[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Proposed Rules]
[Pages 6466-6473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01923]


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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.

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[[Page 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: [email protected]. 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: 
[email protected].

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 in-
person 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 pre-registered speaker has testified if there are no 
additional speakers. The EPA will announce further details at https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission.
    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-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission or 
contact the public hearing team at (888) 372-8699 or by email at 
[email protected]. 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 pre-registered speakers in 
approximate order at: https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-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 [email protected]. 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-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission. 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 pre-register 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-

[[Page 6468]]

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

[[Page 6469]]

    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
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         Source category                NESHAP          NAICS Code \1\
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Miscellaneous Organic Chemical    40 CFR part 63,     3251, 3252, 3253,
 Manufacturing.                    subpart FFFF.       3254, 3255, 3256,
                                                       and 3259, with
                                                       several
                                                       exceptions.
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\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-chemical-manufacturing-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.
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    \1\ Residual 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.
    \2\ U.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).
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    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)

[[Page 6470]]

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 dose-response 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.
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    \3\ U.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-quality-guidelines-requests-correction-and-requests-reconsideration#18003 and in the docket for this rulemaking (see 
Docket ID No. EPA-HQ-OAR-2018-0746).
    \4\ American 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-quality-guidelines-requests-correction-and-requests-reconsideration#18003 and in the docket for this rulemaking (see 
Docket ID No. EPA-HQ-OAR-2018-0746).
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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.
---------------------------------------------------------------------------

    \5\ U.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).
    \6\ U.S. EPA. Process for Developing IRIS Health Assessments. 
Integrated Risk Information System (IRIS). https://www.epa.gov/iris/basic-information-about-integrated-risk-information-system#process.
---------------------------------------------------------------------------

    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

[[Page 6471]]

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\
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    \7\ The age-adjusted inhalation URE for ethylene oxide is 0.005 
per [micro]g/m\3\. The URE is the upper-bound additional lifetime 
cancer risk estimated to result from continuous (24 hours/day) 
lifetime (70 years) exposure to ethylene oxide at a concentration of 
1 [micro]g/m\3\ in air. Because ethylene oxide is mutagenic (i.e., 
damages DNA), an age-dependent adjustment factor was applied to 
account for childhood exposures.
    \8\ Summary 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-OAR-2018-0746-0200.
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    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 dose-response 
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.
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    \9\ Residual 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.
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    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
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    \10\ U.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).
    \11\ Summary 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-OAR-2018-0746-0200.
    \12\ Residual 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.
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    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.
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    \13\ SAB. 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/4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-
007-unsigned.pdf and in the docket for this rulemaking (see Docket 
ID No. EPA-HQ-OAR-2018-0746).
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    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.
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    \14\ Summary 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-OAR-2018-0746-0200.
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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.
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    \15\ Summary 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-OAR-2018-0746-0200.
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    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

[[Page 6472]]

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 Valdez-
Flores (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 Valdez-Flores (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.
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    \16\ TCEQ's age-adjusted URE is 2.3 x 10-6 per 
[micro]g/m\3\.
    \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.
    \18\ Summary 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-OAR-2018-0746-0200.
    \19\ U.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-quality-guidelines-requests-correction-and-requests-reconsideration#18003 and in the docket for this rulemaking (see 
Docket ID No. EPA-HQ-OAR-2018-0746).
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    The questions of the appropriate dose-response 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 low-
exposure 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.
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    \20\ SAB. (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/
368203f97a15308a852574ba005bbd01/5D661BC118B527A3852573B80068C97B/
$File/EPA-SAB-08-004-unsigned.pdf and in the docket for this 
rulemaking (see Docket ID No. EPA-HQ-OAR-2018-0746).
    \21\ SAB. (2015). Science Advisory Board Review of the EPA's 
Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide: 
Revised external review draft--August 2014 [EPA Report]. (EPA-SAB-
15-012). Washington, DC: U.S. EPA, SAB. Available at: https://
yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/
BD2B2DB4F84146A585257E9A0070E655/$File/EPA-SAB-15-012+unsigned.pdf 
and in the docket for this rulemaking (see Docket ID No. EPA-HQ-OAR-
2018-0746).
    \22\ The Akaike information criterion (AIC) is a mathematical 
model for evaluating how well a model fits the underlying dataset 
from which it was generated.
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    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.
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    \23\ U.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).
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    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

[[Page 6473]]

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/laws-regulations/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