[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 [www.gpo.gov]
[FR Doc No: 2024-05905]
[[Page 24089]]
Vol. 89
Friday,
No. 67
April 5, 2024
Part II
Environmental Protection Agency
-----------------------------------------------------------------------
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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov/ 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
https://www.regulations.gov/, 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: [email protected]. 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: [email protected].
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.
---------------------------------------------------------------------------
\1\ Evaluation of the Inhalation Carcinogenicity of Ethylene
Oxide, December 2016, EPA/635/R-16/350Fc.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ 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/.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\3\ https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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:
SCVs at facilities where EtO use is at least 30 tpy
SCVs at facilities where EtO use is at least 10 tpy but less
than 30 tpy
SCVs at facilities where EtO use is at least 1 tpy but less
than 10 tpy
ARVs at facilities where EtO use is at least 30 tpy
CEVs at area source facilities \10\ where EtO use is at least
400 tpy
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
CEVs at area source facilities where EtO use is at least 60
but less than 400 tpy
Group 1 room air emissions \11\ at area source facilities
where EtO use is at least 40 tpy
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Group 2 room air emissions \12\ at area source facilities
where EtO use is at least 20 tpy
---------------------------------------------------------------------------
\12\ As discussed in section III.A, Group 2 room air emissions
cover post-aeration handling of sterilized material.
---------------------------------------------------------------------------
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:
SCVs at facilities where EtO use is at least 10 tpy
SCVs at facilities where EtO use is at least 1 tpy but less
than 10 tpy
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)
----------------------------------------------------------------------------------------------------------------
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: https://www.epa.gov/stationary-sources-air-pollution/ethylene-oxide-emissions-standards-sterilization-facilities. 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 https://www.epa.gov/stationary-sources-air-pollution/risk-and-technology-review-national-emissions-standards-hazardous. 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):
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.
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:
SCVs at facilities where EtO use is at least 40 tpy,
SCVs at facilities where EtO use is at least 10 tpy but
less than 40 tpy,
SCVs at facilities where EtO use is at least 1 tpy but
less than 10 tpy, and
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:
SCVs at facilities where EtO use is at least 10 tpy,
SCVs at facilities where EtO use is at least 1 tpy but
less than 10 tpy, and
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:
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.
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.
Requiring all area source facilities to obtain a title V
operating permit, and
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.''
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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:
99 percent reduction for new and existing SCVs at
facilities where EtO use is less than 1 tpy,
99 percent reduction for new and existing ARVs facilities
where EtO use is at least 1 tpy less than 10 tpy,
99 percent reduction for new and existing ARVs at
facilities where EtO use is less than 1 tpy,
99.94 percent reduction for new and existing CEVs at major
source facilities,
99 percent emission reduction for new and existing CEVs at
area source facilities,
97 percent reduction for new and existing Group 1 room air
emissions at major source facilities,
80 percent emission reduction for new and existing Group 1
room air emissions at area source facilities,
86 percent reduction for new and existing Group 2 room air
emissions at major source facilities, and
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):
99.99 percent reduction for SCVs at facilities where EtO
use is at least 30 tpy,
99.9 percent reduction for SCVs at facilities where EtO
use is at least 10 tpy but less than 30 tpy,
99.8 percent reduction for SCVs at facilities where EtO
use is at least 1 tpy but less than 10 tpy,
99.9 percent reduction for ARVs at facilities where EtO
use is at least 30 tpy,
99.9 percent reduction for CEVs at area source facilities
where EtO use is at least 60 tpy,
98 percent reduction for Group 1 room air emissions at
area sources facilities where EtO use is at least 40 tpy,
98 percent reduction for Group 2 room air emissions at
area sources facilities where EtO use is at least 20 tpy, and
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:
99.8 percent reduction for SCVs at facilities where EtO
use is at least 1 tpy but less than 10 tpy,
99.6 percent reduction for existing ARVs at facilities
where EtO use is at least 10 tpy, and
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.
---------------------------------------------------------------------------
Quarterly reporting of EtO CEMS data,
Minimum data availability of 90 percent for EtO CEMS, and
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\ https://www.epa.gov/electronic-reporting-air-emissions/electronic-reporting-tool-ert.
\20\ https://www.epa.gov/electronic-reporting-air-emissions/cedri.
---------------------------------------------------------------------------
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:
SCVs at facilities where EtO use is at least 1 tpy,
ARVs at facilities where EtO use is at least 30 tpy,
[[Page 24102]]
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.
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:
SCVs at facilities where EtO use is less than 1 tpy,
ARVs at facilities where EtO use is less than 30 tpy,
CEVs at major source facilities,
CEVs at area source facilities where EtO use is less than
60 tpy,
Room air emissions at major source facilities,
Group 1 room air emissions at area source facilities where
EtO use is less than 40 tpy, and
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:
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.
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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:
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.
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.
Step 3: Submit a permit application to the relevant
permitting authority.
Step 4: Complete the necessary facility retrofits, control
device installations, and EtO CEMS installations.
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).
---------------------------------------------------------------------------
\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):
3.2E-4 lb/h for new and existing CEVs at facilities where
EtO use is at least 10 tpy,
1.3E-3 lb/h for new and existing Group 1 room air
emissions at major source facilities, and
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):
99 percent emission reduction for new and existing SCVs at
facilities where EtO use is less than 1 tpy,
99 percent emission reduction for new and existing ARVs at
facilities where EtO use is at least 1 tpy but less than 10 tpy,
99 percent emission reduction for new and existing ARVs at
facilities where EtO use is less than 1 tpy,
99 percent emission reduction for new and existing CEVs at
facilities where EtO use is at least 1 tpy but less than 10 tpy,
99 percent emission reduction for new and existing CEVs at
facilities where EtO use less than 1 tpy.
1.3E-3 lb/h emission limit for new and existing Group 1
room air emissions at area source facilities, and
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):
99 percent emission reduction for new and existing SCVs at
facilities where EtO use is less than 1 tpy,
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
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:
99.94 percent emission reduction for new and existing CEVs
at major source facilities,
99 percent emission reduction for new and existing CEVs at
area source facilities,
97 percent emission reduction for new and existing Group 1
room air emissions at major source facilities,
80 percent emission reduction for new and existing Group 1
room air emissions at area source facilities,
86 percent emission reduction for new and existing Group 2
room air emissions at major source facilities,
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
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.
---------------------------------------------------------------------------
\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, EtOIM is
the inlet EtO mass, and EtOOM 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).
---------------------------------------------------------------------------
Annual EtO use: 200 tpy.
Annual operating hours: 8,000.
Portion of EtO going to CEVs: 1 percent.
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 ($30,000,000/ton) for existing small hard chromium
electroplating to provide an ample margin of safety (taking into
account cost among other factors) (77 FR 58227-8, 58239). We are
finalizing Option 1 for the following reasons. First, while both
options are considered generally available under CAA section 112(d)(5),
Option 1 would achieve much greater emission reduction than Option 2.
Second, Option 1 would incur fewer annual costs than Option 2.
Therefore, pursuant to CAA section 112(d)(5), we are finalizing Option
1 for existing CEVs at area source facilities. Specifically, we are
finalizing a requirement for these facilities to continuously reduce
emissions from existing CEVs by 99 percent.
For new CEVs at area source facilities, we considered two potential
GACT options similar to those evaluated for existing CEVs at area
source facilities. The first potential GACT option would require
achieving 99 percent emission reduction. The second potential GACT
option we considered is a BMP described in section IV.B.3.a, which
would require facilities to lower the in-chamber EtO concentration to 1
ppm before the chamber is opened. The impacts of these options, which
are presented in table 9 of this preamble, are based on a model plant
for new CEVs at a new area source facility with the following
assumptions reflecting the average of each of the parameters at
existing area source facilities:
Annual EtO use: 100 tpy.
Annual operating hours: 8,000.
Portion of EtO going to CEVs: 1 percent.
CEV flow rate: 200 cubic feet per second (cfs).
Number of unique cycles: nine.
Table 9--Nationwide Emissions Reduction and Cost Impacts of Options Considered Under CAA Section 112(d)(5) for New CEVs at Area Source Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital Total annual costs ($/ 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:
Annual EtO use: 140 tpy.
Annual operating hours: 8,000.
Portion of EtO going to Group 1 RAE: 0.4 percent.
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.
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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 retrofit facilities
by scaling the cost from a large facility that conducted a retrofit.
Furthermore, based on our knowledge regarding the application of EPA
Method 204 in general, retrofitting to meet this method can be
complicated, depending on the size of the facility. However, commercial
sterilization facilities tend to be simple buildings (in some cases,
re-purposed warehouses) with a relatively small footprint, which helps
the retrofitting process. The emission standards for room air emissions
that we evaluated assume 100 percent capture of EtO emissions,\36\ and
the costs of complying with the PTE requirements of EPA Method 204 were
included in our BTF and GACT evaluations. We found each emission
standard that we evaluated to be cost-effective (see section IV.B.3.b
of this preamble for more information). In addition, the term
``negative pressure'' is vague and can imply any capture efficiency
between zero and 100 percent. The commenters did not provide specific
suggestions for alternative capture efficiencies, nor did they provide
the criteria that would be used to demonstrate that those efficiencies
are being met, and we are unable to evaluate alternative negative
pressure requirements as a result. Therefore, EPA Method 204 is
appropriate to apply to this source category in order to ensure
complete capture of room air emissions.
---------------------------------------------------------------------------
\36\ Section 2 of EPA Method 204 states, in part, ``If the
criteria are met and if all the exhaust gases from the enclosure are
ducted to a control device, then the volatile organic compounds
(VOC) capture efficiency (CE) is assumed to be 100 percent, and CE
need not be measured.''
---------------------------------------------------------------------------
Comment: Several commenters requested various flexibilities and
clarifications with respect to the PTE requirements of EPA Method 204.
Several commenters expressed concern with Criterion 5.1 of EPA Method
204, stating that it would not be possible to always ensure that doors
are ``at least four equivalent opening diameters'' from all EtO storage
media or post-aeration sterilized product, particularly during loading
and unloading operations. Two commenters recommended that we revise the
standards to permit implementation of cascading air systems to capture
room air emissions.\37\ One commenter stated that these systems would
provide greater flexibility to accommodate sterilization operations
that could not implement a PTE, would offer EtO capture and control
efficiency that was as effective as a PTE, and would have fewer
manufacturing implications and potential adverse impacts. Finally, two
[[Page 24115]]
commenters expressed concern with Criteria 5.2, 5.3, and 5.5 of EPA
Method 204.
---------------------------------------------------------------------------
\37\ These are systems that move air from ambient pressure,
through warehouse ventilation, secondary aeration, primary aeration,
the sterilizer chamber, and ultimately to an air pollution control
device to capture and control EtO emissions. This is opposed to
other systems where air from one source is captured and then
directly sent to a control system.
---------------------------------------------------------------------------
Response: Criterion 5.1 of EPA Method 204 states that ``Any natural
draft opening (NDO) shall be at least four equivalent opening diameters
from each VOC emitting point unless otherwise specified by the
Administrator.'' \38\ We disagree with the commenters' concerns that
Criterion 5.1 of EPA Method 204 will not be possible to meet for doors
where either EtO storage media is moved into a PTE or post-aeration
sterilized material is moved out of a PTE. There may be certain
facility designs where such an exemption is either necessary or
unnecessary in order to ensure complete capture of room air emissions.
However, the EPA does not have enough information to make that
determination for all facilities within the source category as part of
this rulemaking. Criterion 5.1 of EPA Method 204 allows delegated
authorities to exempt any NDO from this requirement, as needed.
Therefore, we are not exempting Criterion 5.1 of EPA Method 204 for
doors where either EtO storage media is moved into a PTE or post-
aeration sterilized material is moved out of a PTE as part of this
final rule. Instead, we are relying on the delegated authorities to
make that determination for their commercial sterilization facilities,
as provided in Criterion 5.1., as they are in a better place to
determine whether there are sufficient measures in place to capture any
emission points within four equivalent opening diameters of an NDO.
With respect to cascading air systems, we disagree with the commenters'
suggestion that they be permitted in place of the PTE requirements of
EPA Method 204, as they are insufficient on their own to ensure
complete capture of room air emissions. However, it is not our intent
to discourage or prohibit the use of these systems altogether.
Cascading air systems may be used to capture and route room air
emissions to a control device. However, in order to ensure complete
capture of room air emissions, if such a system contains one or more
areas that are subject to the PTE requirements of EPA Method 204, then
the entire system must be treated as a single enclosure that is subject
to those requirements.
---------------------------------------------------------------------------
\38\ Per 40 CFR 51.100(s), EtO is a VOC.
---------------------------------------------------------------------------
For all other flexibilities suggested by the commenters, we provide
the following responses:
Criterion 5.2 of EPA Method 204 states that ``Any exhaust
point from the enclosure shall be at least four equivalent duct or hood
diameters from each NDO.'' One commenter stated that Criterion 5.2 may
not be possible for all facilities due to preexisting layouts. This
criterion only applies to temporary total enclosures, as opposed to
PTEs, and is not required in the final rule.
Criterion 5.3 of EPA Method 204 states that ``The total
area of all NDO's shall not exceed 5 percent of the surface area of the
enclosure's four walls, floor, and ceiling.'' One commenter stated that
the presence of garage doors could exceed the requirement that NDOs not
exceed five percent of the PTE total floor space. However, we note that
facilities can be, and have been, re-designed in order to meet the PTE
requirements of EPA Method 204, including Criterion 5.3. Therefore, we
are not finalizing any exceptions for this criterion.
Criterion 5.5 of EPA Method 204 states that ``All access
doors and windows whose areas are not included in section 5.3 and are
not included in the calculation in section 5.4 shall be closed during
routine operation of the process''. Two commenters expressed concern
with Criterion 5.4 of EPA Method 204. However, the commenters did not
provide any explanation as to why exceptions for Criterion 5.5 of EPA
Method 204 should be made. Therefore, we are not finalizing any
exceptions for this criterion.
d. Warehouses
Comment: We received extensive comments on the regulation of
warehouses, particularly stand-alone (i.e., off-site) warehouses. Most
commenters were supportive of regulating emissions from all warehouses,
stating that sterilized materials can continue to off-gas significant
quantities of EtO after being moved to a warehouse. Several commenters
pointed to a stand-alone warehouse in Georgia, where the State
estimated that potential pre-control EtO emissions were approximately
5,000 lb/year. One commenter was opposed to including standards for
stand-alone warehouses as part of this final rule, stating that we
could, instead, identify potentially applicable facilities, collect
data from these facilities, and then determine if further regulation is
necessary.
Response: It is our understanding that there are three types of
warehouses within this industry: attached warehouses, co-located
warehouses, and stand-alone warehouses. Attached warehouses are those
that are part of an EtO sterilization building. Co-located warehouses
are those that are detached from but ``contiguous'' (including
adjacent) to and ``under common control'' with the EtO sterilization
building, including leased properties.\39\ Stand-alone warehouses are
those that are not attached to or co-located with an EtO sterilization
building. According to our record at the time of category listing,
``the Commercial Sterilization Facilities source category includes
``facilities which use ethylene oxide in any equipment which destroys
bacteria, viruses, fungi, insects, or other unwanted microorganisms or
materials when such facilities are engaged in the growth, manufacture,
construction, transportation, retail or wholesale trade, or storage of
commercial products, or when such facilities are engaged in the
operation of museums, art galleries, arboreta, or botanical or
zoological gardens or exhibits. Not included in this category are
hospitals, doctor offices, veterinary offices, clinics, and other
facilities where medical services are rendered'' (emphasis added).\40\
Under this definition, warehouses that are part of facilities which use
EtO, including attached and co-located warehouses, are part of the
source category and, therefore, subject to the standards for Group 2
room air emissions. However, because stand-alone warehouses do not use
EtO, they are not included in the source category definition.
Furthermore, we do not have sufficient information to understand where
these warehouses are located, who owns them, how they are operated, or
what level of emissions potential they may have. While several
commenters note that emissions information is available for at least
one stand-alone warehouse, it is unknown whether the emissions
information for this facility is representative of all stand-alone
warehouses. Thus, standards for these facilities are not included as
part of this final rule. However, as suggested by one commenter, we are
planning to gather information from stand-alone warehouses as soon as
possible to
[[Page 24116]]
understand what the source category looks like and its emission
potential and, if necessary, develop a regulatory action that both
lists a new source category and proposes standards for stand-alone
warehouses handling EtO sterilized medical devices. This information
gathering effort may include engaging with State and local agencies and
non-governmental organizations, as well as conducting an ICR(s)
pursuant to CAA section 114.
---------------------------------------------------------------------------
\39\ This final rule establishes standards under CAA section 112
for both major and area sources of commercial sterilization
facilities. As the EPA explained in its final rule promulgating the
General Provisions for NESHAP pursuant to section 112, ``[f]or the
purposes of implementing section 112, the major/area source
determination is made on a plant-wide basis; that is, HAP emissions
from all sources located within a contiguous area and under common
control are considered in the determination.'' 59 FR 12408, 12411
(March 16, 1994). The EPA noted that ``the common dictionary term
``contiguous'' consists, in part, of ``nearby, neighboring,
adjacent,'' and that ``the EPA has historically interpreted
`contiguous property' to mean the same as `contiguous or adjacent
property' in the development of numerous regulations to implement
the Act.'' Id. at 12412.
\40\ Documentation for Developing the Initial Source Category
List, Final Report, page A-83 (see EPA-450/3-91-030, July 1992).
---------------------------------------------------------------------------
The remaining comments and our specific responses 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.
4. What is the rationale for our final approach and final decisions for
the revisions pursuant to CAA section 112(d)(2), 112(d)(3), and
112(d)(5)?
We evaluated the comments on our proposed standards for 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, as well as our proposed technical correction to the emission
standard for ARVs at facilities where EtO use is at least 10 tpy. As
explained above in section IV.B.3 and in Chapter 4 of the document,
Summary of Public Comments and Responses for the Risk and Technology
Review for Commercial Sterilization Facilities, we made changes in the
final rule based on comments received during the proposed rulemaking.
More information and rationale concerning all the amendments we are
finalizing pursuant to CAA sections 112(d)(2), 112(d)(3), and 112(d)(5)
is in the preamble to the proposed rule (88 FR 22790, April 13, 2023),
in section IV.B.3 of this preamble, 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, which is available in the docket
for this rulemaking. Therefore, we are finalizing the proposed
standards for SCVs and ARVs at facilities where EtO use is less than 1
tpy, finalizing the proposed standards for ARVs at facilities where EtO
use is at least 1 tpy but less than 10 tpy, finalizing standards for
CEVs, finalizing the proposed emission standards for room air emissions
at major sources facilities, finalizing emission standards for room air
emissions at area source facilities, and finalizing the proposed
revisions for ARVs at facilities where EtO use is at least 10 tpy.
C. Residual Risk Review for the Commercial Sterilization Facilities
Source Category
1. What did we propose pursuant to CAA section 112(f) for the
Commercial Sterilization Facilities source category?
Pursuant to CAA section 112(f), we conducted a residual risk review
and presented the results of this review, along with our proposed
decisions regarding risk acceptability and ample margin of safety, in
the April 13, 2023, proposed rule for 40 CFR part 63, subpart O (88 FR
22790). The results of the risk assessment for the proposal are
presented briefly in table 15 of this preamble. As discussed in section
III.A of the proposed rule, all baseline risk results were developed
using the best estimates of actual emissions, and we did not conduct a
separate assessment of allowables at proposal. More detail is in the
residual risk technical support document, Residual Risk Assessment for
the Commercial Sterilization Facilities Source Category in Support of
the 2023 Risk and Technology Review Proposed Rule, which is available
in the docket for this rulemaking (see Docket Item No. EPA-HQ-OAR-2019-
0178-0482).
Table 15--Commercial Sterilization Facilities Source Category Baseline Risk Assessment Results in the Proposal
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated population at Estimated
Maximum increased risk of cancer annual cancer Maximum screening acute
Number of facilities \1\ individual ---------------------------------- incidence Maximum chronic noncancer hazard quotient
cancer risk (in >100-in-1 [gteqt]1-in-1 (cases per noncancer TOSHI (HQ)
1 million) \2\ million million year)
--------------------------------------------------------------------------------------------------------------------------------------------------------
97 \3\................................. 6,000 18,000 8,300,000 0.9 0.04 0.002 (REL).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Number of facilities evaluated in the risk analysis.
\2\ Maximum individual excess lifetime cancer risk due to HAP emissions from the source category.
\3\ As part of the risk assessment for the proposed rulemaking, there were 86 facilities in the Commercial Sterilization Facilities source category in
operation and 11 research and development facilities, for a total of 97 facilities. To exercise caution with respect to this source category, we
included research facilities in our assessment because there was a lack of certainty over whether these were true research facilities, for which CAA
section 112(c)(7) requires that a separate category be established. However, EtO use at these facilities tends to be very low (less than 1 tpy), and
these facilities had low risk.
The results of the proposed chronic baseline inhalation cancer risk
assessment at proposal indicated that, based on estimates of current
actual emissions, the MIR posed by the source category was 6,000-in-1
million. At proposal, the total estimated cancer incidence from this
source category was estimated to be 0.9 excess cancer cases per year,
or one case in every 1.1 years. Approximately 8.3 million people were
estimated to have cancer risks at or above 1-in-1 million from HAP
emitted from the facilities in this source category. At proposal, the
estimated maximum chronic noncancer target organ-specific hazard index
(TOSHI) for the source category was 0.04, indicating low likelihood of
adverse noncancer effects from long-term inhalation exposures.
As shown in table 15 of this preamble, the acute risk screening
assessment of reasonable worst-case inhalation impacts indicates a
maximum acute HQ of 0.002 for propylene oxide based on the reference
exposure level (REL) acute health reference value.\41\ For EtO, the
maximum HQ is 0.0005 based on the acute exposure guideline level
(AEGL)-2 acute health reference value.\42\
---------------------------------------------------------------------------
\41\ Not to be confused with the ``recommended exposure limit'',
which is used by the National Institute for Occupational Safety and
Health.
\42\ Acute RELs, ERPG-1, and AEGL-1 acute health reference
values are not available for ethylene oxide.
---------------------------------------------------------------------------
At proposal, the maximum lifetime individual cancer risk posed by
the 97 modeled facilities, based on whole facility emissions, was
6,000-in-1 million, with EtO emissions from SCVs and Group 2 room air
emissions from the Commercial Sterilization Facilities source category
driving the risk. Regarding the noncancer risk
[[Page 24117]]
assessment, the maximum chronic noncancer TOSHI posed by whole facility
emissions was estimated to be 0.04 (for the neurological system as the
target organ), driven by emissions of EtO from source category sources.
We weighed all health risk factors, including those shown in table
15 of this preamble, in our risk acceptability determination and
proposed that the risks posed by this source category under the current
provisions are unacceptable. At proposal, we identified several options
to control EtO emissions from SCVs and Group 2 room air emissions.
To reduce risks, we considered two additional control options after
implementation of controls under CAA sections 112(d)(2), 112(d)(3), and
112(d)(5). Control Option 1 would have required a 99.94 percent
emission reduction standard for SCVs at facilities where EtO use is at
least 40 tpy, as well as a 2.8 E-3 lb/h standard for existing Group 2
room air emissions at area source facilities where EtO use is at least
20 tpy. We determined that this would have resulted in a source
category MIR of 400-in-1 million. Control Option 2 would have imposed
the same requirements as Control Option 1, but it would also have
required facilities where the MIR is greater than 100-in-1 million
after Control Option 1 is imposed to limit their existing Group 2 room
air emissions to a maximum volumetric flow rate of 2,900 dscfm and a
maximum EtO concentration of 30 ppbv. This would have resulted in a
source category MIR of 100-in-1 million. We proposed Control Option 2
and solicited comment on Control Option 1.
We proposed that, after implementation of the proposed controls for
SCVs and Group 2 room air emissions at commercial sterilization
facilities, the resulting risks would be acceptable for this source
category. In our proposal, we presented the risk impacts using health
risk measures and information, including the MIR, cancer incidence, and
associated uncertainty in emissions estimates after application of the
proposed options to control EtO emissions from Group 2 room air
emissions (88 FR 22790, April 13, 2023). At proposal, we determined
application of the controls for SCVs and Group 2 room air emissions
would reduce the estimated MIR from 6,000-in-1 million to 100-in-1
million.
We then considered whether the standards provide an ample margin of
safety to protect public health and whether, taking into consideration
costs, energy, safety, and other relevant factors, additional standards
are required to prevent an adverse environmental effect. To determine
whether the rule provides an ample margin of safety, we considered the
requirements that we proposed to achieve acceptable risks. In addition,
we considered more stringent controls for SCVs, as well as expanding
the emission standard and work practice standards for existing Group 2
room air emissions to all facilities in the source category. In
considering whether the standards should be tightened to provide an
ample margin of safety to protect public health, we considered the same
risk factors that we considered for our acceptability determination and
also examined the costs, technological feasibility, and other relevant
factors related to emissions control options that might reduce risk
associated with emissions from the source category. Based on these
considerations, we proposed that the standards that we proposed to
achieve acceptable risks, along with a 99.94 percent emission reduction
standard for SCVs at facilities where EtO use is at least 10 tpy but
less than 40 tpy and a 99.8 percent emission reduction standard for
SCVs at facilities where EtO use is at least 1 tpy but less than 10
tpy, would provide an ample margin of safety to protect public health
(section III.D.2 of the proposal preamble, 88 FR 22790, April 13,
2023). We also solicited comment on which of the available control
options should be applied in order to provide an ample margin of safety
to protect public health.
2. How did the risk review change for the Commercial Sterilization
Facilities source category?
a. Commercial Sterilization Facilities Source Category Risk Assessment
and Determination of Risk Acceptability (Step 1)
As part of the final risk assessment, the EPA reanalyzed risks to
include allowable emissions (which we did not include at the proposal
stage), changes since proposal to certain emission standards being
finalized for previously unregulated sources, and three additional
facilities identified by commenters. Allowable emissions are the
maximum amount that facilities are allowed to emit under CAA section
112(d) standards. For previously unregulated sources, since there were
no CAA section 112(d) standards in place, the allowable emissions in
the baseline risk assessment are equal to the uncontrolled emissions
from these sources. In some instances, the actual emissions for these
sources are lower than the allowable emissions. This is because some
facilities are already controlling these sources as a result of local
requirements or through voluntary control measures.\43\ The revised
emissions used to reanalyze risks are available in the docket for this
rulemaking (see section IV.C.3 of this preamble and Appendix 1 of the
Residual Risk Assessment for the Commercial Sterilization Facilities
Source Category in Support of the 2024 Risk and Technology Review Final
Rule).
---------------------------------------------------------------------------
\43\ As discussed later in this section, for previously
unregulated sources, the allowable emissions in the risk assessment
that considers controls we are promulgating under CAA sections
112(d)(2), 112(d)(3), and 112(d)(5) are equal to the controlled
emissions from these sources assuming that they are only controlled
to the degree that we are requiring pursuant to CAA sections
112(d)(2), 112(d)(3), and 112(d)(5). In some instances, the actual
emissions for these sources may still be lower than the allowable
emissions. This is because some facilities are already controlling
these sources to a degree greater than what we are finalizing
pursuant to CAA sections 112(d)(2), 112(d)(3), and 112(d)(5) as a
result of local requirements or through voluntary control measures.
---------------------------------------------------------------------------
Based on the actual emission estimates, the results of the chronic
inhalation cancer risk from the risk assessment indicate that the
maximum lifetime individual cancer risk posed by the 88 facilities
could be as high as 6,000-in-1 million, with EtO as the major
contributor to the risk. The total estimated cancer incidence from the
revised risk assessment is 0.9 excess cancer cases per year, or one
excess case in every 1.1 years. Of the approximately 115 million people
that live within 50 kilometers (km) of the 88 facilities included in
the risk assessment, 8.5 million people were estimated to have cancer
risks greater than or equal to 1-in-1 million from HAP emitted from the
facilities in this source category, and approximately 19,000 are
estimated to have cancer risks greater than 100-in-1 million (table 16
of this preamble).
The estimated maximum chronic noncancer TOSHI for the source
category remained unchanged from the proposal at 0.04, indicating low
likelihood of adverse noncancer effects from long-term inhalation
exposures. Additionally, the worst-case acute HQ remained unchanged
from proposal (0.002 for propylene oxide based on the REL acute health
reference value).
The maximum lifetime individual cancer risk based on whole facility
emissions was 6,000-in-1 million driven by EtO emissions from the
Commercial Sterilization Facilities source category. The maximum
chronic noncancer TOSHI posed by whole facility emissions was estimated
to be 0.04 (for the neurological system as the target organ), driven by
emissions of EtO from source category sources.
[[Page 24118]]
Based on allowable emission estimates, the maximum lifetime
individual cancer risk could be as high as 8,000-in-1 million, with EtO
driving the risk. The total estimated cancer incidence is 8 excess
cancer cases per year, or 1 excess case in every 1.5 months.
Approximately 62 million people were estimated to have cancer risks
greater than or equal to 1-in-1 million from allowable emissions, and
approximately 260,000 are estimated to have cancer risks greater than
100-in-1 million (table 16 of this preamble).
Table 16--Commercial Sterilization Facilities Source Category Baseline Risk Assessment Results Based on Revised Emissions in Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maximum Estimated population at Estimated
individual increased risk of cancer annual cancer Maximum
Number of facilities \1\ cancer risk -------------------------------- incidence chronic Maximum screening acute
(in 1 million) >100-in-1 [gteqt]1-in-1 (cases per noncancer noncancer HQ
\2\ million million year) TOSHI
--------------------------------------------------------------------------------------------------------------------------------------------------------
Actual Emissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
88 \3\.................................... 6,000 19,000 8,500,000 0.9 0.04 0.002 (REL).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Allowable Emissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
88 \3\.................................... 8,000 260,000 62,000,000 8 0.05 ............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Number of facilities evaluated in the risk analysis.
\2\ Maximum individual excess lifetime cancer risk due to HAP emissions from the source category.
\3\ Two of the 90 facilities identified in the source category are planned or under construction and therefore were not included in the risk assessment.
Risks were then estimated after application of the controls
finalized in this rulemaking pursuant to CAA sections 112(d)(2),
112(d)(3), and 112(d)(5). A summary of those controls is presented in
table 17.
Table 17--Summary of Standards After Taking Actions Pursuant to CAA Sections 112(d)(2), 112(d)(3), and 112(d)(5)
----------------------------------------------------------------------------------------------------------------
Emission source Existing or new? EtO use Standards CAA section
----------------------------------------------------------------------------------------------------------------
SCV............................. Existing and new.. At least 10 tpy... 99 percent Current standard.
emission
reduction.
At least 1 but 99 percent Current standard.
less than 10 tpy. emission
reduction.
Less than 1 tpy... 99 percent 112(d)(5).
emission
reduction.
ARV............................. Existing and new.. At least 10 tpy... 99 percent Current standard.
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 at major sources............ Existing and new.. N/A............... 99.94 percent 112(d)(2) and
emission 112(d)(3).
reduction \1\.
CEV at area sources............. Existing and new.. N/A............... 99 percent 112(d)(5).
emission
reduction \1\.
Group 1 room air emissions at Existing and new.. N/A............... 97 percent 112(d)(2) and
major sources. emission 112(d)(3).
reduction \1\ \2\.
Group 1 room air emissions at Existing and new.. N/A............... 80 percent 112(d)(5).
area sources. emission
reduction \1\ \2\.
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\ \2\.
Group 2 room air emissions at Existing.......... N/A............... Lower the EtO 112(d)(5).
area sources. concentration
within each
sterilization
chamber to 1 ppm
before the
chamber can be
opened.\1\
New............... N/A............... 80 percent 112(d)(5).
emission
reduction \1\ \2\.
----------------------------------------------------------------------------------------------------------------
\1\ This standard is different from what was proposed.
\2\ To assure compliance with the emission limit, we are 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.
Based on the risk assessment considering controls finalized under
CAA sections 112(d)(2), 112(d)(3), and 112(d)(5), the maximum lifetime
individual cancer risk could be as high as 6,000-in-1 million, with EtO
driving the risk. For previously unregulated sources, the allowable
emissions in this risk assessment are equal to the controlled emissions
from these sources assuming that they are only controlled to the degree
that we are requiring pursuant to CAA sections 112(d)(2), 112(d)(3),
and 112(d)(5). In some instances, the actual emissions for these
sources may still be lower than the allowable emissions. This is
because some facilities are already controlling these sources to a
degree greater than what we are finalizing pursuant to CAA sections
112(d)(2), 112(d)(3), and 112(d)(5) as a result of local requirements
or through voluntary control measures. The total estimated
[[Page 24119]]
cancer incidence could be as high as 4 excess cancer cases per year, or
1 excess case in every 3 months. As many as 38 million people are
estimated to have cancer risks greater than or equal to 1-in-1 million,
and approximately 85,000 people are estimated to have cancer risks
greater than 100-in-1 million (table 18 of this preamble).
However, as noted above, some facilities are currently performing
better than the controls finalized under CAA sections 112(d)(2),
112(d)(3), and 112(d)(5), and in that case we estimate the maximum
lifetime individual cancer risk as 5,000-in-1 million, with EtO driving
the risk. The total estimated cancer incidence is estimated to be 0.4
excess cancer cases per year, or 1 excess case in every 2.5 years.
Approximately 4.2 million people were estimated to have cancer risks
greater than or equal to 1-in-1 million, and approximately 3,900 are
estimated to have cancer risks greater than 100-in-1 million (table 18
of this preamble), based only on the application of the CAA section
112(d)(2), 112(d)(3), and 112(d)(5) actions being finalized.
Table 18--Commercial Sterilization Facilities Source Category Risk Assessment Results Based on Emissions After
Controls Promulgated Under CAA Sections 112(d)(2)-(3) and 112(d)(5)
----------------------------------------------------------------------------------------------------------------
Estimated population at Estimated
Maximum increased risk of cancer \2\ annual cancer
Number of facilities \1\ individual ---------------------------------- incidence
cancer risk (in >100-in-1 [gteqt]1-in-1 (cases per
1 million) \2\ million million year) \2\
----------------------------------------------------------------------------------------------------------------
88 \3\...................................... \4\ 5,000-6,000 \4\ 3,900- \4\ 4,200,000- \4\ 0.4-4
260,000 62,000,000
----------------------------------------------------------------------------------------------------------------
\1\ Number of facilities evaluated in the risk analysis.
\2\ Maximum individual excess lifetime cancer risk due to HAP emissions from the source category.
\3\ Two of the 90 facilities identified in the source category are planned or under construction and therefore
were not included in the risk assessment.
\4\ 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).
Based on the revised risk assessment results considering controls
finalized under CAA sections 112(d)(2), 112(d)(3), and 112(d)(5), we
continue to find that the risks are unacceptable, as we did during the
proposal due to emissions of EtO from SCVs, ARVs, Group 1 room air
emission, Group 2 room air emissions, and CEVs. Pursuant to CAA section
112(f)(2), the EPA must first determine the emission standards
necessary to reduce risks to an acceptable level, and then determine
whether further HAP emissions reductions are necessary to provide an
ample margin of safety to protect public health or to prevent, taking
into consideration costs, energy, safety, and other relevant factors,
an adverse environmental effect. Immediately below is a discussion of
the standards the EPA has evaluated for bringing risks to an acceptable
level (step 1).
i. SCV Emissions
There are 26 facilities within the source category where the
``revised allowable emissions'' from SCVs (i.e., allowable emissions
after implementing existing and newly promulgated 112(d) standards in
this final rule) contribute to the facilities' MIRs exceeding 100-in-1
million, and EtO usage at these facilities ranges from four tpy to 446
tpy. The previous subpart O required 99 percent emission reduction for
SCVs at facilities where EtO use is at least 1 tpy. An emission
reduction of 99 percent is also the final standard under CAA section
112(d)(5) for the previously unregulated SCVs, which were those at
facilities where EtO use is less than 1 tpy (see section IV.B.2).
Our data do not identify any add-on controls beyond those we have
already considered when promulgating or reviewing the SCV standards in
the previous subpart O or finalizing the standards for the previously
unregulated SCVs in section IV.B. However, our evaluation of the
performance test data and manufacturer guarantees shows that these
controls can achieve greater than 99 percent reduction. We therefore
considered more stringent SCV standards for facilities where EtO use is
at least 1 tpy, which would include all 26 facilities where the revised
allowable emissions from SCVs contribute to the facilities' MIRs
exceeding 100-in-1 million.
We evaluated 99.8 percent reduction of SCV emissions from
facilities using at least 1 tpy but less than 10 tpy of EtO.\44\ As
discussed in section III.D.2 of the proposal preamble (88 FR 22790,
April 13, 2023), 99.8 percent is the maximum emission reduction from
SCV with which compliance can be demonstrated at all facilities with
EtO usage within this range.\45\ A 99.8 percent reduction would
eliminate SCV emissions as a contributor to a facility's MIR exceeding
100-in-1 million for facilities using at least 1 tpy but less than 10
tpy of EtO.\46\ We have determined that a 99.8 percent emission
reduction standard is feasible because of one commenter's statement
that, based on their discussions with control device manufacturers, the
best and most advanced technologies will be guaranteed to meet a 99.9
percent emission reduction standard for SCVs.
---------------------------------------------------------------------------
\44\ The MIRs of facilities with EtO usage less than 1 tpy are
all below 100-in-a-million.
\45\ i.e., Based on facility characteristics, there is no
compliance demonstration issue because the required EtO
concentration to meet this limit would be at or above 30 ppbv (which
is 3 x RDL).
\46\ A facility with usage amount in this range may still have a
MIR exceeding 100-in-a-million due to other emissions.
---------------------------------------------------------------------------
For facilities using at least 10 tpy, further reduction would be
needed to eliminate SCV emissions as a contributor to a facility's MIR
exceeding 100-in-a-million. We evaluated 99.9 percent reduction, which
as mentioned above reflects the manufacturer guaranteed control level.
A 99.9 percent reduction would eliminate SCV emissions as a contributor
to facilities' MIRs exceeding 100-in-1 million for facilities using at
least 10 tpy but less than 30 tpy of EtO. As discussed in section
III.D.2 of the proposal preamble (88 FR 22790, April 13, 2023), we
evaluated a 99.94 percent emission reduction standard for these
facilities as part of Control Option A under the second step of the
residual risk review. However, as discussed in section IV.C.3 of this
preamble, several commenters stated that we do not have representative
performance tests for SCVs. While this is not true for the whole source
category, it is true for facilities where EtO use is at least 10 tpy
but less than 30 tpy. Therefore, as part of this final rule, we did not
evaluate an
[[Page 24120]]
emission reduction standard more stringent than the manufacturer
guarantee for SCVs at these facilities.
For facilities using at least 30 tpy, further reduction would be
needed to eliminate SCV emissions as a contributor to a facility's MIR
exceeding 100-in-1 million. We evaluated 99.99 percent reduction based
on a performance test showing this level of reduction from a facility
within this group. A 99.99 percent reduction would eliminate SCV
emissions as a contributor to a facility's MIR exceeding 100-in-a-
million for facilities using at least 30 tpy of EtO. We received
comment on the technical feasibility of emission standards that exceed
the manufacturer guarantee for SCVs (i.e., 99.9 percent emission
reduction), but we do not have any information suggesting that any
facility within this group cannot achieve 99.99 percent emission
reduction. See section IV.C.3 of this preamble for more information.
ii. ARV Emissions
There are three facilities where revised allowable ARV emissions
contribute to the facility's MIR exceeding 100-in-1 million, and EtO
use at these facilities currently ranges from 44 tpy to 446 tpy of EtO.
The previous subpart O required a 1 ppm maximum outlet concentration or
99 percent emission reduction for ARVs at facilities where EtO use is
at least 10 tpy. As discussed in section IV.B, we are removing the 1
ppm maximum outlet concentration alternative standard, and we are
finalizing 99 percent emission reduction standards under CAA section
112(d)(5) for previously unregulated ARVs, which were those at
facilities where EtO use is less than 10 tpy. As a result, the final
112(d) standard for ARV emissions at all facilities is 99 percent
reduction.
Our data do not identify any add-on controls beyond those we have
already considered when promulgating, or proposing revisions to the
previous ARV standards in subpart O or finalizing the standards for the
previously unregulated ARVs in section IV.B. However, as discussed in
section III.F.3 of the proposal preamble (88 FR 22790, April 13, 2023),
our evaluation of the performance test data shows that these controls
can achieve greater than 99 percent emission reduction.\47\ We
evaluated 99.9 percent reduction of ARV emissions from facilities using
at least 30 tpy of EtO,\48\ which is feasible because it is currently
achieved by one-third of these facilities. Of these 12 facilities that
are currently achieving this emission reduction, nine use catalytic
oxidizers, two use a catalytic oxidizer and gas/solid reactor in
series, one uses a thermal oxidizer, and one uses a gas/solid reactor.
Note that this does not sum to 12 because one facility uses two
different types of control systems to reduce its ARV emissions.\49\ A
99.9 percent emission reduction would eliminate ARV emissions as a
contributor to a facility's MIR to exceed 100-in-1 million for
facilities using at least 30 tpy of EtO.\50\
---------------------------------------------------------------------------
\47\ While the types of controls used for ARVs are the same as
those used for SCVs, the distribution of these controls is
different. For example, the use of catalytic oxidizers and gas/solid
reactors is more prominent when controlling ARV emissions, while the
use wet scrubbers is more prominent when controlling SCV emissions.
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.
\48\ As discussed above, one of the facilities where allowable
ARV emissions contribute to the facility's MIR exceeding 100-in-1
million uses 44 tpy. Evaluating the emission reduction for
facilities where EtO use is at least 30 tpy provides a sufficient
buffer in case the EtO use at this facility drops to below 40 tpy.
\49\ As part of the proposed rulemaking, a similar analysis was
conducted for ARVs at facilities where EtO use is at least 10 tpy.
See section III.F.3.a of the proposal preamble for more details on
that analysis (88 FR 22790, April 13, 2023).
\50\ As part of the proposed rulemaking, we evaluated a 99.9
percent emission reduction standard for ARVs at facilities where EtO
use is at least 10 tpy as part of the technology review (see section
III.F.3 of the proposal preamble (88 FR 22790, April 13, 2023)). For
existing sources, this option was rejected in favor of a more cost-
effective option (i.e., 99.6 percent emission reduction). However,
we proposed a 99.9 percent emission reduction standard for new
sources pursuant to CAA section 112(d)(6).
---------------------------------------------------------------------------
iii. Group 2 Room Air Emissions
There are 13 facilities, all area sources, where revised allowable
Group 2 room air emissions contribute to the facilities' MIRs exceeding
100-in-1 million and the EtO usage at these facilities ranges from 4
tpy to 446 tpy.\51\ Because Group 2 room air emissions contribute to
unacceptable risks from existing area sources in this source category,
we evaluated available control options for reducing risks from Group 2
room air emissions.
---------------------------------------------------------------------------
\51\ As discussed earlier, the EPA has the authority to conduct
an (f)(2) review of GACT standards and is exercising that authority
in this action.
---------------------------------------------------------------------------
As discussed in section IV.B of this preamble, we are finalizing a
GACT standard for previously unregulated Group 2 room air emissions at
existing area source facilities. Specifically, we are finalizing under
CAA section 112(d)(5) that area source facilities lower the EtO
concentration within each sterilization chamber to 1 ppm before the
chamber can be opened.\52\ Because there is still unacceptable risk
from facilities where EtO usage is above 4 tpy, this requirement will
ultimately apply only to existing Group 2 room air emissions at
facilities where EtO use is less than 4 tpy.
---------------------------------------------------------------------------
\52\ As discussed in section IV.B of this preamble, we are
finalizing an 80 percent emission reduction standard for all new
Group 2 room air emissions at area source facilities, regardless of
EtO use, under CAA section 112(d)(5).
---------------------------------------------------------------------------
In evaluating the appropriate GACT standard for previously
unregulated existing Group 2 room air emissions at area source
facilities, we considered an emission reduction of 80 percent that
reflects the use of control devices (Option 1) but did not finalize
that option under CAA section 112(d)(5) for reasons stated in section
IV.B.3.b. However, having determined under CAA section 112(f)(2) that
the risk for the source category is unacceptable, we are determining
the emissions standards necessary to reduce risk to an acceptable level
without considering costs. We evaluated 80 percent emission reduction
of Group 2 room air emissions from area source facilities using at
least 4 tpy but less than 20 tpy of EtO. As discussed in section
IV.B.3.b of this preamble, 80 percent is the manufacturer guarantee for
room air emissions controls provided by one of the commenters. We do
not have any performance test data for Group 2 room air emissions at
these facilities, so it is unknown whether these sources can achieve
greater than 80 percent emission reduction. An 80 percent reduction
would eliminate Group 2 room air emissions as a contributor to a
facility's MIRs exceeding 100-in-1 million for area source facilities
using at least 4 tpy but less than 20 tpy.
For area source facilities using at least 20 tpy, further reduction
would be needed to eliminate Group 2 room air emissions as a
contributor to a facility's MIR exceeding 100-in-a-million. Our data do
not identify any add-on controls beyond those we have already
considered when finalizing the standards for the previously unregulated
Group 2 room air emission in section IV.B. However, our evaluation of
the performance data shows that these controls can achieve greater than
80 percent emission reduction at area source facilities where EtO use
is at least 20 tpy. We therefore considered a more stringent Group 2
room air emission standard for these facilities. We evaluated 98
percent reduction of Group 2 room air emissions from area source
facilities using at least 20 tpy, which is the emission reduction that
has been achieved in one-third of the
[[Page 24121]]
available performance test runs for these facilities.\53\ 98 percent
reduction would eliminate Group 2 room air emissions as a contributor
to a facility's MIR exceeding 100-in-a-million for area source
facilities where EtO use is at least 20 tpy.
---------------------------------------------------------------------------
\53\ All of these facilities use gas/solid reactors to control
their Group 2 room air emissions.
---------------------------------------------------------------------------
iv. CEV Emissions
There is one facility within the source category where revised
allowable emissions from CEVs contribute to the facility's MIR
exceeding 100-in-1 million, and this is an area source facility that
currently uses 446 tpy of EtO. The previous subpart O did not regulate
CEVs at area source facilities. As discussed in section IV.B of this
preamble, we are finalizing a GACT standard for these sources.
Specifically, pursuant to CAA section 112(d)(5), we are finalizing a 99
percent emission reduction standard for CEVs at area source facilities.
Our data do not identify any add-on controls beyond those we have
already considered when finalizing the standards for CEVs in section
IV.B. However, our evaluation of the performance test data shows that
these controls can achieve greater than 99 percent reduction. We
therefore considered a more stringent CEV emission standard for area
source facilities where EtO use is at least 400 tpy. We evaluated 99.9
percent reduction of CEV emissions from facilities where EtO use is at
least 400 tpy, which is the emission reduction that is currently
achieved by 75 percent of these facilities.\54\ A 99.9 percent
reduction would eliminate CEV emissions as a contributer to a
facility's MIR exceeding 100-in-1-million for facilities where EtO use
is at least 400 tpy.
---------------------------------------------------------------------------
\54\ There are three facilities that are currently achieving
this emission reduction. Of these three facilities, two use
catalytic oxidizers, and one uses a wet scrubber.
---------------------------------------------------------------------------
v. Group 1 Room Air Emissions
There are four area source facilities within the source category
where revised allowable Group 1 room air emissions contribute to the
facilities' MIRs exceeding 100-in-1 million, and the EtO usage at these
facilities ranges from 44 to 446 tpy. The previous subpart O did not
regulate Group 1 room air emissions at area source facilities. As
discussed in section IV.B of this preamble, we are finalizing a GACT
standard for these sources. Specifically, pursuant to CAA section
112(d)(5), we are finalizing an 80 percent emission reduction as the
GACT standard for Group 1 room air emissions at area source facilities.
Our data do not identify any add-on controls beyond those we have
already considered when finalizing the standards for Group 1 room air
emissions in section IV.B. However, our evaluation of the performance
test data shows that these controls can achieve greater than 80 percent
reduction. We therefore considered a more stringent Group 1 room air
emission standard for area source facilities where EtO use is at least
40 tpy. We evaluated 98 percent emission reduction of Group 1 room air
emissions from area source facilities using at least 40 tpy, which is
the emission reduction that has been achieved in all but one of the six
available performance test runs for these facilities.\55\ A 98 percent
reduction would eliminate Group 1 room air emissions as a contributor
to a facility's MIRs exceeding 100-in-1-million for area source
facilities where EtO use is at least 40 tpy.
---------------------------------------------------------------------------
\55\ All of these facilities use gas/solid reactors to control
their Group 1 room air emissions.
---------------------------------------------------------------------------
Considering all of the emission reductions that we evaluated above,
the source category MIR would be reduced to 100-in-1 million. This
means that all facilities would have an MIR at or below 100-in-1
million,\56\ and the population exposed to risk levels greater 100-in-1
million would be reduced to zero. In addition, the population exposed
to risk levels greater than or equal to 1-in-1 million living within 50
km of a facility would be reduced to between 710,000 (when considering
some facilities are currently performing better than the standards) and
1.41 million people (when considering all facilities perform at the
level of the standards). Finally, the cancer incidence would be reduced
from 0.9 to between 0.1 (when considering some facilities are currently
performing better than the standards) and 0.2 (when considering all
facilities perform at the level of the standards), or from 1 cancer
case every 1.1 years to 1 cancer case every 5 to 10 years. For these
reasons, we find that the preceding emission reductions that we
evaluated reduce risks to an acceptable level. These emission reduction
measures are:
---------------------------------------------------------------------------
\56\ Considering actual emissions, most facilities (i.e., 87 out
of 88) would have an MIR less than 100-in-1 million.
---------------------------------------------------------------------------
99.99 percent emission reduction for SCVs at facilities
where EtO use is at least 30 tpy,
99.9 percent emission reduction for SCVs at facilities
where EtO use is at least 10 tpy but less than 30 tpy,
99.8 percent emission reduction for SCVs at facilities
where EtO use is at least 1 tpy but less than 10 tpy,
99.9 percent emission reduction for ARVs at facilities
where EtO use is at least 30 tpy,
99.9 percent emission reduction for CEVs at facilities
where EtO use is at least 400 tpy,
98 percent emission reduction for Group 1 room air
emissions at area source facilities where EtO use is at least 40 tpy,
98 percent emission reduction for Group 2 room air
emissions at area source facilities where EtO use is at least 20 tpy,
and
80 percent emission reduction for Group 2 room air
emissions at area source facilities where EtO use is at least 4 tpy but
less than 20 tpy.
b. Ample Margin of Safety (Step 2)
At step 1 of our review of residual risks under CAA section
112(f)(2), we have identified a suite of standards and determined that
they are necessary to reduce risks to an acceptable level. These
include standards for SCVs at facilities with EtO usage of at least 1
tpy, ARVs at facilities with EtO usage of at least 30 tpy, CEVs at area
source facilities with EtO usage of at least 400 tpy, Group 1 room air
emissions at area source facilities with EtO usage of at least 40 tpy,
and Group 2 room air emissions at area source facilities with EtO usage
of at least four tpy. For step 2 of our review of residual risks, we
evaluate whether more stringent standards are necessary to provide an
ample margin of safety to protect public health. While we do not
consider costs in the step 1 analysis, costs are a factor we consider
in the step 2 analysis. For details on the assumptions and
methodologies used in the costs and impacts analyses, see the technical
memorandum titled Ample Margin of Safety Analysis for Ethylene Oxide
Commercial Sterilization--Promulgation Rule Review for the Ethylene
Oxide Commercial Sterilization Source Category, which is available in
the docket for this rulemaking.
As part of the proposed rulemaking, we considered six options
(which are identified in the proposal preamble table 22 (88 FR 22829)
and proposed Control Options A and C as part of the ample margin of
safety analysis. Control Option A would have required 99.94 percent
emission reduction for SCVs at facilities where EtO use is at least 10
tpy but less than 40 tpy. We are not finalizing Control Option A for
the following reasons. First, this option is less stringent than the
standard we have
[[Page 24122]]
already identified in Step 1 (99.99 percent emission reduction) for SCV
emissions at facilities where EtO use is at least 30 tpy.\57\ Second,
for facilities where EtO use is less than 30 tpy, we do not have any
performance tests showing that these facilities can perform better than
the manufacturer guarantee (i.e., 99.9 percent emission reduction for
SCVs). For these reasons, we are not finalizing Control Option A as
part of this rulemaking. Control Option C would have required 99.8
percent emission reduction for SCVs at facilities where EtO use is at
least 1 tpy but less than 10 tpy. As discussed in section IV.C.2.a of
this preamble (step 1 of risk review), Control Option C is one of the
standards identified under the revised Step 1 analysis as necessary to
reduce risks to an acceptable level.
---------------------------------------------------------------------------
\57\ For facilities where use is less than 30 tpy, we do not
have performance test data indicating that 99.99 percent emission
reduction for SCVs is technical feasible.
---------------------------------------------------------------------------
In addition, we evaluated the following options but rejected them
for the reasons discussed below:
[cir] For ARVs at facilities where EtO use is at least 30 tpy, we
do not have data showing that it is technically feasible for all
facilities to achieve greater than 99.9 percent emission reduction
(which is the standard applicable to these sources that we have
determined under step 1 as necessary to reduce risks to an acceptable
level).
For ARVs at facilities where EtO use is less than 10 tpy,
we were unable to identify any cost-effective options that achieve
emission reduction greater than the current 99 percent emission
reduction standard (GACT). More information is presented in the
technical memorandum titled Ample Margin of Safety Analysis for
Ethylene Oxide Commercial Sterilization--Promulgation Rule Review for
the Ethylene Oxide Commercial Sterilization Source Category, which is
available in the docket for this rulemaking.
For Group 2 room air emissions at area source facilities
where EtO use is at least 20 tpy, we do not have data indicating that
it is technically feasible for all facilities to achieve greater than
98 percent emission reduction (which is the standard applicable to
these sources that we have determined under step 1 as necessary to
reduce risks to an acceptable level).
For Group 2 room air emissions at area source facilities
where EtO use is less than 20 tpy, we do not have any performance tests
showing that these facilities can perform better than the manufacturer
guarantee (i.e., 80 percent emission reduction for room air emissions,
which is the standard for facilities using at least 4 tpy but less than
20 tpy of EtO that we have determined under step 1 as necessary to
reduce risks to an acceptable level).
For Group 2 room air emissions at area source facilities
where EtO use is less than 4 tpy, 80 percent emission reduction is not
cost effective.\58\
---------------------------------------------------------------------------
\58\ As discussed in section IV.B.3.b of this preamble, we
analyzed this option as part of the GACT analysis and found it to be
cost-effective. However, this analysis included all facilities in
the source category (i.e., not just those where EtO use is less than
4 tpy).
---------------------------------------------------------------------------
For Group 1 room air emissions at area source facilities
where EtO use is at least 40 tpy, we do not have data indicating that
it is technically feasible for all facilities to achieve greater than
98 percent emission reduction (which is the standard for these affected
sources that we have identified in Step 1 as necessary to reduce risks
to an acceptable level).
For Group 1 room air emissions at area source facilities
where EtO use is less than 40 tpy, we do not have any performance tests
showing that these facilities can perform better than the manufacturer
guarantee (i.e., 80 percent emission reduction for room air emissions,
which we have established in this final rule as the GACT standard for
Group 1 room air emissions at these facilities).
However, there are two potential options. One potential option is
99.6 percent emission reduction for ARVs at facilities where EtO use is
at least 10 tpy but less than 30 tpy. This is cost effective and is
already being achieved by these facilities. The other potential option
is to further reduce CEV emissions at area source facilities.\59\ Under
this option, which would reduce CEV emissions by 99.9 percent at area
source facilities where EtO use is at least 60 tpy less than 400
tpy,\60\ costs were found to be a $6,820,000 total capital investment
and a $1,670,000 total annualized cost. The estimated EtO emissions
reductions are 1.9 tpy (i.e., 3,720 lb/year) with a cost effectiveness
of $895,000 per ton of EtO (i.e., $448 per lb of EtO). Considering EtO
is a highly potent carcinogen, the cost-effectiveness number of this
option is within the range of the values that we have determined to be
cost-effective for highly toxic HAPs. As explained in section IV.B.3.b
of this preamble, 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). While we do not know what the full extent of risk
reductions would be, we estimate that, compared to the measures in step
1, this control option would further reduce the population exposed to
risk levels greater than or equal to 1-in-1 million by additional
10,000-30,000 people. For area sources where EtO use is less than 60
tpy, we do not have any performance test data showing that existing
controls can achieve greater than 99 percent reduction for CEVs (which
is the GACT standard we have established in this final rule for CEV at
area sources). In addition, for area source facilities where EtO use is
at least 400 tpy, we were unable to identify any cost-effective
options. Therefore, we did not consider a more stringent CEV standard
for facilities where EtO use at least 400 tpy.
---------------------------------------------------------------------------
\59\ As discussed in section IV.B.3.b of this preamble, pursuant
to CAA sections 112(d)(2) and 112(d)(3), we are finalizing a 99.94
percent emission reduction standard for CEVs at major source
facilities. We did not identify any cost-effective BTF options.
\60\ As discussed in step 1 analysis, pursuant to CAA section
112(f)(2), this standard for CEVs at area source facilities where
EtO usage is at least 400 tpy is necessary to reduce risks to an
acceptable level.
---------------------------------------------------------------------------
In the post control scenario (i.e., with the implementation of the
standards identified under step 1 and the two potential options
discussed immediately above in this step 2 analysis, we estimated that
the baseline cancer MIR of 6,000-in-1 million for actual emissions and
8,000-in-1 million for allowable emissions would be reduced to 100-in-1
million, with EtO driving the risk. While the MIR for the source
category will be 100-in-1 million, we estimate that most facilities
(i.e., 87 out of 88) will have an MIR less than 100-in-1 million. There
is an estimated reduction in cancer incidence to 0.2 excess cancer
cases per year (or one excess case every 5 years), down from 0.9 excess
cancer cases per year (or one excess cancer case every 1.1 years) for
baseline actual emissions and down from 8 excess cancer cases per year
(or one excess cancer case every 1.5 months) for baseline allowable
emissions. We estimate that, after full implementation of this final
rule, 0 people would have cancer risks greater than 100-in-1 million,
down from 19,000 people for actual emissions and 260,000 people for
allowable emissions. In addition, the number of people estimated to
have a cancer risk greater than or equal to 1-in-1 million would be
reduced to 1.38 million people, down from 8.5 million people for actual
emissions and 62 million people for
[[Page 24123]]
allowable emissions (table 19 of this preamble).
Again, we note that some facilities are currently performing better
than the controls finalized under CAA sections 112(f)(2), and in that
case we estimate the maximum lifetime individual cancer risk as 100-in-
1 million, with EtO driving the risk. The total estimated cancer
incidence is estimated to be 0.1 excess cancer cases per year, or 1
excess case in every 10 years, with approximately 700,000 people
estimated to have cancer risks greater than or equal to 1-in-1 million
and 0 people estimated to have cancer risks greater than 100-in-1
million (table 19 of this preamble).
Table 19--Baseline and Post-Control Risk (After Controls Promulgated Under CAA Sections 112(F)(2) Summary For
the Commercial Sterilization Facilities Source Category Based on Emissions in the Final Rule
----------------------------------------------------------------------------------------------------------------
Inhalation cancer risk Population cancer risk
---------------------------------------------------------------------------------
Maximum Cancer
individual incidence >100-in-1 [gteqt]1-in-1
risk (in 1 Risk driver (cases per million million
million) year)
----------------------------------------------------------------------------------------------------------------
Actual Emissions Baseline Risk 6,000 ethylene oxide.. 0.9 19,000 8,500,000
Allowable Emissions Baseline 8,000 ethylene oxide.. 8 260,000 62,000,000
Risk.
Post-control Risk............. 100 ethylene oxide.. \1\ 0.1-0.2 0 \1\ 700,000-
1,380,000
----------------------------------------------------------------------------------------------------------------
\1\ 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).
Additional details of the analyzed risks can be found in the
Residual Risk Assessment for the Commercial Sterilization Facilities
Source Category in Support of the 2024 Risk and Technology Review Final
Rule, available in the docket for this rulemaking.
Based on our ample margin of safety analysis, including all health
information and the associated cost and feasibility discussed above, we
find that requiring the standards that, based on our analysis, would
bring risks to an acceptable level, along with 99.6 percent emission
reduction for ARVs at facilities where EtO use is at least 10 tpy but
less than 30 tpy and 99.9 percent emission reduction for CEVs at area
source facilities where EtO use is at least 60 tpy but less than 400
tpy, would provide an ample margin of safety to protect public health.
c. Environmental Effects
As explained in our proposed rule, the emissions data indicate that
no environmental HAP are emitted by sources within this source
category. In addition, we are unaware of any adverse environmental
effects caused by HAP emitted by this source category. Therefore, we do
not expect there to be an adverse environmental effect as a result of
HAP emissions from this source category. For the reason stated above,
it is not necessary to set a more stringent standard to prevent, taking
into consideration costs, energy, safety, and other relevant factors,
an adverse environmental effect.
d. Rule Changes
Based on comments received on the proposed rulemaking, we are
finalizing the following emissions standards pursuant to CAA section
112(f)(2):
99.99 percent emission reduction for SCVs at facilities
where EtO use is at least 30 tpy,
99.9 percent emission reduction for SCVs at facilities
where EtO use is at least 10 tpy but less than 30 tpy,
99.8 percent emission reduction for SCVs at facilities
where EtO use is at least 1 tpy but less than 10 tpy,
99.9 percent emission reduction for ARVs at facilities
where EtO use is at least 30 tpy,
99.6 percent emission reduction for ARVs at facilities
where EtO use is at least 10 tpy but less than 30 tpy,
99.9 percent emission reduction for CEVs at area source
facilities where EtO use is at least 60 tpy,
98 percent emission reduction for Group 1 room air
emissions at area source facilities where EtO use is at least 40 tpy,
98 percent emission reduction for Group 2 room air
emissions at area source facilities where EtO use is at least 20 tpy,
and
80 percent emission 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 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'', which would have required facilities to limit their existing Group
2 room air emissions to a maximum volumetric flow rate of 2,900 dscfm
and a maximum EtO concentration of 30 ppbv. We had proposed these
standards based on the risk review we conducted during the proposal
stage, which has been substantially revised. As discussed above, based
on the revised risk review, we are finalizing a different suite of
standards pursuant to CAA section 112(f)(2) to reduce risks to an
acceptable level and provide an ample margin of safety to protect
public health.
3. What key comments did we receive on the risk review, and what are
our responses?
This section provides comment summaries and responses for the key
comments received regarding our exclusion of allowable emissions from
the risk assessment, the control requirements proposed for SCVs, and
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'' evaluated in the residual risk
assessment during the proposal stage, as well as the proposed GACT
standards that were incorporated into the residual risk assessment. We
received comments against the exclusion of allowable emissions from the
risk assessment, the control requirements proposed for SCVs, and 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.'' Other comments on these
issues, as well as on additional issues regarding the residual risk
review and our proposed changes based on the residual risk review, can
be found in the document, Summary of Public Comments and Responses for
the Risk and Technology Review for
[[Page 24124]]
Commercial Sterilization Facilities, available in the docket for this
rulemaking.
Comment: Two commenters contended that we should use allowable
emissions when conducting residual risk assessments. One commenter
stated that actual emissions only provide a snapshot in time and that
there is no legal requirement at the Federal level to maintain
emissions beyond the NESHAP requirements in any given year. The
commenter also referenced a 2010 Science Advisory Board (SAB) report
that recommended we use ``facility-specific allowable emissions
reflecting current regulatory limits.'' \61\
---------------------------------------------------------------------------
\61\ Commenter provided the following reference: EPA Science
Advisory Board, Review of EPA's draft entitled, ``Risk and
Technology Review (RTR) Risk Assessment Methodologies: For Review by
the EPA's Science Advisory Board with Case Studies--MACT I Petroleum
Refining Sources and Portland Cement Manufacturing'', at ii, (May 7,
2010), https://www.regulations.gov/document/EPA-HQ-OAR-2010-0682-0103.
---------------------------------------------------------------------------
Response: We agree with commenters that allowable emissions should
be considered as part of the residual risk assessment. As discussed in
section III.C of the proposed rulemaking (88 FR 22790), because
allowable emissions and risks were higher than actual emissions, and in
light of our finding that risks were unacceptable based on actual
emissions, we determined that a separate assessment of allowable
emissions was unnecessary. However, for the reasons stated by the
commenters, we have incorporated allowable emissions into our revised
risk assessment as part of this final rulemaking.
Comment: Two commenters expressed the following concerns with the
99.94 percent emission reduction standard for SCVs:
Our technical publications on reduction ranges for add-on
control equipment for HAPs do not show that a destruction and removal
efficiency of 99.94 percent is achievable under normal continuous
operation.
The proposed requirement does not require additional
controls based on new technology, but requires achieving greater
efficiency from existing controls. Specifically, one commenter stated
that nothing in the proposal preamble suggests that the control systems
installed in order to meet the current SCV standard need to be replaced
or their performance upgraded. The commenter further stated that our
cost estimates include nothing with respect to controls for SCVs.
Emission control device manufacturers do not guarantee a
destruction removal efficiency of 99.94 percent for SCVs.
Two commenters stated that emissions standards should be based on
achievable, manufacturer guaranteed destruction removal efficiency of
emission control equipment. 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 99.9
percent emission reduction standard for SCVs.
Response: We disagree with the commenters that our technical
publications on reduction ranges for add-on control equipment for HAPs
do not show that an emission reduction of 99.94 percent (and,
therefore, any greater emission reduction) is achievable under normal
continuous operation for SCVs. Such a performance test was conducted
for at least two systems that control SCV emissions, and the reported
emission reduction for both of these systems was 99.99 percent. Below
is a discussion on the relevant points for each performance test:
The first performance test was conducted on November 17,
1999.\62\ It is unknown what the EtO use at this facility was at the
time of the performance test, but it is expected that it was somewhere
between 10 tpy and 30 tpy. At the time of the performance test, the
facility used a wet scrubber to control its SCV emissions.\63\ Prior to
November 2, 2001, we required facilities to test the both the first and
last evacuations of the SCV. The SCV concentration decreases over time,
so any emission reductions between the first and last evacuations are
going to be at least as high as that of the last evacuation. For this
performance test, the average emission reduction at the first
evacuation was 99.9946 percent, and the average emission reduction at
the last evacuation was 99.99 percent. This means that the emission
reduction over all the SCV cycles exceeded 99.99 percent. While this
performance test data is almost 25 years old, emission control
technology has continued to improve over time, and emission reductions
today are likely higher.
---------------------------------------------------------------------------
\62\ https://www.regulations.gov/document/EPA-HQ-OAR-2019-0178-0297.
\63\ This facility continues to use a wet scrubber to control
its SCV emissions to this day.
---------------------------------------------------------------------------
The data from this performance test indicates that, for
facilities where EtO use is at least 30 tpy, any SCV control system
that is achieving higher than 99.9946 percent emission reduction on the
first evacuation is likely achieving at least 99.99 percent emission
reduction overall. Our current performance test data indicates that at
least 15 facilities where EtO use is at least 30 tpy are currently
achieving greater than 99.9946 percent emission reduction on the first
evacuation, and the highest emission reduction on the first evacuation
that we have observed is 99.99999982 percent. Of these 15 facilities
that are currently achieving this emission reduction, eight use wet
scrubbers, three use a wet scrubber and gas/solid reactor in series,
two use thermal oxidizers, one uses a catalytic oxidizer, and one uses
a wet scrubber and catalytic oxidizer in series.
The second performance test was conducted on March 10, 11,
and 12, 2020,\64\ and EtO use at this facility is 229.2 tpy. This
facility uses wet scrubbers and gas/solid reactors in series to control
its SCV emissions. Due to the configuration of the control system at
this facility, there is no mechanism to test the SCVs on their own.
Therefore, this performance test was conducted for all emission sources
at the facility. For lower concentration streams like ARVs, CEVs, and
room air emissions, emission reductions tend to be lower. Therefore, it
is likely that the SCV emission reduction at this facility exceeds
99.99 percent.
---------------------------------------------------------------------------
\64\ https://www.regulations.gov/document/EPA-HQ-OAR-2019-0178-0349.
---------------------------------------------------------------------------
As a general matter, it is not our policy to simply rely on
manufacturer guarantees when setting or revising emission standards.
Typically, we evaluate performance tests to see what the controls are
actually achieving in practice and then set or revise the standards
based on that evaluation. However, if representative performance test
data are not available, then manufacturer guarantees may be considered.
We also note that it is common within this industry to combine
different types of control devices in series when reducing emissions.
Since these control devices are often made by different manufacturers,
there is no manufacturer guarantee available for these systems. We do
not share the commenters' concerns that emission control device
manufacturers do not guarantee a destruction removal efficiency of
99.94 percent for SCVs, as representative performance test data is
available and indicates that these emission reductions (and, in fact,
higher emission reductions) are achievable for higher use facilities.
However, such performance test data are not available for smaller
users, and it is not known whether those facilities can meet the
emission reduction that the higher use facility is demonstrating.
Therefore, we agree with commenters that consideration of manufacturer
guarantees is warranted for lower use facilities, and the
[[Page 24125]]
standards that we are finalizing for SCVs at facilities where EtO use
is less than 30 tpy do not exceed the manufacturer guarantee.
In addition, we disagree with one commenter's assertion that there
is nothing in the proposal preamble to suggest that the control systems
installed in order to meet the current SCV standard need to be replaced
or their performance upgraded. Furthermore, the commenter's assertion
that our cost estimates include nothing with respect to controls for
SCVs is incorrect. As discussed in section II.A of this preamble, under
the first step of the residual risk assessment, if risks are
unacceptable, the EPA must determine the emissions standards necessary
to reduce risk to an acceptable level without considering costs. While
we did not conduct a cost analysis for the SCV standards that we are
finalizing pursuant to CAA section 112(f)(2) step 1 (risk acceptability
analysis), we assume that new controls would be needed in order to
achieve those standards, and the cost of those controls are included in
the total costs of the rule. However, we note that the final standard
is simply an emission reduction standard, and owners and operators may
choose to meet the standard however they see fit (e.g., either through
process changes, the replacement of a control system, or the use of
additional control devices to further reduce emissions from an existing
control system). In some cases, existing controls may already be
achieving the standard, and in that case, no changes are required.
Comment: Several commenters stated that reducing the volumetric
flow rate from Group 2 room air emissions to 2,900 dscfm would be
detrimental to sterilization operations and may make it impossible to
achieve the proposed PTE requirement.
Response: Based on comments received on the proposed rulemaking, we
revised the risk assessment, which resulted in different emission
reduction measures than what we proposed to bring the risk to the
acceptable level. The proposed work practice standards are no longer
necessary to bring the MIR of Group 2 room air emissions at area source
facilities to 100-in-1 million. Therefore, we are not including a work
practice standard that would require any facilities to reduce their
throughput as part of this final rule.
4. What is the rationale for our final approach and final decisions for
the risk review?
As noted in our proposal, we set standards under CAA section
112(f)(2) using ``a two-step standard-setting approach, with an
analytical first step to determine an `acceptable risk' that considers
all health information, including risk estimation uncertainty, and
includes a presumptive benchmark on MIR of approximately 1-in-10
thousand'' (88 FR 22790, April 13, 2023; see also 54 FR 38045,
September 9, 1989). We weigh all health risk factors in our risk
acceptability determination, including the cancer MIR, cancer
incidence, the maximum TOSHI, the maximum acute HQ, the extent and the
distribution of cancer and noncancer risks in the exposed population,
multipathway risks, and the risk estimation uncertainties. 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.
Since proposal, our determinations regarding risk acceptability,
ample margin of safety, or adverse environmental effects have not
changed. The revised risk assessment (see document, Residual Risk
Assessment for the Commercial Sterilization Facilities Source Category
in Support of the 2024 Risk and Technology Review Final Rule, which is
available in the docket for this rulemaking) shows that, after
application of controls finalized in this rulemaking, the MIR for the
source category is 100-in-1 million. Therefore, after application of
the controls for SCVs at facilities where EtO use is at least 1 tpy,
ARVs at facilities where EtO use is at least 30 tpy, CEVs at area
source facilities where EtO use is at least 400 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 four tpy, we find that the risks are acceptable and that
the final standards will achieve an ample margin of safety to protect
public health.
D. Technology Review for the Commercial Sterilization Facilities Source
Category
1. What did we propose pursuant to CAA section 112(d)(6) for the
Commercial Sterilization Facilities source category?
Based on our technology review for the Commercial Sterilization
Facilities source category, we proposed under CAA section 112(d)(6)
changes to the standards for SCVs where EtO use is at least 10 tpy,
SCVs where EtO use is at least 1 tpy but less than 10 tpy, and ARVs
where EtO use is at least 10 tpy. We provide a summary of our findings,
as proposed, in this section. In general, while the types of controls
have essentially remained the same since promulgation of subpart O,
available information show greater emission reduction since then for
some of these control options.
For SCVs, we proposed the following emission standards pursuant to
CAA section 112(d)(6):
99.94 percent reduction for new and existing SCVs at
facilities where EtO use is at least 10 tpy, and
99.8 percent reduction for new and existing SCVs at
facilities where EtO use is at least 1 tpy but less than 10 tpy.
These are the maximum SCV emission reductions with which compliance
can be demonstrated. We evaluated these standards against the maximum
SCV emission reductions that all facilities are currently meeting
within each subcategory. For more information, see sections III.F.1 and
III.F.2 of the proposal preamble (88 FR 22790, April 13, 2023).
For ARVs, we proposed the following emission standards pursuant to
CAA section 112(d)(6):
99.6 percent emission reduction for existing ARVs at
facilities where EtO use is at least 10 tpy, and
99.9 percent emission reduction for new ARVs at facilities
where EtO use is at least 10 tpy.
These are the emission reductions that have been demonstrated by 75
percent and 50 percent of all available performance tests,
respectively. We evaluated both emission reductions for new and
existing ARVs. For more information, see section III.F.3 of the
proposal preamble (88 FR 22790, April 13, 2023).
2. How did the technology review change for the Commercial
Sterilization Facilities source category?
We are finalizing the following emission standards as a result of
the
[[Page 24126]]
technology review for the Commercial Sterilization Facilities source
category, as proposed:
99.8 percent emission reduction for new and existing SCVs
at facilities where EtO use is at least 1 tpy but less than 10 tpy,
99.6 percent emission reduction for existing ARVs at
facilities where EtO use is at least 10 tpy, and
99.9 percent emission reduction for new ARVs at facilities
where EtO use is at least 10 tpy.
For new and existing SCVs at facilities where EtO use is at least
10 tpy, based on comments received on the proposal, we are finalizing a
99.9 percent emission reduction, which is the manufacturer guarantee.
There is a lack of representative performance test data for these SCVs,
and we are unable to determine whether all facilities can achieve an
emission reduction higher than the manufacturer guarantee. For more
information, see section IV.D.3.a of this preamble.
3. What key comments did we receive on the technology review, and what
are our responses?
This section provides comment and responses for the major comments
on our proposed CAA section 112(d)(6) standards. Other comment
summaries and our responses for additional issues raised regarding
these activities, as well as issues raised regarding our proposed
revisions, 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. SCVs at Facilities Where EtO Use Is at Least 10 tpy
Comment: Several commenters questioned whether the proposed
emission standards for SCVs at facilities where EtO use is at least 10
tpy could be achieved with existing technology and stated that we
should consider manufacturer guarantees when revising the standard,
along with a maximum concentration limit. The commenters stated that we
arrived at a 99.94 percent emission reduction standard based on
performance tests that used the previous testing procedures in Subpart
O. These consisted of one-hour test runs that occurred during the
initial vacuum event, when EtO loading to the control system (and,
therefore, emission reduction) is high. The commenters further stated
that we proposed extending the duration of each test run to 24 hours,
which would cover a variety of operating conditions, including periods
of low inlet concentration, which have not been required to be tested.
The commenters contended that the performance test results based on the
proposed testing procedures would be lower than those under the
previous testing procedures. One commenter stated that there are no
data confirming whether state-of-the-art control systems can meet a
99.94 percent emission reduction standard for SCVs where each
performance test run is 24 hours, and another commenter stated that we
must ensure that any required emission reduction standards that are
finalized for SCVs are proven and achievable as part of performance
tests consisting of 24-hour test runs. 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 99.9 percent emission reduction standard for SCVs.
Response: We agree with the commenters that it is not appropriate
to use performance test data based on the previous testing procedures
in Subpart O to justify revisions to the emission standards for SCVs.
We disagree with one commenter's statement that there are no data
confirming whether state-of-the-art control systems can meet a 99.94
percent emission reduction standard for SCVs where each test run is 24
hours. As discussed in section IV.C.3, such data exist for at least one
system that controls SCV emissions. However, the EtO usage at this
facility is fairly high, and we are unable to determine whether smaller
users can meet this emission standard. With respect to the suggestion
by some commenters that we consider a manufacturer guarantee reduction
level, which one commenter stated is 99.9 percent emission reduction
for SCVs, we have no data disputing such level or reason to question
the manufacturer's guarantee. Further, as discussed in our response to
the next comment below, we find the cost of this option to be
reasonable. Therefore, pursuant to CAA section 112(d)(6), we are
finalizing a 99.9 percent emission reduction standard for SCVs at
facilities where EtO use is at least 10 tpy.\65\
---------------------------------------------------------------------------
\65\ We also note that, as discussed in section IV.F.3 of this
preamble, we are finalizing a requirement for owners and operators
to include a representative performance test period for SCVs, along
with a justification, in their stack test protocol, so that the
delegated authorities can review and approve or deny the protocol as
appropriate. This will ensure that performance tests provide a more
accurate representation of SCVs emission reductions.
---------------------------------------------------------------------------
We disagree with the commenter's suggestion that we should consider
a maximum concentration limit along with the percentage reduction
standard. As discussed in section IV.B.3.a, we are concerned that some
owners and operators may dilute the air flow of the emissions stream to
meet a concentration standard, which would not result in any actual
emission reductions. Furthermore, it is not appropriate to establish
upper-bound limitations on air flow within this source category, as
additional flow may be necessary in order to mitigate any potential
safety issues that may arise. Therefore, we are not finalizing any
concentration standards as part of this rulemaking.
Comment: One commenter stated that, for the SCV technology rule
under CAA section 112(d)(6), we merely referred back to, and repeated
the proposed standards of, the residual risk review. The commenter
further stated that we did not conduct the technology review as a
separate analysis, but rather, it was inseparably intertwined with the
residual risk review. Finally, the commenter stated there is no true
technology review in the record and that cost considerations of the
proposed CAA section 112(d)(6) emissions standard for existing SCVs at
facilities where EtO use is at least 40 tpy were never considered, even
though section 112(d)(6) requires considerations of cost.\66\
---------------------------------------------------------------------------
\66\ In support of its comment that control costs must be
considered under section 112(d)(6) review, the commenter cited to
Nat'l Ass'n for Surface Finishing, 795 F.3d at 5 (``in the
technology review, EPA periodically assess, no less often than every
eight years, whether standards should be tightened in view of
developments in technologies and practices since the standard's
promulgation or last revision, and, in particular, the cost and
feasibility of developments and corresponding emissions savings'').
---------------------------------------------------------------------------
Response: We disagree with the commenter's statement that a
``true'' technology review was never conducted. In the proposal
preamble (88 FR 22839-41), the EPA discussed control options that can
achieve further emission reductions compared to the existing subpart O
standards. While the types of controls have essentially remained the
same, available information shows improvement in emission reduction
potential for some of these control options, which we consider to be a
development in control technologies; we analyzed this development and
proposed revisions to the standards pursuant to CAA section 112(d)(6).
The commenter appears to take issue with the fact that these are the
same options as those we evaluated under CAA section 112(f)(2),
specifically under step 2 (ample margin of safety) analysis. However,
in evaluating whether we can achieve further emission reduction and
thus lower risks, we naturally would
[[Page 24127]]
consider controls that reflect the current developments in processes
and technology by this industry (i.e., well performing air pollution
control), which we are also required to evaluate under CAA section
112(d)(6). For the reason stated above, we find the comment that our
technology review was not a ``true'' review to be without merit.
We acknowledge that in proposing a 99.94 percent standard pursuant
to CAA section 112(d)(6) for SCV at facilities using at least 10 tpy
EtO, we inadvertently evaluated the control costs for facilities using
between 10 to 40 tpy only. However, as discussed in our comment
response above, we no longer consider the proposed 99.94 percent
emission reduction standard to be appropriate. As suggested by several
commenters, we evaluated a manufacturer guarantee. Based on one
commenter's discussions with control device manufacturers, the best and
most advanced technologies will be guaranteed to meet 99.9 percent
emission reduction for SCVs. The impacts of this option and the 99.6
percent reduction option that we considered during the proposal stage
are presented below in table 20 for existing sources:
Table 20--Nationwide Emissions Reduction and Cost Impacts of Options Considered Under CAA Section 112(d)(6) for Existing SCVs at Facilities Where EtO
Use Is at Least 10 Tpy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital Total annual EtO emission reductions Cost effectiveness ($/
Option Standard evaluated investment ($) costs ($/yr) (tpy) ton EtO)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................... 99.9 percent emission $1,840,000 $752,000 1.14 [2,280 lb]......... $661,000 [$330/lb].
reduction.
2.................................... 99.6 percent emission 0 0 0....................... N/A.
reduction.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Based on the estimates above, and considering EtO is a highly
potent carcinogen, the cost-effectiveness number of this option is
within the range of the values that we have determined to be cost-
effective for highly toxic HAPs. As explained in section IV.B.3.b of
this preamble, 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). As part of the proposed rulemaking, the highest cost-
effectiveness number that we found was $19,420,188/ton. We did not
receive adverse comment on our finding that this is cost-effective.
While Option 2 would prevent backsliding, it does not achieve
additional emission reduction. Therefore, pursuant to CAA section
112(d)(6), we are revising the standard to require facilities where EtO
use is at least 10 tpy to reduce their emissions from existing SCVs by
99.9 percent.
The impacts of these options for new sources, which are presented
in table 21 of this preamble, are based on a model plant for new SCVs
at a facility using at least 10 tpy of EtO with the following
assumptions reflecting the average of each of the parameters at
existing facilities using at least 10 tpy of EtO:
Annual EtO use: 120 tpy.
Annual operating hours: 8,000.
Portion of EtO going to SCVs: 94.41 percent.
SCV flow rate: 200 cfs.
Table 21--Nationwide Emissions Reduction and Cost Impacts of Options Considered Under CAA Section 112(d)(6) for New SCVs at Facilities Where EtO Use Is
at Least 10 Tpy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital Total annual EtO emission reductions Cost effectiveness ($/
Option Standard evaluated investment ($) costs ($/yr) (tpy) ton EtO)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................... 99.9 percent emission $523,000 $136,000 1.02 [2,040 lb]......... $134,000 [$67/lb].
reduction.
2.................................... 99.6 percent emission 348,000 106,000 0.68 [1,360 lb]......... 158,000 [$79/lb].
reduction.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Based on the estimates above, we find both options to be cost
effective. Option 1 would achieve greater emission reductions than
Option 2, and Option 1 would be more cost-effective. Therefore,
pursuant to CAA section 112(d)(6), we are revising the standard to
require facilities where EtO use is at least 10 tpy to reduce their
emissions from new SCVs by 99.9 percent.
Comment: In response to the EPA's solicitation of comment on
whether to include a mass emission rate standard as an alternative to
the percent emission reduction standard, two commenters were opposed to
such an alternative. One commenter stated that mass emission rate
standards for individual vents do not account for variability between
facilities or variability within facilities. The commenter also stated
that any standard that fails to reflect individual facility dynamics
that materially affect the ability to comply is inappropriate and not
achievable.
Response: We agree with the commenters' concerns regarding the
alternative, equivalent mass rate emission standards. Therefore, they
are not included in this final rule.
b. SCVs at Facilities Where EtO Use Is at Least 1 Tpy but Less Than 10
Tpy
Comment: One commenter stated that they support emission reduction
standards based on manufacturer guarantees for control equipment, along
with a maximum concentration limit, to ensure that compliance can be
achieved and demonstrated. In addition, the commenter did not agree
with our method to calculate alternative, equivalent mass rate emission
standards. Another 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 99.9 percent
emission reduction standard for SCVs.
Response: We agree with the commenter's suggestion that
manufacturer guarantees be considered when finalizing the standard.
Most of the performance tests that are currently available for SCVs are
based on the previous testing procedures, which are not reflective of
actual operating conditions. The one performance test we have that is
based on actual operating conditions is for a facility
[[Page 24128]]
where EtO use exceeds 30 tpy and thus not appropriate for the group of
facilities at issue here (i.e., those using at least 1 tpy but less
than 10 tpy of EtO). Therefore, a manufacturer guarantee is appropriate
to consider in this instance, and a 99.8 percent emission reduction
standard falls within the manufacturer guarantee range for SCV controls
as provided by one of the commenters (99.9 percent emission reduction).
However, this does not change our rationale for a 99.8 percent
reduction standard during the proposal stage, which was that this is
the maximum emission SCV reduction with which compliance can be
demonstrated at all facilities where EtO use is at least 1 tpy but less
than 10 tpy considering current emission profiles.
We disagree with the commenter's recommendation for a maximum
concentration limit. As discussed in section IV.B.3.a, we are concerned
that some owners and operators may dilute the air flow of the emissions
stream to meet a concentration standard, which would not result in any
actual emission reductions. Furthermore, it is not appropriate to
establish upper-bound limitations on air flow within this source
category, as additional flow may be necessary in order to mitigate any
potential safety issues that may arise. Finally, as discussed in
section IV.D.3.a, we are not including any alternative, equivalent mass
rate emission standards in the final rule. Therefore, the commenter's
concerns regarding the methodology used to calculate the limits are no
longer relevant.
c. ARVs at Facilities Where EtO Use Is at Least 10 Tpy
Comment: Several commenters objected to the proposed emission
reduction standards and stated that they are not achievable as written.
One commenter stated that we should require emission reduction
standards based on manufacturer guarantees, along with a maximum
concentration limit. Another commenter stated that sterilization is a
batch process and that the concentration from the aeration area is
subject to constant fluctuation due to differences in product, cycles,
facility design, and EtO decline curve, which makes a consistent
emission reduction challenging to determine. Finally, several
commenters expressed concerns with the use, and our development, of the
alternative, equivalent mass rate emission standards due to the wide
variations in ARV parameters across this group of facilities, as well
as the difficulty in demonstrating compliance with this standard for
larger facilities.
Response: We disagree with the commenters' position that the
proposed emission reduction standards are not achievable. As discussed
in section III.F.3.a of the proposal preamble (88 FR 22790, April 13,
2023), most existing sources (i.e., 75 percent) are already achieving
99.6 percent emission reduction. In addition, 99.9 percent emission
reduction has been demonstrated by 50 percent of existing sources. We
also disagree with one commenter's suggestion that manufacturer
guarantees be considered in this instance for two reasons. First, there
is no need to rely on manufacturer guaranteed emission levels because
there are available performance test data for ARVs that are
representative of actual operating conditions. Unlike SCVs, which go
through different active phases with wildly varying concentrations,
fluctuations in ARV concentrations are slight; an aeration room serves
one purpose, which is to hold product at an elevated temperature, and
the resulting ARV concentration is relatively constant. Therefore, a
one-hour test period for this source is appropriate, and the resulting
performance test data are representative of actual operating
conditions. To that end, we disagree with another commenter's statement
that fluctuations in the ARV make it difficult to comply with an
emission reduction standard. Second, performance test data for ARVs are
plentiful. As discussed in section III.F.3.a of the proposal preamble,
there are 47 facilities where EtO use is at least 10 tpy, 41 of which
have ARVs. Of these 41 facilities, 32 (78 percent) have performance
test data. Because the performance test data from ARVs at these
facilities are both plentiful and representative of actual operating
conditions, there is no need to rely on a manufacturer guaranteed
emission reduction level in this instance. We also disagree with the
commenters' recommendation for a maximum concentration standard. As
discussed in section IV.B.3.a, we are concerned that some owners and
operators may dilute the air flow of the emissions stream to meet a
concentration standard, which would not result in any actual emission
reductions. Furthermore, it is not appropriate to establish upper-bound
limitations on air flow within this source category, as additional flow
may be necessary in order to mitigate any potential safety issues that
may arise. Finally, with respect to the alternative equivalent mass
rate emission standards, we agree with the commenters' concerns, and we
are not including these standards in the final rule.
Comment: One commenter stated that if the lowest practicably
measured concentration is 30 ppbv (our presumed workable-in-practice
detection limit for CEMS), then a source with an inlet concentration
that is too low will be unable to show the required emission reduction,
even if the control system is providing that level of reduction,
because the monitoring approach will be unable to distinguish the true
outlet concentration from 30 ppbv. The commenter further stated that
existing sources would need to have pre-control aeration room
concentrations of at least 7.5 ppmv to make this demonstration. Two
commenters stated that the increased 99.6 percent (existing facilities)
or 99.9 percent (new facilities) ARV emission reduction standards
penalize facilities that have reduced EtO concentrations during the
sterilization cycle. Several commenters noted that facilities have
reduce EtO concentrations during the sterilization cycle (i.e., use of
vacuum and/or nitrogen wash cycles) prior to moving the sterilized load
to aeration to reduce inlet ARV concentrations, and that removals, on a
percent basis, are only achievable with elevated inlet concentrations.
Response: One commenter is correct that, given the lowest
practicable measured concentration (30 ppbv), the pre-control
concentration would need to be 7.5 ppmv in order to demonstrate
compliance with the proposed standard for existing sources. The
performance test data that are available for ARVs at these facilities
consist of 86 test runs. Of these 86 test runs, only five (six percent)
had a measured concentration less than 7.5 ppmv, which suggests low
likelihood that facilities will have difficulty demonstrating
compliance due to low pre-control concentration. based on the current
operating conditions Furthermore, regarding the comment that these
standards would penalize sources who have already worked to reduce
their EtO concentrations during sterilization and, by extension, their
inlet ARV concentrations, as discussed in section III.F.3 of the
proposal preamble, 75 percent of existing sources are already meeting
the proposed standard; it is unclear, and the commenter does not
explain, why a requirement that retains facilities' status quo is a
punishment to those facilities. Most of the industry is either (1)
currently meeting the proposed standard or (2) capable of meeting the
proposed standard based on current operating conditions. In addition,
if a facility with existing ARVs
[[Page 24129]]
wishes to further reduce their EtO concentrations during sterilization,
then operational changes can be made to the aeration room so that the
facility can continue to demonstrate compliance with the emission
reduction standard. Since new facilities are not currently in
operation, there has been no reduction in EtO concentrations during
sterilization and, therefore, no penalty has been incurred.
4. What is the rationale for our final approach for the technology
review?
Our technology review focused on the identification and evaluation
of developments in practices, processes, and control technologies that
have occurred since the standards for Commercial Sterilization
Facilities were originally promulgated on December 6, 1994 (59 FR
62585) and further amended on November 2, 2001 (66 FR 55577).
Specifically, we focused our technology review on all previous
standards for the various emission sources in the Commercial
Sterilization Facilities source category, including SCVs at facilities
where EtO use is at least 10 tpy, SCVs at facilities where EtO use is
at least 1 tpy but less than 10 tpy, and ARVs at facilities where EtO
use is at least 10 tpy. In the proposal, we identified developments for
all emission sources, and we proposed to revise the standards for these
emissions sources under the technology review. Further information
regarding the technology review can be found in the proposed rule (88
FR 22790, April 13, 2023) and in the supporting materials in the
rulemaking docket at Docket ID No. EPA-HQ-OAR-2019-0178.
During the public comment period, we received several comments on
our proposed determinations for the technology review. No information
presented by commenters has led us to change our proposed determination
under CAA section 112(d)(6) for SCVs at facilities where EtO use is at
least 1 tpy but less than 10 tpy and ARVs at facilities where EtO use
is at least 10 tpy, and we are finalizing the changes to those
standards as proposed. For SCVs at facilities where EtO use is at least
10 tpy, based on comments received on the proposal, we are finalizing a
99.9 percent emission reduction standard, which is the manufacturer
guarantee. There is at least one representative performance test
available for SCVs, but it was conducted at a facility with a higher
EtO usage rate, and we are unable to determine whether smaller
facilities can achieve the emission reduction from that performance
test. The key comments and our specific responses can be found in
section IV.D.3 of this preamble and 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.
E. Amendments Addressing Emissions During Periods of SSM
1. What amendments did we propose to address emissions during periods
of SSM?
For all emission points in the Commercial Sterilization Facilities
source category, we proposed eliminating the SSM exemptions and to have
the standards apply at all times. More information concerning the
elimination of SSM provisions is in section III.G. of the proposal
preamble (88 FR 22790, April 13, 2023).
2. How did the SSM provisions change since proposal?
We are finalizing the SSM provisions as proposed (88 FR 22790,
April 13, 2023).
3. What key comments did we receive on the SSM revisions and what are
our responses?
This section provides comment summaries and responses for the key
comments received regarding our proposed revisions. Other comment
summaries and the EPA's responses for additional issues raised
regarding these activities as well as issues raised regarding our
proposed revisions 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.
Comment: One commenter stated that the EPA should consider other
approaches to adequately account for SSM contingencies. The commenter
suggested that the EPA classify sources in SSM states as sub-sources
subject to different emissions limitations or work practice standards.
Another commenter stated that EtO sterilizers do not create emissions
during startup or shut down because, unlike other industrial processes
regulated under the NESHAP program, EtO is not emitted as a byproduct
of combustion or chemical reaction but is released intentionally in a
highly controlled manner. The commenter further stated that
sterilization never begins before control equipment is activated and
always ends before control equipment is deactivated. Similarly, another
commenter stated that the EPA inaccurately assumed that startup and
shutdown are no different than normal operation. The commenter further
stated that constructing and starting new abatement equipment includes
periods of troubleshooting and acceptance testing. The commenter also
stated that the proposal does not address the permit-to-construct
process and related requirements before transferring to an operating
permit. Finally, one commenter suggested that the malfunction exemption
should not be eliminated because, due to the nature of sterilization
operations and various stages of cycles, commercial sterilizers must be
able to address malfunctions that could result in a potential risk to
employees or the facility without the risk of being in noncompliance.
Response: As discussed in section III.G.1 of the proposal preamble
(88 FR 22790, April 13, 2023), it is common practice in this source
category to start an air pollution control device (APCD) prior to
startup of the emissions source it is controlling, so the APCD would be
operating before emissions are routed to it, which has been confirmed
by one of the commenters. In addition, based on responses to the
December 2019 questionnaire and the September 2021 ICR, many facilities
already have measures in place to ensure that the emission standards
are met during periods of SSM, including holding emissions within the
process unit or the APCD itself, or the use of onsite generators in the
event of a power outage.\67\ The comments provided do not support
establishing emission standards that apply only during periods of SSM.
With respect to classifying sources in SSM states as sub-sources
subject to different emissions limitations or work practice standards,
the commenter does not provide any rationale for why this should be
done or any suggestions for what those emission standards should be.
With respect to emission spikes from troubleshooting control devices,
as discussed in section IV.F.3 of this preamble, the EPA is finalizing
a requirement for emission limits to be based on 30-operating day
rolling sums of EtO entering the control system(s) for EtO CEMS, which
will help to mitigate these spikes over time. However, the commenter
does not provide any rationale for why the permitting process should be
considering when evaluating SSM. Finally, we cannot agree with the
commenter's recommendation to keep the malfunction exemption in
[[Page 24130]]
contradiction with Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir. 2008),
in which the court vacated two provisions that exempted sources from
the requirement to comply with otherwise applicable CAA section 112(d)
emission standards during periods of SSM. As discussed in section
III.G.1 of the proposal preamble, in its 2008 decision in Sierra Club
v. EPA, 551 F.3d 1019 (D.C. Cir. 2008), the court held that emissions
standards or limitations must be continuous in nature, which means that
there cannot be exemptions for periods of malfunction. Further, while
the EPA could consider establishing a different standard during
malfunction if warranted and still be consistent with the Sierra Club
decision, the commenter does not provide any specific information
regarding instances where compliance with the standards during
malfunction could result in potential risks to the employees or the
facility or suggestions for what emission standards the EPA should
consider to address the concern. Therefore, the EPA is not finalizing
any emission standards that apply only during periods of SSM.
---------------------------------------------------------------------------
\67\ See memorandum, Review of Startup, Shutdown, and
Malfunction of Process and APCD Equipment in the Ethylene Oxide
Commercial Sterilization Source Category Technology Review Project,
located at Docket ID No. EPA-HQ-OAR-2019-0178.
---------------------------------------------------------------------------
Comment: One commenter stated that a specific area of concern is
the ability to demonstrate compliance during startup and shutdown,
asserting that the proposed rule offered no means for a source to
remain in compliance during the inevitable and foreseeable, but not
predictable, failure of monitoring equipment. The commenter further
suggested that the EPA should consider specific reporting and
monitoring alternative requirements for these scenarios. The commenter
provided the example of a requirement specific to releases from
sterilizer pressure relief devices (PRDs) resulting from malfunctions
or required during shutdown events that the commenter suggested could
be modeled after recent PRD requirements in 40 CFR 63.648(j). Another
commenter recommended that facilities should only be required to report
malfunction events that result in unpermitted releases to the
atmosphere. The commenter stated that, in the example situation where
control equipment unexpectedly goes offline during operations but EtO
remains trapped within the facilities ducts under negative pressure,
there would be no need to create additional administrative compliance
requirements for the facility.
Response: With respect to accounting for the failure of monitoring
equipment when demonstrating compliance, as discussed in section IV.F.3
of this preamble, the EPA is finalizing a minimum data availability
requirement of 90 percent for EtO CEMS. With respect to specific
reporting and monitoring alternative requirements that apply during
periods of SSM, the commenter did not provide any recommendations for
what those requirements should be. In addition, we agree with one
commenter's suggestion that facilities should only be required to
report malfunction events that result in unpermitted releases to the
atmosphere. However, to be clear, we are finalizing reporting
requirements for malfunction events that occur with emissions or
parametric monitoring equipment.
Comment: One commenter suggested that the EPA should not include
the general duty clause in the final rule. The commenter stated that it
is not clear on what basis the EPA is claiming authority to impose a
general standard of behavior on regulated sources. The commenter
asserted that CAA section 112 grants the EPA authority to set emissions
limits and certain specific alternative standards but does not grant
authority to impose a ``vague and subjective code of conduct.'' The
commenter stated that the general duty clause is redundant to proposed
amendment to 40 CFR 63.632(b) that would require compliance ``at all
times.'' The commenter asserted that if compliance with the specific
requirements of the rule will satisfy the general duty, then there is
no need for the EPA to reserve the authority to evaluate a source's
good air pollution control practices. Furthermore, the commenter
asserted that the general duty provisions date back to a regulatory
period during which air quality control rules lacked the specificity of
monitoring, reporting, and recordkeeping that are included in the
proposed rule. The commenter suggested that either the EPA should not
finalize the proposed general duty clause at 40 CFR 63.632(j) or that
the general duty clause from the General Provisions should be
incorporated. The commenter stated that the General Provision contains
language that more clearly explains the EPA's exercise of enforcement
discretion during SSM periods.
Response: As part of the proposed rulemaking, we proposed to add
the following general duty clause to 40 CFR 63.362(j):
``At all times, you must operate and maintain any affected source,
including associated air pollution control equipment and monitoring
equipment, in a manner consistent with safety and good air pollution
control practices for minimizing emissions. The general duty to
minimize emissions does not require the owner or operator to make any
further efforts to reduce emissions if levels required by the
applicable standard have been achieved. Determination of whether a
source is operating in compliance with operation and maintenance
requirements will be based on information available to the
Administrator which may include, but is not limited to, monitoring
results, review of operation and maintenance procedures, review of
operation and maintenance records, and inspection of the source.''
We disagree with the commenter's suggestion to not finalize the
general duty clause. We do not consider this duty clause to be
redundant just because the emission standards apply at all times; the
provision imposes a general duty to operate and maintain any affected
source, including associated air pollution control equipment and
monitoring equipment, in a manner consistent with safety and good air
pollution control practices for minimizing emissions. Commenters did
not provide data supporting the suggestion that this general duty
clause is redundant. Even assuming it were redundant, which it is not,
the commenter does not explain why it must be removed. In addition, the
inclusion of a general duty clause like the one proposed is standard
practice for other NESHAPs. Furthermore, we disagree with the
commenter's suggestion to incorporate the general duty clause from
Subpart A. As discussed in earlier in this section, in its 2008
decision in Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir. 2008), the
court held that under section 302(k) of the CAA, emissions standards or
limitations must be continuous in nature, which means that there cannot
be exemptions for periods of SSM. The general duty clause in Subpart A
contains certain exemptions for periods of SSM. We are therefore
finalizing the general duty provision as proposed.
4. What is the rationale for our final approach and final decisions to
address emissions during periods of SSM?
We evaluated all of the comments on the EPA's proposed amendments
to the SSM provisions. As explained in section III.G of the proposed
rule (88 FR 22790, April 13, 2023), in its 2008 decision in Sierra Club
v. EPA, the court held that under CAA section 302(k), emissions
standards or limitations must be continuous in nature and that the SSM
exemption violates the CAA's requirement that some CAA section 112
standards apply continuously. In addition, as part of this rulemaking,
we have gathered information that indicates many facilities already
have measures in place to ensure that the emission standards are met
during periods of
[[Page 24131]]
SSM. Therefore, we determined that these amendments, which remove and
revise provisions related to SSM, are necessary to be consistent with
the requirement that the standards apply at all times. More information
concerning the amendments we are finalizing for SSM 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 our approach for the SSM provisions as proposed.
F. Other Amendments to the Standards
1. What other amendments did we propose for the Commercial
Sterilization Facilities source category?
We proposed that owners and operators would be required to
demonstrate compliance via annual performance testing and parametric
monitoring of EtO through the use of CEMS. As discussed in section
III.G.2.c of the proposal preamble (88 FR 22790, April 13, 2023), we
did not propose to include requirements for fenceline or ambient air
monitoring as part of this rule for the following reasons:
Typically for this type of monitoring, we require the
fenceline monitor to be located at least 50 meters from the source of
emissions to allow for some dispersion.
In contrast to the large number of dispersed and
difficult-to-monitor emission points for other source categories for
which we have either finalized or proposed fenceline monitoring
requirements (e.g., refineries), current room air releases at
commercial sterilization facilities are typically at ground-level and
consist of uncontrolled building emissions through doorways, loading
points, and ventilation exhausts, all of which can be captured while
inside the building and routed through a vent to a control device.
The proposed PTE design criteria, room air emission
standards, and associated parametric monitoring would effectively and
continuously ensure these previously uncontrolled emissions are
captured and routed to exhaust points that are then subject to removal
or emission rate standards.
With respect to fenceline monitoring, we solicited comment on (1)
whether fenceline monitoring should be required regardless of the
proposed PTE design criteria, proposed room air emission standards, and
proposed continuous parametric monitoring; (2) the technical
feasibility of fenceline monitoring and available technology able to
measure at any potential action level; and (3) the potential cost of
continuous fenceline monitoring and associated work practices if
implemented.
With respect to ambient air monitoring, we solicited comment on how
this could be used to screen for elevated concentrations of EtO above
the ambient baseline and how this information could be used to trigger
a root cause analysis to identify potential source(s) of emission and
to perform corrective action, if a potential source of the emissions
was part of an affected source under the commercial sterilization
proposed rule. We also solicited comment on (1) the feasibility of
other types of air monitoring that could be applied to this sector for
compliance assurance and the costs associated with this type of
monitoring, (2) how frequently this monitoring should occur, (3) the
recordkeeping and reporting requirements for this type of monitoring,
and (4) how should any action-level be defined.
We proposed various changes to the performance testing requirements
to ensure that the results are as accurate as possible, including the
approved test methods, requirements for SCV inlet testing, and 24-hour
test runs for larger users. Furthermore, we proposed various changes to
the parametric monitoring requirements, as well as requirements for
demonstrating continuous compliance with the PTE requirements given in
EPA Method 204.
We also proposed that owners or operators submit electronic copies
of required compliance reports (at 40 CFR 63.366(b) and (c)),
performance test reports (at 40 CFR 63.366(f)), and performance
evaluation reports (at 40 CFR 63.366(g)) through the EPA's CDX using
CEDRI, and we proposed two narrow circumstances in which owners or
operators may, within five business days of the reporting deadline,
seek extensions of that deadline if they are prevented from reporting
by conditions outside of their control. We proposed at 40 CFR 63.366(h)
that an extension may be warranted due to outages of the EPA's CDX or
CEDRI that precludes an owner or operator from accessing the system and
submitting required reports. We also proposed at 40 CFR 63.366(i) that
an extension may be warranted due to a force majeure event, such as an
act of nature, act of war or terrorism, or equipment failure or safety
hazards beyond the control of the facility.
Finally, we proposed to reinstate title V permitting requirements
for all area source facilities, and we proposed compliance mechanisms
for owners and operators of combined emission streams. We also proposed
revisions to clarify text or correct typographical errors, grammatical
errors, and cross-reference errors.
2. How did the other amendments for the Commercial Sterilization
Facilities source category change since proposal?
We are finalizing a requirement for owners and operators to use EtO
CEMS to demonstrate compliance. In addition, for affected sources with
a percent emission reduction standard, we are finalizing a requirement
for source owners or operators to obtain and record hourly average
ppbvd of EtO concentration, dscfm of flow rate, and weight differential
in pounds of EtO used, to calculate and record each day of operation--
where any operation less values obtained during periods of SSM
constitute a day of operation--and the emission limit(s) based on the
30-operating day rolling sum of EtO entering the control system(s), as
determined using values from the current operating day and the previous
29 operating days. However, owners and operators of facilities where
EtO use is less than 100 lb/year will have the option to demonstrate
compliance through annual performance testing and parametric
monitoring. We are not including requirements for fenceline or ambient
air monitoring in this final rule. For EtO CEMS, based on comments
received during the proposed rulemaking, we are finalizing a
requirement for quarterly reporting, as well as a minimum data
availability of 90 percent. For performance testing, we are finalizing
the incorporation of additional test methods. Based on comments
received during the proposed rulemaking, we are also retaining
currently approved test methods that we proposed to remove, and we are
not finalizing a requirement to conduct SCV inlet testing. For
performance test duration, based on comments received during the
proposed rulemaking, we are not finalizing a requirement for 24-hour
test runs. Instead, owners and operators may continue to conduct 1-hour
test runs for ARVs, CEVs, room air emissions, or any combination
thereof. For emission streams that contain an SCV, we are finalizing a
requirement for owners and operators to include a representative test
period as part of their test protocol, which is subject to approval
from the delegated authority. Based on comments received during the
proposed rulemaking, we are finalizing numerous revisions to the
proposed requirements for parametric monitoring. Furthermore, based on
comments received during the proposed
[[Page 24132]]
rulemaking, we are not finalizing a requirement for owners and
operators that are required to comply with EPA Method 204 to conduct
daily inspections of all applicable NDOs. Instead, we a finalizing a
requirement for owners and operators to demonstrate continuous
compliance with EPA Method 204 through the use of either outlet
volumetric flow rate monitors or differential pressure monitors.
We are not finalizing a requirement for all area source facilities
to obtain a title V operating permit. In addition, based on comments
received during the proposed rulemaking, we are finalizing revised
compliance mechanisms for combined emission streams. We are also
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.
3. What key comments did we receive on the other amendments for the
Commercial Sterilization Facilities source category and what are our
responses?
Comment: We received extensive comment on our proposal to allow
either the use of EtO CEMS or annual performance testing with
parametric monitoring for demonstrating compliance with emission
standards. Some commenters stated that EtO CEMS should be the only
mechanism allowed for demonstrating compliance, as it will yield more
real-time data that will allow for potential issues to be identified
and resolved more quickly. Other commenters stated that EtO CEMS are a
relatively new technology and that the available supply, reliability in
industrial facilities, and maintenance support for EtO CEMS is
questionable. Commenters also expressed concerns with parametric
monitoring and pointed to our requirements for CEMS in other rules, as
well as the fact that EtO CEMS are used in a number of sterilization
facilities.
Response: In the majority of instances, parametric monitoring is
used to good effect as an ongoing means of ensuring that control
devices continue to get necessary emission reductions. 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 addition, many facilities in this source
category are controlling their EtO emissions using systems that contain
one or more control devices, each with their own parametric monitoring
requirements. While this has proven to be effective in reducing EtO
emissions, it can lead to multiple, simultaneous parameter collection
and processing, increasing system complexity and increasing the time
necessary for diagnosis and correction of control device or process
problems.
Therefore, the EPA is finalizing a requirement to only use CEMS for
demonstrating compliance. However, facilities where EtO use is less
than 100 lb/year will still have the option to use CEMS or performance
testing and parametric monitoring to demonstrate compliance. This is
because risk remains at acceptable levels for these facilities even
when considering uncontrolled emissions. In addition, these facilities
tend to have relatively simple control systems. Although EtO CEMS is a
relatively new technology in this industry, it has been proven as a
highly effective method for demonstrating compliance. While the use of
these CEMS systems for low-level measurements of EtO is relatively new,
they are in use in this sector; because of this, we find it technically
feasible to require their use more broadly. Additionally, the EtO
instruments used as part of these CEMS are readily available and
although the low-level detection levels are recent, they have been
demonstrated in the field.
Comment: We received extensive comments on our decision to not
include fenceline or ambient air monitoring as part of the proposed
rulemaking. Some commenters were supportive of this exclusion, stating
that this source category is comprised of enclosed facilities with
defined emission points (e.g., windows, doors, ventilation exhaust) and
that PTE is sufficient to ensure the containment of emissions. Other
commenters were opposed to this exclusion, stating that fenceline and
ambient air monitoring are necessary in order to ensure that commercial
sterilization facilities are complying with the rule requirements, as
well as to provide important information about emissions, exposure, and
the efficacy of control equipment to nearby communities, regulatory
agencies, and workers. The commenters pointed to other source
categories where we have either required fenceline monitoring (i.e.,
petroleum refineries) or proposed it (i.e., the Synthetic Organic
Chemical Manufacturing Industry and the Polymers and Resins industry).
Response: We acknowledge that many commenters expressed their
strong support for fenceline monitoring requirements as part of this
rule. As a general matter, fenceline monitoring is considered a
particularly useful compliance monitoring approach if it is infeasible
to enclose an emission source(s). This is the case for source
categories where we have either required or proposed fenceline
monitoring, such as refineries, because facilities within these source
categories cover a wide variety of emission sources where PTE is not
feasible. At such sources, it is frequently impossible to rapidly
detect and remedy a leak or other unauthorized release without the use
of fenceline monitoring.
By contrast, as discussed in section IV.B.3.c, PTE in accordance
with EPA Method 204 has been demonstrated to be feasible for commercial
sterilization facilities. As part of the PTE requirements the EPA is
finalizing in this rule, the EPA is also requiring monitoring of either
the volumetric flow rate from each outlet or differential pressure in
order to ensure that the PTE is operating effectively on a continuous
basis. Furthermore, as discussed above, we are requiring EtO CEMS at
facilities where EtO use is at least 100 lb/year, which includes most
facilities within the source category. The data from these CEMS will
help to ensure that commercial sterilization facilities are complying
with the rule requirements, and the data will be made available to the
public, providing important information about emissions, exposure, and
the efficacy of control equipment to nearby communities, regulatory
agencies, and workers. As noted above, the physical configuration of
commercial sterilizer facilities can also make the implementation of
fenceline monitoring challenging at these sources. For these reasons,
the EPA is not finalizing fenceline monitoring requirements as part of
this rule.
Comment: We received extensive comments on our proposed requirement
that EtO CEMS data be reported on a daily basis. Some commenters were
supportive, stating that daily reporting provides assurance to the
public that emission control devices are working as designed. Other
commenters were opposed, stating that facilities need sufficient time
to conduct QA/QC to verify the accuracy and reliability of the data and
that reporting inaccurate data due to insufficient QA/QC would
undermine public confidence of the CEMS monitoring and potentially
adversely impact the medical supply chain if there is undue public
concern. One commenter questioned whether there is a precedent for
daily reporting, and another was unaware of any other NESHAP that
requires daily reporting for CEMS. Several commenters stated that
quarterly or semi-annual reporting is sufficient and more consistent
with other NESHAPs.
[[Page 24133]]
Response: We agree with the commenters' concern that daily
reporting of CEMS data is not appropriate. Sufficient time is needed so
that the proper QA/QC procedures can be conducted to verify the
accuracy and reliability of the data. Therefore, we are finalizing a
requirement that CEMS data be reported quarterly, which is consistent
with other NESHAPs that regulate pollutants of significant concern, as
well as at least one sterilization facility that uses CEMS to
demonstrate compliance with local requirements.
Comment: One commenter stated we did not address CEMS downtime and
how downtime will be assessed or impact reporting. In addition, two
commenters stated that there should be allowances or an exemption from
sampling during periods of non-operation (e.g., power outages, plant
shutdowns).
Response: Our general policy is to require source owners and
operators to have working monitoring while the emissions-producing
process is operating and to identify those periods where monitoring is
not working while the emissions-producing process is operating, as well
as to quickly correct monitoring issues so that such periods are
minimized. Recognizing that EtO CEMS are a newer technology that may
pose challenges to users who may be unfamiliar with instrument
characteristics, the rule will provide a period of data unavailability
for up to ten percent of process operating time for EtO CEMS in
operation before requiring additional corrective activity by owners or
operators. Such an allowance, referred to as a minimum data
availability requirement, has been used to good effect for other types
of CEMS as they were introduced. As familiarity with those CEMS
increased, so did their minimum data availability requirements; the EPA
expects this pattern to continue for EtO CEMS such that in the future,
the minimum data availability requirement for EtO CEMS will be replaced
by the agency's general policy. Until then, the rule will have a
minimum data availability for EtO CEMS of ninety percent. This means
that EtO emissions data must be collected over at least ninety percent
of the process operating time in order to avoid non-compliance and
potential penalties. Data availability will be determined by assessment
of the ratio of periods of valid EtO CEMS values to process operation
periods, where valid EtO CEMS values occur when a minimum of 4 equally
spaced values occur over an hour of process operation. Periods
associated with normal quality assurance activities, such as daily
calibrations, do not count as periods of data unavailability, however,
periods of out-of-control monitor operation or when the EtO CEMS is
unable to provide quality-assured data, such as those periods
associated with monitor or data acquisition and handling system
failure, do count as periods of data unavailability. Note that source
owners or operators are to record EtO CEMS values during all periods of
operation, include SSM, to the extent that the values are available.
Source owners or operators will need to keep records of periods of
process operation, EtO CEMS availability, and EtO CEMS unavailability;
cause and duration of EtO CEMS unavailability; and of activity taken to
correct and prevent future periods of EtO CEMS unavailability.
Moreover, owners or operators will be required to provide immediate
notice of failure to meet the data availability of 90 percent, as well
as root cause analysis of periods of EtO CEMS monitor unavailability
and specific corrective actions--along with schedule and enumerated
expenditures--planned to address EtO CEMS unavailability.
Comment: Several commenters stated that the requirement to measure
SCV inlets can create significant safety hazards. Two commenters stated
that EtO concentrations in abatement system inlets coming from SCVs can
reach several hundred thousand ppm. The commenters noted that these
concentrations exceed the lower explosion limit of 30,000 ppm, thereby
posing a significant explosion risk. Commenters noted that this
situation could also expose workers to EtO levels above the Immediately
Dangerous to Life or Health limit set by the U.S. Occupational Safety
and Health Administration (OSHA), resulting in hazardous working
conditions. Several commenters stated that we should retain the option
to determine emission reduction using mass balance calculations and
pounds of EtO injected into the sterilization chamber to ensure safe
testing practices.
Response: We agree with the commenters' concerns regarding the
safety risks associated with testing the SCV inlet. Therefore, we are
removing this requirement for SCVs from the final rule. Owners and
operators must instead determine the mass of EtO emissions from the SCV
by measuring the daily change in weight of the EtO drums that are used
to charge the sterilization chamber.
Comment: Several commenters were opposed to our proposed
requirement for each performance test run to be conducted over a 24
hour period for facilities where EtO use is at least 10 tpy, stating
that this requirement is difficult, infeasible, and of limited value.
The commenters stated that there are a limited number of testing
companies with both the experience to conduct performance tests of this
length, as well as the personnel to remain at facilities during these
long performance test periods. The commenters stated that multiple
companies will be in demand for these limited services and that
scheduling these performance tests so that the medical supply chain is
not adversely impacted will be difficult. In general, the commenters
agreed that a performance test run longer than one hour is necessary
but were divided on what constitutes a representative period, with one
commenter stating that eight to 10 hours is representative, and another
stating that six to 12 hours is representative. Several commenters
stated the performance test duration should be determined by the
facility and accompanied with a justification of how normal operations
are captured over this duration. One commenter stated that ARV and room
air emissions are continuous in nature and that one-hour performance
test runs are sufficient for these sources. The commenter also stated
the CEV operations are started and completed within an hour and,
therefore, one-hour performance test runs are appropriate for these
sources as well. Finally, one commenter suggested that each performance
test run for facilities where EtO use is less than 10 tpy should be
longer than one hour.
Response: As discussed earlier, we are finalizing a requirement to
only use EtO CEMS for demonstrating compliance. In addition, owners or
operators of affected sources subject to a percent emission reduction
standard will obtain and record EtO concentration in ppbvd, flow rate
in dscfm, and daily EtO use in pounds; determine daily amounts of EtO
entering and exiting control systems; use those daily amounts to
calculate and record 30-operating day rolling sums; and calculate
emission limits and determine compliance based on those rolling sums.
However, facilities where EtO use is less than 100 lb/year will still
have the option to use CEMS or performance testing and parametric
monitoring to demonstrate compliance. Therefore, our proposal for each
performance test run to be conducted over a 24-hour period for
facilities where EtO use is at least 10 tpy is no longer applies and is
not included in the final rule. For facilities where EtO use is less
than 100 lb/year, we agree that a one-hour performance test period for
[[Page 24134]]
ARVs and room air emissions is appropriate, as these operations are
continuous in nature, with minimal variations in emissions. We also
agree that a one-hour performance test period is appropriate for CEVs,
as these operations are typically started and concluded in less than
one hour. For SCVs, the emissions profile can vary significantly
depending on the number of chambers at a facility and how the emissions
are staggered. Therefore, we are finalizing a requirement for owners
and operators to include a representative performance test period for
SCVs, along with a justification, in their stack test protocol, so that
the delegated authorities can review and approve or deny the protocol
as appropriate.
Comment: We received comments on continuous compliance requirements
for verifying EPA Method 204. Several commenters contended that
continuously verifying the direction of airflow through daily
inspections of each NDO presents significant safety risks and are
redundant or impractical. They noted that NDOs may be located at
ceiling levels (such as a makeup air unit) in processing areas or in
other hard to reach areas where EtO concentrations may require the use
of specialized protective equipment. One commenter stated that
streamers are not practical, may not be observable, and often get stuck
or wrapped around objects. Another commenter noted that smoke testing
in EtO facilities is discouraged due to safety concerns, as any
indication of fire in an EtO facility is highly problematic, and seeing
smoke within the facility should not be routine. Finally, two
commenters questioned the value of daily NDO inspections when other
relevant parameters are being continuously monitored.
One commenter recommended the use of differential pressure
monitoring to verify EPA Method 204, accompanied by a data recording
system to demonstrate continuous compliance. Other commenters were
opposed to any continuous compliance requirements for verifying EPA
Method 204, stating that they would be burdensome, expensive, and
difficult to maintain. Two commenters stated that we should change the
criteria for demonstrating continuous compliance with EPA Method 204
from ``maintained above 0.007 inches of water'' to ``at least 0.007
inches of water'' to align to the Method 204 definition of facial
velocity equivalence.
Response: We agree with the commenters' concerns regarding the
safety and practical aspects of daily NDO inspections. Therefore, we
are not including this requirement in the final rule. In order to
ensure that emissions are not leaving through uncontrolled spaces, it
is critical to demonstrate continuous compliance with EPA Method 204.
In the absence of daily NDO inspections, differential pressure
monitoring and outlet volumetric flow rate monitoring are viable
options for verifying the continuous flow of air into a control device,
and both of these options were included in the proposed rulemaking.
Therefore, we are finalizing a requirement for owners and operators to
demonstrate continuous compliance with EPA Method 204 either through
outlet volumetric flow rate monitoring or through differential pressure
monitoring. We also agree with commenters that, if differential
pressure monitoring is used, the pressure differential should be
maintained at or above 0.007 inch of water in order to demonstrate
continuous compliance, as this is what is required in EPA Method 204.
Comment: We received extensive comments on our proposed requirement
for all area source facilities within the source category to obtain a
title V operating permit. Several commenters were supportive, citing
the serious health concerns of EtO. The commenters stated that
facilities with title V operating permits tend to receive more
oversight and that this, along with increased community engagement,
will ensure that these facilities are complying with the rule
requirements. Other commenters were opposed, stating the current and
proposed NESHAP included substantial compliance, parametric monitoring,
recordkeeping, and reporting obligations. One commenter stated that
subjecting area source EtO commercial sterilizers to the title V
permitting program requires additional regulatory fees; burdensome
permitting, recordkeeping and reporting requirements; increased
administrative costs; as well as Clean Air Act citizen suits. Two
commenters suggested that the proposed requirements could be
incorporated into a State minor source permit without the additional
burden of title V permitting, and that title V permits should apply
only to major sources. Multiple commenters also indicated that the
four-factor balancing test still weighs in favor of continued exclusion
of area source facilities within this source category from title V
permitting requirements.
With respect to the first factor (i.e., whether title V would
result in significant improvements to the compliance requirements,
including monitoring, recordkeeping, and reporting that are proposed
for the area source category), several commenters stated that requiring
title V operating permits would not provide significant improvements to
compliance requirements. Two commenters agreed with our 2005 analysis
that the NESHAP requirements applicable to area sources already
subjected them to continuous monitoring and assessment, reporting, and
certification of compliance status on a semiannual basis, which was
similar to what was required by title V. Commenters stated that the
proposed rule addressed increased transparency and further strengthened
monitoring, recordkeeping, and reporting requirements, including
developing a new performance specification and associated QA procedures
for CEMS capable of detecting EtO at very low levels. One commenter
stated that we recognized that modern NESHAPs have sufficient
parametric monitoring. The commenter also stated that the only gain
that we identified that was not already satisfied was the public
comment period for title V permitting; however, the commenter noted
that many facilities may need construction permits to come into
compliance with the updated requirements, during which many States have
an option to hold a public comment period and a public meeting(s) for
changes that may be of interest to the community. The commenter noted
that, as part of this rulemaking process, the EPA held numerous public
meetings for local communities regarding specific facilities and
additional public outreach meetings for transparency. This commenter
stated these outreach efforts and the potential construction permitting
actions will eliminate the need to have the title V public comment
period. Three commenters stated that one of the primary purposes of the
title V program was to clarify in a single document the various and
complex regulations that applied to a facility in order to improve
compliance. Two commenters stated that we agreed that EtO sterilizers
were still subject only to a single NESHAP. Three commenters stated the
benefit of requiring a title V permit to house all applicable
regulations into a single document would not apply to those area
sources and was not needed, and one commenter added that area sources
should be exempt from title V on that basis alone. One commenter stated
that, in response to a comment on our 2005 proposed rule, we also
indicated that NESHAP provisions independently required schedules of
compliance, provided inspection and entry
[[Page 24135]]
authority, and established emissions limitations and standards that
were enforceable regardless of title V permitting. This commenter noted
the proposed rule asserted that the compliance benefits of title V were
greater today than in 2005 and so the benefits would be greater, but
the commenter argued that we made these statements without providing
supporting analysis.
With respect to the second factor (i.e., whether title V permitting
would impose significant burdens on the area source category and
whether the burdens would be aggravated by any difficulty in obtaining
assistance from permitting authorities), several commenters noted that
requiring area sources to obtain a title V permit would pose
significant burdens on sterilization facilities, with one commenter
stating that it would pose significant burden ``within the time frame
being proposed.'' \68\ Additionally, the commenter stated the State
permitting agencies may be overly burdened in issuing title V permits
at a facility with such low emissions. Several commenters stated that
the proposed title V permitting requirement for area sources would be a
significant burden for small businesses, as these permits required
businesses to prepare significant amounts of paperwork, negotiate
compliance with the permitting authority, and subject their operations
and permit application to public comment or petitions that would
potentially delay operations and create additional regulatory burdens
that, per OMB analysis, may be biased against small businesses. One
commenter noted that small businesses in this industry had no
experience with title V permitting and that obtaining these permits
would require additional resources. The commenter stated that we
ignored the significant cost of uncertainty that title V permitting
introduced to small business planning. The commenter explained that
rather than hiring an engineer to determine how a facility could meet
the requirements, a small business would have to engage in a process
with multiple partners, develop supporting material that may or may not
be sufficient in the eyes of the regulatory authority, and prepare a
public relations strategy in anticipation of community opposition to
their operations, and that this investment must be made without the
certainty of an outcome that will allow continued operation. One
commenter noted that many Small Business Environmental Assistance
Programs are precluded from assisting with title V permitees and, as
such, this rule could strip small businesses of the assistance mandated
under CAA section 507. One commenter stated that our justification
seemed premised on an expectation of noncompliance, although clarified
that we had not alleged that small commercial sterilizers have a
history of noncompliance. The commenter noted that recent controversies
around EtO facilities had centered around large facilities owned by
large businesses. The commenter indicated it was not clear how title V
permitting of area sources would create additional incentives for
compliance or give State enforcement authorities the resources and
expertise they would not otherwise have to enforce this NESHAP. One
commenter stated the addition of title V permitting for area sources
formalized community involvement in the authorization of area source
commercial sterilizers, and that this level of community review was
unnecessary and overly burdensome. Another commenter noted that the
public already had access to commercial sterilizer locations,
emissions, and current standards to which they were subject via our
website and regulations, as well as our community outreach to advise
the public of the hazards of EtO.
---------------------------------------------------------------------------
\68\ Commenter provided the following statement: ``Requiring
areas sources to obtain a title V permit would pose significant
burdens on sterilization facilities especially within the time frame
being proposed.'' (see Docket Item No. EPA-HQ-OAR-2019-0178-0632,
Attachment 2, page 20).
---------------------------------------------------------------------------
With respect to the third factor (i.e., whether the costs of title
V permitting for area sources would be justified taking into
consideration any potential gains in compliance likely to occur for
such sources), two commenters stated there would be no justification
for imposing the burden of title V permitting. One commenter stated
that we could have separated the cost estimate for the 86 area sources
in order to provide more accurate numbers. Additionally, the commenter
stated that the 2019 cost estimates were not accurate, as the new rules
would require facilities to change not only their equipment, but also
their calculation methods, monitoring, and testing. The commenter
stated that those costs needed to be considered in a title V cost
analysis. Three commenters stated that our cost estimate for obtaining
a title V permit underestimated the cost of this requirement and that
we should not add to the burdens for area sources. One commenter stated
that the time and cost of getting a title V permit did not correlate to
the potential gains and that we provided no supporting data for our
conclusion that the average costs associated with title V ($67,211 for
the first year, as calculated in 2019) will likely be less for area
sources. This commenter suggested that our cost determination did not
align with the proposed rule, which said ``the rule amendments proposed
provide for a greater degree of complexity and requirements to achieve
and demonstrate compliance for area sources.'' One commenter noted that
we stated that the burden was not insignificant, but justified the
costs because it represented a small portion of the anticipated costs
related to the amendments of the proposed rule. One commenter stated
that the analysis on title V applicability did not ask how the burden
compared to the cost of complying [with] some other measure, but that
the question was whether the potential compliance benefits outweighed
the steep costs, the answer to which we seemed to concede was ``no.''
With respect to the fourth factor (i.e., whether adequate oversight
by State and local permitting authorities could achieve high compliance
with the NESHAP requirements without relying on title V permitting),
one commenter stated that CAA sections 112, 113, and 114 required
implementation and enforcement programs to be conducted by the EPA or
delegated to the proper State authority and a small business assistance
program to assist area sources exempted from title V with compliance.
The commenter noted that States and the EPA routinely conducted
voluntary compliance assistance outreach and education programs. The
commenter noted that the EPA's review of State-provided empirical data
demonstrated that area sources were adequately compliant with their
requirements without title V permitting. The commenter stated that the
proposed rule is silent on whether permitting authorities could
effectively implement NESHAPs without title V, and that the EPA alluded
to its 2019 ICR, implying that the responses thereto supported the
EPA's title V decision, but the EPA never identified specific data or
explained how it would support any of EPA's cursory statements. The
commenter concluded that there was no more difficulty enforcing the
single NESHAP for area sources now versus in 2005, when EPA
unequivocally determined title V would provide no benefits to its
ability to enforce CAA regulations in tandem with its State and local
partners. The commenter stated that requiring title V now would only
make enforcement more difficult, as State agencies would be flooded
with
[[Page 24136]]
title V applications that would require time and State funds to
implement and could potentially shift attention away from major source
compliance in a way that would compromise (and not improve)
implementation of any final NESHAP program. Another commenter stated
there was already sufficient oversight by State and local permitting
authorities, as well as subpart O requirements. One commenter stated
that, as a State regulatory agency, they had the ability to adequately
ensure compliance with the proposed standard for facilities within
their jurisdiction regardless of whether the facility is subject to
title V permitting. Another commenter stated the proposed removal of
the title V permitting exemption for area sources meant a significant
number of small operations would be required to obtain title V permits
for the first time, and as many of these area sources were subject to a
limited set of applicable requirements and permits, there was little
apparent benefit from the consolidation of these requirements within a
title V permit. One commenter stated that the EPA failed to discuss
whether there was a history of noncompliance with the EtO Commercial
Sterilization NESHAP, which indicated that that there are few potential
gains from the increased burdens. Finally, one commenter stated that
State operating permits (e.g., Synthetic Minor or Federally Enforceable
State Operating Permits) are abundant and adequate to deal with these
GACT sources without the added expense, complication, and delays
associated with title V permitting.
Response: We agree with commenters that the four-factor balancing
test continues to weigh in favor of exempting area source facilities
from title V permitting. In particular, we agree with commenters that
one of the primary benefits of the title V program is to clarify, in a
single document, the various and complex regulations that apply to a
facility in order to improve compliance, and that this benefit is not
realized in this case because commercial sterilization facilities are
subject to only one NESHAP (Subpart O). In addition, we agree with
commenters that, in light of the robust monitoring, recordkeeping and
reporting requirements in the final rule, a title V permit would likely
not add any substantial monitoring, recordkeeping and reporting
requirements. We further note that, even in the absence of title V
permitting requirements, this final rule will ensure transparency
around the emissions from these facilities by requiring that EtO CEMS
data be reported on a quarterly basis, and this data will be made
available to the public.
In summary, the benefits of requiring title V permitting for area
source facilities are not outweighed by the concerns. For the reasons
stated above, we agree with commenters that the four-factor balancing
test continues to weigh in favor of exempting area source facilities
from title V permitting on the basis that title V is unnecessarily
burdensome. Therefore, we are not finalizing title V permitting
requirements for area source facilities.
Comment: One commenter suggested that we require only a single
combined performance test for the outlet point and that the most
stringent applicable standard (i.e., the control level required for the
SCV) should be applied. Two commenters stated that our affected source
proposal is unnecessarily complicated. One commenter stated that where
control equipment has a single inlet and outlet, the facility should
not be required to test individual source inlets or outlets. The
commenter also stated that it is logical that point sources routed to
the same emission control system should be defined as a single unit.
The commenter stated it is important to set emission limits that
reflect this reality and test methods that allow for combined system
testing at the outlet of the system. The commenter also stated that the
proposed language implies that the SCV, CEV, and ARV must be tested
separately, which is challenging given the complexity in design of
existing duct work and access to inlets. The commenter stated that
testing the combined inlet to the APCD would be the safest, most
accurate, and most cost-effective method for determining compliance for
facilities with combined emissions. Another commenter stated that
applying the most restrictive removal efficiency standard when
different sources are combined is impractical.
Response: The EPA is finalizing approaches that will provide
facilities with flexibility in terms of how they choose to demonstrate
compliance with the standards for instances where emission streams are
combined prior to entering a control system. Facilities can determine
compliance via one of two options:
Option 1: Determine the mass of EtO entering the control
device at a point after the emission streams are combined, and apply
the most stringent emission reduction standard that the component
streams are subject to.
Option 2: Determine the mass of EtO entering the control
device at points before the emission streams are combined, and apply
the emission reduction standards that the component streams are subject
to.
Option 1 is consistent with what was proposed, and Option 2 has
been added in order to provide more flexibility for facilities in terms
of how they chose to demonstrate compliance. As an example, suppose an
area source facility uses at least 30 tpy but less than 60 tpy, and the
facility chooses to control all of its ARVs and CEVs with one control
system. The emission reduction standards that apply to the ARVs and
CEVs are 99.9% and 99%, respectively. In this example, suppose the mass
of EtO emissions from the ARVs is 4 lb, and the mass of EtO emissions
from the CEVs is 1 lb, meaning that the mass of EtO emissions from the
combined stream is 5 lb. Under Option 1, the facility would need to
apply an emission reduction of 99.9% to the combined stream, resulting
in an emission limit of 0.005 lb. Under Option 2, the facility would
apply an emission reduction of 99.9% to the ARV stream and an emission
reduction of 99% to the CEV stream, resulting in an emission limit of
0.014 lb. When an affected source is subject to a relatively high
emission reduction standard, it can be difficult to demonstrate
compliance with that standard when the concentration of pollutants
going into the control device is low. By combining emission streams and
increasing the concentration of pollutants in the air stream, it is
easier to demonstrate compliance.
Comment: One commenter recommended the creation of the option for a
site-wide emission limitation. This limitation could take the form of
either overall removal efficiency, or a total mass rate per hour.
Another commenter suggested a site-wide emission limitation based upon
EtO usage and end-state emissions and identified as precedent an
Illinois construction permit containing monthly and annual mass
emissions caps. The commenter also suggested a compliance option by
emission reduction or emission rate standards and identified as
precedent Illinois legislation requiring 99.9 percent emission
reduction at each exhaust point or limitation of EtO emissions to 0.2
ppm.
Response: We agree with the creation of an option for a site-wide
emission limitation and have included this in the final rulemaking.
Specifically, we are finalizing two options for determining compliance
on a site-wide basis:
Option 1: Determine the mass of EtO being used at the
facility and apply the SCV emission reduction standard, which is the
most stringent emission
[[Page 24137]]
reduction standard that any emission stream at the facility is subject
to.
Option 2: Determine the mass of EtO being emitted from
each affected source, and apply the emission reduction standards that
each affected source is subject to. For SCVs, the mass of EtO may be
determined by measuring how much is used and then applying a facility-
specific factor that accounts for EtO entering the control systems from
other affected sources.
We disagree with the suggestion to set an emissions cap, as the
amount of EtO that a facility will use in a given month is unknown.
4. What is the rationale for our final approach and final decisions for
the other amendments for the Commercial Sterilization Facilities source
category?
We are not finalizing a requirement for all area sources facilities
to obtain a title V operating permit, and we are not including
requirements for fenceline or ambient air monitoring as part of this
final rule. Based on the comments received during the proposed
rulemaking, we are requiring EtO CEMS for facilities where EtO use is
at least 100 lb/year, and we are finalizing a requirement for EtO CEMS
data to be reported quarterly. We are not finalizing a requirement for
owners and operators to conduct SCV inlet testing, and we are not
finalizing a requirement for each performance test run to be conducted
over a 24-hour period. Lastly, we are finalizing revised compliance
mechanisms for combined emission streams, as well as the option for
facilities to demonstrate compliance with a site-wide emission limit,
as opposed to having to demonstrate compliance for each individual and
combined emission stream. See section IV.F.3 of this preamble for
further discussion.
In a few instances, we received comments that led to additional
minor editorial corrections and technical clarifications being made in
the final rule, and our rationale for these corrections and technical
clarifications 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.
V. Summary of Cost, Environmental, and Economic Impacts and Additional
Analyses Conducted
A. What are the affected facilities?
As part of the proposed rulemaking, we estimated that there were 86
existing commercial sterilization facilities and two planned
facilities. However, based on comments received on the proposed
rulemaking, we understand that one of the existing facilities has
closed. In addition, the commenters identified three existing
commercial sterilization facilities that were unknown during the
proposed rulemaking. However, it should be noted that EtO use at the
three facilities that were previously unknown is very small (i.e., less
than 1 tpy). A complete list of the known 88 Commercial Sterilization
Facilities that are affected by this rulemaking is available in
Appendix 1 of the document, Residual Risk Assessment for the Commercial
Sterilization Facilities Source Category in Support of the 2024 Risk
and Technology Review Final Rule, which is available in the docket for
this rulemaking.
B. What are the air quality impacts?
At the current level of control prior to the amendments being
finalized in this action, the EPA estimates that EtO emissions were
approximately 23 tpy (actuals) and 160 tpy (allowables) from commercial
sterilization facilities. At the level of control required by the
amendments being finalized in this action, which includes standards for
previously unregulated sources and amendments to all sources where
standards were already in place, we estimated EtO emissions reductions
of 21 tpy (actuals) and 150 tpy (allowables) for the source category.
C. What are the cost impacts?
The total capital investment cost of the final amendments and
standards is estimated to be approximately $313 million in 2021
dollars. We estimate total annual costs of the final amendments to be
approximately $74 million.
The present value (PV) of the estimated compliance costs over the
20-year timeframe from 2025 to 2044 for the final rule is $773 million
in 2021 dollars, discounted at a 7 percent rate. The equivalent
annualized value (EAV) of the costs is $88 million, using a 7 percent
discount rate. Using a 3 percent discount rate, the PV and EAV of the
costs from 2025 to 2044 are estimated to be $932 million and $63
million, respectively.
The nationwide costs of the different amendments being finalized in
this action are presented in table 2 of this preamble. As described in
this preamble, we are finalizing standards for previously unregulated
sources, as well as amendments for sources where standards were already
in place. Many of the emissions capture and control technologies that
are needed to comply with the final rule will impact multiple sources
at once, and those costs form the basis of our impact estimates. These
costs are presented in table 2 of this preamble. There are 90
facilities (including the 88 existing facilities and the two planned
facilities) affected by the amendments, and the number of facilities
associated with each of the specific costs is indicated in table 2. The
facility list was developed using methods described in section II.C of
the proposal preamble (88 FR 22790, April 13, 2023). A complete list of
known commercial sterilization facilities is available in Appendix 1 of
the document, Residual Risk Assessment for the Commercial Sterilization
Facilities Source Category in Support of the 2024 Risk and Technology
Review Final Rule, which is available in the docket for this
rulemaking.
D. What are the economic impacts?
The economic impact analysis is designed to inform decision makers
about the potential economic consequences of the compliance costs
outlined in section V.C of this preamble. The EPA performed a screening
analysis that compared compliance costs to revenues at the ultimate
parent company level (several companies own more than one affected
facility). This is known as the cost-to-revenue or cost-to-sales test,
or the ``sales test.'' The use of a sales test for estimating small
business impacts for a rulemaking is consistent with EPA guidance on
compliance with the Regulatory Flexibility Act (RFA) and is consistent
with guidance published by the U.S. Small Business Administration's
Office of Advocacy that suggests that cost as a percentage of total
revenues is a metric for evaluating cost increases on small entities in
relation to increases on large entities.
There are 88 existing commercial sterilization facilities and 2
planned commercial sterilization facilities, owned by 50 parent
companies, affected by the final amendments. Of the parent companies,
22 companies, or 44 percent, are small entities based on the U.S. Small
Business Administration's table of size standards. Next, we determined
the magnitude of the costs of the amendments being finalized in this
action for each entity and then calculated a cost-to-sales ratio for
each entity by comparing estimated costs to the annual revenues of each
parent company. We then assessed whether there would be potential for a
significant impact on small entities based on the cost-to-sales ratios.
For all entities, the average cost-to-sales ratio is approximately 8
percent; the median cost-to-sales ratio is 0.2 percent; and the
[[Page 24138]]
maximum cost-to-sales ratio is approximately 69 percent. For large
firms, the average cost-to-sales ratio is approximately 0.2 percent;
the median cost-to-sales ratio is 0.03 percent; and the maximum cost-
to-sales ratio is 1.3 percent. This rule has potentially significant
impacts on small entities. For small firms, the average cost-to-sales
ratio is approximately 18 percent, the median cost-to-sales ratio is
4.7 percent, and the maximum cost-to-sales ratio is 69 percent. There
are 13 small entities (59 percent of all affected small entities) with
estimated cost-to-sales ratios of 3 percent or greater. See the
Regulatory Impact Analysis for further detail on the cost estimates,
small entity impact analysis, and a discussion of potential market and
economic impacts.
The EtO sterilization industry is an integral part of the supply
chain for many medical devices and capacity constraints have been
reported. Based on the data we analyzed, we expect that the largest
impacts of this rule are limited to a handful of the companies that
play a key role in the availability of certain medical devices, and
several of them are already in the planning stage for additional
controls.
Some companies involved in medical device sterilization have
installed, or are already planning for installation of, additional
emissions controls. The controls necessary to meet the requirements of
this final rule include PTEs and gas/solid reactors, along with (in
some cases) alterations to facility design to ensure adequate capture
of EtO emissions. Such controls rely on existing technologies that are
commercially available from manufacturers and are already well
established in this industry. In addition, a few companies have
constructed, or are in the process of constructing, new facilities with
state-of-the-art design and control installations to ensure full
capture and control of EtO emissions. These early actions by industry
demonstrate the feasibility of implementing the requirements in this
final rule.
Over the last several years, the industry has demonstrated the
capability to install controls on multiple facilities simultaneously
without interfering with medical supply chains. For example, three
companies re-designed their Illinois and Georgia facilities to comply
with the PTE requirements of EPA Method 204, as well as installed
emission controls at these facilities during overlapping timeframes
from May 2019 through August 2020 without disruption to the medical
supply chain. As discussed in section III.G of this preamble, we have
reviewed the time that it has taken for these projects to be completed,
from submission of the initial permit application to installation of
the continuous compliance mechanisms. Based on this review, we found
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, takes approximately a year from permit
submission to project completion.
The EPA has evaluated available information about the state of
control installations at existing commercial sterilization facilities.
Of the 88 existing facilities, seven appear have already met the
emission standards and will not need to install additional emission
controls. Another 55 facilities appear to only need additional
abatement devices. We expect that 28 facilities still need to meet the
PTE requirements of EPA Method 204 and install additional abatement
devices. Table 22 presents the apparent compliance status with the
final rule for each relevant emission source and facility EtO use
combination, based on controls that are currently in place.
Table 22--Apparent Compliance Status With Final Rule and Compliance Timeframes
----------------------------------------------------------------------------------------------------------------
Number of
Number of facilities
Emission source Facility EtO use facilities with appearing to Compliance
this affected achieve final timeframe
source standard \1\
----------------------------------------------------------------------------------------------------------------
SCV.............................. At least 30 tpy..... 38 19 Two years.
At least 10 but less 9 9 Two years.
than 30 tpy.
At least 1 but less 18 16 Two years.
than 10 tpy.
Less than 1 tpy..... 23 22 Three years.
ARV.............................. At least 30 tpy..... 36 12 Two years.
At least 10 but less 5 5 Three years.
than 30 tpy.
At least 1 but less 10 7 Three years.
than 10 tpy.
Less than 1 tpy..... 4 2 Three years.
CEVs at major source facilities.. N/A................. 0 N/A Three years.
CEVs at area source facilities... At least 60 tpy..... 25 12 Two years.
Less than 60 tpy.... 15 8 Three years.
Group 1 room air emissions at N/A................. 0 N/A Three years.
major sources.
Group 1 room air emissions at At least 40 tpy..... 36 16 Two years.
area sources.
Less than 40 tpy.... 38 7 Three years.
Group 2 room air emissions at N/A................. 1 0 Three years.
major sources.
Group 2 room air emissions at At least 20 tpy..... 44 17 Two years.
area sources.
At least 4 but less 13 1 Two years.
than 20 tpy.
Less than 4 tpy..... 27 27 Three years.
----------------------------------------------------------------------------------------------------------------
\1\ The phrase ``appearing to achieve'' is used (as opposed to ``achieving'') to account for uncertainties in
the data. A notable example is the SCVs where, for a given facility, the emission reduction on the first
evacuation may not high enough to ensure that the standard is being met across all evacuations. Another
uncertainty is the fraction of EtO going to each emission stream. In some instances, there is facility-
specific information available, and in others, there is no information available and default fractions are
applied as a result.
[[Page 24139]]
E. What are the benefits?
The EPA did not monetize the benefits from the estimated emission
reductions of HAP associated with this final action. The EPA currently
does not have sufficient methods to monetize benefits associated with
HAP, HAP reductions, and risk reductions for this rulemaking. However,
we estimate that the final rule amendments would reduce EtO emissions
by 21 tons per year and expect that these reductions will lower the
risk of adverse health effects, including cancer, for individuals in
communities near commercial sterilization facilities. For example, the
estimated cancer incidence due to emissions from the source category
would be reduced from 0.9 to between 0.1 to 0.2, or from 1 cancer case
every 1.1 years to 1 cancer case every 5 to 10 years.
F. What analysis of environmental justice did we conduct?
Consistent with applicable executive orders and EPA policy, the EPA
has carefully analyzed the environmental justice implications of the
benefits associated with the reductions in EtO emissions as a result of
this final rule. The EPA conducted this analysis for the purpose of
providing the public with as full as possible an understanding of the
potential impacts of this final action. The EPA believes that analyses
like this can inform the public's understanding, place EPA's action in
context, and help, identify and illustrate the extent of potential
burdens and protections.
As part of understanding the impacts of this source category and of
this final rule, we examined the potential for the 88 facilities that
were assessed to pose concerns to communities with EJ concerns both in
the baseline i.e., under the current standards) standards considered in
this final rule.
To examine the potential for EJ concerns in the pre-control
baseline, we conducted two baseline demographic analyses, a proximity
analysis and a risk-based analysis. The baseline proximity demographic
analysis is an assessment of individual demographic groups in the total
population living within 10 kilometers (km) and 50 km of the
facilities. In this preamble, we focus on the 10 km radius for the
health risk assessment and for the demographic analysis because it
encompasses all the facility MIR locations and captures 100 percent of
the population with risks greater than 100-in-1 million. The results of
the proximity analysis for populations living within 50 km are included
in the technical report included in the docket for this final rule for
the public's understanding.
The baseline risk-based demographic analysis is an assessment of
risks to individual demographic groups in the population living within
the 10 km and 50 km radii around the facilities prior to the
implementation of any controls finalized by this action (``baseline'').
Again, in this preamble, we present for the public's understanding the
results for populations living within 10 km of facilities. Results for
populations living within 50 km are included in the technical report
included in the docket for this final rule.
Overall, the results of the proximity demographic analysis (see
first three columns of table 23) indicate that the percent of the
population living within 10 km of the 88 facilities that is Hispanic or
Latino is substantially higher than the national average (36 percent
versus 19 percent), driven largely by the seven facilities in Puerto
Rico. The baseline proximity analysis indicates that the proportion of
other demographic groups living within 10 km of commercial sterilizers
is closer to the national average. The baseline risk-based demographic
analysis (see ``baseline'' column in tables 23 to 25), which presents
information for individuals that are expected to have higher cancer
risks (greater than or equal to 1-in-1 million, greater than or equal
to 50-in-1 million, and greater than 100-in-1 million), suggests that
the African American, Hispanic or Latino, below the poverty level, over
25 and without a high school diploma, and linguistically isolated
demographic groups are also disproportionally represented at the higher
risk levels.
The post-control risk-based demographic analysis presents
information on current health risks and how the standards considered in
this final regulatory action would affect the distribution of these
risks across the populations and communities identified in the
baseline. The CAA section 112(d)(2), (3), and (5) post-control scenario
is shown in tables 23 to 25 and the residual risk post-control options
are shown in tables 26 to 28. The post-control options show a
substantial reduction in the number of individuals at each risk level,
as well as a significant reduction in the proportion of African
Americans that experience higher risk levels from facilities in this
source category. We project that a majority of the individuals that
would remain at risk after implementation of the final standards are
Hispanic or Latino, driven largely by the facilities in Puerto Rico.
These three distinct but complementary analyses indicate the
potential for EJ concerns associated with this source category in the
baseline, as well as the substantial anticipated benefits these final
standards will have in reducing EtO emissions and associated health
risks for all of the affected public, including people living in
communities with EJ concerns. Those benefits include that no individual
is expected to be exposed to inhalation cancer risk levels above 100-
in-1 million due to emissions from this source category after
implementation of all the CAA standards finalized in this action.
The methodology and detailed results of the demographic analysis
are presented in a technical report, Analysis of Demographic Factors
for Populations Living Near Ethylene Oxide Commercial Sterilization and
Fumigation Operations, available in the docket for this action, but a
synopsis is provided below. We also received comments on the
demographic analysis. Those comments and our specific responses 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.
1. Demographics
The first three columns of tables 23, 24, and 25 of this document
show the total population, population percentages, and population count
for each demographic group for the nationwide population and the total
population living within 10 km of EtO sterilization facilities. A total
of 17.3 million people live within 10 km of the 88 facilities that were
assessed. The results of the proximity demographic analysis indicate
that the percent of the population that is Hispanic or Latino is
substantially higher than the national average (36 percent versus 19
percent), driven by the seven facilities in Puerto Rico, where an
average of 99 percent of the 658,000 people living within 10 km of the
facilities in PR are Hispanic or Latino. The percent of the population
that is ``Other and multiracial'' (11 percent) is higher than the
national average (8 percent). The percent of people living below the
poverty level (15 percent) and those over the age of 25 without a high
school diploma (16 percent) are higher than the national averages (13
percent and 12 percent, respectively). The percent of people living in
linguistic isolation \69\ is double
[[Page 24140]]
the national average (10 percent versus 5 percent). We note that this
estimate of linguistic isolation is largely driven by the facilities in
Puerto Rico, where an average of 67 percent of the population is in
linguistic isolation in comparison to the national average.
---------------------------------------------------------------------------
\69\ Linguistic Isolation is defined in the U.S. Census Bureau's
American Community Survey as ``a household in which all members age
14 years and over speak a non-English language and also speak
English less than ``very well'' (have difficulty with English).''
---------------------------------------------------------------------------
In summary, the baseline proximity analysis indicates that the
percent of Hispanic or Latino populations living near commercial
sterilizers (within 10 km) is higher than what would be expected based
on the national average distribution. This is largely driven by the
seven facilities located in Puerto Rico where, on average, the
population of 658,000 people living within 10 km of these seven
facilities is 99 percent Hispanic or Latino. In addition, the
population around the facilities in Puerto Rico has 67 percent living
in linguistic isolation, 45 percent living below the poverty level, and
24 percent over 25 without a high school diploma.
2. Baseline Risk-Based Demographics
The baseline risk-based demographic analysis results are shown in
the ``baseline'' column of tables 23, 24, and 25. This analysis
presented information on the populations living within 10 km of the
facilities with estimated actual cancer risks greater than or equal to
1-in-1 million (table 23), greater than or equal to 50-in-1 million
(table 24), and greater than 100-in-1 million (table 25). The risk
analysis indicated that emissions from the source category, prior to
the reductions we are finalizing, expose a total of 5.3 million people
to a cancer risk greater than or equal to 1-in-1 million around 75
facilities, 124,000 people to a cancer risk greater than or equal to
50-in-1 million around 38 facilities, and 19,000 people to a cancer
risk greater than 100-in-1 million around 16 facilities. The
demographics of the baseline population with estimated cancer risks
greater than or equal to 1-in-1 million are very similar to the total
population within 10 km. Specifically, the percent of the population
that is Hispanic or Latino is more than two times larger than the
national average (39 percent versus 19 percent), the percent below the
poverty level is above national average (16 percent versus 13 percent),
the percent over 25 without a high school diploma is above the national
average (18 percent versus 12 percent), and the percent linguistic
isolation is two times the national average (11 percent versus 5
percent).
In contrast, the smaller populations with baseline cancer risk
greater than or equal to 50-in-1 million (124,000 people), and greater
than 100-in-1 million (19,000 people) are predominantly made up of
African Americans (43 and 31 percent versus 12 percent nationally), and
have a higher percentage of the population below the poverty level (22
and 25 percent versus 13 percent nationally). For this same group, the
percent over 25 without a high school diploma is above the national
average (17 and 18 percent versus 12 percent), and linguistic isolation
is above the national average (9 and 16 percent versus 5 percent). This
shows that risks tend to be higher both where more African American
residents reside, and where poverty is higher than in the rest of the
area within 10 km. It should be noted that the higher percentage
African American population with baseline cancer risk greater than or
equal to 50-in-1 million is driven largely by seven facilities located
in or near communities that have African American populations that are
between two and eight times the national average. The higher percentage
African American population with baseline cancer risk greater than 100-
in-1 million is driven largely by three facilities that are located in
communities where the proportion of African American residents is
between 2.5 and 8 times the national average. The population with
higher baseline cancer risks living within 10 km of the facilities
consists of a substantially smaller percentage of Hispanic or Latino
(22 and 26 percent) than the total population living within 10 km (36
percent Hispanic or Latino) and is above the national average (19
percent).
In summary, the baseline risk-based demographic analysis, which
presents information on those specific locations that are expected to
have higher cancer risks, suggests that African Americans, those living
below poverty, and those living in linguistic isolation are
disproportionally represented where risk is highest. The population
with risks greater than 100-in-1 million living within 10 km of a
commercial sterilizer has a proportion of African Americans (31
percent), those living below poverty (25 percent) and those living in
linguistic isolation (16 percent) that is more than twice as large as
the respective national average.
3. Risks Across Demographics Anticipated After Standards Under CAA
Sections 112(d)(2), 112(d)(3), and 112(d)(5)
This analysis presented information on the populations living
within 10 km of the facilities with estimated cancer risks greater than
or equal to 1-in-1 million (table 23), greater than or equal to 50-in-1
million (table 24), and greater than 100-in-1 million (table 25) after
implementation of standards that we are finalizing under CAA sections
112(d)(2), (3), and (5). The results of our analysis of risk-based
demographics considering standards under CAA sections 112(d)(2), (3),
and (5) are shown in the last column of tables 23, 24, and 25 titled
``Baseline and CAA Section 112(d)(2), (3), and (5).'' In this analysis
we evaluated how the final CAA sections 112(d)(2), (3), and (5)
emission reductions in this final regulatory action affect the
distribution of risks identified in the baseline. This enables us to
characterize the post-control risks and to illustrate for the public's
understanding whether this part of the final action affects, creates or
mitigates potential EJ concerns as compared to the baseline.
The risk analysis indicated that the emissions from the source
category, after implementation of the standards (resulting in emissions
reductions) that we are finalizing under CAA sections 112(d)(2), (3),
and (5), reduces the number of people living within 10 km of a facility
and with a cancer risk greater than or equal to 1-in-1 million from 5.3
million people around 75 facilities to 3.2 million people around 70
facilities, reduces the number of people living within 10 km of a
facility and with a cancer risk greater than or equal to 50-in-1
million from 124,000 people around 38 facilities to 23,000 people
around 23 facilities, and reduces the number of people living within 10
km of a facility and with a cancer risk greater than 100-in-1 million
from 19,000 people around 16 facilities to 3,900 people around 13
facilities.
The demographics of the population with estimated cancer risks
greater than or equal to 1-in-1 million considering the standards we
are finalizing under CAA sections 112(d)(2), (3), and (5) are very
similar to both the total population within 10 km and to the baseline
population with risks greater than or equal to 1-in-1 million.
Specifically, the percent of the population that is Hispanic or Latino
is twice the national average (38 percent versus 19 percent), the
percent below the poverty level is above national average (16 percent
versus 13 percent), the percent over 25 without a high school diploma
is above the national average (18 percent versus 12 percent), and the
percent linguistic isolation is two times the national average (11
percent versus 5 percent).
After implementation of the standards that we are finalizing under
CAA sections 112(d)(2), (3), and (5), the percentage and number of
African Americans at cancer risks greater than
[[Page 24141]]
or equal to 50-in-1 million and greater than 100-in-1 million is
significantly reduced. For example, African Americans exposed to risks
greater than 100-in-1 million went from 31 percent or 5,900 people in
the baseline to 6 percent or 220 people after implementation of the
final CAA section 112(d)(2), 112(d)(3), and 112(d)(5) emissions
reductions. It should be noted that while the number of Hispanic or
Latino people with risks greater than 100-in-1 million was reduced from
4,900 to 2,600 people, the percentage of the remaining population at
>100-in-1 million risk that is Hispanic or Latino went up from 26
percent in the baseline to 68 percent after the final CAA section
112(d)(2), 112(d)(3), and 112(d)(5) emissions reductions. However,.
Similarly, the number of people below the poverty level or
linguistically isolated with a cancer risk >100-in-1 million decreased
significantly; however, the percentage of the remaining population at
risk post-emission controls that are in these demographics went up from
the baseline. For example, the proportion of the population with risks
greater than 100-in-1 million that were below the poverty level was
much higher than the baseline (38 percent versus 25 percent), but the
number of people was reduced from 4,700 people to 560 people.
In summary, implementation of the final CAA sections 112(d)(2),
(3), and (5) standards would significantly reduce the number of people
in all demographic groups that are exposed to risks greater than or
equal to 1-in-1 million, greater than and equal to 50-in-1 million, and
greater than 100-in-1 million. Specifically, the percent of the
population that is African American who are at a cancer risk greater
than or equal to 50-in-1 million and greater than 100-in-1 million was
reduced from 43 percent in the baseline to about 13 percent after the
CAA section 112(d)(2), 112(d)(3), and 112(d)(5) controls. The
percentage of Hispanic or Latino people increased as the higher risk
facilities in Puerto Rico make-up an increasing portion of the
remaining populations with higher cancer risks.
Table 23--Comparison at Baseline and CAA Section 112(d)(2), (3), and (5) Post-Control of Demographics of
Populations With Cancer Risk Greater Than or Equal to 1-in-1 Million Living Within 10 km of Facilities That Were
Assessed
----------------------------------------------------------------------------------------------------------------
Total Cancer risk >= 1-in-1 million
population -------------------------------
Demographic group Nationwide living within
10 km of EtO Baseline Post-control
facilities
----------------------------------------------------------------------------------------------------------------
Total Population................................ 328M 17.3M 5.3M 3.2M
Number of Facilities............................ .............. 88 75 70
----------------------------------------------------------------------------------------------------------------
Race and Ethnicity by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
White........................................... 60 percent 40 percent 40 percent 40 percent
[197M] [6.9M] [2.1M] [1.3M]
African American................................ 12 percent 13 percent 15 percent 16 percent
[40M] [2.3M] [770K] [520K]
Native American................................. 0.7 percent 0.3 percent 0.3 percent 0.3 percent
[2M] [51K] [17K] [9K]
Hispanic or Latino (includes white and nonwhite) 19 percent 36 percent 39 percent 38 percent
[62M] [6.2M] [2.1M] [1.2M]
Other and Multiracial........................... 8 percent 11 percent 7 percent 6 percent
[27M] [1.9M] [350K] [190K]
----------------------------------------------------------------------------------------------------------------
Income by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Below Poverty Level............................. 13 percent 15 percent 16 percent 16 percent
[44M] [2.5M] [840K] [520K]
Above Poverty Level............................. 87 percent 85 percent 84 percent 84 percent
[284M] [14.8M] [4.5M] [2.7M]
----------------------------------------------------------------------------------------------------------------
Education by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Over 25 and without a High School Diploma....... 12 percent 16 percent 18 percent 18 percent
[40M] [2.7M] [960K] [590K]
Over 25 and with a High School Diploma.......... 88 percent 84percent 82 percent 82 percent
[288M] [14.6M] [4.3M] [2.7M]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated......................... 5 percent 10 percent 11 percent 11 percent
[18M] [1.8M] [570K] [360K]
----------------------------------------------------------------------------------------------------------------
Notes:
Nationwide population and demographic percentages are based on the Census Bureau's (Census) 2015-2019
American Community Survey (ACS) 5-year block group averages. Total population count within 10 km is based on
2010 Decennial Census block population.
To avoid double counting, the ``Hispanic or Latino'' category is treated as a distinct demographic
category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR
was located at a user assigned receptor at an individual residence and not at a census block centroid, we were
unable to estimate population and demographics for that facility.
The sum of individual populations with a demographic category may not add up to total due to rounding.
[[Page 24142]]
Table 24--Comparison at Baseline and CAA Section 112(d)(2), (3), and (5) Post-Control of Demographics of
Populations With Cancer Risk Greater Than or Equal to 50-in-1 Million Living Within 10 km of Facilities That
Were Assessed
----------------------------------------------------------------------------------------------------------------
Total Cancer risk >= 50-in-1 million
population -------------------------------
Demographic group Nationwide living within
10 km of EtO Baseline Post-control
facilities
----------------------------------------------------------------------------------------------------------------
Total Population................................ 328M 17.3M 124,000 23,000
Number of Facilities............................ .............. 88 38 23
----------------------------------------------------------------------------------------------------------------
Race and Ethnicity by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
White........................................... 60 percent 40 percent 31 percent 30 percent
[197M] [6.9M] [39K] [7K]
African American................................ 12 percent 13 percent 43 percent 13 percent
[40M] [2.3M] [54K] [2.9K]
Native American................................. 0.7 percent 0.3 percent 0.1 percent 0.1 percent
[2M] [51K] [190] [<100]
Hispanic or Latino (includes white and nonwhite) 19 percent 36 percent 22 percent 56 percent
[62M] [6.2M] [27K] [13K]
Other and Multiracial........................... 8 percent 11 percent 3 percent 2 percent
[27M] [1.9M] [3.9K] [400]
----------------------------------------------------------------------------------------------------------------
Income by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Below Poverty Level............................. 13 percent 15 percent 22 percent 29 percent
[44M] [2.5M] [28K] [6.6K]
Above Poverty Level............................. 87 percent 85 percent 78 percent 71 percent
[284M] [14.8M] [96K] [17K]
----------------------------------------------------------------------------------------------------------------
Education by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Over 25 and without a High School Diploma....... 12 percent 16 percent 17 percent 21 percent
[40M] [2.7M] [21K] [5K]
Over 25 and with a High School Diploma.......... 88 percent 84 percent 83 percent 79 percent
[288M] [14.6M] [103K] [18K]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated......................... 5 percent 10 percent 9 percent 30 percent
[18M] [1.8M] [11K] [6.9K]
----------------------------------------------------------------------------------------------------------------
Notes:
Nationwide population and demographic percentages are based on Census' 2015-2019 ACS 5-year block group
averages. Total population count within 10 km is based on 2010 Decennial Census block population.
To avoid double counting, the ``Hispanic or Latino'' category is treated as a distinct demographic
category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR
was located at a user assigned receptor at an individual residence and not at a census block centroid, we were
unable to estimate population and demographics for that facility.
The sum of individual populations with a demographic category may not add up to total due to rounding.
To account for the uncertainty of demographics estimates in smaller populations, any population values
of 100 persons or less have been shown simply as ``<100.''
Table 25--Comparison at Baseline and CAA Section 112(d)(2), (3), and (5) Post-Control of Demographics of
Populations With Cancer Risk Greater Than 100-in-1 Million Living Within 10 km of Facilities That Were Assessed
----------------------------------------------------------------------------------------------------------------
Total Cancer risk > 100-in-1 million
population -------------------------------
Demographic group Nationwide living within
10 km of EtO Baseline Post-control
facilities
----------------------------------------------------------------------------------------------------------------
Total Population................................ 328M 17.3M 19,000 3,900
Number of Facilities............................ .............. 88 16 13
----------------------------------------------------------------------------------------------------------------
Race and Ethnicity by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
White........................................... 60 percent 40 percent 40 percent 25 percent
[197M] [6.9M] [7.7K] [1K]
African American................................ 12 percent 13 percent 31 percent 6 percent
[40M] [3M] [5.9K] [200]
Native American................................. 0.7 percent 0.3 percent 0.1 percent 0 percent
[2M] [51K] [<100] [0]
[[Page 24143]]
Hispanic or Latino (includes white and nonwhite) 19 percent 36 percent 26 percent 68 percent
[62M] [6.2M] [4.9K] [2.6K]
Other and Multiracial........................... 8 percent 11 percent 3 percent 1 percent
[27M] [1.9M] [500] [<100]
----------------------------------------------------------------------------------------------------------------
Income by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Below Poverty Level............................. 13 percent 15 percent 25 percent 38 percent
[44M] [2.5M] [4.7K] [1.4K]
Above Poverty Level............................. 87 percent 85 percent 75 percent 62 percent
[284M] [14.8M] [14K] [2.4K]
----------------------------------------------------------------------------------------------------------------
Education by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Over 25 and without a High School Diploma....... 12 percent 16 percent 18 percent 22 percent
[40M] [2.7M] [3.5K] [900]
Over 25 and with a High School Diploma.......... 88 percent 84 percent 82 percent 78 percent
[288M] [14.6M] [16K] [3K]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated......................... 5 percent 10 percent 16 percent 44 percent
[18M] [1.8M] [3K] [1.7K]
----------------------------------------------------------------------------------------------------------------
Notes:
Nationwide population and demographic percentages are based on Census' 2015-2019 ACS 5-year block group
averages. Total population count within 10 km is based on 2010 Decennial Census block population.
To avoid double counting, the ``Hispanic or Latino'' category is treated as a distinct demographic
category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR
was located at a user assigned receptor at an individual residence and not at a census block centroid, we were
unable to estimate population and demographics for that facility.
The sum of individual populations with a demographic category may not add up to total due to rounding.
To account for the uncertainty of demographics estimates in smaller populations, any population values
of 100 persons or less have been shown simply as ``<100.''
4. Demographics of Affected Populations Anticipated After
Implementation of Residual Risk Standards (Post-Control)
This analysis presented information on the populations living
within 10 km of the facilities with estimated cancer risks greater than
or equal to 1-in-1 million (table 26), greater than or equal to 50-in-1
million (table 27), and greater than 100-in-1 million (table 28) after
implementation of the standards being finalized under CAA section
112(f)(2) as described in section IV.C of this preamble. The
demographic results for the risks after implementation of the residual
risk-based controls are in the column titled ``Residual Risk
Standards.'' These standards will be implemented in addition to the CAA
section 112(d)(2), (3), and (5) standards and are anticipated to result
in additional post-control emissions reductions. Therefore, in this
analysis, we evaluated how all of the final standards and emission
reductions described in this action affect the reduction and
distribution of risks. This enables us to characterize the post-control
risks and to understand whether the final action affects, creates or
mitigates potential EJ concerns as compared to the baseline.
The risk analysis indicated that the number of people exposed to
risks greater than or equal to 1-in-1 million within 10 km of a
facility (table 26) is reduced from 3.2 million people after
implementation of the CAA section 112(d)(2), (3), and (5) controls to
approximately 700,000 people after implementation of the residual risk
standards. This represents a significant reduction (about 80 percent
reduction) in the size of the population facing this level of risk
after implementation of the residual risk standards being finalized,
when compared to the population facing this level of risk after
implementation of just the CAA section 112(d)(2), (3), and (5)
controls. The people with a cancer risk greater than or equal to 1-in-1
million are located around 67 facilities after implementation of the
residual risk standard-based controls.
The demographics of the post-control population living within 10 km
of a facility and with an estimated cancer risks greater than or equal
to 1-in-1 million after implementation of the residual risk standards
and resulting controls (table 26) are very similar to the CAA section
112(d)(2), (3), and (5) post-control population with risks greater than
or equal to 1-in-1 million. Specifically, the percent of the population
that is Hispanic or Latino is nearly twice the national average (34
percent versus 19 percent), the percent below poverty is above national
average (15 percent versus 13 percent), the percent over 25 without a
high school diploma is above the national average (15 percent versus 12
percent), and the percent linguistic isolation is almost two times the
national average (11 percent versus 5 percent).
The risk analysis indicated that the number of people living within
10 km of a facility and exposed to risks greater than or equal to 50-
in-1 million (table 27) is reduced from 23,000 people after
implementation of the CAA section
[[Page 24144]]
112(d)(2), (3), and (5)-based controls to 170 people after
implementation of the residual risk-based controls. This represents a
99 percent reduction in the size of the populations at risk. The people
living within 10 km of a facility and with a cancer risk greater than
or equal to 50-in-1 million after implementation of the final rule are
located around 11 facilities.
The demographic breakdown of the much smaller post-control
population living within 10 km of a facility and with estimated cancer
risks greater than or equal to 50-in-1 million for the residual risk
controls (table 27) is significantly different from the population
after implementation of the CAA section 112(d)(2), (3), and (5)
controls. Specifically for the 170 individuals still at greater than or
equal to 50-in-1 million risk, the percent of the population that is
Hispanic or Latino is significantly higher at 76 percent for the
residual risk controls. This higher percentage is driven by two
facilities in Puerto Rico, for which the population is over 99 percent
Hispanic or Latino. However, the number of Hispanic or Latino people
with risks greater than or equal to 50-in-1 million was reduced by
about 99 percent from 13,000 people to 130 people after anticipated
implementation of the residual risk standard-based controls. Similarly,
the percentage of the population that is below the poverty level or
linguistically isolated went up from the CAA section 112(d)(2), (3),
and (5) post-control population, but the number of people in each
demographic decreased significantly.
The risk analysis indicated that the number of people living within
10 km of a facility and exposed to risks greater than 100-in-1 million
(table 28) is reduced from 3,900 people after implementation of the CAA
section 112(d)(2), (3), and (5)-based controls to zero people for
residual risk-based controls. After implementation of the residual risk
standards, there are no facilities or people with risks greater than
100-in-1 million. Therefore, there are no greater than 100-in-1 million
risk populations or demographics to discuss.
In summary, as shown in the residual risk post-control risk-based
demographic analysis, the standards being finalized will reduce the
number of people and facilities expected to have cancer risks greater
than or equal to 1-in-1 million, greater than or equal to 50-in-1
million, and greater than 100-in-1 million significantly. Under
residual risk-based controls, the number of Hispanic or Latino people
that are exposed to risks greater than or equal to 1-in-1 million is
reduced by 80 percent, the number of Hispanic or Latino people that are
exposed to risks greater than or equal to 50-in-1 million is reduced by
99 percent, and the number of Hispanic or Latino people that are
exposed to risks greater than 100-in-1 million is reduced by 100
percent. We note that, primarily driven by the higher risk facilities
in Puerto Rico, the percentage of population that is Hispanic or
Latino, below the poverty level, over 25 without a high school diploma,
or in linguistic isolation increases as the cancer risk increases from
greater than or equal to 1-in-1 million to greater than 50-in-1
million. Under residual risk-based controls, there are no facilities or
people with risks greater than 100-in-1 million.
Table 26--Comparison of Demographics for Populations With Cancer Risk Greater Than or Equal to 1-in-1 Million
Living Within 10 km of Sterilizer Facilities After Implementation of Various Components of the Final Standards
----------------------------------------------------------------------------------------------------------------
Cancer risk >=1-in-1 million
-------------------------------
Post-control
Demographic group Nationwide CAA section Residual risk
112(d)(2), standards (CAA
(3), and (5) section
standards 112(f)(2))
----------------------------------------------------------------------------------------------------------------
Total Population................................................ 328M 3.2M 700K
Number of Facilities with Pop. Above Cancer Level............... .............. 70 67
----------------------------------------------------------------------------------------------------------------
Race and Ethnicity by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
White........................................................... 60 percent 40 percent 40 percent
[197M] [1.3M] [280K]
African American................................................ 12 percent 16 percent 18 percent
[40M] [520K] [130K]
Native American................................................. 0.7 percent 0.3 percent 0.2 percent
[2M] [9K] [2.2K]
Hispanic or Latino (includes white and nonwhite)................ 19 percent 38 percent 34 percent
[62M] [1.2M] [240K]
Other and Multiracial........................................... 8 percent 6 percent 8 percent
[27M] [190K] [53K]
----------------------------------------------------------------------------------------------------------------
Income by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Below Poverty Level............................................. 13 percent 16 percent 15 percent
[44M] [520K] [100K]
Above Poverty Level............................................. 87 percent 84 percent 85 percent
[284M] [7M] [600K]
----------------------------------------------------------------------------------------------------------------
Education by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
> 25 w/o a HS Diploma........................................... 12 percent 18 percent 15 percent
[40M] [590K] [110K]
> 25 w/HS Diploma............................................... 88 percent 82 percent 85 percent
[288M] [2.7M] [590K]
----------------------------------------------------------------------------------------------------------------
[[Page 24145]]
Linguistically Isolated by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated......................................... 5 percent 11 percent 11 percent
[18M] [360K] [80K]
----------------------------------------------------------------------------------------------------------------
Notes:
Nationwide population and demographic percentages are based on Census' 2015-2019 ACS 5-year block group
averages. Total population count within 10 km is based on 2010 Decennial Census block population.
To avoid double counting, the ``Hispanic or Latino'' category is treated as a distinct demographic
category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR
was located at a user assigned receptor at an individual residence and not at a census block centroid, we were
unable to estimate population and demographics for that facility.
The sum of individual populations with a demographic category may not add up to total due to rounding.
Table 27--Comparison of Demographics for Populations With Cancer Risk Greater Than or Equal to 50-in-1 Million
Living Within 10 km of Sterilizer Facilities After Implementation of Various Components of the Final Rule
----------------------------------------------------------------------------------------------------------------
Cancer risk >=50-in-1 million
post-control
-------------------------------
Demographic group Nationwide CAA section
112(d)(2), Residual risk
(3), and (5) standards
standards (112(f)(2))
----------------------------------------------------------------------------------------------------------------
Total Population................................................ 328M 23,000 170
Number of Facilities with Pop. Above Cancer Level............... .............. 23 11
----------------------------------------------------------------------------------------------------------------
Race and Ethnicity by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
White........................................................... 60 percent 30 percent 12 percent
[197M] [7K] [<100]
African American................................................ 12 percent 13 percent 11 percent
[40M] [2.9K] [<100]
Native American................................................. 0.7 percent 0.1 percent 0.3 percent
[2M] [190] [<100]
Hispanic or Latino (includes white and nonwhite)................ 19 percent 56 percent 76 percent
[62M] [13K] [130]
Other and Multiracial........................................... 8 percent 2 percent 0.4 percent
[27M] [400] [<100]
----------------------------------------------------------------------------------------------------------------
Income by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Below Poverty Level............................................. 13 percent 29 percent 30 percent
[44M] [6.6K] [<100]
Above Poverty Level............................................. 87 percent 71 percent 70 percent
[284M] [17K] [120]
----------------------------------------------------------------------------------------------------------------
Education by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
>25 w/o a HS Diploma............................................ 12 percent 21 percent 31 percent
[40M] [5K] [<100]
>25 w/HS Diploma................................................ 88 percent 79 percent 69 percent
[288M] [18K] [120]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated......................................... 5 percent 30 percent 47 percent
[18M] [6.9K] [<100]
----------------------------------------------------------------------------------------------------------------
Notes:
Nationwide population and demographic percentages are based on Census' 2015-2019 ACS 5-year block group
averages. Total population count within 10 km is based on 2010 Decennial Census block population.
To avoid double counting, the ``Hispanic or Latino'' category is treated as a distinct demographic
category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
[[Page 24146]]
The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR
was located at a user assigned receptor at an individual residence and not at a census block centroid, we were
unable to estimate population and demographics for that facility.
The sum of individual populations with a demographic category may not add up to total due to rounding.
To account for the uncertainty of demographics estimates in smaller populations, any population values
of 100 persons or less have been shown simply as ``<100''.
Table 28--Comparison of Demographics for Populations With Cancer Risk Greater Than 100-in-1 Million Living
Within 10 km of Sterilizer Facilities After Implementation of Various Components of the Final Rule
----------------------------------------------------------------------------------------------------------------
Cancer risk >100-in-1 million
-------------------------------
CAA section
Demographic group Nationwide 112(d)(2), Residual risk
(3), and (5) controls
post-control
----------------------------------------------------------------------------------------------------------------
Total Population................................................ 328M 3,900 0
Number of Facilities with Pop. Above Cancer Level............... .............. 13 0
----------------------------------------------------------------------------------------------------------------
Race and Ethnicity by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
White........................................................... 60 percent 25 percent ..............
[197M] [1K]
African American................................................ 12 percent 6 percent ..............
[40M] [200]
Native American................................................. 0.7 percent 0 percent ..............
[2M] [0]
Hispanic or Latino (includes white and nonwhite)................ 19 percent 68 percent ..............
[62M] [2.6K]
Other and Multiracial........................................... 8 percent 1 percent ..............
[27M] [<100]
----------------------------------------------------------------------------------------------------------------
Income by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Below Poverty Level............................................. 13 percent 38 percent ..............
[44M] [1.4K]
Above Poverty Level............................................. 87 percent 62 percent ..............
[284M] [2.4K]
----------------------------------------------------------------------------------------------------------------
Education by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
>25 w/o a HS Diploma............................................ 12 percent 22 percent ..............
[40M] [900]
>25 w/HS Diploma................................................ 88 percent 78 percent ..............
[288M] [3K]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated by Percent [Number of People]
----------------------------------------------------------------------------------------------------------------
Linguistically Isolated......................................... 5 percent 44 percent ..............
[18M] [1.7K]
----------------------------------------------------------------------------------------------------------------
Notes:
Nationwide population and demographic percentages are based on Census' 2015-2019 ACS 5-year block group
averages. Total population count within 10 km is based on 2010 Decennial Census block population.
To avoid double counting, the ``Hispanic or Latino'' category is treated as a distinct demographic
category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR
was located at a user assigned receptor at an individual residence and not at a census block centroid, we were
unable to estimate population and demographics for that facility.
The sum of individual populations with a demographic category may not add up to total due to rounding.
To account for the uncertainty of demographics estimates in smaller populations, any population values
of 100 persons or less have been shown simply as ``<100''.
VI. Statutory and Executive Order Reviews
A. Executive Orders 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is a ``significant regulatory action'', as defined
under section 3(f)(1) of Executive Order 12866, as amended by Executive
Order 14094. Accordingly, the EPA submitted this action to the Office
of Management and Budget (OMB) for Executive Order 12866 review.
Documentation of any changes made in response to the Executive Order
12866 review is available in the docket. The EPA prepared an analysis
of the potential costs and benefits associated with this action. This
analysis, Regulatory Impact Analysis for the Final National Emission
Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial
Sterilization and Fumigation Operations, is also available in the
docket.
B. Paperwork Reduction Act (PRA)
The information collection activities in this rule have been
submitted for approval to the Office of Management and Budget (OMB)
under the PRA. The Information Collection Request (ICR) document that
the EPA prepared has been assigned EPA ICR number 1666.12. You can find
a copy of the ICR in the docket for this rulemaking, and it is briefly
summarized here.
We are amending the reporting and recordkeeping requirements for
several
[[Page 24147]]
emission sources at commercial sterilization facilities (e.g., SCV,
ARV, CEV, and room air emissions). The amendments also require
electronic reporting, removes the SSM exemption, and imposes other
revisions that affect reporting and recordkeeping. This information was
be collected to assure compliance with 40 CFR part 63, subpart O.
Respondents/affected entities: Owners or operators of commercial
sterilization facilities.
Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart O).
Estimated number of respondents: 88 facilities.
Frequency of response: Quarterly, semiannual, or annual. Responses
include notification of compliance status reports and semiannual
compliance reports.
Total estimated burden: 34,351 hours (per year) for the responding
facilities and 9,174 hours (per year) for the Agency. Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $5,140,563 (per year), which includes
$2,549,368 annualized capital and operation and maintenance costs for
the responding facilities.
An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 603 of the RFA, the EPA prepared a final
regulatory flexibility analysis (FRFA) that examines the impact of the
rule on small entities along with regulatory alternatives that could
minimize the impact. The complete FRFA is available for review in the
docket and is summarized here.
1. Statement of Need and Rule Objectives
This industry is regulated by the EPA because pollutants emitted
from EtO sterilization and fumigation facilities are considered to
cause or contribute significantly to air pollution that may reasonably
be anticipated to endanger public health. This action is being
finalized to comply with CAA section 112 requirements, which direct the
EPA to complete periodic reviews of NESHAPs following initial
promulgation. The requirements are being finalized to address
unacceptable health risks linked to emissions from subpart O facilities
and to provide an ample margin of safety to protect public health.
The EPA is required under CAA section 112(d) to establish emission
standards for each category or subcategory of major and area sources of
HAPs listed for regulation in section 112(b). These standards are
applicable to new or existing sources of HAPs and require the maximum
degree of emission reduction. The EPA is required to review these
standards set under CAA section 112 every eight years following their
promulgation and revise them as necessary, taking into account any
``developments in practices, processes, or control technologies.'' This
review is known as the technology review. It has been over 25 years
since the initial NESHAP for this source category was promulgated in
1994 and roughly 15 years since the last technology review. As such,
this final rule is overdue. This rule also establishes standards for
currently unregulated sources of EtO emissions at subpart O facilities
under CAA section 112(d), such as room air emissions. The decision in
Louisiana Environmental Action Network v. EPA, 955 F.3d 1088 (D.C. Cir.
2020) concluded that the EPA is required to address regulatory gaps
(i.e., ``gap-filling'') when conducting NESHAP reviews. Finally, the
EPA determined that a risk review was warranted (despite not being
required) due to the updated unit risk estimate associated with EtO,
which is significantly higher than it was during the last review of
this NESHAP in 2006. Therefore, the EPA is finalizing requirements
under CAA section 112(f) to address unacceptable health risk attributed
to emissions from subpart O facilities and to provide an ample margin
of safety to protect public health.
2. Significant Issues Raised by the Public Comments in Response to the
Initial Regulatory Flexibility Analysis (IRFA) and EPA Response
While the EPA did not receive any comments specifically in response
to the IRFA, we did receive comments from the Office of Advocacy within
the Small Business Administration (SBA), and a summary of the major
comments and our responses is provided in the next section. The issues
raised by SBA were also reflected in comments from small businesses and
organizations with small business interests.
3. SBA Office of Advocacy Comments and EPA Response
The SBA's Office of Advocacy (hereafter referred to as
``Advocacy'') provided substantive comments on the April 2023 Proposal.
Those comments made the following claims: (1) the proposed compliance
period for existing sources (18 months) would disadvantage small
business; (2) the proposed requirement for area source commercial
sterilization facilities to obtain a title V permit would impose
significant costs and uncertainty for small businesses; and (3) EPA
should adopt the BMP alternatives for GACT at area source facilities.
Based on those claims, Advocacy insisted that EPA reconsider these
policies to reduce the impact on small entities and reduce the
likelihood they will leave the market.
In response to Advocacy's comments, EPA agrees that the proposed
compliance timeframe is too short and that more time is needed to
comply with the rule. Therefore, as part of the final rulemaking, EPA
is providing the maximum amount of time that is allowed under the CAA
to comply with the emission standards, which is three years for
standards that are promulgated pursuant to CAA section 112(d) and two
years for standards that are promulgated pursuant to CAA section
112(f)(2). With respect to 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, the EPA is not finalizing a
requirement for area source facilities to obtain a title V permit. In
addition, with respect to GACT, emission standards were evaluated
against the BMP on a source-by-source basis. In general, we are
finalizing the emission standards for each source pursuant to CAA
section 112(d)(5), with the exception of existing Group 2 room air
emissions at areas source facilities, because they achieve higher
emission reductions than the BMP. Further discussion is available in
section IV.B.3.
More detailed responses to Advocacy's comments 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.
4. Estimate of the Number of Small Entities to Which the Final Rule
Applies
For purposes of assessing the impacts of this rule on small
entities, a small entity is defined as a small business in the
commercial EtO sterilization
[[Page 24148]]
industry whose parent company has revenues or numbers of employees
below the SBA Size Standards for the relevant NAICS code. We have
identified 20 different NAICS codes within this source category. A
complete list of those NAICS codes and SBA Size Standards is available
in section 5.2 of the RIA. The rule contains provisions that will
affect 22 small entities. These small entities are involved in
sterilizing various types of medical devices and spices. In addition,
at least 12 of these small entities are involved in sterilizing the
types of medical devices discussed in section I.A.1 of this preamble.
5. Projected Reporting, Recordkeeping and Other Compliance Requirements
of the Final Rule
Under the rule requirements, small entities will be required to
comply with various emission standards, which may require the use of
one or more new control devices. Small entities will also need to
demonstrate compliance with the emission standards through the use of
an EtO CEMS or through periodic performance testing and parametric
monitoring. This rule includes reporting, recordkeeping, and other
administrative requirements. Under the rule, the EPA estimates that
approximately 13 small entities (60 percent of small entities) could
incur total annual costs associated with the proposal that are at least
three percent of their annual revenues. Considering the level of total
annual costs relative to annual sales for these small entities, the EPA
determined that there is potential for the requirements to have a
`Significant Impact on a Substantial Number of Small Entities'. See
section 5.2 of the RIA for more information on the characterization of
the impacts under the rule.
6. Steps Taken To Minimize Economic Impact to Small Entities
a. Small Business Advocacy Review Panel
As required by section 609(b) of the RFA, the EPA also convened a
Small Business Advocacy Review (SBAR) Panel to obtain advice and
recommendations from small entity representatives (SERs) that
potentially would be subject to the rule's requirements. On November
25, 2020, the EPA's Small Business Advocacy Chairperson convened the
Panel, which consisted of the Chairperson, the Director of the Sector
Policies and Programs Division within the EPA's Office of Air Quality
Planning and Standards, the Administrator of the Office of Information
and Regulatory Affairs within OMB, and the Chief Counsel for Advocacy
of the SBA.
Prior to convening the Panel, the EPA conducted outreach and
solicited comments from the SERs. After the Panel was convened, the
Panel provided additional information to the SERs and requested their
input. In light of the SERs' comments, the Panel considered the
regulatory flexibility issues and elements of the IRFA specified by
RFA/Small Business Regulatory Enforcement and Fairness Act and
developed the findings and discussion summarized in the SBAR report.
The report was finalized on April 26, 2021, and transmitted to the EPA
Administrator for consideration. A copy of the full SBAR Panel Report
is available in the rulemaking docket.
b. Alternatives Considered
The SBAR Panel recommended several flexibilities relating to the
format of the standards, room air emissions requirements,
subcategorization, the compliance timeframe, the consideration of GACT
standards, incentivizing lower EtO use, a compliance alternative for
combined emission streams, proximity requirements, and the
consideration of interactions with OSHA standards. The EPA is including
some of these flexibilities as a part of the rule requirements.
As discussed in section VI.C.3, the EPA is providing the maximum
amount of time that is allowed under the CAA to comply with the
emission standards. In addition, as discussed in section IV.B.3.b, the
EPA is not any finalizing any mass rate emission standards and is
finalizing percent emission reduction standards in their place.
Finally, as discussed in section IV.F.3, the EPA is finalizing
compliance flexibilities for combined emission streams, as well as the
option to demonstrate compliance with a site-wide emission limit, as
opposed to having to demonstrate compliance with each individual or
combined emission stream.
In addition, the EPA is preparing a Small Entity Compliance Guide
to help small entities comply with this rule. The Small Entity
Compliance Guide will be available on the same date as the date of
publication of the final rule or as soon as possible after that date
and will be available on the rule web page at: https://www.epa.gov/stationary-sources-air-pollution/ethylene-oxide-emissions-standards-sterilization-facilities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any State, local, or Tribal governments.
E. Executive Order 13132: Federalism
This action does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the National Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175. None of the commercial sterilization facilities
that have been identified as being affected by this final action are
owned or operated by Tribal governments or located within Tribal lands
within a 10-mile radius. Thus, Executive Order 13175 does not apply to
this action. We conducted an impact analysis using the latitude and
longitude coordinates from the risk modeling input file to identify
Tribal lands within a 10- and 50-mile radius of commercial
sterilization facilities to determine potential air quality impacts on
Tribes. Consistent with the EPA Policy on Consultation and Coordination
with Indian Tribes, although there were no Tribal lands located within
a 10-mile radius of commercial sterilization facilities, the EPA
offered consultation with all Tribes that were identified within a 50-
mile radius of an affected facility, however, only one Tribal official
requested consultation. Additional details regarding the consultation
letter and distribution list can be found in the memorandum, Commercial
Sterilization Facilities RTR Consultation Letter, which is available in
the docket for this rulemaking. The EPA also participated on a phone
call with the National Tribal Air Association on May 25, 2023, and
presented an overview of the rulemaking.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal
agencies to include an evaluation of the health and safety effects of
the planned regulation on children in Federal health
[[Page 24149]]
and safety standards and explain why the regulation is preferable to
potentially effective and reasonable feasible alternatives. This action
is subject to Executive Order 13045 because it is a 3(f)(1) significant
regulatory action as defined by Executive Order 12866, and the EPA
believes that the environmental health or safety risk addressed by this
action has a disproportionate effect on children. The EPA's Policy on
Children's Health also applies to this action. Accordingly, we have
evaluated the environmental health or safety effects of EtO emissions
and exposures on children. The protection offered by these standards
may be especially important for children.
Because EtO is mutagenic (i.e., it can damage DNA), children are
expected to be more susceptible to its harmful effects. To take this
into account, as part of the risk assessment in support of this
rulemaking, the EPA followed its guidelines and applied age-dependent
adjustment factors (ADAFs) for early lifestage exposures (from birth up
to 16 years of age). With the ADAF applied to account for greater
susceptibility of children, the adjusted EtO inhalation URE is 5 x 10-3
per [micro]g/m\3\. It should be noted that, because EtO is mutagenic,
emission reductions in this preamble will be particularly beneficial to
children. In addition, children are at increased risk if they live,
play, or attend school in close proximity to a commercial sterilization
facility, of which there are many cases noted by the public to be the
case. For these reasons, there is both increased susceptibility and
increased exposure for early lifestages as a result of EtO emissions
from commercial sterilization facilities.
A total of 3.97 million children ages 0-17 live within 10km of
commercial sterilization facilities. Due to baseline emissions from
commercial sterilization facilities (prior to application of controls
in this action), there are approximately 1.25 million children (0-17
years) with increased lifetime cancer risks of greater than or equal to
1-in-1 million, 30,000 with increased lifetime cancer risks greater
than or equal to 50-in-1 million, and 4,300 with increased lifetime
cancer risks greater than 100-in-1 million. After application of the
controls in this action, lifetime cancer risks to children from
commercial sterilization facility emissions decrease significantly to
approximately 162,300 children with increased lifetime cancer risks of
greater than or equal to 1-in-1 million, less than 100 with increased
lifetime cancer risks of greater than or equal to 50-in-1 million, and
none with increased lifetime cancer risks greater than 100-in-1
million. The methodology and detailed results of the demographic
analysis are presented in a technical report, Analysis of Demographic
Factors for Populations Living Near Ethylene Oxide Commercial
Sterilization and Fumigation Operations, available in the docket for
this action.
More detailed information on the evaluation of the scientific
evidence and policy considerations pertaining to children, including an
explanation for why the Administrator judges the standards to be
requisite to protect public health, including the health of children,
with an adequate margin of safety, in addition to the summaries of this
action's health and risk assessments are contained in sections II.A and
IV.C of this preamble and further documented in the risk report,
Residual Risk Assessment for the Commercial Sterilization Facilities
Source Category in Support of the 2024 Risk and Technology Review Final
Rule, which is available in Docket ID No. EPA-HQ-OAR-2019-0178.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy. The overall energy impact of this rule
should be minimal for commercial sterilization facilities and their
parent companies. EPA was unable to quantify the degree to which
manufacturers will need to switch sites, so we cannot estimate
potential energy impacts related to transportation. The EPA solicited
comment on any potential impacts the proposed standards may have in
relation to energy use for transportation but did not receive any
comments that would help to quantify such impacts.
I. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR
Part 51
This rulemaking involves technical standards. The EPA conducted
searches for the standards through the Enhanced National Standards
Systems Network Database managed by the American National Standards
Institute (ANSI). We also contacted voluntary consensus standards (VCS)
organizations and accessed and searched their databases. We conducted
searches for EPA Methods 1, 1A, 2, 2A, 2C, 3A, 3B, and 4 of 40 CFR part
60, Appendix A, EPA Method 204 of 40 CFR part 51, Appendix M, and EPA
Methods 301 and 320 in 40 CFR part 63, Appendix A. During the EPA's VCS
search, if the title or abstract (if provided) of the VCS described
technical sampling and analytical procedures that are similar to the
EPA's reference method, the EPA reviewed it as a potential equivalent
method.
The EPA incorporates by reference VCS ANSI/ASME PTC 19.10-1981 Part
10, ``Flue and Exhaust Gas Analyses,'' a method for quantitatively
determining the gaseous constituents of exhausts resulting from
stationary combustion and includes a description of the apparatus, and
calculations used which are used in conjunction with Performance Test
Codes to determine quantitatively, as an acceptable alternative to EPA
Method 3B of appendix A to 40 CFR part 60 for the manual procedures
only and not the instrumental procedures. The ANSI/ASME PTC 19.10-1981
Part 10 method incorporates both manual and instrumental methodologies
for the determination of oxygen content. The manual method segment of
the oxygen determination is performed through the absorption of oxygen.
This method is available at the American National Standards Institute
(ANSI), 1899 L Street NW, 11th floor, Washington, DC 20036 and the
American Society of Mechanical Engineers (ASME), Three Park Avenue, New
York, NY 10016-5990. See https://www.ansi.org and https://www.asme.org.
The EPA incorporates by reference VCS ASTM D6348-12 (Reapproved
2020), ``Determination of Gaseous Compounds by Extractive Direct
Interface Fourier Transform (FTIR) Spectroscopy,'' as an acceptable
alternative to EPA Method 320 of appendix A to 40 CFR part 63 with
caveats requiring inclusion of selected annexes to the standard as
mandatory. The ASTM D6348-12 (R2020) method is an extractive FTIR
spectroscopy-based field test method and is used to quantify gas phase
concentrations of multiple target compounds in emission streams from
stationary sources. This [filig]eld test method provides near real time
analysis of extracted gas samples. In the September 22, 2008, NTTAA
summary, ASTM D6348-03(2010) was determined equivalent to EPA Method
320 with caveats. ASTM D6348-12 (R2020) is a revised version of ASTM
D6348-03(2010) and includes a new section on accepting the results from
direct measurement of a certified spike gas cylinder, but still lacks
the caveats we placed on the D6348-03(2010) version. We are finalizing
that the test plan preparation and implementation in the Annexes to
ASTM D 6348-12 (R2020), Sections Al through A8 are mandatory;
[[Page 24150]]
and in ASTM D6348-12 (R2020) Annex A5 (Analyte Spiking Technique), the
percent (%) R must be determined for each target analyte (equation
A5.5). We are finalizing that, in order for the test data to be
acceptable for a compound, %R must be 70% > R <= 130%. If the %R value
does not meet this criterion for a target compound, the test data is
not acceptable for that compound and the test must be repeated for that
analyte (i.e., the sampling and/or analytical procedure should be
adjusted before a retest). The %R value for each compound must be
reported in the test report, and all field measurements must be
corrected with the calculated %R value for that compound by using the
following equation:
[GRAPHIC] [TIFF OMITTED] TR05AP24.001
The ASTM D6348-12 (R2020) method is available at ASTM
International, 1850 M Street NW, Suite 1030, Washington, DC 20036. See
https://www.astm.org/.
ASTM D3695-88 is already approved for the locations in which it
appears in the amendatory text.
While the EPA identified 12 other VCS as being potentially
applicable, the Agency decided not to use them because these methods
are impractical as alternatives due to lack of equivalency,
documentation, validation data, and other important technical and
policy considerations. The search and review results have been
documented and are in the memorandum, Voluntary Consensus Standard
Results for National Emission Standards for Hazardous Air Pollutants:
Ethylene Oxide Emissions Standards for Sterilization Facilities
Residual Risk and Technology Review, which is available in the docket
for this rulemaking.
Under 40 CFR 63.7(f) and 40 CFR 63.8(f), subpart A--General
Provisions, a source may apply to the EPA for permission to use
alternative test methods or alternative monitoring requirements in
place of any required testing methods, performance specifications, or
procedures in the final rule or any amendments.
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
The EPA believes that the human health or environmental conditions
that exist prior to this action result in or have the potential to
result in disproportionate and adverse human health or environmental
effects on communities with EJ concerns. A total of 17.3 million people
live within 10 km of the 88 facilities that were assessed. The percent
of the population that is Hispanic or Latino is substantially higher
than the national average (36 percent versus 19 percent), driven by the
seven facilities in Puerto Rico, where an average of 99 percent of the
658,000 people living within 10 km of the facilities are Hispanic or
Latino. The proportion of other demographic groups living within 10 km
of commercial sterilizers is similar to the national average. The EPA
also conducted a risk assessment of possible cancer risks and other
adverse health effects, and found that prior to the implementation of
this regulation, cancer risks are unacceptable for several communities.
See section VI.F for an analysis that characterizes communities living
in proximity to facilities and risks prior to implementation of the
final regulation.
The EPA believes that this action is likely to reduce existing
disproportionate and adverse effects on communities with EJ concerns.
This action establishes standards for SCVs and ARVs at facilities where
EtO use is less than 1 tpy, ARVs at facilities where EtO use is at
least 1 tpy but less than 10 tpy, CEVs, and room air emissions. In
addition, it tightens standards for SCVs at facilities where EtO use is
at least 1 tpy, as well as ARVs at facilities where EtO use is at least
10 tpy. This action also finalizes amendments to correct and clarify
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. As a
result of these changes, we expect zero people to be exposed to cancer
risk levels above 100-in-1 million. See section IV for more information
about the control requirements of the regulation and the resulting
reduction in cancer risks.
The EPA additionally identified and addressed environmental justice
concerns by engaging in outreach activities to communities we expect to
be impacted most by the rulemaking The EPA is also requiring owners and
operators of commercial sterilization facilities to submit electronic
copies of required compliance reports, performance test reports, and
performance evaluation reports, which will increase transparency and
will provide greater access to information for the public, including
impacted communities.
The information supporting this Executive order review is contained
in section VI.F of this preamble, as well as in a technical report,
Analysis of Demographic Factors for Populations Living Near Ethylene
Oxide Commercial Sterilization and Fumigation Operations, available in
the docket for this action.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects
40 CFR Part 60
Environmental protection, Administrative practice and procedures,
Hazardous substances, Reporting and recordkeeping requirements.
40 CFR Part 63
Environmental protection, Administrative practice and procedures,
Air pollution control, Hazardous substances, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements.
Michael S. Regan,
Administrator.
For the reasons set forth in the preamble, the EPA amends 40 CFR
parts 60 and 63 as follows:
PART 60--STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES
0
1. The authority citation for part 60 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
[[Page 24151]]
Appendix B to Part 60--Performance Specifications
0
2. Appendix B to part 60 is amended by adding Performance Specification
19 to read as follows:
Appendix B to Part 60--Performance Specifications
* * * * *
Performance Specification 19-Performance Specifications and Test
Procedures for Ethylene Oxide (ETO) Continuous Emission Monitoring
Systems
1.0 Scope and Application
1.1 Analyte. This performance specification (PS) is applicable
for measuring gaseous concentrations of Ethylene Oxide (EtO), CAS:
775-21-8, on a continuous basis in the units of the applicable
standard or in units that can be converted to units of the
applicable standard(s) (e.g., lbs/hr,). This performance
specification may be approved for the measurement of other
pollutants and/or in other sectors by the Administrator on a case-
by-case basis if not otherwise allowed or denied in an applicable
subpart of the regulations.
1.2 Applicability.
1.2.1 This specification is used to evaluate the acceptability
of EtO continuous emission monitoring systems (CEMS) at the time of
installation or soon after and whenever specified in the
regulations. The specification includes requirements for initial
acceptance including instrument accuracy and stability assessments
and use of audit samples if they are available.
1.2.2 The Administrator may require the operator, under section
114 of the Clean Air Act, to conduct CEMS performance evaluations at
other times besides the initial test to evaluate the CEMS
performance. See 40 CFR part 60, Sec. 60.13(c) and Sec.
63.8(e)(1).
1.2.3 A source that demonstrates their CEMS meets the criteria
of this PS may use the system to continuously monitor gaseous EtO
under any regulation or permit that requires compliance with this
PS. If your CEMS reports the EtO concentration in the units of the
applicable standard, no additional CEMS components are necessary. If
your CEMS does not report concentrations in the units of the
existing standard, then other CEMS (i.e., oxygen) or CEMS components
(e.g., temperature, stack gas flow, moisture, and pressure) may be
necessary to convert the units reported by your CEMS to the units of
the standard.
1.2.4 These specification test results are intended to be valid
for the life of the system. As a result, the EtO measurement system
must be tested and operated in a configuration consistent with the
configuration that will be used for ongoing continuous emissions
monitoring.
1.2.5 Substantive changes to the system configuration require
retesting according to this PS. Examples of such conditions include
but are not limited to: major changes in dilution ratio (for
dilution-based systems); changes in sample conditioning and
transport, if used, such as filtering device design or materials;
changes in probe design or configuration and changes in materials of
construction. Changes consistent with instrument manufacturer
upgrade that fall under manufacturer's certification do not require
additional field verification. Manufacturer's upgrades (e.g.,
changes to the quantification algorithm) require recertification by
the manufacturer for those requirements allowed by this PS,
including interference, and level of detection (LOD).
1.2.6 This specification is not designed to evaluate the ongoing
CEMS performance, nor does it identify specific calibration
techniques and auxiliary procedures to assess CEMS performance over
an extended period of time. The requirements in Procedure 7 to
Appendix F of this part are designed to provide a way to assess CEMS
and CEMS components (if applicable) performance over an extended
period of time. The source owner or operator is responsible to
calibrate, maintain, and operate the CEMS properly.
2.0 Summary of Performance Specification
2.1 This specification covers the procedures that each EtO CEMS
must meet during the performance evaluation test. Installation and
measurement location specifications, data reduction procedures, and
performance criteria are included.
2.2 The technology used to measure EtO must provide a distinct
response and address any appropriate interference correction(s). It
must accurately measure EtO in a representative sample of stack
effluent.
2.3 The relative accuracy (RA) must be established against a
reference method (RM) (i.e., Method 320, or other alternative
approved as a RM by the Administrator) on a case-by-case basis if
not otherwise allowed or denied in an applicable subpart of the
regulations.
2.4 A standard addition (SA) procedure using a reference
standard is included in appendix A to this performance specification
for use in verifying LOD. For extractive CEMS, where the SA is done
by dynamic spiking (DS), the appendix A procedure is allowed as an
option for assessing calibration drift and is also referenced by
Procedure 7 of appendix F to this part for ongoing quality control
tests.
3.0 Definitions
3.1 Calibration drift (CD) means the absolute value of the
difference between the CEMS output response and an upscale reference
gas or a zero-level gas, expressed as a percentage of the span
value, when the CEMS is challenged after a stated period of
operation during which no unscheduled adjustments, maintenance or
repairs took place. For other parameters that are selectively
measured by the CEMS (e.g., temperature, velocity, pressure, flow
rate) to measure in the units of the applicable standard, use two
analogous values (e.g., Low: 0-20% of full scale, High: 50-100% of
full scale). 3.2 Calibration Span means the calibrated portion of
the measurement range as specified in the applicable regulation or
another requirement. If the span is not specified in the applicable
regulation or other requirement, then it must be a value
approximately equivalent to three times the applicable emission
standard. When the emission standard is expressed as mass emissions,
use the average flow rate in the duct to calculate the concentration
equivalent of the emission standard.
3.3 Centroidal area means a central area that is geometrically
similar to the stack or duct cross section and is no greater than 10
percent of the stack or duct cross-sectional area.
3.4 Continuous Emission Monitoring System (CEMS) means the total
equipment required to measure the pollutant concentration or
emission rate continuously. The system generally consists of the
following three major subsystems:
3.4.1 Sample interface means that portion of the CEMS used for
one or more of the following: Sample acquisition, sample transport,
sample conditioning, and protection of the monitor from the effects
of the stack effluent.
3.4.2 EtO analyzer means that portion of the EtO CEMS that
measures the total vapor phase EtO concentration and generates a
proportional output.
3.4.3 Data recorder means that portion of the CEMS that provides
a permanent electronic record of the analyzer output. The data
recorder may record other pertinent data such as effluent flow
rates, various instrument temperatures or abnormal CEMS operation.
The data recorder may also include automatic data reduction
capabilities and CEMS control capabilities.
3.5 Diluent gas means a major gaseous constituent in a gaseous
pollutant mixture. For combustion sources, either carbon dioxide
(CO2) or oxygen (O2) or a combination of these
two gases are the major gaseous diluents of interest.
3.6 Dynamic spiking (DS) means the procedure where a known
concentration of EtO gas is injected into the probe sample gas
stream for extractive CEMS at a known flow rate to assess the
performance of the measurement system in the presence of potential
interference from the flue gas sample matrix.
3.7 Flow Rate Sensor means that portion of the CEMS that senses
the volumetric flow rate and generates an output proportional to
that flow rate. The flow rate sensor shall have provisions to check
the CD for each flow rate parameter that it measures individually
(e.g., velocity, pressure).
3.8 Independent measurement(s) means the series of CEMS data
values taken during sample gas analysis separated by two times the
procedure specific response time (RT) of the CEMS.
3.9 Interference means a compound or material in the sample
matrix other than EtO whose characteristics may bias the CEMS
measurement (positively or negatively). The interference may not
prevent the sample measurement but could increase the analytical
uncertainty in the measured EtO concentration through reaction with
EtO or by changing the electronic signal generated during EtO
measurement.
3.10 Interference test means the test to detect CEMS responses
to interferences that are not adequately accounted for in the
calibration procedure and may cause measurement bias.
3.11 Level of detection (LOD) means the lowest level of
pollutant that the CEMS can
[[Page 24152]]
detect in the presence of the source gas matrix interferents with 99
percent confidence.
3.12 Measurement error (ME) is the mean difference between the
concentration measured by the CEMS and the known concentration of a
reference gas standard, divided by the span, when the entire CEMS,
including the sampling interface, is challenged.
3.13 Reference gas standard means the gas mixture containing EtO
at a known concentration and produced and certified in accordance
with ``EPA Traceability Protocol for Assay and Certification of
Gaseous Calibration Standards,'' September 1997, as amended August
25, 1999, EPA-600/R-97/121 or more recent updates. The tests for
analyzer measurement error, calibration drift, and system bias
require the use of calibration gas prepared according to this
protocol. If a zero gas is used for the low-level gas, it must meet
the requirements under the definition for ``zero air'' in 40 CFR
72.2. Alternatively, if the ``protocol'' gas is not commercially
available, you must use a reference gas that has been prepared
according to the procedures in appendix B of this PS.
3.14 Relative accuracy (RA) means the absolute mean difference
between the gas concentration, or the emission rate determined by
the CEMS, and the value determined by the RM, plus the confidence
coefficient of a series of nine test runs, divided by the average of
the RM or the applicable emission standard.
3.15 Response time (RT) means the time it takes for the
measurement system, while operating normally at its target sample
flow rate, dilution ratio, or data collection rate to respond to a
known step change in gas concentration, either from a low- or zero-
level to a high-level gas concentration or from a high-level to a
low or zero-level gas concentration, and to read 95 percent of the
change to the stable instrument response. There may be several RTs
for an instrument related to different functions or procedures
(e.g., DS, LOD, and ME).
3.16 Span value means an EtO concentration approximately equal
to two times the concentration equivalent to the emission standard
unless otherwise specified in the applicable regulation, permit or
another requirement. Unless otherwise specified, the span may be
rounded up to the nearest multiple of 5.
3.17 Stable value means the measure of two or more values that
are statistically the same and the absence of measurement system
drift.
3.18 Standard addition means the addition of known amounts of
EtO gas (either statically or dynamically) measured sample gas
stream.
3.19 Zero gas means a gas with an EtO concentration that is
below the LOD of the measurement system.
4.0 Interferences
Sample gas interferences will vary depending on the instrument
or technology used to make the measurement. Interferences must be
evaluated through the interference test in this PS. Several
compounds including carbon dioxide (CO2), carbon monoxide
(CO), methane (CH4), and water (H2O) are
potential optical interferences with certain types of EtO monitoring
technology.
Note: Interferences may be mitigated though the use of dilution
systems, however this approach could also affect the sensitivity of
the measurement.
5.0 Safety
The procedures required under this PS may involve hazardous
materials, operations, and equipment. This PS may not address all
the safety issues associated with these procedures. It is the
responsibility of the user to establish appropriate safety and
health practices and determine the applicable regulatory limitations
prior to performing these procedures. The CEMS user's manual and as
well as cautions within and materials recommended by the RM should
be consulted for specific precautions to be taken in regard to the
relative accuracy testing.
6.0 Equipment and Supplies
The equipment and supplies are the same as in section 6 of PS
18, except replace HCl for EtO where appropriate. The following
definitions are added and/or revised:
6.1 Moisture Measurement System. If correction of the measured
EtO emissions for moisture is required, you must install, operate,
maintain, and quality assure a continuous moisture monitoring system
for measuring and recording the moisture content of the flue gases.
The following continuous moisture monitoring systems are acceptable:
Any optical measurement system validated according to Method 301 or
section 13.0 of Method 320 in appendix A to part 63 of this chapter;
a continuous moisture sensor; an oxygen analyzer (or analyzers)
capable of measuring O2 both on a wet basis and on a dry
basis; or other continuous moisture measurement methods approved by
the Administrator.
7.0 Reagents and Standards
7.1 Reference Gases means the gas mixture containing EtO at a
known concentration and produced and certified in accordance with
``EPA Traceability Protocol for Assay and Certification of Gaseous
Standards, May 2012 (EPA 600/R-12/531) or more recent updates. The
tests for analyzer measurement error, calibration drift, and system
bias require the use of calibration gas prepared according to this
protocol. If a zero gas is used for the low-level gas, it must meet
the requirements under the definition for ``zero air'' in 40 CFR
72.2. Alternatively, if the ``protocol'' gas is not commercially
available, you must use a reference gas that has been prepared
according to the procedures in appendix B of this PS and meeting the
requirements in section 12.2 of appendix B of this PS, if
applicable.
7.2 Cylinder gas may be diluted for use in this specification,
including measurement error testing. You must document the
quantitative introduction of EtO standards into the system using
Method 205, found in 40 CFR part 51, appendix M, or other procedure
approved by the Administrator. The laboratory/field evaluations in
Method 205 must be conducted at least quarterly and prior to any
audit test (e.g., CGA, RAA) required in QA Procedure 7 (40 CFR part
60, appendix F). Calibration must be conducted on an annual basis or
whenever significant changes are made to the dilution system. In
addition to the requirements in Method 205, when in use, you must
document gas flow rates through each of the channels; if the
dilution system records these values electronically, this is
considered the documentation. For the purpose of this PS, cylinder
gas should not be diluted beyond a dilution ratio of 500:1 using
Method 205.
8.0 CEMS Measurement Location Specifications and Pretest Preparation
8.1 Prior to the start of your initial PS tests, you must ensure
that the CEMS is installed according to the manufacturer's
specifications and the requirements in this section.
8.2 CEMS Installation. Install the CEMS at an accessible
location where the pollutant concentration or emission rate
measurements are directly representative of the EtO emissions. If
the units of the emission standard are expressed as a mass (e.g.,
lb/hr), then the CEMS probe must also be located within 0.5
equivalent diameters of the flow sensor and the CEMS must be located
(1) at least two equivalent diameters downstream from the nearest
control device, the point of pollutant generation, or other point at
which a change in the pollutant concentration or emission rate may
occur and (2) at least a half equivalent diameter upstream from the
effluent exhaust or control device. If the CEMS are to utilize time-
sharing, the distance between each measurement point and the CEMS
should be approximately the same. The CEMS need not be installed at
the same location as the relative accuracy test location. If you
fail the RA requirements in this specification due to the CEMS
measurement location and a satisfactory correction technique cannot
be established, the Administrator may require the CEMS to be
relocated.
8.2.1 Single point sample gas extraction should be (1) no less
than 1.0 m (3.3 ft.) from the stack or duct wall or (2) within the
centroidal area of the stack or duct cross section.
8.2.2 CEMS and Data Recorder Scale Check. After CEMS
installation, record and document the measurement range of the EtO
CEMS. The CEMS operating range and the range of the data recording
device must encompass all potential and expected EtO concentrations,
including the concentration equivalent to the applicable emission
limit and the span value.
9.0 Quality Control--Reserved
10.0 Calibration and Standardization--Reserved
11.0 Performance Specification Test Procedure
After completing the CEMS installation, setup, and calibration,
you must complete the PS test procedures in this section. You must
perform the following procedures and meet the performance
requirements for the initial demonstration of your CEMS:
a. Interference Test;
b. Level of Detection Determination;
c. Response Time Test;
[[Page 24153]]
d. Measurement Error Test;
e. Calibration Drift Test; and
f. Relative Accuracy Test.
g. If CEMS is to be time-shared, determine the response time to
each measurement point, the sampling time at each measurement point,
and the cycle time at each measurement point. The sampling time at
each measurement point shall be at least 3 times as long as the
system response time (RT), and the maximum number of measurement
points shall not exceed the quotient, rounded down to the next whole
number, of 15 minutes divided by the longest cycle time of the
measurement point.
11.1 Interference Test
11.1.1 Prior to its initial use in the field, you must
demonstrate that your monitoring system meets the performance
requirements of the interference test in section 13.5 of this PS to
verify that the candidate system measures EtO accurately in the
presence of common interferences in emission matrices from
commercial sterilizers. In the event this performance specification
is applied in other emission sources, the interference test must
evaluate any other predominant gases is the emission matrices of
those sources.
11.1.2 Your interference test must be conducted in a controlled
environment. The equipment you test for interference must include
the combination of the analyzer, related analysis software, and any
sample conditioning equipment (e.g., dilution module, moisture
removal equipment or other interferent scrubber) used to control
interferents.
11.1.3 If you own multiple measurement systems with components
of the same make and model numbers, you need only perform this
interference test on one analyzer and associated interference
conditioning equipment combination. You may also rely on an
interference test conducted by the manufacturer or a continuous
measurement system integrator on a system having components of the
same make(s) and model(s) of the system that you use.
11.1.4 Perform the interference check using an EtO reference gas
concentration of approximately ten times the LOD or at 50 parts per
billion, whichever is greater.
11.1.5 Introduce the interference test gases listed in table 1
in section 17.0 of this PS to the analyzer/conditioning system
separately or in any combination. The interference test gases need
not be of reference gas quality.
11.1.6 The interference test must be performed by combining an
EtO reference gas with each interference test gas (or gas mixture).
You must measure the baseline EtO response, followed by the response
after adding the interference test gas(es) while maintaining a
constant EtO concentration. You must perform each interference gas
injection and evaluation in triplicate.
Note: The baseline EtO gas may include interference gases at
concentrations typical of ambient air (e.g., 21 percent
O2, 400 parts per million (ppm) CO2, 2 percent
H2O), but these concentrations must be brought to the
concentrations listed in table 1 of this PS when their interference
effects are being evaluated.
11.1.7 You should document the gas volume/rate, temperature, and
pressure used to conduct the interference test. A gas blending
system or manifold may be used.
11.1.8 Ensure the duration of each interference test is
sufficient to condition the EtO measurement system surfaces before a
stable measurement is obtained.
11.1.9 Measure the EtO response of the analyzer/sample
conditioning system combination to the test gases in ppbv. Record
the responses and determine the overall interference response using
table 2 in section 17.0 of this PS.
11.1.10 For each interference gas (or mixture), calculate the
mean difference ([Delta]MCavg) between the measurement
system responses with and without the interference test gas(es)
using equation 1 in section 12.2 of this PS. Summarize the results
following the format contained in table 2 in section 17.
11.1.11 Calculate the percent interference (I) for the gas runs
using equation 2 in section 12.2 of this PS.
11.1.12 The total interference response (i.e., the sum of the
interference responses of all tested gaseous components) must not
exceed the criteria set forth in section 13.5 of this PS.
11.2 Level of Detection Determination
11.2.1 You must determine the minimum amount of EtO that can be
detected above the background in a representative gas matrix.
11.2.2 You must perform the LOD determination in a controlled
environment such as a laboratory or manufacturer's facility.
11.2.3 You must add interference gases listed in table 1 of this
PS to a constant concentration of EtO reference gas.
11.2.3.1 You may not use an effective reference EtO gas
concentration greater than ten times the estimated instrument LOD.
11.2.3.2 Inject the EtO and interferents described in section
11.1.5 of this PS directly into the inlet to the analyzer, allow
time for the value to stabilize and then collect measurement data
for 15 minutes and average those results. Repeat this procedure to
obtain a total of seven or more of these runs, purging the
measurement system with ambient air between each run, to determine
the LOD.
11.2.4 Calculate the standard deviation of the measured values
and define the LOD as three times the standard deviation of these
measurements.
11.2.5 You must verify the controlled environment LOD of section
11.2.2 of this PS for your CEMS during initial setup and field
certification testing using the SA procedure in appendix A of this
PS with the following exceptions:
11.2.5.1 You must make three independent SA measurements spiking
the native source concentration by no more than five times the
controlled environment LOD concentration determined in section
11.2.4.
11.2.5.2 You must perform the SA as a dynamic spike by passing
the spiked source gas sample through all filters, scrubbers,
conditioners, and other monitoring system components used during
normal sampling, and as much of the sampling probe as practical.
11.2.5.3 The amount detected, or standard addition response
(SAR), is based on the average difference of the native EtO
concentration in the stack or duct relative to the native stack
concentration plus the SA. You must be able to detect the effective
spike addition (ESA) above the native EtO present in the stack gas
matrix. The ESA is calculated using equation A7 in appendix A of
this PS.
11.2.5.4 If the field verification of your system LOD does not
demonstrate a SAR greater than or equal to your initial controlled
environment LOD, you must increase the SA concentration
incrementally and repeat the field verification procedure until the
SAR is equal to or greater than LOD. The site-specific standard
addition detection level (SADL) is equal to the standard addition
needed to achieve the acceptable SAR, and the SADL replaces the
controlled environment LOD. The SADL is calculated as the ESA using
equation A7 in appendix A of this PS. As described in section 13.1
of this PS, the controlled environment LOD or the SADL that replaces
a controlled environment LOD must be less than 20 percent of the
applicable emission limit.
11.3 Response Time Determination. You must determine ME- and SA-
RT.
11.3.1 For ME-RT, start the upscale RT determination by
injecting zero gas into the measurement system as required by the
procedures in section 11.4 of this PS. For the SA-RT start the
upscale RT determination at native stack concentration of EtO. Allow
the value to stabilize, which for the purpose of this PS is a change
no change greater than 1.0 percent of span or 10 ppbv (whichever is
greater) for 30 seconds.
11.3.2 When the CEMS output has stabilized, record the response
in ppbv, record the time (hh:mm:ss), and immediately introduce an
upscale (high level) or spike reference gas as required by the
relevant (ME-RT or SA-RT) procedure. Record the time (hh:mm:ss)
required for the measurement system to reach 95 percent of the
change to the final stable value, the difference in these times is
the upscale RT.
11.3.3 Reintroduce the zero gas for the ME-RT or stop the
upscale gas flow for the SA-RT and immediately record the time
(hh:mm:ss). Record the time (hh:mm:ss) required to reach within 95
percent of the previous stable response in 11.3.1 or 10 ppbv
(whichever is greater); the difference in these times is the
downscale RT.
Note: For CEMS that perform a series of operations (purge, blow
back, sample integration, analyze, etc.), you must start adding
reference or zero gas immediately after these procedures are
complete.)
11.3.4 Repeat the entire procedure until you have three sets of
data, then determine the mean upscale and mean downscale RTs for
each relevant procedure (from each measurement point if the CEMS is
time-sharing). Report the greater of the average upscale or average
downscale RTs as the RT for the system.
11.4 Measurement Error (ME) Test
11.4.1 The measurement error test must be performed at the same
time as the calibration drift test when the system is being placed
in service. The measurement error test must be performed any time a
substantive change (see section 1.2.5) has been made to the
measurement system.
11.4.1.1 Introduce reference gases to the CEMS probe, prior to
the sample
[[Page 24154]]
conditioning and filtration system. You may use a gas dilution
system meeting the requirement in section 7.2 of this PS.
11.4.1.2 Challenge the measurement system with a zero gas and at
the three upscale EtO reference gas concentrations in the range
shown in table 3 of this PS. You may introduce different reference
gas concentrations in any order, but you must not introduce the same
gas concentration twice in succession.
11.4.1.3 Introduce the calibration gas into the sampling probe
with sufficient flow rate to replace the entire source gas sample
and continue the gas flow until the response is stable, as evidenced
when the difference between two consecutive measurements is within
1.0 percent of span or 5 ppbv (whichever is less). Record this value
and inject the next calibration gas.
11.4.1.4 Make triplicate measurements for each reference gas for
a total of twelve measurements.
11.4.1.5 At each reference gas concentration, determine the
average of the three CEMS responses (MCl). Calculate the ME using
equation 3A in section 12.3.
11.4.1.6 For non-dilution systems, you may adjust the system to
maintain the correct flow rate at the analyzer during the test, but
you may not make adjustments for any other purpose. For dilution
systems, you must operate the measurement system at the appropriate
dilution ratio during all system ME checks, and you may make only
the adjustments necessary to maintain the proper ratio.
11.4.2 You may use table 5 in section 17.0 to record and report
your ME test results.
11.4.3 If the ME specification in section 13.3 is not met for
all four reference gas concentrations, take corrective action, and
repeat the test until an acceptable 4-level ME test is achieved.
11.5 Seven-Day Calibration Drift (CD) Test
11.5.1 The CD Test Period. Prior to the start of the RA tests,
you must perform a seven-day CD test. The purpose of the seven-day
CD test is to verify the ability of the CEMS to maintain calibration
for each of seven consecutive unit operating days as specified in
section 11.5.5 of this PS.
11.5.2 The CD tests must be performed using the zero gas and
high-level reference gas standards as defined in table 3 of this PS.
11.5.3 Conduct the CD test on each day during continuous
operation of the CEMS and normal facility operations following the
procedures in section 11.7 of this PS, except that the zero gas and
high-level gas need only be introduced to the measurement system
once each for the seven days.
11.5.4 If periodic automatic or manual adjustments are made to
the CEMS zero and upscale response factor settings, conduct the CD
test immediately before these adjustments.
Note: Automatic signal or mathematical processing of all
measurement data to determine emission results may be performed
throughout the entire CD process.
11.5.5 Determine the magnitude of the CD at approximately 24-
hour intervals, for 7 consecutive unit operating days. The 7
consecutive unit operating days need not be 7 consecutive calendar
days.
11.5.6 Record the CEMS response for single measurements of zero
gas and high-level reference gas. You may use table 6 in section 17
of this PS to record and report the results of your 7-day CD test.
Calculate the CD using equation 3B in section 12.3. Report the
absolute value of the differences as a percentage of the span value.
11.5.7 The zero-level and high-level CD for each day must be
less than 5.0 percent of the span value or an absolute difference of
10 ppbv, as specified in section 13.2 of this PS. You must meet this
criterion for 7 consecutive operating days.
11.5.8 Dynamic Spiking Option for Seven-Day CD Test. You have
the option to conduct a high-level dynamic spiking procedure for
each of the 7 days in lieu of the high-level reference gas injection
described in sections 11.5.2 and 11.5.3. If this option is selected,
the daily zero CD check is still required.
11.5.8.1 To conduct each of the seven daily mid-level dynamic
spikes, you must use the DS procedure described in appendix A of
this PS using a single spike chosen to yield the range as indicated
in table 3.
11.5.8.2 You must perform the dynamic spike procedure by passing
the spiked source gas sample through all filters, scrubbers,
conditioners, and other monitoring system components used during
normal sampling, and as much of the sampling probe as practical.
11.5.8.3 Calculate the high-level CD as a percent of span using
equation A6 of appendix A to this PS and calculate the zero-drift
using equation 3B in section 12.3. Record and report the results as
described in sections 11.5.6 and 11.5.7.
11.6 Relative Accuracy Test
11.6.1 Unless otherwise specified in an applicable regulation,
use Method 320 as the RM for EtO measurement. Conduct the RM tests
in such a way that they will yield results representative of the
emissions from the source that can be compared to the CEMS data. You
must collect gas samples that are at stack conditions (hot and wet),
and you must traverse the stack or duct as required in section
11.6.3.
11.6.2 Conduct the diluent (if applicable), moisture (if
needed), and pollutant measurements simultaneously. If the emission
standard is expressed in a mass unit (i.e., lb/hr) you must also
determine the flowrate simultaneously with each test using Method 2,
2A, 2B, 2C or 2D in appendix A-1 to this part, as applicable.
11.6.3 Reference Method Measurement Location and Traverse
Point(s) Selection.
11.6.3.1 Measurement Location. Select, as appropriate, an
accessible RM measurement location at least two equivalent diameters
downstream from the nearest control device, point of pollutant
generation, or other point at which a change in the pollutant
concentration or emission rate may occur, and at least one-half
equivalent diameter upstream from the effluent exhaust or a control
device. When pollutant concentration changes are due solely to
diluent leakage (e.g., air heater leakages) and pollutants and
diluents are simultaneously measured at the same location, a half
diameter may be used in lieu of two equivalent diameters. The
equivalent duct diameter is calculated according to Method 1 in
appendix A-1 to this part. The CEMS and RM sampling locations need
not be the same.
11.6.3.2 Traverse Point Selection. Select traverse points that
assure acquisition of representative RM samples over the stack or
duct cross section according to one of the following options: (a)
sample at twelve traverse points located according to section 11.3
of Method 1 in appendix A-1 to this part or (b) sample at the three
traverse points at 16.7, 50.0, and 83.3 percent of the measurement
line. Alternatively, you may conduct a stratification test following
the procedures in sections 11.6.3.2.1 through 11.6.3.2.4 to justify
sampling at a single point. Stratification testing must be conducted
at the sampling location to be used for the RM measurements during
the RA test and must be made during normal facility operating
conditions. You must evaluate the stratification by measuring the
gas on the same moisture basis as the EtO CEMS (wet or dry).
Stratification testing must be repeated for each RA test program to
justify single point.
11.6.3.2.1 Use a probe of appropriate length to measure the EtO
concentration, as described in this section, using 12 traverse
points located according to section 11.3 of Method 1 in appendix A-1
to this part for a circular stack or nine points at the centroids of
similarly shaped, equal area divisions of the cross section of a
rectangular stack.
11.6.3.2.2 Calculate the mean measured concentration for all
sampling points (MNavg).
11.6.3.2.3 Calculate the percent stratification (St)
of each traverse point using equation 5 in section 12.5.
11.6.3.2.4 The gas stream is considered to be unstratified and
you may perform the RA testing at a single point that most closely
matches the mean if the concentration at each traverse point differs
from the mean measured concentration for all traverse points by no
more than 5.0 percent of the mean concentration of EtO or 10 ppbv,
whichever is less restrictive.
11.6.4 In order to correlate the CEMS and RM data properly,
record the beginning and end of each RM run (including the time of
day in hours, minutes, and seconds) using a clock synchronized with
the CEMS clock used to create a permanent time record with the CEMS
output.
11.6.5 You must conduct the RA test during representative
process and control operating conditions or as specified in an
applicable regulation, permit or subpart.
11.6.6 Conduct a minimum of nine RM test runs.
Note: More than nine RM test runs may be performed. If this
option is chosen, up to three test run results may be excluded so
long as the total number of test run results used to determine the
CEMS RA is greater than or equal to nine. However, all data must be
reported including the excluded test runs.
11.6.7 Analyze the results from the RM test runs using equations
9 through14 in section 12.6. Calculate the RA between the CEMS
results and the RM results.
[[Page 24155]]
11.7 Record Keeping and Reporting
11.7.1 Record the results of the CD test, the RT test, the ME
test, and the RA test. Also keep records of the RM and CEMS field
data, calculations, and reference gas certifications necessary to
confirm that the performance of the CEMS met the performance
specifications.
11.7.2 For systems that use Method 205 to prepare EtO reference
gas standards, record results of Method 205 performance test field
evaluation, reference gas certifications, and gas dilution system
calibration.
11.7.3 Record the LOD and field verified SADL for the CEMS in
ppbv.
11.7.4 Record the results of the interference test.
11.7.5 Report the results of all certification tests to the
appropriate regulatory agency (or agencies), in hardcopy and/or
electronic format, as required by the applicable regulation or
permit.
12.0 Calculations and Data Analysis
12.1 Nomenclature.
Ci = Zero or EtO reference gas concentration used for
test i (ppbv);
CC = Confidence coefficient (ppbv);
CD = Calibration drift (percent);
davg = Mean difference between CEMS response and the
reference gas (ppbv);
di = Difference of CEMS response and the RM value
(ppbv or units of emission standard, as applicable);
I = Total interference from major matrix stack gases (percent);
[Delta]MCavg = Average of the 3 absolute values of
the difference between the measured EtO calibration gas
concentrations with and without interference from selected stack
gases (ppbv);
MCi = Measured EtO (or zero) reference gas
concentration i (ppbv);
MCi = Average of the measured EtO (or zero) reference
gas concentration i (ppbv);
MCint = Measured EtO concentration of the EtO
reference gas plus the individual or combined interference gases
(ppbv);
ME = Measurement error for CEMS (percent);
MNavg = Average concentration at all sampling points
(ppbv);
MNbi = Measured native concentration bracketing each
calibration check measurement (ppbv);
MNi = Measured native concentration for test or run I
(ppbv);
n = Number of measurements in an average value;
RA = Relative accuracy of CEMS compared to a RM (percent);
RMavg = Mean measured RM value (ppbv) or units of the
emission standard);
RMi = RM concentration for test run i (ppbv or units
of the emission standard);
S = Span value (ppmv);
Sd = Standard deviation of the differences (ppmv);
Sti = Stratification at traverse point i (percent);
SADL = Standard addition detection level (ppmv);
t0.975 = One-sided t-value at the 97.5th percentile
obtained from table 4 in section 17.0 for n-1 measurements;
12.2 Calculate the difference between the measured EtO
concentration with and without interferents for each interference
gas (or mixture) for your CEMS as:
[GRAPHIC] [TIFF OMITTED] TR05AP24.002
Calculate the total percent interference as:
[GRAPHIC] [TIFF OMITTED] TR05AP24.003
12.3 Calculate the ME or CD at Concentration i as:
[GRAPHIC] [TIFF OMITTED] TR05AP24.004
12.4 Calculate the average native concentration before and after
each calibration check measurement as:
[GRAPHIC] [TIFF OMITTED] TR05AP24.005
12.5 Calculate the Percent Stratification at Each Traverse Point
as:
[GRAPHIC] [TIFF OMITTED] TR05AP24.006
[[Page 24156]]
12.6 Calculate the RA Using RM and CEMS Data
12.6.1 Determine the CEMS final integrated average pollutant
concentration or emission rate for each RM test period. Consider
system RT, if important, and confirm that the results have been
corrected to the same moisture, temperature, and diluent
concentration basis, as applicable. If the emission standard is
based on a mass emission (i.e., lbs/hr), confirm the results have
been calculated correctly.
12.6.3 Make a direct comparison of the average RM results and
CEMS average value for identical test periods.
12.6.4 For each test run, calculate the arithmetic difference of
the RM and CEMS results using equation 6.
[GRAPHIC] [TIFF OMITTED] TR05AP24.007
12.6.5 Calculate the standard deviation of the differences (Sd)
of the CEMS measured results and RM results using equation 7.
[GRAPHIC] [TIFF OMITTED] TR05AP24.008
12.6.6 Calculate the confidence coefficient (CC) for the RA test
using equation 8.
[GRAPHIC] [TIFF OMITTED] TR05AP24.009
12.6.7 Calculate the mean difference (davg) between the RM and
CEMS values in the units of ppbv or of the emission standard using
equation 9.
[GRAPHIC] [TIFF OMITTED] TR05AP24.010
12.6.8 Calculate the average RM value using equation 10.
[GRAPHIC] [TIFF OMITTED] TR05AP24.011
12.6.9 Calculate RA of the CEMS using equation 11.
[GRAPHIC] [TIFF OMITTED] TR05AP24.012
13.0 Method Performance
13.1 Level of Detection. You may not use a CEMS whose LOD or
SADL is greater than 20 percent of the applicable regulatory limit
or other action level for the intended use of the data. If the
regulatory limit is not based on a concentration, document the
calculated concentration equivalent as required in section 11.7.
13.2 Calibration Drift. The zero- and high-level calibration
drift for the CEMS must not exceed 5.0 percent of the span value or
an absolute difference of 10.0 ppbv for 7 consecutive operating
days.
13.3 Measurement Error. The ME must be less than or equal to 5.0
percent of the span or an absolute difference of 10.0 ppbv value at
the low-, mid-, and high-level reference gas concentrations.
13.4 Relative Accuracy. Unless otherwise specified in an
applicable regulation or permit, the RA of the CEMS, whether
calculated in units of EtO concentration or in units of the emission
standard, must be less than or equal to 20.0 percent of the RM when
RMavg is used in the denominator of equation 11.
13.4.1 In cases where the RA is calculated on a concentration
(ppmv) basis, if the average RM emission level for the test is less
than 50 percent of the EtO concentration equivalent to the emission
standard, you may substitute the EtO concentration equivalent to the
standard in the denominator of equation 14 in place of RMavg.
[[Page 24157]]
13.4.2 Similarly, if the RA is calculated in units of the
emission standard and the EtO emission level measured by the RMs is
less than 50 percent of the emission standard, you may substitute
the emission standard in the denominator of equation 14 in place of
RMavg.
13.4.3 The alternative calculated RA in paragraph 13.4.1 or
13.4.2 must be less than or equal to 15.0 percent.
13.5 Interference Test.
13.5.1 The sum of the interference response(s) from equation 2
must not be greater than 2.5 percent of the calibration span or
3.0 percent of the equivalent EtO concentration used for
the interference test, whichever is less restrictive. The results
are also acceptable if the sum of the interference response(s) does
not exceed ten times the LOD or 30 ppbv.
14.0 Pollution Prevention--[Reserved]
15.0 Waste Management--[Reserved]
16.0 Bibliography
1. ``Method 301--Field Validation of Pollutant Measurement
Methods from Various Waste Media,'' 40 CFR part 63, appendix A.
2. EPA Traceability Protocol for Assay and Certification of
Gaseous Calibration Standards, U.S. Environmental Protection Agency
office of Research and Development, EPA/600/R-12/531, May 2012.
17.0 Tables, Diagrams, Flowcharts, and Validation Data
Table 1--Interference Test Gas Concentrations
------------------------------------------------------------------------
Approximate concentration
Potential interferent gas \1\ (balance N2)
------------------------------------------------------------------------
CO2.................................... 1% 0.2% CO2.
CH4.................................... 20 5 ppm.
H2O.................................... 5% 1% H2O.\1\
N2..................................... Balance.\1\
------------------------------------------------------------------------
\1\ Any of these specific gases can be tested at a lower level if the
manufacturer has provided reliableness for limiting or scrubbing that
gas to a specified level in CEMS field installations.
Table 2--Example Interference Test Data Sheet
------------------------------------------------------------------------
------------------------------------------------------------------------
Date of Test
------------------------------------------------------------------------
Analyzer type
------------------------------------------------------------------------
Model Number
------------------------------------------------------------------------
Serial Number
------------------------------------------------------------------------
Span
------------------------------------------------------------------------
Test Organization
------------------------------------------------------------------------
Test Personnel
------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
EtO EtO concentration Absolute
Interference gas or combination concentration w/interference difference Average absolute
(ppbv) (ppbv) (ppbv) difference (ppbv)
----------------------------------------------------------------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
------------------------------------------------------
[[Page 24158]]
------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
------------------------------------------------------
------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Table 3--Performance Specification Test Zero and Reference Gas Ranges
--------------------------------------------------------------------------------------------------------------------------------------------------------
EtO zero and reference gas concentrations in terms of percent of
span \a\
Test Units ---------------------------------------------------------------------- Section
Zero Low level Mid-level High level
--------------------------------------------------------------------------------------------------------------------------------------------------------
Calibration Drift....................... % Of Span.................. 2.0 percent or calculate the flow using a stable
tracer gas included in your spike gas standard.
8.2.4.2 If you use flow measurements to determine the spike
dilution, then use equation A1 in section 11.2.1 of this appendix
PS-19A to calculate the DF. Determination of the spike dilution
requires measurement of EtO spike flow (Qspike) and total
flow through the CEM sampling system (Qprobe).
8.2.4.3 If your CEMS is capable of measuring an independent
stable tracer gas, you may use a spike gas that includes the tracer
to determine the DF using equation A2 or A3 (sections 11.2.2 and
11.2.3 of this appendix PS-19A) depending on whether the tracer gas
is also present in the native source emissions.
8.2.4.4 For extractive CEMS, you must correct the background
measurements of EtO for the dilution caused by the addition of the
spike gas standard. For spiking systems that alternate between
addition of EtO and zero gas at a constant DF, the background
measurements between spikes will not be equal to the native source
concentration.
8.2.5 Begin by collecting unspiked sample measurements of EtO.
You must use the average of two unspiked sample measurements as your
pre-spike background.
Note: Measurements should agree within 5.0 percent or three
times the level of detection to avoid biasing the spike results.
8.2.5.1 Introduce the EtO gas spike into the permanent CEMS
probe, upstream of the particulate filter or sample conditioning
system and as close to the sampling inlet as practical.
8.2.5.2 Maintain the EtO gas spike for at least twice the DS
response time of your CEMS or until the consecutive measurements
agree within 5.0 percent. Collect two independent measurements of
the native plus spiked EtO concentration.
8.2.5.3 Stop the flow of spike gas for at least twice the DS
response time of your CEMS or until the consecutive measurements
agree within 5.0 percent. Collect two independent measurements of
the native EtO concentration.
8.2.6 Repeat the collection of sample measurements in section
8.2.5 until you have data for each spike concentration including a
final set of unspiked sample measurements according to section
8.2.5.3.
8.2.7 Verify that the CEMS responded as expected for each spike
gas injection, and that the data quality is not impacted by large
shifts in the native source concentration. Discard and repeat any
spike injections as necessary to generate a complete set of the
required replicate spike measurements.
8.2.8 Calculate the standard addition response (SAR) for
extractive CEMS, using equation A4 in section 11.2, of this appendix
PS-19A.
8.2.9 If the DS results do not meet the specifications for the
appropriate performance test in PS-19 or Procedure 7 of appendix F
of this part, you must take corrective action and repeat the DS
procedure.
9.0 Quality Control--Reserved
10.0 Calibration and Standardization--Reserved
11.0 Calculations and Data Analysis
Calculate the SA response for each measurement and its
associated native EtO measurement(s), using equations in this
section. (Note: For cases where the emission standard is expressed
in units of lb/hr or corrected to a specified O2 or
CO2 concentration, an absolute accuracy specification
based on a span at stack conditions may be calculated using the
average concentration and applicable conversion factors. The
appropriate procedures for use in cases where a percent removal
standard is more restrictive than the emission standard is the same
as in PS-2, sections 12 and 13, in this appendix.)
11.1 Nomenclature.
Cspike = Actual EtO reference gas concentration
spiked (e.g., bottle or reference gas concentration) ppmv;
Ctracer spiked = Tracer gas concentration injected
with spike gas (``reference concentration'') ppmv;
DF = Spiked gas dilution factor;
DSCD = Calibration drift determined using DS procedure
(percent);
DSE = Dynamic spike error (ppmv);
ESA = Effective spike addition (ppmv);
MCSA = Measured SA-elevated source gas concentration
(ppmv);
MCspiked = Measured EtO reference gas concentration i
(ppmv);
MCnative = Average measured concentration of the
native EtO (ppmv);
[[Page 24161]]
Mnative tracer = Measured tracer gas concentration
present in native effluent gas (ppmv);
Mspiked tracer = Measured diluted tracer gas
concentration in a spiked sample (ppmv);
Qspike = Flow rate of the dynamic spike gas (Lpm);
Qprobe = Average total stack sample flow through the
system (Lpm);
S = Span (ppmv);
SAR = Standard addition response (ppmv)
11.2 Calculating Dynamic Spike Response and Error.
11.2.1 If you determine your spike DF using spike gas and stack
sample flow measurements, calculate the DF using equation A1:
[GRAPHIC] [TIFF OMITTED] TR05AP24.013
11.2.2 If you determine your spike DF using an independent
stable tracer gas that is not present in the native source
emissions, calculate the DF for DS using equation A2:
[GRAPHIC] [TIFF OMITTED] TR05AP24.014
11.2.3 If you determine your spike dilution factor using an
independent stable tracer that is present in the native source
emissions, calculate the dilution factor for dynamic spiking using
equation A3:
[GRAPHIC] [TIFF OMITTED] TR05AP24.015
11.2.4 Calculate the SA response using equation A4:
[GRAPHIC] [TIFF OMITTED] TR05AP24.016
11.2.5 Calculate the DS error using equation A5.
[GRAPHIC] [TIFF OMITTED] TR05AP24.017
11.2.6 Calculating CD using DS. When using the DS option for
determining mid-level CD, calculate the CD as a percent of span
using equation A6:
[GRAPHIC] [TIFF OMITTED] TR05AP24.018
11.2.7 The effective spike addition (ESA) is the expected
increase in the measured concentration as a result of injecting a
spike. Calculate ESA using equation A7:
[GRAPHIC] [TIFF OMITTED] TR05AP24.019
12.0 Reserved
13.0 Tables and Figures
Table A13--1--Spike Data Sheet
------------------------------------------------------------------------
------------------------------------------------------------------------
Facility Name: Date: Time:
------------------------------------------------------------------------
Unit(s) Tested: Personnel:
------------------------------------------------------------------------
Analyzer Make and Mode
------------------------------------------------------------------------
[[Page 24162]]
Serial Number
------------------------------------------------------------------------
Calibration Span
------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
MCnative Actual value (ppb)
Qspike -----------------------------------------------------------------------------
Qprobe (lpm) (lpm) DF \1\ Cspike \2\ DSE (ppbv)
Pre Post Avg. MCspike \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
SD
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ DF must be less than or equal to 10%.
\2\ Cspike = Actual EtO concentration of the spike gas, ppbv.
\3\ MCspike = Measured EtO concentration of the spiked sample at the target level, ppbv.
PS-19 Appendix B Preparation and Certification of Ethylene Oxide Gas
Standards
1.0 Scope and Application
1.1 This appendix (appendix PS-19B) to Performance Specification
19 (PS-19) describes the procedure and performance criteria for the
preparation and certification of EtO Gas Manufacturer Primary
Standards (GMPS) and Gas Manufacturer Alternative Certified
Standards (GMACS). These procedures are not specific to ethylene
oxide and could be transferable to the preparation of gas standards
for other pollutants regulated under 40 CFR parts 59, 60, 61, 63,
and 65.
2.0 Summary of the Appendix
EPA requires the use of EPA Protocol gas standards for emissions
monitoring. These gases are established following the EPA
Traceability Protocol for Assay and Certification of Gaseous
Standards, May 2012 (EPA 600/R-12/531) otherwise referred in this
appendix PS-19B as the EPA Traceability Protocol. The EPA
Traceability Protocol requires the use of certified reference gas
standards directly traceable to National Institute of Standards and
Technology (NIST) or other recognized national metrology institute
(NMI) reference gas standards. A NIST certified value is a value for
which NIST has the highest confidence in that all known or suspected
sources of bias and imprecision have been accounted for. Without
NIST or other NMI reference gas standards, the necessary EPA
Protocol gas standards cannot be prepared. An alternative approach
is needed to establish a gas standard functionally equivalent to the
EPA Protocol gas standard when NIST or NMI reference gas standard
are not available. This appendix PS-19B is intended to provide
procedures and performance criteria for the establishment of Gas
Manufacturer Alternative Certified Standards (GMACS), the functional
equivalent of EPA Protocol gas standards. GMACS and Gas Manufacturer
Primary Standards (GMPS), the functional equivalent of the NIST or
NMI reference gas standards. The GMPS are the reference gases used
to establish the certified concentrations of the GMACs. The GMPS are
established using a dual certification approach where the
gravimetrically prepared reference value is confirmed using an
independent measurement approach traceable to the International
System of Units (SI) and references materials or devices.
2.1 This appendix PS-19B is intended to be performance-based and
allow specialty gas manufacturers (SGM) flexibility in the
preparation and certification of GMPS and GMACS.
2.2 This appendix PS-19B is not intended to be a replacement for
the EPA Protocol gases established according to the EPA Traceability
Protocol when calibration gases that meet EPA Traceability Protocol
requirements are available. When NIST or other recognized NMI
reference gas standards are manufactured and readily available,
those gases must be used.
2.3 This appendix PS-19B is reliant on the procedures included
the EPA Traceability Protocol for Assay and Certification of Gaseous
Standards, May 2012 (EPA 600/R-12/531). Users of this appendix PS-
19B for the preparation of GMPS and GMACS must be proficient with
the preparation protocol cylinders using this standard.
Note: This appendix PS-19B does not require the user to
participate in any protocol gas verification program.
2.4 Any alternatives to the procedures in this appendix PS-19B
are subject to Administrator review under the alternative test
method the authority to approve alternatives or changes to test
methods specified in the General Provisions to 40 CFR parts 60, 61,
and 63 (Sec. Sec. 60.8(b)(2), 61.13(h)(1)(ii), and 63.7(e)(2)(ii)).
Requests for alternative to the procedures must be submitted to the
agency according to Guideline Document 22 (https://www.epa.gov/system/files/documents/2022-09/gd-022r5.pdf).
3.0 Definitions
3.1 Certification means a set of procedures and performance
criteria used by a SGM to prepare and certify a GMPS and/or GMACS
for commercial sale.
3.2 Certified Reference Material or CRM means a material that
has been certified or verified by either NIST or other NMI (e.g.,
VSL, NPL) and may be used for traceability purposes.
3.3 Dual Method Certification means a process in which the
gravimetric value is independently confirmed by a measured value.
3.4 EPA Protocol Gas means a calibration or reference gas
required for emissions monitoring directly traceable to NIST or
[[Page 24163]]
other accepted NMI reference gas standards, prepared following the
EPA Traceability Protocol
3.5 EPA Traceable Protocol for Assay and Calibration Gas
Standards or commonly referred to as the ``EPA Traceability
Protocol'' means the document The protocol allows producers of these
standards, users of gaseous standards, and other analytical
laboratories to establish traceability of EPA Protocol Gases to
gaseous reference standards produced by the National Institute of
Standards and Technology (NIST).
3.6 Gas Calibration Cylinder means a refillable cylinder that
meets the applicable DOT/TC specifications for high pressure
cylinders. The cylinders shall be permanently stamped with a unique
value.
3.7 Gas Manufacturer Alternative Certified Standards or GMACS
means a gas that has been prepared according to this procedure and
serves as a functional substitute for an EPA Protocol Gas where EPA
Protocol gases are not available.
3.8 Gas Manufacturer Intermediate Standard means a gas reference
standard made by a gas supplier and certified according to the U.S.
EPA protocol rules for GMISs. For the purpose of this Appendix,
GMISs may be assayed against a GMPS.
3.9 Gas Manufacturer Primary Standards or GMPS means a
reference gas standard prepared and certified by the SGM that serves
as a functional substitute for the reference gas standards
established by, but not yet available from NIST or other accepted
NMI and required by the EPA Traceability Protocol to produce EPA
Protocol gases.
3.10 Gravimetry means the quantitative measurement of an
analyte by weight.
3.11 NIST means the National Institute of Standards and
Technology, located in Gaithersburg, Maryland.
3.12 NIST Traceable Reference Material or NTRM means is a
reference material produced by a commercial supplier with a well-
defined traceability linkage to NIST and named by NIST procedures,
on a batch rather than individual basis. This linkage is established
via criteria and protocols defined by NIST that are tailored to meet
the needs of the metrological community to be served.
3.13 Primary Reference Materials or PRM means a mixture
composition is verified against VSL's own primary standard gas
mixtures to confirm the assigned value.
3.14 Protocol Gas means a calibration or reference gas required
for emissions monitoring traceable to NIST or other accepted NMI,
prepared following the EPA Traceability Protocol.
3.15 Research Gas Mixture or RGMs means a reference material
produced by a commercial supplier certified by NIST on an individual
basis, often using non routine procedures, are called Research Gas
Mixtures (RGMs), and may be used for traceability purposes.
3.16 Specialty Gas Manufacturer or SGM means an organization
that prepares and certified gas calibration gas mixtures.
3.17 International System of Units or SI means the standards for
international measurement and are comprised of length (meter), time
(second), amount of substance (mole), electric current (ampere),
temperature (kelvin), luminous intensity (candela), and mass
(kilogram).
3.18 Standard Reference Material or SRM means a material or
substance issued by NIST that meets NIST-specific certification
criteria and is issues with that with a certificate or certificate
of analysis that reports the results of its characterizations and
provides information regarding the appropriate use(s) of the
material.
3.19 Uncertainty means the expression of the statistical
dispersion of the values attributed to a measured quantity. For the
purpose of this appendix, uncertainty is calculated using the root
sum square of all uncertainty budget items associated with each
procedure at k=2 (i.e., approximately 95 confidence).
3.20 VSL means Van Swinden National Lab, located in Delft,
Netherlands.
4.0 Interferences--Reserved
5.0 Safety
The procedures required under this appendix may involve
hazardous materials, operations, and equipment. This procedure may
not address all of the safety problems associated with these
procedures. You as the facility or operator must establish
appropriate safety and health practices and determine the applicable
regulatory limitations prior to performing these procedures. You
should consult instrument operation manuals, material safety data
sheets, compressed gas safety requirements, and other Occupational
Safety and Health Administration regulations for specific
precautions to be taken.
6.0 Equipment and Supplies
This procedure is not prescriptive on the type of equipment or
the supplies necessary for the preparation of GMPS and GMACS gaseous
cylinder standards, however SGM must use the appropriate equipment
and supplies necessary to meet the uncertainty requirements in this
appendix.
7.0 Reagents and Standards--Reserved
8.0 Procedures.
The exact procedures used will depend on the gas manufacturer
and the physical characteristics of the compound being prepared as a
gaseous calibration standard. Any procedure is deemed appropriate so
long as the criteria in section 8.1 for GMPS and section 8.2 for
GMACS are met.
8.1 Preparation and Certification of the GMPS.
The GMPS certified value is established using the dual
certification approach. A candidate GMPS cylinder is prepared
gravimetrically, and its established reference value is confirmed by
an independent measurement traceable to SI units as well as other
appropriate reference materials. The level of agreement between the
gravimetric reference value and the SI-based independent
measurements along with the average value and associated, combined,
expanded uncertainties serve to establish the certified reference
value. If high purity reference material is not readily available
for a gravimetric preparation, a user may petition the Administrator
for an alternative method for preparation of a GMPS.
The procedures for the gravimetric preparation, stability
evaluation, and independent verification of GMPS must meet the
criteria in this section following the procedures in 8.1(a) through
(g).
(a) Raw Materials
(b) GMPS Cylinder Preparation/Creation
(c) GMPS Cylinder Independent Verification
(d) GMPS Cylinder Certification
(e) GMPS Cylinder Stability
(f) GMPS Cylinder Expiration Period
(g) GMPS Documentation
8.1.1 Raw Materials. Raw materials used in the production of
GMPS must be of high quality (e.g., 99+% purity recommended).
Additionally, because raw material purity is the largest component
of uncertainty in gas gravimetry, SGMs must substantiate the purity
of the raw material prior to use, either via (1) a validated
certificate of analysis for the actual lot number purchased provided
by the raw material vendor, or (2) a purity assay conducted by the
SGM on the actual raw material to be used. The uncertainty of the
raw material (Ur) assay must be included as one of the
components of the total combined uncertainty for the mixture.
8.1.2 GMPS Gravimetric Cylinder Preparation/Creation. The GMPS
standards shall be based on a gravimetric preparation. The
gravimetric preparation shall yield an expected concentration for
the target component, and with the required statistical controls in
place to calculate the uncertainty of that concentration.
8.1.2.1 The scale used to generate the gravimetric reference
standard must be independently calibrated over the range of target
masses with ASTM E617-13 Class-1 weights on no less than a yearly
basis. For such certifications, a high accuracy mass comparator
(electronic or pendulum-type scale) is employed as the ``scale.''
The resolution of the scale should be sufficient to be able to
calculate the overall uncertainty of any concentration derived from
these steps.
8.1.2.1.1 The scale used for the gravimetric operation must be
independently calibrated and traceable to NIST standards with a
defined uncertainty (ut).
8.1.2.1.2 The scale calibration must be checked before the start
of each new weighing operation (i.e., the day of) with a weight in
the appropriate range that also meets ASTM E617-13 Class-1
requirements.
8.1.2.1.3 All material and equipment associated with the
gravimetric analysis shall have or apply a procedure to estimate the
uncertainty of the measurement, including but not limited to the
balance(s) used (uca) standard weight (uw).
8.1.2.1.4 The assay purity and associated material uncertainty
(ur) of the assay for each component raw material and the
balance gas must be known. This purity deviation is factored into
the uncertainty of the mass of each material blended into the
mixture.
8.1.2.1.5 The procedures below are minimum requirements and do
not speak to all of the details an SRM would do to ensure the
preparation of a high-accuracy gravimetric candidate GMPS, (e.g.,
controls for external factors that would influence scale reading
accuracy buoyancy effects, moisture/dust adsorption on the cylinder
[[Page 24164]]
surface, and errors caused by the location of the cylinder on the
scale). The SGM should develop and follow and internal standard
operation procedures (SOP) for the preparation of the candidate
GMPS.
8.1.2.1.6 Record the Target cylinder identification number,
blend date, and balance gas on the appropriate form (see figure B-
1). Additionally, record the intended component(s) to be used in the
preparation for this candidate GMPS, identifying the standard type,
material name (e.g., Ethylene Oxide), MW (g/mol), and purity (wt%).
8.1.2.1.7 Add the components to the candidate GMPS, recording
the weight of each component added.
8.1.2.1.8 GMPS Gravimetric Uncertainty. Calculate and document
the gravimetric concentration (GMPS-Cg) for each
component of the candidate GMPS. You must also document the combined
uncertainty, expressed as the root sum of the uncertainty budget
items identified, for the candidate GMPS value (GMPS-
Cgu). Gravimetric preparation uncertainty budget items
include:
(a) The purity of the raw material and the balance gas;
(b) The measured accuracy of the (electronic) balance including
consideration the uncertainty of the calibration weights, the
calibration uncertainty, and its linearity;
(c) The repeatability of the balance readings including errors
caused by the location of the cylinder on the balance;
(d) Balance Buoyancy effects;
(e) Effects of moisture adsorption and dust on the outer surface
of the cylinder;
(f) Cylinder dilutions, if any, used to prepare target
concentrations, including propagated uncertainties.
8.1.3 GMPS Independent Verification. The certification of the
candidate GMPS is based on independent measurements verifying the
reference concentration of the gravimetrically prepared GMPS
candidate. The independent verification must be based on a
measurement approach traceable to the SI and may include the use of
intrinsic NIST or accepted NMI reference materials to establish said
traceability. Candidate independent verification measurement
approaches include classical chemistry, spectroscopic approaches, as
well as other instrumental approaches as long as adequate and
appropriate SI traceability can be incorporated. The approach must
be performed using NIST (or equivalent) traceable calibrations
materials and using procedures that would allow the user to
determine the overall uncertainty of the measurement. In some
instances, a component may not be suitable to analysis using a
classical approach, in those instances alternative approaches may be
used do long as they (1) yield a concentration for the target com,
(2) have a calculated uncertainty, (3) have traceability to the SI,
and (4) documented conformity to the general metrological principles
for primary methods outlined above.
8.1.3.1 GMPS Independent Verification Measurement Uncertainty.
The cumulative uncertainty of the GMPS independent verification
measurement approach is integral to the ability to assess the
overall quality of the independent verification measurement. You
must also document the combined uncertainty, expressed as the root
sum of the uncertainty budget items identified. Ensure that all
known or suspected sources of bias and imprecision have been
accounted for. The following elements are examples of sources of
measurement error that must be included in the overall uncertainty
calculation for the GMPS independent verification measurement:
(a) The uncertainty of the certified reference solution (the
traceability source);
(b) Any propagated uncertainties through serial dilutions;
(c) The errors in volumetric sampling of the candidate GMPS
mixture;
(d) The uncertainty of the instrument calibration curve (least
squares fit and residual);
(e) The bias or error associated with any measurement
interferences;
(f) The repeatability of replicate aliquot injections from the
same sample;
(g) The repeatability of replicate samples of the mixture;
(h) Any external factors influencing sampling or instrument
accuracy;
(i) The uncertainty of measured volumetric gas flows;
(j) The bias or uncertainty associated with quantitative gas
flow delivery;
(k) The error associated with instrumental measurement
analyzers;
(l) Replicate measurement instrument error and precision.
8.1.4 GMPS Certification. The candidate GMPS certified value is
based on three factors:
(a) The relative agreement between the gravimetric reference
value and the independent, measured value of the gravimetrically-
prepared GMPS candidate;
(b) The combined, expanded uncertainty (k=2) of the gravimetric
value and independently measured concentrations values;
(c) The average of the independently measured concentrations
values.
8.1.4.1 GMPS Relative Agreement. Calculate the relative
agreement according to equation B-1, expressed as Relative Percent
Difference (RPD) between the gravimetric concentration (GMPS-
Cg) the independently measured concentrations (GMPS-
Ca). The results of these two analyses must agree within
4.0 percent (%).
[GRAPHIC] [TIFF OMITTED] TR05AP24.020
8.1.4.2 GMPS Combined, Expanded Uncertainty. Determine the
individual uncertainties for the gravimetric approach (GMPS-
Cug) and the independent measurement verification
approach (GMPS-Cua) according to equation B-2. Establish
the GMPS combined, expanded uncertainty (GMPS-Cuc) as the
root sum of the two individual uncertainties with a coverage factor
k=2. The combined uncertainty must <=5.0 percent (%). If these
objectives are not met, the candidate GMPS is not acceptable, and
must not be used.
[GRAPHIC] [TIFF OMITTED] TR05AP24.021
8.1.4.3 GMPS Certified Concentration Value. If the GMPS meets
the Relative Agreement criteria in section 8.1.5.3 and the combined,
expanded uncertainty criteria in section 8.1.5.4, the GMPS is valid.
The GMPS certified value (GMPS-CC) is based on the
independently measurement concentration (GMPS-Ca). The
certification date is the date of the last confirmatory measurement.
8.1.4.4 An SGMs may propose to Administrator an alternative
acceptance values for section 8.1.5.1 or 8.1.5.2 for those
components that are unable to meet the documented criteria. These
proposals must include sufficient documentation that the objectives
are unreasonable for a given component and concentrations.
8.1.5 GMPS Stability Testing. The SGM must test and document
mixture stability of the GMPS to assure that the mixture stays
within claimed accuracy bounds for the entire claimed expiration
period. Alternatively, once a preparation process has been
developed, the SGM can perform a stability study consisting not less
than three cylinders prepared using the defined process and at the
concentration(s) defined by the process. Once the stability study
cylinders have demonstrated acceptable stability for
[[Page 24165]]
the minimum expiration period (6-months), additional GMPS cylinders
can be prepared under identical process conditions.
8.1.5.1 The SGM may select the sampling frequency based on the
targeted expiration period, the gas consumed in the analysis and
expected component behavior. Stability testing data must consist of
at least:
(a) Five discrete samplings of the retained mixture for an
expiration period of 6-months to 1-year;
(b) Ten discrete samplings for an expiration period of 1-3
years; and
(c) Twenty for any period greater than 3 years.
8.1.5.2 Stability testing must be conducted for each cylinder
size/type and at a similar concentration as the candidate GMPS.
Stability analyses must be performed using methods that assure
consistent results can be achieved. If instrumental analysis using a
gas standard is employed, use of a GMPS standard is highly
recommended. In the absence of a certified GMPS, stability testing
must be conducted using the same independent verification
measurement procedures and methodology used in section 8.1.4, or
using another known-to-be-stable gas standard containing the target
component in a similar concentration range.
8.1.5.3 Stability testing data must not show any upward or
downward trends that would cause the mixture to become out of
specification prior to the claimed expiration period.
8.1.6 GMPS Expiration Period. The expiration period for the GMPS
mixture based must be based on the empirical stability test data.
The expiration periods for reactive gases must not exceed the length
of the stability test, however for non-reactive gases you may
forecast an expiration period not to exceed two times the actual
stability testing duration. The maximum expiration period for a GMPS
is time span from the date of preparation to the date of the last/
most recent stability study may not be less than 6-months. Provided
that acceptable stability is observed, the maximum expiration period
may be extended by retaining the stability study cylinders and
performing additional analyses.
8.1.7 GMPS Documentation. You must document the preparation of
the GMPS through the appropriate record keeping and document the
certification of a GMPS. The information is section 8.1.8.1 and
8.1.8.2 must be maintained as a record by the SGM for the purpose of
maintaining traceability and to verify the preparation. The
information in section 8.1.8.3 must be documented and maintained by
the SGM. This documentation and the records of the preparation and
certification must be made available upon request by the appropriate
delegated authority.
8.1.7.1 The following information for the gravimetric
preparation information of the GMPS must be documented and
maintained as a record. This record should include but is not
limited to the: blend date, gravimetric concentration, gravimetric
concentration uncertainties as a percentage and absolute, reference
material information and purity, scale ID, scale accuracy, and
calculated gravimetric uncertainties associated with material,
balance, and environmental effects. You must include sufficient
information that will allow a 3rd party to recalculate the prepared
concentration and expanded uncertainties.
8.1.7.2 The following information for the analytical
verification of the GMPS must be recorded and maintained as a
record. This record should include the confirming methodology and
any associated SOPs, confirming concentration(s), instrumentation
used, calibration standards used and associated COAs, calibration
curve data, replicate analysis calculated, and expanded
uncertainties.
8.1.7.3 The following information must be documented for
inclusion on the COA for the GMACS.
(a) Manufacturer's company name and address of the producing
location
(b) Manufacturer's part number for the GMPS, lot number, and/or
production record.
(c) Cylinder number, cylinder type, cylinder preparation ID,
moisture dew point and cylinder pressure.
(d) Certification date and claimed expiration date.
(e) GMPS component(s) name, final certified concentration(s)
(GMPS-Cc), and balance gas.
(f) Gravimetric value and uncertainty
(g)Verification value and uncertainty
(h) GMPS final certified value and uncertainty absolute as a
percentage (GMPS-Cu)
8.2 Preparation and Certification of the GMACS. The preparation
and certification of the candidate GMACS is also based on the
independent verification of the gravimetrically prepared reference
value. However, the independent verification utilizes the GMPS to
perform the independent verification. This is accomplished by
following the procedures in section 2.1 and 2.2 of the EPA
Traceability Protocol, using the GMPS as the certified reference
material. The measured value of the independent verification
following the EPA Traceability Protocol procedures also establishes
the certified reference value, providing the relative agreement
performance criteria are met.
8.2.1 GMACS Gravimetric Cylinder Preparation/Creation. The
gravimetric preparation of the GMACS is identical to the procedures
used to gravimetrically prepare the GMPS. You must maintain the same
information required for the gravimetric preparation of GMPS, as
found in section 8.1.8.1 for GMACS, as a record.
8.2.2 GMACS Independent Verification and Certification. The
candidate GMACS independent verification of the gravimetrically
prepared reference value is contingent on the SGM following the
procedures in sections 2.1 and 2.2 of the EPA Traceability Protocol.
In addition, the EtO candidate GMACS certified reference value and
associated expanded uncertainty is based on the EPA Traceability
Protocol measured value. This is contingent upon the gravimetric and
measured values meeting the relative agreement performance criteria
established in section 8.1.5.3 and the uncertainty criteria
established in section 8.1.5.4. Gas Manufacturers Intermediate
Standards (GMIS) can be prepared by direct comparison to a GMPS that
has been prepared and certified according to section 2.1.3.1 and 2.2
of the EPA Traceability Protocol. The tagged value of the GMACS must
be based on the EPA Traceability Protocol measured value as long as
the performance criteria in sections 12.1 and 12.2 are met.
8.2.3 GMACS Stability Testing. The SGM must test and document
the stability of the GMACS to assure that the mixture stays within
claimed certified bounds for the entire claimed expiration period.
Use the procedures in section 8.1.6 to assess stability. The GMACS
must also meet the requirements in section 2.1.5.2 of the EPA
Traceability Protocol.
8.2.4 GMACS Expiration Date. The certification period of the
GMACS shall be based on the documented stability tests of the GMPS
in section 8.1.6. The expiration date shall be based on the
certification date, plus the certification period plus one day.
There is not a maximum period of expiration; however, expiration
periods must not be less than six months.
8.2.5 GMACS Documentation You must document and maintain the
same information required for the analytical verification of the
GMPS, as found in section 8.1.8 for GMACS, as a record. The records
of the preparation and certification must be made available upon
request by the appropriate delegated authority.
8.2.6 GMACS Certificate of Analysis (COA). You must provide
comprehensive documentation of the GMPS and GMACS development
process in the form of a GMACS Certificate of Analysis (COA) that
accompanies each commercially distributed GMACS. As a minimum, the
COA must contain the following information:
(a) Identification of the gas as a Gas Manufacturer Alternative
Certified Standard;
(b) The cylinder number;
(c) The certified concentration of the GMACS;
(d) The combined expanded uncertainty (k=2) of the GMACS
reference value (both absolute and relative);
(e) The expiration date;
(f) The reference materials or standards used (i.e., GMPS and
GMIS);
(g) The same information (cylinder number, certified
concentration, uncertainties, expiration dates, etc. for these
cylinders);
(h) The gravimetric and independent measured verification
reference concentration values and associated uncertainties for each
GMPS used;
(i) Associated measurement principles and uncertainties;
(j) Any additional information stipulated by the EPA
Traceability Protocol;
(k) Any comments/special instructions.
The SGM GMACS provider is encouraged to include additional
relevant information to the COA, as appropriate. An example GMACS
COA can be found in section 14 of this appendix.
9.0 Quality Control--Reserved
10.0 Calibration and Standardization
There is a myriad of instrumental and mechanical techniques used
in the
[[Page 24166]]
performance of this Appendix B. When reference methods are used, you
must follow the calibration requirements of those methods and as
defined in this appendix. For all other approaches, it is
recommended to develop internal SOPs and develop.
11.0 Calculations and Data Analysis--Reserved
12.0 Method Performance
12.1 GMPS/GMACS Relative Agreement. As part of the
certification/verification procedures for the candidate GMPS and
GMACS, the relative agreement between the gravimetrically prepared
reference value and the independently measured verification value
must agree within 4.0 percent (%).
12.2 GMACS/GMPS Uncertainty. Final certification of the GMPS and
GMACS reference concentrations must meet the combined expanded
uncertainty (k=2) of <=5.0 percent (%).
13.0 Pollution Prevention--Reserved
14.0 Waste Management--Reserved
15.0 Bibliography
1. EPA Traceability Protocol for Assay and Certification of
Gaseous Calibration Standards, Office of Research and Development,
National Risk Management Research Laboratory, May 2012, EPA 600/R-
12/531. https://www.epa.gov/air-research/epa-traceability-protocol-assay-and-certification-gaseous-calibration-standards.
2. EPA Alternative Method 114, Approval of Alternative Method
for preparation of HCl Gas Standards for PS-18 and Procedure 6,
February 22, 2016, https://www.epa.gov/sites/default/files/2020-08/documents/alt114.pdf.
3. Evaluation of Measurement Data--Guide to the Expression of
Uncertainty in Measurement, JCGM 100:2008, https://www.bipm.org/documents/20126/2071204/JCGM_100_2008_E.pdf/cb0ef43f-baa5-11cf-3f85-4dcd86f77bd6.
16.0 Tables and Figures
Figure B-1 Example Gravimetric Preparation Sheet for GMPS and GMACS
BILLING CODE 6560-50-P
[GRAPHIC] [TIFF OMITTED] TR05AP24.022
[[Page 24167]]
Figure B-2 Apparatus for the assay of the GMACs
[GRAPHIC] [TIFF OMITTED] TR05AP24.023
[[Page 24168]]
Figure B-3 Examples COA
[GRAPHIC] [TIFF OMITTED] TR05AP24.024
BILLING CODE 6560-50-C
0
3. Appendix F to part 60 is amended by adding Procedure 7 to read as
follows:
Appendix F to Part 60--Quality Assurance Procedures
* * * * *
Procedure 7. Quality Assurance Requirements for Gaseous Ethylene Exide
(ETO) Continuous Emission Monitoring Systems Used for Compliance
Determination
1.0 Applicability and Principle
1.1 Applicability. Procedure 7 is used to evaluate the
effectiveness of quality control (QC) and quality assurance (QA)
procedures and to evaluate the quality of data produced by any
ethylene oxide (EtO) gas, CAS: 75-21-8, continuous emission
monitoring system (CEMS) that is used for determining compliance
with emission standards for EtO on a continuous basis as specified
in an applicable permit or regulation.
1.1.1 This procedure specifies the minimum QA requirements
necessary for the control and assessment of the quality of CEMS data
submitted to the Environmental Protection Agency (EPA) or a
delegated authority. If you are responsible for one or more CEMS
used for EtO compliance monitoring you must meet these minimum
requirements and you are encouraged to develop and implement a more
extensive QA program or to continue such programs where they already
exist.
1.1.2 Data collected as a result of QA and quality control (QC)
measures required in this procedure are to be submitted to the EPA
or the delegated authority in accordance with the applicable
regulation or permit. These data are to be used by both the
delegated authority and you, as the CEMS operator, in assessing the
effectiveness of the CEMS QC and QA procedures in the maintenance of
acceptable CEMS operation and valid emission data.
1.2 Principle
1.2.1 The QA procedures consist of two distinct and equally
important functions. One function is the assessment of the quality
of the CEMS data by estimating accuracy. The other function is the
control and improvement of the quality of the CEMS data by
implementing QC policies and corrective actions. These two functions
form an iterative control loop. When the assessment function
indicates that the data quality is inadequate, the control effort
must be increased until the data quality is acceptable. In order to
provide uniformity in the assessment and reporting of data quality,
this procedure specifies the assessment procedures to evaluate
response drift and accuracy. The procedures specified are based on
Performance Specification 19 (PS-19) in appendix B to this part.
[[Page 24169]]
Note 1 to section 1.0: Because the control and corrective
action function encompasses a variety of policies, specifications,
standards and corrective measures, this procedure treats QC
requirements in general terms to allow you, as source owner or
operator to develop the most effective and efficient QC system for
your circumstances.
2.0 Definitions
See PS-19 in appendix B to this part for the primary definitions
used in this Procedure.
3.0 QC Requirements
3.1 You, as a source owner or operator, must develop and
implement a QC program. At a minimum, each QC program must include
written procedures and/or manufacturer's information which should
describe in detail, complete, step-by-step procedures and operations
for each of the following activities:
(a) Calibration Drift (CD) checks of CEMS;
(b) CD determination and adjustment of CEMS;
(c) Routine and preventative maintenance of CEMS (including
spare parts inventory);
(d) Data recording, calculations, and reporting;
(e) Accuracy audit procedures for CEMS including reference
method(s); and
(f) Program of corrective action for malfunctioning CEMS.
3.2 These written procedures must be kept on site and available
for inspection by the delegated authority. As described in section
5.4, whenever excessive inaccuracies occur for two consecutive
quarters, you must revise the current written procedures, or modify
or replace the CEMS to correct the deficiency causing the excessive
inaccuracies.
4.0 Daily Data Quality Requirements and Measurement Standardization
Procedures
4.1 CD Assessment. An upscale gas, used to meet a requirement in
this section must be a gas meeting the requirements in section 7.1
of PS-19 of appendix B to this part.
4.1.1 CD Requirement. Consistent with Sec. 60.13(d) and with
Sec. 63.8(c) of this chapter, you, as source owners or operators of
CEMS must check, record, and quantify the CD at two levels, using a
zero gas and high-level gas at least once daily (approximately every
24 hours). Perform the CD check in accordance with the procedure in
the applicable performance specification (e.g., section 11.3 of PS-
19 in appendix B to this part). The daily zero- and high-level CD
must not exceed two times the drift limits specified in the
applicable performance specification (e.g., section 13.2 of PS-19 in
appendix B to this part.)
4.1.2 Recording Requirement for CD Corrective action. Corrective
actions taken to bring a CEMS back in control after exceeding a CD
limit must be recorded and reported with the associated CEMS data.
Reporting of a corrective action must include the unadjusted
concentration measured prior to resetting the calibration and the
adjusted value after resetting the calibration to bring the CEMS
back into control.
4.1.3 Dynamic Spiking Option for high-level CD. You have the
option to conduct a daily dynamic spiking procedure found in section
11.5.8 of PS-19 of appendix B to this part in lieu of the daily
high-level CD check. If this option is selected, the daily zero CD
check is still required.
4.1.4 Out of Control Criteria for Excessive CD. Consistent with
Sec. 63.8(c)(7)(i)(A) of this chapter, an EtO CEMS is out of
control if the zero or high-level CD exceeds two times the
applicable CD specification in the applicable performance
specification or in the relevant standard. When a CEMS is out of
control, you as owner or operator of the affected source must take
the necessary corrective actions and repeat the tests that caused
the system to go out of control (in this case, the failed CD check)
until the applicable performance requirements are met.
4.1.5 Additional Quality Assurance for Data Above Span. This
procedure must be used when required by an applicable regulation and
may be used when significant data above span are being collected.
Furthermore, the terms of this procedure do not apply to the extent
that alternate terms are otherwise specified in an applicable rule
or permit.
4.1.5.1 Any time the average measured concentration of EtO
exceeds 200 percent of the span value for two consecutive one-hour
averages, conduct the following 'above span' CEMS response check.
4.1.5.1.1 Within a period of 24 hours (before or after) of the
'above span' period, introduce a higher, 'above span' EtO reference
gas standard to the CEMS. Use 'above span' reference gas that meets
the requirements of section 7.0 of PS-19 in appendix B to this part
and target a concentration level between 75 and 125 percent of the
highest hourly concentration measured during the period of
measurements above span or 5 ppmv whichever is greater.
4.1.5.1.2 Introduce the reference gas at the probe for
extractive CEMS.
4.1.5.1.3 At no time may the 'above span' concentration exceed
the analyzer full-scale range.
4.1.5.2 Record and report the results of this procedure as you
would for a daily calibration. The 'above span' response check is
successful if the value measured by the CEMS is within 20 percent of
the certified value of the reference gas.
4.1.5.3 If the 'above span' response check is conducted during
the period when measured emissions are above span and there is a
failure to collect at least one data point in an hour due to the
response check duration, then determine the emissions average for
that missed hour as the average of hourly averages for the hour
preceding the missed hour and the hour following the missed hour.
4.1.5.4 In the event that the 'above span' response check is not
successful (i.e., the CEMS measured value is not within 20 percent
of the certified value of the reference gas), then you must
normalize the one-hour average stack gas values measured above the
span during the 24-hour period preceding or following the 'above
span' response check for reporting based on the CEMS response to the
reference gas as shown in Eq. 7-1:
[GRAPHIC] [TIFF OMITTED] TR05AP24.025
4.2 Out of Control Period Duration for Daily Assessments. The
beginning of the out-of-control period is the hour in which the
owner or operator conducts a daily performance check (e.g.,
calibration drift) that indicates an exceedance of the performance
requirements established under this procedure. The end of the out-
of-control period is the completion of daily assessment of the same
type following corrective actions, which shows that the applicable
performance requirements have been met.
4.3 CEMS Data Status During Out-of-Control Period. During the
period the CEMS is out-of- control, the CEMS data may not be used in
calculating compliance with an emissions limit nor be counted
towards meeting minimum data availability as required and described
in the applicable regulation or permit.
5.0 Data Accuracy Assessment
You must audit your CEMS for the accuracy of EtO measurement on
a regular basis at the frequency described in this section, unless
otherwise specified in an applicable regulation or permit. Quarterly
audits are performed at least once each calendar quarter. Successive
quarterly audits, to the extent practicable, shall occur no closer
than 2 months apart. Annual audits are performed at least once every
four consecutive calendar quarters.
5.1 Concentration Accuracy Auditing Requirements. Unless
otherwise specified in an applicable regulation or permit, you must
audit the EtO measurement accuracy of each CEMS at least once each
calendar quarter, except in the case where the affected facility is
off-line (does not operate). In that case, the audit must be
performed as soon as is practicable in the quarter in which the unit
recommences operation. Successive quarterly audits must, to the
extent practicable, be performed no less than 2 months apart. The
[[Page 24170]]
accuracy audits shall be conducted as follows:
5.1.1 Relative Accuracy Test Audit (RATA). A RATA must be
conducted at least once every four calendar quarters, except as
otherwise noted in sections 5.1.5 or 5.5 of this procedure. Perform
the RATA as described in section 11.6 of PS-19 in appendix B to this
part. If the EtO concentration measured by the RM during a RATA (in
ppmv or other units of the standard) is less than or equal to 20
percent of the concentration equivalent to the applicable emission
standard, you must perform a Cylinder Gas Audit (CGA) or a Dynamic
Spike Audit (DSA) for at least one subsequent (one of the following
three) quarterly accuracy audits.
5.1.2 Quarterly Relative Accuracy Audit (RAA). A quarterly RAA
may be conducted as an option to conducting a RATA in three of four
calendar quarters, but in no more than three quarters in succession.
To conduct an RAA, follow the test procedures in section 11.6 of PS-
19 in appendix B to this part, except that only three test runs are
required. The difference between the mean of the RM values and the
mean of the CEMS responses relative to the mean of the values (or
alternatively the emission standard) is used to assess the accuracy
of the CEMS. Calculate the RAA results as described in section 6.2.
As an alternative to an RAA, a cylinder gas audit or a dynamic
spiking audit may be conducted.
5.1.3 Cylinder Gas Audit. A quarterly CGA may be conducted as an
option to conducting a RATA in three of four calendar quarters, but
in no more than three consecutive quarters. To perform a CGA,
challenge the CEMS with a zero-level and two upscale level audit
gases of known concentrations within the following ranges:
------------------------------------------------------------------------
Audit point Audit range
------------------------------------------------------------------------
1 (Mid-Level)......................... 50 to 60% of span value.
2 (High-Level)........................ 80 to 100% of span value.
------------------------------------------------------------------------
5.1.3.1 Inject each of the three audit gases (zero and two
upscale) three times each for a total of nine injections. Inject the
gases so that the entire measurement system is challenged. Do not
inject the same gas concentration twice in succession.
5.1.3.2 Use EtO audit gases that meet the requirements of
section 7 of PS-19 in appendix B to this part.
5.2.3.3 Calculate results as described in section 6.3.
5.1.4 Dynamic Spiking Audit. A quarterly DSA may be conducted as
an option to conducting a RATA in three of four calendar quarters,
but in no more than three quarters in succession.
5.1.4.1 To conduct a DSA, you must challenge the entire EtO CEMS
with a zero gas in accordance with the procedure in section 11.8 of
PS-19 in appendix B of this part. You must also conduct the DS
procedure as described in appendix A to PS-19 of appendix B to this
part. You must conduct three spike injections with each of two
upscale level audit gases. The upscale level gases must meet the
requirements of section 7 of PS-19 in appendix B to this part and
must be chosen to yield concentrations at the analyzer of 50 to 60
percent of span and 80 to 100 percent of span. Do not inject the
same spike gas concentration twice in succession.
5.1.4.2 Calculate results as described in section 6.4. To
determine CEMS accuracy, you must calculate the dynamic spiking
error (DSE) for each of the two upscale audit gases using equation
A5 in appendix A to PS-19 and equation 7-3 in section 6.4 of this
Procedure.
5.1.5 Other Alternative Quarterly Audits. Other alternative
audit procedures, as approved by the Administrator, may be used for
three of four calendar quarters.
5.2 Out of Control Criteria for Excessive Audit Inaccuracy. If
the results of the RATA, RAA, CGA, or DSA do not meet the applicable
performance criteria in section 5.2.4, the CEMS is out-of-control.
If the CEMS is out-of-control, take necessary corrective action to
eliminate the problem. Following corrective action, the CEMS must
pass a test of the same type that resulted in the out-of-control
period to determine if the CEMS is operating within the
specifications (e.g., a RATA must always follow an out-of-control
period resulting from a RATA).
5.2.1 If the audit results show the CEMS to be out-of-control,
you must report both the results of the audit showing the CEMS to be
out-of-control and the results of the audit following corrective
action showing the CEMS to be operating within specifications.
5.2.2 Out-Of-Control Period Duration for Excessive Audit
Inaccuracy. The beginning of the out-of-control period is the time
corresponding to the completion of the sampling for the failed RATA,
RAA, CGA or DSA. The end of the out-of-control period is the time
corresponding to the completion of the sampling of the subsequent
successful audit.
5.2.3 CEMS Data Status During Out-Of-Control Period. During the
period the CEMS is out-of- control, the CEMS data may not be used in
calculating emission compliance nor be counted towards meeting
minimum data availability as required and described in the
applicable regulation or permit.
5.2.4 Criteria for Excessive Quarterly and Yearly Audit
Inaccuracy. Unless specified otherwise in the applicable regulation
or permit, the criteria for excessive inaccuracy are:
5.2.4.1 For the RATA, the CEMS must meet the RA specifications
in section 13.4 of PS-19 in appendix B to this part.
5.2.4.2 For the CGA, the accuracy must not exceed 10.0 percent
of the span value at the zero gas and the mid- and high-level
reference gas concentrations.
5.2.4.3 For the RAA, the RA must not exceed 20.0 percent of the
RMavg as calculated using equation 7-2 in section 6.2 of this
procedure whether calculated in units of EtO concentration or in
units of the emission standard. In cases where the RA is calculated
on a concentration (ppbv) basis, if the average EtO concentration
measured by the RM during the test is less than 75 percent of the
EtO concentration equivalent to the applicable standard, you may
substitute the equivalent emission standard value (in ppbw) in the
denominator of equation 7-2 in the place of RMavg and the
result of this alternative calculation of RA must not exceed 15.0
percent.
5.2.4.4 For DSA, the accuracy must not exceed 5.0 percent of the
span value at the zero gas and the mid- and high-level reference gas
concentrations or 20.0 percent of the applicable emission standard,
whichever is greater.
5.3 Criteria for Acceptable QC Procedures. Repeated excessive
inaccuracies (i.e., out-of-control conditions resulting from the
quarterly or yearly audits) indicate that the QC procedures are
inadequate or that the CEMS is incapable of providing quality data.
Therefore, whenever excessive inaccuracies occur for two consecutive
quarters, you must revise the QC procedures (see section 3.0) or
modify or replace the CEMS.
5.4 Criteria for Optional QA Test Frequency. If all the quality
criteria are met in sections 4 and 5 of this procedure, the CEMS is
in-control.
5.5.1 Unless otherwise specified in an applicable rule or
permit, if the CEMS is in-control and if your source emits <=75
percent of the EtO emission limit for each averaging period as
specified in the relevant standard for eight consecutive quarters
that include a minimum of two RATAs, you may revise your auditing
procedures to use CGA, RAA or DSA each quarter for seven subsequent
quarters following a RATA.
5.5.2 You must perform at least one RATA that meets the
acceptance criteria every 2 years.
5.5.3 If you fail a RATA, RAA, CGA, or DSA, then the audit
schedule in section 5.2 must be followed until the audit results
meet the criteria in section 5.3.4 to start requalifying for the
optional QA test frequency in section 5.5.
6.0 Calculations for CEMS Data Accuracy
6.1 RATA RA Calculation. Follow equations 9 through 14 in
section 12 of PS-19 in appendix B to this part to calculate the RA
for the RATA. The RATA must be calculated either in units of the
applicable emission standard or in concentration units (ppbv).
6.2 RAA Accuracy Calculation. Use equation 7-2 to calculate the
accuracy for the RAA. The RA may be calculated in concentration
units (ppmv) or in the units of the applicable emission standard.
[GRAPHIC] [TIFF OMITTED] TR05AP24.026
[[Page 24171]]
Where:
RA = Accuracy of the CEMS (percent)
MNavg = Average measured CEMS response during the audit
in units of applicable standard or appropriate concentration.
RMavg = Average reference method value in units of
applicable standard or appropriate concentration.
6.3 CGA Accuracy Calculation. For each gas concentration,
determine the average of the three CEMS responses and subtract the
average response from the audit gas value. For extractive CEMS,
calculate the ME at each gas level using equation 3A in section 12.3
of PS-19 of appendix B to this part.
6.4 DSA Accuracy Calculation. DSA accuracy is calculated as a
percent of span. To calculate the DSA accuracy for each upscale
spike concentration, first calculate the DSE using equation A5 in
appendix A of PS-19 in appendix B to this part. Then use equation 7-
3 to calculate the average DSA accuracy for each upscale spike
concentration. To calculate DSA accuracy at the zero level, use
equation 3A in section 12.3 of PS-19 in appendix B to this part.
[GRAPHIC] [TIFF OMITTED] TR05AP24.027
7.0 Reporting Requirements
At the reporting interval specified in the applicable regulation
or permit, report for each CEMS the quarterly and annual accuracy
audit results from section 6 and the daily assessment results from
section 4. Unless otherwise specified in the applicable regulation
or permit, include all data sheets, calculations, CEMS data records
(i.e., charts, records of CEMS responses), reference gas
certifications and reference method results necessary to confirm
that the performance of the CEMS met the performance specifications.
7.1 Unless otherwise specified in the applicable regulations or
permit, report the daily assessments (CD and beam intensity) and
accuracy audit information at the interval for emissions reporting
required under the applicable regulations or permits.
7.1.1 At a minimum, the daily assessments and accuracy audit
information reporting must contain the following information:
a. Company name and address.
b. Identification and location of monitors in the CEMS.
c. Manufacturer and model number of each monitor in the CEMS.
d. Assessment of CEMS data accuracy and date of assessment as
determined by a RATA, RAA, CGA or DSA described in section 5
including:
i. The RA for the RATA;
ii. The accuracy for the CGA, RAA, or DSA;
iii. The RM results, the reference gas certified values;
iv. The CEMS responses;
v. The calculation results as defined in section 6; and
vi. Results from the performance audit samples described in
section 5 and the applicable RMs.
e. Summary of all out-of-control periods including corrective
actions taken when CEMS was determined out-of-control, as described
in sections 4 and 5. 7.1.2 If the accuracy audit results show the
CEMS to be out-of-control, you must report both the audit results
showing the CEMS to be out-of-control and the results of the audit
following corrective action showing the CEMS to be operating within
specifications.
7.1.2 If the accuracy audit results show the CEMS to be out-of-
control, you must report both the audit results showing the CEMS to
be out-of-control and the results of the audit following corrective
action showing the CEMS to be operating within specifications.
8.0 Bibliography
1. EPA Traceability Protocol for Assay and Certification of Gaseous
Calibration Standards, U.S. Environmental Protection Agency office
of Research and Development, EPA/600/R-12/531, May 2012.
2. Method 205, ``Verification of Gas Dilution Systems for Field
Instrument Calibrations,'' 40 CFR part 51, appendix M.
9.0 [Reserved]
PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES
0
4. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
Subpart A--General Provisions
0
5. Section 63.14 is amended by:
0
a. Revising paragraphs (a) and (f) and paragraph (i) introductory text;
0
b. Redesignating paragraphs (i)(88) through (119) as paragraphs (i)(89)
through (120), and;
0
c. Adding new paragraph (i)(88) and note 2 to paragraph (i).
The revisions and additions read as follows:
Sec. 63.14 Incorporations by reference.
(a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that
specified in this section, the EPA must publish a document in the
Federal Register and the material must be available to the public. All
approved incorporation by reference (IBR) material is available for
inspection at the EPA and at the National Archives and Records
Administration (NARA). Contact the EPA at: EPA Docket Center, Public
Reading Room, EPA WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC, telephone: 202-566-1744. For information on the
availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The
material may be obtained from the sources in the following paragraphs
of this section.
* * * * *
(f) American Society of Mechanical Engineers (ASME), Two Park
Avenue, New York, NY 10016-5990; phone: (800) 843-2763; email:
[email protected]; website: www.asme.org.
(1) ANSI/ASME PTC 19.10-1981, Flue and Exhaust Gas Analyses [Part
10, Instruments and Apparatus], issued August 31, 1981; IBR approved
for Sec. Sec. 63.309(k); 63.365(b); 63.457(k); 63.772(e) and (h);
63.865(b); 63.997(e); 63.1282(d) and (g); 63.1625(b); table 5 to
subpart EEEE; Sec. Sec. 63.3166(a); 63.3360(e); 63.3545(a);
63.3555(a); 63.4166(a); 63.4362(a); 63.4766(a); 63.4965(a); 63.5160(d);
table 4 to subpart UUUU; table 3 to subpart YYYY; Sec. Sec.
63.7822(b); 63.7824(e); 63.7825(b); 63.8000(d); 63.9307(c); 63.9323(a);
63.9621(b) and (c); 63.11148(e); 63.11155(e); 63.11162(f); 63.11163(g);
63.11410(j); 63.11551(a); 63.11646(a); 63.11945; table 4 to subpart
AAAAA; table 5 to subpart DDDDD; table 4 to subpart JJJJJ; table 4 to
subpart KKKKK; table 4 to subpart SSSSS; tables 4 and 5 of subpart
UUUUU; table 1 to subpart ZZZZZ; and table 4 to subpart JJJJJJ.
(2) [Reserved]
* * * * *
(i) ASTM International, 100 Barr Harbor Drive, P.O. Box CB700, West
Conshohocken, Pennsylvania 19428-2959; phone: (800) 262-1373; website:
www.astm.org.
* * * * *
(88) ASTM D6348-12 (Reapproved 2020), Standard Test Method for
Determination of Gaseous Compounds by Extractive Direct Interface
Fourier Transform (FTIR) Spectroscopy,
[[Page 24172]]
Approved December 1, 2020; IBR approved for Sec. 63.365(b).
* * * * *
Note 2 to paragraph (i): Standards listed in this paragraph (i)
may also be available from standards resellers including the
Standards Store, https://global.ihs.com.
* * * * *
0
6. Subpart O is revised and republished to read as follows:
Subpart O--Ethylene Oxide Emissions Standards for Sterilization
Facilities
Sec.
63.360 Applicability.
63.361 Definitions.
63.362 Standards.
63.363 Compliance and performance provisions.
63.364 Monitoring requirements.
63.365 Test methods and procedures.
63.366 Reporting requirements.
63.367 Recordkeeping requirements.
63.368 Implementation and enforcement.
Table 1 to Subpart O of Part 63 Standards for SCVs
Table 2 to Subpart O of Part 63 Standards for ARVs
Table 3 to Subpart O of Part 63 Standards for CEVs
Table 4 to Subpart O of Part 63 Standards for Group 1 Room Air
Emissions
Table 5 to Subpart O of Part 63 Standards for Group 2 Room Air
Emissions
Table 6 to Subpart O of Part 63 Applicability of General Provisions
to Subpart O
Appendix A to Subpart O of Part 63--Monitoring Provisions for EtO
CEMS
Subpart O--Ethylene Oxide Emissions Standards for Sterilization
Facilities
Sec. 63.360 Applicability.
(a) You are subject to the requirements of this subpart if you own
or operate a sterilization facility that has an affected source
specified in paragraph (b) of this section. Table 6 to this subpart
shows which parts of the General Provisions in Sec. Sec. 63.1 through
63.15 apply to you.
(b) The affected sources subject to this subpart are:
(1) Each SCV at any sterilization facility;
(2) Each ARV at any sterilization facility;
(3) Each CEV at any sterilization facility;
(4) The collection of all Group 1 room air emissions at any
sterilization facility; and
(5) The collection of all Group 2 room air emissions at any
sterilization facility.
(c) An existing affected source is one the construction or
reconstruction of which was commenced on or before April 13, 2023.
(d) A new affected source is one the construction or reconstruction
of which is commenced after April 13, 2023.
(e) An SCV, ARV, or CEV is reconstructed if you meet the
reconstruction criteria as defined in Sec. 63.2, and if you commence
reconstruction after April 13, 2023.
(f) This subpart does not apply to beehive fumigators.
(g) This subpart does not apply to research or laboratory
facilities as defined in section 112(c)(7) of title III of the Clean
Air Act Amendment of 1990.
(h) This subpart does not apply to EtO sterilization operations at
stationary sources such as hospitals, doctor's offices, clinics, or
other facilities whose primary purpose is to provide medical or dental
services to humans or animals.
(i) If you are an owner or operator of an area source subject to
this subpart, you are exempt from the obligation to obtain a permit
under 40 CFR part 70 or 71, provided you are not required to obtain a
permit under 40 CFR 70.3(a) or 71.3(a) for a reason other than your
status as an area source under this subpart. Notwithstanding the
previous sentence, you must continue to comply with the provisions of
this subpart applicable to area sources.
(j) You must comply with the provisions of this subpart no later
than the dates specified in paragraphs (j)(1) through (17) of this
section:
(1) If you own or operate an existing affected source, you must
comply with the applicable provisions of this subpart no later than the
dates specified in tables 1 through 5 to this subpart, as applicable.
(2) If you own or operate a new affected source, and the initial
startup of your affected source is on or before April 5, 2024, you must
comply with the provisions of this subpart no later than April 5, 2024.
(3) If you own or operate a new affected source, and the initial
startup is after April 5, 2024, you must comply with the provisions of
this subpart upon startup of your affected source.
(4) If existing SCV, ARV, or CEV or parts of an existing collection
of Group 1 or Group 2 room air emissions are replaced such that the
replacement meets the definition of reconstruction in Sec. 63.2 and
the reconstruction commenced after April 13, 2023, then the existing
affected source becomes a new affected source. The reconstructed source
must comply with the requirements for a new affected source upon
initial startup of the reconstructed source or by April 5, 2024,
whichever is later.
(5) All existing SCVs at facilities that meet or exceed 1 tpy of
EtO use within any consecutive 12-month period after April 7, 2025,
that increase their EtO use after April 6, 2026, such that the SCV
becomes subject to a more stringent emission standard, immediately upon
becoming subject to the more stringent emission standard.
(6) All existing SCVs at facilities that do not exceed 1 tpy of EtO
use within any consecutive 12-month period after April 6, 2026, that
increase their EtO use thereafter, such that the SCV becomes subject to
a more stringent emission standard, immediately upon becoming subject
to the more stringent emission standard.
(7) All new SCVs at facilities that increase their EtO use over a
year after startup such that the SCV becomes subject to a more
stringent emission standard, immediately upon becoming subject to the
more stringent emission standard.
(8) All existing ARVs at facilities that meet or exceed 10 tpy of
EtO use within any consecutive 12-month period after April 7, 2025,
that increase their EtO use after April 6, 2026, such that the ARV
becomes subject to a more stringent emission standard, immediately upon
becoming subject to the more stringent emission standard.
(9) All existing ARVs at facilities that do not exceed 10 tpy of
EtO use within any consecutive 12-month period after April 6, 2026,
that increase their EtO use after thereafter, such that the ARV becomes
subject to a more stringent emission standard, immediately upon
becoming subject to the more stringent emission standard.
(10) All new ARVs at facilities that increase their EtO use over a
year after startup such that the ARV becomes subject to a more
stringent emission standard, immediately upon becoming subject to the
more stringent emission standard.
(11) All existing CEVs at facilities that do not exceed 60 tpy of
EtO use within any consecutive 12-month period after April 6, 2026,
that increase their EtO use thereafter, such that the CEV becomes
subject to a more stringent emission standard, immediately upon
becoming subject to the more stringent emission standard.
(12) All new CEVs at facilities that increase their EtO use over a
year after startup such that the CEV becomes subject to a more
stringent emission standard, immediately upon becoming subject to the
more stringent emission standard.
(13) All existing collections of Group 1 room air emissions at
facilities that do not exceed 40 tpy of EtO use within any consecutive
12-month period after April 6, 2026, that increase their EtO use
thereafter, such that the collection of Group 1 room air emissions
becomes subject to a more stringent emission
[[Page 24173]]
standard, immediately upon becoming subject to the more stringent
emission standard.
(14) All new Group 1 room air emissions at facilities that increase
their EtO use over a year after startup such that the Group 1 room air
emissions become subject to a more stringent emission standard,
immediately upon becoming subject to the more stringent emission
standard.
(15) All existing collections of Group 2 room air emissions at
facilities that meet or exceed 4 tpy of EtO use within any consecutive
12-month period after April 7, 2025, that increase their EtO use after
April 6, 2026, such that the collection of Group 2 room air emissions
becomes subject to a more stringent emission standard, immediately upon
becoming subject to the more stringent emission standard.
(16) All existing collections of Group 2 room air emissions at
facilities that do not exceed 4 tpy of EtO use within any consecutive
12-month period after April 6, 2026, that increase their EtO use
thereafter, such that the collection of Group 2 room air emissions
becomes subject to a more stringent emission standard, immediately upon
becoming subject to the more stringent emission standard.
(17) All new Group 2 room air emissions at facilities that increase
their EtO use over a year after startup such that the Group 2 room air
emissions become subject to a more stringent emission standard,
immediately upon becoming subject to the more stringent emission
standard.
Sec. 63.361 Definitions.
Terms and nomenclature used in this subpart are defined in the
Clean Air Act (the Act) as amended in 1990, Sec. Sec. 63.2 and 63.3,
or in this section. For the purposes of this subpart, if the same term
is defined in subpart A of this part and in this section, it shall have
the meaning given in this section.
Acid-water scrubber means an add-on air pollution control device
that uses an aqueous or alkaline scrubbing liquor to absorb and
neutralize acid gases.
Aeration means, for the purposes of this rule, exposing sterilized
material at elevated temperatures to drive EtO out of the material.
Aeration room means any vessel or room that is used to facilitate
off-gassing of EtO at a sterilization facility. If a facility uses only
combination sterilization units, for the purposes of this rule, there
are no aeration rooms at the facility.
Aeration room vent (ARV) means the point(s) through which the
evacuation of EtO-laden air from an aeration room occurs. For
combination sterilization units, there is no ARV.
Catalytic oxidizer means a combustion device that uses a solid-
phase catalyst to lower the temperature required to promote the
oxidization and achieve adequate reduction of volatile organic
compounds, as well as volatile hazardous air pollutants.
Chamber exhaust vent (CEV) means the point(s) through which EtO-
laden air is removed from the sterilization chamber during chamber
unloading following the completion of sterilization and associated air
washes. This may also be referred to as a ``backvent'' (or ``back
vent''). For combination sterilization units, there is no CEV.
Combination sterilization unit means any enclosed vessel in which
both sterilization and aeration of the same product occur within the
same vessel, i.e., the vessel is filled with ethylene oxide gas or an
ethylene oxide/inert gas mixture for the purpose of sterilizing and is
followed by aeration of ethylene oxide.
Combined emission stream means when the emissions from more than
one emission source are routed together using common ductwork prior to
the control system.
Continuous monitoring system (CMS) means, for the purposes of this
rule, the equipment necessary to continuously samples the regulated
parameter specified in Sec. 63.364 or Sec. 63.365 of this subpart
without interruption, evaluates the detector response at least once
every 15 seconds, and computes and records the average value at least
every 60 seconds, except during allowable periods of calibration and
except as defined otherwise by the continuous emission monitoring
system (CEMS) performance specifications (PS) in appendix B to part 60
of this chapter.
Control System Residence Time means the time elapsed from entrance
of flow into the control system until gaseous materials exit the
control system. For control systems with multiple exhaust streams
whereby the residence time may vary for the streams, the residence time
for purposes of complying with this subpart means the longest residence
time for any exhaust stream in use. If a peak shaver is used, it is
part of the control system, and its residence time must be considered.
Deviation means any instance in which an owner or operator of an
affected source, subject to this subpart:
(1) Fails to meet any requirement or obligation established by this
subpart including, but not limited to, any emission limitation,
parameter value, or best management practice; or
(2) Fails to meet any term or condition that is adopted to
implement an applicable requirement in this subpart or that is included
in the operating permit for any facility required to obtain such a
permit.
EtO dispensing means charging a sterilization chamber or chambers
with EtO from non-cartridge storage media (e.g., drums, cylinders) via
the use of piping, lines, and other equipment. This includes injection
rooms and post-injection handling of containers.
Gas/solid reactor means an add-on air pollution control device that
uses a dry, solid-phase system to chemically convert EtO so that it
becomes bound to the solid packing. This may also be referred to as a
``dry bed reactor'' or a ``dry bed scrubber.''
Group 1 room air emissions mean emissions from indoor EtO storage,
EtO dispensing, vacuum pump operations, and pre-aeration handling of
sterilized material.
Group 2 room air emissions mean emissions from post-aeration
handling of sterilized material.
Indoor EtO storage means the storage of EtO within non-cartridge
media (e.g., drums, cylinders) inside a sterilization building.
Initial startup means the moment when an affected source subject to
an emissions standard in Sec. 63.362 first begins operation.
Injection room means any room where EtO is injected into containers
(e.g., bags, pouches) that are filled with product to be sterilized.
Maximum ethylene glycol concentration means the concentration of
ethylene glycol in the scrubber liquor of an acid-water scrubber
control device established during a performance test when the scrubber
achieves the appropriate control of EtO emissions.
Maximum gas/solid reactor pressure drop means the pressure drop of
the gas/solid reactor established during a performance test when the
gas/solid reactor achieves the appropriate control of EtO emissions.
Maximum liquor tank level means the level of scrubber liquor in the
acid-water scrubber liquor recirculation tank established during a
performance test when the scrubber achieves the appropriate control of
EtO emissions.
Maximum scrubber liquor pH means the pH of the acid-water scrubber
liquor established during a performance test when the scrubber achieves
the appropriate control of EtO emissions.
Minimum stack volumetric flow rate means the stack volumetric flow
rate corrected established during a compliance demonstration when
[[Page 24174]]
permanent total enclosure (PTE) requirements are met.
Minimum temperature at the inlet to the catalyst bed means the
temperature at the inlet to the catalyst bed established during a
performance test when the catalytic oxidizer achieves the appropriate
control of EtO emissions.
Minimum temperature difference across the catalyst bed means the
temperature difference across the catalyst bed established during a
performance test when the catalytic oxidizer achieves the appropriate
control of EtO emissions.
Minimum temperature in or immediately downstream of the firebox
means the temperature in or immediately downstream of the firebox
established during a performance test when the thermal oxidizer
achieves the appropriate control of EtO emissions.
Natural draft opening (NDO) means any permanent opening in the
enclosure that remains open during operation of the facility and is not
connected to a duct in which a fan is installed.
Operating day means any day that a facility is engaged in a
sterilization operation.
Peak shaver means a device that is used to reduce high EtO
concentrations within an exhaust stream such that the downstream
control device is not overwhelmed.
Permanent total enclosure (PTE) means a permanently installed
enclosure that meets the criteria of Method 204 of appendix M, 40 CFR
part 51 for a PTE. A PTE completely surrounds a source of emissions
such that all EtO emissions are captured, contained, and directed to a
control system or to an outlet(s).
Post-aeration handling of sterilized material means the storage and
transportation of material that has been removed from aeration but has
not been placed in a vehicle for the sole purpose of distribution to
another facility. Post-aeration handling of sterilized material ends
when that vehicle is closed for the final time before leaving the
facility. This definition does not include handling of material that
has been both previously sterilized and not removed from aeration
following re-sterilization.
Post-injection handling of containers means the storage and
transportation of containers (e.g., bags, pouches) that have been
injected with EtO but have not been placed in a sterilization chamber.
Pre-aeration handling of sterilized material means the storage and
transportation of material that has been removed from a sterilization
chamber but has not been placed in an aeration room. If only
combination sterilization units are used, and if material is not moved
out of the vessel between sterilization and aeration, then emissions
from this source do not exist. This does not include post-injection
handling of containers.
Rolling sum means the weighted sum of all data, meeting QA/QC
requirements or otherwise normalized, collected during the applicable
rolling time period. The period of a rolling sum stipulates the
frequency of data collection, summing, and reporting. As an example, to
demonstrate compliance with a rolling 30-operating day sum emission
reduction standard determined from hourly data, you must (1) determine
the total mass of ethylene oxide prior to control and following control
for each operating day; (2) then sum the current daily total mass prior
to control with the previous 29 operating day total mass values and
repeat the same process for the current daily total mass following
control; and (3) then divide the 30-operating day total mass emissions
following control by the 30-operating day total mass prior to control
and subtract the resulting value from one to obtain the 30-operating
day emission reduction achieved.
Single-item sterilization means a process in which one or more
items are placed in a pouch, EtO is injected into the pouch, and the
sealed pouch is placed in a vessel to allow sterilization to occur.
Sterilization chamber means any enclosed vessel or room that is
filled with EtO gas, or an EtO/inert gas mixture, for the purpose of
sterilizing and/or fumigating at a sterilization facility. This does
not include injection rooms.
Sterilization chamber vent (SCV) means the point (prior to the
vacuum pump) through which the evacuation of EtO from the sterilization
chamber occurs following sterilization or fumigation, including any
subsequent air washes.
Sterilization facility means any stationary source where EtO is
used in the sterilization or fumigation of materials, including but not
limited to facilities that engage in single-item sterilization.
Sterilization operation means any time when EtO is removed from the
sterilization chamber through the SCV or the chamber exhaust vent, when
EtO is removed from the aeration room through the aeration room vent,
when EtO is stored within the building, when EtO is dispensed from a
container to a chamber, when material is moved from sterilization to
aeration, or when materials are handled post-aeration.
Thermal oxidizer means all combustion devices except flares.
Vacuum pump operation means the operation of vacuum pumps,
excluding dry seal vacuum pumps, for the purpose of removing EtO from a
sterilization chamber.
Sec. 63.362 Standards.
(a) Compliance date. If you own or operate an affected source, you
must comply with the applicable requirement by the compliance date
specified in Sec. 63.360(j). The standards of this section are
summarized in tables 1 through 5 to this subpart.
(b) Applicability of standards. The standards in paragraphs (c)
through (k) of this section apply at all times. If using EtO CEMS to
determine compliance with an applicable standard, this compliance
demonstration is based on the previous 30-operating days of data. If
using EtO CEMS to determine compliance with an applicable emission
reduction standard in paragraphs (c) through (g) and (i) of this
section for each operating day, you must determine the total inlet mass
to and outlet mass from the control system using the procedures laid
out in Sec. 63.364(f) and appendix A to this subpart, and you must
maintain the emission limit based on the inlet mass and the applicable
emission reduction standard. If using EtO CEMS to determine compliance
with an applicable emission reduction standard in paragraph (j) of this
section, you must continuously comply with the requirements of that
paragraph.
(c) SCV. You must comply with each applicable standard in table 1
to this subpart, and you must meet each applicable requirement
specified in Sec. 63.363. If a SCV is combined with a stream from
another emission source, you must comply with the appropriate emission
standard as prescribed in paragraph (i) of this section.
(d) ARV. You must comply with each applicable standard in table 2
to this subpart, and you must meet each applicable requirement
specified in Sec. 63.363. If an ARV is combined with a stream from
another emission source, you must comply with the appropriate emission
standard as prescribed in paragraph (i) of this section.
(e) CEV. You must comply with each applicable standard in table 3
to this subpart, and you must meet each applicable requirement
specified in Sec. 63.363. If a CEV is combined with a stream from
another emission source, you must comply with the appropriate emission
standard as prescribed in paragraph (i) of this section.
(f) Group 1 room air emissions. You must comply with the applicable
[[Page 24175]]
standard in table 4 to this subpart, and you must meet each applicable
requirement specified in Sec. 63.363. If Group 1 room air emissions
are combined with a stream from another emission source, you must
comply with the appropriate emission standard as prescribed in
paragraph (i) of this section.
(g) Group 2 room air emissions. You must comply with the applicable
standard in table 5 to this subpart, and you must meet each applicable
requirement specified in Sec. 63.363. If Group 2 room air emissions
are combined with a stream from another emission source, you must
comply with the appropriate emission standard as prescribed in
paragraph (i) of this section. If you are required to limit the
sterilization chamber concentration of EtO to 1 ppmv prior to opening
the sterilization chamber door, you must meet the monitoring
requirements specified in Sec. 63.364(h).
(h) Capture systems. Room air emissions for which numerical limits
are prescribed must be captured and routed under negative pressure to a
control system. You may assume the capture system efficiency is 100
percent if both conditions in paragraphs (h)(1) and (2) of this section
are met:
(1) The capture system meets the criteria in Method 204 of appendix
M to 40 CFR part 51 for a PTE and directs all the exhaust gases from
the enclosure to an add-on control system.
(2) All sterilization operations creating exhaust gases for which
the compliance demonstration is applicable are contained within the
capture system.
(i) Requirements for combined emission streams. When streams from
two or more emission sources are combined, you must demonstrate
compliance by either the approach specified in paragraph (i)(1) of this
section or the approach specified in paragraph (i)(2) of this section
in lieu of the applicable standards in paragraphs (c) through (g) of
this section for the affected source. The combined emission stream
limit is based on as 30-operating day rolling sum. In order to elect to
comply with a combined emission streams limit, you must use a CEMS on
each exhaust stack at the facility to determine compliance.
(1) Monitoring after emission streams are combined. You must follow
requirements of paragraphs (i)(1)(i) through (iii) of this section to
determine the applicable combined emission streams limitation and
demonstrate compliance. Under this approach, you must first determine
the 30-operating day rolling sum of mass inlet to the control system.
Then, the emission limitation is determined by applying the most
stringent emission reduction standard to the 30-operating day rolling
sum of the inlet mass. You must maintain actual emissions at or below
that rate. For example, suppose a facility controls all of its ARVs and
CEVs with one control system and that the emission reduction standards
that apply to the ARVs and CEVs are 99.9% and 99%, respectively.
Further suppose that the mass of uncontrolled EtO emissions from the
combined stream is 5 lb during the 30-operating day period. Under this
approach, the facility would need to apply an emission reduction of
99.9% to the combined stream, resulting in an emission limit of 0.005
lb for the 30-operating day period.
(i) The combined emission streams limit for each 30-operating day
period is determined daily by using equation 1 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.028
Where:
CESCombined = The combined emission stream limit based
upon monitoring after the emission streams are combined, in pounds.
M30day = The 30-operating day total mass sent to controls
for the combined emission stream (i.e., monitoring data at the inlet
of the control system), as calculated using equation A-3 and
determined in accordance with appendix A to this subpart. The term
``M30day'' as used in this equation is equivalent to the
term ``E30day'' as designated in equation A-3.
Max(ER) = The most stringent emission reduction standard specified
in tables 1 through 5 of this subpart applicable to any of the
constituent streams, in decimal format.
(ii) The 30-operating day rolling sum of emissions for the combined
emission stream (i.e., monitoring data at the outlet of the control
system) is calculated daily using equation A-3 and determined in
accordance with appendix A to this subpart. For purposes of this
section, this value is designated as ECombined. If the
combined emission stream is split between two or more control systems,
further sum the 30-operating day rolling sum of emissions from each
control system to obtain ECombined.
(iii) Compliance with the combined emission streams limitation
shall be determined by demonstrating that ECombined, as
calculated in accordance with paragraph (i)(1)(ii) of this section, for
each 30-operating day period is at or below CESCombined, as
calculated in paragraph (i)(1)(i) of this section.
(2) Monitoring before emission streams are combined. You must
follow requirements of paragraphs (i)(2)(i) through (iii) of this
section to determine the applicable combined emission streams
limitation and demonstrate compliance. Under this approach, you must
first determine 30-operating day rolling sum of inlet mass to the
control system for each component stream. Then, the emission limitation
is determined by applying the applicable emission reduction standards
to the 30-operating day rolling sum of each component stream and
summing across the components. You must maintain actual emissions at or
below that rate. For example, suppose a facility controls all of its
ARVs and CEVs with one control system and that the emission reduction
standards that apply to the ARVs and CEVs are 99.9% and 99%,
respectively. Further suppose that during a 30-operating day period the
mass of uncontrolled EtO emissions from the ARVs is 4 lb and the mass
of uncontrolled EtO emissions from the CEVs is 1 lb. Under this
approach, the facility would need to apply an emission reduction of
99.9% to the ARV stream and an emission reduction of 99% to the CEV
stream, resulting in an emission limit of 0.014 lb for the 30-operating
day period.
(i) The combined emission streams limit for each 30-operating day
period is determined daily by using equation 2 to this paragraph.
[[Page 24176]]
[GRAPHIC] [TIFF OMITTED] TR05AP24.029
Where:
CESStreams = The combined emission stream limit based
upon monitoring before the emission streams are combined, in pounds.
Mc,i = The 30-operating day total mass sent to controls
for each non-SCV constituent emission stream (i.e., monitoring data
at the inlet of the control system), as calculated using equation A-
3 and determined in accordance with appendix A to this subpart. The
term ``Mc,i'' as used in this equation is equivalent to
the term ``E30day'' as designated in equation A-3.
ERi = The applicable emission reduction standard from
tables 2 through 5 of this subpart to each non-SCV constituent
emission stream i.
i = Non-SCV constituent emission stream index.
n = Total number of non-SCV constituent emission streams.
Mc,j = The 30-operating day total mass sent to controls
for each SCV emission stream, as determined in accordance with
equation 10 of Sec. 63.364(f)(1)(i)(C)(1).
ERj = The applicable SCV emission reduction standard in
table 1 to this subpart, in decimal format.
j = SCV emission stream index.
m = Total number of SCV emission streams.
(ii) The 30-operating day rolling sum emissions for the combined
emission stream (i.e., monitoring data at the outlet of the control
system) is calculated daily using equation A-3 and determined in
accordance with appendix A to this subpart. For purposes of this
section, this value is designated as ECombined. If the
combined emission stream is split between two or more control systems,
then further sum the 30-operating day rolling sum emissions from each
control system to obtain ECombined.
(iii) Compliance with the combined emission streams limitation
shall be determined by demonstrating that ECombined, as
calculated in accordance with paragraph (i)(2)(ii) of this section, for
each 30-operating day period is at or below CESStreams, as
calculated paragraph (i)(2)(i) of this section.
(3) If room air emissions are both subject to an emission standard
and split between two or more control systems, then these control
systems must be treated as part of the same control system.
(j) Site-wide emission limitation. You may choose to comply with a
site-wide emission limitation (SWEL) specified in this paragraph (j) in
lieu of the applicable standards in paragraphs (c) through (g) of this
section for the facility. The SWEL, which is calculated daily, is based
on the previous 30 operating days of data. In order to elect to comply
with a SWEL, you must utilize an EtO CEMS on each exhaust stack at the
facility to determine compliance. The owner or operator may demonstrate
compliance via one of the two SWEL approaches in lieu of the applicable
standard(s) in paragraphs (c) through (g) of this section for the
facility. If electing to comply with a SWEL, you must comply with
paragraph (j)(3) of this section.
(1) SWEL based upon facility EtO use. If you elect to comply with a
SWEL based upon facility EtO use, you must follow requirements of
paragraphs (j)(1)(i) through (iii) of this section to determine the
applicable SWEL and demonstrate compliance. Under this approach, you
first determine the 30-operating day rolling sum of EtO use. The SWEL
is determined by multiplying by 0.99 and then applying the required SCV
percent emission reduction standard in table 1 to this subpart to the
30-operating day rolling sum of EtO usage. Then, for each CEMS at the
outlet of the control systems at the facility, determine the 30-
operating day rolling sum of emissions. Finally, determine the facility
actual emissions by summing the 30-operating day rolling sums for each
CEMS at the facility. You must maintain actual emissions at or below
the SWEL.
(i) The SWEL for each 30-operating day period is determined daily
by using equation 3 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.030
Where:
SWELFac = SWEL based upon facility EtO use, in pounds.
MFac = Facility EtO use over the previous 30 operating
days, in pounds, as determined in accordance with equation 11 of
Sec. 63.364(i)(2).
0.99 = Adjustment factor for EtO residual in sterilized product.
ERSCV = The applicable SCV emission reduction standard in
table 1 to this subpart, in decimal format.
(ii) The 30-operating day rolling sum of emissions are determined
daily using equation 4 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.031
Where:
EFac = The total emissions from the facility over the
previous 30-operating days, in pounds.
Eo,i = The 30-operating day rolling sum of emissions
calculated at each exhaust stack, i, monitored by an EtO CEMS, as
calculated using equation A-3 of appendix A to this subpart.
i = Exhaust stack index
n = Total number of exhaust stacks
(iii) Compliance with the SWEL based upon facility EtO usage shall
be
[[Page 24177]]
determined by demonstrating that EFac, as calculated in
accordance with paragraph (j)(1)(ii) of this section, for each 30-
operating day period is at or below the SWEL, as calculated paragraph
(j)(1)(i) of this section.
(2) SWEL based upon emissions streams. If you elect to comply with
a SWEL based upon emissions streams, you must follow requirements of
paragraphs (j)(2)(i) through (iii) of this section to determine the
applicable SWEL and demonstrate compliance. Under this approach, for
each non-SCV affected source, you must determine the mass of EtO sent
to controls and apply the applicable emission reduction standard. For
each SCV affected source, you must determine the mass of EtO sent to
controls as specified in Sec. 63.364(f)(1)(i)(C)(1) and apply the
applicable emission reduction standard. The SWEL is determined by
summing across the result of this calculation for each affected source
(both non-SCV and SCV). Then, for each CEMS at the outlet of the
control system(s) at the facility, determine the 30-operating day
rolling sum of emissions. Finally, determine the facility actual
emissions by summing the 30-operating day rolling sums for each CEMS at
the facility. You must maintain actual emissions at or below the SWEL.
(i) The SWEL for each 30-operating day period is determined daily
by using equation 5 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.032
Where:
SWELStreams = SWEL based upon individual emissions
streams, in pounds.
Mc,i = The 30-operating day total mass sent to controls
(i.e., monitoring data at the inlet of the control system) for each
non-SCV emission stream, as calculated using equation A-3 and
determined in accordance with appendix A to this subpart. The term
``Mc,i'' as used in this equation is equivalent to the
term ``E30day'' as designated in equation A-3.
ERi = The applicable emission reduction standard to each
non-SCV emission stream, i, specified in tables 1 through 5 of this
subpart, in decimal format.
i = Non-SCV emission streams index.
n = Total number of non-SCV emission streams.
Mc,j = The 30-operating day total mass sent to controls
for each SCV emission stream, as determined in accordance with
equation 10 in Sec. 63.364(f)(1)(i)(C)(1).
ERj = The applicable SCV emission reduction standard in
table 1 to this subpart, in decimal format.
j = SCV emission stream index.
m = Total number of SCV emission streams.
(ii) The 30-operating day rolling sum of emissions are determined
daily using equation 4 to this section.
(iii) Compliance with the SWEL based upon emission streams shall be
determined by demonstrating that EFac, as calculated in
accordance with paragraph (j)(2)(ii) of this section, for each 30-
operating day period is at or below SWELStreams, as
calculated in paragraph (j)(2)(i) of this section.
(3) Boundary. The boundary for this approach includes all affected
sources at the facility.
(k) General duty. At all times, you must operate and maintain any
affected source, including associated air pollution control equipment
and monitoring equipment, in a manner consistent with safety and good
air pollution control practices for minimizing emissions. The general
duty to minimize emissions does not require the owner or operator to
make any further efforts to reduce emissions if levels required by the
applicable standard have been achieved. Determination of whether a
source is operating in compliance with operation and maintenance
requirements will be based on information available to the
Administrator which may include, but is not limited to, monitoring
results, review of operation and maintenance procedures, review of
operation and maintenance records, and inspection of the source.
Sec. 63.363 Compliance and performance provisions.
(a) Continuous compliance. You must demonstrate continuous
compliance with the applicable emission standard(s) using an EtO CEMS,
including a shared EtO CEMS, installed and operated in accordance with
the requirements of Performance Specification 19 in appendix B and
Procedure 7 in appendix F to part 60 of this chapter. Alternatively, if
you own or operate a facility where EtO use is less than 100 pounds/yr,
you may demonstrate continuous compliance by conducting annual
performance tests using the performance testing requirements in Sec.
63.7, according to the applicability in table 6 to this subpart, the
procedures listed in this section, and the test methods listed in Sec.
63.365. If you elect to demonstrate compliance through periodic
performance testing, you must also demonstrate continuous compliance
with each operating limit required under this section according to the
methods specified in Sec. 63.364. If you own or operate an area source
facility where EtO use is less than 100 pounds/yr where an existing
collection of Group 2 room air emission is operated in accordance with
the PTE requirements of EPA Method 204 of appendix M to part 51 of this
chapter, you may instead conduct these performance tests once every
three years.
(b) Initial compliance for Facilities that use EtO CEMS. To
demonstrate initial compliance with an emission standard using a CEMS
that measures HAP concentrations directly (i.e., an EtO CEMS), the
initial performance test must consist of the first 30 operating days
after the certification of the CEMS according to Performance
Specification 19 in Appendix B to part 40 of this chapter. The initial
compliance demonstration period must be completed on or before the date
that compliance must be demonstrated (i.e., 180 days after the
applicable compliance date). You must follow the procedures in appendix
A to this subpart.
(1) The CEMS performance test must demonstrate compliance with the
applicable EtO standards in tables 1 through 5 to this subpart.
Alternatively, the CEMS performance test may demonstrate compliance
with Sec. 63.362(i) or (j).
(i) You may time-share your CEMS among different measurement points
provided that:
(A) The measurement points are approximately equidistant from the
CEMS;
(B) The sampling time at each measurement point is at least 3 times
as long as the CEMS response time;
(C) The CEMS completes at least one complete cycle of operation for
each shared measurement point within a 15-minute period; and
[[Page 24178]]
(D) The CEMS meets the other requirements of PS 19.
(2) You must collect hourly data from auxiliary monitoring systems
during the performance test period, to convert the pollutant
concentrations to pounds per hour.
(c) Initial compliance demonstration where facility EtO use is less
than 100 pounds per year. If you own or operate an affected source that
is both subject to an emission standard in Sec. 63.362 and located
within a facility where EtO use is less than 100 pounds per year, you
may comply with paragraphs (c)(1) and (2) of this section:
(1) Conduct an initial compliance demonstration using the
procedures listed in Sec. 63.7 of this part according to the
applicability in table 6 to this subpart, the procedures listed in this
section, and the test methods listed in Sec. 63.365;
(2) Complete the initial compliance demonstration within 180 days
after the compliance date for the affected source as determined in
Sec. 63.360(j).
(d) Operating limits for facility where EtO use is less than 100
lb/yr. If annual EtO use at the facility is less than 100 lb, the
procedures in paragraphs (d)(1) through (5) of this section may be used
to determine compliance with the standard(s) under Sec. 63.362(c)
through (g) and to establish operating limits for each of the control
devices, as applicable:
(1) You must determine the percent emission reduction of the
control system used to comply with Sec. 63.362(c) through (g) using
the test methods and procedures in Sec. 63.365(d)(1).
(2) If an acid-water scrubber(s) is used to comply with a standard,
then you must establish as an operating limit:
(i) The maximum ethylene glycol concentration using the procedures
described in Sec. 63.365(e)(1)(i);
(ii) The maximum liquor tank level using the procedures described
in Sec. 63.365(e)(1)(ii); or
(iii) The maximum scrubber liquor pH using the procedures described
in Sec. 63.365(e)(1)(iii).
(3) If a thermal oxidizer(s) is used to comply with a standard, you
must establish as an operating limit the minimum temperature in or
immediately downstream of the firebox using the procedures described in
Sec. 63.365(e)(2).
(4) If a catalytic oxidizer(s) is used to comply with the standard,
you must establish as operating limits both:
(i) The minimum temperature at the inlet to the catalyst bed using
the procedures described in Sec. 63.365(e)(3); and
(ii) The minimum temperature difference across the catalyst bed
using the procedures described in Sec. 63.365(e)(3).
(5) If a gas/solid reactor(s) is used to comply with the standard,
you must establish as an operating limit the pressure drop across the
media beds and conduct weekly sampling and analysis of the media.
Determine the maximum gas/solid reactor pressure drop using the
procedures described in Sec. 63.365(e)(4).
(e) Other control technology for facility where EtO use is less
than 100 lb/yr. If you are conducting a performance test using a
control technology other than an acid-water scrubber, catalytic
oxidizer, thermal oxidizer, or gas/solid reactor, you must provide to
the Administrator information describing the design and operation of
the air pollution control system, including recommendations for the
parameters to be monitored that will demonstrate continuous compliance.
Based on this information, the Administrator will determine the
parameter(s) to be measured during the performance test. During the
performance test required in paragraph (a) of this section, using the
methods approved in Sec. 63.365(e)(5), you must determine the site-
specific operating limit(s) for the operating parameters approved by
the Administrator. You must submit the information at least sixty days
before the performance test is scheduled to begin. The information on
the control technology must include the five items listed in paragraphs
(1) through (5) of this section:
(1) Identification of the specific parameters you propose to use as
additional operating limits;
(2) A discussion of the relationship between these parameters and
emissions of regulated pollutants, identifying how emissions of
regulated pollutants change with changes in these parameters and how
limits on these parameters will serve to limit emissions of regulated
pollutants;
(3) A discussion of how you will establish the upper and/or lower
values which will establish the operating limits for these parameters;
(4) A discussion identifying the methods you will use to measure
and the instruments you will use to monitor these parameters, as well
as the relative accuracy and precision of these methods and
instruments; and
(5) A discussion identifying the frequency and methods for
recalibrating the instruments you will use for monitoring these
parameters.
(f) Other emission streams. If the emission stream does not consist
only of an SCV(s), the procedures in paragraphs (f)(1) through (3) of
this section shall be used to determine initial compliance with the
emission limits under Sec. 63.362(d) through (g), as applicable:
(1) You must comply with paragraph (c) of this section, as
applicable.
(2) If you are complying with a percent emission reduction standard
as specified in tables 1 through 5 to this subpart, you must determine
compliance with Sec. 63.362(c) through (g), as applicable, using the
test methods and procedures in Sec. 63.365(d)(1).
(3) If you are required to operate any portion of the facility
under PTE, you must initially demonstrate that the PTE meets the
requirements of Method 204 of 40 CFR part 51, appendix M, and that all
exhaust gases from the enclosure are delivered to a control system or
stack(s). You must also meet the requirements in Sec. 63.363(f)(3)(i)
and either Sec. 63.363(f)(3)(ii) or (iii):
(i) Maintain direction of the airflow into the enclosure at all
times, verifying daily using the procedures described in Sec.
63.364(f)(5) and meet either of the requirements.
(ii) Establish as an operating limit the minimum volumetric flow
rate through the affected stack(s) using the procedures described in
Sec. 63.365(f)(1); or
(iii) Install, operate, calibrate, and maintain a continuous
pressure differential monitoring system using the procedures described
in Sec. 63.364(f)(4).
Sec. 63.364 Monitoring requirements.
(a) General requirements. (1) If you own or operate an affected
source subject to an emission standard in Sec. 63.362, you must comply
with the monitoring requirements in Sec. 63.8, according to the
applicability in table 6 to this subpart, and in this section.
(2) If you own or operate an affected source at a facility where
EtO use is less than 100 lb/yr that is subject to an emission standard
in Sec. 63.362, you may monitor the parameters specified in paragraphs
(b), (c), (d), (e), (g), and (i) of this section. All monitoring
equipment shall be installed such that representative measurements of
emissions or process parameters from the source are obtained. For
monitoring equipment purchased from a vendor, verification of the
operational status of the monitoring equipment shall include completion
of the manufacturer's written specifications or recommendations for
installation, operation, and calibration of the system.
(3) If you own or operate an affected source that is subject to an
emission standard in Sec. 63.362 and that is required to monitor using
EtO CEMS, you must
[[Page 24179]]
comply with paragraphs (f), (g), and (i) of this section.
(4) If you comply with the management practice for Group 2 room air
emissions at area sources, you must comply with paragraph (h) of this
section.
(5) You must keep the written procedures required by Sec.
63.8(d)(2) on record for the life of the affected source or until the
affected source is no longer subject to the provisions of this part, to
be made available for inspection, upon request, by the Administrator.
If the performance evaluation plan is revised, you must keep previous
(i.e., superseded) versions of the performance evaluation plan on
record to be made available for inspection, upon request, by the
Administrator, for a period of 5 years after each revision to the plan.
The program of corrective action should be included in the plan
required under Sec. 63.8(d)(2).
(b) Acid-water scrubbers. If you are demonstrating continuous
compliance through periodic performance testing on an acid-water
scrubber(s), you must:
(1) Ethylene glycol concentration. Sample the scrubber liquor from
the acid-water scrubber(s) and analyze and record at least once per
week the ethylene glycol concentration of the scrubber liquor using the
test methods and procedures in Sec. 63.365(e)(1). Monitoring is
required during a week only if the scrubber unit has been operated. You
must maintain the weekly ethylene glycol concentration below the
operating limit established during the most recent performance test;
(2) Scrubber liquor tank level. Measure and record at least once
per day the level of the scrubber liquor in the recirculation tank(s).
You must install, maintain, and use a liquid level indicator to measure
the scrubber liquor tank level (i.e., a marker on the tank wall, a
dipstick, a magnetic indicator, etc.). Monitoring is required during a
day only if the scrubber unit has been operated. You must maintain the
daily scrubber liquor height in each recirculation tank below the
applicable operating limit established during the most recent
performance test; or
(3) pH. Monitor and record at least every 15 minutes the scrubber
liquor pH. Monitoring is required when the scrubber is operating. A
data acquisition system for the pH monitor shall compute and record
each 3-hour average scrubber liquor pH value, rolled hourly. This must
be done by first averaging the scrubber liquor pH readings obtained
over a clock hour, i.e., beginning and ending on the hour. All data
collected during the operating hour must be used, even if the scrubber
unit is not operating for a complete hour. Then, the average of the
previous 3 operating hours must be calculated to determine the 3-hour
rolling average scrubber liquor pH. You must maintain the 3-hour
rolling average scrubber liquor pH below the applicable operating limit
established during the most recent performance test. You must ensure
the pH monitoring system meets the following requirements:
(i) The pH sensor must be installed in a position that provides a
representative measurement of scrubber liquor pH;
(ii) The sample must be properly mixed and representative of the
fluid to be measured; and
(iii) A performance evaluation (including a two-point calibration
with one of the two buffer solutions having a pH within 1 of the pH of
the operating limit) of the pH monitoring system must be conducted in
accordance with your monitoring plan at the time of each performance
test but no less frequently than quarterly.
(c) Oxidizers. If you are demonstrating continuous compliance
through periodic performance testing on a catalytic oxidizer or thermal
oxidizer, the requirements in paragraphs (c)(1) and (2) of this section
apply:
(1) For thermal oxidizers, you must monitor and record at least
every 15 minutes the temperature in or immediately downstream of the
firebox using the temperature monitor described in paragraph (c)(4) of
this section. Monitoring is required when the thermal oxidizer is
operating. A data acquisition system for the temperature monitor shall
compute and record each 3-hour average temperature value, rolled
hourly. This must be done by first averaging the temperature readings
over a clock hour, i.e., beginning and ending on the hour. All data
collected during the operating hour must be used, even if the thermal
oxidizer is not operating for a complete hour. Then, the average of the
previous 3 operating hours must be calculated to determine the 3-hour
rolling average temperature in or immediately downstream of the
firebox. You must maintain the 3-hour rolling average temperature above
the operating limit established during the most recent performance
test.
(2) For catalytic oxidizers, you must monitor and record at least
every 15 minutes the temperature at the inlet to the catalyst bed using
the temperature monitor described in paragraph (c)(4) of this section.
Monitoring is required when the catalytic oxidizer is operating. A data
acquisition system for the temperature monitor shall compute and record
each 3-hour average temperature, rolled hourly. This must be done by
first averaging the temperature readings over a clock hour, i.e.,
beginning and ending on the hour. All data collected during the
operating hour must be used, even if the catalytic oxidizer is not
operating for a complete hour. Then, the average of the previous 3
operating hours must be calculated to determine the 3-hour rolling
average temperature at the inlet to the catalyst bed. You must maintain
the 3-hour rolling average temperature above the operating limit
established during the most recent performance test.
(3) For catalytic oxidizers, you must monitor and record at least
every 15 minutes the temperature increase across the catalyst bed,
immediately downstream of the catalytic bed, using the temperature
monitor described in paragraph (c)(4) of this section. Monitoring is
required when the catalytic oxidizer is operating. A data acquisition
system for the temperature monitor shall compute and record each 3-hour
average temperature increase, rolled hourly. This must be done by first
computing the difference in outlet temperature minus inlet temperature
(monitored under paragraph (c)(2)), and second averaging the
temperature difference values over a clock hour, i.e., beginning and
ending on the hour. All data collected during the operating hour must
be used, even if the catalytic oxidizer is not operating for a complete
hour. Then, the average of the previous 3 operating hours must be
calculated to determine the 3-hour rolling average temperature increase
across the catalyst bed. You must maintain the 3-hour average
temperature increase above the operating limit established during the
most recent performance test.
(4) You must install, calibrate, operate, and maintain a
temperature monitor with a minimum accuracy of 1 percent
over the normal range of the temperature measured, expressed in degrees
Celsius, or 2.8 degrees Celsius, whichever is greater. You must verify
the accuracy of the temperature monitor twice each calendar year at
least five months apart with a reference temperature monitor (traceable
to National Institute of Standards and Technology (NIST) standards or
an independent temperature measurement device dedicated for this
purpose). During accuracy checking, the probe of the reference device
shall be at the same location as that of the temperature monitor being
tested. As an alternative, the accuracy of the temperature monitor may
be verified in a calibrated oven (traceable to NIST standards).
(5) For catalytic oxidizers, if the monitor indicates that the
temperature is below the operating limit, within 7 calendar days you
must:
[[Page 24180]]
(i) Correct the temperature or temperature increase so that it
falls within the established operating range; or
(ii) Replace the catalyst bed. Following replacement of the
catalyst bed, you must conduct a new performance test within 180 days
and re-establish the operating limits.
(d) Gas-solid reactors. If you are demonstrating continuous
compliance through periodic performance testing on a gas/solid
reactor(s), you must:
(1) Media analysis. Sample the media from the gas/solid reactor(s)
and have the manufacturer analyze at least once per week. Monitoring is
required during a week only if the gas/solid reactor unit has been
operated; and
(2) Pressure drop. Monitor and record at least every 15 minutes the
pressure drop. Monitoring is required when the gas/solid reactor is
operating. A data acquisition system for the pressure drop monitor
shall compute and record each 3-hour average gas/solid reactor pressure
drop value, rolled hourly. This must be done by first averaging the
gas/solid reactor pressure drop readings obtained over a clock hour,
i.e., beginning and ending on the hour. All data collected during the
operating hour must be used, even if the gas/solid reactor unit is not
operating for a complete hour. Then, the average of the previous 3
operating hours must be calculated to determine the 3-hour rolling
average gas/solid reactor pressure drop. You must maintain the 3-hour
rolling average gas/solid reactor pressure drop below the applicable
operating limit established during the most recent performance test.
(e) Performance testing, other control technology. If you are
complying with Sec. 63.363(d) or (e) using periodic performance
testing and the use of a control device other than acid-water
scrubbers, catalytic or thermal oxidizers, or gas/solid reactors, you
must monitor the parameters as approved by the Administrator using the
methods and procedures in Sec. 63.365(e).
(f) EtO CEMS configurations. If you are using EtO CEMS to
demonstrate compliance with an emission standard, you must install and
operate an EtO CEMS on each outlet for the control system in accordance
with the requirements of Appendix A to subpart O of this part. You must
also conduct monitoring for each inlet to the control system that is
used to demonstrate compliance with the emission reduction standard in
accordance with the requirements of appendix A to this subpart, with
the exception for SCV emission streams to the control system.
(1) EtO CEMS inlet configuration. The following caveats apply:
(i) SCVs. If you do not own or operate a single-item sterilizer, to
demonstrate compliance with the percent emission reduction standards
for emissions streams that are comprised only of SCVs, you may use the
following procedures as an alternative to monitoring the inlet emission
stream to determine the mass emissions of EtO being emitted via
sterilization chamber(s) vents prior to the controls.
(A) Determine the mass (MSCV,n) of EtO used for each
charge and at each sterilization chamber used during the previous 30
days using the procedures in either paragraph (f)(1)(i)(A)(1) or (2) of
this section.
(1) Weigh the EtO gas cylinder(s) used to charge the sterilizer(s)
before and after charging. Record these weights to the nearest 45 g
(0.1 lb) and calculate the theoretical mass (Mc) vented to
the controls using equation 1 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.033
Where:
MSCV,n = Theoretical total mass of EtO vented to controls
per charge, g (lb)
Mcharge = total mass of sterilizer gas charge, g (lb)
%EOw = weight percent of EtO
(2) Install a calibrated rate meter at the sterilizer inlet(s) and
continuously measure the flow rate (Qm) and duration of each
sterilizer charge. Calculate the theoretical mass (MSCV,n)
vented to the controls using equation 2 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.034
Where:
MSCV,n = theoretical total mass of EtO sent to controls
per charge
Qm = volumetric flow rate, liters per minute (L/min)
corrected to 20 [deg]C and 101.325 kilopascals (kPa) (scf per minute
(scfm) corrected to 68 [deg]F and 1 atmosphere of pressure (atm))
Tn = time duration of each charge, min
%EOv = volume fraction percent of EtO
n = number of EtO charges
MW = molecular weight of EtO, 44.05 grams per gram-mole (g/g-mole)
(44.05 pounds per pound-mole (lb/lb-mole))
SV = standard volume, 24.05 liters per gram-mole (L/g-mole) at 20
[deg]C and 101.325 kPa (385.1 scf per pound-mole (scf/lb-mole) at 68
[deg]F and 1 atm).
(B) Determine the adjustment factor (f) using equation 8 to this
paragraph. Determine the mass of EtO sent to controls from all non-SCV
affected sources, I, using equation 4 to this paragraph. For facilities
where EtO use is less than 4 tpy, if not all Group 2 room air emissions
are routed to a control device, do not include Group 2 room air
emissions in I, and subtract 0.002 from this factor.
[[Page 24181]]
[GRAPHIC] [TIFF OMITTED] TR05AP24.035
Where:
f = Adjustment factor.
I = Mass of non-SCV EtO routed to control devices over the previous
30 operating days
MFac = Facility EtO use over the previous 30-operating
days, in pounds, as determined in accordance with equation 11 of
Sec. 63.364(i)(2)
[GRAPHIC] [TIFF OMITTED] TR05AP24.036
Where:
I = Mass of non-SCV EtO routed to control devices over the previous
30 operating days
Mc,i = The 30-operating day total mass sent to controls
(i.e., monitoring data at the inlet of the control system) for each
non-SCV emission stream, as calculated using equation A-3 and
determined in accordance with appendix A to this subpart. The term
``Mc,i'' as used in this equation is equivalent to the
term ``E30day'' as designated in equation A-3.
i = Non-SCV emission stream index.
n = Total number of non-SCV emission streams.
(C)(1) Determine the mass rate of EtO sent to controls during the
previous 30 days using equation 5 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.037
Where:
MSCV = Total mass of EtO sent to controls over the
previous 30 operating days, g/hr (lb/hr)
f = Adjustment factor
MSCV,n = Theoretical mass of EtO sent to controls per
charge per chamber, g (lb)
n = Total number of charges during the previous 30 operating days
(2) If both this approach is chosen and the SCV is (or SCVs are)
combined with another emission stream, then the owner or operator
cannot monitor the point after the combination occurs.
(ii) Room air emissions. If room air emissions are both subject to
an emission standard and split between two or more control systems,
then monitoring must be conducted for room air emissions before they
are combined with other streams.
(2) EtO CEMS on exhaust configurations. Exhaust gases from the
emission sources under this subpart exhaust to the atmosphere through a
variety of different configurations, including but not limited to
individual stacks, a common stack configuration, or a main stack plus a
bypass stack. For the CEMS used to provide data under this subpart, the
continuous monitoring system installation requirements for these
exhaust configurations are as follows:
(i) Single unit-single stack configurations. For an emission source
that exhausts to the atmosphere through a single, dedicated stack, you
shall either install the required CEMS in the stack or at a location in
the ductwork downstream of all emissions control devices, where the
pollutant and diluents concentrations are representative of the
emissions that exit to the atmosphere.
(ii) Unit utilizing common stack with other emission source(s).
When an emission source utilizes a common stack with one or more other
emission sources, but no emission sources not subject to this rule, you
shall either:
(A) Install the required CEMS in the duct from each emission
source, leading to the common stack; or
(B) Install the required CEMS in the common stack.
(iii) Unit(s) utilizing common stack with non-commercial
sterilization emission source(s). (A) When one or more emission sources
shares a common stack with one or more emission sources not subject to
this rule, you shall either:
(1) Install the required CEMS in the ducts from each emission
source that is subject to this rule, leading to the common stack; or
(2) Install the required CEMS described in this section in the
common stack and attribute all of the emissions measured at the common
stack to the emission source(s).
(B) If you choose the common stack monitoring option:
(1) For each hour in which valid data are obtained for all
parameters, you must calculate the pollutant emission rate; and
(2) You must assign the calculated pollutant emission rate to each
of the units subject to the rule that share the common stack.
(iv) Unit with multiple parallel control devices with multiple
stacks. If the exhaust gases from an emission source, which is
configured such that emissions are controlled with multiple parallel
control devices or multiple series of control devices are discharged to
the atmosphere through more than one stack, you shall install the
required CEMS described in each of the multiple stacks. You shall
calculate hourly, flow-weighted, average pollutant emission rates for
the unit as follows:
(A) Calculate the pollutant emission rate at each stack or duct for
each hour in which valid data are obtained for all parameters;
(B) Multiply each calculated hourly pollutant emission rate at each
stack or duct by the corresponding hourly gas flow rate at that stack
or duct;
[[Page 24182]]
(C) Sum the products determined under paragraph (f)(2)(iv)(B) of
this section; and
(D) Divide the result obtained in paragraph (f)(2)(I(C) of this
section by the total hourly gas flow rate for the unit, summed across
all of the stacks or ducts.
(g) PTE monitoring. If you are required to operate all or a portion
of your sterilization facility under PTE conditions, you must:
(1) Initial compliance. Demonstrate initial procedures in Sec.
63.365(g)(1) and continued compliance with the provisions in this
section. You must follow the requirements of either paragraphs (g)(2)
and (3) of this section or paragraph (g)(4) of this section.
(2) Continuous compliance. If you choose to demonstrate continuous
compliance through volumetric flow rate monitoring, you must monitor
and record at least every 15 minutes the volumetric flow rate from each
outlet where air from the PTE is sent using a flow rate monitoring
system described in paragraph (g)(3) of this section. Monitoring is
required when the portion of the facility covered by PTE is operated. A
data acquisition system for the flow rate monitoring system shall
compute and record each 3-hour average flow rate value, rolled hourly.
This must be done by first averaging the flow rate readings over a
clock hour, i.e., beginning and ending on the hour. All data collected
during the operating hour must be used, even the portion of the
facility covered by PTE is not operated for a complete hour. Then, the
average of the previous 3 operating hours must be calculated to
determine the 3-hour rolling average flow rate. You must maintain the
3-hour rolling average flow rate above the applicable operating limits
established during the most recent compliance demonstration.
(3) Continuous flow rate monitoring system for PTE. You must
install, operate, calibrate, and maintain instruments, according to the
requirements in paragraphs (g)(3)(i) through (ix) of this section, for
continuously measuring and recording the stack gas flow rate to allow
determination of compliance with the minimum volumetric flow rate
through the affected stack operating limit(s).
(i) You must install each sensor of the flow rate monitoring system
in a location that provides representative measurement of the exhaust
gas flow rate. The flow rate sensor is that portion of the system that
senses the volumetric flow rate and generates an output proportional to
that flow rate.
(ii) The flow rate monitoring system must be designed to measure
the exhaust flow rate over a range that extends from a value of at
least 20 percent less than the lowest expected exhaust flow rate to a
value of at least 20 percent greater than the highest expected exhaust
flow rate.
(iii) The flow rate monitoring system must be equipped with a data
acquisition and recording system that is capable of recording values
over the entire range specified in paragraph (g)(3)(ii) of this
section.
(iv) The signal conditioner, wiring, power supply, and data
acquisition and recording system for the flow rate monitoring system
must be compatible with the output signal of the flow rate sensors used
in the monitoring system.
(v) The flow rate monitoring system must be designed to complete a
minimum of one cycle of operation for each successive 15-minute period.
(vi) The flow rate sensor must have provisions to determine the
daily zero and upscale calibration drift (CD) (see sections 3.1 and 8.3
of Performance Specification 2 in appendix B to Part 60 of this chapter
for a discussion of CD).
(A) Conduct the CD tests at two reference signal levels, zero
(e.g., 0 to 20 percent of span) and upscale (e.g., 50 to 70 percent of
span).
(B) The absolute value of the difference between the flow monitor
response and the reference signal must be equal to or less than 3
percent of the flow monitor span.
(vii) You must perform an initial relative accuracy test of the
flow rate monitoring system according to section 8.2 of Performance
Specification 6 of appendix B to part 60 of the chapter with the
exceptions in paragraphs (g)(3)(vii)(A) and (B) of this section.
(A) The relative accuracy test is to evaluate the flow rate
monitoring system alone rather than a continuous emission rate
monitoring system.
(B) The relative accuracy of the flow rate monitoring system shall
be no greater than 10 percent of the mean value of the reference method
data.
(viii) You must verify the accuracy of the flow rate monitoring
system at least once per year by repeating the relative accuracy test
specified in paragraph (g)(3)(vii) of this section.
(ix) You must operate the flow rate monitoring system and record
data during all periods of operation of the affected facility including
periods of startup, shutdown, and malfunction.
(4) Pressure differential monitor. You must instead install,
operate, calibrate, and maintain a continuous pressure differential
monitoring system, as follows, to verify the presence of PTE. You must
operate this system whenever the facility is in operation. You must
also maintain the pressure differential at or above 0.007 inches of
water over a three-hour rolling average.
(i) This monitoring system must measure the pressure differential
between the interior and exterior of the PTE, with at least one
monitoring device located in each room that borders the PTE. These
monitoring devices shall be designed to provide measurements of
pressure differential to at least the nearest 0.001 inches of water and
having a complete cycle time no greater than 5 minutes.
(ii) A data acquisition system for the monitoring system shall
compute and record each 3-hour average pressure differential value,
rolled hourly. This must be done by first averaging the pressure
differential readings over a clock hour, i.e., beginning and ending on
the hour. All data collected during the operating hour must be used,
even in portions of the facility covered by PTE that are not operated
for a complete hour. Then, the average of the previous 3 operating
hours must be calculated to determine the 3-hour rolling average
pressure differential. If data are not recorded from an alternative
monitoring device, during any malfunction of the principal monitoring
device(s) or the automatic recorder, you must manually record the
measured data at least hourly.
(h) Sterilization chamber end-cycle EtO concentration. As part of
your monitoring plan, you must document your approach for determining
the EtO sterilization chamber concentration. If you choose a parametric
approach you must meet the requirements in paragraph (h)(1) of this
section and if you choose a direct measurement approach you must meet
the requirements in paragraph (h)(2) of this section. Alternatively,
you may petition the administrator for an alternative monitoring
approach under Sec. 63.8(f).
(1) If you choose a parametric approach for determining chamber EtO
concentrations you must document parameter(s) used in the calculation
to determine of EtO concentrations and the calculation(s) used to
determine the chamber concentration. Any instrumentation used for
parametric monitoring must also be identified in the monitoring plan
and at a minimum this plan should include the following for each
instrument:
(i) Parameter measured and measurement principle of the monitor.
(ii) Instrument name, model number, serial number, and range.
(iii) Manufacturer recommended operation practices, including daily
operational check.
[[Page 24183]]
(iv) Procedures for calibration, the frequency of calibration, and
accuracy requirements of the calibration.
(v) Description for how the information from the parameter monitor
is being collected and stored.
(2) If you choose a direct measurement approach for determining
chamber EtO calibrations you must document the procedures used for the
operation of the instruments. Any instrument used for direct
measurement of EtO must be identified in the monitoring plan and at a
minimum this plan must include the following information:
(i) Instrument name, model number, serial number, and range.
(ii) Description of the measurement principle and any potential
interferences.
(iii) If applicable, the description of the sampling condition
system.
(iv) Procedures for calibration, the frequency of calibration, and
accuracy requirements of the calibration.
(v) Description for how the information from the parameter monitor
is being collected and stored.
(i) EtO usage. If you own or operate a sterilization facility
subject to the requirements of this subpart you must monitor and record
on a daily basis the daily and 30-operating day EtO usage according to
the requirements of this paragraph. Additionally, you must record EtO
usage for each calendar month.
(1) Monitor and record on a daily basis, the daily total mass of
ethylene oxide, in pounds, used at the facility. The daily total mass
must be determined using the methodology specified in Sec.
63.365(c)(1)(i) and (ii).
(2) Determine and record daily the 30-operating day rolling
ethylene oxide usage rate using equation 6 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.038
Where:
MFac = Facility EtO use over the previous 30 operating
days, in pounds.
mFac,i = Daily EtO use for operating day i, in pounds, as
determined in accordance with paragraph (i)(1) of this section
i = Operating day index.
(3) Determine and record the total mass of EtO used in each
calendar month.
Sec. 63.365 Test methods and procedures.
(a) General--(1) Performance testing for facility where EtO use is
less than 100 pounds per year. If you own or operate an affected source
at a facility where EtO use is less than 100 lb/yr that is subject to
an emission standard in Sec. 63.362, you must comply with the
performance testing requirements in Sec. 63.7, according to the
applicability in table 6 to this subpart, using the methods in
paragraph (b) or (c) of this section, following the applicable
procedures for initial compliance and continuous compliance in
paragraphs (d), (e), and (f) of this section.
(2) Facilities subject to capture efficiency. If you are subject to
capture efficiency requirements in Sec. 63.362, you must follow the
applicable procedures for initial and continuous compliance in
paragraph (f) of this section.
(b) Test methods for facility where EtO use is less than 100 pounds
per year. You must use the following test methods to determine the
average mass emissions of EtO in lb/hr at the inlet of a control system
(MAPCD, i) and/or outlet of a control system or stack
(EAPCD, o).
(1) Select the location of the sampling ports and the number of
traverse points according to Method 1 of appendix A-1 to part 60 of
this chapter. Alternatively, for ducts less than 0.3 meter (12 in.) in
diameter, you may choose to locate sample ports according to Method 1A
of appendix A-1 to part 60 of this chapter.
(2) Determine the flow rate through the control system exhaust(s)
continuously during the test period according to either Methods 2, 2A,
or 2C of appendix A-1 to part 60 of this chapter, as appropriate. If
using Method 2, 2A, or 2C, you must complete velocity traverses
immediately before and subsequently after each test run. If your test
run is greater than 1 hour, you must also complete a velocity traverse
at least every hour. Average the velocity collected during a test run
and calculate volumetric flow as outlined in the appropriate method.
(3) Determine the oxygen and carbon dioxide concentration of the
effluent according to Method 3A or 3B of appendix A-2 to part 60 of
this chapter. The manual procedures (but not instrumental procedures)
of voluntary consensus standard ANSI/ASME PTC 19.10-1981 (incorporated
by reference, see Sec. 63.14) may be used as an alternative to EPA
Method 3B.
(4) Determine the moisture content of the stack gas according to
Method 4 of appendix A-3 to part 60 of this chapter. Alternatively, you
may use an on-line technique that has been validated using Method 301
of appendix A to this part.
(5) Determine the EtO concentration according to either paragraph
(b)(5)(i) or (ii) of this section.
(i) Follow Method 320 of appendix A to this part and the following
paragraphs (5)(i)(A) through (D).
(A) The instrumentation used for measurement must have the
measurement range to properly quantify the EtO in the gas stream.
Additionally, for outlet emission streams, the instrumentation must
have a method detection limit an order of magnitude below concentration
equivalent of the emission limit.
(B) Instrumentation used must be continuous in nature with an
averaging time of one minute or less.
(C) Calibration Spectra and all other analyte spiking required in
the method must use EtO gaseous cylinder standard(s) which meet the
criteria found in Performance Specification 19 of appendix B to part 60
if this chapter.
(D) Other methods and materials may be used; however, these
alternative test methods are subject to Administrator approval.
(ii) Alternatively, ASTM D6348-12 (Reapproved 2020), (incorporated
by reference, see Sec. 63.14) may be used with the following
conditions:
(A) The test plan preparation and implementation in the Annexes to
ASTM D 6348-12 (R2020), Sections A1 through A8 are mandatory; and
(B) In ASTM D6348-12 (R2020) Annex A5 (Analyte Spiking Technique),
the percent (%) R must be determined for each target analyte (equation
A5.5). In order for the test data to be acceptable
[[Page 24184]]
for a compound, %R must be 70% >= R <= 130%. If the %R value does not
meet this criterion for a target compound, the test data is not
acceptable for that compound and the test must be repeated for that
analyte (i.e., the sampling and/or analytical procedure should be
adjusted before a retest). The %R value for each compound must be
reported in the test report, and all field measurements must be
corrected with the calculated %R value for that compound by using
equation 1 to this paragraph:
[GRAPHIC] [TIFF OMITTED] TR05AP24.039
(6) Calculate the mass emission of EtO by using equations 2 and 3
to this paragraph:
[GRAPHIC] [TIFF OMITTED] TR05AP24.040
Where:
MAPCD, i = average inlet mass rate of EtO per hour, lb/hr
CEtO,i = inlet EtO concentration, ppmdv.
Qi = average inlet volumetric flow per hour at standard conditions,
dscf/hr
44.05 = molecular weight (MW) of EtO, lb/lb-mole
MW/385.1 x 10\6\ = conversion factor, from ppmv at standard
conditions to lb/cf
EAPCD, o = average outlet mass rate of EtO per hour, lb/
hr
CEtO,o = outlet EtO concentration, ppbdv.
Qo = average outlet volumetric flow per hour at standard
conditions, dscf/hr
MW/385.1 x 10\9\ = conversion factor, from ppbv at standard
conditions to lb/cf
(c) Alternative approach for SCVs for facility where EtO use is
less than 100 pounds per year. If you do not own or operate a single-
item sterilizer, to demonstrate compliance with the percent emission
reduction standards for emissions streams that are comprised only of
SCVs, you may use the following procedures as an alternative to
paragraph (b) of this section to determine the mass emissions of EtO
being emitted via sterilization chamber(s) vents prior to the controls.
(1) Determine the mass (MSCV,n) of EtO used for each
charge and at each sterilization chamber used during the performance
tests using the procedures in either paragraph (c)(1)(i) or (ii) of
this section.
(i) Weigh the EtO gas cylinder(s) used to charge the sterilizer(s)
before and after charging. Record these weights to the nearest 45 g
(0.1 lb) and calculate the theoretical mass (MSCV,n) vented
to the controls using equation 4 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.041
Where:
MSCV,n = Theoretical total mass of EtO vented to
controls per charge, g (lb)
Mcharge = total mass of sterilizer gas charge, g
(lb)
%E.O.w = weight percent of EtO
(ii) Install a calibrated rate meter at the sterilizer inlet(s) and
continuously measure the flow rate (Qm) and duration of each
sterilizer charge. Calculate the theoretical mass (MSCV,n)
vented to the controls using equation 5 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.042
Where:
MSCV,n = Total mass of EtO sent to controls per
charge
Qm = volumetric flow rate, liters per minute (L/min)
corrected to 20 [deg]C and
[[Page 24185]]
101.325 kilopascals (kPa) (scf per minute (scfm) corrected to 68
[deg]F and 1 atmosphere of pressure (atm))
Tn = time duration of each charge, min
n = number of EtO charges
%E.O.v = volume fraction percent of EtO
MW = molecular weight of EtO, 44.05 grams per gram-mole (g/g-
mole) (44.05 pounds per pound-mole (lb/lb-mole))
SV = standard volume, 24.05 liters per gram-mole (L/g-mole) at
20 [deg]C and 101.325 kPa (385.1 scf per pound-mole (scf/lb-mole) at
68 [deg]F and 1 atm).
(2) Determine the mass rate of EtO sent to controls during the
performance test using equation 6 to this paragraph.
[GRAPHIC] [TIFF OMITTED] TR05AP24.043
Where:
MSCV = Total mass of EtO sent to controls per hour,
g/hr (lb/hr)
MSCV,n = Total mass of EtO sent to controls per
charge per chamber, g (lb)
Tt = Total time of the performance test, hour
n = Total number of charges during testing period
f = Portion of EtO use that is assumed to be routed to the
control system (0.93 if aeration is conducted in separate vessel;
0.98 otherwise)
(d) Compliance determination for facility where EtO use is less
than 100 pounds per year. Each compliance demonstration shall consist
of three separate runs using the applicable methods in paragraph (b) or
(c) of this section. To determine compliance with the relevant
standard, arithmetic mean of the three runs must be used. These
procedures may be performed over a run duration of 1-hour (for a total
of three 1-hour runs), except for the SCV testing from this category,
where each run shall consist of the entirety of the sterilizer chamber
evacuation and subsequent washes. The owner or operator may not conduct
performance tests during periods of malfunction. The owner or operator
must record the process information that is necessary to document
operating conditions during the test and include in such record an
explanation to support that such conditions represent the entire range
of normal operation, including operational conditions for maximum
emissions if such emissions are not expected during maximum production.
The owner or operator must also account for the control system
residence time when conducting the performance test. Upon request, the
owner or operator shall make available to the Administrator such
records as may be necessary to determine the conditions of performance
tests. The following procedures shall be used to demonstrate compliance
with a removal efficiency standard. In addition to these procedures,
the procedures in paragraph (e) of this section must be followed to
establish the operating parameter limits for each applicable emission
control(s).
(1) You may determine the mass rate emissions of the stream prior
to the control system and at the outlet of the control system using the
test methods in paragraph (b) of this section. If the vent stream is
comprised only of one or more SCVs, then you may use the procedures in
paragraph (c) of this section for the mass rate emissions at the inlet.
(2) Calculate the total mass of EtO per hour that is routed to the
control system by summing the mass of EtO per hour from each vent.
(3) Determine percent emission reduction (%ER) using the equation 7
to this paragraph:
[GRAPHIC] [TIFF OMITTED] TR05AP24.044
Where:
% ER = percent emission reduction
MAPCD,i = total mass of EtO per hour to the control
device
EAPCD,o = total mass of EtO per hour from the
control device
(4) Repeat these procedures two additional times. The arithmetic
average percent efficiency of the three runs shall determine the
overall efficiency of the control system.
(e) Determination of operating limits for control device(s). If you
are using performance testing to demonstrate compliance with removal
efficiency standards, and if you are not demonstrating continual
compliance with the applicable standard(s) using an EtO CEMS, you must
also determine the operating limit(s) for each control device and then
monitor the parameter(s) for each control device. The procedures in the
following paragraphs shall be used to establish the parameter operating
limits to be continually monitored in Sec. 63.364.
(1) Acid-water scrubbers. The procedures in paragraph (e)(1) of
this section shall be used to determine the operating limits for acid-
water scrubbers.
(i) Ethylene glycol concentration. For determining the ethylene
glycol concentration operating limit, you must establish the maximum
ethylene glycol concentration as the ethylene glycol concentration
averaged over three test runs; use the sampling and analysis procedures
in ASTM D3695-88 (incorporated by reference, see Sec. 63.14) to
determine the ethylene glycol concentration.
(ii) Scrubber liquor tank level. During the performance test, you
must monitor and record the scrubber liquor tank level to the nearest
\1/4\ inch at the end of each of the three test runs. Use the data
collected during the most recent performance test to calculate the
average scrubber liquor tank level. This scrubber liquor tank level is
the maximum operating limit for your scrubber liquor tank. Repeat this
procedure for every scrubber liquor tank that is included in the
performance test.
(iii) Scrubber liquor pH. During the performance test, you must
monitor and record the scrubber liquor pH at least once every 15
minutes during each of the three test runs. You must use pH
[[Page 24186]]
monitors as described in Sec. 63.364(b)(3). Use the data collected
during the most recent performance test to calculate the average
scrubber pH measured. This scrubber liquor pH is the maximum operating
limit for your acid-water scrubber. Repeat this procedure for every
scrubber liquor tank that is included in the performance test.
(2) Thermal oxidizers. The procedures in this paragraph shall be
used to determine the operating limits for thermal oxidizers.
(i) During the performance test, you must monitor and record the
temperature at least once every 15 minutes during each of the three
test runs. You must monitor the temperature in the firebox of the
thermal oxidizer or immediately downstream of the firebox. You must use
temperature monitors as described in Sec. 63.364(c)(4).
(ii) Use the data collected during the performance test to
calculate and record the average temperature for each test run
maintained during the performance test. The average temperature of the
test runs is the minimum operating limit for your thermal oxidizer,
unless it exceeds the recommended maximum oxidation temperature
provided by the oxidation unit manufacturer. If this occurs, the
minimum operating limit for your thermal oxidizer consists of the
recommended maximum oxidation temperature provided by the oxidation
unit manufacturer.
(iii) Paragraphs (e)(2)(i) and (ii) of this section must be
completed for each thermal oxidizer that is involved in the performance
test.
(3) Catalytic oxidizers. The procedures in this paragraph shall be
used to determine the operating limits for catalytic oxidizers.
(i) Prior to the start of the performance test, you must check the
catalyst bed for channeling, abrasion, and settling. If problems are
found during the inspection, you must replace the catalyst bed or take
other correction action consistent with the manufacturer's
recommendations.
(ii) During the performance test, you must monitor and record the
temperature at the inlet to the catalyst bed and the temperature
difference across the catalyst bed at least once every 15 minutes
during each of the three test runs. You must use temperature monitors
as described in Sec. 63.364(c)(4).
(iii) Use the data collected during the performance test to
calculate and record the average temperature at the inlet to the
catalyst bed and the average temperature difference across the catalyst
bed maintained for each test run, and then calculate the arithmetic
averages of the test runs. These arithmetic averages of the test runs
are the minimum operating limits for your catalytic oxidizer, unless it
exceeds the recommended maximum oxidation temperature provided by the
oxidation unit manufacturer. If this occurs, the minimum operating
limit for your catalytic oxidizer consists of the recommended maximum
oxidation temperature provided by the oxidation unit manufacturer.
(iv) Paragraphs (e)(3)(i) through (iii) of this section must be
completed for each catalytic oxidizer that is involved in the
performance test.
(4) Gas/solid reactors. During the performance test, you must
monitor and record the gas/solid reactor pressure drop at least once
every 15 minutes during each of the three test runs. Use the data
collected during the most recent performance test to calculate the gas/
solid reactor pressure measured. This gas/solid reactor pressure is the
maximum operating limit for your gas/solid. Repeat this procedure for
every gas/solid reactor that is included in the performance test.
(5) Other control system for facility where EtO use is less than
100 pounds per year. If you seek to demonstrate compliance with a
standard found at Sec. 63.362 with a control device other than an
acid-water scrubber, catalytic oxidizer, thermal oxidizer, or gas/solid
reactor, you must provide to the Administrator the information
requested under Sec. 63.363(e). You must submit a monitoring plan that
contains the following items: a description of the device; test results
collected in accordance with Sec. 63.363(e) verifying the performance
of the device for controlling EtO emissions to the atmosphere to the
levels required by the applicable standards; the appropriate operating
parameters that will be monitored, identifying the ongoing QA
procedures and performance specifications that will be conducted on the
instruments; the frequency of conducting QA and performance checks; and
the frequency of measuring and recording to establish continuous
compliance with the standards. Your monitoring plan is subject to the
Administrator's approval. Upon approval by the Administrator you must
install, calibrate, operate, and maintain the monitor(s) approved by
the Administrator based on the information submitted in your monitoring
plan. You must include in your monitoring plan proposed performance
specifications and quality assurance procedures for your monitors. The
Administrator may request further information and shall approve
appropriate test methods and procedures.
(f) Determination of compliance with PTE requirement. If you are
required to operate any portion of your facility with PTE, you must
demonstrate initial compliance with the requirements of this subpart by
following the procedures of paragraphs (f)(1) through (3) of this
section, as applicable, during the initial compliance demonstration or
during the initial certification of the CEMS tests.
(1) Determine the capture efficiency by verifying the capture
system meets the criteria in section 6 of Method 204 of appendix M to
part 51 of this chapter and directs all the exhaust gases from the
enclosure to an add-on control device.
(2) Ensure that the air passing through all NDOs flows into the
enclosure continuously. If the facial velocities (FVs) are less than or
equal to 9,000 meters per hour (492 feet per minute), the continuous
inward flow of air shall be verified by continuous observation using
smoke tubes, streamers, tracer gases, or other means approved by the
Administrator over the period that the volumetric flow rate tests
required to determine FVs are carried out. If the FVs are greater than
9,000 meters per hour (492 feet per minute), the direction of airflow
through the NDOs shall be presumed to be inward at all times without
verification.
(3) If you are demonstrating continuous compliance through
monitoring the volumetric flow rate, you must monitor and record the
volumetric flow rate (in cubic feet per second) from the PTE through
the stack(s) at least once every 15 minutes during each of the three
test runs. Use the data collected during the most recent compliance
demonstration to calculate the average volumetric flow rate measured
during the compliance demonstration. This volumetric flow rate is the
minimum operating limit for the stack. Repeat this procedure for every
stack that is included in the compliance demonstration.
Sec. 63.366 Reporting requirements.
(a) General requirements. The owner or operator of an affected
source subject to the emissions standards in Sec. 63.362 must fulfill
all reporting requirements in Sec. 63.10(a), (d), (e), and (f),
according to the applicability in table 6 to this subpart. These
reports will be made to the Administrator at the appropriate address
identified in Sec. 63.13 or submitted electronically.
(b) Initial compliance report submission. You must submit an
initial compliance report that provides summary, monitoring system
[[Page 24187]]
performance, and deviation information to the Administrator on April 5,
2027, or once the report template for this subpart has been available
on the Compliance and Emissions Data Reporting Interface (CEDRI)
website for one year, whichever date is later, to the EPA via CEDRI,
which can be accessed through the EPA's Central Data Exchange (CDX)
(https://cdx.epa.gov/). The EPA will make all the information submitted
through CEDRI available to the public without further notice to you. Do
not use CEDRI to submit information you claim as confidential business
information (CBI). Anything submitted using CEDRI cannot later be
claimed CBI. You must use the appropriate electronic report template on
the CEDRI website (https://www.epa.gov/electronic-reporting-air-emissions/cedri) for this subpart. The date report templates become
available will be listed on the CEDRI website. The report must be
submitted by the deadline specified in this subpart, regardless of the
method in which the report is submitted. Although we do not expect
persons to assert a claim of CBI, if you wish to assert a CBI claim,
submit a complete report, including information claimed to be CBI, to
the EPA. The CBI report must be generated using the appropriate form on
the CEDRI website or an alternate electronic file consistent with the
extensible markup language (XML) schema listed on the CEDRI website.
Submit the CBI file on a compact disc, flash drive, or other commonly
used electronic storage medium and clearly mark the medium as CBI. Mail
the electronic medium to U.S. EPA/OAQPS/CORE CBI Office, Attention:
Commercial Sterilization Facilities Sector Lead, MD C404-02, 4930 Old
Page Rd., Durham, NC 27703. The same file with the CBI omitted must be
submitted to the EPA via the EPA's CDX as described earlier in this
paragraph. All CBI claims must be asserted at the time of submission.
Furthermore, under CAA section 114(c), emissions data is not entitled
to confidential treatment, and the EPA is required to make emissions
data available to the public. Thus, emissions data will not be
protected as CBI and will be made publicly available. Reports of
deviations from an operating limit shall include all information
required in Sec. 63.10(c)(5) through (13), as applicable in table 6 to
this subpart, along with information from any calibration tests in
which the monitoring equipment is not in compliance with Performance
Specification 19 in appendix B and Procedure 7 in appendix F to part 60
of this chapter or the method used for parameter monitoring device
calibration. Reports shall also include the name, title, and signature
of the responsible official who is certifying the accuracy of the
report. If your report is submitted via CEDRI, the certifier's
electronic signature during the submission process replaces this
requirement. When no deviations have occurred or monitoring equipment
has not been inoperative, repaired, or adjusted, such information shall
be stated in the report. In addition, the summary report shall include:
(1) The following information:
(i) Date that facility commenced construction or reconstruction;
(ii) Hours of commercial sterilization operation over the previous
12 months; and
(iii) Monthly EtO use, in tons, over the previous 36 months.
(iv) If you are electing to determine the mass of EtO sent to the
control device from the SCV(s) via the procedure in Sec.
63.364(f)(1)(i), you must report the daily EtO use from each applicable
chamber for the previous 7 months.
(v) An indication if you are required to comply with one or more
combined emission stream limitations. If so, indicate the affected
sources that are included in each combined emission stream limitation.
(vi) An indication if you are electing to comply with a site-wide
emission limit. If you are electing to comply with a site-wide emission
limit, report the daily EtO use over the previous 7 months.
(2) If your sterilization facility is demonstrating continuous
compliance through periodic performance testing, you must report the
following:
(i) Control system ID;
(ii) Control device ID;
(iii) Control device type; and
(iv) Recirculation tank ID if an acid-water scrubber is used to
meet the emission standard and you elect to comply with the maximum
scrubber liquor height limit;
(3) You must report the following for each sterilization chamber at
your facility:
(i) The sterilization chamber ID;
(ii) The ID of the control system that the SCV was routed to, if
applicable;
(iii) The portion of SCV exhaust that was routed to the control
system, if applicable;
(iv) The ID of the EtO CEMS that was used to monitor SCV emissions,
if applicable;
(v) The portion of SCV exhaust that was monitored with the EtO
CEMS, if applicable;
(vi) The ID of the control system that the CEV was routed to, if
applicable;
(vii) The portion of CEV exhaust that was routed to the control
system, if applicable;
(viii) The ID of the EtO CEMS that was used to monitor CEV
emissions, if applicable;
(ix) The portion of CEV exhaust that was monitored with the EtO
CEMS, if applicable;
(4) If emissions from any room in your facility are subject to an
emission standard, you must report the following for each room where
there is the potential for EtO emissions:
(i) Room ID;
(ii) Documentation of emissions occurring within the room,
including aeration, EtO storage, EtO dispensing, pre-aeration handling
of sterilized material, and post-aeration handling of sterilized
material;
(iii) The ID of the control system that the room air was routed to,
if applicable;
(iv) The portion of room air that was routed to the control system,
if applicable;
(v) The ID of the EtO CEMS that was used to monitor room air
emissions, if applicable;
(vi) The portion of room air that was monitored with the EtO CEMS,
if applicable;
(5) If an EtO CEMS was used to demonstrate continuous compliance
with an emission standard for more than 30-operating days, you must
report the following:
(i) The information specified in section 11 of appendix A to this
subpart.
(ii) The affected sources that are included in each inlet that is
being monitored with EtO CEMS;
(iii) The IDs of each inlet(s) to and outlet(s) from each control
system.
(iv) The daily sum of EtO for each inlet, along with 30-operating
day rolling sums.
(v) The daily sum of EtO emissions from each outlet of the control
system, along with 30-operating day rolling sums.
(vi) For each day, calculate and report the daily mass emission
limit that the control system must achieve based on the previous 30
days of data. For control systems with multiple emission streams, and
complying with a combined emission stream limitation in Sec. 63.362(i)
or a SWEL in Sec. 63.362(j), report the daily 30-operating day mass
emission limit as determined in accordance with CES in Sec.
63.362(i)(1)(i) and (i)(2)(i) or with Sec. 63.362(j)(1)(i) and
(j)(2)(i), as applicable.
(vii) For each day, the mass of EtO emitted from the control system
over the previous 30 operating days.
(6) If any portion of your facility is required to be operated with
PTE, you must report the following:
[[Page 24188]]
(i) If you are choosing to demonstrate continuous compliance
through the use of volumetric flow rate monitoring, you must report the
3-hr rolling average, rolled hourly volumetric flow from each outlet
where air from the PTE is sent, in cubic feet per second.
(ii) If you are choosing to demonstrate continuous compliance
through use of differential pressure monitoring, you must report the 3-
hr rolling average, rolled hourly pressure differential reading, in
inches water.
(7) If you are complying with the requirement to follow the best
management practice to limit sterilization chamber concentration of EtO
to 1 ppmv prior to opening the sterilization chamber door, you must
provide a certification from your responsible official that this
approach is being followed and you are meeting the monitoring
requirements at Sec. 63.362(h).
(8) If you own or operate an existing collection of Group 2 room
air emissions at an area source facility and facility EtO use is less
than 4 tpy, you must report the following for each room where there are
Group 2 room air emissions:
(i) Room ID;
(ii) Number of room air changes per hour;
(iii) Room temperature, in degrees Celsius; and
(iv) EtO concentration, in ppmv dry basis (ppbvd).
(9) If you own or operate an existing collection of Group 2 room
air emissions at an area source facility and EtO use is less than 4
tpy, you are not required to report the information in paragraph (b)(8)
of this section if you meet the following requirements:
(i) You are complying with the best management practice to limit
sterilization chamber concentration of EtO to 1 ppmv prior to opening
the sterilization chamber door; and
(ii) The requirements of Sec. 63.363 are met.
(10) Report the number of deviations to meet an applicable
standard. For each instance, report the date, time, the cause and
duration of each deviation. For each deviation the report must include
a list of the affected sources or equipment, an estimate of the
quantity of each regulated pollutant emitted over any emission limit,
and a description of the method used to determine the emissions.
(c) Quarterly compliance report submission. You must submit
compliance reports that provide summary, monitoring system performance,
and deviation information to the Administrator within 30 days following
the end of each calendar quarter. Beginning on April 5, 2027, or once
the report template for this subpart has been available on the
Compliance and Emissions Data Reporting Interface (CEDRI) website for 1
year, whichever date is later, submit all subsequent reports to the EPA
via CEDRI, which can be accessed through the EPA's CDX (https://cdx.epa.gov/). The EPA will make all the information submitted through
CEDRI available to the public without further notice to you. Do not use
CEDRI to submit information you claim as CBI. Anything submitted using
CEDRI cannot later be claimed CBI. You must use the appropriate
electronic report template on the CEDRI website (https://www.epa.gov/electronic-reporting-air-emissions/cedri) for this subpart. The date
report templates become available will be listed on the CEDRI website.
The report must be submitted by the deadline specified in this subpart,
regardless of the method in which the report is submitted. Although we
do not expect persons to assert a claim of CBI, if you wish to assert a
CBI claim, submit a complete report, including information claimed to
be CBI, to the EPA. The CBI report must be generated using the
appropriate form on the CEDRI website or an alternate electronic file
consistent with the XML schema listed on the CEDRI website. Submit the
CBI file on a compact disc, flash drive, or other commonly used
electronic storage medium and clearly mark the medium as CBI. Mail the
electronic medium to U.S. EPA/OAQPS/CORE CBI Office, Attention:
Commercial Sterilization Facilities Sector Lead, MD C404-02, 4930 Old
Page Rd., Durham, NC 27703. The same file with the CBI omitted must be
submitted to the EPA via the EPA's CDX as described earlier in this
paragraph. All CBI claims must be asserted at the time of submission.
Furthermore, under CAA section 114(c), emissions data is not entitled
to confidential treatment, and the EPA is required to make emissions
data available to the public. Reports of deviations from an operating
limit shall include all information required in Sec. 63.10(c)(5)
through (13), as applicable in table 6 to this subpart, and information
from any calibration tests in which the monitoring equipment is not in
compliance with Performance Specification 19 in appendix B and
Procedure 7 in appendix F to part 60 of this chapter or the method used
for parameter monitoring device calibration. Reports shall also include
the name, title, and signature of the responsible official who is
certifying the accuracy of the report. If your report is submitted via
CEDRI, the certifier's electronic signature during the submission
process replaces this requirement. When no deviations have occurred or
monitoring equipment has not been inoperative, repaired, or adjusted,
such information shall be stated in the report. In addition, the
summary report shall include:
(1) The information listed in paragraphs (b)(1)(i) through (vi) of
this section, with the exception that monthly EtO use, in tons, only
needs reported for the previous 12 months;
(2) If your sterilization facility is demonstrating continuous
compliance through periodic performance testing, you must report the ID
for any control system that has not operated since the end of the
period covered by the previous compliance report. If a control system
has commenced operation since end of the period covered by the previous
compliance report, or if any of the information in paragraphs (b)(2)(i)
through (iv) of this section has changed for a control system that was
included in the previous compliance report, you must report the
information in paragraphs (b)(2)(i) through (iv) of this section for
those control systems;
(3) You must report the ID for any sterilization chamber that has
not operated since then end of the period covered by the previous
compliance report. If a sterilization chamber has commenced operation
since the end of the period covered by the previous compliance report,
or if any of the information in paragraphs (b)(3)(i) through (ix) of
this section has changed for a sterilization chamber that was included
in the previous compliance report, you must report the information in
paragraphs (b)(3)(i) through (ix) of this section for those
sterilization chambers;
(4) If emissions from any room in your facility are subject to an
emission standard, you must report the ID for any room where there has
not been the potential for EtO emissions since the end of the period
covered by the previous compliance report. If a room has had the
potential for EtO emissions since the end of the period covered by the
previous compliance report, or if any of the information in paragraphs
(b)(4)(i) through (vi) of this section has changed for a room where
there is the potential for EtO emissions that was included in the
previous compliance report, you must report the information in
paragraphs (b)(4)(i) through (vi) of this section for those rooms;
(5) If an EtO CEMS was used to demonstrate continuous compliance,
you must report the information specified in paragraphs (b)(5)(i)
through (vi) of this section.
[[Page 24189]]
(6) If any portion of your facility is required to be operated with
PTE, you must report the information listed in paragraph (b)(6) of this
section.
(7) If you are complying with the requirement to follow the best
management practice to limit sterilization chamber concentration of EtO
to 1 ppmv prior to opening the sterilization chamber door, you must
provide a certification from your responsible official that this
approach is being followed and you are meeting the monitoring
requirements at Sec. 63.362(h).
(8) If you own or operate an existing collection of Group 2 room
air emissions at an area source facility and facility EtO use is less
than 4 tpy, you must report the ID for any room where Group 2 room air
emissions have ceased since end of the period covered by the previous
compliance report. If a room has had Group 2 room air emissions since
the end of the period covered by the previous compliance report, or if
any of the information in paragraphs (b)(8)(i) through (iv) of this
section has changed for a room where there are Group 2 room air
emissions that were included in the previous compliance report, you
must report the information in paragraphs (b)(8)(i) through (iv) of
this section for each room where there are Group 2 room air emissions.
(9) If you own or operate an existing collection of Group 2 room
air emissions at an area source facility and facility EtO use is less
than 4 tpy, you are not required to report the information in paragraph
(c)(8) of this section if you meet the requirements in paragraph (b)(9)
of this section.
(10) Report the number of deviations to meet an applicable
standard. For each instance, report the date, time, the cause, and
duration of each deviation. For each deviation, the report must include
a list of the affected sources or equipment, the quantity of each
regulated pollutant emitted over any emission limit, and a description
of the method used to determine the emissions.
(d) Construction and reconstruction application. You must fulfill
all requirements for construction or reconstruction of a facility in
Sec. 63.5, according to the applicability in table 6 to this subpart,
and in this paragraph.
(1) Applicability. (i) This paragraph (d) and Sec. 63.5 implement
the preconstruction review requirements of section 112(i)(1) for
facilities subject to these emissions standards. In addition, this
paragraph (d) and Sec. 63.5 include other requirements for constructed
and reconstructed facilities that are or become subject to these
emissions standards.
(ii) After April 5, 2024, the requirements in this section and in
Sec. 63.5 apply to owners or operators who construct a new facility or
reconstruct a facility subject to these emissions standards after April
5, 2024. New or reconstructed facilities subject to these emissions
standards with an initial startup date before the effective date are
not subject to the preconstruction review requirements specified in
paragraphs (b)(2) and (3) of this section and Sec. 63.5(d)(3) and (4)
and (e).
(2) Advance approval. After April 5, 2024, whether or not an
approved permit program is effective in the jurisdictional authority in
which a facility is (or would be) located, no person may construct a
new facility or reconstruct a facility subject to these emissions
standards, or reconstruct a facility such that the facility becomes a
facility subject to these emissions standards, without obtaining
advance written approval from the Administrator in accordance with the
procedures specified in paragraph (b)(3) of this section and Sec.
63.5(d)(3) and (4) and (e).
(3) Application for approval of construction or reconstruction. The
provisions of paragraph (b)(3) of this section and Sec. 63.5(d)(3) and
(4) implement section 112(i)(1) of the Act.
(i) General application requirements. (A) An owner or operator who
is subject to the requirements of paragraph (b)(2) of this section
shall submit to the Administrator an application for approval of the
construction of a new facility subject to these emissions standards,
the reconstruction of a facility subject to these emissions standards,
or the reconstruction of a facility such that the facility becomes a
facility subject to these emissions standards. The application shall be
submitted as soon as practicable before the construction or
reconstruction is planned to commence (but not sooner than the
effective date) if the construction or reconstruction commences after
the effective date. The application shall be submitted as soon as
practicable before the initial startup date but no later than 60 days
after the effective date if the construction or reconstruction had
commenced and the initial startup date had not occurred before the
effective date. The application for approval of construction or
reconstruction may be used to fulfill the initial notification
requirements of paragraph (e)(1)(iii) of this section. The owner or
operator may submit the application for approval well in advance of the
date construction or reconstruction is planned to commence in order to
ensure a timely review by the Administrator and that the planned
commencement date will not be delayed.
(B) A separate application shall be submitted for each construction
or reconstruction. Each application for approval of construction or
reconstruction shall include at a minimum:
(1) The applicant's name and address.
(2) A notification of intention to construct a new facility subject
to these emissions standards or make any physical or operational change
to a facility subject to these emissions standards that may meet or has
been determined to meet the criteria for a reconstruction, as defined
in Sec. 63.2.
(3) The address (i.e., physical location) or proposed address of
the facility.
(4) An identification of the relevant standard that is the basis of
the application.
(5) The expected commencement date of the construction or
reconstruction.
(6) The expected completion date of the construction or
reconstruction.
(7) The anticipated date of (initial) startup of the facility.
(8) The type and quantity of hazardous air pollutants emitted by
the facility, reported in units and averaging times and in accordance
with the test methods specified in the standard, or if actual emissions
data are not yet available, an estimate of the type and quantity of
hazardous air pollutants expected to be emitted by the facility
reported in units and averaging times specified. The owner or operator
may submit percent reduction information, if the standard is
established in terms of percent reduction. However, operating
parameters, such as flow rate, shall be included in the submission to
the extent that they demonstrate performance and compliance.
(9) Other information as specified in paragraph (b)(3)(ii) of this
section and Sec. 63.5(d)(3).
(C) An owner or operator who submits estimates or preliminary
information in place of the actual emissions data and analysis required
in paragraphs (b)(3)(i)(B)(8) and (b)(3)(ii) of this section shall
submit the actual, measured emissions data and other correct
information as soon as available but no later than with the
notification of compliance status required in paragraph (c)(2) of this
section.
(ii) Application for approval of construction. Each application for
approval of construction shall include, in addition to the information
required in paragraph (b)(3)(i)(B) of this section, technical
information describing the proposed nature, size, design, operating
design capacity, and method of
[[Page 24190]]
operation of the facility subject to these emissions standards,
including an identification of each point of emission for each
hazardous air pollutant that is emitted (or could be emitted) and a
description of the planned air pollution control system (equipment or
method) for each emission point. The description of the equipment to be
used for the control of emissions shall include each control device for
each hazardous air pollutant and the estimated control efficiency
(percent) for each control device. The description of the method to be
used for the control of emissions shall include an estimated control
efficiency (percent) for that method. Such technical information shall
include calculations of emission estimates in sufficient detail to
permit assessment of the validity of the calculations. An owner or
operator who submits approximations of control efficiencies under
paragraph (b)(3) of this section shall submit the actual control
efficiencies as specified in paragraph (b)(3)(i)(C) of this section.
(4) Approval of construction or reconstruction based on prior
jurisdictional authority preconstruction review. (i) The Administrator
may approve an application for construction or reconstruction specified
in paragraphs (b)(2) and (3) of this section and Sec. 63.5(d)(3) and
(4) if the owner or operator of a new or reconstructed facility who is
subject to such requirement demonstrates to the Administrator's
satisfaction that the following conditions have been (or will be) met:
(A) The owner or operator of the new or reconstructed facility
subject to these emissions standards has undergone a preconstruction
review and approval process in the jurisdictional authority in which
the facility is (or would be) located before the effective date and has
received a federally enforceable construction permit that contains a
finding that the facility will meet these emissions standards as
proposed, if the facility is properly built and operated;
(B) In making its finding, the jurisdictional authority has
considered factors substantially equivalent to those specified in Sec.
63.5(e)(1).
(ii) The owner or operator shall submit to the Administrator the
request for approval of construction or reconstruction no later than
the application deadline specified in paragraph (b)(3)(i) of this
section. The owner or operator shall include in the request information
sufficient for the Administrator's determination. The Administrator
will evaluate the owner or operator's request in accordance with the
procedures specified in Sec. 63.5. The Administrator may request
additional relevant information after the submittal of a request for
approval of construction or reconstruction.
(e) Notification requirements. The owner or operator of an affected
source subject to an emissions standard in Sec. 63.362 shall fulfill
all notification requirements in Sec. 63.9, according to the
applicability in table 6 to this subpart, and in this paragraph (e).
(1) Initial notifications. (i) If you own or operate an affected
source subject to an emissions standard in Sec. 63.362, you may use
the application for approval of construction or reconstruction under
paragraph (d)(3)(ii) of this section and Sec. 63.5(d)(3),
respectively, if relevant to fulfill the initial notification
requirements.
(ii) The owner or operator of a new or reconstructed facility
subject to these emissions standards that has an initial startup date
after the effective date and for which an application for approval of
construction or reconstruction is required under paragraph (d)(3) of
this section and Sec. 63.5(d)(3) and (4) shall provide the following
information in writing to the Administrator:
(A) A notification of intention to construct a new facility subject
to these emissions standards, reconstruct a facility subject to these
emissions standards, or reconstruct a facility such that the facility
becomes a facility subject to these emissions standards with the
application for approval of construction or reconstruction as specified
in paragraph (d)(3)(i)(A) of this section;
(B) A notification of the date when construction or reconstruction
was commenced, submitted simultaneously with the application for
approval of construction or reconstruction, if construction or
reconstruction was commenced before the effective date of these
standards;
(C) A notification of the date when construction or reconstruction
was commenced, delivered or postmarked no later than 30 days after such
date, if construction or reconstruction was commenced after the
effective date of these standards;
(D) A notification of the anticipated date of startup of the
facility, delivered or postmarked not more than 60 days nor less than
30 days before such date; and
(E) A notification of the actual date of initial startup of the
facility, delivered or postmarked within 15 calendar days after that
date.
(iii) After the effective date, whether or not an approved permit
program is effective in the jurisdictional authority in which a
facility subject to these emissions standards is (or would be) located,
an owner or operator who intends to construct a new facility subject to
these emissions standards or reconstruct a facility subject to these
emissions standards, or reconstruct a facility such that it becomes a
facility subject to these emissions standards, shall notify the
Administrator in writing of the intended construction or
reconstruction. The notification shall be submitted as soon as
practicable before the construction or reconstruction is planned to
commence (but no sooner than the effective date of these standards) if
the construction or reconstruction commences after the effective date
of the standard. The notification shall be submitted as soon as
practicable before the initial startup date but no later than 60 days
after the effective date of this standard if the construction or
reconstruction had commenced and the initial startup date has not
occurred before the standard's effective date. The notification shall
include all the information required for an application for approval of
construction or reconstruction as specified in paragraph (d)(3) of this
section and Sec. 63.5(d)(3) and (4). For facilities subject to these
emissions standards, the application for approval of construction or
reconstruction may be used to fulfill the initial notification
requirements of Sec. 63.9.
(2) If an owner or operator of a facility subject to these
emissions standards submits estimates or preliminary information in the
application for approval of construction or reconstruction required in
paragraph (d)(3)(ii) of this section and Sec. 63.5(d)(3),
respectively, in place of the actual emissions data or control
efficiencies required in paragraphs (d)(3)(i)(B)(8) and (b)(3)(ii) of
this section, the owner or operator shall submit the actual emissions
data and other correct information as soon as available but no later
than with the initial notification of compliance status.
(3) If you own or operate an affected source subject to an
emissions standard in Sec. 63.362, you must also include the amount of
EtO used at the facility during the previous consecutive 12-month
period in the initial notification report required by Sec. 63.9(b)(2)
and (3). For new sterilization facilities subject to this subpart, the
amount of EtO used at the facility shall be an estimate of expected use
during the first consecutive 12-month period of operation.
(4) Beginning October 7, 2024, you must submit all subsequent
Notification of Compliance Status reports in PDF formatto the EPA
following the
[[Page 24191]]
procedure specified in Sec. 63.9(k), except any medium submitted
through mail must be sent to the attention of the Commercial
Sterilization Sector Lead.
(f) Performance test submission. Beginning on June 4, 2024, within
60 days after the date of completing each performance test required by
this subpart, you must submit the results of the performance test
following the procedures specified in paragraphs (f)(1) through (3) of
this section.
(1) Data collected using test methods supported by the EPA's
Electronic Reporting Tool (ERT) as listed on the EPA's ERT website
(https://www.epa.gov/electronic-reporting-air-emissions/electronic-reporting-tool-ert) at the time of the test. Submit the results of the
performance test to the EPA via the CEDRI, which can be accessed
through the EPA's CDX (https://cdx.epa.gov/). The data must be
submitted in a file format generated using the EPA's ERT.
Alternatively, you may submit an electronic file consistent with the
XML schema listed on the EPA's ERT website.
(2) Data collected using test methods that are not supported by the
EPA's ERT as listed on the EPA's ERT website at the time of the test.
The results of the performance test must be included as an attachment
in the ERT or an alternate electronic file consistent with the XML
schema listed on the EPA's ERT website. Submit the ERT generated
package or alternative file to the EPA via CEDRI.
(3) CBI. Do not use CEDRI to submit information you claim as CBI.
Anything submitted using CEDRI cannot later be claimed CBI. Although we
do not expect persons to assert a claim of CBI, if you wish to assert a
CBI claim for some of the information submitted under paragraph
(f)(1)(i) or (ii) of this section, you must submit a complete file,
including information claimed to be CBI, to the EPA. The file must be
generated using the EPA's ERT or an alternate electronic file
consistent with the XML schema listed on the EPA's ERT website. Submit
the file on a compact disc, flash drive, or other commonly used
electronic storage medium and clearly mark the medium as CBI. Mail the
electronic medium to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group
Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Rd.,
Durham, NC 27703. The same file with the CBI omitted must be submitted
to the EPA via the EPA's CDX as described in paragraphs (f)(1)(i) and
(ii) of this section. All CBI claims must be asserted at the time of
submission. Furthermore, under CAA section 114(c), emissions data is
not entitled to confidential treatment, and the EPA is required to make
emissions data available to the public. Thus, emissions data will not
be protected as CBI and will be made publicly available.
(g) Performance evaluation submission. Beginning on June 4, 2024,
within 60 days after the date of completing each CEMS performance
evaluation (as defined in Sec. 63.2), you must submit the results of
the performance evaluation following the procedures specified in
paragraphs (g)(1) through (3) of this section.
(1) Performance evaluations of CEMS measuring relative accuracy
test audit (RATA) pollutants that are supported by the EPA's ERT as
listed on the EPA's ERT website at the time of the evaluation. Submit
the results of the performance evaluation to the EPA via CEDRI, which
can be accessed through the EPA's CDX. The data must be submitted in a
file format generated using the EPA's ERT. Alternatively, you may
submit an electronic file consistent with the XML schema listed on the
EPA's ERT website.
(2) Performance evaluations of CEMS measuring RATA pollutants that
are not supported by the EPA's ERT as listed on the EPA's ERT website
at the time of the evaluation. The results of the performance
evaluation must be included as an attachment in the ERT or an alternate
electronic file consistent with the XML schema listed on the EPA's ERT
website. Submit the ERT generated package or alternative file to the
EPA via CEDRI.
(3) CBI. Do not use CEDRI to submit information you claim as CBI.
Anything submitted using CEDRI cannot later be claimed CBI. Although we
do not expect persons to assert a claim of CBI, if you wish to assert a
CBI claim for some of the information submitted under paragraph
(g)(1)(i) or (ii) of this section, you must submit a complete file,
including information claimed to be CBI, to the EPA. The CBI file must
be generated using the EPA's ERT or an alternate electronic file
consistent with the XML schema listed on the EPA's ERT website. Submit
the CBI file on a compact disc, flash drive, or other commonly used
electronic storage medium and clearly mark the medium as CBI. Mail the
electronic medium to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group
Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Rd.,
Durham, NC 27703. The same file with the CBI omitted must be submitted
to the EPA via the EPA's CDX as described in paragraphs (g)(1)(i) and
(ii) of this section. All CBI claims must be asserted at the time of
submission. Furthermore, under CAA section 114(c), emissions data is
not entitled to confidential treatment, and the EPA is required to make
emissions data available to the public. Thus, emissions data will not
be protected as CBI and will be made publicly available.
(h) Extensions for CDX/CEDRI outages. If you are required to
electronically submit a report through CEDRI in the EPA's CDX, you may
assert a claim of EPA system outage for failure to timely comply with
that reporting requirement. To assert a claim of EPA system outage, you
must meet the requirements outlined in paragraphs (h)(1) through (7) of
this section.
(1) You must have been or will be precluded from accessing CEDRI
and submitting a required report within the time prescribed due to an
outage of either the EPA's CEDRI or CDX systems.
(2) The outage must have occurred within the period of time
beginning five business days prior to the date that the submission is
due.
(3) The outage may be planned or unplanned.
(4) You must submit notification to the Administrator in writing as
soon as possible following the date you first knew, or through due
diligence should have known, that the event may cause or has caused a
delay in reporting.
(5) You must provide to the Administrator a written description
identifying:
(i) The date(s) and time(s) when CDX or CEDRI was accessed and the
system was unavailable;
(ii) A rationale for attributing the delay in reporting beyond the
regulatory deadline to EPA system outage;
(iii) A description of measures taken or to be taken to minimize
the delay in reporting; and
(iv) The date by which you propose to report, or if you have
already met the reporting requirement at the time of the notification,
the date you reported.
(6) The decision to accept the claim of EPA system outage and allow
an extension to the reporting deadline is solely within the discretion
of the Administrator.
(7) In any circumstance, the report must be submitted
electronically as soon as possible after the outage is resolved.
(i) Extensions for force majeure events. If you are required to
electronically submit a report through CEDRI in the EPA's CDX, you may
assert a claim of force majeure for failure to timely comply with that
reporting requirement. To assert a claim of force majeure, you must
meet the requirements outlined in paragraphs (i)(1) through (5) of this
section.
[[Page 24192]]
(1) You may submit a claim if a force majeure event is about to
occur, occurs, or has occurred or there are lingering effects from such
an event within the period of time beginning five business days prior
to the date the submission is due. For the purposes of this section, a
force majeure event is defined as an event that will be or has been
caused by circumstances beyond the control of the affected facility,
its contractors, or any entity controlled by the affected facility that
prevents you from complying with the requirement to submit a report
electronically within the time period prescribed. Examples of such
events are acts of nature (e.g., hurricanes, earthquakes, or floods),
acts of war or terrorism, or equipment failure or safety hazard beyond
the control of the affected facility (e.g., large scale power outage).
(2) You must submit notification to the Administrator in writing as
soon as possible following the date you first knew, or through due
diligence should have known, that the event may cause or has caused a
delay in reporting.
(3) You must provide to the Administrator:
(i) A written description of the force majeure event;
(ii) A rationale for attributing the delay in reporting beyond the
regulatory deadline to the force majeure event;
(iii) A description of measures taken or to be taken to minimize
the delay in reporting; and
(iv) The date by which you propose to report, or if you have
already met the reporting requirement at the time of the notification,
the date you reported.
(4) The decision to accept the claim of force majeure and allow an
extension to the reporting deadline is solely within the discretion of
the Administrator.
(5) In any circumstance, the reporting must occur as soon as
possible after the force majeure event occurs.
Sec. 63.367 Recordkeeping requirements.
(a) If you own or operate an affected source subject to Sec.
63.362, you must comply with the recordkeeping requirements in Sec.
63.10(a) through (c), according to the applicability in table 6 to this
subpart, and in this section. All records required to be maintained by
this subpart or a subpart referenced by this subpart shall be
maintained in such a manner that they can be readily accessed and are
suitable for inspection.
(b) You must maintain the previous five years of records specified
in Sec. 63.366(b) and (c), as applicable.
(c) You must maintain the previous five years of records for
compliance tests and associated data analysis, as applicable.
(d) Any records required to be maintained by this subpart that are
submitted electronically via the EPA's CEDRI may be maintained in
electronic format. This ability to maintain electronic copies does not
affect the requirement for facilities to make records, data, and
reports available upon request to a delegated air agency or the EPA as
part of an on-site compliance evaluation.
(e) If you are using an EtO CEMS to demonstrate continuous
compliance, you must maintain the previous five years of records for
all required certification and QA tests.
(f) For each deviation from an emission limit, operating limit, or
best management practice, you must keep a record of the information
specified in paragraph (g)(1) through (4) of this section. The records
shall be maintained as specified in Sec. 63.10(b)(1).
(1) The occurrence and duration of each startup, shutdown, or
malfunction of process, air pollution control, and monitoring
equipment.
(2) In the event that an affected unit does not meet an applicable
standard, record the number of deviations. For each deviation, record
the date, time, cause, and duration of each deviation.
(3) For each failure to meet an applicable standard, record and
retain a list of the affected sources or equipment, an estimate of the
quantity of each regulated pollutant emitted over any emission limit
and a description of the method used to estimate the emissions.
(4) Record actions taken to minimize emissions in accordance with
Sec. 63.362(k) and any corrective actions taken to return the affected
unit to its normal or usual manner of operation.
Sec. 63.368 Implementation and enforcement.
(a) This subpart can be implemented and enforced by the U.S. EPA or
a delegated authority such as the applicable State, local, or Tribal
agency. If the U.S. EPA Administrator has delegated authority to a
State, local, or Tribal agency, then that agency, in addition to the
U.S. EPA, has the authority to implement and enforce this subpart.
Contact the applicable U.S. EPA Regional Office to find out whether
implementation and enforcement of this subpart are delegated to a
State, local, or Tribal agency.
(b) In delegating implementation and enforcement authority of this
subpart to a State, local, or Tribal agency under subpart E of this
part, the authorities contained in paragraph (c) of this section are
retained by the Administrator of U.S. EPA and cannot be transferred to
the State, local, or Tribal agency.
(c) The authorities that cannot be delegated to State, local, or
Tribal agencies are as specified in paragraphs (c)(1) through (5) of
this section.
(1) Approval of alternatives to the requirements in Sec. Sec.
63.360 and 63.362.
(2) Approval of major alternatives to test methods under Sec.
63.7(e)(2)(ii) and (f), as defined in Sec. 63.90, and as required in
this subpart.
(3) Approval of major alternatives to monitoring under Sec.
63.8(f), as defined in Sec. 63.90, and as required in this subpart.
(4) Approval of major alternatives to recordkeeping and reporting
under Sec. 63.10(f), as defined in Sec. 63.90, and as required in
this subpart.
(5) Approval of an alternative to any electronic reporting to the
EPA required by this subpart.
Table 1 to Subpart O of Part 63--Standards for SCVs
As required in Sec. 63.362(c), for each SCV, you must meet the
applicable standard in the following table:
----------------------------------------------------------------------------------------------------------------
You must comply with
For each . . . For which . . . You must . . . the standard . . .
----------------------------------------------------------------------------------------------------------------
1. Existing SCV...................... a. Facility EtO use is i. Continuously reduce Until April 6, 2026.
at least 10 tpy. EtO emissions by 99
percent \1\.
b. Facility EtO use is i. Continuously reduce Until April 6, 2026.
at least 1 tpy but EtO emissions by 99
less than 10 tpy. percent \1\.
ii. Continuously reduce No later than April 6,
EtO emissions by 99.8 2026.
percent 2 3.
c. Facility EtO use is i. Continuously reduce No later than April 6,
at least 30 tpy. EtO emissions by 99.99 2026.
percent 2 3.
d. Facility EtO use is i. Continuously reduce No later than April 6,
at least 10 tpy but EtO emissions by 99.9 2026.
less than 30 tpy. percent 2 3.
e. Facility EtO use is i. Continuously reduce No later than April 5,
less than 1 tpy. EtO emissions by 99 2027.
percent 2 4.
[[Page 24193]]
2. New SCV........................... a. Initial startup is i. Continuously reduce No later than April 5,
on or before April 5, EtO emissions by 99.99 2024.
2024, and facility EtO percent 2 5.
use is at least 30 tpy.
b. Initial startup is i. Continuously reduce No later than April 5,
on or before April 5, EtO emissions by 99.9 2024.
2024, and facility EtO percent 2 5.
use is at least 10 tpy
but less than 30 tpy.
c. Initial startup is i. Continuously reduce No later than April 5,
on or before April 5, EtO emissions by 99.8 2024.
2024, and facility EtO percent 2 5.
use is at least 1 tpy
but less than 10 tpy.
d. Initial startup is i. Continuously reduce No later than April 5,
on or before April 5, EtO emissions by 99 2024.
2024, and facility EtO percent 2 6.
use is less than 1 tpy.
e. Initial startup is i. Continuously reduce Upon startup of the
after April 5, 2024, EtO emissions by 99.99 source.
and facility EtO use percent 2 5.
is at least 30 tpy.
f. Initial startup is i. Continuously reduce Upon startup of the
after April 5, 2024, EtO emissions by 99.9 source.
and facility EtO use percent 2 5.
is at least 10 tpy but
less than 30 tpy.
g. Initial startup is i. Continuously reduce Upon startup of the
after April 5, 2024, EtO emissions by 99.8 source.
and facility EtO use percent 2 5.
is at least 1 tpy but
less than 10 tpy.
h. Initial startup is i. Continuously reduce Upon startup of the
after April 5, 2024, EtO emissions by 99 source.
and facility EtO use percent 2 6.
is less than 1 tpy.
----------------------------------------------------------------------------------------------------------------
\1\ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-
month period after December 6, 1996.
\2\ If using EtO CEMS to determine compliance, this standard is based on the previous 30 operating days of data.
\3\ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-
month period after April 7, 2025.
\4\ The standard applies if the facility has used less than 1 tpy of EtO within all consecutive 12-month periods
after April 6, 2026.
\5\ The standard applies if the facility is expected to meet or exceed the specified EtO use within one year
after startup. Afterwards, the standard applies if the facility has met or exceeded the specified EtO use
within any consecutive 12-month period after startup.
\6\ The standard applies if the facility is not expected to meet or exceed 1 tpy of EtO use within one year
after startup. Afterwards, the standard applies if the facility has used less than 1 tpy of EtO within all
consecutive 12-month periods after startup.
Table 2 to Subpart O of Part 63--Standards for ARVs
As required in Sec. 63.362(d), for each ARV, you must meet the
applicable standard in the following table:
----------------------------------------------------------------------------------------------------------------
You must comply with
For each . . . For which . . . You must . . . the standard . . .
----------------------------------------------------------------------------------------------------------------
1. Existing ARV...................... a. Facility EtO use is i. Continuously reduce Until April 6, 2026.
at least 10 tpy. EtO emissions by 99
percent \1\.
b. Facility EtO use is i. Continuously reduce No later than April 6,
at least 30 tpy. EtO emissions by 99.9 2026.
percent 2 3.
c. Facility EtO use is i. Continuously reduce No later than April 6,
at least 10 tpy but EtO emissions by 99.6 2026.
less than 30 tpy. percent 2 3.
d. Facility EtO use is i. Continuously reduce No later than April 5,
less than 10 tpy. EtO emissions by 99 2027.
percent 2 4.
2. New ARV........................... a. Initial startup is i. Continuously reduce No later than April 5,
on or before April 5, EtO emissions by 99.9 2024.
2024, and facility EtO percent 2 5.
use is at least 10 tpy.
b. Initial startup is i. Continuously reduce No later than April 5,
on or before April 5, EtO emissions by 99 2024.
2024, and facility EtO percent 2 6.
use is less than 10
tpy.
c. Initial startup is i. Continuously reduce Upon startup of the
after April 5, 2024, EtO emissions by 99.9 source.
and facility EtO use percent 2 5.
is at least 10 tpy.
d. Initial startup is i. Continuously reduce Upon startup of the
after April 5, 2024, EtO emissions by 99 source.
and facility EtO use percent 2 6.
is less than 10 tpy.
----------------------------------------------------------------------------------------------------------------
\1\ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-
month period after December 6, 1996.
\2\ If using CEMS to determine compliance, this standard is based on a rolling 30-operating day average.
\3\ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-
month period after April 7, 2025.
\4\ The standard applies if the facility has used less than 10 tpy of EtO within all consecutive 12-month
periods after April 6, 2026.
\5\ The standard applies if the facility is expected to meet or exceed the specified EtO use within one year
after startup. Afterwards, the standard applies if the facility has met or exceeded the specified EtO use
within any consecutive 12-month period after startup.
\6\ The standard applies if the facility is not expected to meet or exceed 10 tpy of EtO use within one year
after startup. Afterwards, the standard applies if the facility has used less than 10 tpy of EtO within all
consecutive 12-month periods after startup.
Table 3 to Subpart O of Part 63--Standards for CEVs
As required in Sec. 63.362(e), for each CEV, you must meet the
applicable standard in the following table:
----------------------------------------------------------------------------------------------------------------
You must comply with
For each . . . For which . . . You must . . . the standard . . .
----------------------------------------------------------------------------------------------------------------
1. Existing CEV at a major source a. Not applicable...... i. Continuously reduce No later than April 5,
facility. EtO emissions by 99.94 2027.
percent \1\.
2. Existing CEV at an area source a. Facility EtO use is i. Continuously reduce No later than April 6,
facility. at least 60 tpy. EtO emissions by 99.9 2026.
percent 1 2.
b. Facility EtO use is i. Continuously reduce No later than April 5,
less than 60 tpy. EtO emissions by 99 2027.
percent 1 3.
3. New CEV at a major source facility a. Initial startup is i. Continuously reduce No later than April 5,
on or before April 5, EtO emissions by 99.94 2024.
2024. percent \1\.
[[Page 24194]]
b. Initial startup is i. Continuously reduce Upon startup of the
after April 5, 2024. EtO emissions by 99.94 source.
percent \1\.
4. New CEV at an area source facility a. Initial startup is i. Continuously reduce No later than April 5,
on or before April 5, EtO emissions by 99.9 2024.
2024, and facility EtO percent 1 4.
use is at least 60 tpy.
b. Initial startup is i. Continuously reduce No later than April 5,
on or before April 5, EtO emissions by 99 2024.
2024, facility EtO use percent 1 5.
is less than 60 tpy.
c. Initial startup is i. Continuously reduce Upon startup of the
after April 5, 2024, EtO emissions by 99.9 source.
and facility EtO use percent 1 4.
is at least 60 tpy.
d. Initial startup is i. Continuously reduce Upon startup of the
after April 5, 2024, EtO emissions by 99 source.
facility EtO use is percent 1 5.
less than 60 tpy.
----------------------------------------------------------------------------------------------------------------
\1\ If using CEMS to determine compliance, this standard is based on a rolling 30-operating day average.
\2\ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-
month period after April 7, 2025.
\3\ The standard applies if the facility has used less than 60 tpy of EtO within all consecutive 12-month
periods after April 6, 2026.
\4\ The standard applies if the facility is expected to meet or exceed the specified EtO use within one year
after startup. Afterwards, the standard applies if the facility has met or exceeded the specified EtO use
within any consecutive 12-month period after startup.
\5\ The standard applies if the facility is not expected to meet or exceed 60 tpy of EtO use within one year
after startup. Afterwards, the standard applies if the facility has used less than 60 tpy of EtO within all
consecutive 12-month periods after startup.
Table 4 to Subpart O of Part 63--Standards for Group 1 Room Air
Emissions
As required in Sec. 63.362(f), for your collection of Group 1 room
air emissions at each facility, you must meet the applicable standard
in the following table:
----------------------------------------------------------------------------------------------------------------
You must comply with
For each . . . For which . . . You must . . . the requirement(s) . .
.
----------------------------------------------------------------------------------------------------------------
1. Existing collection of Group 1 a. Not applicable...... i. Operate all areas of No later than April 5,
room air emissions at a major source the facility that 2027.
facility. contain Group 1 room
air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.
Also,
ii. Continuously reduce
EtO emissions by 97
percent \1\.
2. Existing collection of Group 1 a. Facility EtO use is i. Operate all areas of No later than April 6,
room air emissions at an area source at least 40 tpy. the facility that 2026.
facility. contain Group 1 room
air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.\2\
Also,
ii. Continuously reduce
EtO emissions by 98
percent \1\ \2\.
b. Facility EtO use is i. Operate all areas of No later than April 5,
less than 40 tpy. the facility that 2027.
contain Group 1 room
air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.
Also,
ii. Continuously reduce
EtO emissions by 80
percent \1\ \3\.
3. New collection of Group 1 room air a. Initial startup is i. Operate all areas of No later than April 5,
emissions at a major source facility. on or before April 5, the facility that 2024.
2024. contain Group 1 room
air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.
Also,
ii. Continuously reduce
EtO emissions by 97
percent \1\.
b. Initial startup is i. Operate all areas of Upon startup of the
after April 5, 2024. the facility that source.
contain Group 1 room
air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.
Also,
ii. Continuously reduce
EtO emissions by 97
percent \1\.
4. New collection of Group 1 room air a. Initial startup is i. Operate all areas of No later than April 5,
emissions at an area source facility. on or before April 5, the facility that 2024.
2024, and facility EtO contain Group 1 room
use is at least 40 tpy. air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.\4\
Also,
ii. Continuously reduce
EtO emissions by 98
percent \1\ \4\.
b. Initial startup is i. Operate all areas of No later than April 5,
on or before April 5, the facility that 2024.
2024, and facility EtO contain Group 1 room
use is less than 40 air emissions with
tpy. PTE, with all exhaust
gas streams being
captured and routed to
a control system.\5\
Also,
ii. Continuously reduce
EtO emissions by 80
percent \1\ \5\.
c. Initial startup is i. Operate all areas of Upon startup of the
after April 5, 2024, the facility that source.
and facility EtO use contain Group 1 room
is at least 40 tpy. air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.\4\
Also,
ii. Continuously reduce
EtO emissions by 98
percent \1\ \4\.
d. Initial startup is i. Operate all areas of Upon startup of the
after April 5, 2024, the facility that source.
and facility EtO use contain Group 1 room
is less than 40 tpy. air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.\5\
Also,
ii. Continuously reduce
EtO emissions by 80
percent \1\ \5\.
----------------------------------------------------------------------------------------------------------------
\1\ If using CEMS to determine compliance, this standard is based on a rolling 30-operating day average.
\2\ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-
month period after April 7, 2025.
\3\ The standard applies if the facility has used less than 40 tpy of EtO within all consecutive 12-month
periods after April 6, 2026.
\4\ The standard applies if the facility is expected to meet or exceed the specified EtO use within one year
after startup. Afterwards, the standard applies if the facility has met or exceeded the specified EtO use
within any consecutive 12-month period after startup.
\5\ The standard applies if the facility is not expected to meet or exceed 40 tpy of EtO use within one year
after startup. Afterwards, the standard applies if the facility has used less than 40 tpy of EtO within all
consecutive 12-month periods after startup.
[[Page 24195]]
Table 5 to Subpart O of Part 63--Standards for Group 2 Room Air
Emissions
As required in Sec. 63.362(g), for your collection of Group 2 room
air emissions, you must meet the applicable standard in the following
table:
----------------------------------------------------------------------------------------------------------------
You must comply with
For each . . . For which . . . You must . . . the requirement(s) . .
.
----------------------------------------------------------------------------------------------------------------
1. Existing collection of Group 2 a. Not applicable...... i. Operate all areas of No later than April 5,
room air emissions at a major source the facility that 2027.
facility. contain Group 2 room
air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.
Also,
ii. Continuously reduce
EtO emissions by 86
percent \1\.
2. Existing collection of Group 2 a. Facility EtO use is i. Operate all areas of No later than April 6,
room air emissions at an area source at least 20 tpy. the facility that 2026.
facility. contain Group 2 room
air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.\2\
Also,.
ii. Continuously reduce
EtO emissions by 98
percent \1\ \2\.
b. Facility EtO use is i. Operate all areas of No later than April 6,
at least 4 tpy but the facility that 2026.
less than 20 tpy. contain Group 2 room
air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.\2\
Also,
ii. Continuously reduce
EtO emissions by 80
percent \1\ \2\.
c. Facility EtO use is Lower the EtO No later than April 5,
less than 4 tpy. concentration within 2027.
each sterilization
chamber to 1 ppm
before the chamber can
be opened \3\.
3. New collection of Group 2 room air a. Initial startup is i. Operate all areas of No later than April 5,
emissions at a major source facility. on or before April 5, the facility that 2024.
2024. contain Group 2 room
air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.
Also,
ii. Continuously reduce
EtO emissions by 86
percent \1\.
b. Initial startup is i. Operate all areas of Upon startup of the
after April 5, 2024. the facility that source.
contain Group 2 room
air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.
Also,
ii. Continuously reduce
EtO emissions by 86
percent \1\.
4. New collection of Group 2 room air a. Initial startup is i. Operate all areas of No later than April 5,
emissions at an area source facility. on or before April 5, the facility that 2024.
2024, and facility EtO contain Group 2 room
use is at least 20 tpy. air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.\5\
Also,
ii. Continuously reduce
EtO emissions by 98
percent \1\ \5\.
b. Initial startup is i. Operate all areas of No later than April 5,
on or before April 5, the facility that 2024.
2024, and facility EtO contain Group 2 room
use is less than 20 air emissions with
tpy. PTE, with all exhaust
gas streams being
captured and routed to
a control system.\6\
Also,
ii. Continuously reduce
EtO emissions by 80
percent \1\ \6\.
c. Initial startup is i. Operate all areas of Upon startup of the
after April 5, 2024, the facility that source.
and facility EtO use contain Group 2 room
is at least 20 tpy. air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.\5\
Also,
ii. Continuously reduce
EtO emissions by 98
percent \1\ \5\.
d. Initial startup is i. Operate all areas of Upon startup of the
after April 5, 2024, the facility that source.
and facility EtO use contain Group 2 room
is less than 20 tpy. air emissions with
PTE, with all exhaust
gas streams being
captured and routed to
a control system.\6\
Also,
ii. Continuously reduce
EtO emissions by 80
percent \1\ \6\.
----------------------------------------------------------------------------------------------------------------
\1\ This standard is based on a rolling 30-operating day average.
\2\ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-
month period after April 7, 2025.
\3\ The standard applies if the facility has used less than 4 tpy of EtO within all consecutive 12-month periods
after April 6, 2026.
\4\ The standard applies if the facility is expected to meet or exceed the specified EtO use within one year
after startup. Afterwards, the standard applies if the facility has met or exceeded the specified EtO use
within any consecutive 12-month period after startup.
\5\ The standard applies if the facility is not expected to meet or exceed 20 tpy of EtO use within one year
after startup. Afterwards, the standard applies if the facility has used less than 20 tpy of EtO within all
consecutive 12-month periods after startup.
Table 6 to Subpart O of Part 63--Applicability of General Provisions to
This Subpart
As specified in Sec. 63.360, the parts of the General Provisions
that apply to you are shown in the following table:
------------------------------------------------------------------------
Citation Subject Applies to subpart O
------------------------------------------------------------------------
Sec. 63.1(a)(1)............ Applicability.. Yes, additional terms
defined in Sec.
63.361; when overlap
between subparts A and
O occurs, subpart O
takes precedence.
Sec. 63.1(a)(2)-(3)........ ............... Yes.
Sec. 63.1(a)(4)............ ............... Yes. Subpart O clarifies
the applicability of
each paragraph in
subpart A to facilities
subject to subpart O.
Sec. 63.1(a)(5)............ [Reserved]..... No.
Sec. 63.1(a)(6)-(8)........ ............... Yes.
Sec. 63.1(a)(9)............ [Reserved].....
Sec. 63.1(a)(10)-(14)...... ............... Yes.
Sec. 63.1(b)(1)-(2)........ ............... Yes.
Sec. 63.1(b)(3)............ ............... No.
Sec. 63.1(c)(1)............ ............... No. Subpart O clarifies
the applicability of
each paragraph in
subpart A to facilities
subject to subpart O in
this table.
Sec. 63.1(c)(2)............ ............... Yes.
[[Page 24196]]
Sec. 63.1(c)(3)............ [Reserved]..... No.
Sec. 63.1(c)(4)............ ............... Yes.
Sec. 63.1(c)(5)............ ............... No. Sec. 63.360
specifies
applicability.
Sec. 63.1(c)(6)............ ............... Yes.
Sec. 63.1(d)............... [Reserved]..... No.
Sec. 63.1(e)............... ............... Yes.
Sec. 63.2.................. Definitions.... Yes, additional terms
defined in Sec.
63.361; when overlap
between subparts A and
O occurs, subpart O
takes precedence.
Sec. 63.3.................. Units and Yes, other units used in
abbreviations. subpart O are defined
in the text of subpart
O.
Sec. 63.4(a)(1)-(3)........ Prohibited Yes.
activities.
Sec. 63.5(a)............... Construction/ No. Sec. 63.366(b)(1)
Reconstruction. contains applicability
requirements for
constructed or
reconstructed
facilities.
Sec. 63.5(b)(1)............ ............... Yes.
Sec. 63.5(b)(2)............ [Reserved].....
Sec. 63.5(b)(3)............ ............... No. See Sec.
63.366(b)(2).
Sec. 63.5(b)(4)-(6)........ ............... Yes.
Sec. 63.5(c)............... [Reserved].....
Sec. 63.5(d)(1)-(2)........ ............... No. See Sec.
63.366(b)(3).
Sec. 63.5(d)(3)-(4)........ ............... Yes.
Sec. 63.5(e)............... ............... Yes.
Sec. 63.5(f)(1)-(2)........ ............... No. See Sec.
63.366(b)(4).
Sec. 63.6(a)............... Applicability.. Yes.
Sec. 63.6(b)-(c)........... ............... No. Sec. 63.360(j)
specifies compliance
dates for facilities.
Sec. 63.6(d)............... [Reserved].....
Sec. 63.6(e)(1)(i)......... ............... No.
Sec. 63.6(e)(1)(ii)........ Requirement to No.
correct
malfunctions
ASAP.
Sec. 63.6(e)(1)(iii)....... ............... Yes.
Sec. 63.6(e)(2)............ [Reserved]..... No.
Sec. 63.6(e)(3)............ SSM Plan No.
Requirements.
Sec. 63.6(f)(1)............ SSM exemption.. No.
Sec. 63.6(f)(2)(i)......... Methods for Yes.
Determining
Compliance.
Sec. 63.6(f)(2)(ii)........ ............... No. Sec. 63.363
specifies parameters
for determining
compliance.
Sec. 63.6(f)(2)(iii)-(iv).. ............... Yes.
Sec. 63.6(f)(2)(v)......... ............... No.
Sec. 63.6(f)(3)............ ............... Yes.
Sec. 63.6(g)............... Alternative Yes.
Standard.
Sec. 63.6(h)............... Compliance with No. Subpart O does not
opacity and contain any opacity or
visible visible emission
emission standards.
standards.
Sec. 63.6(i)(1)-(14), and Compliance Yes.
(16). Extension.
Sec. 63.6(j)............... Presidential Yes.
Compliance
Exemption.
Sec. 63.7(a)............... Applicability Yes.
and
Performance
Test Dates.
Sec. 63.7(b)............... Notification of Yes.
Performance
Test.
Sec. 63.7(c)............... Quality Yes.
Assurance/Test
Plan.
Sec. 63.7(d)............... Testing Yes.
Facilities.
Sec. 63.7(e)(1)............ SSM exemption.. No.
Sec. 63.7(e)(2)-(4)........ Conduct of Yes. Sec. 63.365 also
Performance contains test methods
Tests. specific to facilities
subject to the
emissions standards.
Sec. 63.7(f)............... Alternative Yes.
Test Method.
Sec. 63.7(g)............... Performance Yes, except this subpart
Test Data specifies how and when
Analysis. the performance test
and performance
evaluation results are
reported.
Sec. 63.7(h)............... Waiver of Tests Yes.
Sec. 63.8(a)(1)............ Applicability Yes.
of Monitoring
Requirements.
Sec. 63.8(a)(2)............ Performance Yes.
Specifications.
Sec. 63.8(a)(3)............ [Reserved]..... No.
Sec. 63.8(a)(4)............ Monitoring with Yes.
Flares.
Sec. 63.8(b)(1)............ Monitoring..... Yes.
Sec. 63.8(b)(2)-(3)........ Multiple Yes.
Effluents and
Multiple
Monitoring
Systems.
Sec. 63.8(c)(1)(i)......... General duty to No.
minimize
emissions and
CMS operation.
Sec. 63.8(c)(1)(ii)........ ............... No. A startup, shutdown,
and malfunction plan is
not required for these
standards.
Sec. 63.8(c)(1)(iii)....... Requirement to No.
develop SSM
Plan for CMS.
Sec. 63.8(c)(2)-(3)........ ............... Yes.
Sec. 63.8(c)(4)-(5)........ ............... No. Frequency of
monitoring measurements
is provided in Sec.
63.364; opacity
monitors are not
required for these
standards.
Sec. 63.8(c)(6)............ ............... No. Performance
specifications are
contained in Sec.
63.365.
[[Page 24197]]
Sec. 63.8(c)(7)(i)(A)-(B).. ............... No. Performance
specifications are
contained in Sec.
63.365.
Sec. 63.8(c)(7)(i)(C)...... ............... No. Opacity monitors are
not required for these
standards.
Sec. 63.8(c)(7)(ii)........ ............... No. Performance
specifications are
contained in Sec.
63.365.
Sec. 63.8(c)(8)............ ............... No.
Sec. 63.8(d)(1)-(2)........ ............... Yes.
Sec. 63.8(d)(3)............ Written No.
procedures for
CMS.
Sec. 63.8(e)(1)............ CMS Performance Yes, but only applies
Evaluation. for CEMS, except this
subpart specifies how
and when the
performance evaluation
results are reported.
Sec. 63.8(e)(2)............ ............... Yes.
Sec. 63.8(e)(3)............ ............... Yes.
Sec. 63.8(e)(4)............ ............... Yes.
Sec. 63.8(e)(5)(i)......... ............... Yes.
Sec. 63.8(e)(5)(ii)........ ............... No. Opacity monitors are
not required for these
standards.
Sec. 63.8(f)(1)-(5)........ ............... Yes.
Sec. 63.8(f)(6)............ ............... No.
Sec. 63.8(g)(1)............ ............... Yes.
Sec. 63.8(g)(2)............ ............... No.
Sec. 63.8(g)(3)-(5)........ ............... Yes.
Sec. 63.9(a)............... Notification Yes.
requirements.
Sec. 63.9(b)(1)-(i)........ ............... Yes.
Sec. 63.9(b)(1)(ii)-(iii).. Initial No. Sec.
Notifications. 63.366(c)(1)(i)
contains language for
facilities that
increase usage such
that the source becomes
subject to the
emissions standards.
Sec. 63.9(b)(2)-(3)........ Initial Yes. Sec. 63.366(c)(3)
Notifications. contains additional
information to be
included in the initial
report for existing and
new facilities.
Sec. 63.9(b)(4)-(5)........ Initial No. Sec.
Notifications. 63.366(c)(1)(ii) and
(iii) contains
requirements for new or
reconstructed
facilities subject to
the emissions
standards.
Sec. 63.9(c)............... Request for Yes.
Compliance
Extension.
Sec. 63.9(d)............... Notification of No.
Special
Compliance
Requirements
for New
Sources.
Sec. 63.9(e)............... Notification of Yes.
Performance
Test.
Sec. 63.9(f)............... Notification of No. Opacity monitors are
VE/Opacity not required for these
Test. standards.
Sec. 63.9(g)(1)............ Additional Yes.
Notifications
When Using CMS.
Sec. 63.9(g)(2)-(3)........ Additional No. Opacity monitors and
Notifications relative accuracy
When Using CMS. testing are not
required for these
standards.
Sec. 63.9(h)(1)-(3)........ Notification of Yes, except Sec.
Compliance 63.9(h)(5) does not
Status. apply because Sec.
63.366(c)(2) instructs
facilities to submit
actual data.
Sec. 63.9(i)............... Adjustment of Yes.
Submittal
Deadlines.
Sec. 63.9(j)............... Change in Yes.
previous
information.
Sec. 63.9(k)............... Electronic Yes, as specified in
reporting Sec. 63.9(j).
procedures.
Sec. 63.10(a).............. Recordkeeping/ Yes.
Reporting.
Sec. 63.10(b)(1)........... Recordkeeping/ Yes.
Reporting.
Sec. 63.10(b)(2)(i)........ Recordkeeping No. See 63.367(f) for
for startup recordkeeping
and shutdown. requirements.
Sec. 63.10(b)(2)(ii)....... Recordkeeping No. See 63.367(f) for
for SSM and recordkeeping
failures to requirements.
meet standards.
Sec. 63.10(b)(2)(iii)...... Records related Yes.
to maintenance
of air
pollution
control
equipment.
Sec. 63.10(b)(2)(iv)-(v)... Actions taken No.
to minimize
emissions
during SSM.
Sec. 63.10(b)(2)(vi)....... CMS Records.... Yes.
Sec. 63.10(b)(2)(vii)-(ix). Records........ Yes.
Sec. 63.10(b)(2)(x)-(xi)... CMS Records.... Yes.
Sec. 63.10(b)(2)(xii)...... Records........ Yes.
Sec. 63.10(b)(2)(xiii)..... Records........ Yes.
Sec. 63.10(b)(2)(xiv)...... Records........ Yes.
Sec. 63.10(b)(3)........... Records........ Yes.
Sec. 63.10(c)(1)-(14)...... Records........ Yes.
Sec. 63.10(c)(15).......... Use of SSM Plan No.
Sec. 63.10(d)(1)........... General Yes.
Reporting
Requirements.
Sec. 63.10(d)(2)........... Report of No. This subpart
Performance specifies how and when
Test Results. the performance test
results are reported.
Sec. 63.10(d)(3)........... Reporting No. Subpart O does not
Opacity or VE contain opacity or
Observations. visible emissions
standards.
Sec. 63.10(d)(4)........... Progress Yes.
Reports.
Sec. 63.10(d)(5)........... SSM Reports.... No. See Sec. 63.366
for malfunction
reporting requirements.
Sec. 63.10(e)(1)........... Additional CEMS Yes.
Reports.
[[Page 24198]]
Sec. 63.10(e)(2)(i)........ Additional CMS Yes, except this subpart
Reports. specifies how and when
the performance
evaluation results are
reported.
Sec. 63.10(e)(2)(ii)....... Additional COMS No. Opacity monitors are
Reports. not required for these
standards.
Sec. 63.10(e)(3)(i)-(iv)... Reports........ Yes.
Sec. 63.10(e)(3)(v)........ Excess No. Sec. 63.366(b) and
Emissions (c) specify contents
Reports. and submittal dates for
excess emissions and
monitoring system
performance reports.
Sec. 63.10(e)(3)(vi)-(viii) Excess Yes.
Emissions
Report and
Summary Report.
Sec. 63.10(e)(4)........... Reporting COMS No. Opacity monitors are
data. not required for these
standards.
Sec. 63.10(f).............. Waiver for Yes.
Recordkeeping/
Reporting.
Sec. 63.11................. Control device Yes.
requirements
for flares and
work practice
requirements
for equipment
leaks.
Sec. 63.12................. Delegation..... Yes.
Sec. 63.13................. Addresses...... Yes.
Sec. 63.14................. Incorporation Yes.
by Reference.
Sec. 63.15................. Availability of Yes.
Information.
------------------------------------------------------------------------
Appendix A to Subpart O of Part 63--Monitoring Provisions for EtO CEMS
1. Applicability
These monitoring provisions apply to the measurement of EtO
emissions from commercial sterilization facilities, using CEMS. The
CEMS must be capable of measuring EtO in lb/hr.
2. Monitoring of EtO Emissions
2.1 Monitoring System Installation Requirements. Install EtO
CEMS and any additional monitoring systems needed to convert
pollutant concentrations to lb/hr in accordance with Sec. 63.365
and Performance Specification 19 (PS 19) of appendix B to part 60 of
this chapter.
2.2 Primary and Backup Monitoring Systems. In the electronic
monitoring plan described in section 10.1.1.2.1 of this appendix,
you must designate a primary EtO CEMS. The primary EtO CEMS must be
used to report hourly EtO concentration values when the system is
able to provide quality-assured data, i.e., when the system is ``in
control''. However, to increase data availability in the event of a
primary monitoring system outage, you may install, operate,
maintain, and calibrate backup monitoring systems, as follows:
2.2.1 Redundant Backup Systems. A redundant backup monitoring
system is a separate EtO CEMS with its own probe, sample interface,
and analyzer. A redundant backup system is one that is permanently
installed at the unit or stack location and is kept on ``hot
standby'' in case the primary monitoring system is unable to provide
quality-assured data. A redundant backup system must be represented
as a unique monitoring system in the electronic monitoring plan.
Each redundant backup monitoring system must be certified according
to the applicable provisions in section 3 of this appendix and must
meet the applicable on-going QA requirements in section 5 of this
appendix.
2.2.2 Non-redundant Backup Monitoring Systems. A non-redundant
backup monitoring system is a separate EtO CEMS that has been
certified at a particular unit or stack location but is not
permanently installed at that location. Rather, the system is kept
on ``cold standby'' and may be reinstalled in the event of a primary
monitoring system outage. A nonredundant backup monitoring system
must be represented as a unique monitoring system in the electronic
monitoring plan. Non-redundant backup EtO CEMS must complete the
same certification tests as the primary monitoring system, with one
exception. The 7-day calibration error test is not required for a
non-redundant backup EtO CEMS. Except as otherwise provided in
section 2.2.4.4 of this appendix, a non-redundant backup monitoring
system may only be used for 720 hours per year at a particular unit
or stack location.
2.2.3 Temporary Like-kind Replacement Analyzers. When a primary
EtO analyzer needs repair or maintenance, you may temporarily
install a like-kind replacement analyzer, to minimize data loss.
Except as otherwise provided in section 2.2.4.4 of this appendix, a
temporary like-kind replacement analyzer may only be used for 720
hours per year at a particular unit or stack location. The analyzer
must be represented as a component of the primary EtO CEMS and must
be assigned a 3-character component ID number, beginning with the
prefix ``LK''.
2.2.4 Quality Assurance Requirements for Non-redundant Backup
Monitoring Systems and Temporary Like-kind Replacement Analyzers. To
quality-assure the data from non-redundant backup EtO monitoring
systems and temporary like-kind replacement EtO analyzers, the
following provisions apply:
2.2.4.1 When a certified non-redundant backup EtO CEMS or a
temporary like-kind replacement EtO analyzer is brought into
service, a calibration error test and a linearity check must be
performed and passed. A single point system integrity check is also
required.
2.2.4.2 Each non-redundant backup EtO CEMS or temporary like-
kind replacement EtO analyzer shall comply with all required daily,
weekly, and quarterly quality-assurance test requirements in section
5 of this appendix, for as long as the system or analyzer remains in
service.
2.2.4.3 For the routine, on-going quality-assurance of a non-
redundant backup EtO monitoring system, a relative accuracy test
audit (RATA) must be performed and passed at least once every 8
calendar quarters at the unit or stack location(s) where the system
will be used.
2.2.4.4 To use a non-redundant backup EtO monitoring system or a
temporary like-kind replacement analyzer for more than 720 hours per
year at a particular unit or stack location, a RATA must first be
performed and passed at that location.
2.3 Monitoring System Equipment, Supplies, Definitions, and
General Operation.
The following provisions apply:
2.3.1 PS 19, Sections 3.0, 6.0, and 11.0 of appendix B to part
60 of this chapter.
3. Initial Certification Procedures
The initial certification procedures for the EtO CEMS used to
provide data under this subpart are as follows:
3.1 Your EtO CEMS must be certified according to PS 19,
section(s) 13.
3.2 Any additional stack gas flow rate monitoring system(s)
needed to express pollutant concentrations in lb/hr must be
certified according to part 75 of this chapter.
4. Recertification Procedures
Whenever the owner or operator makes a replacement,
modification, or change to a certified CEMS that may significantly
affect the ability of the system to accurately measure or record
pollutant gas concentrations or stack gas flow rates, the owner or
operator shall recertify the monitoring system. Furthermore,
whenever the owner or operator makes a replacement, modification, or
change to the flue gas handling system or the unit operation that
may significantly change the concentration or flow profile, the
owner or operator shall recertify the monitoring system. The same
tests performed for the initial certification of the monitoring
system shall be repeated for recertification, unless otherwise
specified by the Administrator. Examples of changes that require
recertification include: Replacement of a gas analyzer; complete
monitoring
[[Page 24199]]
system replacement, and changing the location or orientation of the
sampling probe.
5. On-Going Quality Assurance Requirements
On-going QA test requirements for EtO CEMS must be implemented
as follows:
5.1 The quality assurance/quality control procedures in
Procedure 7 of appendix F to part 60 of this chapter shall apply.
5.2 Stack gas flow rate, diluent gas, and moisture monitoring
systems must meet the applicable ongoing QA test requirements of
part 75 of this chapter.
5.2.1 Out-of-Control Periods. A EtO CEMS that is used to provide
data under this appendix is considered to be out-of-control, and
data from the CEMS may not be reported as quality-assured, when any
acceptance criteria for a required QA test is not met. The EtO CEMS
is also considered to be out-of-control when a required QA test is
not performed on schedule or within an allotted grace period. To end
an out-of-control period, the QA test that was either failed or not
done on time must be performed and passed. Out-of-control periods
are counted as hours of monitoring system downtime.
5.2.2 Grace Periods. For the purposes of this appendix, a
``grace period'' is defined as a specified number of unit or stack
operating hours after the deadline for a required quality-assurance
test of a continuous monitor has passed, in which the test may be
performed and passed without loss of data.
5.2.2.1 For the flow rate monitoring systems described in
section 5.1 of this appendix, a 168 unit or stack operating hour
grace period is available for quarterly linearity checks, and a 720
unit or stack operating hour grace period is available for RATAs, as
provided, respectively, in sections 2.2.4 and 2.3.3 of appendix B to
part 75 of this chapter.
5.2.2.2 For the purposes of this appendix, if the deadline for a
required gas audit or RATA of a EtO CEMS cannot be met due to
circumstances beyond the control of the owner or operator:
5.2.2.2.1 A 168 unit or stack operating hour grace period is
available in which to perform the gas audit; or
5.2.2.2.2 A 720 unit or stack operating hour grace period is
available in which to perform the RATA.
5.2.2.3 If a required QA test is performed during a grace
period, the deadline for the next test shall be determined as
follows:
5.2.2.3.1 For the gas audit of an EtO CEMS, the grace period
test only satisfies the audit requirement for the calendar quarter
in which the test was originally due. If the calendar quarter in
which the grace period audit is performed is a QA operating quarter,
an additional gas audit is required for that quarter.
5.2.2.3.2 For the RATA of an EtO CEMS, the next RATA is due
within three QA operating quarters after the calendar quarter in
which the grace period test is performed.
5.2.3 Conditional Data Validation. For recertification and
diagnostic testing of the monitoring systems that are used to
provide data under this appendix, and for the required QA tests when
nonredundant backup monitoring systems or temporary like-kind
replacement analyzers are brought into service, the conditional data
validation provisions in Sec. Sec. 75.20(b)(3)(ii) through
(b)(3)(ix) of this chapter may be used to avoid or minimize data
loss. The allotted window of time to complete calibration tests and
RATAs shall be as specified in Sec. 75.20(b)(3)(iv) of this
chapter; the allotted window of time to complete a gas audit shall
be the same as for a linearity check (i.e., 168 unit or stack
operating hours).
5.3 Data Validation.
5.3.1 Out-of-Control Periods. An EtO CEMS that is used to
provide data under this appendix is considered to be out-of-control,
and data from the CEMS may not be reported as quality-assured, when
any acceptance criteria for a required QA test is not met. The EtO
CEMS is also considered to be out-of-control when a required QA test
is not performed on schedule or within an allotted grace period. To
end an out-of-control period, the QA test that was either failed or
not done on time must be performed and passed. Out-of-control
periods are counted as hours of monitoring system downtime.
5.3.2 Grace Periods. For the purposes of this appendix, a
``grace period'' is defined as a specified number of unit or stack
operating hours after the deadline for a required quality-assurance
test of a continuous monitor has passed, in which the test may be
performed and passed without loss of data.
5.3.2.1 For the monitoring systems described in section 5.1 of
this appendix, a 168 unit or stack operating hour grace period is
available for quarterly linearity checks, and a 720 unit or stack
operating hour grace period is available for RATAs, as provided,
respectively, in sections 2.2.4 and 2.3.3 of appendix B to part 75
of this chapter.
5.3.2.2 For the purposes of this appendix, if the deadline for a
required gas audit/data accuracy assessment or RATA of an EtO CEMS
cannot be met due to circumstances beyond the control of the owner
or operator:
5.3.2.2.1 A 168 unit or stack operating hour grace period is
available in which to perform the gas audit or other quarterly data
accuracy assessment; or
5.3.2.2.2 A 720 unit or stack operating hour grace period is
available in which to perform the RATA.
5.3.2.3 If a required QA test is performed during a grace
period, the deadline for the next test shall be determined as
follows:
5.3.2.3.1 For a gas audit or RATA of the monitoring systems
described in sections 5.1 and 5.2 of this appendix, determine the
deadline for the next gas audit or RATA (as applicable) in
accordance with section 2.2.4(b) or 2.3.3(d) of appendix B to part
75 of this chapter; treat a gas audit in the same manner as a
linearity check.
5.3.2.3.2 For the gas audit or other quarterly data accuracy
assessment of an EtO CEMS, the grace period test only satisfies the
audit requirement for the calendar quarter in which the test was
originally due. If the calendar quarter in which the grace period
audit is performed is a QA operating quarter, an additional gas
audit/data accuracy assessment is required for that quarter.
5.3.2.3.3 For the RATA of an EtO CEMS, the next RATA is due
within three QA operating quarters after the calendar quarter in
which the grace period test is performed.
5.3.3 Conditional Data Validation. For recertification and
diagnostic testing of the monitoring systems that are used to
provide data under this appendix, the conditional data validation
provisions in Sec. 75.20(b)(3)(ii) through (ix) of this chapter may
be used to avoid or minimize data loss. The allotted window of time
to complete calibration tests and RATAs shall be as specified in
Sec. 75.20(b)(3)(iv) of this chapter; the allotted window of time
to complete a quarterly gas audit or data accuracy assessment shall
be the same as for a linearity check (i.e., 168 unit or stack
operating hours).
6. Missing Data Requirements
For the purposes of this appendix, the owner or operator of an
affected unit shall not substitute for missing data from EtO CEMS.
Any process operating hour for which quality-assured EtO
concentration data are not obtained is counted as an hour of
monitoring system downtime.
7. Bias Adjustment
Bias adjustment of hourly emissions data from an EtO CEMS is not
required.
8. QA/QC Program Requirements
The owner or operator shall develop and implement a quality
assurance/quality control (QA/QC) program for the EtO CEMS that are
used to provide data under this subpart. At a minimum, the program
shall include a written plan that describes in detail (or that
refers to separate documents containing) complete, step-by-step
procedures and operations for the most important QA/QC activities.
Electronic storage of the QA/QC plan is permissible, provided that
the information can be made available in hard copy to auditors and
inspectors. The QA/QC program requirements for the other monitoring
systems described in section 5.2 of this appendix are specified in
section 1 of appendix B to part 75 of this chapter.
8.1 General Requirements for EtO CEMS.
8.1.1 Preventive Maintenance. Keep a written record of
procedures needed to maintain the EtO CEMS in proper operating
condition and a schedule for those procedures. This shall, at a
minimum, include procedures specified by the manufacturers of the
equipment and, if applicable, additional or alternate procedures
developed for the equipment.
8.1.2 Recordkeeping and Reporting. Keep a written record
describing procedures that will be used to implement the
recordkeeping and reporting requirements of this appendix.
8.1.3 Maintenance Records. Keep a record of all testing,
maintenance, or repair activities performed on any EtO CEMS in a
location and format suitable for inspection. A maintenance log may
be used for this purpose. The following records should be
maintained: Date, time, and description of any testing, adjustment,
repair, replacement, or preventive maintenance action performed on
any monitoring system and records of any corrective actions
associated with a monitor outage period. Additionally, any
adjustment that may significantly affect a system's ability to
accurately measure emissions data must be recorded and a written
explanation of the
[[Page 24200]]
procedures used to make the adjustment(s) shall be kept.
8.2 Specific Requirements for EtO CEMS. The following
requirements are specific to EtO CEMS:
8.2.1 Keep a written record of the procedures used for each type
of QA test required for each EtO CEMS. Explain how the results of
each type of QA test are calculated and evaluated.
8.2.2 Explain how each component of the EtO CEMS will be
adjusted to provide correct responses to calibration gases after
routine maintenance, repairs, or corrective actions.
9. Data Reduction and Calculations
9.1 Design and operate the EtO CEMS to complete a minimum of one
cycle of operation (sampling, analyzing, and data recording) for
each successive 15-minute period.
9.2 Reduce the EtO concentration data to hourly averages in
accordance with Sec. 60.13(h)(2) of this chapter.
9.3 Convert each hourly average EtO concentration to an EtO mass
emission rate (lb/hr) using an equation that has the general form of
equation A-1 of this appendix:
[GRAPHIC] [TIFF OMITTED] TR05AP24.045
Where:
Eho = EtO mass emission rate for the hour, lb/hr
K = Units conversion constant, 1.144E-10 lb/scf-ppbv,
Ch = Hourly average EtO concentration, ppbv,
Qh = Stack gas volumetric flow rate for the hour, scfh.
(Note: Use unadjusted flow rate values; bias adjustment is not
required.)
9.4 Use equation A-2 of this appendix to calculate the daily
total EtO emissions. Report each daily total to the same precision
as the most stringent standard that applies to any affected source
exhausting to the emission stream (e.g., if the emission stream
includes contributions from an SCV and ARV subject to 99.99% and
99.9% emission reduction standards, respectively, report to four
significant figures), expressed in scientific notation.
[GRAPHIC] [TIFF OMITTED] TR05AP24.046
Where:
Eday = Total daily EtO emissions, lb.
Eho = Hourly EtO emission rate for unit or stack
sampling hour ``h'' in the averaging period, from equation A-1 of
this appendix, lb/hr.
9.5 Use equation A-3 of this appendix to calculate the 30-
operating day rolling total EtO emissions. Report each 30-operating
day rolling total to the same precision as the most stringent
standard that applies to any affected source exhausting to the
emission stream (e.g., if the emission stream includes contributions
from an SCV and ARV subject to 99.99% and 99.9% emission reduction
standards, respectively, report to four significant figures),
expressed in scientific notation.
[GRAPHIC] [TIFF OMITTED] TR05AP24.047
Where:
E30day = Total EtO emissions during the 30-operating
day, lb.
Eday,i = Total daily EtO emissions, in lbs, for each
operating day i from equation A-2 of this appendix, lb.
i = Operating day index.
10. Recordkeeping Requirements
10.1 For each EtO CEMS installed at an affected source, and for
any other monitoring system(s) needed to convert pollutant
concentrations to units of the applicable emissions limit, the owner
or operator must maintain a file of all measurements, data, reports,
and other information required by this appendix in a form suitable
for inspection, for 5 years from the date of each record, in
accordance with Sec. 63.367. The file shall contain the information
in paragraphs 10.1.1 through 10.1.8 of this section.
10.1.1 Monitoring Plan Records. For each affected source or
group of sources monitored at a common stack, the owner or operator
shall prepare and maintain a monitoring plan for the EtO CEMS and
any other monitoring system(s) (i.e., flow rate, diluent gas, or
moisture systems) needed to convert pollutant concentrations to
units of the applicable emission standard. The monitoring plan shall
contain essential information on the continuous monitoring systems
and shall explain how the data derived from these systems ensure
that all EtO emissions from the unit or stack are monitored and
reported.
10.1.1.1 Updates. Whenever the owner or operator makes a
replacement, modification, or change in a certified continuous EtO
monitoring system that is used to provide data under this subpart
(including a change in the automated data acquisition and handling
system or the flue gas handling system) which affects information
reported in the monitoring plan (e.g., a change to a serial number
for a component of a monitoring system), the owner or operator shall
update the monitoring plan.
10.1.1.2 Contents of the Monitoring Plan. For EtO CEMS, the
monitoring plan shall contain the applicable electronic and hard
copy information in sections 10.1.1.2.1 and 10.1.1.2.2 of this
appendix. For stack gas flow rate, diluent gas, and moisture
monitoring systems, the monitoring plan shall include the electronic
and hard copy information required for those systems under Sec.
75.53(g) of this chapter. The electronic monitoring plan shall be
evaluated using CEDRI.
10.1.1.2.1 Electronic. Record the unit or stack ID number(s);
monitoring location(s); the EtO monitoring methodology used (i.e.,
CEMS); EtO monitoring system information, including, but not limited
to: unique system and component ID numbers; the make, model, and
serial number of the monitoring equipment; the sample acquisition
method; formulas used to calculate emissions; monitor span and range
information (if applicable).
10.1.1.2.2 Hard Copy. Keep records of the following: schematics
and/or blueprints showing the location of the monitoring system(s)
and test ports; data flow diagrams; test protocols; monitor span and
range calculations (if applicable); miscellaneous technical
justifications.
10.1.2 EtO Emissions Records. For EtO CEMS, the owner or
operator must record the following information for each unit or
stack operating hour:
10.1.2.1 The date and hour;
10.1.2.2 Monitoring system and component identification codes,
as provided in the electronic monitoring plan, for each hour in
which the CEMS provides a quality-assured value of EtO concentration
(as applicable);
10.1.2.3 The pollutant concentration, for each hour in which a
quality-assured value is obtained. Record the data in parts per
billion by volume (ppbv), with one leading non-zero digit and one
decimal place, expressed in scientific notation. Use the following
rounding convention: If the digit immediately following the first
decimal place
[[Page 24201]]
is 5 or greater, round the first decimal place upward (increase it
by one); if the digit immediately following the first decimal place
is 4 or less, leave the first decimal place unchanged.
10.1.2.4 A special code, indicating whether or not a quality-
assured EtO concentration value is obtained for the hour. This code
may be entered manually when a temporary like-kind replacement EtO
analyzer is used for reporting; and
10.1.2.5 Monitor data availability, as a percentage of unit or
stack operating hours, calculated according to Sec. 75.32 of this
chapter.
10.1.3 Stack Gas Volumetric Flow Rate Records.
10.1.3.1 Hourly measurements of stack gas volumetric flow rate
during unit operation are required to demonstrate compliance with
EtO emission standards.
10.1.3.2 Use a flow rate monitor that meets the requirements of
part 75 of this chapter to record the required data. You must keep
hourly flow rate records, as specified in Sec. 75.57(c)(2) of this
chapter.
10.1.4 EtO Emission Rate Records. Record the following
information for each affected unit or common stack:
10.1.4.1 The date and hour;
10.1.4.2 The hourly EtO emissions rate (lb/hr), for each hour in
which valid values of EtO concentration and stack gas volumetric
flow rate are obtained for the hour. Report each emission rate to
the same precision as the most stringent standard that applies to
any affected source exhausting to the emission stream (e.g., if the
emission stream includes contributions from an SCV and ARV subject
to 99.99% and 99.9% emission reduction standards, respectively,
report to four significant figures), expressed in scientific
notation. Use the following rounding convention: If the digit
immediately following the first decimal place is 5 or greater, round
the first decimal place upward (increase it by one); if the digit
immediately following the first decimal place is 4 or less, leave
the first decimal place unchanged;
10.1.4.4 A code indicating that the EtO emission rate was not
calculated for the hour, if valid data for EtO concentration and/or
any of the other necessary parameters are not obtained for the hour.
For the purposes of this appendix, the substitute data values
required under part 75 of this chapter for stack gas flow rate are
not considered to be valid data.
10.1.5 Certification and Quality Assurance Test Records. For the
EtO CEMS used to provide data under this subpart at each affected
unit (or group of units monitored at a common stack), record the
following information for all required certification,
recertification, diagnostic, and quality-assurance tests:
10.1.5.1 EtO CEMS.
10.1.5.1.1 For each required 7-day and daily calibration drift
(CD) test or daily calibration error test (including daily
calibration transfer standard tests) of the EtO CEMS, record the
test date(s) and time(s), reference gas value(s), monitor
response(s), and calculated calibration drift or calibration error
value(s). If you use the dynamic spiking option for the mid-level
calibration drift check under PS 19, you must also record the
measured concentration of the native EtO in the flue gas before and
after the spike and the spiked gas dilution factor.
10.1.5.1.2 or each required RATA of an EtO CEMS, record the
beginning and ending date and time of each test run, the reference
method(s) used, and the reference method and EtO CEMS run values.
Keep records of stratification tests performed (if any), all of the
raw field data, relevant process operating data, and all of the
calculations used to determine the relative accuracy.
10.1.5.1.3 For each required measurement error (ME) test of an
EtO monitor, record the date and time of each gas injection, the
reference gas concentration (low, mid, or high) and the monitor
response for each of the three injections at each of the three
levels. Also record the average monitor response and the ME at each
gas level and the related calculations.
10.1.5.1.4 For each required level of detection (LOD) test of an
EtO monitor performed in a controlled environment, record the test
date, the concentrations of the reference gas and interference
gases, the results of the seven (or more) consecutive measurements
of EtO, the standard deviation, and the LOD value. For each required
LOD test performed in the field, record the test date, the three
measurements of the native source EtO concentration, the results of
the three independent standard addition (SA) measurements known as
standard addition response (SAR), the effective spike addition gas
concentration, the resulting standard addition detection level
(SADL) value and all related calculations. For extractive CEMS
performing the SA using dynamic spiking, you must record the spiked
gas dilution factor.
10.1.5.1.5 For each required ME/level of detection response time
test of an EtO monitor, record the test date, the native EtO
concentration of the flue gas, the reference gas value, the stable
reference gas readings, the upscale/downscale start and end times,
and the results of the upscale and downscale stages of the test.
10.1.5.1.6 For each required interference test of an EtO
monitor, record (or obtain from the analyzer manufacturer records
of): The date of the test; the gas volume/rate, temperature, and
pressure used to conduct the test; the EtO concentration of the
reference gas used; the concentrations of the interference test
gases; the baseline EtO responses for each interferent combination
spiked; and the total percent interference as a function of span or
EtO concentration.
10.1.5.1.7 For each quarterly relative accuracy audit (RAA) of
an EtO monitor, record the beginning and ending date and time of
each test run, the reference method used, the EtO concentrations
measured by the reference method and CEMS for each test run, the
average concentrations measured by the reference method and the
CEMS, and the calculated relative accuracy. Keep records of the raw
field data, relevant process operating data, and the calculations
used to determine the relative accuracy.
10.1.5.1.8 For each quarterly cylinder gas audit (CGA) of an EtO
monitor, record the date and time of each injection, and the
reference gas concentration (zero, mid, or high) and the monitor
response for each injection. Also record the average monitor
response and the calculated ME at each gas level.
10.1.5.1.9 For each quarterly dynamic spiking audit (DSA) of an
EtO monitor, record the date and time of the zero gas injection and
each spike injection, the results of the zero gas injection, the gas
concentrations (mid and high) and the dilution factors and the
monitor response for each of the six upscale injections as well as
the corresponding native EtO concentrations measured before and
after each injection. Also record the average dynamic spiking error
for each of the upscale gases, the calculated average DSA Accuracy
at each upscale gas concentration, and all calculations leading to
the DSA Accuracy.
10.1.5.2 Additional Monitoring Systems. For the stack gas flow
rate monitoring systems described in section 3.2 of this appendix,
you must keep records of all certification, recertification,
diagnostic, and on-going quality-assurance tests of these systems,
as specified in Sec. 75.59(a) of this chapter.
11. Reporting Requirements
11.1 General Reporting Provisions. The owner or operator shall
comply with the following requirements for reporting EtO emissions
from each affected unit (or group of units monitored at a common
stack):
11.1.1 Notifications, in accordance with paragraph 11.2 of this
section;
11.1.2 Monitoring plan reporting, in accordance with paragraph
11.3 of this section;
11.1.3 Certification, recertification, and QA test submittals,
in accordance with paragraph 11.4 of this section; and
11.1.4 Electronic quarterly report submittals, in accordance
with paragraph 11.5 of this section.
11.2 Notifications. The owner or operator shall provide
notifications for each affected unit (or group of units monitored at
a common stack) in accordance with Sec. 63.366.
11.3 Monitoring Plan Reporting. For each affected unit (or group
of units monitored at a common stack) using EtO CEMS, the owner or
operator shall make electronic and hard copy monitoring plan
submittals as follows:
11.3.1 For a sterilization facility that begins reporting hourly
EtO concentrations with a previously certified CEMS, submit the
monitoring plan information in section 10.1.1.2 of this appendix
prior to or concurrent with the first required quarterly emissions
report. For a new sterilization facility, submit the information in
section 10.1.1.2 of this appendix at least 21 days prior to the
start of initial certification testing of the CEMS. Also submit the
monitoring plan information in Sec. 75.53(g) of this chapter
pertaining to any required flow rate monitoring systems within the
applicable timeframe specified in this section, if the required
records are not already in place.
11.3.2 Update the monitoring plan when required, as provided in
paragraph 10.1.1.1 of this appendix. An electronic monitoring plan
information update must be submitted either
[[Page 24202]]
prior to or concurrent with the quarterly report for the calendar
quarter in which the update is required.
11.3.3 All electronic monitoring plan submittals and updates
shall be made to the Administrator using CEDRI. Hard copy portions
of the monitoring plan shall be kept on record according to section
10.1 of this appendix.
11.4 Certification, Recertification, and Quality-Assurance Test
Reporting Requirements. Use CEDRI to submit the results of all
required certification, recertification, quality-assurance, and
diagnostic tests of the monitoring systems required under this
appendix electronically. Submit the test results concurrent with the
quarterly electronic emissions report. However, for RATAs of the EtO
monitor, if this is not possible, you have up to 60 days after the
test completion date to submit the test results; in this case, you
may claim provisional status for the emissions data affected by the
test, starting from the date and hour in which the test was
completed and continuing until the date and hour in which the test
results are submitted. If the test is successful, the status of the
data in that time period changes from provisional to quality-
assured, and no further action is required. However, if the test is
unsuccessful, the provisional data must be invalidated and
resubmission of the affected emission report(s) is required.
11.4.1 For each daily CD (or calibration error) assessment
(including daily calibration transfer standard tests), and for each
seven-day calibration drift (CD) test of an EtO monitor, report:
11.4.1.1 Facility ID information;
11.4.1.2 The monitoring component ID;
11.4.1.3 The instrument span and span scale;
11.4.1.4 For each gas injection, the date and time, the
calibration gas level (zero or high-level), the reference gas value
(ppbv), and the monitor response (ppbv);
11.4.1.5 A flag to indicate whether dynamic spiking was used for
the high-level value;
11.4.1.6 Calibration drift (percent of span or reference gas, as
applicable);
11.4.1.7 When using the dynamic spiking option, the measured
concentration of native EtO before and after each mid-level spike
and the spiked gas dilution factor; and
11.4.1.8 Reason for test.
11.4.2 For each RATA of an EtO CEMS, report:
11.4.2.1 Facility ID information;
11.4.2.2 Monitoring system ID number;
11.4.2.3 Type of test (i.e., initial or annual RATA);
11.4.2.4 Reason for test;
11.4.2.5 The reference method used;
11.4.2.6 Starting and ending date and time for each test run;
11.4.2.7 Units of measure;
11.4.2.8 The measured reference method and CEMS values for each
test run, on a consistent moisture basis, in appropriate units of
measure;
11.4.2.9 Flags to indicate which test runs were used in the
calculations;
11.4.2.10 Arithmetic mean of the CEMS values, of the reference
method values, and of their differences;
11.4.2.11 Standard deviation, using equation 7 in section 12.6
of PS 19 in appendix B to part 60 of this chapter;
11.4.2.12 Confidence coefficient, using equation 8 in section
12.6 of PS 19 in appendix B to part 60 of this chapter;
11.4.2.13 t-value; and
11.4.2.14 Relative accuracy calculated using equation 11 in
section 12.6 of PS 19 in appendix B to part 60 of this chapter.
11.4.3 For each measurement error (ME) test of an EtO monitor,
report:
11.4.3.1 Facility ID information;
11.4.3.2 Monitoring component ID;
11.4.3.3 Instrument span and span scale;
11.4.3.4 For each gas injection, the date and time, the
calibration gas level (zero, low, mid, or high), the reference gas
value in ppbv and the monitor response.
11.4.3.5 For extractive CEMS, the mean reference value and mean
of measured values at each reference gas level (ppbv).
11.4.3.6 ME at each reference gas level; and
11.4.3.7 Reason for test.
11.4.4 For each interference test of an EtO monitoring system,
report:
11.4.4.1 Facility ID information;
11.4.4.2 Date of test;
11.4.4.3 Monitoring system ID;
11.4.4.4 Results of the test (pass or fail);
11.4.4.5 Reason for test; and
11.4.4.6 A flag to indicate whether the test was performed: On
this particular monitoring system; on one of multiple systems of the
same type; or by the manufacturer on a system with components of the
same make and model(s) as this system.
11.4.5 For each LOD test of an EtO monitor, report:
11.4.5.1 Facility ID information;
11.4.5.2 Date of test;
11.4.5.3 Reason for test;
11.4.5.4 Monitoring system ID;
11.4.5.5 A code to indicate whether the test was done in a
controlled environment or in the field;
11.4.5.6 EtO reference gas concentration;
11.4.5.7 EtO responses with interference gas (seven
repetitions);
11.4.5.8 Standard deviation of EtO responses;
11.4.5.9 Effective spike addition gas concentrations;
11.4.5.10 EtO concentration measured without spike;
11.4.5.11 EtO concentration measured with spike;
11.4.5.12 Dilution factor for spike;
11.4.5.13 The controlled environment LOD value (ppbv or ppbv-
meters);
11.4.5.14 The field determined standard addition detection level
(SADL in ppbv or ppbv-meters); and
11.4.5.15 Result of LOD/SADL test (pass/fail).
11.4.6 For each ME or LOD response time test of an EtO monitor,
report:
11.4.6.1 Facility ID information;
11.4.6.2 Date of test;
11.4.6.3 Monitoring component ID;
11.4.6.4 The higher of the upscale or downscale tests, in
minutes; and
11.4.6.5 Reason for test.
11.4.7 For each quarterly RAA of an EtO monitor, report:
11.4.7.1 Facility ID information;
11.4.7.2 Monitoring system ID;
11.4.7.3 Begin and end time of each test run;
11.4.7.4 The reference method used;
11.4.7.5 The reference method and CEMS values for each test run,
including the units of measure;
11.4.7.6 The mean reference method and CEMS values for the three
test runs;
11.4.7.7 The calculated relative accuracy, percent; and
11.4.7.8 Reason for test.
11.4.8 For each quarterly cylinder gas audit of an EtO monitor,
report:
11.4.8.1 Facility ID information;
11.4.8.2 Monitoring component ID;
11.4.8.3 Instrument span and span scale;
11.4.8.4 For each gas injection, the date and time, the
reference gas level (zero, mid, or high), the reference gas value in
ppbv, and the monitor response.
11.4.8.5 For extractive CEMS, the mean reference gas value and
mean monitor response at each reference gas level (ppbv).
11.4.8.6 ME at each reference gas level; and
11.4.8.7 Reason for test.
11.4.9 For each quarterly DSA of an EtO monitor, report:
11.4.9.1 Facility ID information;
11.4.9.2 Monitoring component ID;
11.4.9.3 Instrument span and span scale;
11.4.9.4 For the zero gas injection, the date and time, and the
monitor response (Note: The zero gas injection from a calibration
drift check performed on the same day as the upscale spikes may be
used for this purpose.);
11.4.9.5 Zero spike error;
11.4.9.6 For the upscale gas spiking, the date and time of each
spike, the reference gas level (mid- or high-), the reference gas
value (ppbv), the dilution factor, the native EtO concentrations
before and after each spike, and the monitor response for each gas
spike;
11.4.9.7 Upscale spike error;
11.4.9.8 DSA at the zero level and at each upscale gas level;
and
11.4.9.9 Reason for test.
11.4.10 Reporting Requirements for Diluent Gas, Flow Rate, and
Moisture Monitoring Systems. For the certification, recertification,
diagnostic, and QA tests of stack gas flow rate, moisture, and
diluent gas monitoring systems that are certified and quality-
assured according to part 75 of this chapter, report the information
in section 10.1.8.2 of this appendix.
11.5 Quarterly Reports.
11.5.1 The owner or operator of any affected unit shall use
CEDRI to submit electronic quarterly reports to the Administrator in
an XML format specified by the Administrator, for each affected unit
(or group of units monitored at a common stack). If the certified
EtO CEMS is used for the initial compliance demonstration, EtO
emissions reporting shall begin with the first operating hour of the
30-operating day compliance demonstration period. Otherwise, EtO
emissions reporting shall begin with the first operating hour after
successfully completing all required certification tests of the
CEMS.
11.5.2 The electronic reports must be submitted within 30 days
following the end
[[Page 24203]]
of each calendar quarter, except for units that have been placed in
long-term cold storage.
11.5.3 Each electronic quarterly report shall include the
following information:
11.5.3.1 The date of report generation;
11.5.3.2 Facility identification information;
11.5.3.3 The information in sections 10.1.2 through 10.1.4 of
this appendix, as applicable to the type(s) of monitoring system(s)
used to measure the pollutant concentrations and other necessary
parameters.
11.5.3.4 The results of all daily calibrations (including
calibration transfer standard tests) of the EtO monitor as described
in section 10.1.8.1.1 of this appendix; and
11.5.3.5 If applicable, the results of all daily flow monitor
interference checks, in accordance with section 10.1.8.2 of this
appendix.
11.5.4 Compliance Certification. Based on reasonable inquiry of
those persons with primary responsibility for ensuring that all EtO
emissions from the affected unit(s) have been correctly and fully
monitored, the owner or operator shall submit a compliance
certification in support of each electronic quarterly emissions
monitoring report. The compliance certification shall include a
statement by a responsible official with that official's name,
title, and signature, certifying that, to the best of his or her
knowledge, the report is true, accurate, and complete.
[FR Doc. 2024-05905 Filed 4-4-24; 8:45 am]
BILLING CODE 6560-50-P