National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations, 67889-67899 [2019-26804]
Download as PDF
Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Proposed Rules
95°22′11″ W to lat. 30°23′32″ N, long.
95°22′51″ W to lat. 30°23′12″ N, long.
95°19′51″ W. This Class D airspace area is
effective during the specific dates and times
established in advance by a Notice to
Airmen. The effective date and time will
thereafter be continuously published in the
Chart Supplement.
*
*
*
ASW TX D
*
*
Galveston, TX [Amended]
Scholes International Airport at Galveston,
TX
(Lat. 29°15′55″ N, long. 94°51′38″ W)
That airspace extending upward from the
surface up to but not including 2,500 feet
MSL within a 4.1-mile radius of Scholes
International Airport at Galveston. This Class
D airspace area is effective during the
specific dates and times established in
advance by a Notice to Airmen. The effective
date and time will thereafter be continuously
published in the Chart Supplement.
*
*
*
*
*
ASW TX D Houston, TX [Amended]
Sugar Land Regional Airport, TX
(Lat. 29°37′20″ N, long. 95°39′24″ W)
That airspace extending upward from the
surface to and including 2,600 feet MSL
within a 4.2-mile radius of Sugar Land
Regional Airport. This Class D airspace area
is effective during the specific dates and
times established in advance by a Notice to
Airmen. The effective date and time will
thereafter be continuously published in the
Chart Supplement.
Paragraph 6002 Class E Airspace Areas
Designated as Surface Areas.
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*
*
*
*
ASW TX E2 Conroe, TX [Amended]
Conroe-North Houston Regional Airport, TX
(Lat. 30°21′12″ N, long. 95°24′54″ W)
That airspace extending upward from the
surface to and including 2,700 feet MSL
within a 4.8-mile radius of Conroe-North
Houston Regional Airport, excluding that
airspace from lat. 30°25′24″ N, long.
95°22′11″ W to lat. 30°23′32″ N, long.
95°22′51″ W to lat. 30°23′12″ N, long.
95°19′51″ W. This Class E airspace area is
effective during the specific dates and times
established in advance by a Notice to
Airmen. The effective date and time will
thereafter be continuously published in the
Chart Supplement.
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ASW TX E2 Galveston, TX [Amended]
Scholes International Airport at Galveston,
TX
(Lat. 29°15′55″ N, long. 94°51′38″ W)
That airspace extending upward from the
surface up to but not including 2,500 feet
MSL within a 4.1-mile radius of Scholes
International Airport at Galveston. This Class
E airspace area is effective during the specific
dates and times established in advance by a
Notice to Airmen. The effective date and time
will thereafter be continuously published in
the Chart Supplement.
*
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ASW TX E2 Houston, TX [Amended]
Sugar Land Regional Airport, TX
(Lat. 29°37′20″ N, long. 95°39′24″ W)
That airspace extending upward from the
surface to and including 2,600 feet MSL
within a 4.2-mile radius of Sugar Land
Regional Airport. This Class E airspace area
is effective during the specific dates and
times established in advance by a Notice to
Airmen. The effective date and time will
thereafter be continuously published in the
Chart Supplement.
*
*
*
*
*
ASW TX E2 Temple, TX [Amended]
Draughon-Miller Central Texas Regional
Airport, TX
(Lat. 31°09′07″ N, long. 97°24′28″W)
Within a 4.2-mile radius of DraughonMiller Central Texas Regional Airport. This
Class E airspace area is effective during the
specific dates and times established in
advance by a Notice to Airmen. The effective
date and time will thereafter be continuously
published in the Chart Supplement.
Paragraph 6004 Class E Airspace Areas
Designated as an Extension to a Class D or
Class E Surface Area.
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ASW TX E4
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ASW TX E5 Houston, TX [Amended]
Point of Origin
(Lat. 30°35′01″ N, long. 95°28′01″ W)
Scholes International Airport at Galveston,
TX
(Lat. 29°15′55″ N, long. 94°51′38″ W)
Conroe-North Houston Regional Airport,
TX
(Lat. 30°21′12″ N, long. 95°24′54″ W)
That airspace extending upward from 700
feet above the surface within an area
bounded by a line beginning at the Point of
Origin to lat. 29°45′00″ N, long. 94°44′01″ W;
thence from lat. 29°45′00″ N, long. 94°44′01″
W to a point of tangency with the east arc of
a 6.6-mile radius of Scholes International
Airport at Galveston, and within a 6.6-mile
radius of Scholes International Airport at
Galveston; thence from lat. 29°16′48″ N, long.
94°59′06″ W; to lat. 29°30′01″ N, long.
95°54′01″ W; to lat. 30°26′01″ N, long.
95°42′01″ W; to the Point of Origin, and
within a 7.3-mile radius of Conroe-North
Houston Regional Airport.
*
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ASW TX E5 Angleton/Lake Jackson, TX
[Amended]
Texas Gulf Coast Regional Airport, TX
PO 00000
*
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ASW TX E5 Temple, TX [Amended]
Draughon-Miller Central Texas Regional
Airport, TX
(Lat. 31°09′07″ N, long. 97°24′28″ W)
Draughon-Miller Central Texas Regional:
RWY 15–LOC
(Lat. 31°08′20″ N, long. 97°24′16″ W)
That airspace extending upward from 700
feet above the surface within a 6.7-mile
radius of Draughon-Miller Central Texas
Regional Airport, and within 4 miles either
side of the 343° bearing of the DraughonMiller Central Texas Regional: RWY 15–LOC
extending from the 6.7-mile radius to 14.2
miles northwest of the airport.
Issued in Fort Worth, Texas, on December
4, 2019.
Steve Szukala,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[FR Doc. 2019–26608 Filed 12–11–19; 8:45 am]
Temple, TX [Removed]
ASW TX E5 Anahuac, TX [Amended]
Chambers County Airport, TX
(Lat. 29°46′11″ N, long. 94°39′49″ W)
That airspace extending upward from 700
feet above the surface within a 6.1-mile
radius of Chambers County Airport.
*
(Lat. 29°06′31″ N, long. 95°27′44″ W)
That airspace extending upward from 700
feet above the surface within a 6.6-mile
radius of Texas Gulf Coast Regional Airport.
BILLING CODE 4910–13–P
*
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[EPA–HQ–OAR–2019–0178; FRL–10003–08–
OAR]
RIN 2060–AU37
National Emission Standards for
Hazardous Air Pollutants: Ethylene
Oxide Commercial Sterilization and
Fumigation Operations
Environmental Protection
Agency (EPA).
ACTION: Advance notice of proposed
rulemaking.
AGENCY:
In this advance notice of
proposed rulemaking (ANPRM), the
U.S. Environmental Protection Agency
(EPA) is soliciting information that will
aid in potential future revisions to the
Ethylene Oxide Emission Standards for
Sterilization Facilities. The EPA is
soliciting information and requesting
comment on potential control measures
for reducing ethylene oxide (EtO)
emissions from commercial sterilization
facilities. These control measures
include controls for fugitive emissions
of EtO, safety measures for the chamber
exhaust vents (CEVs), process
equipment improvements, and advances
in add-on control technologies for point
sources. In addition, the EPA is
considering, and requesting comment
on, how best to assess potential impacts
on small businesses. The EPA is also
SUMMARY:
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taking comment on the available EtO
usage data for individual facilities and
on additional data contained in the
modeling file that will be used to
evaluate the impact of emissions from
commercial EtO sterilizers.
DATES: Comments. Comments must be
received on or before February 10, 2020.
ADDRESSES: You may send comments,
identified by Docket ID No. EPA–HQ–
OAR–2019–0178, by any of the
following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov/ (our
preferred method). Follow the online
instructions for submitting comments.
• Email: a-and-r-docket@epa.gov.
Include Docket ID No. EPA–HQ–OAR–
2019–0178 in the subject line of the
message.
• Fax: (202) 566–9744. Attention
Docket ID No. EPA–HQ–OAR–2019–
0178.
• Mail: U.S. Environmental
Protection Agency, EPA Docket Center,
Docket ID No. EPA–HQ–OAR–2019–
0178, Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington,
DC 20460.
• Hand/Courier Delivery: EPA Docket
Center, WJC West Building, Room 3334,
1301 Constitution Avenue NW,
Washington, DC 20004. The Docket
Center’s hours of operation are 8:30
a.m.–4:30 p.m., Monday–Friday (except
federal holidays).
Instructions: All submissions received
must include the Docket ID No. for this
action. Comments received may be
posted without change to https://
www.regulations.gov/, including any
personal information provided. For
detailed instructions on sending
comments and additional information
on the rulemaking process, see the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT: For
questions about this action, contact Mr.
Jonathan Witt, Sector Policies and
Programs Division (E143–05), Office of
Air Quality Planning and Standards,
U.S. Environmental Protection Agency,
Research Triangle Park, NC 27711;
telephone number: (919) 541–5645;
email address: witt.jon@epa.gov.
SUPPLEMENTARY INFORMATION:
Docket. The EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OAR–2019–0178. All
documents in the docket are listed in
Regulations.gov. Although listed, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
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the internet and will be publicly
available only in hard copy. Publicly
available docket materials are available
either electronically in Regulations.gov
or in hard copy at the EPA Docket
Center, Room 3334, WJC West Building,
1301 Constitution Avenue NW,
Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. 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.
Instructions. Direct your comments to
Docket ID No. EPA–HQ–OAR–2019–
0178. The EPA’s policy is that all
comments received will be included in
the public docket without change and
may be made available online at https://
www.regulations.gov/, including any
personal information provided, unless
the comment includes information
claimed to be CBI or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov/ or email. This
type of information should be submitted
by mail as discussed below.
The EPA may publish any comment
received to its public docket.
Multimedia submissions (audio, video,
etc.) must be accompanied by a written
comment. The written comment is
considered the official comment and
should include discussion of all points
you wish to make. The EPA will
generally not consider comments or
comment contents located outside of the
primary submission (i.e., on the Web,
cloud, or other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www.epa.gov/dockets/
commenting-epa-dockets.
The https://www.regulations.gov/
website allows you to submit your
comment anonymously, which means
the EPA will not know your identity or
contact information unless you provide
it in the body of your comment. If you
send an email comment directly to the
EPA without going through https://
www.regulations.gov/, your email
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the internet. If you
submit an electronic comment, the EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
digital storage media you submit. If the
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EPA cannot read your comment due to
technical difficulties and cannot contact
you for clarification, the EPA may not
be able to consider your comment.
Electronic files should not include
special characters or any form of
encryption and be free of any defects or
viruses. For additional information
about the EPA’s public docket, visit the
EPA Docket Center homepage at https://
www.epa.gov/dockets.
The EPA is soliciting comment on
numerous aspects of the action. The
EPA has indexed each comment
solicitation with an alpha-numeric
identifier (e.g., ‘‘C–1,’’ ‘‘C–2,’’ ‘‘C–3’’) to
provide a consistent framework for
effective and efficient provision of
comments. Accordingly, the EPA asks
that commenters include the
corresponding identifier when
providing comments relevant to that
comment solicitation. The EPA asks that
commenters include the identifier in
either a heading, or within the text of
each comment (e.g., ‘‘In response to
solicitation of comment C–1, . . .’’) to
make clear which comment solicitation
is being addressed. The EPA emphasizes
that the Agency is not limiting comment
to these identified areas and encourages
provision of any other comments
relevant to this action.
Submitting CBI. Do not submit
information containing CBI to the EPA
through https://www.regulations.gov/ or
email. Clearly mark the part or all of the
information that you claim to be CBI.
For CBI information on any digital
storage media that you mail to the EPA,
mark the outside of the digital storage
media as CBI and then identify
electronically within the digital storage
media the specific information that is
claimed as CBI. In addition to one
complete version of the comments that
includes information claimed as CBI,
you must submit a copy of the
comments that does not contain the
information claimed as CBI directly to
the public docket through the
procedures outlined in Instructions
above. If you submit any digital storage
media that does not contain CBI, clearly
indicate on the outside of the digital
storage media that it does not contain
CBI. Information not marked as CBI will
be included in the public docket and the
EPA’s electronic public docket without
prior notice. Information marked as CBI
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. Send or deliver
information identified as CBI only to the
following address: OAQPS Document
Control Officer (C404–02), OAQPS, U.S.
Environmental Protection Agency,
Research Triangle Park, North Carolina
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27711, Attention Docket ID No. EPA–
HQ–OAR–2019–0178.
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:
ANPRM advance notice of proposed
rulemaking
APCD air pollution control device
ARV aeration room vent
CAA Clean Air Act
CBI Confidential Business Information
CEV chamber exhaust vent
CFR Code of Federal Regulations
EOSA Ethylene Oxide Sterilization
Association
EPA Environmental Protection Agency
EtO ethylene oxide
GACT generally available control
technology
HAP hazardous air pollutant(s)
IR infrared
IRIS Integrated Risk Information System
LEL lower explosive limit
MACT maximum achievable control
technology
NAICS North American Industry
Classification System
NATA National Air Toxics Assessment
NESHAP national emission standards for
hazardous air pollutants
OAQPS Office of Air Quality Planning and
Standards
OMB Office of Management and Budget
OSHA Occupational Safety and Health
Administration
ppmv parts per million by volume
PRA Paperwork Reduction Act
PTE permanent total enclosure
SBA Small Business Administration
SBAR Small Business Advocacy Review
SCV sterilization chamber vent
tpy tons per year
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Organization of this document. The
information in this preamble is
organized as follows:
I. General Information
A. What is the purpose of this ANPRM?
B. Does this action apply to me?
C. Where can I get a copy of this document
and other related information?
II. Background
A. Statutory Background
B. Regulatory Background
C. Risks Associated With EtO Emissions
III. Small Business Considerations
IV. Request for Comment
A. Modeling File and Annual EtO Usage
Data
B. Control of Fugitive Emissions
C. Chamber Exhaust Vent Control and
Safety Considerations
D. Other Point Source Control Options
E. Types of Sterilization Facilities
V. Statutory and Executive Order Reviews
inform the EPA as the Agency considers
proposing a future rulemaking to further
address emissions of EtO from
commercial sterilizers. This ANPRM
focuses on considerations pertinent to
potential future amendments to 40 CFR
part 63, subpart O, in order to further
address emissions of EtO from
commercial sterilizers. Subpart O
contains the emissions control
standards for hazardous air pollutants
(HAP) that apply to commercial EtO
sterilization facilities. In this ANRPM,
the EPA identifies additional control
technologies and measures that may be
used to reduce emissions of EtO and
provides an opportunity for
stakeholders to provide additional
information about these technologies
and measures. In addition, the EPA is
seeking information about the costs
associated with controlling EtO
emissions from all sources and,
specifically, those that qualify as small
businesses. The EPA is also taking
comment on facility and emissions data
as part of the modeling file that will be
used to evaluate the impact of emissions
from commercial EtO sterilizers.
B. Does this action apply to me?
The current standards in 40 CFR part
63, subpart O, regulate emissions of EtO
from existing and new commercial
sterilization operations using 907
kilograms per year (1 ton per year (tpy))
of EtO or more. The EtO Commercial
Sterilization and Fumigation Operations
source category covers the use of EtO as
a sterilant and fumigant following the
production of various products (e.g.,
medical equipment and supplies) and in
miscellaneous sterilization and
fumigation operations at both major and
area sources. These commercial
sterilization facilities use EtO as a
sterilant for heat- or moisture-sensitive
materials and as a fumigant to control
microorganisms or insects. Materials
may be sterilized at the facility that
produces or uses the product, or by
contract sterilizers (i.e., firms under
contract to sterilize products
manufactured by other companies).
Table 1 of this preamble lists the entities
that are regulated by the current subpart
O rule.
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NAICS
code 1
Source category
Pharmaceutical Preparation Manufacturing ........................................
Spice and Extract Manufacturing .....
Dried and Dehydrated Food Manufacturing ........................................
Packaging and Labeling Services ....
1 North
System.
American
Industry
325412
311942
311423
561910
Classification
The table is not meant to be
exhaustive, but rather provides a guide
for readers regarding the entities that are
likely to be affected by future regulation
for this source category. The EtO
Commercial Sterilization and
Fumigation Operations source category
includes medical equipment suppliers;
pharmaceutical suppliers; other healthrelated industries; spice manufacturers;
and contract sterilizers (see 57 FR
31576, July 16, 1992). 40 CFR part 63,
subpart O, also applies to large libraries
and large museums and archives, but
does not apply to hospitals, doctor
offices, clinics, or other facilities whose
primary purpose is to provide medical
services to humans or animals; beehive
fumigators; and research and laboratory
facilities. In addition, review and
comments are welcome from
manufacturers of devices capable of
measuring, monitoring, reducing,
abating, or destroying EtO, particularly
if such devices are or will soon be
available in the commercial
marketplace.
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
ANPRM is available on the internet.
Following signature by the EPA
Administrator, the EPA will post a copy
of this ANPRM at the following address:
https://www.epa.gov/stationary-sourcesair-pollution/ethylene-oxide-emissionsstandards-sterilization-facilities.
Following publication in the Federal
Register, the EPA will post the Federal
Register version of the ANPRM and key
technical documents at this same
website.
TABLE 1—NESHAP AND INDUSTRIAL
SOURCE CATEGORIES AFFECTED BY
THIS ACTION
II. Background
NAICS
code 1
Source category
I. General Information
A. What is the purpose of this ANPRM?
This ANPRM is intended to solicit
information from the public in order to
TABLE 1—NESHAP AND INDUSTRIAL
SOURCE CATEGORIES AFFECTED BY
THIS ACTION—Continued
Surgical and Medical Instrument
Manufacturing ...............................
Surgical Appliance and Supplies
Manufacturing ...............................
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339112
339113
A. Statutory Background
Section 112 of the Clean Air Act
(CAA) establishes the regulatory process
used to develop standards for emissions
of HAP from stationary sources. In the
first stage of this process, the EPA
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promulgates technology-based standards
under CAA section 112(d) for categories
of sources identified as emitting one or
more of the HAP listed in CAA section
112(b). 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 10 tpy or more of a
single HAP or 25 tpy or more of any
combination of HAP. All other sources
are ‘‘area sources.’’ For major sources,
CAA section 112(d)(2) provides that the
technology-based national emission
standards for hazardous air pollutants
(NESHAP) must reflect the maximum
degree of emission reductions of HAP
achievable (after considering cost,
energy requirements, and non-air
quality health and environmental
impacts). These standards that reflect
the maximum degree of emission
reductions of HAP are commonly
referred to as maximum achievable
control technology (MACT) standards.
CAA section 112(d)(3) also establishes a
minimum control level for MACT
standards, known as the MACT ‘‘floor.’’
The EPA must also consider control
options that are more stringent than the
floor. Standards more stringent than the
floor are commonly referred to as
beyond-the-floor standards. The EPA
may establish standards more stringent
than the floor based on considerations
of the cost of achieving the emission
reductions, any non-air quality health
and environmental impacts, and energy
requirements. In certain instances, as
provided in CAA section 112(h), the
EPA may set work practice standards
where it is not feasible to prescribe or
enforce a numerical emission standard.
For area sources, CAA section 112(d)(5)
gives the EPA discretion to set standards
based on generally available control
technologies or management practices
(GACT standards) in lieu of MACT
standards.
In the second stage, the EPA evaluates
MACT standards to determine whether
additional standards are needed to
address any remaining risk associated
with HAP emissions. This second stage
is commonly referred to as the ‘‘residual
risk review.’’ In addition to the residual
risk review required by CAA section
112(f)(2), CAA section 112(d)(6) requires
the EPA to review standards set under
CAA section 112 every 8 years. This
review is commonly referred to as the
‘‘technology review’’ and the EPA often
conducts the residual risk review
simultaneously with the first required
technology review in what is commonly
referred to as a ‘‘risk and technology
review.’’ The methodology used by the
agency to conduct risk and technology
reviews is explained in the document
titled CAA Section 112 Risk and
Technology Reviews: Statutory
Authority and Methodology, in the
docket for this ANPRM.
In the CAA section (d)(6) technology
reviews, the EPA is to review standards
set under CAA section 112 and revise
them ‘‘as necessary (taking into account
developments in practices, processes,
and control technologies)’’ no less
frequently than every 8 years. CAA
section 112(d)(6). In conducting these
reviews, the EPA is not required to
recalculate the MACT floor. 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, 673 (D.C. Cir.
2013).
B. Regulatory Background
On July 16, 1992 (57 FR 31576), the
EPA published a list of major and area
sources for which NESHAP were to be
promulgated (i.e., the source category
list). Ethylene oxide commercial
sterilization and fumigation operations
were listed as a category of major
sources and area sources.
On December 6, 1994 (59 FR 62585),
the EPA promulgated MACT and GACT
standards for the EtO Emission
Standards for Sterilization Facilities
source category. In that final rule, the
EPA set MACT for major sources under
CAA section 112(d)(2). For area sources,
the EPA established GACT standards
pursuant to CAA section 112(d)(5). This
rulemaking addressed EtO emissions
originating from three major types of
emission points: The sterilization
chamber vent (SCV), the aeration room
vent (ARV), and the CEV. The SCV
evacuates EtO from the sterilization
chamber following sterilization,
fumigation, and any subsequent gas
washes. The ARV evacuates EtO-laden
air from the aeration room, which is
used to facilitate off-gassing. 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. Another
source of emissions within this source
category are fugitive emissions, but the
EPA has not set standards for those
emissions.
Following promulgation of the rule,
the EPA suspended certain compliance
deadlines and ultimately removed the
MACT and GACT standards for CEVs
due to safety concerns. In the late 1990s,
there were multiple explosions at
commercial EtO sterilization facilities.
In response, the EPA suspended all rule
compliance dates pending the
investigation of the explosions (62 FR
64736, December 9, 1997). In 1998, the
suspension of the compliance dates was
extended for the ARVs and the CEVs (63
FR 66990, December 4, 1998), although
the requirements for the SCVs went into
effect in 1998. It was also later
determined that EtO emissions from
aeration rooms could be safely
controlled, and the suspensions for the
ARVs were not further extended past
December 2000 (64 FR 67789, December
3, 1999). For CEVs, it was determined
that the primary contributing issue
leading to the explosions was that EtO
concentrations were above the safe limit
(i.e., above the lower explosive limit
(LEL)), within the CEV gas streams, and
the EPA extended the suspension of the
rule requirements for CEVs. The EPA
could not conclude at the time that the
CEVs could be safely controlled, so
MACT and GACT requirements for
CEVs were removed in 2001 (66 FR
55577, November 2, 2001) and have not
been re-instated. The EPA is soliciting
comment on the impacts associated
with potentially reinstating
requirements for CEVs in a future
rulemaking.
In addition, the EPA conducted a
residual risk analysis and a technology
review under CAA section 112(f)(2) and
CAA section 112(d)(6), respectively, and
issued a final decision on the risk and
technology review (71 FR 17712, April
7, 2006). No changes were made to the
requirements as part of that action.
The HAP standards that currently
apply to sterilization facilities covered
by 40 CFR part 63, subpart O are shown
in the following table:
TABLE 2—CURRENT ETO STANDARDS FOR COMMERCIAL STERILIZERS
Existing and new sources
subcategory 1
Sterilization chamber vent
(SCV)
Sources using 10 ton or more of
EtO in any consecutive 12month period.
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99 percent
63.362(c)).
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(see
40
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Aeration room vent
(ARV)
Chamber exhaust vent
(CEV) 2
1 ppm maximum outlet concentra- No control.
tion or 99-percent emission reduction (see 40 CFR 63.362(d)).
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TABLE 2—CURRENT ETO STANDARDS FOR COMMERCIAL STERILIZERS—Continued
Existing and new sources
subcategory 1
Sterilization chamber vent
(SCV)
Sources using 1 ton or more of
EtO but less than 10 ton of EtO
in any consecutive 12-month period.
Sources using less than 1 ton of
EtO in any consecutive 12month period.
99 percent
63.362(c)).
(see
40
Aeration room vent
(ARV)
Chamber exhaust vent
(CEV) 2
CFR
No control .....................................
No control.
Recordkeeping (minimal recordkeeping requirements apply
(see 40 CFR 63.367(c)).).
Recordkeeping (minimal recordkeeping requirements apply
(see 40 CFR 63.367(c)).).
Recordkeeping (minimal recordkeeping requirements apply
(see 40 CFR 63.367(c)).).
1 Determined
2 The
as a rolling 12-month emission rate.
CEV emission source was included in the original standard but was later eliminated from 40 CFR part 63, subpart O, in 2001.
The NESHAP applies to both major
and area sources that use at least 1 ton
of EtO in sterilization or fumigation
operations in each 12-month period.
C. Risks Associated With EtO Emissions
The National Air Toxics Assessment
(NATA) released in August 2018
identified EtO emissions as a potential
concern in several areas across the
country. (NATA is the Agency’s
nationwide air toxics screening tool,
designed to help the EPA and state,
local, and tribal air agencies identify
areas, pollutants, or types of sources for
further examination.) The latest NATA
estimates that EtO significantly
contributes to potential elevated cancer
risks in some census tracts across the
U.S. (less than 1 percent of the total
number of tracts). These elevated risks
are largely driven by an EPA risk value
that was updated in December 2016.1
The EPA conducted a previous
assessment of the health effects of EtO
exposure in 1985. Subsequently, EtO
was designated a HAP under the 1990
CAA amid increasing concerns
regarding the adverse effects of EtO
exposure due to newly published
human and animal studies of this
chemical. Consequently, the EPA’s
Office of Air and Radiation expressed an
interest in having the Integrated Risk
Information System (IRIS) Program
update the EPA’s 1985 EtO assessment.
In response, the IRIS Program began
work on the current EtO assessment in
the early 2000s and, following two
external peer reviews, completed this
work in December 2016.
Further investigation on NATA inputs
and results led to the EPA identifying
commercial sterilization using EtO as a
source category contributing to some of
these risks, which has led the EPA to
evaluate, in greater depth, the potential
health risks associated with emissions
of EtO. Over the past year, the EPA has
been gathering additional information to
help evaluate opportunities to reduce
EtO emissions through potential rule
revisions and more immediate emission
reduction steps. Considering these
results, the EPA is seeking comment in
this ANPRM on a number of potential
control strategies for facilities in the EtO
Emission Standards for Sterilization
Facilities source category that would
seek to reduce the fugitive emissions of
EtO and to improve point source
emission controls for commercial
sterilizers.
III. Small Business Considerations
When the EPA undertakes a proposed
rulemaking, it should identify any small
entities within the source category and
determine whether there is the potential
for significant economic impacts to
small businesses or other entities from
any regulatory actions being considered.
An entity is determined to be small
based on the ultimate parent company’s
NAICS code and as defined by the U.S.
Small Business Administration (SBA)
(https://www.sba.gov/document/
support--table-size-standards).2 A
parent company’s size is defined in
terms of annual revenue or number of
employees; Table 3 of this preamble
lists the size standards for parent
companies of entities regulated by the
current 40 CFR part 63, subpart O rule.
TABLE 3—SBA SIZE STANDARDS BY NAICS CODE
Source category
Size standards
(annual revenue—
millions)
Size standards
(number of
employees)
Surgical and Medical Instrument Manufacturing ......................................................
Surgical Appliance and Supplies Manufacturing ......................................................
Pharmaceutical Preparation Manufacturing .............................................................
Spice and Extract Manufacturing .............................................................................
Dried and Dehydrated Food Manufacturing .............................................................
Packaging and Labeling Services ............................................................................
................................
................................
................................
................................
................................
$12
1,000
750
1,250
500
750
................................
NAICS
code
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339112
339113
325412
311942
311423
561910
..............
..............
..............
..............
..............
..............
To date, of the 108 facilities that the
EPA has identified within the EtO
Emission Standards for Sterilization
Facilities source category, we have
identified approximately 35 facilities
owned by small businesses. At the
parent company level, there are 59 total
parent companies, 27 of which are small
parent companies.
Identifying potential impacts on
specific entities is challenging because
of the lack of detailed facility data for
this source category. Among other
things, the EPA is seeking information
about the costs associated with
controlling EtO emissions from sources
that qualify as small businesses. The
EPA will use information received in
response to this ANPRM to further
assess the potential impacts of emission
reduction strategies that may be
considered. Given the potential impacts
of certain emission reduction strategies
1 Evaluation of the Inhalation Carcinogenicity of
Ethylene Oxide, December 2016, EPA/635/R–16/
350Fc.
2 SBA determines whether an entity qualifies as
a small business concern by counting its receipts,
employees, or other measures including those of all
its domestic and foreign affiliates, regardless of
whether the affiliates are organized for profit (13
CFR 121.103(a)(6)).
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on these small businesses, the EPA
intends to convene a Small Business
Advocacy Review (SBAR) Panel before
taking any significant regulatory action.
The EPA is in the process of requesting
nominations for small entity
representatives to serve as part of a
possible SBAR Panel.
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IV. Request for Comment
The EPA is requesting comment (1) on
available control technologies for
reducing emissions of EtO and (2) on
developments in practices,
measurement, monitoring, processes,
and control technologies for the control
of EtO from commercial sterilization
facilities. The EPA has been
investigating these issues through
discussions with stakeholders, reviews
of operating permits, and research. As
part of the information gathering to date,
the EPA has consulted with the EtO
sterilization industry, including
companies, trade associations, and
control technology vendors, to better
understand the current state of controls
for EtO emission sources. The EPA held
teleconferences and meetings with 12
different EtO trade associations, air
pollution control device (APCD)
manufacturers, industry representatives,
and other government agencies to better
understand sterilization processes,
emissions (including measurement and
monitoring), current control techniques,
and how widely such techniques are
used, as well as how control efficiencies
are determined and guaranteed by
manufacturers. The discussions have
focused on common operational
practices, including practices used by
EtO commercial sterilization facilities to
determine EtO concentration at various
emissions points in the process. Despite
this outreach and information gathering,
there are still several important
information gaps that would be useful to
fill prior to any future rulemaking
activity.
Through information gathering and
discussions with stakeholders, the EPA
identified the process controls and
operational practices discussed below
for consideration as possible methods
for reducing the amount of EtO released
into the ambient air. Under section
114(a) of the CAA, the EPA may require
sources to report data in a manner
prescribed by the Agency. For the EtO
Commercial Sterilization and
Fumigation Operations source category,
the EPA intends to undertake a CAA
section 114 information collection to
provide information to support any
future rulemaking actions, such as the
upcoming technology review.
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A. Modeling File and Annual EtO Usage
Data
In order to ensure the accuracy of the
data that could be used for any future
rulemaking for this source category, the
EPA is soliciting comment on available
EtO usage data for individual facilities
and on additional data contained in the
modeling file that the EPA intends to
use to evaluate the impacts of EtO
emissions (Comment C–1). For the
modeling file, the EPA requests that
companies review the data for their
facilities to ensure that the information
presented is accurate and complete,
including current facility and process
information, emissions data,3 and
release parameters. The EPA further
requests that after reviewing the
modeling file for this purpose,
companies submit to the EPA any
corrected and supplemental information
as part of their comments. The modeling
file is available at the following website:
https://www.epa.gov/stationary-sourcesair-pollution/ethylene-oxide-emissionsstandards-sterilization-facilities. The
current known EtO usage data is
available in the docket.
B. Control of Fugitive Emissions
Fugitive EtO emissions at commercial
sterilization facilities generally occur
from (1) off-gassing associated with the
handling of EtO prior to charging the
sterilizer chamber; (2) off-gassing of
sterilized product following product
transfer from the sterilizer chamber to
the aeration room; (3) off-gassing from
uncontrolled and under-controlled
aeration rooms; and (4) any off-gassing
that may occur after product is removed
from the aeration room. For the purpose
of this rule, fugitive emissions are those
emissions which are not routed to an
existing pollution control device. The
magnitude of the fugitive emissions
from the industry is not well
characterized, and the extent of the
fugitive emissions may be dependent on
building design, the building air
handling system, and the capacity of the
existing air pollution control system. A
recent analysis of ambient air
monitoring data performed in close
proximity to a commercial sterilizer in
Illinois 4 indicated that the previous EtO
emission estimates for this facility may
have been underestimated. Specifically,
this analysis indicated that the fugitive
component of the emissions accounted
for approximately 0.5 percent of the
total EtO usage at that facility, which
3 Primarily derived from the EPA’s 2014 National
Emissions Inventory, version 2.
4 https://www.epa.gov/il/outdoor-air-monitoringwillowbrook-community.
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was significantly higher than previously
assumed.
The EPA is requesting comment on
the use of an emission factor of 0.5
percent of EtO usage for the calculation
of fugitive emissions from this source
category (Comment C–2a). In addition,
the EPA is requesting comment on any
data that can be used to help quantify
facility-wide and area/room-specific
fugitive emissions from commercial EtO
sterilizers (e.g., internal and ambient air
monitoring data), along with relevant
monitoring characteristics such as
monitoring collection equipment and
techniques, averaging time, equipment
detection limits, equipment quality
assurance, and quality control
procedures employed (Comment C–2b).
If commenters believe that alternative
fugitive EtO calculation procedures or
emission factors should be considered,
the EPA requests that commenters
provide documentation that supports
the basis or bases for why an alternative
methods or factors should be considered
(Comment C–2c).
1. Permanent Total Enclosure
Permanent total enclosures (PTEs) are
permanently installed structures that
completely surround source(s) of
emissions such that all volatile organic
compound emissions (i.e., EtO
emissions) are captured and contained
for discharge to a control device(s).
Specifically, PTEs could capture
emissions from sterilizer chamber
rooms, aeration rooms, EtO drum
storage areas, shipping areas, or any
facility areas through which sterilized
product is moved or EtO equipment is
in service. The EPA’s current
understanding is that the existing
building, or portions of the building, in
which EtO could be released could
serve as the enclosure, for example, by
enclosing and adapting the building or
portions of the building to meet the
design criteria of a PTE. EPA Method
204 (40 CFR part 51, appendix M)
provides the design criteria as well as
procedures for verifying the capture
efficiency of the enclosure.5
Additionally, EPA Method 204 includes
requirements to route the captured and
contained EtO-laden gas for delivery to
an APCD. Based on recent regulations
enacted in Illinois,6 as well as
increasing public awareness, multiple
EtO commercial sterilization facilities
have either implemented or are
5 40 CFR part 51, appendix M, EPA Method 204—
Criteria and Verification of a Permanent or
Temporary Total Enclosure. U.S. EPA.
6 https://www.ilga.gov/legislation/publicacts/
fulltext.asp?Name=101-0022 and
https://www.ilga.gov/legislation/publicacts/
fulltext.asp?Name=101-0023.
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planning to implement PTEs to capture
and control fugitive emissions from the
sterilization processes.
The EPA is requesting facility-specific
data items that can be used more
accurately to assess the cost and
emission capture/reduction of PTEs
(Comment C–3). In addition, the EPA
welcomes detailed facility-specific data
and information regarding building and
chamber design, including details on
the square feet and height of the rooms
where EtO is used, their temperature set
point (during summer, winter, and
intermediate seasons), relative
humidity, air flow, number of air
changes per hour, area of natural draft
openings as defined in EPA Method
204, the typical EtO concentration in
parts per million by volume (ppmv)
within these rooms, and quantification
of emissions reductions obtained via
PTE, along with a description of the
measurement device(s), measurement
device detection limits and
interferences, and measurement device
quality assurance and quality control
procedures and costs, the time required
to implement PTE, the number of
facilities currently implementing PTE or
planning to do so, and the extent to
which aspects of PTE might differ for
small business facilities (also Comment
C–3).
2. Pollution Prevention and Other
Operational Practices
Some facilities follow other
operational practices to reduce fugitive
emissions. These operational practices
include leak detection and repair
programs that encompass monitoring for
fugitive leaks from drums, valves, and
connection lines containing EtO;
controlling air flow in the building to
capture fugitive emissions (e.g., sweep
vents) in areas where EtO is processed
and sending these emissions to existing
controls; putting process controls in
place to minimize storage of fumigated
material in uncontrolled areas; reducing
emissions from EtO-laden waste water;
and reducing levels of EtO injected into
the sterilization chamber.
Fugitive emissions may occur from
EtO drum storage and handling. The
EPA understands that personnel at
commercial sterilizer facilities inspect
the valves on EtO drums for leaks when
delivered to their facilities and that the
connectors are also checked for leaks
after they are attached to a sterilizer
chamber.7 EtO drums contain
approximately 400 pounds of
compressed EtO liquid along with a
blanket of nitrogen. The pressurized
7 National
Fire Prevention Association 55 Chapter
14.
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drums are commonly equipped with
two valves: One for the nitrogen blanket,
and the other for unloading the EtO
liquid. Leak checks similar to what is
required by EPA Method 21 (40 CFR
part 60, appendix A) are conducted on
these valves and connectors.
Additionally, the drum storage room
area may be enclosed and vented to
either an APCD or to the atmosphere.
The EPA requests comment on these
and additional operational practices for
monitoring leaks from EtO drums,
including appropriate procedures
and/or methods to use and the optimal
frequency of monitoring; the emission
reductions likely to be achieved by
specific practices; the costs associated
with specific practices; the time
required to implement a leak check
program for EtO drums; the number of
facilities currently implementing these
leak checks or plan to do so; and the
extent to which aspects of these leak
checks might differ for small business
facilities (Comment C–4).
EtO supply lines are used to connect
the EtO drum to the sterilizer chamber.
Prior to its use for charging EtO, the EtO
line connection is often pressurized
with nitrogen from the storage drum to
the sterilizer chamber, to confirm that
there are no leaks. The line connection
is held at that pressure for a set time
period, and if the line connection is able
to maintain the pressure level, it is
considered leak free. The EPA is seeking
comment on the available operational
practices for conducting regular
pressure testing on the connection line
between the EtO drum and sterilizer
chamber. The EPA solicits comment on
the feasibility of conducting the tests,
the methods to be used or considered
for use, the optimal frequency of such
tests or methods, emission reductions
likely to be achieved by specific
practices, and the costs associated with
specific practices, the time required to
implement a leak check program for EtO
supply lines, the number of facilities
currently implementing these leak
checks or plan to do so, and the extent
to which aspects of these leak checks
might differ for small business facilities
(Comment C–5).
Sweep vents or floor vents are used to
move and capture room air from the
main room areas as operators move
sterilized product from area to area at
the facility. Sweep vents often maintain
the sterilizer chamber room area and the
aeration room area under negative
pressure. Some facilities route the room
air captured in sweep vents to an APCD,
and other facilities vent the captured
room air to the atmosphere. The floor
sweeps serve to reduce the EtO in work
areas to minimize occupational
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67895
exposure to EtO. Facilities often
measure the EtO concentration in the
sterilizer chamber room area and
aeration room area using a gas
chromatography or infrared instrument.
The EPA solicits comment on
circumstances in which it would not be
feasible to connect sweep vents to an
APCD (including specific facility
designs that may affect such feasibility);
the level of capture likely be achieved
for EtO fugitive emissions by specific
practices; the costs associated with
specific practices; the time required to
implement sweep vents or floor vents;
the number of facilities currently
implementing sweep vents or floor
vents; and the extent to which aspects
of sweep vents or floor vents might
differ for small business facilities
(Comment C–6).
The EPA is aware that emissions may
occur from water that comes into
contact with EtO during the sterilization
process. Potential emissions may come
from, but are not limited to, disposal of
water used in once-through liquid-ring
vacuum pumps, as well as water used
in recovering EtO for re-use in
sterilization. The EPA solicits comment
on the circumstances in which EtO may
come into contact with water within
commercial sterilization facilities; the
frequency with which such water is or
should be disposed; methods of
disposal; any operational practices that
are or may be used to mitigate emissions
from waste water; the feasibility of
implementing such operational
practices; and costs associated with
disposal and with specific operational
practices, the time required to
implement wastewater EtO emissions
reductions; the number of facilities
currently implementing wastewater EtO
emissions reductions; and the extent to
which aspects of wastewater EtO
emissions reductions might differ for
small business facilities (Comment C–7).
The EPA is also interested in
obtaining information on other
operational practices, not discussed in
the preceding paragraphs, that may be
available to reduce EtO emissions from
commercial sterilization facilities. The
EPA solicits comment on the
availability, applicability, and technical
feasibility of such operational practices;
the emission reductions likely to be
achieved by such measures; the cost of
such measures; the time required to
implement such measures; the number
of facilities currently implementing
such measures; and the extent to which
aspects of such measures might differ
for small business facilities (Comment
C–8).
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C. Chamber Exhaust Vent Control and
Safety Considerations
1. Reinstating the Chamber Exhaust
Vent Control Requirement
The CEV evacuates EtO-laden air from
the sterilization chamber prior to
unloading and while the chamber is
being unloaded (and reloaded). The
chamber exhaust enables facilities to
meet U.S. Occupational Safety and
Health Administration (OSHA)
workplace exposure standards.8
Following the removal of the CEV
regulatory requirement in 2001 (66 FR
55577, November 2, 2001), many EtO
sterilization facilities ceased, or never
implemented, controls for EtO
emissions from the CEV. In more recent
years, however, facilities have begun to
control EtO from the CEV, and multiple
facilities currently control the CEV. The
safety issues that prevented earlier
control techniques from being applied
were linked to EtO concentrations in the
sterilizer chamber that exceeded the
LEL for EtO. Since the late 1990s and
early 2000s, facilities have revised their
operating procedures related to the CEV.
Currently, some facilities that control
EtO emissions from the CEV have made
process changes to avoid exceedance of
the LEL; such process changes include
(1) reducing the EtO concentration in
the sterilizer chamber before opening
the sterilizer chamber door and venting
emissions to an APCD, and (2) using an
automated lock on the sterilizer
chamber door that does not allow the
door to open until EtO concentration is
significantly less than the LEL. As part
of the process change, facilities have
enacted additional final air washes in
the sterilization cycle to further reduce
the EtO concentration in the sterilizer
chamber prior to opening the sterilizer
door and venting to the APCD. In
addition, the automated lock on the
sterilizer chamber door does not allow
the door to open until a non-explosive
EtO concentration level is achieved in
the chamber. The MACT floor for CEVs
at existing and new sources, for sources
using 10 tpy or more of EtO, is routing
emissions from the CEV such that they
are combined with a stream that is
already being routed to a control device
that achieves 99-percent emission
reduction.9 Typical APCDs used to
control EtO emissions from CEVs
8 29
CFR 1910.1047.
Hearne and K. Schmidtke, MRI, to D.
Markwordt, U.S. EPA. October 24, 1994. Revised
Calculation of MACT Floors for Major Source
Chamber Exhaust Vents at Ethylene Oxide
Commercial Sterilization and Fumigation
Operations; National Emissions Standards for
Hazardous Air Pollutants (NESHAP) (Legacy Docket
ID No. A–88–03, Docket Entry IV–B–02).
9 D.
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include the following: Catalytic
oxidizers, dry bed scrubbers, wet acid
scrubbers, combination wet acid
scrubbers and dry bed scrubbers, and
balancer/abator systems. The EPA
solicits comment on implications of
potentially reinstating the requirement
to control the CEV and is soliciting
information regarding the feasibility,
emission reductions achieved, cost, the
time required to reinstate the
requirements; the number of facilities
currently reducing their CEV emissions;
the extent to which aspects of CEV
emissions reductions might differ for
small business facilities, and associated
safety considerations (Comment C–9).
2. Implementing an In-Chamber
Concentration Limit
To further reduce EtO emissions from
the SCV, some facilities set an upper inchamber concentration limit on the EtO
in the sterilization chamber prior to
opening the chamber door and engaging
the CEV. Increased air washes to remove
EtO from the sterilizer chamber have
been implemented over time to
accommodate control of the CEV. To
safely control the CEV, the
concentration must be significantly
below the LEL of EtO. The reduction of
the in-chamber concentration at the end
of the sterilization cycle is directly
linked to venting of the CEV to an APCD
and has enabled control of the CEV. A
2007 report from the National Institute
for Occupational Safety and Health
determined that additional air washes
were essential for mitigating any safety
issues.10 A report by the Chemical
Safety and Hazard Investigation Board
on an explosion that occurred at a
commercial EtO sterilization facility in
2004 arrived at the same conclusion.11
While an in-chamber, EtO
concentration monitoring technique was
not available when the original
NESHAP was promulgated in 1994, inchamber monitors are available today.
Monitors based on the photoacoustic
principle are available and currently in
use at sterilization facilities. These
monitors are used to measure the inchamber concentration of EtO to
confirm that the chamber concentration
is well below the LEL of EtO. The LEL
of EtO is 3.0 percent by volume, or
10 National Institute for Occupational Safety and
Health, Preventing Worker Injuries and Deaths from
Explosions in Industrial Ethylene Oxide
Sterilization Facilities (Revised Edition). August
2007. https://www.cdc.gov/niosh/docs/2007-164/.
11 Chemical Safety and Hazard Investigation
Board, Investigation Report: Sterigenics (4
Employees Injured). March 2006. https://
www.csb.gov/sterigenics-ethylene-oxide-explosion/.
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30,000 ppmv.12 To ensure safe
conditions when opening the sterilizer
chamber at the end of the sterilization
cycle and to ensure limited fugitive
emissions released from the open
sterilizer chamber door, facilities reduce
the EtO concentration to significantly
less than the LEL, often to ranges of 10
to 25 percent of the LEL (i.e., 3,000 to
7,500 ppmv). (LESNI 2019) 13
The reduction of the in-chamber
concentration is achieved through
additional air washes in the sterilizer
chamber. The number of additional air
washes required to reach a
concentration below the LEL is
dependent on the parameters in the
individual validated sterilization cycle.
Some cycles that operate under shallow
vacuum conditions, or need higher EtO
concentration levels to reach sterility,
may require additional air washes to
lower the in-chamber concentration to
this level.
The addition of air washes may
increase the costs to operate the
sterilizer chamber vacuum pump, as
well as the costs to operate the APCD
used to control emissions from the SCV.
In addition, the overall facility
sterilization capacity may be reduced
due to the increased length of time
required to complete the sterilization
cycle. The EPA solicits comment on (1)
the feasibility of using additional air
washes in the sterilization chamber to
further decrease in-chamber EtO
concentration; (2) the emission
reductions likely to be achieved by
additional air washes; (3) associated
costs; (4) the EtO concentration that
should be typically reached before
allowing activation of the CEV; (5) the
time required to implement an EtO
concentration reduction program; (6) the
number of facilities currently reducing
EtO concentration before activating the
CEV; and (7) the extent to which EtO
concentration reduction efforts might
differ for small business facilities
(Comment C–10).
3. Interlock System Tied to In-Chamber
Concentration Limit
To further reduce fugitive emissions
of EtO from leaving the sterilizer
chamber and risking the immediate
health and safety of facility operators,
most facilities have installed door
interlock systems on their sterilizer
chambers. These door interlock systems
are tied to the monitoring and control
12 https://pubchem.ncbi.nlm.nih.gov/compound/
Ethylene-oxide#section=Lower-Explosive-Limit(LEL).
13 See memorandum, Meeting Minutes for
Discussion with Representative of LESNI, located at
Docket ID No. EPA–HQ–OAR–2019–0178. March 7,
2019.
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1. Balancer/Abator System
Add-on control devices such as wet
acid scrubbers, catalytic oxidizers, and
dry bed scrubbers are commonly used to
control the emissions of EtO from the
commercial sterilization source
category. Generally, the add-on APCD is
designed based on the maximum flow
rates and EtO concentrations from the
emission sources vented to the device.
An APCD used for reducing the EtO
emissions from the Commercial
Sterilization and Fumigation Operations
source category that was developed
since the initial NESHAP is a
combination water balancer and
catalytic oxidizer, also referred to as the
balancer/abator system. This system
vents EtO to the water balancer, where
a significant portion of the EtO is stored
within the water, so that a flow of air
at a constant EtO concentration can be
fed to the catalytic oxidizer. The SCVs
are first vented to the water balancer,
and the stream from the balancer is then
to the catalytic oxidizer. The ARVs and
CEVs are sources of more dilute EtOladen streams and, therefore, are not
vented to the water balancer—they are
vented directly to the catalytic oxidizer.
Emissions from the ARVs and CEVs are
first mixed with the stripped EtO stream
from the SCV and then emissions from
all three vents are routed to the catalytic
oxidizer. The water balancer does not
convert the EtO into ethylene glycol, as
the scrubbing water is not acidic enough
to drive the conversion (i.e., addition of
sulfuric acid would drive the
conversion to ethylene glycol).
One advantage of this APCD is related
to the intermittent venting of high EtO
concentration streams from the sterilizer
chamber. The concentration of EtO
within an SCV stream can vary
depending on how much EtO is used for
sterilizing a product, as well as what
sterilization phase the chamber is in at
the time of exhaust (e.g., dwell period,
gas washing, etc.). The number of
chambers venting to one balancer also
has an impact on overall concentration.
The water balancer essentially ‘‘stores’’
the EtO peaks from the SCV in the
water, and the catalytic oxidizer is
designed based on a relatively constant
flowrate and EtO concentration from the
combination of the stream from the
balancer and the ARV and CEV
emission streams, rather than based on
the peak flowrates and EtO
concentrations from the SCV.
The balancer/abator system design
was introduced in the U.S. in 2006, and
there are at least four facilities currently
using this APCD in four states and
territories. The balancer/abator system
achieves 99.9-percent reduction of EtO
emissions and EtO concentrations of 0.5
milligrams per normal cubic meter
(roughly equivalent to 0.27 ppmv)
(LESNI 2019).15 The ARV and CEV
concentrations are characterized as
dilute concentrations in a high-volume
air flowrate. The balancer/abator system
helps normalize both the flowrate and
the EtO concentration fluctuations. The
EPA is soliciting comment on use of the
balancer/abator system, the emission
reductions likely to be achieved from
such use, the associated costs, the time
required to implement a balancer/abator
system, the number of facilities
14 See memorandum, Meeting Minutes for
Discussion with Representatives of AdvaMed,
located at Docket ID No. EPA–HQ–OAR–2019–
0178. July 2, 2019.
15 See memorandum, Meeting Minutes for
Discussion with Representative of LESNI, located at
Docket ID No. EPA–HQ–OAR–2019–0178. March 7,
2019.
equipment already operating within the
sterilizer chamber. The interlock system
ensures that the sterilizer chamber doors
are unable to be opened by facility
personnel prior to achieving the
prescribed in-chamber concentration of
EtO, i.e., below the LEL. By preventing
premature opening of the sterilizer
chamber door prior to reaching a nonexplosive EtO concentration, the door
interlock system accomplishes two
things: (1) It ensures that gas from the
sterilizer chamber is prevented from
being directed to the CEV until the EtO
concentration within the chamber is
well below the LEL, and (2) it greatly
reduces the amount of fugitive EtO that
operators will be exposed to over the
course of the work day. Industry trade
associations have indicated that
environmental health and safety issues
surrounding worker exposure have been
a major focus of EtO sterilizationcentered working groups over recent
years (AdvaMed 2019).14
The combination of an in-chamber
EtO concentration limit and an interlock
system tied to that limit enables
facilities to continue to meet OSHA
workplace exposure standards with
respect to emissions from the sterilizer
chamber.
The EPA is soliciting comment on
cost, the time required to implement an
interlock system, the number of
facilities currently utilizing interlock
systems, and the extent to which aspects
interlock systems might differ for small
business facilities, and safety
considerations for an interlock system
on the sterilizer chamber door that is
linked to the in-chamber concentration
(Comment C–11).
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currently using balancer/abator systems,
and the extent to which aspects of a
balancer/abator system might differ for
small business facilities (Comment C–
12).
2. Improvements to Existing Point
Source Controls
While the current standard for control
device efficiency requires 99-percent
removal (along with a 1-ppmv
alternative for ARVs), the EPA is aware
of many situations in which testing has
revealed emission control performance
that is significantly superior to the
current standard. The EPA is soliciting
comment on potential improvements to
control device efficiencies and observed
removal efficiencies or outlet
concentrations, along with any costs
potential implementation issues
associated with achieving those higher
control efficiencies, the time required to
improve existing point source controls,
the number of facilities that have made
improvements to their existing point
source controls, and the extent to which
improvements to existing point source
controls might differ for small business
facilities (Comment C–13).
3. Improved Monitoring Instruments for
Ethylene Oxide
Since the regulations at 40 CFR part
63, subpart O, were finalized in 2001,
there have been significant
improvements in monitoring
equipment, including new continuous
monitoring instruments that are
considerably more sensitive than
previous monitoring technology. In the
past, there have been concerns over
detecting low concentrations of EtO, but
instrumentation is now available with a
detection capability in the single parts
per billion by volume within the
exhaust stack for the APCD. Instrument
manufacturers have developed
innovative techniques which use optical
spectroscopy that allow for greater
sensitivity and better time-resolution
than the current monitoring techniques
specified in the rule. The EPA is
requesting comment on the feasibility of
using continuous monitoring systems
and is soliciting comment on the cost
considerations for installing and
operating the monitoring units,
particularly for control devices. The
EPA is also soliciting comment on the
number of facilities currently using
improved monitoring instruments
(Comment C–14).
4. Accelerated Aerator Design and
Aeration Cells
One process equipment improvement
available is the use of accelerated
aeration cells. The use of focused
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aeration was discussed in the 1992 EtO
Sterilization Background Information
Document,16 including use of both
smaller, heated aeration chambers (43
degrees Celsius (°C)) and vacuum cycles
on the small aeration cells. The use of
aeration cells rather than aeration rooms
significantly reduces the volume of air
vented to the APCD. The EPA does not
have information on the total number of
facilities that are using aeration cells.
A large aeration room requires large
volumetric flowrates to move the EtO
out of the room. Such rooms have low
EtO concentrations and large volumes of
gas and entail many air changeovers
(e.g., 20 air changes per hour). It may
take 5 to 10 days to complete the
aeration cycle for such a room.
Replacing the large aeration room with
an aeration cell reduces the volumetric
flowrate from the emission source. Use
of smaller aeration cells may reduce the
amount of aeration time needed, remove
the EtO more efficiently, and reduce the
residual EtO in the final product.
Combining heated aeration cells with
high-turbulence air flow or with
vacuum cycles is a newer approach to
aeration for commercial sterilization,
sometimes referred to as acceleration
aeration. Heated chambers are typically
in the range of 40 °C to 60 °C. Inlet air
is introduced at multiple inlet ports
along the side of the aeration cell and
removed at multiple outlet points along
the top of the cell to provide even
distribution of air throughout the cell.
Combining aeration cells with highturbulence air movement throughout the
cell can accelerate the aeration process
by reducing the number of air
changeovers needed to remove the EtO
from the product. One manufacturer
noted that shallow vacuum intervals
vary between 50 and 700 millibars, and
that the use of shallow vacuum is
expected to reduce the aeration time by
65 percent or more compared with
traditional aeration procedures. Based
on discussions with one trade
organization, at least one company is
currently modifying a facility so that it
will incorporate the new accelerated
aerator design (EOSA 2019).17
The EPA is soliciting comment on the
use of accelerated aeration design and
aeration cells; the emission reductions
likely to be achieved by such changes;
16 U.S. EPA, Office of Air Quality Planning and
Standards, Emission Standards Division. Ethylene
Oxide Emissions for Commercial Sterilization
Fumigation Operations Background Information for
Proposed Standards. October 1992 (Legacy Docket
A–88–03, Docket Entry II–A–022).
17 See memorandum, Meeting Minutes for
Discussion with Representatives of the Ethylene
Oxide Sterilization Association (EOSA), located at
Docket ID No. EPA–HQ–OAR–2019–0178. March
18, 2019.
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the feasibility of implementation of such
changes; associated costs; the time
required to implement accelerated
aeration design or aeration cells; the
number of facilities currently using
accelerated aeration design or aeration
cells; and the extent to which aspects
accelerated aeration or aeration cells
might differ for small business facilities
(Comment C–15).
5. Cascading Air Method
Some facilities use cascading air to
reduce the overall volume of air use for
sterilization processes. A facility using a
cascading technique does not use fresh
air as feed air but rather reuses air from
a low-concentration fugitive area as the
feed air to another area. For example,
reuse of the fugitive air from the
warehouse can be used as intake air to
the aeration room or aeration cell. Use
of cascading air reduces the amount of
air that needs to be processed by the
APCD. In this example, rather than
using a larger APCD to handle and
control the volume of air from the ARV
plus the warehouse room area, the
facility routes the warehouse air to the
aeration room, and the ARV emissions
are then routed to a smaller APCD.
The EPA solicits comment of the
feasibility of the cascading air
technique; the emissions reductions that
are likely to be achieved; the feasibility
of implementation; associated costs; the
time required to implement the
cascading air method; the number of
facilities currently using the cascading
air method; and the extent to which
aspects of the cascading air method
might differ for small business facilities
(Comment C–16).
E. Types of Sterilization Facilities
1. Single-Item Sterilizer Facilities
The EPA has identified 27
commercial EtO sterilization facilities
that use a single-item sterilizer model.
While a traditional sterilization chamber
tends to be a larger vessel that
accommodates pallets containing
diverse products, a single-item sterilizer
is generally smaller and may use much
less EtO to sterilize products (e.g.,
approximately 10 percent of the EtO
that a traditional sterilization chamber
would use). In the single-item
sterilization process, workers place the
product into a plastic pouch, a slight
vacuum is applied, EtO gas is injected
into the pouch and sealed, and the
sealed pouch is placed in a room,
chamber, or cabinet under specific
temperature and humidity where EtO
both sterilizes and then off-gasses or
aerates. The EtO slowly dissipates from
the pouch or bag by diffusion. Once the
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product is removed from the room,
chamber, or cabinet, the product is held
in the warehouse for 2 days before
shipping. Just as is the case with
traditional sterilizer chambers, EtO is
stored in a pressurized drum when the
single-item sterilization approach is
used, although the cylinder tends to be
smaller than EtO storage drums used at
traditional sterilization facilities. EtO
usage in a single-item sterilizer facility
is often much less than in traditional
sterilizer chambers.
Facilities using the single-item
sterilizer process were previously
thought to typically use much less than
1 ton of EtO per year,18 and under 40
CFR part 63, subpart O, processes that
use less than 1 ton of EtO are only
subject to the recordkeeping
requirements. Processes that use over 1
ton of EtO per year are subject to
additional requirements. A recent
review of single-item sterilizers found
the EtO usage for at least four of these
facilities to be in excess of 1 ton.19 The
EPA is requesting comment on (1)
specific emissions controls that are used
or could be used at single-item
sterilizers in EtO commercial
sterilization, and (2) whether there are
any technical or process differences
between single-item sterilization and
traditional sterilizer chambers that
should be considered when adopting
measures to reduce emissions. The EPA
is seeking additional information on
costs associated with single-item
sterilization use (including costs related
to machine purchase and maintenance,
design considerations, and
implementation) and on costs associated
with compliance with the NESHAP’s
emissions limits under the current
subpart O regulations. The EPA also
solicits comment on the number of
facilities that are single-item
sterilization facilities (Comment C–17).
2. Combination Sterilizer Facilities
The EPA is aware of another
technology, a combination sterilizer,
that is used in the EtO commercial
sterilization industry. In combination
sterilizers, the sterilization step and
aeration step occur in sequence in the
same chamber. The chamber is
evacuated and EtO gas is injected into
the chamber. After the sterilization
process is completed, air washes are
used to remove most of the EtO from the
product. The exhausted EtO may be
vented to the atmosphere or to a carbon
canister, with charcoal adsorbent, to
18 Ethylene Oxide Commercial Sterilization and
Fumigation Operations NESHAP Implementation
Document, EPA–456/R–97–004, March 2004.
19 See annual EtO usage data provided in Docket
ID No. EPA–HQ–OAR–2019–0178.
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control the EtO. One advantage of this
sterilization approach is a reduction of
EtO fugitive emissions due to the
elimination of the step in which product
is moved from the sterilization chamber
to the aeration equipment.
The EPA is seeking information and
comment on the viability of replacing
traditional EtO sterilization operations
with combination sterilizers. The EPA is
also seeking information on the
emissions associated with combination
sterilizers relative to traditional
sterilizers; the control devices typically
used for these types of chambers; costs
associated with operating emissions
controls for combination EtO sterilizers;
and the number of facilities currently
using combination sterilizers (Comment
C–18).
3. Sterilization Facilities Owned by
Small Businesses
As discussed in section III of this
ANPRM, small businesses make up a
significant portion of the EtO
Commercial Sterilization and
Fumigation Operations source category.
Given their prevalence within this
industry, it is important that the EPA
understand any technical or process
differences between facilities owned by
small businesses and facilities in the
rest of the source category. Specifically,
the EPA requests comment on the extent
to which facilities owned by small
businesses may differ operationally
from facilities operated by larger
businesses, including whether the
emissions profiles differ consistently.
The EPA also solicits comment on
whether small businesses tend to own
small facilities, and whether small
businesses tend to use processes that
have higher or lower emissions
(Comment C–19).
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4. Other Distinctions Among
Sterilization Facilities
While the EPA has noted differences
between the types of sterilization
facilities mentioned above, the EPA is
also soliciting comment on whether
there are other types of sterilization
facilities that are markedly different in
terms of processes, operations, costs, or
environmental impact when compared
with traditional sterilization facilities
(Comment C–20).
V. Statutory and Executive Order
Reviews
Additional information about statutes
and relevant Executive Orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executive-orders.
Under Executive Order 12866,
Regulatory Planning and Review (58 FR
51735, October 4, 1993), this action is a
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significant regulatory action that was
submitted to the Office of Management
and Budget (OMB) for review. Any
changes made in response to OMB
recommendations have been
documented in the docket. This action
does not propose or impose any
requirements, and instead seeks
comments and suggestions for the
Agency to consider in possibly
developing a subsequent proposed rule.
Should the EPA subsequently determine
to pursue a rulemaking, the EPA will
address relevant statutes and Executive
Orders as applicable to that rulemaking.
Dated: December 5, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019–26804 Filed 12–11–19; 8:45 am]
BILLING CODE 6560–50–P
CHEMICAL SAFETY AND HAZARD
INVESTIGATION BOARD
40 CFR Part 1604
[Docket Number: CSB–2019–0004]
RIN 3301–AA00
Accidental Release Reporting
Chemical Safety and Hazard
Investigation Board.
ACTION: Notice of proposed rulemaking.
AGENCY:
This proposed rule describes
when an owner or operator is required
to file a report of an accidental release
and the required content of such a
report. The purpose of the proposed rule
is to ensure that the CSB receives rapid,
accurate reports of any accidental
release that meets established statutory
criteria.
DATES: Comments must be submitted by
January 13, 2020.
ADDRESSES: You may send comments,
identified by docket number and/or RIN
number, by any of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Email: reportingrule@csb.gov.
Include docket number and/or RIN
number, 3301–AA00, in the subject line
of the message.
• Mail: Chemical Safety and Hazard
Investigation Board, 1750 Pennsylvania
Ave. NW, Suite 910, Washington, DC
20006, ATTN: Reporting Rule Comment.
Instructions: All submissions must
include the agency name and docket
number, CSB–2019–0004, or Regulatory
Information Number, 3301–AA00, for
this rulemaking. For detailed
instructions on sending comments and
SUMMARY:
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additional information on the
rulemaking process, see the ‘‘Public
Participation and Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this proposed
rule, call or email Mr. Thomas Goonan,
General Counsel of the Chemical Safety
and Hazard Investigation Board, by
telephone at 202–261–7600, or by email
at rulemaking@csb.gov.
SUPPLEMENTARY INFORMATION: The
enabling statute of the Chemical Safety
and Hazard Investigation Board (CSB)
provides that the CSB ‘‘shall establish
by regulation requirements binding on
persons for reporting accidental releases
into the ambient air subject to the
Board’s investigative jurisdiction.’’ 42
U.S.C. 7412(r)(6)(C)(iii). The proposed
rule is intended to satisfy this statutory
requirement.
Background
The CSB was established by the Clean
Air Act Amendments of 1990. The
statute directs the CSB, among other
things, to investigate and report on any
accidental release ‘‘resulting in a
fatality, serious injury or substantial
property damages.’’ 42 U.S.C.
7412(r)(6)(C)(i) and (ii). The statute also
requires the CSB to issue a rule
governing the reporting of accidental
releases to the CSB. 42 U.S.C.
7412(r)(6)(C)(iii).
Although the CSB’s enabling
legislation was enacted in 1990, the CSB
did not begin operations until 1998.
Since 1998, the CSB has not
promulgated an accidental releasereporting requirement as envisioned in
the CSB enabling legislation.
In 2004, the DHS Inspector General
recommended that the CSB implement
the statutory reporting requirement:
‘‘The CSB needs to refine its mechanism
for learning of chemical incidents, and
it should publish a regulation describing
how the CSB will receive the
notifications it needs.’’ (Department of
Homeland Security, Office of Inspector
General, ‘‘A Report on the Continuing
Development of the U.S. Chemical
Safety and Hazard Investigation Board,’’
OIG–04–04, Jan. 2004, at 14.) In 2008,
the Government Accountability Office
(GAO) also recommended that the CSB
fulfill its statutory obligation by issuing
a reporting rule. (U.S. Government
Accountability Office, ‘‘Chemical Safety
Board: Improvements in Management
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Agencies
[Federal Register Volume 84, Number 239 (Thursday, December 12, 2019)]
[Proposed Rules]
[Pages 67889-67899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26804]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[EPA-HQ-OAR-2019-0178; FRL-10003-08-OAR]
RIN 2060-AU37
National Emission Standards for Hazardous Air Pollutants:
Ethylene Oxide Commercial Sterilization and Fumigation Operations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Advance notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: In this advance notice of proposed rulemaking (ANPRM), the
U.S. Environmental Protection Agency (EPA) is soliciting information
that will aid in potential future revisions to the Ethylene Oxide
Emission Standards for Sterilization Facilities. The EPA is soliciting
information and requesting comment on potential control measures for
reducing ethylene oxide (EtO) emissions from commercial sterilization
facilities. These control measures include controls for fugitive
emissions of EtO, safety measures for the chamber exhaust vents (CEVs),
process equipment improvements, and advances in add-on control
technologies for point sources. In addition, the EPA is considering,
and requesting comment on, how best to assess potential impacts on
small businesses. The EPA is also
[[Page 67890]]
taking comment on the available EtO usage data for individual
facilities and on additional data contained in the modeling file that
will be used to evaluate the impact of emissions from commercial EtO
sterilizers.
DATES: Comments. Comments must be received on or before February 10,
2020.
ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OAR-2019-0178, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
Email: [email protected]. Include Docket ID No. EPA-
HQ-OAR-2019-0178 in the subject line of the message.
Fax: (202) 566-9744. Attention Docket ID No. EPA-HQ-OAR-
2019-0178.
Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Docket ID No. EPA-HQ-OAR-2019-0178, Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington, DC 20460.
Hand/Courier Delivery: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operation are 8:30 a.m.-4:30 p.m., Monday-
Friday (except federal holidays).
Instructions: All submissions received must include the Docket ID
No. for this action. Comments received may be posted without change to
https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: For questions about this action,
contact Mr. Jonathan Witt, Sector Policies and Programs Division (E143-
05), Office of Air Quality Planning and Standards, U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711; telephone number:
(919) 541-5645; email address: [email protected].
SUPPLEMENTARY INFORMATION:
Docket. The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2019-0178. All documents in the docket are
listed in Regulations.gov. Although listed, some information is not
publicly available, e.g., Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in
Regulations.gov or in hard copy at the EPA Docket Center, Room 3334,
WJC West Building, 1301 Constitution Avenue NW, Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. 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.
Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2019-0178. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at https://www.regulations.gov/, including any personal
information provided, unless the comment includes information claimed
to be CBI or other information whose disclosure is restricted by
statute. Do not submit information that you consider to be CBI or
otherwise protected through https://www.regulations.gov/ or email. This
type of information should be submitted by mail as discussed below.
The EPA may publish any comment received to its public docket.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the Web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
The https://www.regulations.gov/ website allows you to submit your
comment anonymously, which means the EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send an email comment directly to the EPA without going through
https://www.regulations.gov/, your email address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the internet. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comment and with any
digital storage media you submit. If the EPA cannot read your comment
due to technical difficulties and cannot contact you for clarification,
the EPA may not be able to consider your comment. Electronic files
should not include special characters or any form of encryption and be
free of any defects or viruses. For additional information about the
EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.
The EPA is soliciting comment on numerous aspects of the action.
The EPA has indexed each comment solicitation with an alpha-numeric
identifier (e.g., ``C-1,'' ``C-2,'' ``C-3'') to provide a consistent
framework for effective and efficient provision of comments.
Accordingly, the EPA asks that commenters include the corresponding
identifier when providing comments relevant to that comment
solicitation. The EPA asks that commenters include the identifier in
either a heading, or within the text of each comment (e.g., ``In
response to solicitation of comment C-1, . . .'') to make clear which
comment solicitation is being addressed. The EPA emphasizes that the
Agency is not limiting comment to these identified areas and encourages
provision of any other comments relevant to this action.
Submitting CBI. Do not submit information containing CBI to the EPA
through https://www.regulations.gov/ or email. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information on
any digital storage media that you mail to the EPA, mark the outside of
the digital storage media as CBI and then identify electronically
within the digital storage media the specific information that is
claimed as CBI. In addition to one complete version of the comments
that includes information claimed as CBI, you must submit a copy of the
comments that does not contain the information claimed as CBI directly
to the public docket through the procedures outlined in Instructions
above. If you submit any digital storage media that does not contain
CBI, clearly indicate on the outside of the digital storage media that
it does not contain CBI. Information not marked as CBI will be included
in the public docket and the EPA's electronic public docket without
prior notice. Information marked as CBI will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2. Send or deliver
information identified as CBI only to the following address: OAQPS
Document Control Officer (C404-02), OAQPS, U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina
[[Page 67891]]
27711, Attention Docket ID No. EPA-HQ-OAR-2019-0178.
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:
ANPRM advance notice of proposed rulemaking
APCD air pollution control device
ARV aeration room vent
CAA Clean Air Act
CBI Confidential Business Information
CEV chamber exhaust vent
CFR Code of Federal Regulations
EOSA Ethylene Oxide Sterilization Association
EPA Environmental Protection Agency
EtO ethylene oxide
GACT generally available control technology
HAP hazardous air pollutant(s)
IR infrared
IRIS Integrated Risk Information System
LEL lower explosive limit
MACT maximum achievable control technology
NAICS North American Industry Classification System
NATA National Air Toxics Assessment
NESHAP national emission standards for hazardous air pollutants
OAQPS Office of Air Quality Planning and Standards
OMB Office of Management and Budget
OSHA Occupational Safety and Health Administration
ppmv parts per million by volume
PRA Paperwork Reduction Act
PTE permanent total enclosure
SBA Small Business Administration
SBAR Small Business Advocacy Review
SCV sterilization chamber vent
tpy tons per year
Organization of this document. The information in this preamble is
organized as follows:
I. General Information
A. What is the purpose of this ANPRM?
B. Does this action apply to me?
C. Where can I get a copy of this document and other related
information?
II. Background
A. Statutory Background
B. Regulatory Background
C. Risks Associated With EtO Emissions
III. Small Business Considerations
IV. Request for Comment
A. Modeling File and Annual EtO Usage Data
B. Control of Fugitive Emissions
C. Chamber Exhaust Vent Control and Safety Considerations
D. Other Point Source Control Options
E. Types of Sterilization Facilities
V. Statutory and Executive Order Reviews
I. General Information
A. What is the purpose of this ANPRM?
This ANPRM is intended to solicit information from the public in
order to inform the EPA as the Agency considers proposing a future
rulemaking to further address emissions of EtO from commercial
sterilizers. This ANPRM focuses on considerations pertinent to
potential future amendments to 40 CFR part 63, subpart O, in order to
further address emissions of EtO from commercial sterilizers. Subpart O
contains the emissions control standards for hazardous air pollutants
(HAP) that apply to commercial EtO sterilization facilities. In this
ANRPM, the EPA identifies additional control technologies and measures
that may be used to reduce emissions of EtO and provides an opportunity
for stakeholders to provide additional information about these
technologies and measures. In addition, the EPA is seeking information
about the costs associated with controlling EtO emissions from all
sources and, specifically, those that qualify as small businesses. The
EPA is also taking comment on facility and emissions data as part of
the modeling file that will be used to evaluate the impact of emissions
from commercial EtO sterilizers.
B. Does this action apply to me?
The current standards in 40 CFR part 63, subpart O, regulate
emissions of EtO from existing and new commercial sterilization
operations using 907 kilograms per year (1 ton per year (tpy)) of EtO
or more. The EtO Commercial Sterilization and Fumigation Operations
source category covers the use of EtO as a sterilant and fumigant
following the production of various products (e.g., medical equipment
and supplies) and in miscellaneous sterilization and fumigation
operations at both major and area sources. These commercial
sterilization facilities use EtO as a sterilant for heat- or moisture-
sensitive materials and as a fumigant to control microorganisms or
insects. Materials may be sterilized at the facility that produces or
uses the product, or by contract sterilizers (i.e., firms under
contract to sterilize products manufactured by other companies). Table
1 of this preamble lists the entities that are regulated by the current
subpart O rule.
Table 1--NESHAP and Industrial Source Categories Affected by This Action
------------------------------------------------------------------------
NAICS
Source category code
\1\
------------------------------------------------------------------------
Surgical and Medical Instrument Manufacturing.................. 339112
Surgical Appliance and Supplies Manufacturing.................. 339113
Pharmaceutical Preparation Manufacturing....................... 325412
Spice and Extract Manufacturing................................ 311942
Dried and Dehydrated Food Manufacturing........................ 311423
Packaging and Labeling Services................................ 561910
------------------------------------------------------------------------
\1\ North American Industry Classification System.
The table is not meant to be exhaustive, but rather provides a
guide for readers regarding the entities that are likely to be affected
by future regulation for this source category. The EtO Commercial
Sterilization and Fumigation Operations source category includes
medical equipment suppliers; pharmaceutical suppliers; other health-
related industries; spice manufacturers; and contract sterilizers (see
57 FR 31576, July 16, 1992). 40 CFR part 63, subpart O, also applies to
large libraries and large museums and archives, but does not apply to
hospitals, doctor offices, clinics, or other facilities whose primary
purpose is to provide medical services to humans or animals; beehive
fumigators; and research and laboratory facilities. In addition, review
and comments are welcome from manufacturers of devices capable of
measuring, monitoring, reducing, abating, or destroying EtO,
particularly if such devices are or will soon be available in the
commercial marketplace.
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 ANPRM is available on the internet. Following signature by the EPA
Administrator, the EPA will post a copy of this ANPRM at the following
address: 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 of the ANPRM and key technical documents at this same
website.
II. Background
A. Statutory Background
Section 112 of the Clean Air Act (CAA) establishes the regulatory
process used to develop standards for emissions of HAP from stationary
sources. In the first stage of this process, the EPA
[[Page 67892]]
promulgates technology-based standards under CAA section 112(d) for
categories of sources identified as emitting one or more of the HAP
listed in CAA section 112(b). 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 10
tpy or more of a single HAP or 25 tpy or more of any combination of
HAP. All other sources are ``area sources.'' For major sources, CAA
section 112(d)(2) provides that the technology-based national emission
standards for hazardous air pollutants (NESHAP) must reflect the
maximum degree of emission reductions of HAP achievable (after
considering cost, energy requirements, and non-air quality health and
environmental impacts). These standards that reflect the maximum degree
of emission reductions of HAP are commonly referred to as maximum
achievable control technology (MACT) standards. CAA section 112(d)(3)
also establishes a minimum control level for MACT standards, known as
the MACT ``floor.''
The EPA must also consider control options that are more stringent
than the floor. Standards more stringent than the floor are commonly
referred to as beyond-the-floor standards. The EPA may establish
standards more stringent than the floor based on considerations of the
cost of achieving the emission reductions, any non-air quality health
and environmental impacts, and energy requirements. In certain
instances, as provided in CAA section 112(h), the EPA may set work
practice standards where it is not feasible to prescribe or enforce a
numerical emission standard. For area sources, CAA section 112(d)(5)
gives the EPA discretion to set standards based on generally available
control technologies or management practices (GACT standards) in lieu
of MACT standards.
In the second stage, the EPA evaluates MACT standards to determine
whether additional standards are needed to address any remaining risk
associated with HAP emissions. This second stage is commonly referred
to as the ``residual risk review.'' In addition to the residual risk
review required by CAA section 112(f)(2), CAA section 112(d)(6)
requires the EPA to review standards set under CAA section 112 every 8
years. This review is commonly referred to as the ``technology review''
and the EPA often conducts the residual risk review simultaneously with
the first required technology review in what is commonly referred to as
a ``risk and technology review.'' The methodology used by the agency to
conduct risk and technology reviews is explained in the document titled
CAA Section 112 Risk and Technology Reviews: Statutory Authority and
Methodology, in the docket for this ANPRM.
In the CAA section (d)(6) technology reviews, the EPA is to review
standards set under CAA section 112 and revise them ``as necessary
(taking into account developments in practices, processes, and control
technologies)'' no less frequently than every 8 years. CAA section
112(d)(6). In conducting these reviews, the EPA is not required to
recalculate the MACT floor. 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, 673 (D.C. Cir. 2013).
B. Regulatory Background
On July 16, 1992 (57 FR 31576), the EPA published a list of major
and area sources for which NESHAP were to be promulgated (i.e., the
source category list). Ethylene oxide commercial sterilization and
fumigation operations were listed as a category of major sources and
area sources.
On December 6, 1994 (59 FR 62585), the EPA promulgated MACT and
GACT standards for the EtO Emission Standards for Sterilization
Facilities source category. In that final rule, the EPA set MACT for
major sources under CAA section 112(d)(2). For area sources, the EPA
established GACT standards pursuant to CAA section 112(d)(5). This
rulemaking addressed EtO emissions originating from three major types
of emission points: The sterilization chamber vent (SCV), the aeration
room vent (ARV), and the CEV. The SCV evacuates EtO from the
sterilization chamber following sterilization, fumigation, and any
subsequent gas washes. The ARV evacuates EtO-laden air from the
aeration room, which is used to facilitate off-gassing. 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. Another source of emissions
within this source category are fugitive emissions, but the EPA has not
set standards for those emissions.
Following promulgation of the rule, the EPA suspended certain
compliance deadlines and ultimately removed the MACT and GACT standards
for CEVs due to safety concerns. In the late 1990s, there were multiple
explosions at commercial EtO sterilization facilities. In response, the
EPA suspended all rule compliance dates pending the investigation of
the explosions (62 FR 64736, December 9, 1997). In 1998, the suspension
of the compliance dates was extended for the ARVs and the CEVs (63 FR
66990, December 4, 1998), although the requirements for the SCVs went
into effect in 1998. It was also later determined that EtO emissions
from aeration rooms could be safely controlled, and the suspensions for
the ARVs were not further extended past December 2000 (64 FR 67789,
December 3, 1999). For CEVs, it was determined that the primary
contributing issue leading to the explosions was that EtO
concentrations were above the safe limit (i.e., above the lower
explosive limit (LEL)), within the CEV gas streams, and the EPA
extended the suspension of the rule requirements for CEVs. The EPA
could not conclude at the time that the CEVs could be safely
controlled, so MACT and GACT requirements for CEVs were removed in 2001
(66 FR 55577, November 2, 2001) and have not been re-instated. The EPA
is soliciting comment on the impacts associated with potentially
reinstating requirements for CEVs in a future rulemaking.
In addition, the EPA conducted a residual risk analysis and a
technology review under CAA section 112(f)(2) and CAA section
112(d)(6), respectively, and issued a final decision on the risk and
technology review (71 FR 17712, April 7, 2006). No changes were made to
the requirements as part of that action.
The HAP standards that currently apply to sterilization facilities
covered by 40 CFR part 63, subpart O are shown in the following table:
Table 2--Current EtO Standards for Commercial Sterilizers
----------------------------------------------------------------------------------------------------------------
Existing and new sources subcategory Sterilization chamber Aeration room vent Chamber exhaust vent
\1\ vent (SCV) (ARV) (CEV) \2\
----------------------------------------------------------------------------------------------------------------
Sources using 10 ton or more of EtO 99 percent (see 40 CFR 1 ppm maximum outlet No control.
in any consecutive 12-month period. 63.362(c)). concentration or 99-
percent emission
reduction (see 40 CFR
63.362(d)).
[[Page 67893]]
Sources using 1 ton or more of EtO 99 percent (see 40 CFR No control............. No control.
but less than 10 ton of EtO in any 63.362(c)).
consecutive 12-month period.
Sources using less than 1 ton of EtO Recordkeeping (minimal Recordkeeping (minimal Recordkeeping (minimal
in any consecutive 12-month period. recordkeeping recordkeeping 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 as a rolling 12-month emission rate.
\2\ The CEV emission source was included in the original standard but was later eliminated from 40 CFR part 63,
subpart O, in 2001.
The NESHAP applies to both major and area sources that use at least
1 ton of EtO in sterilization or fumigation operations in each 12-month
period.
C. Risks Associated With EtO Emissions
The National Air Toxics Assessment (NATA) released in August 2018
identified EtO emissions as a potential concern in several areas across
the country. (NATA is the Agency's nationwide air toxics screening
tool, designed to help the EPA and state, local, and tribal air
agencies identify areas, pollutants, or types of sources for further
examination.) The latest NATA estimates that EtO significantly
contributes to potential elevated cancer risks in some census tracts
across the U.S. (less than 1 percent of the total number of tracts).
These elevated risks are largely driven by an EPA risk value that was
updated in December 2016.\1\ The EPA conducted a previous assessment of
the health effects of EtO exposure in 1985. Subsequently, EtO was
designated a HAP under the 1990 CAA amid increasing concerns regarding
the adverse effects of EtO exposure due to newly published human and
animal studies of this chemical. Consequently, the EPA's Office of Air
and Radiation expressed an interest in having the Integrated Risk
Information System (IRIS) Program update the EPA's 1985 EtO assessment.
In response, the IRIS Program began work on the current EtO assessment
in the early 2000s and, following two external peer reviews, completed
this work in December 2016.
---------------------------------------------------------------------------
\1\ Evaluation of the Inhalation Carcinogenicity of Ethylene
Oxide, December 2016, EPA/635/R-16/350Fc.
---------------------------------------------------------------------------
Further investigation on NATA inputs and results led to the EPA
identifying commercial sterilization using EtO as a source category
contributing to some of these risks, which has led the EPA to evaluate,
in greater depth, the potential health risks associated with emissions
of EtO. Over the past year, the EPA has been gathering additional
information to help evaluate opportunities to reduce EtO emissions
through potential rule revisions and more immediate emission reduction
steps. Considering these results, the EPA is seeking comment in this
ANPRM on a number of potential control strategies for facilities in the
EtO Emission Standards for Sterilization Facilities source category
that would seek to reduce the fugitive emissions of EtO and to improve
point source emission controls for commercial sterilizers.
III. Small Business Considerations
When the EPA undertakes a proposed rulemaking, it should identify
any small entities within the source category and determine whether
there is the potential for significant economic impacts to small
businesses or other entities from any regulatory actions being
considered. An entity is determined to be small based on the ultimate
parent company's NAICS code and as defined by the U.S. Small Business
Administration (SBA) (https://www.sba.gov/document/support--table-size-standards).\2\ A parent company's size is defined in terms of annual
revenue or number of employees; Table 3 of this preamble lists the size
standards for parent companies of entities regulated by the current 40
CFR part 63, subpart O rule.
---------------------------------------------------------------------------
\2\ SBA determines whether an entity qualifies as a small
business concern by counting its receipts, employees, or other
measures including those of all its domestic and foreign affiliates,
regardless of whether the affiliates are organized for profit (13
CFR 121.103(a)(6)).
Table 3--SBA Size Standards by NAICS Code
----------------------------------------------------------------------------------------------------------------
Size standards Size standards
NAICS code Source category (annual revenue-- (number of
millions) employees)
----------------------------------------------------------------------------------------------------------------
339112............................. Surgical and Medical Instrument .................. 1,000
Manufacturing.
339113............................. Surgical Appliance and Supplies .................. 750
Manufacturing.
325412............................. Pharmaceutical Preparation .................. 1,250
Manufacturing.
311942............................. Spice and Extract Manufacturing.... .................. 500
311423............................. Dried and Dehydrated Food .................. 750
Manufacturing.
561910............................. Packaging and Labeling Services.... $12 ..................
----------------------------------------------------------------------------------------------------------------
To date, of the 108 facilities that the EPA has identified within
the EtO Emission Standards for Sterilization Facilities source
category, we have identified approximately 35 facilities owned by small
businesses. At the parent company level, there are 59 total parent
companies, 27 of which are small parent companies.
Identifying potential impacts on specific entities is challenging
because of the lack of detailed facility data for this source category.
Among other things, the EPA is seeking information about the costs
associated with controlling EtO emissions from sources that qualify as
small businesses. The EPA will use information received in response to
this ANPRM to further assess the potential impacts of emission
reduction strategies that may be considered. Given the potential
impacts of certain emission reduction strategies
[[Page 67894]]
on these small businesses, the EPA intends to convene a Small Business
Advocacy Review (SBAR) Panel before taking any significant regulatory
action. The EPA is in the process of requesting nominations for small
entity representatives to serve as part of a possible SBAR Panel.
IV. Request for Comment
The EPA is requesting comment (1) on available control technologies
for reducing emissions of EtO and (2) on developments in practices,
measurement, monitoring, processes, and control technologies for the
control of EtO from commercial sterilization facilities. The EPA has
been investigating these issues through discussions with stakeholders,
reviews of operating permits, and research. As part of the information
gathering to date, the EPA has consulted with the EtO sterilization
industry, including companies, trade associations, and control
technology vendors, to better understand the current state of controls
for EtO emission sources. The EPA held teleconferences and meetings
with 12 different EtO trade associations, air pollution control device
(APCD) manufacturers, industry representatives, and other government
agencies to better understand sterilization processes, emissions
(including measurement and monitoring), current control techniques, and
how widely such techniques are used, as well as how control
efficiencies are determined and guaranteed by manufacturers. The
discussions have focused on common operational practices, including
practices used by EtO commercial sterilization facilities to determine
EtO concentration at various emissions points in the process. Despite
this outreach and information gathering, there are still several
important information gaps that would be useful to fill prior to any
future rulemaking activity.
Through information gathering and discussions with stakeholders,
the EPA identified the process controls and operational practices
discussed below for consideration as possible methods for reducing the
amount of EtO released into the ambient air. Under section 114(a) of
the CAA, the EPA may require sources to report data in a manner
prescribed by the Agency. For the EtO Commercial Sterilization and
Fumigation Operations source category, the EPA intends to undertake a
CAA section 114 information collection to provide information to
support any future rulemaking actions, such as the upcoming technology
review.
A. Modeling File and Annual EtO Usage Data
In order to ensure the accuracy of the data that could be used for
any future rulemaking for this source category, the EPA is soliciting
comment on available EtO usage data for individual facilities and on
additional data contained in the modeling file that the EPA intends to
use to evaluate the impacts of EtO emissions (Comment C-1). For the
modeling file, the EPA requests that companies review the data for
their facilities to ensure that the information presented is accurate
and complete, including current facility and process information,
emissions data,\3\ and release parameters. The EPA further requests
that after reviewing the modeling file for this purpose, companies
submit to the EPA any corrected and supplemental information as part of
their comments. The modeling file is available at the following
website: https://www.epa.gov/stationary-sources-air-pollution/ethylene-oxide-emissions-standards-sterilization-facilities. The current known
EtO usage data is available in the docket.
---------------------------------------------------------------------------
\3\ Primarily derived from the EPA's 2014 National Emissions
Inventory, version 2.
---------------------------------------------------------------------------
B. Control of Fugitive Emissions
Fugitive EtO emissions at commercial sterilization facilities
generally occur from (1) off-gassing associated with the handling of
EtO prior to charging the sterilizer chamber; (2) off-gassing of
sterilized product following product transfer from the sterilizer
chamber to the aeration room; (3) off-gassing from uncontrolled and
under-controlled aeration rooms; and (4) any off-gassing that may occur
after product is removed from the aeration room. For the purpose of
this rule, fugitive emissions are those emissions which are not routed
to an existing pollution control device. The magnitude of the fugitive
emissions from the industry is not well characterized, and the extent
of the fugitive emissions may be dependent on building design, the
building air handling system, and the capacity of the existing air
pollution control system. A recent analysis of ambient air monitoring
data performed in close proximity to a commercial sterilizer in
Illinois \4\ indicated that the previous EtO emission estimates for
this facility may have been underestimated. Specifically, this analysis
indicated that the fugitive component of the emissions accounted for
approximately 0.5 percent of the total EtO usage at that facility,
which was significantly higher than previously assumed.
---------------------------------------------------------------------------
\4\ https://www.epa.gov/il/outdoor-air-monitoring-willowbrook-community.
---------------------------------------------------------------------------
The EPA is requesting comment on the use of an emission factor of
0.5 percent of EtO usage for the calculation of fugitive emissions from
this source category (Comment C-2a). In addition, the EPA is requesting
comment on any data that can be used to help quantify facility-wide and
area/room-specific fugitive emissions from commercial EtO sterilizers
(e.g., internal and ambient air monitoring data), along with relevant
monitoring characteristics such as monitoring collection equipment and
techniques, averaging time, equipment detection limits, equipment
quality assurance, and quality control procedures employed (Comment C-
2b). If commenters believe that alternative fugitive EtO calculation
procedures or emission factors should be considered, the EPA requests
that commenters provide documentation that supports the basis or bases
for why an alternative methods or factors should be considered (Comment
C-2c).
1. Permanent Total Enclosure
Permanent total enclosures (PTEs) are permanently installed
structures that completely surround source(s) of emissions such that
all volatile organic compound emissions (i.e., EtO emissions) are
captured and contained for discharge to a control device(s).
Specifically, PTEs could capture emissions from sterilizer chamber
rooms, aeration rooms, EtO drum storage areas, shipping areas, or any
facility areas through which sterilized product is moved or EtO
equipment is in service. The EPA's current understanding is that the
existing building, or portions of the building, in which EtO could be
released could serve as the enclosure, for example, by enclosing and
adapting the building or portions of the building to meet the design
criteria of a PTE. EPA Method 204 (40 CFR part 51, appendix M) provides
the design criteria as well as procedures for verifying the capture
efficiency of the enclosure.\5\ Additionally, EPA Method 204 includes
requirements to route the captured and contained EtO-laden gas for
delivery to an APCD. Based on recent regulations enacted in
Illinois,\6\ as well as increasing public awareness, multiple EtO
commercial sterilization facilities have either implemented or are
[[Page 67895]]
planning to implement PTEs to capture and control fugitive emissions
from the sterilization processes.
---------------------------------------------------------------------------
\5\ 40 CFR part 51, appendix M, EPA Method 204--Criteria and
Verification of a Permanent or Temporary Total Enclosure. U.S. EPA.
\6\ https://www.ilga.gov/legislation/publicacts/fulltext.asp?Name=101-0022 and
https://www.ilga.gov/legislation/publicacts/fulltext.asp?Name=101-0023.
---------------------------------------------------------------------------
The EPA is requesting facility-specific data items that can be used
more accurately to assess the cost and emission capture/reduction of
PTEs (Comment C-3). In addition, the EPA welcomes detailed facility-
specific data and information regarding building and chamber design,
including details on the square feet and height of the rooms where EtO
is used, their temperature set point (during summer, winter, and
intermediate seasons), relative humidity, air flow, number of air
changes per hour, area of natural draft openings as defined in EPA
Method 204, the typical EtO concentration in parts per million by
volume (ppmv) within these rooms, and quantification of emissions
reductions obtained via PTE, along with a description of the
measurement device(s), measurement device detection limits and
interferences, and measurement device quality assurance and quality
control procedures and costs, the time required to implement PTE, the
number of facilities currently implementing PTE or planning to do so,
and the extent to which aspects of PTE might differ for small business
facilities (also Comment C-3).
2. Pollution Prevention and Other Operational Practices
Some facilities follow other operational practices to reduce
fugitive emissions. These operational practices include leak detection
and repair programs that encompass monitoring for fugitive leaks from
drums, valves, and connection lines containing EtO; controlling air
flow in the building to capture fugitive emissions (e.g., sweep vents)
in areas where EtO is processed and sending these emissions to existing
controls; putting process controls in place to minimize storage of
fumigated material in uncontrolled areas; reducing emissions from EtO-
laden waste water; and reducing levels of EtO injected into the
sterilization chamber.
Fugitive emissions may occur from EtO drum storage and handling.
The EPA understands that personnel at commercial sterilizer facilities
inspect the valves on EtO drums for leaks when delivered to their
facilities and that the connectors are also checked for leaks after
they are attached to a sterilizer chamber.\7\ EtO drums contain
approximately 400 pounds of compressed EtO liquid along with a blanket
of nitrogen. The pressurized drums are commonly equipped with two
valves: One for the nitrogen blanket, and the other for unloading the
EtO liquid. Leak checks similar to what is required by EPA Method 21
(40 CFR part 60, appendix A) are conducted on these valves and
connectors. Additionally, the drum storage room area may be enclosed
and vented to either an APCD or to the atmosphere. The EPA requests
comment on these and additional operational practices for monitoring
leaks from EtO drums, including appropriate procedures and/or methods
to use and the optimal frequency of monitoring; the emission reductions
likely to be achieved by specific practices; the costs associated with
specific practices; the time required to implement a leak check program
for EtO drums; the number of facilities currently implementing these
leak checks or plan to do so; and the extent to which aspects of these
leak checks might differ for small business facilities (Comment C-4).
---------------------------------------------------------------------------
\7\ National Fire Prevention Association 55 Chapter 14.
---------------------------------------------------------------------------
EtO supply lines are used to connect the EtO drum to the sterilizer
chamber. Prior to its use for charging EtO, the EtO line connection is
often pressurized with nitrogen from the storage drum to the sterilizer
chamber, to confirm that there are no leaks. The line connection is
held at that pressure for a set time period, and if the line connection
is able to maintain the pressure level, it is considered leak free. The
EPA is seeking comment on the available operational practices for
conducting regular pressure testing on the connection line between the
EtO drum and sterilizer chamber. The EPA solicits comment on the
feasibility of conducting the tests, the methods to be used or
considered for use, the optimal frequency of such tests or methods,
emission reductions likely to be achieved by specific practices, and
the costs associated with specific practices, the time required to
implement a leak check program for EtO supply lines, the number of
facilities currently implementing these leak checks or plan to do so,
and the extent to which aspects of these leak checks might differ for
small business facilities (Comment C-5).
Sweep vents or floor vents are used to move and capture room air
from the main room areas as operators move sterilized product from area
to area at the facility. Sweep vents often maintain the sterilizer
chamber room area and the aeration room area under negative pressure.
Some facilities route the room air captured in sweep vents to an APCD,
and other facilities vent the captured room air to the atmosphere. The
floor sweeps serve to reduce the EtO in work areas to minimize
occupational exposure to EtO. Facilities often measure the EtO
concentration in the sterilizer chamber room area and aeration room
area using a gas chromatography or infrared instrument. The EPA
solicits comment on circumstances in which it would not be feasible to
connect sweep vents to an APCD (including specific facility designs
that may affect such feasibility); the level of capture likely be
achieved for EtO fugitive emissions by specific practices; the costs
associated with specific practices; the time required to implement
sweep vents or floor vents; the number of facilities currently
implementing sweep vents or floor vents; and the extent to which
aspects of sweep vents or floor vents might differ for small business
facilities (Comment C-6).
The EPA is aware that emissions may occur from water that comes
into contact with EtO during the sterilization process. Potential
emissions may come from, but are not limited to, disposal of water used
in once-through liquid-ring vacuum pumps, as well as water used in
recovering EtO for re-use in sterilization. The EPA solicits comment on
the circumstances in which EtO may come into contact with water within
commercial sterilization facilities; the frequency with which such
water is or should be disposed; methods of disposal; any operational
practices that are or may be used to mitigate emissions from waste
water; the feasibility of implementing such operational practices; and
costs associated with disposal and with specific operational practices,
the time required to implement wastewater EtO emissions reductions; the
number of facilities currently implementing wastewater EtO emissions
reductions; and the extent to which aspects of wastewater EtO emissions
reductions might differ for small business facilities (Comment C-7).
The EPA is also interested in obtaining information on other
operational practices, not discussed in the preceding paragraphs, that
may be available to reduce EtO emissions from commercial sterilization
facilities. The EPA solicits comment on the availability,
applicability, and technical feasibility of such operational practices;
the emission reductions likely to be achieved by such measures; the
cost of such measures; the time required to implement such measures;
the number of facilities currently implementing such measures; and the
extent to which aspects of such measures might differ for small
business facilities (Comment C-8).
[[Page 67896]]
C. Chamber Exhaust Vent Control and Safety Considerations
1. Reinstating the Chamber Exhaust Vent Control Requirement
The CEV evacuates EtO-laden air from the sterilization chamber
prior to unloading and while the chamber is being unloaded (and
reloaded). The chamber exhaust enables facilities to meet U.S.
Occupational Safety and Health Administration (OSHA) workplace exposure
standards.\8\ Following the removal of the CEV regulatory requirement
in 2001 (66 FR 55577, November 2, 2001), many EtO sterilization
facilities ceased, or never implemented, controls for EtO emissions
from the CEV. In more recent years, however, facilities have begun to
control EtO from the CEV, and multiple facilities currently control the
CEV. The safety issues that prevented earlier control techniques from
being applied were linked to EtO concentrations in the sterilizer
chamber that exceeded the LEL for EtO. Since the late 1990s and early
2000s, facilities have revised their operating procedures related to
the CEV.
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\8\ 29 CFR 1910.1047.
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Currently, some facilities that control EtO emissions from the CEV
have made process changes to avoid exceedance of the LEL; such process
changes include (1) reducing the EtO concentration in the sterilizer
chamber before opening the sterilizer chamber door and venting
emissions to an APCD, and (2) using an automated lock on the sterilizer
chamber door that does not allow the door to open until EtO
concentration is significantly less than the LEL. As part of the
process change, facilities have enacted additional final air washes in
the sterilization cycle to further reduce the EtO concentration in the
sterilizer chamber prior to opening the sterilizer door and venting to
the APCD. In addition, the automated lock on the sterilizer chamber
door does not allow the door to open until a non-explosive EtO
concentration level is achieved in the chamber. The MACT floor for CEVs
at existing and new sources, for sources using 10 tpy or more of EtO,
is routing emissions from the CEV such that they are combined with a
stream that is already being routed to a control device that achieves
99-percent emission reduction.\9\ Typical APCDs used to control EtO
emissions from CEVs include the following: Catalytic oxidizers, dry bed
scrubbers, wet acid scrubbers, combination wet acid scrubbers and dry
bed scrubbers, and balancer/abator systems. The EPA solicits comment on
implications of potentially reinstating the requirement to control the
CEV and is soliciting information regarding the feasibility, emission
reductions achieved, cost, the time required to reinstate the
requirements; the number of facilities currently reducing their CEV
emissions; the extent to which aspects of CEV emissions reductions
might differ for small business facilities, and associated safety
considerations (Comment C-9).
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\9\ D. Hearne and K. Schmidtke, MRI, to D. Markwordt, U.S. EPA.
October 24, 1994. Revised Calculation of MACT Floors for Major
Source Chamber Exhaust Vents at Ethylene Oxide Commercial
Sterilization and Fumigation Operations; National Emissions
Standards for Hazardous Air Pollutants (NESHAP) (Legacy Docket ID
No. A-88-03, Docket Entry IV-B-02).
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2. Implementing an In-Chamber Concentration Limit
To further reduce EtO emissions from the SCV, some facilities set
an upper in-chamber concentration limit on the EtO in the sterilization
chamber prior to opening the chamber door and engaging the CEV.
Increased air washes to remove EtO from the sterilizer chamber have
been implemented over time to accommodate control of the CEV. To safely
control the CEV, the concentration must be significantly below the LEL
of EtO. The reduction of the in-chamber concentration at the end of the
sterilization cycle is directly linked to venting of the CEV to an APCD
and has enabled control of the CEV. A 2007 report from the National
Institute for Occupational Safety and Health determined that additional
air washes were essential for mitigating any safety issues.\10\ A
report by the Chemical Safety and Hazard Investigation Board on an
explosion that occurred at a commercial EtO sterilization facility in
2004 arrived at the same conclusion.\11\
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\10\ National Institute for Occupational Safety and Health,
Preventing Worker Injuries and Deaths from Explosions in Industrial
Ethylene Oxide Sterilization Facilities (Revised Edition). August
2007. https://www.cdc.gov/niosh/docs/2007-164/.
\11\ Chemical Safety and Hazard Investigation Board,
Investigation Report: Sterigenics (4 Employees Injured). March 2006.
https://www.csb.gov/sterigenics-ethylene-oxide-explosion/.
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While an in-chamber, EtO concentration monitoring technique was not
available when the original NESHAP was promulgated in 1994, in-chamber
monitors are available today. Monitors based on the photoacoustic
principle are available and currently in use at sterilization
facilities. These monitors are used to measure the in-chamber
concentration of EtO to confirm that the chamber concentration is well
below the LEL of EtO. The LEL of EtO is 3.0 percent by volume, or
30,000 ppmv.\12\ To ensure safe conditions when opening the sterilizer
chamber at the end of the sterilization cycle and to ensure limited
fugitive emissions released from the open sterilizer chamber door,
facilities reduce the EtO concentration to significantly less than the
LEL, often to ranges of 10 to 25 percent of the LEL (i.e., 3,000 to
7,500 ppmv). (LESNI 2019) \13\
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\12\ https://pubchem.ncbi.nlm.nih.gov/compound/Ethylene-oxide#section=Lower-Explosive-Limit-(LEL).
\13\ See memorandum, Meeting Minutes for Discussion with
Representative of LESNI, located at Docket ID No. EPA-HQ-OAR-2019-
0178. March 7, 2019.
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The reduction of the in-chamber concentration is achieved through
additional air washes in the sterilizer chamber. The number of
additional air washes required to reach a concentration below the LEL
is dependent on the parameters in the individual validated
sterilization cycle. Some cycles that operate under shallow vacuum
conditions, or need higher EtO concentration levels to reach sterility,
may require additional air washes to lower the in-chamber concentration
to this level.
The addition of air washes may increase the costs to operate the
sterilizer chamber vacuum pump, as well as the costs to operate the
APCD used to control emissions from the SCV. In addition, the overall
facility sterilization capacity may be reduced due to the increased
length of time required to complete the sterilization cycle. The EPA
solicits comment on (1) the feasibility of using additional air washes
in the sterilization chamber to further decrease in-chamber EtO
concentration; (2) the emission reductions likely to be achieved by
additional air washes; (3) associated costs; (4) the EtO concentration
that should be typically reached before allowing activation of the CEV;
(5) the time required to implement an EtO concentration reduction
program; (6) the number of facilities currently reducing EtO
concentration before activating the CEV; and (7) the extent to which
EtO concentration reduction efforts might differ for small business
facilities (Comment C-10).
3. Interlock System Tied to In-Chamber Concentration Limit
To further reduce fugitive emissions of EtO from leaving the
sterilizer chamber and risking the immediate health and safety of
facility operators, most facilities have installed door interlock
systems on their sterilizer chambers. These door interlock systems are
tied to the monitoring and control
[[Page 67897]]
equipment already operating within the sterilizer chamber. The
interlock system ensures that the sterilizer chamber doors are unable
to be opened by facility personnel prior to achieving the prescribed
in-chamber concentration of EtO, i.e., below the LEL. By preventing
premature opening of the sterilizer chamber door prior to reaching a
non-explosive EtO concentration, the door interlock system accomplishes
two things: (1) It ensures that gas from the sterilizer chamber is
prevented from being directed to the CEV until the EtO concentration
within the chamber is well below the LEL, and (2) it greatly reduces
the amount of fugitive EtO that operators will be exposed to over the
course of the work day. Industry trade associations have indicated that
environmental health and safety issues surrounding worker exposure have
been a major focus of EtO sterilization-centered working groups over
recent years (AdvaMed 2019).\14\
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\14\ See memorandum, Meeting Minutes for Discussion with
Representatives of AdvaMed, located at Docket ID No. EPA-HQ-OAR-
2019-0178. July 2, 2019.
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The combination of an in-chamber EtO concentration limit and an
interlock system tied to that limit enables facilities to continue to
meet OSHA workplace exposure standards with respect to emissions from
the sterilizer chamber.
The EPA is soliciting comment on cost, the time required to
implement an interlock system, the number of facilities currently
utilizing interlock systems, and the extent to which aspects interlock
systems might differ for small business facilities, and safety
considerations for an interlock system on the sterilizer chamber door
that is linked to the in-chamber concentration (Comment C-11).
D. Other Point Source Control Options
1. Balancer/Abator System
Add-on control devices such as wet acid scrubbers, catalytic
oxidizers, and dry bed scrubbers are commonly used to control the
emissions of EtO from the commercial sterilization source category.
Generally, the add-on APCD is designed based on the maximum flow rates
and EtO concentrations from the emission sources vented to the device.
An APCD used for reducing the EtO emissions from the Commercial
Sterilization and Fumigation Operations source category that was
developed since the initial NESHAP is a combination water balancer and
catalytic oxidizer, also referred to as the balancer/abator system.
This system vents EtO to the water balancer, where a significant
portion of the EtO is stored within the water, so that a flow of air at
a constant EtO concentration can be fed to the catalytic oxidizer. The
SCVs are first vented to the water balancer, and the stream from the
balancer is then to the catalytic oxidizer. The ARVs and CEVs are
sources of more dilute EtO-laden streams and, therefore, are not vented
to the water balancer--they are vented directly to the catalytic
oxidizer. Emissions from the ARVs and CEVs are first mixed with the
stripped EtO stream from the SCV and then emissions from all three
vents are routed to the catalytic oxidizer. The water balancer does not
convert the EtO into ethylene glycol, as the scrubbing water is not
acidic enough to drive the conversion (i.e., addition of sulfuric acid
would drive the conversion to ethylene glycol).
One advantage of this APCD is related to the intermittent venting
of high EtO concentration streams from the sterilizer chamber. The
concentration of EtO within an SCV stream can vary depending on how
much EtO is used for sterilizing a product, as well as what
sterilization phase the chamber is in at the time of exhaust (e.g.,
dwell period, gas washing, etc.). The number of chambers venting to one
balancer also has an impact on overall concentration. The water
balancer essentially ``stores'' the EtO peaks from the SCV in the
water, and the catalytic oxidizer is designed based on a relatively
constant flowrate and EtO concentration from the combination of the
stream from the balancer and the ARV and CEV emission streams, rather
than based on the peak flowrates and EtO concentrations from the SCV.
The balancer/abator system design was introduced in the U.S. in
2006, and there are at least four facilities currently using this APCD
in four states and territories. The balancer/abator system achieves
99.9-percent reduction of EtO emissions and EtO concentrations of 0.5
milligrams per normal cubic meter (roughly equivalent to 0.27 ppmv)
(LESNI 2019).\15\ The ARV and CEV concentrations are characterized as
dilute concentrations in a high-volume air flowrate. The balancer/
abator system helps normalize both the flowrate and the EtO
concentration fluctuations. The EPA is soliciting comment on use of the
balancer/abator system, the emission reductions likely to be achieved
from such use, the associated costs, the time required to implement a
balancer/abator system, the number of facilities currently using
balancer/abator systems, and the extent to which aspects of a balancer/
abator system might differ for small business facilities (Comment C-
12).
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\15\ See memorandum, Meeting Minutes for Discussion with
Representative of LESNI, located at Docket ID No. EPA-HQ-OAR-2019-
0178. March 7, 2019.
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2. Improvements to Existing Point Source Controls
While the current standard for control device efficiency requires
99-percent removal (along with a 1-ppmv alternative for ARVs), the EPA
is aware of many situations in which testing has revealed emission
control performance that is significantly superior to the current
standard. The EPA is soliciting comment on potential improvements to
control device efficiencies and observed removal efficiencies or outlet
concentrations, along with any costs potential implementation issues
associated with achieving those higher control efficiencies, the time
required to improve existing point source controls, the number of
facilities that have made improvements to their existing point source
controls, and the extent to which improvements to existing point source
controls might differ for small business facilities (Comment C-13).
3. Improved Monitoring Instruments for Ethylene Oxide
Since the regulations at 40 CFR part 63, subpart O, were finalized
in 2001, there have been significant improvements in monitoring
equipment, including new continuous monitoring instruments that are
considerably more sensitive than previous monitoring technology. In the
past, there have been concerns over detecting low concentrations of
EtO, but instrumentation is now available with a detection capability
in the single parts per billion by volume within the exhaust stack for
the APCD. Instrument manufacturers have developed innovative techniques
which use optical spectroscopy that allow for greater sensitivity and
better time-resolution than the current monitoring techniques specified
in the rule. The EPA is requesting comment on the feasibility of using
continuous monitoring systems and is soliciting comment on the cost
considerations for installing and operating the monitoring units,
particularly for control devices. The EPA is also soliciting comment on
the number of facilities currently using improved monitoring
instruments (Comment C-14).
4. Accelerated Aerator Design and Aeration Cells
One process equipment improvement available is the use of
accelerated aeration cells. The use of focused
[[Page 67898]]
aeration was discussed in the 1992 EtO Sterilization Background
Information Document,\16\ including use of both smaller, heated
aeration chambers (43 degrees Celsius ([deg]C)) and vacuum cycles on
the small aeration cells. The use of aeration cells rather than
aeration rooms significantly reduces the volume of air vented to the
APCD. The EPA does not have information on the total number of
facilities that are using aeration cells.
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\16\ U.S. EPA, Office of Air Quality Planning and Standards,
Emission Standards Division. Ethylene Oxide Emissions for Commercial
Sterilization Fumigation Operations Background Information for
Proposed Standards. October 1992 (Legacy Docket A-88-03, Docket
Entry II-A-022).
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A large aeration room requires large volumetric flowrates to move
the EtO out of the room. Such rooms have low EtO concentrations and
large volumes of gas and entail many air changeovers (e.g., 20 air
changes per hour). It may take 5 to 10 days to complete the aeration
cycle for such a room. Replacing the large aeration room with an
aeration cell reduces the volumetric flowrate from the emission source.
Use of smaller aeration cells may reduce the amount of aeration time
needed, remove the EtO more efficiently, and reduce the residual EtO in
the final product.
Combining heated aeration cells with high-turbulence air flow or
with vacuum cycles is a newer approach to aeration for commercial
sterilization, sometimes referred to as acceleration aeration. Heated
chambers are typically in the range of 40 [deg]C to 60 [deg]C. Inlet
air is introduced at multiple inlet ports along the side of the
aeration cell and removed at multiple outlet points along the top of
the cell to provide even distribution of air throughout the cell.
Combining aeration cells with high-turbulence air movement throughout
the cell can accelerate the aeration process by reducing the number of
air changeovers needed to remove the EtO from the product. One
manufacturer noted that shallow vacuum intervals vary between 50 and
700 millibars, and that the use of shallow vacuum is expected to reduce
the aeration time by 65 percent or more compared with traditional
aeration procedures. Based on discussions with one trade organization,
at least one company is currently modifying a facility so that it will
incorporate the new accelerated aerator design (EOSA 2019).\17\
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\17\ See memorandum, Meeting Minutes for Discussion with
Representatives of the Ethylene Oxide Sterilization Association
(EOSA), located at Docket ID No. EPA-HQ-OAR-2019-0178. March 18,
2019.
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The EPA is soliciting comment on the use of accelerated aeration
design and aeration cells; the emission reductions likely to be
achieved by such changes; the feasibility of implementation of such
changes; associated costs; the time required to implement accelerated
aeration design or aeration cells; the number of facilities currently
using accelerated aeration design or aeration cells; and the extent to
which aspects accelerated aeration or aeration cells might differ for
small business facilities (Comment C-15).
5. Cascading Air Method
Some facilities use cascading air to reduce the overall volume of
air use for sterilization processes. A facility using a cascading
technique does not use fresh air as feed air but rather reuses air from
a low-concentration fugitive area as the feed air to another area. For
example, reuse of the fugitive air from the warehouse can be used as
intake air to the aeration room or aeration cell. Use of cascading air
reduces the amount of air that needs to be processed by the APCD. In
this example, rather than using a larger APCD to handle and control the
volume of air from the ARV plus the warehouse room area, the facility
routes the warehouse air to the aeration room, and the ARV emissions
are then routed to a smaller APCD.
The EPA solicits comment of the feasibility of the cascading air
technique; the emissions reductions that are likely to be achieved; the
feasibility of implementation; associated costs; the time required to
implement the cascading air method; the number of facilities currently
using the cascading air method; and the extent to which aspects of the
cascading air method might differ for small business facilities
(Comment C-16).
E. Types of Sterilization Facilities
1. Single-Item Sterilizer Facilities
The EPA has identified 27 commercial EtO sterilization facilities
that use a single-item sterilizer model. While a traditional
sterilization chamber tends to be a larger vessel that accommodates
pallets containing diverse products, a single-item sterilizer is
generally smaller and may use much less EtO to sterilize products
(e.g., approximately 10 percent of the EtO that a traditional
sterilization chamber would use). In the single-item sterilization
process, workers place the product into a plastic pouch, a slight
vacuum is applied, EtO gas is injected into the pouch and sealed, and
the sealed pouch is placed in a room, chamber, or cabinet under
specific temperature and humidity where EtO both sterilizes and then
off-gasses or aerates. The EtO slowly dissipates from the pouch or bag
by diffusion. Once the product is removed from the room, chamber, or
cabinet, the product is held in the warehouse for 2 days before
shipping. Just as is the case with traditional sterilizer chambers, EtO
is stored in a pressurized drum when the single-item sterilization
approach is used, although the cylinder tends to be smaller than EtO
storage drums used at traditional sterilization facilities. EtO usage
in a single-item sterilizer facility is often much less than in
traditional sterilizer chambers.
Facilities using the single-item sterilizer process were previously
thought to typically use much less than 1 ton of EtO per year,\18\ and
under 40 CFR part 63, subpart O, processes that use less than 1 ton of
EtO are only subject to the recordkeeping requirements. Processes that
use over 1 ton of EtO per year are subject to additional requirements.
A recent review of single-item sterilizers found the EtO usage for at
least four of these facilities to be in excess of 1 ton.\19\ The EPA is
requesting comment on (1) specific emissions controls that are used or
could be used at single-item sterilizers in EtO commercial
sterilization, and (2) whether there are any technical or process
differences between single-item sterilization and traditional
sterilizer chambers that should be considered when adopting measures to
reduce emissions. The EPA is seeking additional information on costs
associated with single-item sterilization use (including costs related
to machine purchase and maintenance, design considerations, and
implementation) and on costs associated with compliance with the
NESHAP's emissions limits under the current subpart O regulations. The
EPA also solicits comment on the number of facilities that are single-
item sterilization facilities (Comment C-17).
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\18\ Ethylene Oxide Commercial Sterilization and Fumigation
Operations NESHAP Implementation Document, EPA-456/R-97-004, March
2004.
\19\ See annual EtO usage data provided in Docket ID No. EPA-HQ-
OAR-2019-0178.
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2. Combination Sterilizer Facilities
The EPA is aware of another technology, a combination sterilizer,
that is used in the EtO commercial sterilization industry. In
combination sterilizers, the sterilization step and aeration step occur
in sequence in the same chamber. The chamber is evacuated and EtO gas
is injected into the chamber. After the sterilization process is
completed, air washes are used to remove most of the EtO from the
product. The exhausted EtO may be vented to the atmosphere or to a
carbon canister, with charcoal adsorbent, to
[[Page 67899]]
control the EtO. One advantage of this sterilization approach is a
reduction of EtO fugitive emissions due to the elimination of the step
in which product is moved from the sterilization chamber to the
aeration equipment.
The EPA is seeking information and comment on the viability of
replacing traditional EtO sterilization operations with combination
sterilizers. The EPA is also seeking information on the emissions
associated with combination sterilizers relative to traditional
sterilizers; the control devices typically used for these types of
chambers; costs associated with operating emissions controls for
combination EtO sterilizers; and the number of facilities currently
using combination sterilizers (Comment C-18).
3. Sterilization Facilities Owned by Small Businesses
As discussed in section III of this ANPRM, small businesses make up
a significant portion of the EtO Commercial Sterilization and
Fumigation Operations source category. Given their prevalence within
this industry, it is important that the EPA understand any technical or
process differences between facilities owned by small businesses and
facilities in the rest of the source category. Specifically, the EPA
requests comment on the extent to which facilities owned by small
businesses may differ operationally from facilities operated by larger
businesses, including whether the emissions profiles differ
consistently. The EPA also solicits comment on whether small businesses
tend to own small facilities, and whether small businesses tend to use
processes that have higher or lower emissions (Comment C-19).
4. Other Distinctions Among Sterilization Facilities
While the EPA has noted differences between the types of
sterilization facilities mentioned above, the EPA is also soliciting
comment on whether there are other types of sterilization facilities
that are markedly different in terms of processes, operations, costs,
or environmental impact when compared with traditional sterilization
facilities (Comment C-20).
V. Statutory and Executive Order Reviews
Additional information about statutes and relevant Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
Under Executive Order 12866, Regulatory Planning and Review (58 FR
51735, October 4, 1993), this action is a significant regulatory action
that was submitted to the Office of Management and Budget (OMB) for
review. Any changes made in response to OMB recommendations have been
documented in the docket. This action does not propose or impose any
requirements, and instead seeks comments and suggestions for the Agency
to consider in possibly developing a subsequent proposed rule. Should
the EPA subsequently determine to pursue a rulemaking, the EPA will
address relevant statutes and Executive Orders as applicable to that
rulemaking.
Dated: December 5, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-26804 Filed 12-11-19; 8:45 am]
BILLING CODE 6560-50-P