6466 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 

(3) Whether the specialty of a 

provider is included in the most recent 

staffing shortage determination by VA 

under 38 U.S.C. 7412. 

(4) Whether the covered facility is in 

the local community of a VA facility 

that has been designated by VA as an 

underserved facility pursuant to criteria 

developed under section 401 of Public 

Law 115–182. 

(5) Whether the covered facility is 

located in a community that is 

designated by the Secretary of Health 

and Human Services as a health 

professional shortage area under 42 

U.S.C. 254e. 

(6) Whether the covered facility is in 

a rural or remote area, where: 

(i) A rural area means an area 

identified by the U.S. Census Bureau as 

rural; and 

(ii) A remote area means an area 

within a zip-code designated as a 

frontier and remote area (FAR) code by 

the Economic Research Service within 

the United States Department of 

Agriculture, based on the most recent 

decennial census and to include all 

identified FAR code levels. 

(7) Such other criteria as VA 

considers important in determining 

those covered facilities that are not 

adequately serving area veterans. These 

factors may include but are not limited 

to: 

(i) Proximity of a non-VA covered 

facility to a VA health care facility, such 

that residents placed in non-VA covered 

facilities may also receive training in 

VA health care facilities. 

(ii) Programmatic considerations 

related to establishing or maintaining a 

sustainable residency program, such as: 

Whether the stated objectives of a 

residency program align with VA’s 

workforce needs; the likely or known 

available educational infrastructure of a 

new residency program or existing 

residency program (including the ability 

to attract and retain qualified teaching 

faculty); and the ability of the residency 

program to remain financially 

sustainable after the cessation of 

funding that VA may furnish under 

§ 17.248. 

(b) Priority in placements. For the 

duration in which the PPGMER is 

administered, no fewer than 100 

residents will be placed in covered 

facilities operated by either the Indian 

Health Service, an Indian tribe, a tribal 

organization, or covered facilities 

located in the same areas as VA 

facilities designated by VA as 

underserved pursuant to criteria 

developed under section 401 of Public 

Law 115–182. 

§ 17.247 Determination process for 

placement of residents. 

Section 403 of Public Law 115–182 

does not authorize a grant program or 

cooperative agreement program through 

which covered facilities or any other 

entity may apply for residents to be 

placed in covered facilities or to apply 

for VA to pay or reimburse costs under 

§ 17.248. VA therefore will not conduct 

a public solicitation to determine those 

covered facilities in which residents 

may be placed or to determine costs that 

may be paid or reimbursed under 

§ 17.248. VA will instead determine 

those covered facilities in which 

residents may be placed and determine 

any costs to be paid or reimbursed 

under § 17.248 in accordance with the 

following parameters: 

(a) VA Central Office will issue a 

request for proposal (RFP) to VA health 

care facilities to announce opportunities 

for residents to be placed in covered 

facilities and to have costs paid or 

reimbursed under § 17.248. This RFP 

will describe, at a minimum: 

(1) Consideration factors to include 

the criteria in § 17.246, that will be used 

to evaluate any responses to the RFP, as 

well as the relative importance of such 

consideration factors; 

(2) Information required to be in any 

responses to the RFP; and 

(3) The process to submit a response 

to the RFP. 

(b) VA health care facilities, in 

collaboration with covered facilities, 

will submit responses to the RFP to VA 

Central Office. 

(c) Consistent with paragraph (a) of 

this section, VA Central Office will 

evaluate responses to the RFP from VA 

health care facilities and will determine 

those covered facilities where residents 

may be placed and costs under § 17.248 

are paid or reimbursed. 

§ 17.248 Costs of placing residents and 

new residency programs. 

Once VA determines in which 

covered facilities residents will be 

placed in accordance with §§ 17.246 

through 17.247, payment or 

reimbursement is authorized for the 

following costs: 

(a) Resident stipends and benefits. For 

residents placed in covered facilities, 

VA may pay only the proportionate cost 

of resident stipends and benefits that are 

associated with residents participating 

in educational activities directly related 

to the PPGMER, in accordance with any 

contract, agreement, or other 

arrangement VA has legal authority to 

form. 

(b) Costs associated with new 

residency programs. (1) If a covered 

facility establishes a new residency 

program in which a resident is placed, 

VA will reimburse the following costs in 

accordance with any contract, 

agreement, or other arrangement VA has 

legal authority to form. 

(i) Curriculum development costs, to 

include but not be limited to costs 

associated with needs analysis, didactic 

activities, materials, equipment, 

consultant fees, and instructional 

design. 

(ii) Recruitment and retention of 

faculty costs, to include but not be 

limited to costs associated with 

advertising available faculty positions, 

and monetary incentives to fill such 

positions such as relocation costs and 

educational loan repayment. 

(iii) Accreditation costs, to include 

but not be limited to the administrative 

fees incurred by a covered facility in 

association with applying for only 

initial accreditation of the program by 

the Accreditation Council for Graduate 

Medical Education (ACGME). 

(iv) Faculty salary costs, to include 

only the proportionate cost of faculty 

performing duties directly related to the 

PPGMER. 

(v) Resident education expense costs, 

to include but not be limited to costs 

associated with the required purchase of 

medical equipment and required 

training, national resident match 

program participation fees, and 

residency program management 

software fees. 

(2) VA considers new residency 

programs as only those residency 

programs that have initial ACGME 

accreditation or have continued ACGME 

accreditation without outcomes, and 

have not graduated an inaugural class, 

at the time VA has determined those 

covered facilities where residents will 

be placed under § 17.247(c). 

[FR Doc. 2022–02292 Filed 2–3–22; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[EPA–HQ–OAR–2018–0746; FRL–6494.1– 

01–OAR] 

RIN 2060–AV54 

Reconsideration of the 2020 National 

Emission Standards for Hazardous Air 

Pollutants: Miscellaneous Organic 

Chemical Manufacturing Residual Risk 

and Technology Review 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule; reconsideration 

of final rule. 


lotter on DSK11XQN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 6467 

SUMMARY: On August 12, 2020, the U.S. 

Environmental Protection Agency (EPA) 

published the final National Emission 

Standards for Hazardous Air Pollutants 

(NESHAP): Miscellaneous Organic 

Chemical Manufacturing Residual Risk 

and Technology Review. Subsequently, 

the Agency received and granted 

petitions for reconsideration on two 

issues, specifically, the use of the EPA’s 

2016 Integrated Risk Information 

System (IRIS) value for ethylene oxide 

in assessing cancer risk for the source 

category and the use of the Texas 

Commission on Environmental Quality 

(TCEQ) risk value for ethylene oxide as 

an alternative risk value to the EPA’s 

IRIS value. Here, the EPA is addressing 

these two issues and is also requesting 

public comment. The EPA is seeking 

comment only on the two identified 

petition issues. The EPA will not 

respond to comments addressing any 

other issues or any other provisions of 

the final rule. 

DATES: 

Comments. Comments must be 

received on or before March 24, 2022. 

Public hearing: If anyone contacts us 

requesting a public hearing on or before 

February 9, 2022, we will hold a virtual 

public hearing. See SUPPLEMENTARY

INFORMATION for information on 

requesting and registering for a public 

hearing. 

ADDRESSES: You may send comments, 

identified by Docket ID No. EPA–HQ– 

OAR–2018–0746, by any of the 

following methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov/ (our 

preferred method). Follow the online 

instructions for submitting comments. 

• Email: a-and-r-docket@epa.gov. 

Include Docket ID No. EPA–HQ–OAR– 

2018–0746 in the subject line of the 

message. 

• Fax: (202) 566–9744. Attention 

Docket ID No. EPA–HQ–OAR–2018– 

0746. 

• Mail: U.S. Environmental 

Protection Agency, EPA Docket Center, 

Docket ID No. EPA–HQ–OAR–2018– 

0746, Mail Code 28221T, 1200 

Pennsylvania Avenue NW, Washington, 

DC 20460. 

• Hand/Courier Delivery: EPA Docket 

Center, WJC West Building, Room 3334, 

1301 Constitution Avenue NW, 

Washington, DC 20004. The Docket 

Center’s hours of operation are 8:30 

a.m.–4:30 p.m., Monday–Friday (except 

Federal holidays). 

Instructions: All submissions received 

must include the Docket ID No. for this 

rulemaking. Comments received may be 

posted without change to https://

www.regulations.gov/, including any 

personal information provided. For 

detailed instructions on sending 

comments and additional information 

on the rulemaking process, see the 

SUPPLEMENTARY INFORMATION section of 

this document. Out of an abundance of 

caution for members of the public and 

our staff, the EPA Docket Center and 

Reading Room are open to the public by 

appointment only to reduce the risk of 

transmitting COVID–19. Our Docket 

Center staff also continues to provide 

remote customer service via email, 

phone, and webform. Hand deliveries 

and couriers may be received by 

scheduled appointment only. For 

further information on EPA Docket 

Center services and the current status, 

please visit us online at https://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

questions about this proposed action, 

contact Ms. Tegan Lavoie, Sector 

Policies and Programs Division (E–143– 

01), Office of Air Quality Planning and 

Standards, U.S. Environmental 

Protection Agency, Research Triangle 

Park, North Carolina 27711; telephone 

number: (919) 541–5110; and email 

address: lavoie.tegan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Participation in virtual public 

hearing. Please note that because of the 

current Centers for Disease Control and 

Prevention (CDC) recommendations, as 

well as state and local orders for social 

distancing to limit the spread of 

COVID–19, the EPA cannot hold inperson public meetings at this time. 

If requested, the virtual hearing will 

be held on February 22, 2022. The 

hearing will convene at 11:00 a.m. 

Eastern Time (ET) and will conclude at 

7:00 p.m. ET. The EPA may close a 

session 15 minutes after the last preregistered speaker has testified if there 

are no additional speakers. The EPA 

will announce further details at https:// 

www.epa.gov/stationary-sources-airpollution/miscellaneous-organicchemical-manufacturing-nationalemission. 

The EPA will begin pre-registering 

speakers for the hearing upon 

publication of this document in the 

Federal Register. To register to speak at 

the virtual hearing, please use the 

online registration form available at 

https://www.epa.gov/stationary-sourcesair-pollution/miscellaneous-organicchemical-manufacturing-nationalemission or contact the public hearing 

team at (888) 372–8699 or by email at 

SPPDpublichearing@epa.gov. The last 

day to pre-register to speak at the 

hearing will be February 16, 2022. Prior 

to the hearing, the EPA will post a 

general agenda that will list preregistered speakers in approximate 

order at: https://www.epa.gov/ 

stationary-sources-air-pollution/ 

miscellaneous-organic-chemicalmanufacturing-national-emission. 

The EPA will make every effort to 

follow the schedule as closely as 

possible on the day of the hearing, if 

requested, however, please plan for the 

hearings to run either ahead of schedule 

or behind schedule. 

If a hearing is requested, each 

commenter will have 5 minutes to 

provide oral testimony. The EPA 

encourages commenters to provide the 

EPA with a copy of their oral testimony 

electronically (via email) by emailing it 

to lavoie.tegan@epa.gov. The EPA also 

recommends submitting the text of your 

oral testimony as written comments to 

the rulemaking docket. 

The EPA may ask clarifying questions 

during the oral presentations but will 

not respond to the presentations at that 

time. Written statements and supporting 

information submitted during the 

comment period will be considered 

with the same weight as oral testimony 

and supporting information presented at 

the public hearing. 

Please note that any updates made to 

any aspect of the hearing, if requested, 

will be posted online at https://

www.epa.gov/stationary-sources-airpollution/miscellaneous-organicchemical-manufacturing-nationalemission. While the EPA expects the 

hearing, if requested, to go forward as 

set forth above, please monitor our 

website to determine if there are any 

updates. The EPA does not intend to 

publish a document in the Federal 

Register announcing updates. 

If you require the services of a 

translator or special accommodation 

such as audio description, please preregister for the hearing with the public 

hearing team and describe your needs 

by February 11, 2022. The EPA may not 

be able to arrange accommodations 

without advanced notice. 

Docket. The EPA has established a 

docket for this rulemaking under Docket 

ID No. EPA–HQ–OAR–2018–0746. All 

documents in the docket are listed in 

https://www.regulations.gov/. Although 

listed, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy. With the 

exception of such material, publicly 

available docket materials are available 

electronically in Regulations.gov. 

Instructions. Direct your comments to 

Docket ID No. EPA–HQ–OAR–2018– 


lotter on DSK11XQN23PROD with PROPOSALS1
6468 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 

0746. The EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available online at https:// 

www.regulations.gov/, including any 

personal information provided, unless 

the comment includes information 

claimed to be CBI or other information 

whose disclosure is restricted by statute. 

Do not submit electronically any 

information that you consider to be CBI 

or other information whose disclosure is 

restricted by statute. This type of 

information should be submitted by 

mail as discussed below. 

The EPA may publish any comment 

received to its public docket. 

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://www.epa.gov/dockets/ 

commenting-epa-dockets. 

The https://www.regulations.gov/ 

website allows you to submit your 

comment anonymously, which means 

the EPA will not know your identity or 

contact information unless you provide 

it in the body of your comment. If you 

send an email comment directly to the 

EPA without going through https://

www.regulations.gov/, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the internet. If you 

submit an electronic comment, the EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

digital storage media you submit. If the 

EPA cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, the EPA may not 

be able to consider your comment. 

Electronic files should not include 

special characters or any form of 

encryption and be free of any defects or 

viruses. For additional information 

about the EPA’s public docket, visit the 

EPA Docket Center homepage at https:// 

www.epa.gov/dockets. 

Due to public health concerns related 

to COVID–19, the Docket Center and 

Reading Room are open to the public by 

appointment only. Our Docket Center 

staff also continues to provide remote 

customer service via email, phone, and 

webform. Hand deliveries or couriers 

will be received by scheduled 

appointment only. For further 

information and updates on EPA Docket 

Center services, please visit us online at 

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

The EPA continues to carefully and 

continuously monitor information from 

the CDC, local area health departments, 

and our Federal partners so that we can 

respond rapidly as conditions change 

regarding COVID–19. 

Submitting CBI. Do not submit 

information containing CBI to the EPA 

through https://www.regulations.gov/ or 

email. Clearly mark the part or all of the 

information that you claim to be CBI. 

For CBI information on any digital 

storage media that you mail to the EPA, 

mark the outside of the digital storage 

media as CBI and then identify 

electronically within the digital storage 

media the specific information that is 

claimed as CBI. In addition to one 

complete version of the comments that 

includes information claimed as CBI, 

you must submit a copy of the 

comments that does not contain the 

information claimed as CBI directly to 

the public docket through the 

procedures outlined in Instructions 

above. If you submit any digital storage 

media that does not contain CBI, mark 

the outside of the digital storage media 

clearly that it does not contain CBI. 

Information not marked as CBI will be 

included in the public docket and the 

EPA’s electronic public docket without 

prior notice. Information marked as CBI 

will not be disclosed except in 

accordance with procedures set forth in 

40 Code of Federal Regulations (CFR) 

part 2. Send or deliver information 

identified as CBI only to the following 

address: OAQPS Document Control 

Officer (C404–02), OAQPS, U.S. 

Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711, Attention Docket ID No. EPA– 

HQ–OAR–2018–0746. Note that written 

comments containing CBI and 

submitted by mail may be delayed and 

no hand deliveries will be accepted. 

Preamble acronyms and 

abbreviations. Throughout this 

document wherever ‘‘we,’’ ‘‘us,’’ or 

‘‘our’’ is used, it is intended to refer to 

the EPA. We use multiple acronyms and 

terms in this preamble. While this list 

may not be exhaustive, to ease the 

reading of this preamble and for 

reference purposes, the EPA defines the 

following terms and acronyms here: 

ACC American Chemistry Council 

AIC Akaike Information Criterion 

ATSDR Agency for Toxic Substances and 

Disease Registry 

CAA Clean Air Act 

CBI Confidential Business Information 

CFR Code of Federal Regulations 

DSD Development Support Document 

EPA Environmental Protection Agency 

HAP hazardous air pollutant(s) 

IRIS Integrated Risk Information System 

MACT maximum achievable control 

technology 

MON Miscellaneous Organic Chemical 

Manufacturing NESHAP 

NAICS North American Industry 

Classification System 

NESHAP national emission standards for 

hazardous air pollutants 

NIOSH National Institute for Occupational 

Safety and Health 

NTTAA National Technology Transfer and 

Advancement Act 

OAQPS Office of Air Quality Planning and 

Standards 

OAR Office of Air and Radiation 

OMB Office of Management and Budget 

PRA Paperwork Reduction Act 

RFA Regulatory Flexibility Act 

RFC request for correction 

RTR residual risk and technology review 

SAB Science Advisory Board 

SSM startup, shutdown, and malfunction 

TCEQ Texas Commission on Environmental 

Quality 

UMRA Unfunded Mandates Reform Act 

URE unit risk estimate 

Organization of this document. The 

information in this preamble is 

organized as follows: 

I. General Information 

A. What is the statutory authority for the 

reconsideration action? 

B. Does this action apply to me? 

C. Where can I get a copy of this document 

and other related information? 

II. Background 

III. Reconsideration Issues and Request for 

Public Comments 

A. Use of the EPA’s IRIS Value for Ethylene 

Oxide in Assessing Cancer Risk for the 

Source Category 

B. Use of the TCEQ Risk Value for Ethylene 

Oxide in Assessing Cancer Risk for the 

Source Category 

IV. Summary of Cost, Environmental, and 

Economic Impacts 

A. What are the affected sources? 

B. What are the air quality impacts? 

C. What are the cost impacts? 

D. What are the economic impacts? 

E. What are the benefits? 

V. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

B. Paperwork Reduction Act (PRA) 

C. Regulatory Flexibility Act (RFA) 

D. Unfunded Mandates Reform Act 

(UMRA) 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 


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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 6469 

1Residual Risk Assessment for the Miscellaneous 

Organic Chemical Manufacturing Source Category 

in Support of the 2020 Risk and Technology 

Review: Final Rule, August 2020. Available at: 

https://www.regulations.gov/document/EPA-HQOAR-2018-0746-0189. 

2U.S. EPA. Evaluation of the Inhalation 

Carcinogenicity of Ethylene Oxide (CASRN 75–21– 

8) In Support of Summary Information on the 

Integrated Risk Information System (IRIS). 

December 2016. EPA/635/R–16/350Fa. Available at: 

https://cfpub.epa.gov/ncea/iris/iris_documents/ 

documents/toxreviews/1025tr.pdf and in the docket 

for this rulemaking (see Docket ID No. EPA–HQ– 

OAR–2018–0746). 

I. National Technology Transfer and 

Advancement Act (NTTAA) and 1 CFR 

Part 51 

J. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

I. General Information 

A. What is the statutory authority for the 

reconsideration action? 

The statutory authority for this action 

is provided by sections 112 and 

307(d)(7)(B) of the Clean Air Act (CAA) 

(42 U.S.C. 7412 and 7607(d)(7)(B)). 

B. Does this action apply to me? 

Regulated entities. Categories and 

entities potentially regulated by this 

action are shown in Table 1 of this 

preamble. 

TABLE 1—NESHAP AND INDUSTRIAL SOURCE CATEGORIES AFFECTED BY THIS PROPOSED ACTION

Source category NESHAP NAICS Code 1

Miscellaneous Organic Chemical Manufacturing ........ 40 CFR part 63, subpart FFFF ..... 3251, 3252, 3253, 3254, 3255, 3256, and 3259, 

with several exceptions. 

1 North American Industry Classification System. 

Table 1 of this preamble is not 

intended to be exhaustive, but rather 

provides a guide for readers regarding 

the entities that this proposed action is 

likely to affect. To determine whether 

your facility is affected, you should 

examine the applicability criteria in the 

appropriate NESHAP. If you have any 

questions regarding the applicability of 

any aspect of these NESHAP, please 

contact the person listed in the 

preceding FOR FURTHER INFORMATION

CONTACT section of this preamble. 

C. Where can I get a copy of this 

document and other related 

information? 

In addition to being available in the 

docket, an electronic copy of this action 

is available on the internet. Following 

signature by the EPA Administrator, the 

EPA will post a copy of this proposed 

action at https://www.epa.gov/ 

stationary-sources-air-pollution/ 

miscellaneous-organic-chemicalmanufacturing-national-emission. 

Following publication in the Federal 

Register, the EPA will post the Federal 

Register version of the proposal at this 

same website. 

II. Background 

On December 17, 2019, the EPA 

published a proposed rule in the 

Federal Register addressing the risk and 

technology review (RTR) for the 

Miscellaneous Organic Chemical 

Manufacturing NESHAP (MON), 40 CFR 

part 63, subpart FFFF (84 FR 69182). On 

August 12, 2020, after receiving and 

addressing public comments, the EPA 

finalized determinations pursuant to 

CAA sections 112(d)(6) and (f)(2) for the 

Miscellaneous Organic Chemical 

Manufacturing source category and 

amended the rule based on those 

determinations (85 FR 49084). The 

August 2020 final action, herein referred 

to as the ‘‘2020 MON final rule,’’ 

included amendments pursuant to the 

technology review for equipment leaks 

and heat exchange systems, and also 

amendments pursuant to the risk review 

to specifically address ethylene oxide 

emissions from storage tanks, process 

vents, and equipment leaks. In addition, 

the 2020 MON final rule corrected and 

clarified regulatory provisions related to 

emissions during periods of startup, 

shutdown, and malfunction (SSM), 

including removing general exemptions 

for periods of SSM, adding work 

practice standards for periods of SSM 

where appropriate, and clarifying 

regulatory provisions for certain vent 

control bypasses. The final action also 

added monitoring and operational 

requirements for flares that control 

ethylene oxide emissions and flares 

used to control emissions from 

processes that produce olefins and 

polyolefins, added provisions for 

electronic reporting of performance test 

results and other reports, and included 

other technical corrections to improve 

consistency and clarity. 

In the 2020 MON final rule’s risk 

assessment,1 we calculated cancer risks 

using the EPA’s IRIS inhalation unit risk 

estimate (URE) for ethylene oxide,2 and 

the risk review included a 

determination that the risks for this 

source category under the current 

Maximum Achievable Control 

Technology (MACT) provisions were 

unacceptable due to ethylene oxide 

emissions. When risks are unacceptable, 

the EPA must determine the emissions 

standards necessary to reduce risk to an 

acceptable level. As such, the EPA 

promulgated final amendments to the 

MON pursuant to CAA section 112(f)(2) 

that require control of ethylene oxide 

emissions for process vents, storage 

tanks, and equipment in ethylene oxide 

service. The 2020 MON final rule 

reduced risks to an acceptable level that 

also provides an ample margin of safety 

to protect public health. The final rule 

preamble stated that ‘‘the EPA remains 

open to new and updated scientific 

information,’’ and new dose-response 

values, such as those then being 

developed by the TCEQ (85 FR 49098). 

However, by the close of the public 

comment period for the proposed 

rulemaking (March 19, 2020), the TCEQ 

dose-response value had not yet been 

finalized and could not be considered in 

the final action. 

Following promulgation of the 2020 

MON final rule, the EPA received five 

separate petitions for reconsideration 

from four petitioners. The EPA received 

two petitions from the American 

Chemistry Council (ACC) (one petition 

dated October 2020, one dated 

December 2020), one from the TCEQ 

(dated October 2020), one from Squire 

Patton Boggs (US) LLP (submitted on 

behalf of Huntsman Petrochemical, LLC) 

(dated October 2020), and one from 

Earthjustice (submitted on behalf of 

RISE St. James, Louisiana Bucket 

Brigade, Louisiana Environmental 

Action Network, Texas Environmental 

Justice Advocacy Services (t.e.j.a.s.), Air 

Alliance Houston, Ohio Valley 

Environmental Coalition, Blue Ridge 

Environmental Defense League, Inc., 

Environmental Justice Health Alliance 

for Chemical Policy Reform, Sierra Club, 

Environmental Integrity Project, and 

Union of Concerned Scientists) (dated 

October 2020). Copies of the petitions 

are available in the docket for this 

rulemaking (see Docket ID No. EPA– 

HQ–OAR–2018–0746). 

Three petitioners (ACC, TCEQ, 

Huntsman Petrochemical, LLC) 


lotter on DSK11XQN23PROD with PROPOSALS1
6470 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 

3U.S. EPA. EPA’s Response to American 

Chemistry Council (ACC)’s Request for Correction 

to the IRIS Value for Ethylene Oxide (EtO) used in 

the National Air Toxics Assessment (NATA) in 

2018. December 13, 2021. Available at: https://

www.epa.gov/quality/epa-information-qualityguidelines-requests-correction-and-requestsreconsideration#18003 and in the docket for this 

rulemaking (see Docket ID No. EPA–HQ–OAR– 

2018–0746). 

4American Chemistry Council. Request for 

Correction under the Information Quality Act: 2014 

National Air Toxics Assessment (NATA). 

September 20, 2018. Available at: https://

www.epa.gov/quality/epa-information-qualityguidelines-requests-correction-and-requestsreconsideration#18003 and in the docket for this 

rulemaking (see Docket ID No. EPA–HQ–OAR– 

2018–0746). 

5U.S. EPA. Framework for Human Health Risk 

Assessment to Inform Decision Making. EPA/100/ 

R–14/001. April 2014. Available at https://

www.epa.gov/sites/default/files/2014-12/ 

documents/hhra-framework-final-2014.pdf and in 

the docket for this rulemaking (see Docket ID No. 

EPA–HQ–OAR–2018–0746). 

6U.S. EPA. Process for Developing IRIS Health 

Assessments. Integrated Risk Information System 

(IRIS). https://www.epa.gov/iris/basic-informationabout-integrated-risk-information-system#process. 

7The age-adjusted inhalation URE for ethylene 

oxide is 0.005 per mg/m3. The URE is the upperbound additional lifetime cancer risk estimated to 

result from continuous (24 hours/day) lifetime (70 

years) exposure to ethylene oxide at a concentration 

of 1 mg/m3 in air. Because ethylene oxide is 

mutagenic (i.e., damages DNA), an age-dependent 

adjustment factor was applied to account for 

childhood exposures. 

requested the EPA reconsider the rule to 

reassess the risk assessment for the 2020 

MON final rule using the TCEQ’s 

alternative risk value for ethylene oxide 

instead of the EPA’s 2016 IRIS value for 

ethylene oxide. These three petitioners 

further argued that the EPA’s 2016 IRIS 

value for ethylene oxide is flawed, 

citing disagreement with the 2016 IRIS 

assessment’s model selection and 

inclusion of breast cancer data. In their 

October 2020 petition, ACC argued that 

‘‘CAA Section 307(d)(7)(B) requires EPA 

to convene a reconsideration proceeding 

where (1) it was either impractical to 

raise an objection during the comment 

period or new information becomes 

available after the close of the comment 

period; and (2) such information is of 

central relevance to the outcome of the 

rule.’’ Earthjustice did not raise a 

similar issue in their petition. Two 

petitioners (ACC and Earthjustice) 

raised other issues unrelated to the use 

of the IRIS value or TCEQ value for 

assessing risk from ethylene oxide 

emissions (see Docket ID No. EPA–HQ– 

OAR–2018–0746). 

On June 22, 2021, the EPA sent letters 

to all the petitioners informing them 

that: (1) The EPA was granting 

reconsideration requests on two specific 

issues (described later in this section), 

(2) the EPA intended to issue a Federal 

Register document initiating a notice 

and comment rulemaking on the issues 

for which the Agency granted 

reconsideration, and (3) the EPA was 

continuing to review the other issues in 

the petitions for reconsideration and 

may choose to initiate reconsideration 

of additional issues in the future. Copies 

of the letters to petitioners are available 

in the docket for this rulemaking (see 

Docket ID No. EPA–HQ–OAR–2018– 

0746). 

Pursuant to CAA section 307(d)(7)(B), 

the Agency granted reconsideration of 

the following aspects of the 2020 MON 

final rule: (1) The use of the EPA’s IRIS 

value for ethylene oxide in assessing 

cancer risk for the source category, and 

(2) the use of the TCEQ risk value for 

ethylene oxide as an alternative risk 

value to the EPA’s IRIS value for 

purposes of evaluating risk under CAA 

section 112(f)(2). Reconsideration was 

granted on these two topics on the 

following bases: The TCEQ risk value 

for ethylene oxide was finalized after 

the comment period for the proposed 

MON rulemaking closed, and the 2020 

MON final rule preamble stated that the 

EPA remains open to new and updated 

scientific information, such as the TCEQ 

value; and because the risk posed by 

ethylene oxide is of central relevance to 

the EPA’s determination that the risks 

from sources in the Miscellaneous 

Organic Chemical Manufacturing source 

category remaining after imposition of 

the then-current CAA section 112(d)(2) 

MACT standards were unacceptable and 

that more stringent standards are 

required. Because the criteria for 

mandatory reconsideration under CAA 

section 307(d)(7)(B) have been satisfied, 

the Agency is publishing this proposed 

reconsideration action in the Federal 

Register and requesting public comment 

on the issues discussed in this action. 

The EPA is seeking comment only on 

the issues subject to mandatory 

reconsideration and discussed in this 

proposed rule. The Agency will not 

respond to any comments addressing 

other issues raised by petitioners related 

to the 2020 MON final rule, or the EPA’s 

December 13, 2021 response 3 to the 

Request for Correction (RFC) 4 of the 

IRIS value for ethylene oxide that was 

submitted to the EPA by petitioner ACC 

under the Information Quality Act, 

Public Law 106–554 (IQA). As 

discussed in section III.B of this 

preamble, the ACC requested correction 

of the ethylene oxide information in the 

EPA’s most recent update to the 

National Air Toxics Assessment (NATA) 

released on August 22, 2018. In the 

EPA’s response to the RFC, the EPA 

found that the RFC did not identify a 

need for correction in the 2016 ethylene 

oxide IRIS Assessment and determined 

that the inhalation URE derived in the 

2016 ethylene oxide IRIS Assessment 

was the appropriate human health value 

to use for ethylene oxide in the 2014 

NATA. The EPA’s response to the RFC 

noted that the EPA’s use of the IRIS 

value in CAA rulemakings would be 

addressed in the reconsideration of the 

2020 MON final rule, and that the 

review would include consideration of 

additional information presented in 

comments on the 2020 MON rule that 

were not included in the 2018 RFC and 

addressed in the EPA’s response to the 

RFC. As such, we are not reconsidering 

comments on the EPA’s reliance upon 

the National Institute for Occupational 

Safety and Health (NIOSH) worker 

exposure studies, selection of doseresponse models, and consideration of 

endogenous sources (i.e., what the body 

produces) of ethylene oxide that were 

previously addressed in the response to 

ACC’s RFC. 

III. Reconsideration Issues and Request 

for Public Comments 

The EPA is proposing to take 

comment on the two selected issues 

raised in the petitions for 

reconsideration as described in sections 

III.A. and III.B. below. 

A. Use of the EPA’s IRIS Value for 

Ethylene Oxide in Assessing Cancer 

Risk for the Source Category 

The EPA’s IRIS program was created 

to provide an internal Agency database 

of human health effects that may result 

from chronic exposure to chemicals 

found in the environment to which the 

public might be exposed. The IRIS 

database is intended to be used by the 

EPA’s program and regional offices in 

risk assessments to inform decision 

making.5 The development of IRIS 

values includes a robust peer-review, 

beginning with internal reviews to reach 

consensus within the Agency on the 

scientific positions, followed by 

external federal agency review, an 

opportunity for public review and 

comment, and an independent, external 

peer-review by the EPA’s Science 

Advisory Board (SAB).6 During this 

process, the EPA considers and 

responds to comments received from the 

public and the SAB, and revises the 

assessment to ensure that the best 

available science is represented. 

During development of the 2020 MON 

final rule, the EPA used the 2016 IRIS 

cancer risk value for ethylene oxide 7 in 

the risk review. The EPA received and 

responded to numerous public 

comments on the use of the IRIS value 

in the 2020 MON final rule. A summary 

of these comments and responses is 

available in the preamble of the 2020 


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8Summary of Public Comments and Responses 

for the Risk and Technology Review for 

Miscellaneous Organic Chemical Manufacturing, 

August 2020. Available at: https://

www.regulations.gov/document/EPA-HQ-OAR2018-0746-0200. 

9Residual Risk Assessment for the Miscellaneous 

Organic Chemical Manufacturing Source Category 

in Support of the 2020 Risk and Technology 

Review: Final Rule, August 2020. Available at: 

https://www.regulations.gov/document/EPA-HQOAR-2018-0746-0189. 

10U.S. EPA. Risk and Technology Review (RTR) 

Risk Assessment Methodologies: For Review by the 

EPA’s Science Advisory Board with Case Studies— 

MACT I Petroleum Refining Sources and Portland 

Cement Manufacturing, June 2009. EPA–452/R–09– 

006. Available at https://www3.epa.gov/airtoxics/ 

rrisk/rtrpg.html and in the docket for this 

rulemaking (see Docket ID No. EPA–HQ–OAR– 

2018–0746). 

11Summary of Public Comments and Responses 

for the Risk and Technology Review for 

Miscellaneous Organic Chemical Manufacturing, 

August 2020. Available at: https://

www.regulations.gov/document/EPA-HQ-OAR2018-0746-0200. 

12Residual Risk Assessment for the 

Miscellaneous Organic Chemical Manufacturing 

Source Category in Support of the 2020 Risk and 

Technology Review: Final Rule, August 2020. 

Available at: https://www.regulations.gov/ 

document/EPA-HQ-OAR-2018-0746-0189. 

13SAB. Recommendations of the SAB Risk and 

Technology Review Methods Panel are provided in 

their report, Review of EPA’s draft entitled, ‘‘Risk 

and Technology Review (RTR) Risk Assessment 

Methodologies: For Review by the EPA’s Science 

Advisory Board with Case Studies—MACT I 

Petroleum Refining Sources and Portland Cement 

Manufacturing. Available at: https://

yosemite.epa.gov/sab/sabproduct.nsf/4AB3966E263

D943A8525771F00668381/$File/EPA-SAB-10-007- 

unsigned.pdf and in the docket for this rulemaking 

(see Docket ID No. EPA–HQ–OAR–2018–0746). 

14Summary of Public Comments and Responses 

for the Risk and Technology Review for 

Miscellaneous Organic Chemical Manufacturing, 

August 2020. Available at: https://

www.regulations.gov/document/EPA-HQ-OAR2018-0746-0200. 

15Summary of Public Comments and Responses 

for the Risk and Technology Review for 

Miscellaneous Organic Chemical Manufacturing, 

August 2020. Available at: https://

www.regulations.gov/document/EPA-HQ-OAR2018-0746-0200. 

MON final rule (85 FR 49084; August 

12, 2020) and also in the ‘‘Summary of 

Public Comments and Responses for the 

Risk and Technology Review for 

Miscellaneous Organic Chemical 

Manufacturing’’ document in the docket 

for this rulemaking.8

For CAA section 112(f)(2) risk 

reviews, the EPA performs health risk 

assessments for the hazardous air 

pollutants (HAP) that are emitted from 

the source category after imposition of 

MACT standards under CAA section 

112(d)(2). Consistent with the purpose 

of the IRIS database for use by the EPA’s 

program and regional offices in risk 

assessments and the advice from the 

SAB, the ‘‘Residual Risk Assessment for 

the Miscellaneous Organic Chemical 

Manufacturing Source Category in 

Support of the 2020 Risk and 

Technology Review: Final Rule’’ in the 

docket for this rulemaking 9 described 

that the preferred source of chronic 

dose-response data is the IRIS database. 

If the EPA’s IRIS program does not have 

an up-to-date hazard and/or doseresponse assessment for a HAP, the EPA 

considers publicly available 

assessments that have been developed 

by other government agencies in a 

manner that is conceptually similar to 

the EPA’s approach. This includes 

consistency with the EPA’s risk 

assessment guidelines, incorporation of 

an independent external peer review, 

inclusion of a public review period, and 

use of the best available science with 

respect to dose-response information. 

Application of this approach 

generally results in the following 

priority order for sources of risk values 

such as an inhalation URE: (1) U.S. EPA 

IRIS, (2) Agency for Toxic Substances 

and Disease Registry (ATSDR), (3) 

California EPA, and (4) other sources. 

Documentation of this approach, as 

applied in the CAA section 112(f)(2) 

reviews, is in the EPA report titled 

‘‘Risk and Technology (RTR) Risk 

Assessment Methodologies: For Review 

by the EPA’s Science Advisory Board: 

Case Studies—MACT I Petroleum 

Refining Sources and Portland Cement 

Manufacturing’’.10 This approach is also 

documented in the risk assessment 

technical support document for each 

RTR NESHAP rulemaking and is 

included in the rulemaking docket for 

this action.11 12

This approach was presented to the 

SAB in 2009. In a May 7, 2010, memo 13

to the EPA Administrator regarding 

review of the EPA’s RTR assessment 

methodologies, the SAB panel 

supported the EPA’s approach to 

selecting dose-response chronic toxicity 

values. In the same memo, they also 

noted that: ‘‘The preferred database for 

chronic dose-response data is and 

should be the IRIS database. However, 

some chemicals of interest do not have 

IRIS values, and values for other 

chemicals have not been reviewed 

recently. The Panel urges the Agency to 

address these gaps and provide the 

resources necessary to maintain the 

updating process. Additional sources of 

data may also be considered if they have 

undergone adequate and rigorous 

scientific peer review.’’ Id. at 5. 

In the 2020 MON final rule, the EPA 

followed this documented approach in 

selecting the 2016 EPA IRIS value for 

ethylene oxide for use in the risk 

review. We have carefully reviewed the 

three petitioners’ comments that the 

2016 IRIS value for ethylene oxide 

should not have been used, but after 

careful consideration of the issues 

raised, we have determined that these 

petitioners have not identified a basis 

for changing our approach to the risk 

assessment in the 2020 MON final rule. 

The substantive arguments raised by 

these petitioners regarding the 2016 IRIS 

value have been addressed in the EPA’s 

response to the RFC, in the 2020 MON 

final rule’s preamble (85 FR 49084; 

August 12, 2020), and in the response to 

comment document 14 for the 2020 

MON final rule; beyond these alleged 

flaws in the 2016 IRIS value, these 

petitioners have presented no new 

arguments for why the EPA should not 

follow the documented approach for 

selecting risk values. The EPA proposes 

to not change its decision to use the IRIS 

inhalation URE for ethylene oxide in the 

2020 MON final rule. Consequently, the 

EPA is proposing no changes to our risk 

assessment for the 2020 MON final rule. 

B. Use of the TCEQ Risk Value for 

Ethylene Oxide in Assessing Cancer 

Risk for the Source Category 

During development of the 2020 MON 

final rule, the EPA received and 

responded to numerous public 

comments related to the use of the 

TCEQ’s risk value for ethylene oxide as 

an alternative to the EPA’s IRIS value in 

the 2020 MON risk assessment. TCEQ 

submitted its draft Development 

Support Document (DSD), which 

included the dose-response analysis 

underlying TCEQ’s draft cancer risk 

value, as a comment during the 2020 

MON rulemaking’s comment period. 

Because the TCEQ risk value was not 

final until after the close of the 

comment period, the EPA did not 

directly assess the draft DSD from TCEQ 

in our final rule; however, the EPA 

received and addressed public 

comments from other groups (e.g., ACC) 

that included the same analytical 

approaches utilized by TCEQ. A 

summary of these comments and 

responses is available in the 2020 MON 

final rule’s preamble (85 FR 49084; 

August 12, 2020) and in the response to 

comment document 15 for the 2020 

MON final rule. In this action, the EPA 

reaffirms those responses in support of 

its decision to use the IRIS inhalation 

URE in the 2020 MON final rule. 

As part of this proposed 

reconsideration of the 2020 MON final 

rule, the EPA reviewed the final TCEQ 

ethylene oxide DSD, which TCEQ 

referenced in its petition for 

reconsideration, including the assertion 

that the final DSD contained ‘‘additional 

scientific analyses’’. Based on this 

review, we have determined that TCEQ 


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6472 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 

16TCEQ’s age-adjusted URE is 2.3 × 10¥6 per mg/ 

m3. 

17 Valdez-Flores C, Sielken RL Jr, Teta MJ. 2010. 

Quantitative cancer risk assessment based on 

NIOSH and UCC epidemiological data for workers 

exposed to ethylene oxide. Regul Toxicol 

Pharmacol, 56(3): 312–20. 

18Summary of Public Comments and Responses 

for the Risk and Technology Review for 

Miscellaneous Organic Chemical Manufacturing, 

August 2020. Available at: https://

www.regulations.gov/document/EPA-HQ-OAR2018-0746-0200. 

19U.S. EPA. EPA’s Response to American 

Chemistry Council (ACC)’s Request for Correction 

to the IRIS Value for Ethylene Oxide (EtO) used in 

the National Air Toxics Assessment (NATA) in 

2018. December 13, 2021. Available at: https://

www.epa.gov/quality/epa-information-qualityguidelines-requests-correction-and-requestsreconsideration#18003 and in the docket for this 

rulemaking (see Docket ID No. EPA–HQ–OAR– 

2018–0746). 

20SAB. (2007). Science Advisory Board Review of 

Office of Research and Development (ORD) draft 

assessment entitled, ‘‘Evaluation of the 

Carcinogenicity of Ethylene Oxide’’ [EPA Report]. 

(EPA–SAB–08–004). Washington, DC: U.S. EPA, 

SAB. Available at: http://yosemite.epa.gov/sab/ 

sabproduct.nsf/368203f97a15308a852574ba

005bbd01/5D661BC118B527A3852573

B80068C97B/$File/EPA-SAB-08-004-unsigned.pdf 

and in the docket for this rulemaking (see Docket 

ID No. EPA–HQ–OAR–2018–0746). 

21SAB. (2015). Science Advisory Board Review of 

the EPA’s Evaluation of the Inhalation 

Carcinogenicity of Ethylene Oxide: Revised external 

review draft—August 2014 [EPA Report]. (EPA– 

SAB–15–012). Washington, DC: U.S. EPA, SAB. 

Available at: https://yosemite.epa.gov/sab/ 

sabproduct.nsf/fedrgstr_activites/BD2B2DB4F84146

A585257E9A0070E655/$File/EPA-SAB-15- 

012+unsigned.pdf and in the docket for this 

rulemaking (see Docket ID No. EPA–HQ–OAR– 

2018–0746). 

22The Akaike information criterion (AIC) is a 

mathematical model for evaluating how well a 

model fits the underlying dataset from which it was 

generated. 

23U.S. EPA. Evaluation of the Inhalation 

Carcinogenicity of Ethylene Oxide (CASRN 75–21– 

8) In Support of Summary Information on the 

Integrated Risk Information System (IRIS). 

December 2016. EPA/635/R–16/350Fa. Available at: 

https://cfpub.epa.gov/ncea/iris/iris_documents/ 

documents/toxreviews/1025tr.pdf and in the docket 

for this rulemaking (see Docket ID No. EPA–HQ– 

OAR–2018–0746). 

did not submit new data for the EPA’s 

consideration that would cause us to 

use the final TCEQ cancer risk value 

instead of the IRIS cancer risk value for 

the MON risk review. Rather, TCEQ has 

pursued a different approach to 

analyzing the same NIOSH occupational 

exposure dataset that is the basis of the 

2016 IRIS cancer risk value. 

By using this approach, TCEQ 

estimated a risk value for ethylene oxide 

that is 2000-fold lower than that of the 

IRIS risk value.16 TCEQ’s analytical 

approach (i.e., modeling mortality using 

a Cox proportional hazards model) 

closely mirrors the approach by ValdezFlores (2010) 17 previously presented by 

other public commenters in the 2020 

MON final rule, and which the EPA 

addressed in both its response to 

comments document 18 and its 

December 13, 2021 response 19 to the 

ACC’s 2018 RFC regarding the EPA’s 

use of the IRIS value for ethylene oxide. 

In addition to pursuing an analytical 

approach similar to that used by ValdezFlores (2010), TCEQ went a step further 

and excluded women from their 

analysis. This exclusion included all 

lymphoid cancers in women, as well as 

the exclusion of breast cancer as an 

endpoint. Although modeling cancer 

mortality (instead of cancer incidence, 

which the EPA modeled) and excluding 

women from the lymphoid cancer 

analysis impacted the final URE value, 

the 2000-fold difference in the IRIS 

versus TCEQ risk values is driven 

primarily by two major differences: (1) 

TCEQ selected a different statistical 

model to represent the occupational 

exposure data; and (2) TCEQ excluded 

breast cancer from the derivation of a 

cancer risk value based on the claim 

that there is insufficient weight of 

evidence that ethylene oxide exposure 

causes breast cancer. 

The questions of the appropriate doseresponse model to use to evaluate the 

risk of ethylene oxide and the strength 

of the evidence linking ethylene oxide 

exposure to breast cancer were 

addressed in the 2016 ethylene oxide 

IRIS assessment. These questions were 

raised again in comments on the 2020 

MON final rule and responded to in 

both the preamble (85 FR 49084; August 

12, 2020) and associated response to 

comments document 18 for the 2020 

MON final rule. Briefly, these responses 

note that the EPA’s 2016 IRIS risk value 

for ethylene oxide is based on a 

statistical model selected to best 

represent the available data on cancers 

in workers exposed to ethylene oxide. 

This model, a two-piece linear spline 

model, was selected after extensive 

review by the EPA and the SAB. The 

Agency and the SAB 20 21 carefully 

considered and evaluated multiple 

alternative models, including a Cox 

proportional hazards regression model 

similar to that used by TCEQ. In its 

response to the SAB’s 

recommendations, the EPA noted: ‘‘The 

EPA has followed the SAB’s 

recommendations for model selection. 

Model selection for both the breast 

cancer incidence (see section 4.1.2.3) 

and lymphoid cancer (see section 

4.1.1.2) data prioritizes functional forms 

that allow more local fits in the lowexposure range (e.g., spline models), 

relies less on AIC, 22 and includes 

consideration of biological plausibility 

. . .’’ (IRIS, 2016, Appendix I, p. I–3). 

As such, in the 2016 ethylene oxide IRIS 

assessment, the EPA selected a model 

that best represented potential general 

population exposures, making it align 

well with the purpose of the risk 

assessment in the 2020 MON final rule, 

which sought to assess general risk 

exposure to the public. 

Additionally, the EPA considered the 

weight of evidence regarding the risk of 

breast cancer from exposure to ethylene 

oxide in the IRIS process. In the 2016 

IRIS ethylene oxide assessment, the EPA 

determined that the available 

epidemiological evidence for a causal 

relationship between ethylene oxide 

exposure and breast cancer was strong, 

and there were sufficient data to include 

breast cancer in the derivation of the 

URE. The SAB supported this 

determination. Comments on the 

evidence for breast cancer as an 

endpoint following ethylene oxide 

exposure were also addressed during 

the review process for the IRIS ethylene 

oxide assessment. For example, in 

response to a public comment on the 

IRIS 2013 draft claiming that the 

evidence for breast cancer is too weak 

to rely on in setting the URE, the EPA 

responded: 

‘‘Although the epidemiological 

database for breast cancer is more 

limited (i.e., few studies with sufficient 

numbers of female breast cancer cases) 

than that for lymphohematopoietic 

cancers, the EPA determined that the 

available evidence is sufficient to 

consider breast cancer a potential 

hazard from ethylene oxide exposure 

. . .The 2007 SAB panel did not object 

to the derivation of unit risk estimates 

based on the available breast cancer 

evidence.’’ (IRIS, 2016, Appendix K, p. 

K–3).23 The IRIS cancer risk value is 

representative of potential health risks 

to the general population because it 

reflects the combined cancer risk of 

developing lymphoid cancers in all 

people, and breast cancer in women. 

After careful consideration of the 

TCEQ DSD and material provided in the 

petitions for reconsideration that 

requested the EPA use TCEQ’s final 

cancer risk value, the EPA is proposing 

to determine that the TCEQ assessment 

and the petitions for reconsideration do 

not provide a scientifically supportable 

basis for relying on the URE developed 

by TCEQ to assess the residual risk for 

sources in the 2020 MON final rule. No 

new studies or other information have 

been identified by TCEQ or the 

petitioners requesting reconsideration 

that would call into question the 

conclusions in the 2016 IRIS ethylene 

oxide assessment or suggest that TCEQ’s 

URE provides a better estimate of the 

risk of exposure from ethylene oxide. 

The 2016 ethylene oxide IRIS 


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assessment remains the best available 

science, and the EPA proposes to 

reaffirm its decision to use the IRIS 

inhalation URE in the 2020 MON final 

rule. 

IV. Summary of Cost, Environmental, 

and Economic Impacts 

A. What are the affected sources? 

We estimate that, as of November 6, 

2018, there were 201 MON facilities, 

nine of which reported ethylene oxide 

emissions to the 2014 National 

Emissions Inventory. However, as the 

EPA is not proposing any changes to the 

regulatory text or regulatory 

requirements in this action, we do not 

anticipate that any sources will be 

affected by this reconsideration. A 

complete list of known MON facilities is 

available in Appendix 1 of the 

document, Residual Risk Assessment for 

the Miscellaneous Organic Chemical 

Manufacturing Source Category in 

Support of the 2019 Risk and 

Technology Review Proposed Rule, 

which is available in the docket for this 

rulemaking (see Docket Item No. EPA– 

HQ–OAR–2018–0746–0011). 

B. What are the air quality impacts? 

The EPA does not project any air 

quality impacts associated with this 

action because this action does not 

propose any changes to the standards or 

other requirements on affected sources. 

C. What are the cost impacts? 

The EPA does not project any 

incremental costs associated with this 

action because it does not propose any 

changes to the standards or other 

requirements on affected sources. 

D. What are the economic impacts? 

The EPA does not project any 

economic impacts because there are no 

incremental costs associated with this 

action. 

E. What are the benefits? 

The EPA does not project any 

incremental benefits associated with 

this action because it does not propose 

any changes to the standards or other 

requirements on affected sources. 

V. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive Orders can be 

found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is not a significant 

regulatory action and was therefore not 

submitted to the Office of Management 

and Budget (OMB) for review. 

B. Paperwork Reduction Act (PRA) 

This action does not impose an 

information collection burden under the 

PRA. 

C. Regulatory Flexibility Act (RFA) 

I certify that this action will not have 

a significant economic impact on a 

substantial number of small entities 

under the RFA. In making this 

determination, the EPA concludes that 

the impact of concern for this rule is any 

significant adverse economic impact on 

small entities and that the Agency is 

certifying that this rule will not have a 

significant economic impact on a 

substantial number of small entities if 

the rule has no net burden on the small 

entities subject to the rule. As we are 

not proposing any changes to the 

regulatory text or regulatory 

requirements, we do not anticipate any 

economic impacts resulting from this 

action. We have therefore concluded 

that this action will have no net 

regulatory burden for all directly 

regulated small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain any 

unfunded mandate as described in 

UMRA, 2 U.S.C. 1531–1538, and does 

not significantly or uniquely affect small 

governments. The action proposes no 

enforceable duty on any state, local or 

tribal governments or the private sector. 

E. Executive Order 13132: Federalism 

This action does not have federalism 

implications. It will 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. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications as specified in Executive 

Order 13175. None of the MON facilities 

that have been identified as being 

affected by this action are owned or 

operated by tribal governments or 

located within tribal lands within a 10 

mile radius. Thus, Executive Order 

13175 does not apply to this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This action is not subject to Executive 

Order 13045 because it is not 

economically significant as defined in 

Executive Order 12866, and because this 

action does not present any changes to 

the rule that would affect environmental 

health or safety risks, including those 

that would present a disproportionate 

risk to children. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211, because it is not a 

significant regulatory action under 

Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) and 1 CFR 

Part 51 

This rulemaking does not involve 

technical standards. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes that this action is 

not subject to Executive Order 12898 (59 

FR 7629, February 16, 1994) because it 

does not establish an environmental 

health or safety standard. This 

regulatory action acts to clarify the 

language in the preamble of a previously 

promulgated regulatory action and does 

not have any impact on human health 

or the environment. 

Michael S. Regan, 

Administrator. 

[FR Doc. 2022–01923 Filed 2–3–22; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 22–39; RM–11917; DA 22– 

87; FR ID 69837] 

Television Broadcasting Services 

Billings, Montana 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The Federal Communication 

Commission (Commission) has before it 

a petition for rulemaking filed by 

Scripps Broadcasting Holdings LCC 

(Petitioner), the licensee of WTVQ–TV, 

channel 10, Billings, Montana. The 


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