunctive relief and 

monetary penalties against sources that 

violate a SIP’s emission rules, such an 

affirmative defense would ‘‘block that 

aspect of the Act’s enforcement 

regime.’’ 22

On June 26, 2023, Colorado 

submitted, among other revisions to the 

Colorado SIP that will be addressed in 

a separate rulemaking action, revisions 

to sections II.E. and II.J. of the Common 

Provisions Regulation which removed 

these rules from the Colorado SIP by 

making them State-only and therefore 

not federally enforceable under the 

CAA. The June 26, 2023, revision to 

sections II.E. and II.J. of the Common 

Provisions Regulation was submitted in 

response to the SIP call in the 2015 SSM 

SIP Action, and it is this SIP revision 

that the EPA is proposing to approve 

with today’s action. 

II. Analysis of SIP Submission 

As discussed in detail in the 2015 

SSM SIP Action, affirmative defense 

provisions like those in the Colorado 

SIP at sections II.E. and II.J. of the 

Common Provisions Regulation are 

inconsistent with CAA requirements. 

The EPA is proposing to find that the 

portion of Colorado’s June 26, 2023, SIP 

submission removing these provisions 

from the SIP by making them State-only 

is consistent with CAA requirements 

and that it adequately addresses the 

specific deficiencies that the EPA 

identified in the 2015 SSM SIP Action 

with respect to the Colorado SIP. 

III. Proposed Action 

The EPA is proposing to approve the 

portion of Colorado’s June 26, 2023, SIP 

submission revising the Colorado SIP by 

removing Common Provisions 

Regulation sections II.E. and II.J. from 

the SIP by making them State-only. We 

are proposing approval of the SIP 

revisions because we have determined 

that they are consistent with the 

requirements for SIP provisions under 

the CAA. The EPA is further proposing 

to determine that finalizing such SIP 

revisions would correct the deficiencies 

identified in the 2015 SSM SIP Action. 

The EPA is not reopening the 2015 SSM 

SIP Action and is only taking comment 

on whether these SIP revisions are 

consistent with CAA requirements and 

whether they address the ‘‘substantial 

inadequacy’’ of the specific Colorado 

SIP provisions identified in the 2015 

SSM SIP Action. 

IV. Incorporation by Reference 

In this action, we are proposing to 

include in a final rule regulatory text 

that includes incorporation by 

reference. In accordance with the 

requirements of 1 CFR 51.5 the EPA is 

proposing to incorporate by reference 

the revisions that would designate them 

as State-only, and thus remove from ‘‘5 

CCR 1001–02, Common Provisions 

Regulation’’ of the Colorado SIP, 

sections II.E., ‘‘Affirmative Defense 

Provision for Excess Emissions During 

Malfunctions,’’ and II.J., ‘‘Affirmative 

Defense Provision for Excess Emissions 

During Startup and Shutdown,’’ as 

described in section III. of this 

preamble. The EPA has made, and will 

continue to make, these documents 

generally available electronically 

through https://www.regulations.gov 

and in hard copy at the EPA Region 8 

office. 

V. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

Act and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, the 

EPA’s role is to approve State choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely proposes to approve State law as 

meeting Federal requirements and does 

not impose additional requirements 

beyond those imposed by State law. 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.); 

• 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 approves a State program; 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• 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 CAA; and 

In addition, the SIP is not approved 

to apply on any Indian reservation land 

or in any other area where EPA or an 

Indian Tribe has demonstrated that a 

Tribe has jurisdiction. In those areas of 

Indian country, the proposed 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, 

Feb. 16, 1994) directs Federal agencies 

to identify and address 

‘‘disproportionately high and adverse 

human health or environmental effects’’ 

of their actions on minority populations 

and low-income populations to the 

greatest extent practicable and 

permitted by law. The EPA defines 

environmental justice (EJ) as ‘‘the fair 

treatment and meaningful involvement 

of all people regardless of race, color, 

national origin, or income with respect 

to the development, implementation, 

and enforcement of environmental laws, 

regulations, and policies.’’ The EPA 

further defines the term fair treatment to 

mean that ‘‘no group of people should 

bear a disproportionate burden of 

environmental harms and risks, 

including those resulting from the 

negative environmental consequences of 

industrial, governmental, and 

commercial operations or programs and 

policies.’’ 

Colorado 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 proposed 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 210 / Wednesday, October 30, 2024 / Proposed Rules 86309 

action. Due to the nature of the action 

being proposed here, this action is 

expected to have a neutral to positive 

impact on the air quality of the affected 

area. Consideration of EJ is not required 

as part of this proposed action, and 

there is no information in the record 

inconsistent with the stated goal of E.O. 

12898 of achieving EJ for people of 

color, low-income populations, and 

Indigenous peoples. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Greenhouse gases, Incorporation by 

reference, Intergovernmental relations, 

Lead, Nitrogen dioxide, Ozone, 

Particulate matter, Reporting and 

recordkeeping requirements, Sulfur 

oxides, Volatile organic compounds. 

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

Dated: October 22, 2024. 

K.C. Becker, 

Regional Administrator, Region 8. 

[FR Doc. 2024–25228 Filed 10–29–24; 8:45 am] 

BILLING CODE 6560–50–P 


ddrumheller on DSK120RN23PROD with PROPOSALS1