Rule2024-05905
National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review
Primary source
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Published
April 5, 2024
Effective
April 5, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This action finalizes the residual risk and technology review (RTR) conducted for the Commercial Sterilization Facilities source category regulated under national emission standards for hazardous air pollutants (NESHAP) under the Clean Air Act. The EPA is finalizing decisions concerning the RTR, including definitions for affected sources, emission standards for previously unregulated sources, amendments pursuant to the risk review to address ethylene oxide (EtO) emissions from certain sterilization chamber vents (SCVs), aeration room vents (ARVs), chamber exhaust vents (CEVs), and room air emissions, and amendments pursuant to the technology review for certain SCVs and ARVs. In addition, we are taking final action to correct and clarify regulatory provisions related to emissions during periods of startup, shutdown, and malfunction (SSM), including removing exemptions for periods of SSM. We are also taking final action to require owners and operators to demonstrate compliance through the use of EtO continuous emissions monitoring systems (CEMS), with exceptions for very small users of EtO; add provisions for electronic reporting of performance test results and other reports; and include other technical revisions to improve consistency and clarity. We estimate that these final amendments will reduce EtO emissions from this source category by approximately 21 tons per year (tpy).
Full Text
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[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Rules and Regulations]
[Pages 24090-24203]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05905]
[[Page 24089]]
Vol. 89
Friday,
No. 67
April 5, 2024
Part II
Environmental Protection Agency
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40 CFR Parts 60 and 63
National Emission Standards for Hazardous Air Pollutants: Ethylene
Oxide Emissions Standards for Sterilization Facilities Residual Risk
and Technology Review; Final Rule
Federal Register / Vol. 89 , No. 67 / Friday, April 5, 2024 / Rules
and Regulations
[[Page 24090]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 60 and 63
[EPA-HQ-OAR-2019-0178; FRL-7055-02-OAR]
RIN 2060-AU37
National Emission Standards for Hazardous Air Pollutants:
Ethylene Oxide Emissions Standards for Sterilization Facilities
Residual Risk and Technology Review
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This action finalizes the residual risk and technology review
(RTR) conducted for the Commercial Sterilization Facilities source
category regulated under national emission standards for hazardous air
pollutants (NESHAP) under the Clean Air Act. The EPA is finalizing
decisions concerning the RTR, including definitions for affected
sources, emission standards for previously unregulated sources,
amendments pursuant to the risk review to address ethylene oxide (EtO)
emissions from certain sterilization chamber vents (SCVs), aeration
room vents (ARVs), chamber exhaust vents (CEVs), and room air
emissions, and amendments pursuant to the technology review for certain
SCVs and ARVs. In addition, we are taking final action to correct and
clarify regulatory provisions related to emissions during periods of
startup, shutdown, and malfunction (SSM), including removing exemptions
for periods of SSM. We are also taking final action to require owners
and operators to demonstrate compliance through the use of EtO
continuous emissions monitoring systems (CEMS), with exceptions for
very small users of EtO; add provisions for electronic reporting of
performance test results and other reports; and include other technical
revisions to improve consistency and clarity. We estimate that these
final amendments will reduce EtO emissions from this source category by
approximately 21 tons per year (tpy).
DATES: This final rule is effective on April 5, 2024. The incorporation
by reference (IBR) of certain material listed in the rule is approved
by the Director of the Federal Register April 5, 2024. The
incorporation by reference (IBR) of certain other material listed in
the rule was approved by the Director of the Federal Register before
February 27, 2021.
ADDRESSES: The U.S. Environmental Protection Agency (EPA) has
established a docket for this action under Docket ID No. EPA-HQ-OAR-
2019-0178. All documents in the docket are listed on the <a href="https://www.regulations.gov/">https://www.regulations.gov/</a> website. Although listed, some information is not
publicly available, e.g., Confidential Business Information 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 form. Publicly
available docket materials are available either electronically through
<a href="https://www.regulations.gov/">https://www.regulations.gov/</a>, or in hard copy at the EPA Docket Center,
WJC West Building, Room Number 3334, 1301 Constitution Ave. NW,
Washington, DC. The Public Reading Room hours of operation are 8:30
a.m. to 4:30 p.m. Eastern Standard Time (EST), Monday through Friday.
The telephone number for the Public Reading Room is (202) 566-1744, and
the telephone number for the EPA Docket Center is (202) 566-1742.
FOR FURTHER INFORMATION CONTACT: For questions about this final action,
contact U.S. EPA, Attn: Jonathan Witt, Mail Drop: E143-05, 109 T.W.
Alexander Drive, P.O. Box 12055, RTP, North Carolina 27711; telephone
number: (919) 541-5645; and email address: <a href="/cdn-cgi/l/email-protection#25524c51510b4f4a4b654055440b424a53"><span class="__cf_email__" data-cfemail="dcabb5a8a8f2b6b3b29cb9acbdf2bbb3aa">[email protected]</span></a>. For
specific information regarding the risk modeling methodology, contact
U.S. EPA, Attn: Matthew Woody, Mail Drop: C539-02, 109 T.W. Alexander
Drive, P.O. Box 12055, RTP, North Carolina 27711; telephone number:
(919) 541-1535; and email address: <a href="/cdn-cgi/l/email-protection#4a3d25252e3364272b3e3e0a2f3a2b642d253c"><span class="__cf_email__" data-cfemail="a6d1c9c9c2df88cbc7d2d2e6c3d6c788c1c9d0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Preamble acronyms and abbreviations. 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:
ADAF age-dependent adjustment factor
AEGL acute exposure guideline level
APCD air pollution control device
ARV aeration room vent
ASME American Society of Mechanical Engineers
BTF Beyond-the-Floor
BMP best management practice
CAA Clean Air Act
CDX Central Data Exchange
CEDRI Compliance and Emissions Data Reporting Interface
CEMS continuous emission monitoring system
CEV chamber exhaust vent
CFR Code of Federal Regulations
cfs cubic feet per second
dscfm dry standard cubic feet per minute
EJ environmental justice
EPA Environmental Protection Agency
ERT Electronic Reporting Tool
EtO ethylene oxide
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FR Federal Register
FRFA final regulatory flexibility analysis
FTIR Fourier Transform Infrared Spectroscopy
GACT generally available control technology
HAP hazardous air pollutants(s)
HEM Human Exposure Model
HQ hazard quotient
ICR Information Collection Request
ID Interim Decision
IFU instructions for use
IRFA initial regulatory flexibility analysis
IRIS Integrated Risk Information System
ISO International Organization for Standardization
km kilometer
lb pound
lb/h pounds per hour
LEL lower explosive limit
LPL lower prediction limit
MACT maximum achievable control technology
MIR maximum individual risk
mg/L milligrams per liter
NAICS North American Industry Classification System
NDO natural draft opening
NESHAP national emission standards for hazardous air pollutants
OMB Office of Management and Budget
OPP Office of Pesticide Programs
OSHA Occupational Safety and Health Administration
PID Proposed Interim Decision
ppbv parts per billion by volume
ppm parts per million
ppmv parts per million by volume
PTE permanent total enclosure
REL reference exposure level
RDL Representative detection level
RFA Regulatory Flexibility Act
RIA regulatory impact assessment
RTR risk and technology review
SAB Science Advisory Board
SBA Small Business Administration
SBAR Small Business Advocacy Review
SCV sterilization chamber vent
SER small entity representative
SSM startup, shutdown, and malfunction
TOSHI target organ-specific hazard index
tpy tons per year
UPL upper prediction limit
[micro]g/m\3\ micrograms per cubic meter
UMRA Unfunded Mandates Reform Act
URE unit risk estimate
VCS voluntary consensus standards
Background information. On April 13, 2023, the EPA proposed
revisions to the Commercial Sterilization Facilities NESHAP based on
our RTR. In this action, we are finalizing decisions and revisions for
the rule. We summarize some of the more significant comments we timely
received regarding the proposed rule and provide our responses in this
preamble. A summary of all other public comments on the proposal and
the EPA's responses to
[[Page 24091]]
those comments is available in Summary of Public Comments and Responses
for the Risk and Technology Review for Commercial Sterilization
Facilities, Docket ID No. EPA-HQ-OAR-2019-0178. A ``track changes''
version of the regulatory language that incorporates the changes in
this action is available in the docket.
Organization of this document. The information in this preamble is
organized as follows:
I. General Information
A. Executive Summary
B. Does this action apply to me?
C. Where can I get a copy of this document and other related
information?
D. Judicial Review and Administrative Reconsideration
II. Background
A. What is the statutory authority for this action?
B. What is the Commercial Sterilization Facilities source
category and how does the NESHAP regulate HAP emissions from the
source category?
C. What changes did we propose for the Commercial Sterilization
Facilities source category in our April 13, 2023, RTR proposal?
III. What is included in this final rule?
A. What are the final rule amendments addressing the affected
source definitions?
B. What are the final rule amendments pursuant to CAA sections
112(d)(2), 112(d)(3), and 112(d)(5) for the Commercial Sterilization
Facilities source category?
C. What are the final rule amendments based on the risk review
for the Commercial Sterilization Facilities source category?
D. What are the final rule amendments based on the technology
review for the Commercial Sterilization Facilities source category?
E. What are the final rule amendments addressing emissions
during periods of startup, shutdown, and malfunction?
F. What other changes have been made to the NESHAP?
G. What are the effective and compliance dates of the standards?
IV. What is the rationale for our final decisions and amendments for
the Commercial Sterilization Facilities source category?
A. Amendments Addressing the Affected Source Definitions
B. Amendments Pursuant to CAA sections 112(d)(2), 112(d)(3), and
112(d)(5) for the Commercial Sterilization Facilities Source
Category
C. Residual Risk Review for the Commercial Sterilization
Facilities Source Category
D. Technology Review for the Commercial Sterilization Facilities
Source Category
E. Amendments Addressing Emissions During Periods of SSM
F. Other Amendments to the Standards
V. Summary of Cost, Environmental, and Economic Impacts and
Additional Analyses Conducted
A. What are the affected facilities?
B. What are the air quality impacts?
C. What are the cost impacts?
D. What are the economic impacts?
E. What are the benefits?
F. What analysis of environmental justice did we conduct?
VI. Statutory and Executive Order Reviews
A. Executive Orders 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
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 and Executive Order 14096: Revitalizing Our Nation's
Commitment to Environmental Justice for All
K. Congressional Review Act (CRA)
I. General Information
A. Executive Summary
1. Purpose of the Regulatory Action
Exercising authority under multiple provisions of section 112 of
the Clean Air Act (CAA), we are finalizing revisions to the NESHAP for
Commercial Sterilization Facilities (40 CFR part 63, subpart O) by both
amending the current standards and establishing standards for
previously unregulated emissions within this source category. First, we
are finalizing emission standards under CAA sections 112(d)(2)-(3) and
(d)(5) for previously unregulated emission sources of EtO. Second, we
are finalizing risk-based standards under CAA section 112(f)(2) to
protect public health with an ample margin of safety. Third, we are
finalizing emission standards under CAA section 112(d)(6) based on our
review of developments in practices, processes, and control
technologies for this source category.
This final rulemaking reflects the EtO toxicological assessment
that EPA's Integrated Risk Information System (IRIS) Program completed
in December 2016,\1\ which indicated that EtO is a far more potent
carcinogen than we had understood when the RTR for this source category
was conducted in 2006. There are 88 commercial sterilization facilities
in this source category, many of which are located near residences,
schools, and other public facilities. Many of these facilities are also
located in communities with environmental justice (EJ) concerns. We
have determined that approximately 23 of these facilities pose high
lifetime cancer risks to the surrounding communities, and some
facilities pose exceptionally high risks that are among some of the
highest for a CAA section 112(f)(2) risk assessment. Throughout this
rulemaking process, we have engaged in outreach activities to these
communities, along with their State and local governments, to discuss
their concerns, along with the need and potential solutions for
reducing emissions and increasing transparency on exposure and
potential impacts to communities, which this final rule will achieve.
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\1\ Evaluation of the Inhalation Carcinogenicity of Ethylene
Oxide, December 2016, EPA/635/R-16/350Fc.
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This important action will reduce EtO emissions and lifetime cancer
risks in multiple communities across the country, including communities
with EJ concerns, and it updates our standards using proven and cost-
effective control technologies that are already in use at some
facilities in this source category. The protections offered by these
standards will be especially important for children. In addition, this
rule will advance the President's Cancer Moonshot,\2\ by preventing
cancer before it starts. Recognizing that we now have additional
information about the health risks of EtO that was not available at the
time of the 2006 RTR, and in order to ensure that our standards for
this source category adequately protect public health, we have
conducted a second residual risk review under CAA section 112(f)(2), as
discussed in section I.A.3 of this preamble.
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\2\ <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2023/09/13/fact-sheet-as-part-of-president-bidens-unity-agenda-white-house-cancer-moonshot-announces-new-actions-and-commitments-to-end-cancer-as-we-know-it/">https://www.whitehouse.gov/briefing-room/statements-releases/2023/09/13/fact-sheet-as-part-of-president-bidens-unity-agenda-white-house-cancer-moonshot-announces-new-actions-and-commitments-to-end-cancer-as-we-know-it/</a>.
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In deciding to conduct this second residual risk review, we
considered the health effects of EtO exposure, the impacts to
surrounding communities, the advantages of EtO reductions, and the
distribution of those reductions consistent with the clear goal of CAA
section 112(f)(2) to protect the most exposed and susceptible
populations. While commercial sterilizers provide a critical benefit
for the health of all, protecting people who live near commercial
sterilization facilities from the disproportionate risk of being
significantly harmed by toxic air
[[Page 24092]]
pollution is also a core responsibility for the EPA under the CAA.
At the same time, we recognize that commercial sterilization
facilities play a vital role in maintaining an adequate supply of
sterilized medical devices for public health needs in the U.S.
According to the U.S. Food and Drug Administration (FDA), ``Literature
shows that about fifty percent of all sterile medical devices in the
U.S. are sterilized with ethylene oxide.'' FDA also notes that, ``For
many medical devices, sterilization with ethylene oxide may be the only
method that effectively sterilizes and does not damage the device
during the sterilization process.'' \3\ In developing this final rule,
therefore, we carefully considered the important function these
facilities serve, drawing from extensive engagement with industry
stakeholders as well as Federal agencies with expertise in and
responsibility for the medical device supply chain.
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\3\ <a href="https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices">https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices</a>.
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To ensure our actions with respect to this source category are
based on the most accurate and complete information possible, we have
had many interactions with the EtO commercial sterilization industry in
recent years, including meetings, requests for information, and
outreach specific to this final rulemaking. This has enabled us to work
from the best possible information when conducting the analyses to
support this final rulemaking, including the current configuration of
facilities and the performance of control technologies that are
currently used.
We have engaged with the U.S. Department of Health and Human
Services, particularly FDA, regarding the potential impacts of this
final rule on commercial facilities that sterilize medical devices.
These discussions have focused on identifying and discussing any
concerns regarding the potential impact on the availability of certain
medical devices that are sterilized with EtO, in cases where
alternative sterilization methods are not readily available, in
particular, devices that are (1) experiencing or at risk of
experiencing a shortage, (2) intended to provide life-supporting, life-
sustaining care or that is intended for use in emergency medical care
or during surgery, (3) used in pediatric services, and/or (4)
sterilized exclusively at a particular facility.
Mindful of the vital role that commercial sterilizers play in
supplying the nation with sterile medical devices, and the core
objective of protecting public health under CAA section 112, the EPA
has carefully evaluated the feasibility and cost of compliance with
this rule, and potential implications for the medical device supply
chain.\4\ The EPA notes that a number of the facilities covered by this
final rule have already implemented one or more of the controls that
will be needed for compliance. Moreover, the EPA's own experience
working with facility owners, as well as State and local agencies that
have regulated EtO emissions from these facilities, confirms that it is
feasible for individual facilities to install the required controls
well within the deadlines provided in this rule, and for multiple
facilities to do so simultaneously.
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\4\ For more information, see the document Regulatory Impact
Analysis for the Final National Emission Standards for Hazardous Air
Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation
Operations, available in the docket for this rulemaking.
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In addition, as a result of the comments received, as well as the
EPA's consultation with FDA and other Federal partners, the final rule
incorporates several key changes from the proposed rule, including
modifications to the format of certain standards and compliance
flexibilities. We are also providing sufficient compliance time to
enable these facilities to continue sterilizing products while
installing and testing new control systems and associated equipment
that will afford ample protection for nearby communities. These
modifications to the proposed rule are intended to facilitate cost-
effective compliance, and to avoid any impacts to the integrity of the
medical device supply chain, while ensuring that these standards reduce
cancer risks for communities exposed to EtO emissions.
Given that key industry players are already planning for
compliance, and in light of the significant changes made between the
proposal and this final rule, the EPA does not anticipate that the
implementation of these standards will have any adverse impacts on the
medical supply chain. However, as the Agency proceeds to implement this
final rule, we intend to continue to work closely with FDA, the
relevant trade associations, and facility owners to monitor the process
of planning for compliance, to proactively identify any anticipated
changes in facility operations that might implicate the medical supply
chain, and to take appropriate steps to address any such impacts. In
addition, in order to increase the resilience of the medical supply
chain, we support the development and implementation of viable, safe,
and cost-effective alternatives to EtO sterilization.
On April 13, 2023, the Office of Pesticide Programs (OPP) published
a notice announcing the availability of a proposed interim decision
(PID) as part of its periodic review of the registration of EtO under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (88 FR
22447). The PID contained a number of measures aimed at protecting
workers from excessive EtO exposure. Since the issuance of the PID, OPP
has been actively collaborating with the Office of Air and Radiation to
ensure that the requirements of the FIFRA Interim Decision (ID) do not
interfere with the requirements of this rule, and vice versa. The ID
will contain the final requirements to mitigate worker exposure to EtO,
considering the comments received on the PID. Furthermore, OPP has been
consulting regularly with other Federal agencies and with industry
trade groups, to discuss how best to harmonize the requirements of the
FIFRA ID with the requirements of this rule, and to ensure that the
operative standards, once finalized, will protect both workers and
neighboring communities from the risks of EtO exposure while mitigating
and managing any risk to the supply chain for sterile medical devices.
2. Summary of the Major Provisions of the Regulatory Action in Question
We are finalizing numeric emission limits, operating limits, and
management practices under CAA sections 112(d)(2)-(3), (d)(5), and
(d)(6) for EtO emissions from certain emission sources, and also
finalizing standards under CAA section 112(f)(2) for certain emission
sources in order to ensure that the standards provide an ample margin
of safety to protect public health.\5\
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\5\ In 1992, pursuant to CAA section 112(c)(1), we published a
list of major and area sources for regulation under CAA section 112,
including major and area sources at commercial sterilization
facilities. 57 FR 31576, 31586 (July 16, 1992). Area sources at
commercial sterilization facilities were listed for regulation under
CAA section 112(c)(3) based on our finding that they present a
threat of adverse effects to human health or the environment (by
such sources individually or in the aggregate) warranting regulation
under that section. Id. at 31586.
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For the following, previously unregulated emission sources at
commercial sterilization facilities, we are setting standards under CAA
sections 112(d)(2)-(3) or (d)(5): SCVs and ARVs at facilities where EtO
use is less than 1 tpy,\6\ ARVs at facilities where
[[Page 24093]]
EtO use is at least 1 tpy but less than 10 tpy,\7\ CEVs,\8\ and room
air emissions.\9\
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\6\ In developing the original rule, EPA considered potential
standards for SCV and ARV at area source facilities where EtO use is
less than 1 tpy but the Agency understood these sources at the time
to have low emission contributions (e.g., a facility with EtO use of
1,999 lb/yr would have roughly less than 167 lb/month of usage and
emissions, and less than 41 lb/week usage and emissions.) At the
time, EPA considered costs for monitoring, recordkeeping, and
reporting under the rule. Threshold cutoffs for area sources are at
the discretion of the Agency.
\7\ EPA considered standards for ARV and CEV at area source
facilities where EtO use is at least 1 tpy and less than 10 tpy. As
noted, the Agency understood at the time that the largest emission
source of EtO occurred from the SCV, and therefore finalized
emission reduction standards for all SCV at facilities where EtO use
is at least 1 tpy. At the time ARV sources were understood to have
low emission contributions. As noted, threshold cutoffs for area
sources are at the discretion of the Agency.
\8\ The standards for CEVs were originally promulgated on
December 6, 1994. Following promulgation of the rule, we suspended
certain compliance deadlines and ultimately removed the standards
for CEVs due to safety concerns. In the late 1990s, there were
multiple explosions at EtO commercial sterilization facilities using
oxidizers to control emissions from the CEV. For CEVs, it was
determined that the primary contributing issue leading to the
explosions was that EtO concentrations were above a safe level
(i.e., above the lower explosive limit (LEL)) within the CEV gas
streams. We could not conclude at the time that the CEVs could be
safely controlled, so the standards for CEVs were removed on
November 2, 2001 (66 FR 55583). However, as discussed in section
III.B.5 of the proposal preamble (88 FR 22790), facilities with
controlled CEVs have revised their operating procedures to address
the explosion issue by not exceeding 10 to 25 percent of the LEL. We
have, therefore, determined that CEVs can be safely controlled.
\9\ As discussed in section III.A, room air emissions include
emissions resulting from indoor EtO storage, EtO dispensing, vacuum
pump operation, pre-aeration handling of sterilized material, and
post-aeration handling of sterilized material.
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Next, based on our assessment of the residual risk after
considering the emission reductions from the previous standards in
subpart O, as well as the standards under CAA sections 112(d)(2)-(3) or
(d)(5) for the previously unregulated sources, we are finalizing more
stringent standards under CAA section 112(f)(2) to address risk at the
following types of sources:
<bullet> SCVs at facilities where EtO use is at least 30 tpy
<bullet> SCVs at facilities where EtO use is at least 10 tpy but less
than 30 tpy
<bullet> SCVs at facilities where EtO use is at least 1 tpy but less
than 10 tpy
<bullet> ARVs at facilities where EtO use is at least 30 tpy
<bullet> CEVs at area source facilities \10\ where EtO use is at least
400 tpy
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\10\ As discussed in section III.B of the proposal preamble (88
FR 22790, April 13, 2023), CAA section 112(a) defines a major source
as ``any stationary source or group of stationary sources located
within a contiguous area and under common control that emits or has
the potential to emit considering controls, in the aggregate, 10 tpy
or more of any HAP or 25 tpy or more of any combination of HAPs. .
.''. It further defines an area source as ``any stationary source of
HAPs that is not a major source''. A synthetic area source facility
is one that otherwise has the potential to emit HAPs in amounts that
are at or above those for major sources of HAP, but that has taken a
restriction so that its potential to emit is less than the threshold
amounts for major sources. Most of the EtO used at these facilities
is released through SCVs and ARVs, and subpart O contains emission
standards for these sources at facilities where EtO use is at least
10 tpy. Some State and local governments also regulate EtO emissions
from these facilities. Based on these facts, as well as our review
of the permits for these facilities, it is our understanding that
all facilities that use more than 10 tpy are synthetic area sources.
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<bullet> CEVs at area source facilities where EtO use is at least 60
but less than 400 tpy
<bullet> Group 1 room air emissions \11\ at area source facilities
where EtO use is at least 40 tpy
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\11\ As discussed in section III.A, Group 1 room air emissions
cover indoor EtO storage, EtO dispensing, vacuum pump operation, and
pre-aeration handling of sterilized material.
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<bullet> Group 2 room air emissions \12\ at area source facilities
where EtO use is at least 20 tpy
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\12\ As discussed in section III.A, Group 2 room air emissions
cover post-aeration handling of sterilized material.
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<bullet> Group 2 room air emissions at area source facilities where EtO
use is at least 4 tpy but less than 20 tpy
Finally, under CAA section 112(d)(6), we are revising current
standards for the following sources that were regulated in the previous
40 CFR part 63, subpart O:
<bullet> SCVs at facilities where EtO use is at least 10 tpy
<bullet> SCVs at facilities where EtO use is at least 1 tpy but less
than 10 tpy
<bullet> ARVs at facilities where EtO use is at least 10 tpy
Table 1 summarizes the final CAA section 112(d) and 112(f)(2)
standards.
Table 1--Summary of Standards After Taking Actions Pursuant to CAA Sections 112(d)(2), 112(d)(3), 112(d)(5),
112(f)(2), and 112(d)(6)
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Emission source Existing or new? EtO use Standards CAA section
----------------------------------------------------------------------------------------------------------------
SCV............................. Existing and new.. At least 30 tpy... 99.99 percent 112(f)(2).
emission
reduction.
At least 10 tpy 99.9 percent 112(f)(2).
but less than 30 emission
tpy. reduction.
At least 10 tpy... 99.9 percent 112(d)(6).
emission
reduction.
At least 1 but 99.8 percent 112(f)(2) and
less than 10 tpy. emission 112(d)(6).
reduction.
Less than 1 tpy... 99 percent 112(d)(5).
emission
reduction.
ARV............................. Existing.......... At least 30 tpy... 99.9 percent 112(f)(2).
emission
reduction.
At least 10 tpy 99.6 percent 112(f)(2).
but less than 30 emission
tpy. reduction.
At least 10 tpy... 99.6 percent 112(d)(6).
emission
reduction.
At least 1 but 99 percent 112(d)(5).
less than 10 tpy. emission
reduction.
Less than 1 tpy... 99 percent 112(d)(5).
emission
reduction.
New............... At least 30 tpy... 99.9 percent 112(f)(2).
emission
reduction.
At least 10 tpy... 99.9 percent 112(d)(6).
emission
reduction.
At least 1 but 99 percent 112(d)(5).
less than 10 tpy. emission
reduction.
Less than 1 tpy... 99 percent 112(d)(5).
emission
reduction.
CEVs at major source facilities. Existing and new.. N/A............... 99.94 percent 112(d)(2) and
emission 112(d)(3).
reduction \1\.
CEVs at area source facilities.. Existing and new.. At least 400 tpy.. 99.9 percent 112(f)(2).
emission
reduction.
At least 60 but 99.9 percent 112(f)(2).
less than 400 tpy. emission
reduction.
Less than 60 tpy.. 99 percent 112(d)(5).
emission
reduction.
Group 1 room air emissions at Existing and new.. N/A............... 97 percent 112(d)(2) and
major sources. emission 112(d)(3).
reduction 2 3.
Group 1 room air emissions at Existing and new.. At least 40 tpy... 98 percent 112(f)(2).
area sources. emission
reduction \3\.
Less than 40 tpy.. 80 percent 112(d)(5).
emission
reduction \3\.
[[Page 24094]]
Group 2 room air emissions at Existing and new.. N/A............... 86 percent 112(d)(2) and
major sources. emission 112(d)(3).
reduction 1 3.
Group 2 room air emissions at Existing.......... At least 20 tpy... 98 percent 112(f)(2).
area sources. emission
reduction \3\.
At least 4 but 80 percent 112(f)(2).
less than 20 tpy. emission
reduction \3\.
Less than 4 tpy... Lower the EtO 112(d)(5).
concentration
within each
sterilization
chamber to 1 ppm
before the
chamber can be
opened \4\.
New............... At least 20 tpy... 98 percent 112(f)(2).
emission
reduction \3\.
At least 4 but 80 percent 112(f)(2).
less than 20 tpy. emission
reduction \3\.
Less than 4 tpy... 80 percent 112(d)(5).
emission
reduction \3\.
----------------------------------------------------------------------------------------------------------------
\1\ MACT floor.
\2\ Beyond-the-Floor (BTF) standard.
\3\ To assure compliance with the emission limit, we are requiring each facility to operate area sources with
these emissions in accordance with the PTE requirements of EPA Method 204 of appendix M to 40 CFR part 51.
\4\ Owners and operators may also apply for an alternative means of emission limitation under CAA section
112(h)(3).
To demonstrate compliance with the emission limits, we are
finalizing capture requirements. We are also finalizing a requirement
for facilities to monitor with an EtO continuous emissions monitoring
system (CEMS), with exceptions for small users.
3. EPA Authority
We note that the EPA completed a residual risk and technology
review under CAA sections 112(f)(2) and 112(d)(6), respectively, for
this source category in 2006 (71 FR 17712). While CAA section 112(f)(2)
requires only a one-time risk review, which is to be conducted within
eight years of the date the initial standards are promulgated, it does
not limit our discretion or authority to conduct another risk review
should we consider that such review is warranted. As discussed in more
detail in section IV.C of this preamble, as our understanding of the
health effects of EtO developed, we conducted a second residual risk
review under CAA section 112(f)(2) for commercial sterilization
facilities using EtO in order to ensure that the standards provide an
ample margin of safety to protect public health.
As discussed in further detail in section IV.C, this second
residual risk review also encompasses certain area sources for which we
did not evaluate residual risk in our 2006 rulemaking. Although CAA
section 112(f)(5) states that a risk review is not required for
categories of area sources subject to generally available control
technology (GACT) standards, it does not prohibit such review. In 2006,
we undertook a CAA section 112(f)(2) analysis only for area source
emissions standards that were issued as maximum achievable control
technology (MACT) standards and exercised our discretion under CAA
section 112(f)(5) not to do a CAA section 112(f)(2) analysis for those
emission points for which GACT standards were established (67 FR
17715). However, as we made clear in that prior risk assessment, ``[w]e
have the authority to revisit (and revise, if necessary) any rulemaking
if . . . significant improvements to science [suggest that] the public
is exposed to significant increases in risk as compared to the [2006
risk assessment].'' Id. In light of the updated IRIS cancer unit risk
estimate (URE) for EtO, which is approximately 60 times greater than
the value we used in our previous risk assessment, we are now
exercising our discretionary authority to conduct another CAA section
112(f)(2) analysis and to include in this analysis area source
commercial sterilizers using EtO for which we have promulgated, or have
considered, GACT standards.
Section 112(d)(6) of the CAA requires EPA to review and revise, as
necessary, standards promulgated under CAA section 112 at least every
eight years, taking into account developments in practices, processes,
and control technologies. We last completed this required technology
review for the Ethylene Oxide Commercial Sterilization NESHAP (40 CFR
63, subpart O) in 2006. Accordingly, in this final action, we are also
conducting a CAA section 112(d)(6) review of the current standards in
this source category.
4. Costs and Benefits
Table 2 of this preamble summarizes the costs of this final action
for 40 CFR part 63, subpart O (Ethylene Oxide Commercial Sterilization
NESHAP).
Table 2--Total Capital Investment and Total Annual Cost
[2021$]
----------------------------------------------------------------------------------------------------------------
Number of
facilities w/costs Total capital Total annual
Requirement associated with investment costs
new requirements
----------------------------------------------------------------------------------------------------------------
Permanent total enclosure................................... 28 $77,500,000 $8,280,000
Additional control devices.................................. 83 187,000,000 43,000,000
Monitoring and testing...................................... 89 48,100,000 19,400,000
Recordkeeping and reporting................................. \1\ 90 .............. \2\ 2,600,000
---------------------------------------------------
Total................................................... \1\ 90 313,000,000 74,000,000
----------------------------------------------------------------------------------------------------------------
\1\ This includes the 88 facilities that are currently operating, as well as two planned facilities that are
expected to start operating within the next few years.
\2\ This includes $763,000 of one-time annual costs for reading the rule and developing record systems.
[[Page 24095]]
The capital costs for permanent total enclosure (PTE) and
additional gas/solid reactors were annualized to 20 years. We estimate
that these amendments will reduce EtO emissions from this source
category by 21 tpy. Table 3 of this preamble summarizes the cancer risk
reductions that will result from the final amendments, which are
updated based on revisions made in the final rule and described in more
detail in section IV.C.2.
Table 3--Summary of Cancer Risk Reductions
----------------------------------------------------------------------------------------------------------------
Cancer risks after
Current cancer risks-- Current cancer risks-- implementation of final
actual emissions allowable emissions amendments
----------------------------------------------------------------------------------------------------------------
Maximum Individual Risk (MIR) \1\.... 6,000-in-1 million..... 8,000-in-1 million \3\. 100-in-1 million.
Number of People with Cancer Risks 19,000................. 260,000................ 0.
>100-in-1 million.
Number of People with Cancer Risks 8.5 million............ 62 million............. 700,000 to 1.4
>=1-in-1 million. million.\2\
Estimated Annual Cancer Incidence 0.9.................... 8...................... 0.1 to 0.2.\2\
(cases per year).
----------------------------------------------------------------------------------------------------------------
\1\ The MIR or maximum individual lifetime cancer risk is defined as the increase in estimated cancer risk
associated with a 70-year lifetime of continuous exposure at the highest concentration of HAP where people are
likely to live.
\2\ Ranges in values account for if all facilities were performing at the level of the standards (high end) to
considering facilities that are currently performing better than the standards (low end).
As indicated in table 3, we project that the standards in the final
rule will significantly reduce incremental lifetime cancer risks
associated with emissions of EtO from this source category. We estimate
that the current maximum increase in lifetime cancer risk associated
with any facility in this source category is 6,000-in-1 million based
on estimated actual emissions (or 8,000-in-1 million based on allowable
emissions) under the existing standards, and that approximately 19,000
people are exposed to EtO from this source category at levels that
would correspond to a lifetime cancer risk of greater than 100-in-1
million (which is our presumptive upper bound threshold for acceptable
health risks), based on actual emissions. When considering allowable
emissions, this number increases to 260,000. Under the final rule, no
individual will be exposed to EtO at levels that correspond to a
lifetime cancer risk of greater than 100-in-1 million, and the number
of people with a potential risk of greater than or equal to 1-in-1
million will be reduced by approximately 92 percent.
See section V of this preamble for further discussion of the costs
and a discussion of the benefits of the final standards. See section
IV.F of this preamble for discussion of the revisions to monitoring,
recordkeeping, reporting, and testing requirements. See section IV.C
for a discussion of the risk assessment results.
B. Does this action apply to me?
Regulated entities. Categories and entities potentially regulated
by this action are shown in table 4 of this preamble.
Table 4--NESHAP and Industrial Source Categories Affected by This Final
Action
------------------------------------------------------------------------
Industrial category NESHAP NAICS \1\ code
------------------------------------------------------------------------
Surgical and Medical Instrument 40 CFR part 63, 339112
Manufacturing. subpart O.
Surgical Appliance and Supplies 40 CFR part 63, 339113
Manufacturing. subpart O.
Pharmaceutical Preparation 40 CFR part 63, 325412
Manufacturing. subpart O.
Spice and Extract Manufacturing... 40 CFR part 63, 311942
subpart O.
Dried and Dehydrated Food 40 CFR part 63, 311423
Manufacturing. subpart O.
Packaging and Labeling Services... 40 CFR part 63, 561910
subpart O.
------------------------------------------------------------------------
\1\ North American Industry Classification System.
Table 4 of this preamble is not intended to be exhaustive, but
rather to provide a guide for readers regarding entities likely to be
affected by the final action for the source category listed. 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 this NESHAP,
please contact the appropriate 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 final action will also be available on the internet. Following
signature by the EPA Administrator, the EPA will post a copy of this
final action at: <a href="https://www.epa.gov/stationary-sources-air-pollution/ethylene-oxide-emissions-standards-sterilization-facilities">https://www.epa.gov/stationary-sources-air-pollution/ethylene-oxide-emissions-standards-sterilization-facilities</a>. Following
publication in the Federal Register, the EPA will post the Federal
Register version and key technical documents at this same website.
Additional information is available on the RTR website at <a href="https://www.epa.gov/stationary-sources-air-pollution/risk-and-technology-review-national-emissions-standards-hazardous">https://www.epa.gov/stationary-sources-air-pollution/risk-and-technology-review-national-emissions-standards-hazardous</a>. This information
includes an overview of the RTR program and links to project websites
for the RTR source categories.
D. Judicial Review and Administrative Reconsideration
Under Clean Air Act (CAA) section 307(b)(1), judicial review of
this final action is available only by filing a petition for review in
the United States Court of Appeals for the District of Columbia Circuit
(the Court) by June 4, 2024. Under CAA section 307(b)(2), the
requirements established by this final rule may not be challenged
separately in any civil or criminal proceedings brought by the EPA to
enforce the requirements.
Section 307(d)(7)(B) of the CAA further provides that only an
objection to a rule or procedure which was raised with reasonable
specificity during the period for public comment (including any public
hearing) may be raised
[[Page 24096]]
during judicial review. This section also provides a mechanism for the
EPA to reconsider the rule if the person raising an objection can
demonstrate to the Administrator that it was impracticable to raise
such objection within the period for public comment or if the grounds
for such objection arose after the period for public comment (but
within the time specified for judicial review) and if such objection is
of central relevance to the outcome of the rule. Any person seeking to
make such a demonstration should submit a Petition for Reconsideration
to the Office of the Administrator, U.S. EPA, Room 3000, WJC South
Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460, with a copy
to both the person(s) listed in the preceding FOR FURTHER INFORMATION
CONTACT section, and the Associate General Counsel for the Air and
Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S.
EPA, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
II. Background
A. What is the statutory authority for this action?
The statutory authority for this action is provided by sections 112
and 301 of the Clean Air Act (CAA), as amended (42 U.S.C. 7401 et
seq.). The discussion that follows identifies the relevant statutory
sections and briefly explains the contours of the methodology used to
implement these statutory requirements. A more comprehensive discussion
appears in the document titled CAA Section 112 Risk and Technology
Reviews: Statutory Authority and Methodology, in the docket for this
rulemaking. Section 112 of the CAA establishes a two-stage regulatory
process to address emissions of hazardous air pollutants (HAP) from
stationary sources. In the first stage, we must identify categories of
sources emitting one or more of the HAP listed in CAA section 112(b)
and then promulgate technology-based NESHAP for those sources. Sources
of HAP emissions are either major sources or area sources, and CAA
section 112 establishes different requirements for major source
standards and area source standards. ``Major sources'' are those that
emit, or have the potential to emit, any single HAP at a rate of 10
tons per year (tpy) or more, or 25 tpy or more of any combination of
HAP. All other sources are ``area sources.'' For major sources, these
standards are commonly referred to as maximum achievable control
technology (MACT) standards and must reflect the maximum degree of
emission reductions of HAP achievable (after considering cost, energy
requirements, and non-air quality health and environmental impacts). In
developing MACT standards, CAA section 112(d)(2) directs the EPA to
consider the application of measures, processes, methods, systems, or
techniques, including, but not limited to, those that reduce the volume
of or eliminate HAP emissions through process changes, substitution of
materials, or other modifications; enclose systems or processes to
eliminate emissions; collect, capture, or treat HAP when released from
a process, stack, storage, or fugitive emissions point; are design,
equipment, work practice, or operational standards; or any combination
of the above.
For these MACT standards, the statute specifies certain minimum
stringency requirements, which are referred to as MACT floor
requirements, and which may not be based on cost considerations. See
CAA section 112(d)(3). For new sources, the MACT floor cannot be less
stringent than the emission control achieved in practice by the best-
controlled similar source. The MACT standards for existing sources can
be less stringent than floors for new sources, but they cannot be less
stringent than the average emission limitation achieved by the best-
performing 12 percent of existing sources in the category or
subcategory (or the best-performing five sources for categories or
subcategories with fewer than 30 sources). In developing MACT
standards, we must also consider control options that are more
stringent than the floor under CAA section 112(d)(2). We may establish
standards more stringent than the floor, based on the consideration of
the cost of achieving the emissions reductions, any non-air quality
health and environmental impacts, and energy requirements. For area
sources, CAA section 112(d)(5) allows the EPA to set standards based on
GACT in lieu of MACT standards. For categories of major sources and any
area source categories subject to MACT standards, the second stage in
standard-setting focuses on identifying and addressing any remaining
(i.e., ``residual'') risk pursuant to CAA section 112(f). Section
112(f) specifically states that the EPA ``shall not be required'' to
conduct risk review under this subsection for categories of area
sources subject to GACT standards but does not limit the EPA's
authority or discretion from conducting such review. As discussed in
more detail in section III.C of this preamble, in light of the updated
URE regarding EtO, the EPA is choosing to exercise that discretion.
In the second stage of the regulatory process, the CAA requires the
EPA to undertake two different analyses, which we refer to as the
technology review and the residual risk review. Under the technology
review, we must review the technology-based standards and revise them
``as necessary (taking into account developments in practices,
processes, and control technologies)'' no less frequently than every 8
years, pursuant to CAA section 112(d)(6). In conducting this review,
the EPA is not required to recalculate the MACT floors that were
established in earlier rulemakings. Natural Resources Defense Council
(NRDC) v. EPA, 529 F.3d 1077, 1084 (D.C. Cir. 2008). Association of
Battery Recyclers, Inc. v. EPA, 716 F.3d 667 (D.C. Cir. 2013). The EPA
may consider cost in deciding whether to revise the standards pursuant
to CAA section 112(d)(6). The EPA is required to address regulatory
gaps, such as missing standards for listed air toxics known to be
emitted from the source category, and any new MACT standards must be
established under CAA sections 112(d)(2) and (3), or, in specific
circumstances, CAA sections 112(d)(4) or (h). Louisiana Environmental
Action Network (LEAN) v. EPA, 955 F.3d 1088 (D.C. Cir. 2020).
The residual risk review in the second stage of the regulatory
process focuses on identifying and addressing any remaining (i.e.,
``residual'') risk pursuant to CAA section 112(f). For source
categories subject to MACT standards, section 112(f)(2) of the CAA
requires the EPA to determine whether promulgation of additional
standards is needed to provide an ample margin of safety to protect
public health or to prevent an adverse environmental effect. Section
112(d)(5) of the CAA provides that this residual risk review is not
required for categories of area sources subject to GACT standards.
Section 112(f)(2)(B) of the CAA further expressly preserves the EPA's
use of the two-step approach for developing standards to address any
residual risk and the Agency's interpretation of ``ample margin of
safety'' developed in the National Emissions Standards for Hazardous
Air Pollutants: Benzene Emissions from Maleic Anhydride Plants,
Ethylbenzene/Styrene Plants, Benzene Storage Vessels, Benzene Equipment
Leaks, and Coke By-Product Recovery Plants (Benzene NESHAP) (54 FR
38044, September 14, 1989). The EPA notified Congress in the Residual
Risk Report that the Agency intended to use the Benzene NESHAP approach
in making CAA section 112(f) residual risk
[[Page 24097]]
determinations (EPA-453/R-99-001, p. ES-11). The EPA subsequently
adopted this approach in its residual risk determinations, and the
United States Court of Appeals for the District of Columbia Circuit
upheld the EPA's interpretation that CAA section 112(f)(2) incorporates
the approach established in the Benzene NESHAP. See NRDC v. EPA, 529
F.3d 1077, 1083 (D.C. Cir. 2008).
The approach incorporated into the CAA and used by the EPA to
evaluate residual risk and to develop standards under CAA section
112(f)(2) is a two-step approach. In the first step, the EPA determines
whether risks are acceptable. This determination ``considers all health
information, including risk estimation uncertainty, and includes a
presumptive limit on maximum individual lifetime [cancer] risk (MIR)
\13\ of approximately 1-in-10 thousand.'' (54 FR 38045). If risks are
unacceptable, the EPA must determine the emissions standards necessary
to reduce risk to an acceptable level without considering costs. In the
second step of the approach, the EPA considers whether the emissions
standards provide an ample margin of safety to protect public health
``in consideration of all health information, including the number of
persons at risk levels higher than approximately 1-in-1 million, as
well as other relevant factors, including costs and economic impacts,
technological feasibility, and other factors relevant to each
particular decision.'' Id. The EPA must promulgate emission standards
necessary to provide an ample margin of safety to protect public health
or determine that the standards being reviewed provide an ample margin
of safety without any revisions. After conducting the ample margin of
safety analysis, we consider whether a more stringent standard is
necessary to prevent an adverse environmental effect, taking into
consideration costs, energy, safety, and other relevant factors. For
more information on the statutory authority for this rule, see 88 FR
22790, April 13, 2023.
---------------------------------------------------------------------------
\13\ Although defined as ``maximum individual risk,'' MIR refers
only to cancer risk and reflects the estimated risk if an individual
were exposed to the maximum level of a pollutant for a 70-year
lifetime.
---------------------------------------------------------------------------
B. What is the Commercial Sterilization Facilities source category and
how does the NESHAP regulate HAP emissions from the source category?
The EPA promulgated the EtO Commercial Sterilization Facilities
NESHAP on December 6, 1994 (59 FR 62585). The standards are codified at
40 CFR part 63, subpart O. The EtO commercial sterilization industry
consists of facilities operating a sterilizer process that uses EtO to
sterilize or fumigate materials (e.g., medical equipment and supplies,
spices, and other miscellaneous products and items). The source
category covered by this MACT standard currently includes 88
facilities.
The original 1994 rulemaking for this source category set standards
for EtO emissions originating from three emission points: sterilization
chamber vents (SCV), aeration room vents (ARV), and chamber exhaust
vents (CEV). The SCV evacuates EtO from the sterilization chamber
following sterilization, fumigation, and any subsequent gas washes
before the chamber door is opened. The ARV evacuates EtO-laden air from
the aeration room or chamber that is used to facilitate off-gassing of
the sterile product and packaging. The CEV evacuates EtO-laden air from
the sterilization chamber after the chamber door is opened for product
unloading following the completion of sterilization and associated gas
washes. Other sources of emissions within this source category are room
air emissions from equipment used to charge EtO into sterilization
chambers, as well as EtO residuals desorbing from sterilized products
within the facility, but the current EtO Commercial Sterilization
NESHAP does not include standards for room air emissions.
In the chamber EtO sterilization process, items to be sterilized
are placed in a chamber and exposed to EtO gas at a predetermined
concentration, temperature, humidity, and pressure for a period of time
known as the dwell period. Following the dwell period, the EtO gas is
evacuated from the chamber, and the sterilized materials are then
aerated to remove EtO residuals from the product. After the aeration
step, sterilized materials are typically moved to a shipping/warehouse
area for storage until they are ready to be distributed to the
customer. Sterilizer process equipment and emission control
configurations vary across facilities. The most common sterilizer
process equipment configuration includes a separate sterilizer chamber,
separate aeration room, and chamber exhaust on the sterilizer chamber
(also referred to as a back-vent). Another common configuration
includes a combination sterilizer where the sterilization and aeration
steps of the process occur within the same chamber.
Another EtO sterilization process is single-item sterilization
where small individual items are sterilized in sealed pouches. EtO gas
is introduced into the sealed pouch, either by injection or use of an
EtO ampule, and the sealed pouch is then placed in a chamber where the
sterilization step and aeration step occur.
In 2006, we finalized a residual risk review and a technology
review under CAA section 112(f)(2) and CAA section 112(d)(6),
respectively (71 FR 17712, April 7, 2006). No changes were made to the
EtO Commercial Sterilization NESHAP in that action.
The current emission standards for commercial sterilization
facilities in 40 CFR part 63, subpart O are shown in table 5:
Table 5--Current EtO Standards for Commercial Sterilizers
----------------------------------------------------------------------------------------------------------------
Existing and new sources subcategory
(in any consecutive 12-month period) Sterilization chamber Aeration room vent Chamber exhaust vent
\1\ vent (SCV) (ARV) (CEV) \2\
----------------------------------------------------------------------------------------------------------------
Sources using 10 tons or more of EtO. 99 percent emission 1 part per million No control.
reduction (see 40 CFR (ppm) maximum outlet
63.362(c)). concentration or 99
percent emission
reduction (see 40 CFR
63.362(d)).
Sources using 1 ton or more of EtO 99 percent emission No control............. No control.
but less than 10 tons of EtO. reduction (see 40 CFR
63.362(c)).
Sources using less than 1 ton of EtO. No control required; No control required; No control required;
minimal recordkeeping minimal recordkeeping minimal recordkeeping
requirements apply requirements apply requirements apply
(see 40 CFR (see 40 CFR (see 40 CFR
63.367(c)).). 63.367(c)).). 63.367(c)).).
----------------------------------------------------------------------------------------------------------------
\1\ Determined on a rolling 12-month basis.
\2\ The CEV emission source was included in the original standard but was later eliminated from the 40 CFR part
63, subpart O regulation in 2001.
[[Page 24098]]
For more information on the commercial sterilization industry and
the current standards under 40 CFR part 63, subpart O, see 88 FR 22790,
April 13, 2023.
We note that hospital sterilizers are regulated under a different
NESHAP (40 CFR part 63, subpart WWWWW), which is not addressed in this
rulemaking.\14\ We are aware of the potential risk posed by EtO
emissions from this source category and will address hospital
sterilizers in a future rulemaking.
---------------------------------------------------------------------------
\14\ Hospitals are defined at 40 CFR 63.10448 to mean facilities
that provide medical care and treatment for patients who are acutely
ill or chronically ill on an inpatient basis under supervision of
licensed physicians and under nursing care offered 24 hours per day.
Hospitals include diagnostic and major surgery facilities but
exclude doctor's offices, clinics, or other facilities whose primary
purpose is to provide medical services to humans or animals on an
outpatient basis.
---------------------------------------------------------------------------
C. What changes did we propose for the Commercial Sterilization
Facilities source category in our April 13, 2023, RTR proposal?
On April 13, 2023, the EPA published a proposed rule in the Federal
Register for the EtO Commercial Sterilization NESHAP, 40 CFR part 63,
subpart O, that took into consideration the RTR analyses. In the
proposed rule, we proposed emission standards under CAA sections
112(d)(2)-(3) or (d)(5) for a number of unregulated emission sources of
EtO. We then proposed tightening certain of these proposed standards
and existing standards with risk-based standards under CAA section
112(f)(2) in order to protect public health with an ample margin of
safety. Finally, we proposed revisions to certain existing standards
under CAA section 112(d)(6) based on our review of developments in
practices, processes, and control technologies for this source
category.
For the following emission sources that were unregulated, we
proposed to set standards under CAA sections 112(d)(2)-(3) or (d)(5):
<bullet> SCVs, ARVs, and CEVs at facilities where EtO use is less
than 1 tpy,
<bullet> ARVs and CEVs at facilities where EtO use is at least 1
tpy but less than 10 tpy,
<bullet> CEVs at facilities where EtO use is at least 10 tpy, and
<bullet> Room air emissions.
Next, based on our assessment of the residual risk after
considering the emission reductions from the standards in subpart O, as
well as the proposed standards for the unregulated sources, we proposed
more stringent standards under CAA section 112(f)(2) to address risk
for the following types of sources:
<bullet> SCVs at facilities where EtO use is at least 40 tpy,
<bullet> SCVs at facilities where EtO use is at least 10 tpy but
less than 40 tpy,
<bullet> SCVs at facilities where EtO use is at least 1 tpy but
less than 10 tpy, and
<bullet> Group 2 room air emissions at area source facilities where
EtO use is at least 20 tpy.
Finally, under CAA section 112(d)(6), we proposed to revise
standards for the following sources that were regulated in the previous
40 CFR part 63, subpart O:
<bullet> SCVs at facilities where EtO use is at least 10 tpy,
<bullet> SCVs at facilities where EtO use is at least 1 tpy but
less than 10 tpy, and
<bullet> ARVs at facilities where EtO use is at least 10 tpy.
Table 6 summarizes the proposed section CAA section 112(d) and
112(f)(2) standards.
Table 6--Summary of Standards After Proposed Actions Pursuant to CAA Sections 112(d)(2), 112(d)(3), 112(d)(5),
112(f)(2), and 112(d)(6)
----------------------------------------------------------------------------------------------------------------
Emission source Existing or new? EtO use Standards CAA section
----------------------------------------------------------------------------------------------------------------
SCV............................. Existing and new.. At least 40 tpy... 99.94 percent 112(f)(2).
emission
reduction.
At least 10 tpy 99.94 percent 112(f)(2).
but less than 40 emission
tpy. reduction.
At least 10 tpy... 99.94 percent 112(d)(6).
emission
reduction.
At least 1 but 99.8 percent 112(f)(2) and
less than 10 tpy. emission 112(d)(6).
reduction.
Less than 1 tpy... 99 percent 112(d)(5).
emission
reduction.
ARV............................. Existing.......... At least 10 tpy... 99.6 percent 112(d)(6).
emission
reduction.
At least 1 but 99 percent 112(d)(5).
less than 10 tpy. emission
reduction.
Less than 1 tpy... 99 percent 112(d)(5).
emission
reduction.
New............... At least 10 tpy... 99.9 percent 112(d)(6).
emission
reduction.
At least 1 but 99 percent 112(d)(5).
less than 10 tpy. emission
reduction.
Less than 1 tpy... 99 percent 112(d)(5).
emission
reduction.
CEV............................. Existing and new.. At least 10 tpy... 3.2E-4 lb/h....... 112(d)(2) and (3).
At least 1 but 99.9 percent 112(d)(5).
less than 10 tpy. emission
reduction.
Less than 1 tpy... 99 percent 112(d)(5).
emission
reduction.
Group 1 room air emissions...... Existing and new.. N/A............... 1.3E-3 lb/h \1\... 112(d)(2) and
112(d)(3).
Group 1 room air emissions at Existing and new.. N/A............... 1.3E-3 lb/h \1\... 112(d)(5).
area sources.
Group 2 room air emissions at Existing and new.. N/A............... 2.8E-3 lb/h \1\... 112(d)(2) and
major sources. 112(d)(3).
Group 2 room air emissions at Existing.......... At least 20 tpy... 2.8E-3 lb/h \1\... 112(f)(2).
area sources. Less than 20 tpy.. Follow either the 112(d)(5).
Cycle Calculation
Approach or the
Bioburden/
Biological
Indicator
Approach to
achieve sterility
assurance in
accordance with
ISO 11135:2014
(July 15, 2014)
and ISO 11138-
1:2017 (March
2017).
[[Page 24099]]
New............... N/A............... 2.8E-3 lb/h \1\... 112(d)(5).
----------------------------------------------------------------------------------------------------------------
\1\ To assure compliance with the emission limit, we proposed requiring each facility to operate areas with
these emissions in accordance with the PTE requirements of EPA Method 204 of appendix M to 40 CFR part 51.
To demonstrate compliance with the emission limits, we proposed
capture requirements. We also proposed that facilities either monitor
with an EtO CEMS or conduct initial and annual performance tests with
continuous parameter monitoring.
We also proposed the following amendments:
<bullet> Corrections and clarifications to regulatory provisions
related to emissions during periods of SSM, including removing general
exemptions for periods of SSM and adding work practice standards for
periods of SSM where appropriate.
<bullet> Revisions to monitoring and performance testing
requirements and addition of provisions for electronic reporting of
performance test results and reports, performance evaluation reports,
and compliance reports.
<bullet> Requiring all area source facilities to obtain a title V
operating permit, and
<bullet> Compliance requirements for facilities using combined
emission streams.
III. What is included in this final rule?
This action finalizes the EPA's determinations pursuant to the RTR
provisions of CAA section 112 for the Commercial Sterilization
Facilities source category and amends the EtO Commercial Sterilization
NESHAP based on those determinations. This action also finalizes other
changes to the NESHAP, including adding requirements and clarifications
for periods of SSM; requiring the use of CEMS to demonstrate compliance
for facilities where EtO use is at least 100 pounds (lb)/year; adding
provisions for electronic reporting of performance test results and
reports, performance evaluation reports, and compliance reports; and
other minor editorial and technical changes. This action also reflects
several changes to the April 2023 proposal in consideration of comments
received during the public comment period described in section IV of
this preamble.
A. What are the final rule amendments addressing the affected source
definitions?
The previous subpart O did not contain definitions for affected
sources, which meant that the definition of an ``affected source'' at
40 CFR 63.2 applied.\15\ We did not believe that this was appropriate
because a facility may not route all emissions from a particular type
of point source to the same control system, thus making compliance
demonstration with the standards difficult. For SCVs, ARVs, and CEVs,
we are finalizing, as proposed, the affected source definition as the
individual vent. For Group 1 and Group 2 room air emissions, we are
finalizing, as proposed, the affected source definition as the
collection of all room air emissions for each group at any
sterilization facility. Group 1 room air emissions are defined as
emissions from indoor EtO storage, EtO dispensing, vacuum pump
operations, and pre-aeration handling of sterilized material. Group 2
room air emissions are defined as emissions from post-aeration handling
of sterilized material.
---------------------------------------------------------------------------
\15\ 40 CFR 63.2 defines an affected source as ``the collection
of equipment, activities, or both within a single contiguous area
and under common control that is included in a section 112(c) source
category or subcategory for which a section 112(d) standard or other
relevant standard is established pursuant to section 112 of the
Act.''
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Section IV.A.3 of this preamble provides a summary of key comments
we received on the affected source definitions and our responses.
B. What are the final rule amendments pursuant to CAA sections
112(d)(2), 112(d)(3), and 112(d)(5) for the Commercial Sterilization
Facilities source category?
We are finalizing EtO emissions standards pursuant to CAA sections
112(d)(2)-(3) and 112(d)(5) for major and area sources that were
previously unregulated. Please note that the final standards for some
of these sources are further tightened pursuant to CAA section
112(f)(2), as shown in table 1 in section I.A above and discussed in
more detail below in sections III.C and IV.\16\
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\16\ These sources include CEVs at area source facilities where
EtO use is at least 60 tpy, Group 1 room air emissions at area
source facilities where EtO use is at least 40 tpy, and Group 2 room
air emissions at area source facilities where EtO use is at least 4
tpy.
---------------------------------------------------------------------------
Pursuant to CAA section 112(d)(2)-(3) or 112(d)(5), we are
establishing in this final rule the following emission standards for
the previously unregulated sources:
<bullet> 99 percent reduction for new and existing SCVs at
facilities where EtO use is less than 1 tpy,
<bullet> 99 percent reduction for new and existing ARVs facilities
where EtO use is at least 1 tpy less than 10 tpy,
<bullet> 99 percent reduction for new and existing ARVs at
facilities where EtO use is less than 1 tpy,
<bullet> 99.94 percent reduction for new and existing CEVs at major
source facilities,
<bullet> 99 percent emission reduction for new and existing CEVs at
area source facilities,
<bullet> 97 percent reduction for new and existing Group 1 room air
emissions at major source facilities,
<bullet> 80 percent emission reduction for new and existing Group 1
room air emissions at area source facilities,
<bullet> 86 percent reduction for new and existing Group 2 room air
emissions at major source facilities, and
<bullet> 80 percent emission reduction for new Group 2 room air
emissions at area source facilities.
As discussed in more detail below in section IV.C.3 of this notice,
we are not finalizing any of the alternative emission limits for
percent reduction standards on which we had solicited comment as part
of the proposed rulemaking. Further, based on comments received on the
proposed rulemaking, we are finalizing a revised best management
practice (BMP) as the GACT standard under CAA section 112(d)(5) for
existing Group 2 room air emissions at area sources. The BMP requires
the in-chamber EtO concentration to be lowered to 1 part per million
(ppm) before the chamber can be opened, as opposed to the proposed
measure that would have required these facilities to follow either the
Cycle Calculation Approach or the Bioburden/Biological Indicator
Approach to achieve sterility assurance in accordance with
International Organization for Standardization (ISO) 11135:2014 and ISO
11138-1:2017. In addition, we are finalizing, as proposed, a
requirement that facilities operate all areas with room air emissions
subject to an emission standard in accordance with the PTE requirements
of EPA
[[Page 24100]]
Method 204, irrespective of which CAA section 112 authority is invoked.
Lastly, we are finalizing the removal of the 1 ppm alternative for ARVs
at facilities where EtO use is at least 10 tpy. Section IV.B of this
preamble provides in more detail the standards we are finalizing
pursuant to CAA section 112(d)(2), 112(d)(3), and 112(d)(5), our
rationales for the final standards and for changes since proposal, and
a summary of key comments we received on the proposed standards and our
responses.
C. What are the final rule amendments based on the risk review for the
Commercial Sterilization Facilities source category?
This section introduces the final amendments to the Commercial
Sterilization Facilities NESHAP being promulgated pursuant to CAA
section 112(f). As in the proposal, we determined that the risks for
this source category were unacceptable under the previous provisions,
and we are making a final determination of unacceptability as part of
this final action, warranting necessary emission reductions as directed
under the provisions we are finalizing pursuant to CAA sections
112(d)(2), 112(d)(3), and 112(d)(5) in this rulemaking. When risks are
unacceptable after considering the emission reductions from the
standards in subpart O, we must determine the emissions standards
necessary to reduce risk to an acceptable level. As such, we are
promulgating final amendments to the Commercial Sterilization
Facilities NESHAP pursuant to CAA section 112(f)(2) that will reduce
risk to an acceptable level and will also provide an ample margin of
safety to protect public health (see section IV.C of the preamble for
further discussion). Based on comments received during the proposed
rulemaking, we are finalizing the following EtO emissions standards
under CAA section 112(f)(2):
<bullet> 99.99 percent reduction for SCVs at facilities where EtO
use is at least 30 tpy,
<bullet> 99.9 percent reduction for SCVs at facilities where EtO
use is at least 10 tpy but less than 30 tpy,
<bullet> 99.8 percent reduction for SCVs at facilities where EtO
use is at least 1 tpy but less than 10 tpy,
<bullet> 99.9 percent reduction for ARVs at facilities where EtO
use is at least 30 tpy,
<bullet> 99.9 percent reduction for CEVs at area source facilities
where EtO use is at least 60 tpy,
<bullet> 98 percent reduction for Group 1 room air emissions at
area sources facilities where EtO use is at least 40 tpy,
<bullet> 98 percent reduction for Group 2 room air emissions at
area sources facilities where EtO use is at least 20 tpy, and
<bullet> 80 percent reduction for Group 2 room air emissions at
area source facilities where EtO use is at least 4 tpy but less than 20
tpy.
We are not finalizing alternative emission limits for percent
reduction standards for the same reasons discussed in section III.B of
this preamble. Further, based on comments received during the proposed
rulemaking, we are not finalizing any of the work practice standards
that were proposed for facilities where the MIR remained greater than
100-in-1 million after the imposition of requirements under ``Control
Option 1''.\17\ These standards would have required facilities to limit
their Group 2 room air emissions to a maximum volumetric flow rate of
2,900 dry standard cubic feet per minute (dscfm) and a maximum EtO
concentration of 30 parts-per-billion by volume (ppbv).
---------------------------------------------------------------------------
\17\ Refer to section III.D.1.b of the proposal preamble (88 FR
22790, April 13, 2023) for further discussion of Control Option 1.
---------------------------------------------------------------------------
Section IV.C.3 of this preamble provides a summary of key comments
we received regarding the risk review and our responses.
D. What are the final rule amendments based on the technology review
for the Commercial Sterilization Facilities source category?
We determined that there are developments in practices, processes,
and control technologies that warrant revisions to the previous
standards for this source category. Therefore, to satisfy the
requirements of CAA section 112(d)(6), we are revising the standards to
include, as in the proposed rule:
<bullet> 99.8 percent reduction for SCVs at facilities where EtO
use is at least 1 tpy but less than 10 tpy,
<bullet> 99.6 percent reduction for existing ARVs at facilities
where EtO use is at least 10 tpy, and
<bullet> 99.9 percent reduction for new ARVs at facilities where
EtO use is at least 10 tpy.
Based on comments received during the proposed rulemaking, we are
finalizing a 99.9 percent emission reduction standard for SCVs at
facilities where EtO use is at least 10 tpy, which is different from
the 99.94 percent emission reduction standard that was proposed (see
section IV.D.3.a of this document for further discussion). We are not
finalizing any of the alternative emission limits for percent reduction
standards that we had solicited comment on as part of the proposed
rulemaking. As part of the technology review, we also identified
regulatory gaps (previously unregulated processes or pollutants) and
are establishing new standards to fill those gaps as described in
section III.B of this preamble. Section IV.D.3 of this preamble
provides a summary of key comments we received regarding the technology
review and our responses.
E. What are the final rule amendments addressing emissions during
periods of startup, shutdown, and malfunction?
In its 2008 decision in Sierra Club v. EPA, 551 F.3d 1019 (D.C.
Cir. 2008), the United States Court of Appeals for the District of
Columbia Circuit vacated portions of two provisions in our CAA section
112 regulations governing the emissions of HAP during periods of SSM.
Specifically, the court vacated the SSM exemption contained in 40 CFR
63.6(f)(1) and 40 CFR 63.6(h)(1), holding that under section 302(k) of
the CAA, emissions standards or limitations must be continuous in
nature and that the SSM exemption violates the CAA's requirement that
some section 112 standards apply continuously. We have eliminated the
SSM exemption in this rule. Consistent with Sierra Club v. EPA, the EPA
has established standards in this rule that apply at all times. We have
also revised table 6 in subpart O (the General Provisions Applicability
Table) in several respects as is explained in section III.G.1 of the
proposal preamble (88 FR 22790). For example, we have eliminated and
revised certain recordkeeping that is related to the SSM exemption as
described in detail in the proposed rule and summarized again in
section IV.E.1 of this preamble.
In establishing standards in this rule, we have considered startup
and shutdown periods and, for the reasons explained in section III.G.1
of the proposal preamble and section IV.E of this preamble, have not
established alternate standards for those periods.
The EPA is also finalizing provisions related to malfunctions as
proposed. Periods of startup, normal operations, and shutdown are all
predictable and routine aspects of a source's operations. Malfunctions,
in contrast, are neither predictable nor routine. Instead, they are, by
definition, sudden, infrequent, and not reasonably preventable failures
of emissions control, process, or monitoring equipment. (40 CFR 63.2)
(Definition of malfunction). The EPA interprets CAA section 112 as not
requiring emissions that occur during periods of malfunction to be
factored into development of CAA section 112
[[Page 24101]]
standards. This reading has been upheld as reasonable by the D.C.
Circuit in U.S. Sugar Corp. v. EPA, 830 F.3d 579, 606-610 (2016).
Section IV.E.3 of this preamble provides a summary of key comments
we received on the SSM provisions and our responses.
F. What other changes have been made to the NESHAP?
This rule also finalizes, as proposed, revisions to several other
requirements in the Commercial Sterilization Facilities NESHAP. We
describe these revisions in this section as well as other proposed
provisions that have changed since proposal.
1. Demonstrating Compliance
In the majority of instances, parametric monitoring is used to good
effect as an ongoing means of ensuring that these devices continue to
get necessary emission reductions.\18\ However, given the nature of
EtO, in which small amounts can have large risk impacts, parametric
monitoring alone will not be sensitive enough to detect very small
fluctuations in EtO concentration. Based on comments received during
the proposed rulemaking, the EPA is finalizing a requirement to use EtO
CEMS for demonstrating compliance. However, facilities where EtO use is
less than 100 lb/year will have the option to use EtO CEMS or
performance testing and parametric monitoring to demonstrate
compliance. Based on comments received during the proposed rulemaking,
we are promulgating the following requirements:
---------------------------------------------------------------------------
\18\ Parametric monitoring is an approach that measures one or
more key indicators of process operation or emission control device
operation, typically on a continuous basis. The parameters are known
to affect emission levels associated with the process or the control
efficiency of the source's air pollution control device.
---------------------------------------------------------------------------
<bullet> Quarterly reporting of EtO CEMS data,
<bullet> Minimum data availability of 90 percent for EtO CEMS, and
<bullet> Use of either outlet volumetric flow rate monitors or
differential pressure monitors to demonstrate continuous compliance
with EPA Method 204.
Based on comments received during the proposed rulemaking, we are
not finalizing a requirement for the mass of EtO being routed to a
control device from an SCV to be determined through inlet testing.
Based on comments received during the proposed rulemaking, we are
finalizing revisions to parametric monitoring requirements, and we are
finalizing technical edits to Performance Specification 19 and QA
Procedure 7.
2. Electronic Reporting
To increase the ease and efficiency of data submittal and data
accessibility, we are finalizing, as proposed, a requirement that
owners or operators of commercial sterilization facilities submit
compliance reports (being finalized at 40 CFR 63.366(b) and (c)),
performance test reports (being finalized at 40 CFR 63.366(f)), and
performance evaluation reports (being finalized at 40 CFR 63.366(g))
electronically through the EPA's Central Data Exchange (CDX) using the
Compliance and Emissions Data Reporting Interface (CEDRI). The final
rule requires that performance test results collected using test
methods that are supported by the EPA's Electronic Reporting Tool (ERT)
as listed on the ERT website \19\ at the time of the test be submitted
in the format generated through the use of the ERT and that other
performance test results be submitted in portable document format (PDF)
using the attachment module of the ERT. Similarly, performance
evaluation results of CEMS measuring relative accuracy test audit
pollutants that are supported by the ERT at the time of the test must
be submitted in the format generated through the use of the ERT and
other performance evaluation results be submitted in PDF using the
attachment module of the ERT. For compliance reports, the final rule
requires that owners or operators use the appropriate spreadsheet
template to submit information to CEDRI. The final version of the
template for these reports is in the docket and will be located on the
CEDRI website.\20\ Furthermore, we are finalizing as proposed
provisions that allow facility operators the ability to seek extensions
for submitting electronic reports for circumstances beyond the control
of the facility, i.e., for a possible outage in the CDX or CEDRI or for
a force majeure event in the time just prior to a report's due date, as
well as the process to seek such an extension.
---------------------------------------------------------------------------
\19\ <a href="https://www.epa.gov/electronic-reporting-air-emissions/electronic-reporting-tool-ert">https://www.epa.gov/electronic-reporting-air-emissions/electronic-reporting-tool-ert</a>.
\20\ <a href="https://www.epa.gov/electronic-reporting-air-emissions/cedri">https://www.epa.gov/electronic-reporting-air-emissions/cedri</a>.
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For a more detailed discussion of these final amendments to the
Commercial Sterilization Facilities NESHAP, see section IV.G.2.g of the
proposal preamble (88 FR 22790, April 13, 2023), as well as section
VI.B below on compliance with the Paperwork Reduction Act. For a more
thorough discussion of electronic reporting, see the memorandum,
Electronic Reporting Requirements for New Source Performance Standards
(NSPS) and National Emission Standards for Hazardous Air Pollutants
(NESHAP) Rules, which is available in the docket for this rulemaking
(see Docket Item No. EPA-HQ-OAR-2019-0178-0398).
3. Title V Permitting
Because of the lack of other Federal requirements under the CAA
that commercial sterilization facilities are subject to, as well as the
robust monitoring and reporting requirements of the final rule, we are
not finalizing a requirement for area source facilities subject to
subpart O to obtain a title V permit from the delegated authority in
which the source is located.
4. Combined Emission Streams
To increase the ease and efficiency of complying with the revised
NESHAP, we are finalizing, based on comments received during the
proposed rulemaking, alternative compliance approaches for combined
emission streams. For these streams, facilities will now be allowed to
demonstrate compliance with a mass emission limit that is determined
based on the emission standards to which the component streams are
subject, as well as characteristics specific to those facilities. In
addition, we are finalizing an option for owners and operators to
demonstrate compliance with a site-wide emission limitation, as opposed
to demonstrating compliance for each individual and combined emission
stream.
5. Minor Clarifications and Corrections
We are including several additional minor clarifying edits in the
final rule based on comments received during the public comment period.
The comments and our specific responses to these items can be found in
the document, Summary of Public Comments and Responses for the 2024
Risk and Technology Review for Commercial Sterilization Facilities,
available in the docket for this rulemaking.
G. What are the effective and compliance dates of the standards?
The revisions to the standards being promulgated in this action are
effective on April 5, 2024. The compliance date for the standards
promulgated pursuant to CAA section 112(f)(2) for the following
existing sources is April 6, 2026:
<bullet> SCVs at facilities where EtO use is at least 1 tpy,
<bullet> ARVs at facilities where EtO use is at least 30 tpy,
[[Page 24102]]
<bullet> CEVs at area source facilities where EtO use is at least
60 tpy,
<bullet> Group 1 room air emissions at area source facilities where
EtO use is at least 40 tpy, and
<bullet> Group 2 room air emissions at area source facilities where
EtO use is at least 4 tpy.
The compliance date for the standards promulgated pursuant to CAA
section 112(d)(2)-(3), 112(d)(5) or 112(d)(6) for the following
existing sources is April 5, 2027:
<bullet> SCVs at facilities where EtO use is less than 1 tpy,
<bullet> ARVs at facilities where EtO use is less than 30 tpy,
<bullet> CEVs at major source facilities,
<bullet> CEVs at area source facilities where EtO use is less than
60 tpy,
<bullet> Room air emissions at major source facilities,
<bullet> Group 1 room air emissions at area source facilities where
EtO use is less than 40 tpy, and
<bullet> Group 2 room air emissions at area source facilities where
EtO use is less than 4 tpy.
As required by CAA section 112(i)(1), new sources must comply with
each applicable standard immediately upon its effective date, which is
April 5, 2024, or upon startup, whichever is later.
The compliance schedules for existing sources have changed since
proposal. We had proposed an 18-months compliance deadline for all of
the proposed standards for existing sources. Based on the comments
received, we have determined that 18 months is not a sufficient period
for sources to comply with the CAA section 112(d)(2)-(3), 112(d)(5) and
112(d)(6) standards for existing sources, for the following reasons:
<bullet> Most commercial sterilization facilities were not
initially designed to be compliant with the PTE requirements of EPA
Method 204. We have learned from the comments received that for these
facilities, the capture requirements associated with the emission
reduction standards for Group 1 and Group 2 room air emissions in the
final rule will likely require a redesign of a portion if not all of
the facility. Many facilities will also need to purchase additional
equipment (e.g., fans, transformers, variable frequency drives, etc.)
to meet the capture requirements. Moreover, compliance with the final
emission standards will likely require the installation of additional
control devices. We have reviewed the time that it has taken for
previous projects of this nature to be completed, from submission of
the initial State or local permit application to installation of the
continuous compliance mechanisms. Based on this analysis, we find that
the process of bringing a facility into compliance with the PTE
requirements of EPA Method 204, as well as installing and verifying
additional emission controls, can take approximately a year from permit
submission to project completion. However, this estimate does not
account for the time needed to design and plan before the initial
permit application is submitted, nor for the time needed to avoid
impacts on medical device supply chains, to procure control devices
from a limited number of vendors, and to account for the other
complexities identified below.
<bullet> The process of redesigning a facility or installing
additional controls will require some reduction in sterilization
capacity. Moreover, the process of coming into compliance with the
standards may require multiple facilities to reduce their sterilization
capacity simultaneously. Based on comments received during the proposed
rulemaking, the average reduction in capacity during the re-design and
installation period can range from 10 percent \21\ to 20 percent.\22\
In addition, there is already strain on the medical device supply
chain, and it is difficult for most facilities to absorb any additional
demand for sterilized product. Three years is needed to ensure that
owners and operators can come into compliance with the emissions
standards while at the same time minimizing any potential impacts to
the medical device supply chain, for which reliability is important to
protect public health.
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\21\ Commenter provided the following statement: ``For example,
a 10% reduction in capacity across the 83 commercial sterilizers in
the U.S. implies that an additional 8 sterilization facilities will
be required to maintain existing throughput'' (see Docket Item No.
EPA-HQ-OAR-2019-0178-0618).
\22\ Commenter provided the following statement: ``During . . .
upgrades, EtO sterilization capacity was reduced by more than 20
percent as emissions control equipment was installed and tested.''
(see Docket Item No. EPA-HQ-OAR-2019-0178-0566).
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<bullet> There are a limited number of vendors that specialize in
the redesign of facilities to be compliant with the PTE requirements of
EPA Method 204. In addition, there are a limited number of control
technology vendors that supply the types of advanced control systems
that the EPA expects will be necessary for facilities to comply with
the final standards. Three years is needed to ensure that all owners
and operators can receive the necessary services and have the proper
equipment in place by the compliance date.
For the same reasons explained above, existing sources will need
more than the proposed 18 months to comply with the standards
promulgated under CAA section 112(f)(2). As with standards promulgated
under section 112(d)(2)-(3), 112(d)(5) and 112(d)(6), in most instances
compliance with the section 112(f)(2) standards will require sources to
plan, purchase, and install equipment for EtO control. For example, for
SCVs at facilities where EtO use is at least 30 tpy, if an existing
affected source currently does not achieve 99.99 percent control of EtO
emissions and a new control system is needed to meet that limit, the
facility will need time to properly engineer the project, obtain
capital authorization and funding, procure the equipment, construct the
equipment, start up the equipment, set up new software, develop
operating procedures, and train operators on the new equipment. The
additional factors identified above, such as avoiding impacts to
medical device supply chains and securing control devices from a
limited number of vendors, apply similarly to section 112(f)(2)
standards as to standards promulgated under section 112(d)(2)-(3),
112(d)(5) and 112(d)(6).
If facilities commence work on these emissions reduction efforts
immediately after this rule becomes effective, we believe that sources
will be able to comply with the standards in this final rule within the
two year compliance window set by Sec. 112(f)(4), without substantial
interruption in operations.
Specifically, we offer the following timeline as a general guide to
completing the necessary upgrades in a timely manner:
<bullet> Step 1: Secure vendors for facility retrofits, control
devices, EtO CEMS, and any other equipment and services that will be
needed in order to comply with the NESHAP.
<bullet> Step 2: Work with vendors on (1) any new facility designs
that will be required in order to meet the PTE requirements of EPA
Method 204, (2) any new control system designs that will be required in
order to meet the emission standards, (3) a schedule to ensure timely
compliance with the NESHAP, and (4) purchase of the equipment that will
be required in order to meet items (1) and (2), along with EtO CEMS.
<bullet> Step 3: Submit a permit application to the relevant
permitting authority.
<bullet> Step 4: Complete the necessary facility retrofits, control
device installations, and EtO CEMS installations.
<bullet> Step 5: Test the control systems and facility air handling
systems in order to ensure that the NESHAP is being met.
We recognize that this is a significant undertaking for the
industry, and we encourage facilities to engage in these
[[Page 24103]]
steps as early as practicable, as opposed to delaying action until
closer to the end of the compliance period.
Although we believe sources that follow this timeline will be able
to comply with these standards within two years, to minimize any
potential impact to the medical device supply chain, we are allowing up
to three years for existing sources to comply with section 112(d)(2)-
(3), 112(d)(5) and 112(d)(6) standards, the maximum timeframe
authorized under CAA section 112(i)(3)(A). Further, CAA section
112(i)(3)(B) and EPA's regulation at 40 CFR 63.6(i)(4)(i)(A) authorize
States with delegated authority to implement and enforce this NESHAP to
grant an existing source an additional year to comply with section
112(d) standards, if such additional period is necessary for the
installation of controls.\23\ In addition, for each standard, owners
and operators will have 180 days after the end of the relevant
compliance period to begin demonstrating compliance with that standard.
See 40 CFR 63.7(a)(2).
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\23\ This flexibility has been available since the NESHAP was
first promulgated (59 FR 62585, December 6, 1994) and continues to
be available in the current NESHAP.
---------------------------------------------------------------------------
Lastly, if more time is needed to comply with any standard in this
final rule, CAA section 112(i)(4) provides that ``The President may
exempt any stationary source from compliance with any standard or
limitation under this section for a period of not more than 2 years if
the President determines that the technology to implement such standard
is not available and that it is in the national security interests of
the United States to do so. An exemption under this paragraph may be
extended for 1 or more additional periods, each period not to exceed 2
years. The President shall report to Congress with respect to each
exemption (or extension thereof) made under this paragraph.''
IV. What is the rationale for our final decisions and amendments for
the Commercial Sterilization Facilities source category?
For each issue, this section provides a description of what we
proposed and what we are finalizing for the issue, the EPA's rationale
for the final decisions and amendments, and a summary of key comments
and responses. For all comments not discussed in this preamble, comment
summaries and the EPA's responses can be found in the comment summary
and response document available in the docket.
A. Amendments Addressing the Affected Source Definitions
1. What amendments did we propose to address the affected source
definitions?
For SCVs, ARVs, and CEVs, we proposed to define the affected source
as the individual vent. For Group 1 and Group 2 room air emissions we
proposed to define the affected source as the collection of all room
air emissions for each group at any sterilization facility. More
information concerning the affected source definitions is in section
III.A. of the proposal preamble (88 FR 22790, April 13, 2023).
2. How did the affected source definitions change since proposal?
We are finalizing the affected source definitions as proposed (88
FR 22790, April 13, 2023).
3. What key comments did we receive on the affected source definitions
and what are our responses?
Comment: Two commenters suggested that the definition of an
affected source should be based on control system outlets, stating that
when emission streams are combined, the limit must be based on the
actual achievable rate of control with further consideration for the
modeled risk of the facility. One commenter suggested that the affected
source should be defined as the sterilization facility as a whole, and
another commenter stated the affected source definition(s) should
consider destruction efficiency. Additionally, commenters expressed
concerns that the affected source definitions for point sources (i.e.,
SCVs, ARVs, and CEVs) would disproportionately favor facilities with
smaller capacity and facilities with multiple individual vents
regardless of size. Specifically, one commenter stated that a facility
with multiple individual vents would have a higher ``emission rate
ceiling'' with respect to mass rate (i.e., lb/h) emission limits.
Response: We disagree with the commenters' suggestion that the
definition of an affected source should be based on control system
outlets or the sterilization facility as a whole. There are many
different ways in which emission sources can be combined and controlled
at commercial sterilization facilities. If affected source definitions
were based on control system outlets, it is not clear which outlets
(and, by extension, emission source combinations) would be selected and
what the criteria for selecting those outlets would be. It is not
feasible to set an emission standard for every conceivable combination
of emission sources. Furthermore, the commenters do not provide any
suggestions on which control system outlets should be considered when
defining affected sources. The most straightforward approach is to
define the affected source as the emission source itself and to have
owners and operators decide how best to combine and control emissions
from affected sources at their facilities. With respect to defining the
affected source as the sterilization facility as a whole, there is very
limited data available where a performance test has been conducted for
an entire facility. Furthermore, defining the affected source as the
sterilization facility would require a compliance mechanism that some
facilities may find unnecessarily complicated, given that compliance
demonstration has typically been conducted on a source-by-source basis.
It is not clear and the commenter does not provide any explanation on
how to base an affected source definition on destruction efficiency.
Lastly, regarding the comment that the definition of affected
sources for point sources is disproportionally favorable to facilities
with smaller capacity or with multiple individual vents, this is not an
issue in the final rule. All of the emission standards in this final
rule are in a percent reduction format, which is the same regardless of
facility size or how many vents are in place. Therefore, concerns
regarding ``emission rate ceilings'' are no longer relevant.
Comment: One commenter stated that there is unnecessary complexity
to the proposed definitions of Group 1 and Group 2 room air emissions
due to the variability in size and facility configuration, particularly
as they apply to the proposed format of the emission standards for
these sources (i.e., lb/h). The commenter also stated that the
definitions favor facilities which have smaller capacity and noted that
individual facility characteristics must be considered for Group 1 and
Group 2 emissions. Specifically, the commenter stated that emission
rates should be based on technological feasibility to control
emissions, including feasibility limitations regarding low inlet
concentrations.
Response: We disagree with one commenter's assertion that there is
unnecessary complexity to the proposed definitions of Group 1 and Group
2 room air emissions due to the variability in size and facility
configuration. All sterilization facilities, regardless of size or
configuration, follow the same basic procedure: sterilization and its
associated activities (e.g., EtO storage and dispensing, vacuum pump
[[Page 24104]]
operation, handling of pre-aeration sterilized product), aeration, and
shipping. Group 1 room air emissions simply cover all activities that
occur prior to aeration, and Group 2 room air emissions cover all
activities that occur after aeration. Combining room air emissions
based on whether they occur before or after aeration is a clear way to
defining room air emissions affected sources. It also reflects the most
common controlled room air configuration that we have observed. With
respect to considering individual facility characteristics The simplest
breakdown of controlled room air emissions that we have observed
involves capturing and routing all emissions from post-aeration
handling of sterilization material to one control system, and then
capturing and routing all other room air emission sources (i.e., Group
1 room air emissions) to another control system. It is important to
define the affected sources for room air emissions in this manner so
that owners and operators can have flexibility in how they chose to
control their emissions,\24\ and so that facilities who have already
chosen to control their emissions in this manner can continue to do so
while minimizing any potential compliance issues. With respect to the
comment that the definition of affected sources for room air emissions
is disproportionally favorable to facilities with smaller capacity, the
comment appears to pertain more to the setting of the emission
standards themselves, rather than the affected source definition. As
discussed in section IV.B.3.b of this preamble, we are no longer
finalizing mass rate emission standards, and we are accounting for
technical feasibility (e.g., manufacturer guarantees, emission
reductions achieved in performance tests) when finalizing emission
standards. The emission standards in this final rule for room air
emissions are in a percent reduction format, which is the same
regardless of facility size.
---------------------------------------------------------------------------
\24\ The EPA has not observed any instance where a facility is
routing a portion of its Group 1 room air emissions to one control
system, and the other portion to a different control system.
---------------------------------------------------------------------------
4. What is the rationale for our final approach and final decisions to
address the affected source definitions?
We evaluated the comments on our proposed affected source
definitions. For the reasons explained in the proposed rule (88 FR
22790, April 13, 2023), we determined that these amendments are
necessary because the definition of an ``affected source'' at 40 CFR
63.2 is not appropriate for this source category. More information
concerning the amendments we are finalizing for affected source
definitions is in the preamble to the proposed rule and in the comments
and our specific responses to the comments in the document, Summary of
Public Comments and Responses for the Risk and Technology Review for
Commercial Sterilization Facilities, available in the docket for this
rulemaking. Therefore, we are finalizing the affected source
definitions as proposed.
B. Amendments Pursuant to CAA Sections 112(d)(2), 112(d)(3), and
112(d)(5) for the Commercial Sterilization Facilities Source Category
1. What did we propose pursuant to CAA sections 112(d)(2), 112(d)(3),
and 112(d)(5) for the Commercial Sterilization Facilities source
category?
We proposed to establish standards under CAA sections 112(d)(2)-(3)
and 112(d)(5) for the following emission sources that were unregulated:
SCVs, ARVs, and CEVs at facilities where EtO use is less than 1 tpy,
ARVs and CEVs at facilities where EtO use is at least 1 tpy but less
than 10 tpy, CEVs at facilities where EtO use is at least 10 tpy, and
room air emissions. We also proposed a technical correction to the
emission standard for ARVs at facilities where EtO use is at least 10
tpy. We proposed the following emission standards pursuant to CAA
section 112(d)(2)-(3):
<bullet> 3.2E-4 lb/h for new and existing CEVs at facilities where
EtO use is at least 10 tpy,
<bullet> 1.3E-3 lb/h for new and existing Group 1 room air
emissions at major source facilities, and
<bullet> 2.8E-3 lb/h for new and existing Group 2 room air
emissions at major source facilities.
For more information, see section III.B of the proposal preamble
(88 FR 22790, April 13, 2023). We proposed the following emission
standards pursuant to CAA section 112(d)(5):
<bullet> 99 percent emission reduction for new and existing SCVs at
facilities where EtO use is less than 1 tpy,
<bullet> 99 percent emission reduction for new and existing ARVs at
facilities where EtO use is at least 1 tpy but less than 10 tpy,
<bullet> 99 percent emission reduction for new and existing ARVs at
facilities where EtO use is less than 1 tpy,
<bullet> 99 percent emission reduction for new and existing CEVs at
facilities where EtO use is at least 1 tpy but less than 10 tpy,
<bullet> 99 percent emission reduction for new and existing CEVs at
facilities where EtO use less than 1 tpy.
<bullet> 1.3E-3 lb/h emission limit for new and existing Group 1
room air emissions at area source facilities, and
<bullet> 2.8E-3 lb/h emission limit for new Group 2 room air
emissions at area source facilities.
These are emissions standards that reflect the use of generally
available control technologies. For more information, see section III.B
of the proposal preamble (88 FR 22790, April 13, 2023).
For existing Group 2 room air emissions at area source facilities,
pursuant to CAA section 112(d)(5), we proposed a requirement for
facilities to follow either the Cycle Calculation Approach or the
Bioburden/Biological Indicator Approach to achieve sterility assurance
in accordance with ISO 11135:2014 and ISO 11138-1:2017. This is a BMP
that would reduce EtO use per sterilization cycle (i.e., pollution
prevention). For more information, see section III.B.8.g of the
proposal preamble (88 FR 22790, April 13, 2023). In order to ensure
complete capture of EtO emissions and, in turn, compliance with the
proposed standards, we proposed to require each facility to operate
areas with room air emissions subject to an emission standard in
accordance with the PTE requirements of EPA Method 204 of appendix M to
40 CFR part 51. For more information, see section III.B of the proposal
preamble (88 FR 22790, April 13, 2023).
We addressed a necessary correction to the emission standards for
these sources in 40 CFR 63.362(d) that allow facilities to either
achieve 99 percent emission reduction or limit the outlet concentration
to a maximum of 1 part per million by volume (ppmv), ``whichever is
less stringent, from each aeration room vent.'' We proposed removing
the less stringent 1 ppmv concentration alternative for these sources
because it is not equivalent and therefore not an appropriate
alternative to 99 percent emission reduction standard. For more
information, see section III.B.2 of the proposal preamble (88 FR 22790,
April 13, 2023).
2. How did the revisions pursuant to CAA sections 112(d)(2), 112(d)(3),
and 112(d)(5) change since proposal for the Commercial Sterilization
Facilities source category?
We are finalizing as proposed the following standards under CAA
section 112(d)(5):
<bullet> 99 percent emission reduction for new and existing SCVs at
facilities where EtO use is less than 1 tpy,
<bullet> 99 percent emission reduction for new and existing ARVs at
facilities
[[Page 24105]]
where EtO use is at least 1 tpy but less than 10 tpy, and
<bullet> 99 percent emission reduction for new and existing ARVs at
facilities where EtO use is less than 1 tpy.
In addition, we are finalizing a requirement for each facility to
operate areas with room air emissions subject to an emission standard
in accordance with the PTE requirements of EPA Method 204 of appendix M
to 40 CFR part 51. We are also finalizing the removal of the 1 ppm
alternative for ARVs at facilities where EtO use is at least 10 tpy, as
proposed.
Based on comments received during the proposed rulemaking, we have
revised the proposed standards for the following affected sources. The
final emission standards pursuant to CAA sections 112(d)(2), 112(d)(3),
and 112(d)(5) are as follows:
<bullet> 99.94 percent emission reduction for new and existing CEVs
at major source facilities,
<bullet> 99 percent emission reduction for new and existing CEVs at
area source facilities,
<bullet> 97 percent emission reduction for new and existing Group 1
room air emissions at major source facilities,
<bullet> 80 percent emission reduction for new and existing Group 1
room air emissions at area source facilities,
<bullet> 86 percent emission reduction for new and existing Group 2
room air emissions at major source facilities,
<bullet> For existing Group 2 room air emissions at area source
facilities, lower the EtO concentration within each sterilization
chamber to 1 ppm before the chamber can be opened, and
<bullet> 80 percent emission reduction for new Group 2 room air
emissions at area source facilities.
For new and existing CEVs at major source facilities, as well as
new and existing room air emissions at major source facilities, based
on comments received during the proposed rulemaking, we have re-
calculated the MACT floor based on percent emission reduction, as
opposed to mass rate emissions. The primary reason for finalizing this
change is that there is a serious concern that mass rate emission
standards could result in operational reductions that could adversely
impact the medical supply chain. The revised MACT floor for new and
existing CEVs at major source facilities is 99.94 percent emission
reduction. Because we were unable to identify more stringent (i.e.,
beyond the floor or ``BTF'') options that are cost-effective, we are
finalizing 99.94 percent emission reduction as the MACT standard under
CAA section 112(d)(2)-(3) for new and existing CEVs at major source
facilities. The revised MACT floor for new and existing Group 1 room
air emissions at major source facilities is 90 percent emission
reduction. We were able to identify a more stringent (i.e., 97 percent
control) and cost-effective BTF option and, therefore, we are
finalizing a 97 percent emission reduction standard as the MACT
standard under CAA section 112(d)(2)-(3) for new and existing Group 1
room air emissions at major source facilities. The revised MACT floor
for new and existing Group 2 room air emissions at major source
facilities is 86 percent emission reduction. Because the concentration
that corresponds to this emission reduction is three times the
representative detection level (RDL) for EtO, there are no BTF options
to consider due to the potential difficulty of demonstrating compliance
with limits lower than the MACT floor. Therefore, we are finalizing 86
percent emission reduction as the MACT standards for new and existing
Group 2 room air emissions at major source facilities. For more
information, see section IV.B.3.b of this preamble.
For both new and existing Group 1 room air emissions at area source
facilities, as well as new Group 2 room air emissions at area source
facilities, based on comments received during the proposed rulemaking,
we are finalizing an 80 percent emission reduction standard, consistent
with the manufacturer guarantee for the control technology on which the
standard is based. The primary reason for the change from mass rate to
percent reduction is that there is a serious concern that mass rate
emission standards could result in operational reductions in order to
meet the standards while still ensuring work health and safety, but
that could adversely impact the medical supply chain. In addition,
while some sources have demonstrated emission reductions higher than 80
percent, those reductions are limited to facilities with higher EtO
usage rates, and we cannot determine whether smaller users of EtO can
meet those emission reductions. For more information, see section
IV.B.3.b of this preamble.
For existing Group 2 room air emissions at area source facilities,
based on comments received during the proposed rulemaking, we are
finalizing a revised BMP due to concerns that the BMP that we proposed
(as well as alternatives for which we solicited comment in the
proposal), would adversely impact the medical supply chain due to
inefficiencies that would arise, as well as having to lengthen cycle
dwell times in order to ensure sterility. The final requirement reduces
existing Group 2 room air emissions at area source facilities by 20
percent, does not interfere with sterility assurance, and is expected
to impact only 20 percent of facilities. We do not anticipate any
severe negative impacts to the medical supply chain as a result of
finalizing this requirement. For more information, see section IV.B.3.a
of this preamble.
3. What key comments did we receive on the proposal revisions pursuant
to CAA section 112(d)(2), 112(d)(3), and 112(d)(5), and what are our
responses?
This section provides comment and responses for the key comments
received regarding BMPs, mass rate emission standards, PTE, and
warehouses. Other comment summaries and our responses for additional
issues raised regarding these activities, as well as issues raised
regarding our proposed emission standards for SCVs and ARVs at
facilities where EtO use is less than 1 tpy, ARVs at facilities where
EtO use is a least 1 tpy but less than 10 tpy, room air emissions at
major source facilities, and our proposed technical correction to the
emission standard for ARVs at facilities where EtO use is at least 10
tpy can be found in the document, Summary of Public Comments and
Responses for the Risk and Technology Review for Commercial
Sterilization Facilities, available in the docket for this rulemaking.
a. BMP
Comment: Several commenters contended that we should not require
facilities to follow either the Cycle Calculation Approach or the
Bioburden/Biological Indicator Approach to achieve sterility assurance
in accordance with ISO 11135:2014 and ISO 11138-1:2017. They stated
that owners and operators should have the flexibility to optimize
cycles using a variety of ISO/AAMI 11135 methods and that we should not
limit or restrict the validation method that may be used.
One commenter stated that requiring facilities to follow the Cycle
Calculation or Bioburden/Biological Indicator Approach would result in
more dedicated product loads, more cycles needed to sterilize different
project mixes, and most chambers not being filled to capacity. The
commenter stated that de-consolidation of existing cycles to implement
an appropriate Cycle Calculation or Bioburden/Biological Indicator
approach would require (1) creation and validation of new product
families, new process challenge devices, and biological indicators, (2)
cycle development, and (3) maintenance through requalification and
annual reporting. The commenter noted that the
[[Page 24106]]
extra burden associated with maintaining more cycles would create more
work and require more chamber time, resulting in less sterilization
capacity. Two commenters stated that requiring either the Cycle
Calculation or Bioburden/Biological Indicator approach could limit
research for product innovation as available development time in EtO
sterilization chambers would be taken up for optimizing existing
products.
Two commenters stated the ISO standards were intended for the
process of EtO sterilization and not emission reduction or controls.
One commenter further contended it is a faulty approach to base
emission standards on international standards, as these standards are
revised periodically and may continue to evolve. Another commenter
noted that ISO/AAMI standards are currently being revised to be more
flexible to achieve optimized cycles, while minimizing impact on
sterilization capacity. The commenter contended that cycle validation
must focus on achieving sterility required for patient safety and
assuring product performance and reliability, and that reducing EtO use
cannot take priority over patient safety.
One commenter stated that conducting Cycle Calculation studies for
every product type or category would not be feasible with the current
capacity. The commenter stated this would require effort to redesign
sterilization cycles, evaluate product and packaging performance, and
validate the redesigned cycles. The commenter also stated that the new
validation work will impact sterilization capacity as sterilizer
equipment is not available for production use during study times (i.e.,
production capacity is diverted to cycle validation). The commenter
further stated that sites that use more than one vendor would have to
redesign sterilization cycles at each vendor and that, given the
limited resources and expertise, this would not be possible to achieve
on this scale. Another commenter stated they have not been able to
ensure product sterility using Cycle Calculation approach.
Finally, one commenter stated that the Bioburden/Biological
Indicator methods limit the number of products that can be validated in
a single cycle. The commenter stated that the Bioburden/Biological
Indicator approach may be limited to a range of products with similar
attributes and drive up the number of required cycles. The commenter
also stated that each validated cycle will require requalification
every few years, and the additional testing at sterilizers and testing
laboratories will decrease available sterilization capacity. The
commenter stated that the inability to fill a sterilization chamber
fully with product and waiting until full can lead to inefficient use
of sterilization chambers and supply issues. Another commenter stated
the Bioburden/Biological Indicator approach results in additional cost
and delays, as it requires that the product bioburden levels be
enumerated and characterized, and that consistency in the bioburden
population and the bioburden's resistance to the sterilization process
remain relatively stable over a multi-year period. The commenter also
stated that it may take many years to establish the range in numbers
and types of bioburden to properly perform a validation using this
proposed Bioburden/Biological Indicator approach. Another commenter
stated that the Bioburden approach would require upgrades to supplier
facilities, manufacturing facility, and microbiological control
practices.
Response: We agree with the commenters' concerns regarding
potential inefficiencies in the sterilization process that may arise
from requiring facilities to follow either the Cycle Calculation
Approach or the Bioburden/Biological Indicator Approach to achieve
sterility assurance in accordance with ISO 11135:2014 and ISO 11138-
1:2017, along with the potentially adverse impacts to the medical
supply chain that could result from the proposed approach. These
inefficiencies include reduced cycle optimization (i.e., not being able
to sterilize as much product per load or chamber), having to run more
cycles overall in order to meet the demand for sterile medical devices,
and diverting already strained resources away from normal operations to
developing new cycle validations. We also agree with the commenters'
concerns that requiring facilities to follow this requirement would
limit research for product innovation. Given the current strain on
resources, some companies may not be able to invest in additional
chambers to conduct research. In addition, we agree with the
commenters' concerns that because this requirement is based on
international standards, which are revised periodically, this could
result in potential future complications. Therefore, we are not
including this requirement in the final rule.
Comment: As mentioned above, the EPA solicited comments on several
other BMPs, including limiting EtO concentration limit and limiting
packaging and pallet material. Two commenters stated that it is not
technically feasible for facilities and products to meet a 290
milligrams per liter (mg/L) EtO concentration limit. One commenter
stated that many industry guidelines and studies show that 400 mg/L is
the minimum recommended concentration, and many products use higher
concentrations to meet sterility assurance and product quality
requirements as set forth by FDA. Another commenter stated that process
efficiency is reduced with concentrations below 400 mg/L and that
efficiency is constant at concentrations greater than 500 mg/L. One
commenter indicated that an EtO concentration range of 400 to 650 mg/L
is common practice because it achieves microbiological lethality for
most products within a reasonable exposure time. Another commenter
stated that product design, stability post-sterilization, and lethality
are the drivers behind the choice of EtO concentration. The commenter
also stated that research and development with biological indicators is
routinely conducted using 600 mg/L cycles and that enforcing a lower
limit may have an unintended negative consequence on the availability
of biological indicators required for sterilization process validation
and routine monitoring. One commenter stated we should not propose to
limit the EtO concentration to 290 mg/L for small facilities and that
we should, instead, allow performance-based standards. In addition,
several commenters stated that an upper-bound limit on EtO
concentration may lead to longer cycle times and dwell times and that
longer dwell times would impact sterilization capacity and would lead
to offshoring, as well as the construction of additional facilities.
One commenter stated limiting packaging and pallet material will
interrupt trade, reduce innovation, increase the cost of medical
devices, and disrupt the medical device manufacturing industry without
a quantifiable reduction in EtO emissions. Two commenters stated that
packaging and pallet material selection will drive the design of
medical products. Two commenters noted that packaging requirements are
in place to ensure a sterile barrier until use and to prevent product
damage. One commenter stated packaging must pass rigorous test
requirements, according to industry standards. Another commenter
indicated that facilities use barcode instructions for use (IFUs) in
place of paper IFUs when possible. However, paper IFUs are regulated by
FDA. Two commenters noted that paper IFUs have not been documented to
be a source of residual emissions. Another commenter
[[Page 24107]]
stated that there is no evidence that barcode materials would have less
EtO retention than paper, and that labeling decisions have practical
and legal considerations. One commenter noted that a minimal amount of
plastic wrap is used to ensure the structural integrity of pallets
during shipping and that excessive plastic is not in the interest of
sterilization facilities, as it slows EtO penetration. The commenter
also stated that kits are transported in cardboard to protect from
punctures, and it is not possible to eliminate cardboard. A puncture to
a kit means the kit needs to be re-sterilized, requiring use of
additional EtO. One commenter stated that changes to pallet material
could have supply chain issues given interoperability and weight
requirements. Finally, another commenter stated that pallet materials
impact the strength and design of pallet, and any issues would have
implications for the entre medical device supply chain.
Response: We agree with the commenters' concerns regarding the
issues with prescribing an upper-bound limit on in-chamber EtO
concentration, as well as the negative impacts to the medical supply
chain that could result from increasing the dwell time to maintain
sterility as an outcome of such a requirement. Therefore, we are not
including this requirement in the final rule. We also agree with the
commenters' concerns regarding the need to ensure a sterile barrier
through sufficient packaging, as well as the potential supply chain
impacts from placing limits on the types of pallets that may be used.
Therefore, we are not requiring limits on packaging or transport
materials as part of this rulemaking.
Comment: One commenter recommended an end of sterilization cycle
chamber limit of less than 1 ppm (with a zero mg/L reading) in the
sterilization chamber (EtO remaining calculated measurement) as a BMP.
The commenter stated that removing EtO from the sterilization chamber
is the most efficient stage for EtO removal. The commenter further
stated that longer EtO dwell times, as well as the potential for the
elimination of nitrogen gas washes to keep total cycle time equivalent,
could result in more EtO residual at aeration and the greater potential
for room air emissions after aeration.
Response: We agree with the commenter's suggestion of a requirement
to limit the in-chamber EtO concentration to 1 ppm. It does not
interfere with sterility assurance, and, based on responses to the
December 2019 questionnaire and September 2021 Information Collection
Request (ICR), 80 percent of all commercial sterilization facilities,
regardless of annual EtO use, are already meeting this limit. Those who
are not meeting the limit currently are close to the limit,\25\ so we
do not anticipate any severe negative impacts to the medical device
supply chain as a result of finalizing this requirement. We estimate
that the emission reductions from applying this requirement to the
source category would be 20 percent. In addition, since 80 percent of
facilities are already meeting this limit, this would result in an 80
percent reduction in costs. We have evaluated the changes in cost,
emissions, and cost-effectiveness for this BMP, and it is more cost-
effective than the other options we considered. Therefore, for Group 2
room air emissions we are finalizing the BMP such that the in-chamber
EtO concentration is to be lowered to 1 ppm before the chamber can be
opened. We note that, even though this BMP is expected to result in
fewer emission reductions than the BMP we proposed, this rule will
still reduce EtO emissions (and, therefore, lifetime cancer risks) in
multiple communities across the country. As discussed in section
IV.C.2.a.iii, this BMP will ultimately apply only to facilities where
EtO use is less than 4 tpy. We are finalizing the requirement that area
source facilities whose EtO usage is at least 4 tpy but less than 20
tpy and area source facilities whose EtO usage is at least 20 tpy are
required to reduce Group 2 room air emissions by 80 percent and 98
percent, respectively (see section IV.C.2.a.iii for more information).
For SCVs and ARVs at facilities where EtO use is less than 1 tpy, as
well as ARVs at facilities where EtO use is less than 10 tpy, our
general rationale for proposing emission standards over the BMP was
that emission standards would both achieve greater emission reduction
and incur fewer annual costs than the BMP. However, even considering
lower annual costs for the BMP, the emission standards would still
achieve greater emission reduction. Therefore, for SCVs and ARVs at
facilities where EtO use is less than 1 tpy, as well as ARVs at
facilities where EtO use is less than 10 tpy, we are finalizing the
emission standards as proposed pursuant to CAA section 112(d)(5). For
CEVs at area source facilities, as well as room air emissions at area
source facilities, we are also evaluating percent emission reduction
standards, as opposed to mass rate emission standards. The revised GACT
analyses for those emission sources are presented in section IV.B.3.b
of this preamble.
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\25\ The highest concentration that was reported prior to
opening the chamber door was 20 ppm. While this may seem high, this
is reduced from starting EtO concentrations of several thousand ppm
(see section IV.F.3 of this preamble for further discussion).
---------------------------------------------------------------------------
Comment: Several commenters stated that we do not have the
legislative authority or expertise to regulate sterilization cycles and
that FDA is the Federal agency that has authority to regulate medical
device sterilization. They stated that Congress gave FDA the authority
to ensure the availability of safe and effective medical products and
that we must not finalize any regulatory requirements that are under
FDA purview.
Response: The EPA proposed the BMP (i.e., require facilities to
follow either the Cycle Calculation Approach or the Bioburden/
Biological Indicator Approach) pursuant to CAA section 112(d)(5), which
authorizes the EPA to set standards for area sources that provide for
the use of generally available control technologies or management
practices to reduce emissions. In addition, CAA section 112(h)(1)
authorizes the EPA to promulgate a design, equipment, work practice or
operational standard, or a combination thereof, if the EPA does not
think it can prescribe an emission standard. We have identified
modification of the post-sterilization process (e.g., reducing the EtO
concentration within the sterilization chamber prior to opening the
chamber) as a BMP that can reduce EtO emissions from certain affected
sources at commercial sterilization area source facilities. Neither CAA
section 112(d)(5) nor section 112(h)(1) limits the scope of management
or work practices that the EPA may consider in setting standards to
control HAP, nor did the commenter identify any such legal limitation
in the CAA or other applicable legal authorities. As discussed above,
we are not finalizing the proposed BMP; in response to comment, we are
finalizing a requirement for area source facilities with existing Group
2 room air emissions to lower the in-chamber EtO concentration to 1 ppm
before the chamber is opened.\26\ As discussed in
[[Page 24108]]
section IV.C.2.a.iii of this preamble, this requirement will ultimately
apply only to existing Group 2 room air emissions at facilities where
EtO use is less than 4 tpy. Based on responses to the December 2019
questionnaire and the September 2021 ICR, we have not identified any
facilities where EtO use is less than 4 tpy that are not currently
meeting this requirement. Therefore, in general, we do not anticipate
that any facilities will need to go through a new cycle validation as a
result of this requirement. Based on our conversations with FDA, this
requirement is not anticipated to have an adverse impact on the medical
device supply chain.
---------------------------------------------------------------------------
\26\ We have previously regulated the in-chamber EtO
concentration when we established standards for CEVs at facilities
where EtO use is at least 1 tpy but less than 10 tpy (59 FR 62586,
December 6, 1994). These requirements were removed initially due to
safety concerns regarding the regulation of emissions from CEVs, not
related to any limitations on our authority. See discussion in
section III.B.5 of the proposal preamble (88 FR 22790, April 13,
2023) for more information regarding why safety is not a concern
regarding the requirements finalized in this action.
---------------------------------------------------------------------------
b. Mass Rate Emission Standards
Comment: Several commenters were opposed to mass rate emission
standards, stating that they do not account for the substantial
variability among volumetric flow rates in sterilization operations.
The commenters expressed concerns with potential operational reductions
needed in order to meet the standards while still ensuring worker
health and safety, as well as compliance with EPA Method 204. The
commenters suggested that we finalize emission reduction and outlet
concentration standards instead. In addition, these commenters
recommended that these standards be based on control device
manufacturer guarantees. One commenter stated that, based on their
discussions with control device manufacturers, they believe that the
best and most advanced technologies will be guaranteed to meet a 99
percent emission reduction standard for CEVs and an 80 percent emission
reduction standard for room air emissions.
Response: We agree with the commenters' concerns regarding the
potential impacts of mass rate emission standards. Given the low outlet
EtO concentration of these streams, along with current EtO detection
levels, a mass rate emission standard essentially functions as an
upper-bound limit on volumetric flow rate. It may not be appropriate to
limit volumetric flow rate in this fashion, as additional flow may be
needed in order to demonstrate compliance with EPA Method 204 or to
ensure worker health and safety. If volumetric flow rate is limited, a
facility may be forced to reduce its sterilization capacity in order to
meet the mass rate emission standards. However, we disagree with the
commenters' suggestion that outlet concentration standards be
considered. We are concerned that some owners and operators may choose
to dilute the air flow of the emissions stream rather than control
emissions, in order to meet an outlet concentration standard, which
would not result in emission reductions. In order to ensure emission
reductions from an outlet concentration standard, an upper-bound limit
on the volumetric flow rate would be necessary. As we have discussed
before, this may be inappropriate for the source category. Therefore,
although we proposed mass emission rate standards, we are finalizing
percentage emission reduction standards in their place, and those
specific standards are discussed later in this section.
We re-calculated the MACT floor for existing CEVs at major source
facilities. We ranked the percent reduction performance of the CEVs
``for which the EPA has emissions information'' and found the best
performing 12 percent of CEVs consists of one CEV that is being
controlled by a gas/solid reactor.\27\ Because the variability and
uncertainty associated using available, short-term data would tend to
reduce the minimum percent reduction, we then used the lower, not
upper, prediction limit approach to develop the MACT floor for existing
sources.\28\ The LPL approach predicts the level of emissions that the
sources upon which the floor is based are expected to meet over time,
considering both the average emissions level achieved as well as
emissions variability and the uncertainty that exists in the
determination of emissions variability given the available, short-term
data. For LPLs, our practice is to use the first percentile, or LPL 1,
as that is the level of emission reductions that we are 99 percent
confident is achieved by the average source represented in a dataset
over a long-term period based on its previous, measured performance
history as reflected in short term stack test data. The LPL 1 value of
the existing source MACT floor is 99.94 percent emission reduction. The
LPL 1 EtO concentration that corresponds to this emission reduction
rate is 49 ppbv. Based on our review of available EtO measurement
instruments and our demonstration program, we find the in-stack
detection level for EtO, given the current technology, and potential
makeup of emission streams, is approximately 10 ppbv. Some EtO CEMS
manufacturers claim instrument detection levels much lower than 10
ppbv. However, we believe at the current time, 10 ppbv is the lowest
level that can be consistently demonstrated and replicated across a
wide range of emission profiles. We expect that EtO CEMS manufacturers,
measurement companies, and laboratories will continue to improve EtO
detection levels (making them lower). In the meantime, consistent with
our practice regarding reducing relative measurement imprecision by
applying a multiplication factor of three to the RDL, the average
detection level of the best performers, or, in this case, the better
performing instruments, so that measurements at or above this level
have a measurement accuracy within 10 to 20 percent--similar to that
contained in the American Society of Mechanical Engineers (ASME) ReMAP
study,\29\ we apply a multiplication factor of three to the RDL of 10
ppbv, which yields a workable-in-practice lower measurable value of 30
ppbv. For reference, below is the equation that relates the percent
emission reduction, inlet EtO concentration, and outlet EtO
concentration:
---------------------------------------------------------------------------
\27\ See CAA section 112(d)(3). See also, National Ass'n of
Clean Water Agencies v. EPA, 734 F.3d 1115, 1131 (2013) (citing
Sierra Club v. EPA, 167 F.3d 658, 661 and 662) (``We accorded
Chevron deference to EPA's . . . estimate of the MACT floor, noting
that the requirement that the existing unit floors `not be less
stringent than the average emissions limitation achieved by the best
performing 12 percent of units' does not, on its own, dictate `how
the performance of the best units is to be calculated, . . . [and]
recognizing that `EPA typically has wide latitude in determining the
extent of data gathering necessary to solve a problem.' ''
\28\ The variability for a DRE format limit requires use of a
lower prediction limit (LPL), the UPL template was therefore
modified for use to determine the LPL; rather than use of the 99th
percentile that captures the ``right tail'' of the data
distribution, the LPL template uses the 1st percentile, i.e.,
captures the ``left tail'' of the data distribution (the t-statistic
is 0.01). The LPL differs from the more commonly used UPL in that
variability and uncertainty associated with percent reduction limits
tend to make the predicted limits smaller than their averages; for
UPL applications, variability and uncertainty associated with
emission limits tend to make those predicted limits larger than
their averages. Both approaches--UPL and LPL--rely on the same set
of equations developed for the UPL; they only differ in the selected
percentile. In other words, the LPL relies on calculations
associated with the first percentile (LPL 1) of the data
distribution, which is below the fiftieth percentile (LPL 50), or
average for data with a normal distribution, while the UPL relies on
calculations associated with the ninety-ninth percentile (UPL 99) of
the data distribution, which is above the fiftieth percentile (UPL
50), or average for data with a normal distribution. Also note that
for data in a normal distribution, LPL 50 = UPL 50.
\29\ See the discussion in the MATS rule preamble at 77 FR 9370,
February 16, 2012.
[GRAPHIC] [TIFF OMITTED] TR05AP24.000
Where, ER is the percent emission reduction, EtO<INF>IM</INF> is
the inlet EtO mass, and EtO<INF>OM</INF> is the outlet EtO mass. Since
[[Page 24109]]
the outlet EtO concentration that corresponds to the MACT floor of
99.94 percent emission reduction is above 3xRDL, there are more
stringent (i.e., BTF) options to consider.\30\ We considered two BTF
options for reducing EtO emissions from this source: the first option
is 99.95 percent emission reduction, and the second option reflects the
most stringent emission reduction for which compliance can be
demonstrated. With respect to the second option, the most stringent
emission reduction for which compliance can be demonstrated is that
which corresponds to an outlet concentration of 30 ppbv (i.e., 3xRDL).
This emission reduction is 99.96 percent, which is lower than all of
the reported emission reductions in the test runs that were used to
calculate the MACT floor. The impacts of these options are presented in
table 7. Because we have not identified any major source facilities
with existing CEVs, the impacts are based on a model plant for existing
CEVs at a synthetic area source facility with the following assumptions
reflecting the average of each of the parameters at synthetic area
source facilities:
---------------------------------------------------------------------------
\30\ As Judge Williams explained in his concurring opinion in
Sierra Club v. EPA, CAA ``Section 112(d)(2) calls for emissions
standards that are the most stringent that the EPA finds to be
`achievable,' taking into account a variety of factors including
cost. . . . The ``achievable'' standards have come to be known as
the ``beyond-the-floor'' standards, . . . meaning, obviously, ones
more stringent than the ``floors'' established under Sec.
112(d)(3).'' 479 F.3d 875, 884 (D.C. Cir. 2007).
---------------------------------------------------------------------------
<bullet> Annual EtO use: 200 tpy.
<bullet> Annual operating hours: 8,000.
<bullet> Portion of EtO going to CEVs: 1 percent.
<bullet> CEV flow rate: 278 cubic feet per second (cfs).
Table 7--Nationwide Emissions Reduction and Cost Impacts of BTF Options Considered Under CAA Sections 112(d)(2) and 112(d)(3) for CEVs at Major Source
Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital Total annual EtO emission reductions Cost effectiveness ($/
Option Proposed standard investment ($) costs ($/yr) (tpy) ton EtO)
--------------------------------------------------------------------------------------------------------------------------------------------------------
MACT Floor........................... 99.94 percent emission $830,000 $176,000 2.4E-2 [480 lb/yr]...... $735,000 [$370/lb].
reduction.
1.................................... 99.95 percent emission 184,000 65,500 2.0E-4 [0.4 lb/year].... 328,000,000 [$164,000/
reduction. lb].
2.................................... 99.96 percent emission 184,000 66,200 2.0E-4 [0.4 lb/year].... 331,000,000 [$166,000/
reduction. lb].
--------------------------------------------------------------------------------------------------------------------------------------------------------
While we acknowledge that EtO is a highly toxic HAP, the cost
estimates above are far outside the range of the cost-effectiveness
values that we have determined to be cost-effective for highly toxic
HAPs (e.g., we finalized a requirement with a cost-effectiveness of
$15,000/lb ($30,000,000/ton) for existing small hard chromium
electroplating to provide an ample margin of safety (taking into
account cost among other factors) (77 FR 58227-8, 58239). Based on the
estimates above, we find neither option to be cost effective.
Therefore, the final MACT standard for existing CEVs at major source
facilities is 99.94 percent emission reduction.
For new sources, CAA section 112(d)(3) requires that the standard
shall not be less stringent than the emission control that is achieved
in practice by the best controlled similar source. In this case, the
best controlled similar source is also the CEV that is being controlled
by a gas/solid reactor and the data of which is used to determine the
MACT floor for existing sources. Therefore, the new source MACT floor
is equivalent to the existing source MACT floor, which is 99.94 percent
emission reduction. As explained above, because this emission reduction
limit is above the lowest level at which compliance can be
demonstrated, the EPA considered more stringent (i.e., BTF) options. We
considered the same BTF options as those evaluated for existing CEVs at
major source facilities, for the same reasons explained above. The
first BTF option would require achieving 99.95 percent emission
reduction, and the second BTF option would require achieving 99.96
percent emission reduction. The impacts of these options are presented
in table 7 of this preamble. Because we have not identified any major
source facilities with existing CEVs, the impacts are based on a model
plant for existing CEVs at a synthetic area source facility. Based on
the estimates above and for the reason explained above, we find neither
option to be cost effective. Therefore, the final MACT standard for new
CEVs at major source facilities is 99.94 percent emission reduction.
For the reasons explained above, our final MACT standards under CAA
sections 112(d)(2) and (3) for both new and existing CEVs at major
source facilities require these facilities to reduce the EtO emissions
from new and existing CEVs by 99.94 percent.
For existing CEVs at area source facilities, we considered two
potential GACT options for reducing EtO emissions from this group: the
first option reflects the use of emission controls on the CEVs, and the
second option reflects applying a BMP to lower the in-chamber EtO
concentration to 1 ppm before the chamber is opened (i.e., pollution
prevention). With respect to the first option, because 34 out of 40
area source facilities with CEVs already using controls to reduce CEV
emissions, and we have no reason to believe that the other six cannot
do the same, we consider emission controls to be generally available
for existing CEVs at these facilities. Evaluating the available
information on controls, including the documented control efficiency
for 12 facilities in the category, we determined that a control
efficiency of 99 percent is generally available for existing CEVs at
area source facilities. The second potential GACT option we considered
was the same management practice discussed in section IV.B.3.a of this
preamble, which would require facilities to lower the in-chamber EtO
concentration to 1 ppm before the chamber is opened. The impacts of
these two options are presented in table 8.
[[Page 24110]]
Table 8--Nationwide Emissions Reduction and Cost Impacts of Options Considered Under CAA Section 112(d)(5) for Existing CEVs at Area Source Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital Total annual costs ($/ EtO emission Cost effectiveness ($/
Option Proposed standard investment ($) yr) reductions (tpy) ton EtO)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................. 99 percent emission $1,750,000 $740,000.............. 3.84 [7,680 lb/year].. 193,000 [$96/lb]
reduction.
2.................................. BMP (estimated 20 percent 0 $3,560,000 (one-time 0.796 [1,590 lb/year]. $4,470,000 [$2,240/lb]
emission reduction). annual cost) \1\.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber EtO concentration to 1 ppm before the
chamber is opened, as well as preparing and submitting the necessary paperwork to FDA for approval. It is expected that facilities will only incur
this cost once and it is assumed to be incurred in the first year of compliance, but it is treated as an annual cost for the purposes of estimating
total annual costs (i.e., annualized capital costs plus annual costs) in the analysis.
Based on the estimates above, and considering EtO is a highly
potent carcinogen, the cost-effectiveness numbers of these options are
within the range of the values that we have determined to be cost-
effective for highly toxic HAPs. Such values include hexavalent
chromium, where we finalized a requirement with a cost-effectiveness of
$15,000/lb ($30,000,000/ton) for existing small hard chromium
electroplating to provide an ample margin of safety (taking into
account cost among other factors) (77 FR 58227-8, 58239). We are
finalizing Option 1 for the following reasons. First, while both
options are considered generally available under CAA section 112(d)(5),
Option 1 would achieve much greater emission reduction than Option 2.
Second, Option 1 would incur fewer annual costs than Option 2.
Therefore, pursuant to CAA section 112(d)(5), we are finalizing Option
1 for existing CEVs at area source facilities. Specifically, we are
finalizing a requirement for these facilities to continuously reduce
emissions from existing CEVs by 99 percent.
For new CEVs at area source facilities, we considered two potential
GACT options similar to those evaluated for existing CEVs at area
source facilities. The first potential GACT option would require
achieving 99 percent emission reduction. The second potential GACT
option we considered is a BMP described in section IV.B.3.a, which
would require facilities to lower the in-chamber EtO concentration to 1
ppm before the chamber is opened. The impacts of these options, which
are presented in table 9 of this preamble, are based on a model plant
for new CEVs at a new area source facility with the following
assumptions reflecting the average of each of the parameters at
existing area source facilities:
<bullet> Annual EtO use: 100 tpy.
<bullet> Annual operating hours: 8,000.
<bullet> Portion of EtO going to CEVs: 1 percent.
<bullet> CEV flow rate: 200 cubic feet per second (cfs).
<bullet> Number of unique cycles: nine.
Table 9--Nationwide Emissions Reduction and Cost Impacts of Options Considered Under CAA Section 112(d)(5) for New CEVs at Area Source Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital Total annual costs ($/ EtO emission Cost effectiveness ($/
Option Proposed standard investment ($) yr) reductions (tpy) ton EtO)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................. 99 percent emission $553,000 $142,000.............. 0.99 [1,980 lb/year].. $144,000 [$72/lb]
reduction.
2.................................. BMP (estimated 20 percent 0 $80,000 (one-time 0.20 [400 lb/year].... $400,000 [$200/lb]
emission reduction). annual cost) \1\.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber EtO concentration to 1 ppm before the
chamber is opened, as well as re-submitting to FDA for approval. It is expected that facilities will only incur this cost once and it is assumed to be
incurred in the first year of compliance, but it is treated as an annual cost for the purposes of estimating total annual costs (i.e., annualized
capital costs plus annual costs) in the analysis.
Based on the estimates above, and considering EtO is a highly
potent carcinogen, the cost-effectiveness number of Option 2 is within
the range of the values that we have determined to be cost-effective
for highly toxic HAPs. While both options are considered generally
available under CAA section 112(d)(5), Option 1 would achieve greater
emission reductions than Option 2, and it is more cost-effective.
Therefore, we are finalizing Option 1 as the standard for new CEVs at
area source facilities under CAA section 112(d)(5). The standard
requires these facilities to continuously reduce emissions from new
CEVs by 99 percent.
We have re-calculated the MACT floor for existing Group 1 room air
emissions at major source facilities. We ranked the performance of the
facilities with Group 1 room air emissions for which data are available
based on percent emission reduction. There are only three performance
tests that are currently available, only one of which contains three
test runs. Therefore, the best performing 12 percent of facilities for
which data are available consists of one facility with three test runs
that is controlling its Group 1 room air emissions with a gas/solid
reactor. That facility reported an emission reduction of 98 percent. We
then used the LPL approach, as mentioned previously, to develop the
MACT floor for existing sources. The LPL 1 value of the existing source
MACT floor is 90 percent emission reduction. The outlet EtO
concentration (UPL 99 value) that corresponds to this emission
reduction is 93 ppbv. Since this is above 3xRDL, there are more
stringent (i.e., BTF) options to consider. We considered two BTF
options for reducing EtO emissions from this source: the first option
we considered was 95 percent emission reduction. The first option
reflects the lowest emission reduction that we have observed in
performance tests, and The second option reflects the most stringent
emission reduction for which compliance can be demonstrated. With
respect to the second option, the most stringent emission reduction for
which compliance can be demonstrated is that which corresponds to an
outlet concentration of 30 ppbv (i.e., 3xRDL). This emission reduction
is 97 percent, which is lower than two of the three reported values in
the test runs that were used to calculate the MACT floor. The impacts
of these options are presented in table 10 (along with the MACT floor
impacts). Because we have
[[Page 24111]]
not identified any major source facilities with existing Group 1 room
air emissions, the impacts are based on a model plant for existing
Group 1 room air emissions at a synthetic area source facility with the
following assumptions reflecting the average of each of the parameters
at synthetic area source facilities:
<bullet> Annual EtO use: 140 tpy.
<bullet> Annual operating hours: 8,000.
<bullet> Portion of EtO going to Group 1 RAE: 0.4 percent.
<bullet> Group 1 room air emission flow rate: 400 cubic feet per
second (cfs).
Table 10--Nationwide Emissions Reduction and Cost Impacts of BTF Options Considered Under CAA Sections 112(d)(2) and 112(d)(3) for Group 1 Room Air
Emissions at Major Source Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital Total annual EtO emission reductions Cost effectiveness ($/
Option Proposed standard investment ($) costs ($/yr) (tpy) ton EtO)
--------------------------------------------------------------------------------------------------------------------------------------------------------
MACT floor........................... 90 percent emission reduction $830,000 $176,000 0.168 [336 lb/year]..... $1,050,000 [$525/lb].
1.................................... 95 percent emission reduction 553,000 129,000 2.80E-2 [56.0 lb/year].. $4,610,000 [$2,300/lb].
2.................................... 97 percent emission reduction 461,000 113,000 1.12E-2 [22.4 lb/year].. $10,100,000 [$5,040/lb].
--------------------------------------------------------------------------------------------------------------------------------------------------------
Based on the estimates above, and considering EtO is a highly
potent carcinogen, the cost-effectiveness numbers are within the range
of the values that we have determined to be cost-effective for highly
toxic HAPs. While both options are considered BTF under CAA sections
112(d)(2), Option 2 would achieve greater emission reductions than
Option 1. Therefore, the final MACT standard under CAA sections
112(d)(2) and (3) for existing Group 1 room air emissions at major
source facilities is 97 percent emission reduction.
For new sources, CAA section 112(d)(3) requires that the standard
shall not be less stringent than the emission control that is achieved
in practice by the best controlled similar source. In this case, the
best controlled similar source is also the Group 1 room air emissions
that are being controlled by a gas/solid reactor and the data of which
is used to determine the MACT floor for existing sources. Therefore,
the new source MACT floor is equivalent to the existing source MACT
floor, which is 90 percent emission reduction. We considered the same
BTF options as those evaluated for existing Group 1 room air emissions
at major source facilities for the same reasons explained above. The
first BTF option would require achieving 95 percent emission reduction,
and the second BTF option would require achieving 97 percent emission
reduction. The impacts of these options are presented in table 10 of
this preamble. Because we have not identified any major source
facilities with existing Group 1 room air emissions, the impacts are
based on a model plant for new Group 1 room air emissions at a
synthetic area source facility. Based on the estimates above, and
considering EtO is a highly potent carcinogen, the cost-effectiveness
numbers are within the range of the values that we have determined to
be cost-effective for highly toxic HAPs. While both options are
considered BTF under CAA sections 112(d)(2), Option 2 would achieve
greater emission reductions than Option 1. Therefore, the final
standard for new Group 2 room air emissions at major source facilities
is 97 percent emission reduction. We also considered non-air quality
health and environmental impacts and energy requirements when
evaluating the BTF options. Further discussion of these considerations
is presented in the document MACT Floor Analysis for Ethylene Oxide
Commercial Sterilization--Chamber Exhaust Vents and Room Air Emission
Sources--Promulgation Rule Review for the Ethylene Oxide Commercial
Sterilization Source Category, available in the docket for this
rulemaking.
For existing Group 1 room air emissions at area source facilities,
we considered two potential GACT options for reducing EtO emissions
from this group: the first option reflects the use of emission controls
on Group 1 room air emissions, and the second option is the same BMP
discussed above (lowering the in-chamber EtO concentration to 1 ppm
before the chamber is opened). With respect to the first option, 32 out
of 74 area source facilities with Group 1 room air emissions are
already using controls to reduce those emissions.\31\ We considered a
standard of 80 percent emission reduction, which is the manufacturer
guarantee for room air emissions controls provided by one of the
commenters. We find this standard to be reasonable for existing Group 1
room air emissions at area source facilities because it is the
manufacturer guarantee, which means that it is a level of emission
reduction that all sources can achieve. While some sources have
demonstrated emission reductions higher than 80 percent, those
reductions are limited to facilities with higher EtO usage rates, and
we cannot determine whether smaller users of EtO can meet those
emission reductions. The second potential GACT option we considered was
the same management practice discussed in section IV.B.3.a, which would
require facilities to lower the in-chamber EtO concentration to 1 ppm
before the chamber is opened. During the sterilization process, EtO
becomes trapped within the material and continues to off-gas after the
sterilization process is complete. Therefore, if more EtO is driven out
of the product prior to opening the chamber, this can lead to a
reduction in post-sterilization EtO emissions, including those from
pre-aeration handling of sterilized material. The impacts of these
options are presented in table 11.
---------------------------------------------------------------------------
\31\ The Group 1 room air emission reduction at these facilities
ranges from 52 percent to 99.8 percent. It should be noted that the
facility with the emission reduction at the upper bound of this
range uses 135 tpy of EtO.
[[Page 24112]]
Table 11--Nationwide Emissions Reduction and Cost Impacts of Options Considered Under CAA Section 112(d)(5) for Existing Group 1 Room Air Emissions at
Area Source Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital Total annual costs ($/ EtO emission Cost effectiveness ($/
Option Proposed standard investment ($) yr) reductions (tpy) ton EtO)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................. 80 percent emission $91,000,000 $12,900,000........... 3.66 [7,320 lb/year].. $3,530,000 [$1,770/
reduction. lb].
2.................................. BMP (estimated 20 percent $0 $5,040,000 (one-time 1.13 [2,260 lb/year].. $4,460,000 [$2,230/
emission reduction). annual cost) \1\. lb].
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber EtO concentration to 1 ppm before the
chamber is opened, as well as re-submitting to FDA for approval. It is expected that facilities will only incur this cost once and it is assumed to be
incurred in the first year of compliance, but it is treated as an annual cost for the purposes of estimating total annual costs (i.e., annualized
capital costs plus annual costs) in the analysis.
Based on the estimates above, and considering EtO is a highly
potent carcinogen, the cost-effectiveness numbers of these options are
within the range of the values that we have determined to be cost
effective for highly toxic HAPs. We are finalizing Option 1 because
while both options are considered generally available under CAA section
112(d)(5), Option 1 would achieve greater emission reduction than
Option 2. Therefore, pursuant to CAA section 112(d)(5), we are
finalizing Option 1 for existing Group 1 room air emissions at area
source facilities. Specifically, we are finalizing a requirement for
these facilities to continuously reduce emissions from existing Group 1
room air emissions by 80 percent.
For new Group 1 room air emissions at area source facilities, we
considered the same two potential GACT options as those evaluated for
existing Group 1 room air emissions at area source facilities for the
same reasons explained above. The first potential GACT option (Option
1) would require achieving an emission reduction of 80 percent. The
second potential GACT option we considered (Option 2) is a BMP that
would require facilities to lower the in-chamber EtO concentration to 1
ppm before the chamber is opened. The impacts of these options, which
are presented in table 12 of this preamble, are based on a model plant
for new Group 1 room air emissions at an area source facility with the
assumptions reflecting the average of each of the parameters at area
source facilities with new Group 1 room air emissions as described in
section III.B.8.c of the proposal preamble.
Table 12--Model Plant Emissions Reduction and Cost Impacts of Options Considered Under CAA Section 112(d)(5) for New Group 1 Room Air Emissions at Area
Source Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital Total annual costs ($/ EtO emission Cost effectiveness ($/
Option Proposed standard investment ($) yr) reductions (tpy) ton EtO)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................. 80 percent emission $922,000 $192,000.............. 0.288 [576 lb/year]... $666,000 [$333/lb].
reduction.
2.................................. BMP........................ 0 $80,000 (one-time 7.20E-2 [144 lb/year]. $1,110,000 [$556/lb].
(estimated 20 percent annual cost) \1\.
emission reduction).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber EtO concentration to 1 ppm before the
chamber is opened, as well as re-submitting to FDA for approval. It is expected that facilities will only incur this cost once and it is assumed to be
incurred in the first year of compliance, but it is treated as an annual cost for the purposes of estimating total annual costs (i.e., annualized
capital costs plus annual costs) in the analysis.
Based on the estimates above, we find both options to be cost
effective. While both options are considered generally available under
CAA section 112(d)(5), Option 1 would achieve greater emission
reductions than Option 2. Therefore, pursuant to CAA section 112(d)(5),
we are finalizing standards for new Group 1 room air emissions at area
source facilities. Specifically, we are finalizing a requirement for
these facilities to continuously reduce emissions from new Group 1 room
air emissions by 80 percent.
We re-calculated the MACT floor for existing Group 2 room air
emissions at major source facilities. We ranked the performance of the
facilities with Group 2 room air emissions for which data are available
based on percent emission reduction. There are only three performance
tests that are currently available, only one of which contains three
test runs. Therefore, the best performing 12 percent of facilities for
which data are available consists of one facility with three test runs
that is controlling its Group 2 room air emissions with a gas/solid
reactor. That facility reported an emission reduction of 96 percent. As
mentioned previously, we then used the LPL approach to develop the MACT
floor for existing sources. The LPL 1 value of the existing source MACT
floor is 94 percent emission reduction. The outlet EtO concentration
(LPL 1 value) that corresponds to this emission reduction is 10 ppbv.
Since this is below 3xRDL, we adjusted the MACT floor by determining
the emission reduction using 30 ppbv and the LPL 1 value of the inlet
EtO concentration of the Group 2 room air emissions stream at the
facility, which is 0.12 ppmv. This results in an adjusted MACT floor of
86 percent emission reduction. Since this represents 3xRDL, there are
no more stringent (i.e., BTF) options to consider, as there would be
difficulty demonstrating compliance at any such lower limit. Therefore,
the final MACT standard under CAA sections 112(d)(2) and (3) for
existing Group 2 room air emissions at major source facilities is 86
percent emission reduction.
For new sources, CAA section 112(d)(3) requires that the standard
shall not be less stringent than the emission control that is achieved
in practice by the best controlled similar source. In this case, the
best controlled similar source is also the Group 2 room air emissions
that are being controlled by a gas/solid reactor and the data of which
is used to determine the MACT
[[Page 24113]]
floor for existing sources. Therefore, the new source MACT floor is
equivalent to the existing source MACT floor, which is 86 percent
emission reduction. As explained above, because this emission limit
represents the lowest level at which compliance can be demonstrated,
the EPA did not consider more stringent (i.e., BTF) options. Therefore,
the proposed standard for new Group 2 room air emissions at major
source facilities is 86 percent emission reduction.
For existing Group 2 room air emissions at area source facilities,
we considered two potential GACT options for reducing EtO emissions
from this group: the first option reflects the use of emission controls
on Group 2 room air emissions, and the second option is the same BMP
discussed above (lowering the in-chamber EtO concentration to 1 ppm
before the chamber is opened). With respect to the first option, 30 out
of 80 area source facilities with Group 2 room air emissions are
already using controls to reduce those emissions.\32\ We considered a
standard of 80 percent emission reduction, which is the manufacturer
guarantee for room air emissions controls provided by one of the
commenters. We find this standard to be reasonable for existing Group 2
room air emissions at area source facilities because it is the
manufacturer guarantee, which means that it is a level of emission
reduction that all sources can achieve. While some sources have
demonstrated emission reductions higher than 80 percent, those
reductions are limited to facilities with higher EtO usage rates, and
we cannot determine whether smaller users of EtO can meet those
emission reductions. The second potential GACT option we considered was
the same management practice discussed in section IV.B.3.a, which would
require facilities to lower the in-chamber EtO concentration to 1 ppm
before the chamber is opened. During the sterilization process, EtO
becomes trapped within the material and continues to off-gas after the
sterilization process is complete. Therefore, if more EtO is driven out
of the product prior to opening the chamber, this can lead to a
reduction in post-sterilization EtO emissions, including those from
post-aeration handling of sterilized material. The impacts of these
options are presented in table 13.
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\32\ The Group 2 room air emission reduction at these facilities
ranges from 30 percent to 99.97 percent. It should be noted that the
facility with the emission reduction at the upper bound of this
range uses 135 tpy of EtO.
Table 13--Nationwide Emissions Reduction and Cost Impacts of Options Considered Under CAA Section 112(d)(5) for
Existing Group 2 Room Air Emissions at Area Source Facilities
----------------------------------------------------------------------------------------------------------------
EtO emission Cost
Option Proposed Total capital Total annual reductions effectiveness
standard investment ($) costs ($/yr) (tpy) ($/ton EtO)
----------------------------------------------------------------------------------------------------------------
1........................... 80 percent $236,000,000 $32,700,000.... 1.10 [2,200 lb/ $29,700,000
emission year]. [$14,900/lb].
reduction.
2........................... BMP (estimated 0 $5,440,000 (one- 0.311 [622 lb/ $17,500,000
20 percent time annual year]. [$8,750/lb].
emission cost) \1\.
reduction).
----------------------------------------------------------------------------------------------------------------
\1\ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber
EtO concentration to 1 ppm before the chamber is opened, as well as re-submitting to FDA for approval. It is
expected that facilities will only incur this cost once and it is assumed to be incurred in the first year of
compliance, but it is treated as an annual cost for the purposes of estimating total annual costs (i.e.,
annualized capital costs plus annual costs) in the analysis.
Based on the estimates above, and considering EtO is a highly
potent carcinogen, the cost-effectiveness numbers of these options are
within the range of the values that we have determined to be cost-
effective for highly toxic HAPs. Further, as discussed in section
III.B.8.g of the proposal preamble (88 FR 28790, April 13, 2023), there
are multiple factors we consider in assessing the cost of the emission
reductions. See NRDC v. EPA, 749 F.3d 1055, 1060 (D.C. Cir. April 18,
2014) (``Section 112 does not command the EPA to use a particular form
of cost analysis.''). These factors include, but are not limited to,
total capital costs, total annual costs, cost-effectiveness, and annual
costs compared to total revenue (i.e., costs to sales ratios). Our
established methodology for assessing economic impacts of regulations
indicates that the potential for adverse economic impacts begins when
the cost to sales ratio exceeds three percent. According to our
estimates, the annual cost of the emission control option for most of
the affected sources discussed above is well below three percent.\33\
However, reducing existing Group 2 room air emissions at area source
facilities using emission control devices (Option 1), would
significantly impact several companies operating a total of nine area
source facilities with Group 2 room air emissions. We estimate that the
annual cost of controls at the level under Option 1 would exceed three
percent of revenue for these companies.\34\ Based on the available
economic information, assuming market conditions remain approximately
the same, we are concerned that these companies would not be able to
sustain the costs associated with Option 1. In addition, according to
FDA, six of these facilities could impact the availability of the
medical devices described in section I.A.1 of this preamble. Therefore,
pursuant to CAA section 112(d)(5), we are finalizing Option 2 as the
GACT standard for existing Group 2 room air emissions at area source
facilities. Specifically, this GACT standard requires facilities to
lower the in-chamber EtO concentration to 1 ppm before the chamber is
opened.\35\
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\33\ See memorandum, Technical Support Document for Proposed
Rule--Industry Profile, Review of Unregulated Emissions, CAA Section
112(d)(6) Technology Review, and CAA Section 112(f) Risk Assessment
for the Ethylene Oxide Emissions Standards for Sterilization
Facilities NESHAP, located at Docket ID No. EPA-HQ-OAR-2019-0178.
\34\ The issue of high cost-to-sales ratios is present only for
this option and, thus, is not discussed for other options.
\35\ As discussed in section IV.C.2.a.iii of this preamble, this
GACT standard will ultimately apply only to facilities where EtO use
is less than 4 tpy. Facilities where EtO use is at least 4 tpy will
be required to meet an emission standard established under CAA
section 112(f)(2).
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For new Group 2 room air emissions at area sources facilities, we
considered the same two potential GACT options as those evaluated for
existing Group 1 room air emissions at area source facilities for the
same reasons explained above. The first potential GACT option (Option
1) would require achieving an emission reduction of 80 percent. The
second potential GACT option we considered (Option 2) is a BMP that
would require facilities to lower the in-chamber EtO concentration to 1
ppm before the chamber is opened. The impacts of these options, which
are presented in table 14 of this preamble, are based on a model plant
for new Group 2 room air emissions at an area source facility with the
assumptions reflecting the average of each of the parameters at area
source facilities with
[[Page 24114]]
new Group 1 room air emissions as described in section III.B.8.h of the
proposal preamble.
Table 14--Model Plant Emissions Reduction and Cost Impacts of Options Considered Under CAA Section 112(d)(5) for
New Group 2 Room Air Emissions at Area Source Facilities
----------------------------------------------------------------------------------------------------------------
EtO emission Cost
Option Proposed Total capital Total annual reductions effectiveness
standard investment ($) costs ($/yr) (tpy) ($/ton EtO)
----------------------------------------------------------------------------------------------------------------
1........................... 80 percent $1,840,000 $332,000....... 3.6E-2 [72 lb/ $9,170,000
emission year]. [$4,560/lb].
reduction.
2........................... BMP (estimated 0 $40,000 (one- 9.1E-3 [18 lb/ $4,375,000
20 percent time annual year]. [$2,190/lb].
emission cost)\1\.
reduction).
----------------------------------------------------------------------------------------------------------------
\1\ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber
EtO concentration to 1 ppm before the chamber is opened, as well as re-submitting to FDA for approval. It is
expected that facilities will only incur this cost once and it is assumed to be incurred in the first year of
compliance, but it is treated as an annual cost for the purposes of estimating total annual costs (i.e.,
annualized capital costs plus annual costs) in the analysis.
Based on the estimates above, and considering EtO is a highly
potent carcinogen, the cost-effectiveness numbers of these options are
within the range of the values that we have determined to be cost-
effective for highly toxic HAPs. As discussed earlier in this section,
this includes hexavalent chromium, where we finalized a requirement
with a cost-effectiveness of $15,000/lb ($30,000,000/ton) for existing
small hard chromium electroplating to provide an ample margin of safety
(taking into account cost among other factors) (77 FR 58227-8, 58239).
Although both options are considered generally available under CAA
section 112(d)(5), Option 1 would achieve four times the emission
reductions of Option 2. Therefore, pursuant to CAA section 112(d)(5),
we are finalizing standards for new Group 2 room air emissions at area
source facilities. Specifically, we are finalizing a requirement for
these facilities to continuously reduce emissions from new Group 2 room
air emissions by 80 percent.
c. PTE
Comment: We received extensive comment on our proposal to require
that each facility must operate areas with room air emissions subject
to an emission standard under the PTE requirements of EPA Method 204.
Some commenters were supportive of this requirement, stating that other
regulatory bodies have already required this and that this is the
correct protocol for ensuring that emissions are captured and routed to
a control system. Other commenters were opposed to this requirement,
stating that EPA Method 204 was established for smaller point source
operations (e.g., paint booths, spray coating), as opposed to larger
sterilization facilities. Several commenters cited other technical
concerns, including the fact that not every facility is currently
configured to meet the PTE requirements of EPA Method 204. The
commenters suggested broad alternatives, including a simple requirement
to operate areas with room air emissions subject to an emission
standard under negative pressure.
Response: We strongly disagree with the commenters that EPA Method
204 is not appropriate to apply to this source category. The design
requirements of EPA Method 204 are agnostic to the industry it is
applied. It has been applied widely to any industrial processes that
needs to control VOC emissions, including several existing commercial
sterilizers that have already been complying with EPA Method 204. In
order to meet the emission standards, it is necessary to ensure that
all emissions are captured and routed to a control system. Our
established protocol in numerous new source performance standards,
NESHAPs, and federally enforceable State and local programs (e.g.,
title V permits, State implementation plans) for ensuring complete
capture of room air emissions is EPA Method 204. We recognize that many
commercial sterilizers will need to retrofit their facilities to meet
the PTE requirements of EPA Method 204, similar to facilities that have
already done so. We have accounted for the cost to re
[…truncated; see source link]Indexed from Federal Register on April 5, 2024.
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