United States
Environmental Protection
Agency
Office of Air Quality
Planning and Standards
Research Triangle Park, NC 27711
EPA-456/R-97-004
September 1997
Air
ETHYLENE OXIDE COMMERCIAL
EPA STERILIZATION AND FUMIGATION
OPERATIONS NESHAP
IMPLEMENTATION DOCUMENT
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ETHYLENE OXIDE
COMMERCIAL STERILIZATION AND
FUMIGATION OPERATIONS NESHAP
IMPLEMENTATION DOCUMENT
Prepared for:
Program Review Group
Information Technology and Program Integration Division
Office of Air Quality Planning and Standards
U. S. Environmental Protection Agency
Research Triangle Park, NC 27711
U.S. Environmental Protection Agency
Region 5, Library (PL-12J)
77 West Jackson Boulevard, 12th Floor
Chicago, IL 60604-3590
Prepared by:
Midwest Research Institute
Crossroads Corporate Park, 5520 Dillard Road, Suite 100
Gary, North Carolina 27511
September 1997
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Disclaimer
The information provided in this document is intended as supplemental information to the
regulated community. In case of any discrepancy between information provided in this document
and the codified National Emission Standards for Hazardous Air Pollutants for Commercial
Ethylene Oxide Sterilization and Fumigation Operations (40 CFR Part 63, Subpart O),
information contained in the codified standards will apply.
Mention of trade names or commercial products is not intended to constitute endorsement
or recommendation for use. Copies of this report are available through the library Services
Office (MD-35), U. S. Environmental Protection Agency, Research Triangle Park, NC 27711, or
from National Technical Services, 5285 Port Royal Road, Springfield, Virginia 22161
IV
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TABLE OF CONTENTS
Page
CHAPTER 1. INTRODUCTION 1-1
1.1 BACKGROUND 1-1
1.2 PURPOSE OF DOCUMENT 1-2
1.3 ORGANIZATION 1-2
CHAPTER 2. SUMMARY OF THE REGULATION 2-3
2.1 COMPLIANCE DATES 2-3
2.2 EMISSIONS REDUCTIONS AND LIMITS 2-4
2.3 INITIAL PERFORMANCE TESTING 2-4
(J| 2.4 ONGOING MONITORING 2-4
v^ 2.5 RECORDKEEPING 2-5
<> 2.6 REPORTING 2-5
®
£> CHAPTER 3. APPLICABILITY OF THE REGULATION 3-1
' 3.1 APPLICABILITY 3-1
O 3.2 EXEMPTIONS 3-1
3.3 SOURCE DESCRIPTION 3-1
3.3.2 Sterilant Gases 3-2
3.3.3 Sterilization Cycle 3-2
3.3.4 Emission Sources 3-4
3.4 NUMBER AND LOCATION OF AFFECTED SOURCES 3-4
CHAPTER 4. EMISSION LIMITS AND CONTROL TECHNIQUES 4-1
4.1 EMISSION LIMITS 4-1
4.2 CONTROL TECHNIQUES 4-1
4.2.1 Acid-water Scrubber 4-1
4.2.2 Catalytic Oxidation Unit 4-2
4.2.3 Thermal Oxidation Unit 4-2
CHAPTER 5. DEMONSTRATING COMPLIANCE 5-1
5.1 INITIAL PERFORMANCE TESTING 5-1
5.2 ESTABLISHING SITE-SPECIFIC OPERATING PARAMETERS 5-1
5.3 ONGOING MONITORING 5-3
CHAPTER 6. RECORDKEEPING AND REPORTING REQUIREMENTS 6-1
6.1 RECORDKEEPING 6-1
6.1.1 Malfunction Records 6-1
6.1.2 Records to Demonstrate Compliance 6-1
6.1.3 Performance Test Results 6-2
6.1.4 Continuous Monitoring System Records 6-2
6.1.5 Documentation Supporting Initial Notification and Notification of
Compliance Status 6-2
6.1.6 Records for Sources Not Subject to Emissions Standards 6-2
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LIST OF FIGURES
No. Page
3-1. Applicability flowchart for sources using 1 to 10 tons of ethylene oxide
per year 3-2
3-2. Applicability flowchart for sources using 10 or more tons of ethylene
oxide per year 3-3
3-3. Schematic of an ethylene oxide gas sterilizer 3-5
3-4. Schematic of emission sources at commercial sterilization facilities 3-8
4-1. Schematic of a typical acid water scrubber system 4-2
4-2. Schematic of a typical catalytic oxidation system 4-3
4-3. Schematic of a typical thermal oxidation system 4-4
LIST OF TABLES
3-1. Number of Facilities Per State 3-9
4-1. Emissions Reductions and Limits 4-1
5-1. Site-specific Operating Parameters 5-2
5-2. Summary of Ongoing Monitoring Requirements for the Sterilization
Chamber Vent Standard 5-4
5-3. Summary of Ongoing Monitoring Requirements for the Aeration Room
Vent Standard 5-5
5-4. Summary of Ongoing Monitoring Requirements for the Chamber Exhaust
Vent Standard 5-6
vu
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CHAPTER 1
INTRODUCTION
1.1 BACKGROUND
Under Section 112 of the Clean Air Act (CAA), the U. S. Environmental Protection
Agency (EPA) is required to develop national emission standards for hazardous air pollutants
(NESHAP) for source categories that have been identified as major sources of hazardous air
pollutants (HAP). Section 112(b) of the CAA identifies ethylene oxide (EO) as a HAP because
it is suspected to cause cancer in humans, is highly mutagenic and teratogenic, and has
significant acute and subchronic exposure health effects. To meet the requirements of the CAA,
EPA promulgated NESHAP for ethylene oxide commercial sterilization and fumigation
operations in the December 6, 1994 Federal Register as subpart O of part 63 of the Code of
Federal Regulations.
Under this NESHAP, the EPA has elected to regulate both major (i.e., sources that emit
or have the potential to emit 10 tons per year or more of any HAP or 25 tons per year or more of
any combination of HAP) and area sources (i.e., any HAP source that is not a major source)
because of the high toxicity of EO. Therefore, consistent with section 112(d) of the CAA,
existing and new major sources will control emissions to the level achievable by the maximum
achievable control technology (MACT); existing and new area sources will control emissions
using generally available control technology (GACT).
Commercial sterilization and fumigation sources using EO as a sterilant for heat and
moisture sensitive products and as a fumigant to control microorganisms or insects are subject to
the regulation. However, the regulation exempts EO sterilizers in hospitals. Products that are
typically sterilized or fumigated with EO include medical equipment and supplies,
Pharmaceuticals, spices, books, museum artifacts, and cosmetics. Approximately 200 EO
commercial sterilization and fumigation sources exist in the United States; approximately 150 of
these sources are expected to be affected by the regulation. The EPA estimates that full
compliance with the regulation will reduce the amount of EO released into the air by 1,100 tons.
1-1
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INTRODUCTION
1.2 PURPOSE OF DOCUMENT
Under sections 112(d) and 112(1) of the CAA, EPA provides guidance useful to EPA
Regional Office and State and local agency personnel who will be responsible for implementing
NESHAP. The purpose of this document is to provide these personnel with implementation
materials to assist them in conducting complete and efficient inspections at ethylene oxide
commercial sterilization and fumigation operations to determine compliance with the NESHAP.
1.3 ORGANIZATION
Chapter 2 of this document presents a summary of the requirements of the regulation.
Strategies for determining applicability of the regulation, including flowcharts, are provided in
Chapter 3. Chapter 4 discusses the emission reductions and limits in the regulation and the
control techniques that may be used to meet these standards. Requirements for demonstrating
compliance with the regulation are discussed in Chapter 5. Chapter 6 summarizes the
recordkeeping and reporting requirements of the regulation. Chapter 7 covers inspection
procedures, including inspector checklists. A summary of commonly asked questions and
answers are included in Chapter 8, and a list of other available implementation materials is
included in Chapter 9. Appendix A contains a glossary of terms and nomenclature used in the
regulation. A detailed "table of contents" of the regulation is included as Appendix B. A list of
known facilities is included as Appendix C.
1-2
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CHAPTER 2
SUMMARY OF THE REGULATION
The regulation affects sources using EO for commercial sterilization or fumigation
operations. How a source is affected depends on the amount of EO that the source uses. In
general, the regulation specifies:
/ Compliance dates
/ Emission reductions and limits
/ Initial performance testing
/ Ongoing monitoring
/ Recordkeeping
/ Reporting
Each of these requirements is summarized below. These requirements are discussed in more
detail in subsequent chapters of this document. In addition, a detailed "table of contents" of the
regulation is included in Appendix B of this document. It lists the requirements of the regulation
and provides a cross-reference to the codified sections of the regulation where these requirements
are found.
2.1 COMPLIANCE DATES1
All existing sources (i.e., initial startup date before December 8, 1997) that are subject to
emissions standards (see section 2.2 below) must be in compliance with the regulation by
December 6, 1997. All new sources (i.e., initial startup date after December 8, 1997) that are
subject to emission standards must be in compliance with the regulation upon initial startup of
the source.
'As of the publication date of this implementation document, the U. S. EPA is
considering an extension of the compliance dates for these NESHAP. Readers are encouraged to
consult future Federal Register notices for the latest compliance date information.
2-1
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SUMMARY OF THE REGULATION
2.2 EMISSIONS REDUCTIONS AND LIMITS
The regulation specifies the following emission reductions and limits that depend on the
piece of equipment and the amount of EO that the facility uses per year:
S For sterilization chamber vents (SCV's), at sources using 1 or more ton of EO per year,
99 percent reduction;
/ For aeration room vents (ARV's) at sources using 10 or more tons of EO per year,
99 percent reduction OR 1 part per million by volume (ppmv) concentration limit; and
/ For chamber exhaust vents (CEV's)/back draft vents at sources using 10 or more tons of
EO per year, manifold to emission reduction device used to control SCV or ARV OR 99
percent reduction; for CEV's/back draft vents at sources using 1 to 10 tons of EO per
year, 5,300 ppmv chamber concentration limit prior to activation of chamber exhaust.
2.3 INITIAL PERFORMANCE TESTING
Initial performance testing is required to demonstrate that the source is meeting the emissions
standards. This is a one-time test. The regulation contains the test methods that will be used to
determine initial compliance. During this initial performance test, the source will also establish
operating parameter values that will be the bases for demonstrating ongoing compliance through
monitoring of these parameters.
2.4 ONGOING MONITORING
Compliance with the regulation is demonstrated through ongoing monitoring of the operating
parameter values established during initial testing. The monitoring requirements vary depending
on the type of emission reduction technique the source uses. If using an acid-water scrubber, the
source must monitor the ethylene glycol concentration or the scrubber liquor tank level once per
week. If using a catalytic or thermal oxidation unit, the source must monitor the temperature
continuously. For any type of emission reduction technique used to control emissions for ARV
and for CEV (1 to 10 tons), the source may monitor the EO concentration once per hour for ARV
and before activating the chamber exhaust for CEV.
2-2
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SUMMARY OF THE REGULATION
2.5 RECORDKEEPING
The regulation requires that all sources keep records to document compliance with the
regulation. Records for sources using 1 ton or more of EO per year include performance test
results, monitoring and calibration data, and malfunctions and exceedances data. Records for
sources using less than 1 ton of EO per year include annual usage data to demonstrate that they
are not subject to the emission reduction requirements.
2.6 REPORTING
Reports for sources using 1 or more tons the EO per year include initial notification that the
source is subject to the regulation, notification of performance tests and monitoring system
evaluations, initial statement of compliance, and semi-annual compliance reports (on-going)
containing information on the compliance status of the source.
2-3
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CHAPTER 3
APPLICABILITY OF THE REGULATION
I
3.1 APPLICABILITY
The regulation applies to virtually all commercial sterilization and fumigation sources that
use EO as a sterilant for heat and moisture sensitive products or as a fumigant to control
microorganisms or insects, regardless of size (see exemptions listed in section 3.2). Both major
and area sources are covered by the regulation. (Major sources are sources emitting 10 or more
tons per year of any HAP or 25 or more tons per year of any combination of HAP's. Area
sources, also referred to as "nonmajor sources," are sources that do not qualify as major.) The
flowcharts in Figures 3-1 and 3-2 may be used to determine applicability of the requirements of
the regulation to a particular source. Figure 3-1 highlights the requirements for sources using
1 to 10 tons of EO per year; Figure 3-2 highlights the requirements for sources using 10 tons or
more of EO per year.
3.2 EXEMPTIONS
The regulation specifically exempts certain types of sources. These sources are:
/ Beehive fumigators;
/ Research and laboratory facilities, as defined in section 112(c)(7) of the CAA; and
/ Medical facilities such as hospitals, doctors offices, clinics, or other facilities whose
primary purpose is providing medical services to humans or animals.
3.3 SOURCE DESCRIPTION
The commercial sterilization source category covers the use of EO as a sterilant/fumigant in
the production of medical equipment supplies and in miscellaneous sterilization and fumigation
operations. Commercial sterilization facilities use EO as a sterilant for heat- or moisture-
sensitive materials or as a fumigant to control microorganisms or insects. A variety of materials
are sterilized or fumigated with EO, including medical equipment (e.g., syringes and surgical
gloves), spices, cosmetics, and Pharmaceuticals. Libraries and museums use EO to fumigate
books and other historical items.
3-1
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APPLICABILITY OF THE REGULATION
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APPLICABILITY OF THE REGULATION
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APPLICABILITY OF THE REGULATION
There are two main types of EO sterilization processes: (1) bulk sterilization and (2) single-
item sterilization. Using the single-item sterilization process, items are placed in a plastic pouch,
sterilant gas is injected into the pouch, and the sealed pouch is placed into an aeration cabinet or
room to allow sterilization to occur. Single-item sterilizers typically use much less than 1 ton of
EO per year, and therefore, they may only be subject to minimal recordkeeping requirements of
the NESHAP. Bulk sterilization is by far the more commonly used EO sterilization process.
Using this process, products to ':e sterilized are placed in a sterilization chamber and are exposed
to a sterilant gas at a predetermined temperature, humidity level, and pressure. The equipment,
sterilant gases, and sterilization cycle used for bulk sterilization processes are described below.
3.3.1 Equipment
A schematic of a gas sterilizer is shown in Figure 3-3. The main components of the sterilizer
are the chamber and vacuum pump. Chambers used by commercial sterilization facilities
typically range in volume from 2.8 cubic meters (m3) (100 cubic feet [ft3]) to 28 m3 (1,000 ft3). A
vacuum pump is used to remove air from the chamber before sterilization begins and to evacuate
the sterilant gas after the sterilization cycle is complete.
3.3.2 Sterilant Gases
Ethylene oxide is an extremely effective sterilant gas. The EO penetrates product packaging
(e.g., cardboard shipping box, plastic shrink wrap, paper box, and product wrapping) and
destroys bacteria and viruses on the product. The product remains sterile until use because
bacteria and viruses cannot penetrate the product wrapping. The most widely used sterilant gas is
a mixture of 12 percent by weight EO and 88 percent by weight dichlorodifluoromethane
(CFC-12), referred to as 12/88. Two other commonly used sterilant gases are (1) 100 percent
pure EO and (2) a mixture of 10 percent by weight EO and 90 percent by weight carbon dioxide,
referred to as 10/90.
3.3.3 Sterilization Cycle
The typical sterilization cycle consists of six phases: (1) presterilization conditioning,
(2) sterilization, (3) evacuation, (4) air wash, (5) chamber exhaust, and (6) aeration. Each of
these phases is discussed briefly below.
3-4
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APPLICABILITY OF THE REGULATION
CONTUCX.
VACUUM PUMP
DOC*
Figure 3-3. Schematic of a gas sterilizer.
(Courtesy of Union Carbide Corporation, Linde Division.)
3-5
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APPLICABILITY OF THE REGULATION
3-3.3.1 Presterilization Conditioning. After the products have been loaded into the chamber
and the airtight door is sealed, a partial vacuum is drawn inside the chamber. This initial
vacuum, or drawdown, prevents dilution of the sterilant gas. Also, if flammable gas mixtures are
used, the removal of air reduces the potential for ignition. The initial drawdown takes from
about 5 to 45 minutes, depending on the product being sterilized. The chamber temperature is
adjusted to ensure proper sterilization, and the relative humidity is raised to ensure susceptibility
of microorganisms to the sterilant gas.
3.3.3.2 Sterilization. The sterilant, which is supplied as a liquid, is vaporized and introduced
into the chamber to achieve the desired concentration of EO. The chamber pressure, which
depends on the type of sterilant gas used, is maintained for about 4 to 6 hours.
3.3.3.3 Evacuation. Following sufficient exposure time, the sterilant gas is evacuated from
the chamber with a vacuum pump. This postcycle vacuum phase typically lasts about
10 minutes.
3.3.3.4 Air Wash. The pressure in the chamber is bought to atmospheric pressure by
introducing either air, nitrogen, or CO2 (depending on the flammability of the sterilant gas
mixture). The combination of evacuation and air wash phases is repeated from two to four times
to remove as much of the EO from the product as possible. The purpose of the air washes is to
allow residual EO to diffuse from the product to help meet Food and Drug Administration (FDA)
guidelines on residual EO levels for medical devices, EPA residual tolerances for agricultural
products, and the Occupational Safety and Health Administration (OSHA) standard for exposure
in the workplace.
3.3.3.5 Chamber Exhaust. Prior to unloading the sterilizer, the chamber door is
automatically cracked, and the chamber exhaust is activated. The chamber exhaust is an exhaust
system that evacuates EO-laden air from the chamber prior to unloading and while the chamber
is being unloaded (and reloaded). The chamber exhaust is a worker safety system that is
responsible for removing EO from the void space in the sterilizer chamber. The chamber exhaust
does not dramatically effect residual EO concentrations in the products being sterilized.
3.3.3.6 Aeration. Following their removal from the sterilization chamber, the sterile
products are placed in an aeration room and kept there for several hours or days depending on the
3-6
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APPLICABILITY OF THE REGULATION
product. The purpose of aeration is to allow further diffusion of residual EO from the products
prior to shipping in order to comply with the FDA and EPA guidelines for residual EO. Ethylene
oxide concentrations in the aeration room are maintained at relatively low levels by ventilating
the room at a rate of about 20 air changes per hour. Also, aeration rooms are frequently heated to
aid in EO offgasing.
3.3.4 Emission Sources
The four principal sources of EO emissions from sterilization/fumigation processes are the
following:
/ Sterilizer vent(s) (i.e., the vent on the vacuum pump gas/liquid separator);
/ Sterilization chamber vacuum pump drain;
/ Chamber exhaust vent(s); and
/ Aeration room vent(s).
A schematic of these emission sources is shown in Figure 3-4.
3.4 NUMBER AND LOCATION OF AFFECTED SOURCES
Approximately 200 EO commercial sterilization and fumigation sources exist in the United
States; approximately 150 of these sources are expected to be affected by the NESHAP.
Table 3-1 lists the number of facilities by State according to EPA's data base compiled during
the development of the NESHAP. Appendix C of this document lists the known facilities that
are affected by this regulation.
3-7
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APPLICABILITY OF THE REGULATION
EMISSIONS
VENT
VENT OR EMISSION
CONTROL DEVICE
(GAS)
.SEPARATOR
VENT
(LIQUID)
DRAIN
ETHYLENE
OXIDE
PRODUCTS FOR
STERILIZATION
STERILIZATION
CHAMBER
STERILIZED
'PRODUCTS
AERATION
ROOM
Figure 3-4. Schematic of emission sources at commercial sterilization facilities.
3-8
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APPLICABILITY OF THE REGULATION
Table 3-1. Number of Facilities per State2
State
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Dlinois
Indiana
Iowa
Maryland
Massachusetts
Michigan
Minnesota
No. of facilities
3
2
19
3
6
2
5
4
8
4
3
5
9
8
6
State
Mississippi
Missouri
New Hampshire
New Jersey
New York
North Carolina
Ohio
Pennsylvania
Puerto Rico
Rhode Island
South Carolina
Tennessee
Texas
Virginia
Washington
No. of facilities
2
5
2
17
13
7
2
9
14
2
2
3
12
5
2
One facility is located in each of the following States: Alabama, Hawaii, Kentucky, Maine,
Nevada, New Mexico, North Dakota, Oregon, South Dakota, Utah, Wisconsin, and West
Virginia.
Total No. of 196
facilities
1 Data base of facilities compiled by EPA during the development of the NESHAP.
3-9
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CHAPTER 4
EMISSION LIMITS AND CONTROL TECHNIQUES
4.1 EMISSION LIMITS
The regulation specifies emissions standards as shown in Table 4-1 and provides reference
emission reduction techniques that may be used to comply -A ith the requirements. However, a
source may use other emission reduction techniques, as long as the level of emission reduction is
the same or better.
Table 4-1. Emissions Reductions and Limits
Source size, yearly
EO usage
<1 ton
^1 ton and < 10 tons
> 10 tons
Emissions standards for each source type
Sterilization chamber
vent, SCV
Aeration room vent,
ARV
Chamber exhaust vent,
CEV
No controls required; minimal recordkeeping requirements apply.
99% emission
reduction
99% emission
reduction
No control
1 ppmv maximum
outlet concentration
--OR--
99% emission
reduction
Maximum chamber
concentration limit of
5,300 ppmv prior to
activation of the chamber
exhaust1
Manifold to a control
device used to comply
with SCV or ARV
standards
-OR--
99 percent emission
reduction
aAffected sources may show compliance by manifolding emissions to a control device used to
comply with the SCV or ARV standards by reducing emissions by at least 99 percent.
4.2 CONTROL TECHNIQUES
As mentioned above, the emission reductions and limits are based on the use of certain
control techniques. However, a source may choose to use an alternative control technique, as
long as the emission reductions and limits are met. The following paragraphs discuss the control
techniques upon which the emissions limits found in Table 4.1 are based.
4.2.1 Acid-water Scrubber
An acid-water scrubber, depicted in Figure 4-1, consists of a countercurrent packed tower, a
reaction vessel, and a holding tank. In the countercurrent tower, the sterilant gas contacts an
4-1
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EMISSION LIMITS AND CONTROL TECHNIQUES
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Figure 4-1. Schematic of a typical acid water scrubber system.
acidic water solution, generally aqueous sulfuric acid. Because EO is extremely water soluble,
most of the EO is absorbed into the scrubber liquor. Next, the liquor is sent to the reaction
vessel, which is a small storage tank operated at atmospheric pressure, to complete the hydrolysis
of EO. After the reaction is complete, the liquor is sent to the storage vessel. The liquor in the
storage vessel is recirculated to operate the tower until the concentration of ethylene glycol in the
liquor reaches a predetermined weight percentage. (At this point the scrubber efficiency
declines.) The spent solution is neutralized and then disposed or sold. Typical EO removal
efficiencies of acid-water scrubbers are at least 99 percent.
4.2.2 Catalytic Oxidation Unit
Figure 4-2 shows a schematic of a catalytic oxidation unit. If necessary, inlet gas is first
mixed with a large volume of air to dilute the control device inlet EO concentration to
5,000 ppmv or less. This dilution prevents excessive catalyst bed temperatures (which can
damage the catalyst) from occurring during the oxidation of EO. The gas stream passes through
a filter for dust removal and is preheated to the reaction temperature with steam or electricity.
4-2
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EMISSION LIMITS AND CONTROL TECHNIQUES
FILTER
STEAM
COIL
CATALYST
BED
STEAM
9 PS1S
BYPASS
TO ATMOSPHERE
Figure 4-2. Catalytic oxidation system.
The gas then enters the catalyst bed(s), where the EO is oxidized. Because catalytic oxidation is
applicable to the control of lower EO concentrations, facilities can manifold several EO emission
sources to one control device. In some situations, low-concentration emission sources can
provide part or all of the necessary diluent air. Typical EO removal efficiencies of catalytic
oxidation units are greater than 99 percent.
4.2.3 Thermal Oxidation Unit
A thermal oxidation unit is depicted in Figure 4-3. Ethyiene oxide, which has a high heating
value, a relatively low ignition temperature, and a very wide range of mixtures combustible in
air, can be easily and efficiently destroyed by thermal oxidation using flares. However, because
of difficulties with sustaining combustion, commercially available flares are not applicable for
facilities emitting only small amounts of EO. Flares operated within specified conditions of
waste gas heat content and flare exit velocity will achieve at least 98 percent EO destruction
efficiency.
4-3
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EMISSION LIMITS AND CONTROL TECHNIQUES
STERILIZER
TO ATMOSPHERE
ON FAILURE
EXHAUST
TO ATMOSPHERE
SUPPLEMENTAL FUEL
(AS NEEDED)
Figure 4-3. Schematic of a typical thermal oxidation system.
4-4
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CHAPTER 5
DEMONSTRATING COMPLIANCE
There are three components to demonstrating compliance with the emissions standards of this
regulation:
/ Initial performance testing
/ Site-specific operating parameters setting
/ Ongoing compliance monitoring
5.1 INITIAL PERFORMANCE TESTING
The initial performance test serves two primary purposes. First, it is necessary to determine
if the source is in compliance with the emissions standards listed in Table 4-1 of this document.
Second, the initial performance test establishes values for the air pollution control system
operating parameters. Monitoring and recording these operating parameters during ongoing
sterilization processes will indicate whether or not the source is in compliance with the emissions
standards.
Each existing source that is subject to emissions standards is required to perform an initial
performance test by June 4, 1998. For sources with an initial startup date of December 8, 1997
or later, the initial performance test must be completed within 180 days after initial startup.
Section 63.365 of the regulation specifies test methods and procedures to be used to determine
the efficiency of the control devices,
5.2 ESTABLISHING SITE-SPECIFIC OPERATING PARAMETERS
During initial performance testing, applicable air pollution control technique operating
parameters must be recorded. These site-specific operating parameters are determined by the air
pollution control technique or strategy that the source is using and are listed in Table 5-1.
Table 5-1 also refers to the location in the NESHAP for the procedure to be used to establish the
site-specific operating parameter.
If a facility chooses to use a control technology other than an acid-water scrubber or catalytic
or thermal oxidizer to comply with the emissions standards, the owner or operator of the facility
must submit to the appropriate enforcement agency their own recommendations for operating
5-1
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DEMONSTRATING COMPLIANCE
Table 5-1. Site-specific Operating Parameters
Air pollution control
system or strategy
Site-specific operating parameter
Procedure in regulation
Sterilization Chamber Vent (SCV) Standard
Acid-water scrubber
Catalytic or thermal
oxidizer
1 . Maximum ethylene glycol
concentration in scrubber liquor
--OR-
2. Maximum scrubber liquor level in
recirculation tank
Baseline temperature during initial
performance test
§63.365(e)(l)
§ 63.365(e)(2)
§63.365(0(1)
Aeration Room Vent (ARV) Standard
Catalytic or thermal
oxidizer
Baseline temperature during initial
performance test
§ 63.365(0(2)
Chamber Exhaust Vent (CEV) Standard
Manifolding emissions to a
control device controlling
emissions from the SCV
and/or the ARV
Not manifolding emissions
and using an acid- water
scrubber
Not manifolding emissions
and using a catalytic or
thermal oxidizer
See appropriate columns above for that vent
type and control device
1. Maximum ethylene glycol
concentration in scrubber liquor
-OR--
2. Maximum scrubber liquor level in
recirculation tank
Baseline temperature during initial
performance test
See appropriate
columns above.
§63.365(e)(l)
§ 63.365(e)(2)
§ 63.365(0(3)
5-2
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DEMONSTRATING COMPLIANCE
parameters to be established and monitored to indicate proper operation and maintenance of their
air pollution control system.
5.3 ONGOING MONITORING
During performance testing, site-specific operating parameters are established, as discussed
above. Facilities must continue to monitor these operating parameters to ensure ongoing
continuous compliance with the emissions standards. By monitoring and recording the
appropriate air pollution control system parameters and comparing the monitored values to the
maximum or minimum value established during the performance test, the enforcing agency can
determine if the facility is in compliance with the emissions standards. Tables 5-2, 5-3, and 5-4
summarize the ongoing monitoring requirements associated with the sterilization chamber vent
standard, aeration room vent standard, and the chamber exhaust vent standard, respectively.
Each of these tables includes the equipment specifications and the monitoring frequency, as well
as indicators of a violation of the standard for the various air pollution control systems and
strategies that may be used.
5-3
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DEMONSTRATING COMPLIANCE
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5-6
-------
CHAPTER 6
RECORDKEEPING AND REPORTING REQUIREMENTS
Most of the recordkeeping and reporting requirements are not detailed in the NESHAP.
Instead, they are contained in the General Provisions to part 63 and simply referenced in Table 1
of Section 63.360 in the NESHAP. This table provides specific references to those sections of
the General Provisions that apply to the commercial sterilization and fumigation NESHAP. The
EPA chose to reference the recordkeeping and reporting requirements of the General Provisions
to help reduce unnecessary repetitiveness, and to help provide consistency between the different
NESHAP in part 63.
6.1 RECORDKEEPING
The regulation requires sources to keep records to document compliance status with the
regulation. These records include:
/ Malfunction records
/ Records to demonstrate compliance
/ Performance test results
/ Continuous monitoring system records
/ Documentation supporting initial notification and notification of compliance status
/ EO usage records for sources not subject to emissions standards
These records must be maintained in a form suitable and readily available for expeditious
inspection and review. They may be maintained on microfilm, computer, computer floppy disks,
magnetic tape disks, or microfiche. The files must be retained for at least 5 years, and the most
recent 2 years of data must be retained on site.
6.1.1 Malfunction Records
Sources must maintain records of the occurrence and duration of each malfunction of the air
pollution control equipment. Records of each period during which a CMS is malfunctioning or
inoperative (including out-of-control periods) are also required.
6.1.2 Records to Demonstrate Compliance
Sources are also required to maintain records of all required measurements needed to
demonstrate compliance with the standard. These records should include the data compiled
6-1
-------
RECORDING AND REPORTING REQUIREMENTS
according to Tables 5-2, 5-3 and 5-4 of this document, which detail the monitoring requirements
oftheNESHAP.
6.1.3 Performance Test Results
Sources must maintain records of all results of performance tests and CMS performance
evaluations, as well as all measurements necessary to determine the conditions of performance
tests and performance evaluations.
6.1.4 Continuous Monitoring System Records
Records relating to CMS must include: (1) all CMS calibration checks; (2) all adjustments
and maintenance performed on CMS; (3) all required CMS measurements (including monitoring
data recorded during unavoidable CMS breakdowns and out-of-control periods); (4) the date and
time identifying each period during which the CMS was inoperative except for zero (low-level)
and high-level checks; (5) the specific identification (i.e., the date and time of commencement
and completion) of each time period of excess emissions and parameter monitoring exceedances
that occurs during periods other than startups, shutdowns, and malfunctions of the source; (6) the
nature and cause of any malfunction (if known); the corrective action taken or preventive
measures adopted; (7) the nature of the repairs or adjustment to the CMS that was inoperative or
out of control; (8) the total process operating time during the reporting period; and (9) all
procedures that are part of a quality control program developed and implemented for CMS.
6.1.5 Documentation Supporting Initial Notification and Notification of Compliance Status
Sources are required to maintain all documentation supporting the initial notifications and
notifications of compliance status required by the NESHAP.
6.1.6 Records for Sources Not Subject to Emissions Standards
Sources that use 1 to 10 tons of EO per year and that are not subject to emissions standards
(see Table 4-1 of this document) are only required to keep records of EO usage on a 12-month
rolling basis. Sources that use less than 1 ton of EO per year are also only required to keep EO
usage records on a 12-month rolling basis.
6-2
-------
RECORDING AND REPORTING REQUIREMENTS
6.2 REPORTING
The regulation requires that sources submit reports and notifications, which include:
/ Initial notification
/ Notification of construction/reconstruction
-------
RECORDING AND REPORTING REQUIREMENTS
the source being an affected source. All applications must be submitted to the Administrator as
soon as practicable to ensure timely review.
6.2.3 Notification of Performance Test and CMS Performance Evaluation
Sources must notify the Administrator in writing of intent to conduct an initial performance
test at least 60 calendar days before the scheduled date of the test to allow the Administrator to
review and approve their site-specific test plan and to have an observer present at the test.
Simultaneously with this notification, the source will also notify the Administrator of the date of
the continuous monitoring system (CMS) performance evaluation. The Administrator may or
may not choose to have an observer present. If the scheduled date for the test is changed for
unforeseen reasons, the source will inform the Administrator within 5 calendar days of the
originally scheduled test date and will specify the date of the rescheduled test.
6.2.4 Test Plans
Before conducting the initial performance test, sources are required to develop and, if
requested by the Administrator, submit a site-specific test plan and a CMS performance
evaluation test plan to the Administrator for approval. The test plan will include: (1) a test
program summary, (2) the test schedule, (3) data quality objectives (i.e., pretest expectations of
precision, accuracy, and completeness of data), (4) an internal and external quality assurance
(QA) program. The CMS performance evaluation test plan will include: (1) the evaluation
program summary, (2) the performance evaluation schedule, (3) data quality objectives, and
(4) both an internal an external QA program. If requested by the Administrator, the source will
submit these test plans at least 60 calendar days before the performance test is scheduled to take
place. The Administrator will then either approve or disapprove the test plans within 30 calendar
days after receipt of the plans.
6.2.5 Notification of Compliance Status
Sources are required to submit a notification of compliance status within 60 days after the
initial performance test. The notification must include: (1) the methods that were used to
determine compliance; (2) the results of the performance test and the CMS performance
evaluation; (3) the methods that will be used for determining continuing compliance; (4) the type
and quality of HAPs emitted, reported in units and averaging times specified in the regulation;
6-4
-------
RECORDING AND REPORTING REQUIREMENTS
(5) an analysis demonstrating whether the source is a major source or an area source; (6) a
description of the air pollution control equipment (or method) for each emission point, including
the control efficiency for each control device (or method); and (7) a statement as to whether the
source has complied with the relevant standard or other requirements.
6.2.6 Excess Emissions and CMS Performance Report/Summary Report
Sources are required to submit an excess emissions and CMS performance report and/or a
summary report to the Administrator semiannually. These reports are due 30 calendar days after
each half of the calendar year (i.e., July 30 and January 30). A summary report may be submitted
in lieu of the full excess emissions and CMS performance report if the total duration of excess
emissions or process or control system parameter exceedances for the reporting period is less
than 1 percent of the total operating time for the reporting period, and if the CMS downtime of
the reporting period is less than 5 percent of the total operating time for the reporting period.
Otherwise, the summary report and the excess emissions and CMS performance report is
required.
The summary report must include: (1) the company name and address of the source; (2) an
identification of each HAP monitored at the source; (3) the beginning and ending dates of the
reporting period; (4) a brief description of the process units; (5) the relevant emission and
operating parameter limitations specified in the NESHAP; (6) the monitoring equipment and
manufacturer(s) and model number(s); (7) the date of the latest CMS certification or audit; (8)
the total operating time of the source during the reporting period; (8) an emission data summary,
including the total duration of excess emissions during the reporting period, the total during of
excess emissions expressed as a percent of the total source operating time during that reporting
period;, and a breakdown of the total duration of excess emissions during the reporting period
into those that are due to startup/shutdown, control equipment problems, process problems, other
known causes, and other unknown causes; (9) a CMS performance summary, including the total
CMS down time during the reporting period, the total duration of CMS downtime expressed as a
percent of the total source operating time during that reporting period, and a breakdown of the
total CMS downtime during the reporting period into periods that are due to monitoring
equipment malfunctions, nonmonitoring equipment malfunctions, quality assurance/quality
6-5
-------
RECORDING AND REPORTING REQUIREMENTS
control calibration, other known causes, and other unknown causes; (10) a description of any
changes in CMS, processes, or controls since the last reporting period; (11) the name, title, and
signature of the responsible official who is certifying the accuracy of the report; and (12) the date
of the report.
The excess emissions and CMS performance report must include: (1) the name, title, and
signature of the responsible official who is certifying the accuracy of the report; (2) information
from any calibration tests in which the monitoring equipment is not in compliance with
performance specification (PS) -9 of 40 CFR part 60 or the method used for temperature
calibration; (3) the date and time identifying each period during which the CMS was inoperative,
except for zero (low-level) and high-level checks; (4) the date and time identifying each period
during which the CMS was out of control; (5) the date and time of commencement and
completion of each period of excess emissions and parameter monitoring exceedances that
occurs during startups, shutdowns, and malfunction of the source; (6) the date and time of
commencement and completion of each period of excess emissions and parameter monitoring
exceedances that occurs during periods other than startups, shutdowns, and malfunctions of the
source; (7) the nature and cause of any malfunction (if known); (8) the corrective action taken or
preventive measures adopted; (9) the nature of the repairs or adjustment to the CMS that was
inoperative or out of control; and (10) the total process operating time during the reporting
period. When no excess emissions or exceedances have occurred or monitoring equipment has
not been inoperative, repaired, or adjusted, such information should be stated in the report.
6-6
-------
CHAPTER 7
INSPECTION PROCEDURES
The following comprise sample checklists that may be used during inspections of affected
sources.
7-1
-------
RECORDING AND REPORTING REQUIREMENTS
INSPECTION CHECKLIST
PART A. GENERAL PROCESS INFORMATION
Applicable Rule: 40 CFR Part 63, Subpart O-NESHAP for Ethylene Oxide Commercial
Sterilization and Fumigation Operations.
Plant Name
Plant Address
City_ State.
Plant Contact/Title
Owner/Operator, Title
Street Address (if different than plant's)
Zip Code_
.Plant Phone number
Sate
City
1. Inspection Date: / / Time:
2. Indicate whether a facility is a new or existing source:
New source Existing source
3. Indicate the facility's compliance date: / /
4. Indicate the facility's annual EO use in previous 12 months: _
5. Indicate the facility's compliance approach
Sterilization chamber vent:
Acid-Water scrubber Oxidizer Other (_
Chamber exhaust vent:
5,300 ppm limit Manifolded to control device
Acid-Water scrubber Oxidizer Other (
Zip Code
Dedicated control device
Aeration room vent:
1 ppm max
Manifolded to control device
Acid-Water scrubber Oxidizer Other (_
J
Dedicated control device
Investigator/Title:.
Date: / /
7-2
-------
RECORDING AND REPORTING REQUIREMENTS
INSPECTION CHECKLIST
PART B. MONITORING REQUIREMENTS FOR
STERILIZATION CHAMBER VENTS
Inspection
steps
Value
Y
N
Inspector
notes
General
1. From Part A of the Inspection
Checklist, determine the
dedicated control device used to
comply with the standard.
2. Determine that source has
complied with the requirements
for the appropriate dedicated
control device; follow the
inspection steps listed on the
appropriate forms:
7-3
-------
RECORDING \ND REPORTING REQUIREMENTS
Inspection
Value
N
Inspector notes
Acid-Water Scrubbers
Enter tr.c site-specific operating
parameter value established
during the initial performance test
(i.e., either the maximum
ethylene glycol concentration in
the scrubber liquor or the
maximum scrubber liquor level in
the recirculation tank).
2. Obtain records of ongoing
monitoring data.
3. Answer (a) or (b):
(a) Has the ethylene glycol
concentration in the scrubber
liquor been monitored and
recorded once per week?
(b) Has the scrubber liquor level in
the recirculation tank been
monitored and recorded once per
week?
4. Answer (a) or (b):
(a) Has the source exceeded the
maximum ethylene glycol
concentration in the scrubber
liquor established during the
initial performance test?
(b) Has the source exceeded the
maximum scrubber liquor level
established during the initial
performance test?
If the answer to step 4 is "Yes,"
has the source reported the excess
emissions to the Administrator?
Stop here.
7-4
-------
RECORDING AND REPORTING REQUIREMENTS
Inspection steps
Value
Y N
Inspector notes
Thermal or Catalytic Oxidizers
Obtain and enter the site-specific
operating parameter value
established during the initial
performance test (i.e., oxidation
temperature at outlet to catalyst
bed or at exhaust point from
thermal combustion chamber).
2. Obtain records of ongoing
monitoring data.
3. Does the source operate a
temperature monitor accurate to
within ±10°F as verified twice
each calendar year with a
reference temperature monitor?
4. Does the source operate a data
acquisition system that computes
and records the average oxidation
temperature over the length of the
cycle and a three-cycle block
average every third cycle?
Has the oxidation temperature,
averaged over 3 cycles, been
more than 10°F below the
baseline temperature established
during the initial performance
test?
6. If the answer to step 5 is "Yes,"
has the source reported the excess
emissions to the Administrator?
Stop here.
7-5
-------
RECORDING AND REPORTING REQUIREMENTS
Inspection steps
Value Y
N
Inspector notes
Other Control Devices
I . Enter the site-specific operating
parameter value established
during the initial performance
test.
2. Obtain records of ongoing
monitoring data.
3. Does the source operate a
monitoring device(s) accurate to
within the tolerances in the site
specific monitoring plan
approved by the Administrator
and verified in accordance with
this plan?
.;%=
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if.
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^jj&jT
4. Does the source operate a data i^^^^l
acquisition system that computes ^^^^H
and records a monitoring ^^^^1
parameter(s) according to the j^^^^l
schedule specified in the site ^^^^1
specific monitoring plan ll^^l
approved by the Administrator? pflll
fc^^K^^^^^^HM
5. Have the recorded values shown ^oHH
violation of the parameters? IEBH
6. If the answer to step 5 is "Yes," ^^^H
has the source reported the excess jji^^^l
emissions to the Administrator? ^^^^H
Stop here. pHHR
;_ C.
7-6
-------
RECORDING AND REPORTING REQUIREMENTS
INSPECTION CHECKLIST
PART C. MONITORING REQUIREMENTS FOR
CHAMBER EXHAUST VENTS
Step in inspection
Value
Y
N
Inspector notes
General
1. From Part A of the Inspection
Checklist, determine the method of
compliance:
(a) Monitor EO concentration. Go to
Step 2.
(b) Manifold emissions to control device.
Go to Step 5.
(c) Emissions controlled via dedicated
control device. Go to Step 6.
2. Obtain records of ongoing monitoring
data.
3. Has the ethylene oxide concentration
exceeded the 5,300 ppm limit?
4. If the answer to step 3 is "Yes," has
the source reported the excess
emissions to the Administrator? Stop
here.
5. Detemune that source has complied
with the requirements for that control
device on that emissions point
(continue on Part B, or Part D as
appropriate).
6. Determine that source has complied
with the requirements for the
appropriate dedicated control device
as follows:
7-7
-------
RECORDING AND REPORTING REQUIREMENTS
Step in inspection
Value
N
Inspector notes
Acid-Water Scrubbers
Enter the site-specific operating
parameter value established during
the initial performance test (i.e., either
the maximum ethylene glycol
concentration in the scrubber liquor
or the maximum scrubber liquor level
in the recirculation tank).
2. Obtain records of ongoing monitoring
data.
3. Answer (a) or (b):
(a) Has the ethylene glycol concentration
in the scrubber liquor been monitored
and recorded once per week?
(b) Has the scrubber liquor level in the
recirculation tank been monitored and
recorded once per week?
4. Answer (a) or (b):
(a) Has the source exceeded the
maximum ethylene glycol
concentration in the scrubber liquor
established during the initial
performance test?
(b) Has the source exceeded the
maximum scrubber liquor level
established during the initial
performance test?
5. If the answer to step 4 is "Yes," has
the source reported the excess
emissions to the Administrator? Stop
here.
7-8
-------
RECORDING AND REPORTING REQUIREMENTS
Step in inspection
Value
Y N I Inspector notes
Thermal or Catalytic Oxidizers
Enter the site-specific operating
parameter value established during
the initial performance test (i.e.,
oxidation temperature at outlet to
catalyst bed or at exhaust point from
thermal combustion chamber).
2. Obtain records of ongoing monitoring
data.
Does the source operate a temperature
monitor accurate to within ±10°F as
verified twice each calendar year with
a reference temperature monitor?
4. Does the source operate a data
acquisition system that computes and
records the average oxidation
temperature over the length of the
cycle and a three-cycle block average
every third cycle?
Has the oxidation temperature,
averaged over 3 cycles, been more
than 10°F below the baseline
temperature established during the
initial performance test?
6. If the answer to step 5 is "Yes," has
the source reported the excess
emissions to the Administrator? Stop
here.
7-9
-------
RECORDING AND REPORTING REQUIREMENTS
Step in inspection
Value
N
Inspector notes
Other Control Devices
Enter the site-specific operating
parameter value established during
the initial performance test.
2. Obtain records of ongoing monitoring
data.
3. Does the source operate a monitoring
device(s) accurate to within the
tolerances in the site specific
monitoring plan approved by the
Administrator and verified in
accordance with this plan?
4. Does the source operate a data
acquisition system that computes and
records a monitoring parameter(s)
according to the schedule specified in
the site specific monitoring plan
approved by the Administrator?
5. Have the recorded values shown
violation of the parameters?
6. If the answer to step 5 is "Yes," has
the source reported the excess
emissions to the Administrator? Stop
here.
7-10
-------
RECORDING AND REPORTING REQUIREMENTS
INSPECTION CHECKLIST
PART D. MONITORING REQUIREMENTS FOR
AERATION ROOM VENTS
Step in inspection
Value
Y
N
Inspector notes
General
1. From Part A of the Inspection
Checklist, determine the method of
compliance:
(a) Monitor EO concentration. Go to
Step 2.
(b) Manifold emissions to control device.
Go to Step 5.
(c) Emissions controlled via dedicated
control device. Go to Step 6.
2. Obtain records of ongoing monitoring
data.
3.
Has the ethylene oxide concentration
exceeded the 1 ppm limit?
4. If the answer to step 3 is "Yes," has
the source reported the excess
emissions to the Administrator? Stop
here.
5. Determine that source has complied
with the requirements for that control
device on that emissions point
(continue on Part B, or Part D as
appropriate).
6. Determine that source has complied
with the requirements for the
appropriate device as follows:
7-11
-------
RECORDING AND REPORTING REQUIREMENTS
Step in inspection
Value
N
Inspector notes
Acid-Water Scrubbers
Enter the site-specific operating
parameter value established during
the initial performance test (i.e., either
the maximum ethylene glycol
concentration in the scrubber liquor
or the maximum scrubber liquor level
in the recirculation tank).
2. Obtain records of ongoing monitoring
data.
3. Answer (a) or (b):
(a) Has the ethylene glycol concentration
in the scrubber liquor been monitored
and recorded once per week?
(b) Has the scrubber liquor level in the
recirculation tank been monitored and
recorded once per week?
4. Answer (a) or (b):
(a) Has the source exceeded the
maximum ethylene glycol
concentration in the scrubber liquor
established during the initial
performance test?
(b) Has the source exceeded the
maximum scrubber liquor level
established during the initial
performance test?
If the answer to step 4 is "Yes," has
the source reported the excess
emissions to the Administrator? Stop
here.
7-12
-------
RECORDING AND REPORTING REQUIREMENTS
Step in inspection
Value
N
Inspector notes
Thermal or Catalytic Oxidizers
1. Enter the site-specific operating
parameter value established during
the initial performance test (i.e.,
oxidation temperature at outlet to
catalyst bed or at exhaust point from
thermal combustion chamber).
2. Obtain records of ongoing monitoring
data.
3. Does the source operate a temperature
monitor accurate to within ±10°F as
verified twice each calendar year with
a reference temperature monitor?
4. Does the source operate a data
acquisition system that computes and
records the average oxidation
temperature over the length of the
cycle and a three-cycle block average
every third cycle?
Has the oxidation temperature,
averaged over 3 cycles, been more
than 10°F below the baseline
temperature established during the
initial performance test?
If the answer to step 5 is "Yes," has
the source reported the excess
emissions to the Administrator? Stop
here.
7-13
-------
RECORDING AND REPORTING REQUIREMENTS
Step in inspection
Value
Y
N
Inspector notes
Other Control Devices
1 . Enter the site-specific operating
parameter value established during
the initial performance test.
2. Obtain records of ongoing monitoring
data.
3. Does the source operate a monitoring
device(s) accurate to within the
tolerances in the site specific
monitoring plan approved by the
Administrator and verified in
accordance with this plan?
4. Does the source operate a data
acquisition system that computes and
records a monitoring parameter(s)
according to the schedule specified in
the site specific monitoring plan
approved by the Administrator?
5. Have the recorded values shown
violation of the parameters?
6. If the answer to step 5 is "Yes," has
the source reported the excess
emissions to the Administrator? Stop
here.
A»
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7-14
-------
RECORDING AND REPORTING REQUIREMENTS
INSPECTION CHECKLIST
PART D. RECORDKEEPING REQUIREMENTS
Step in inspection
1 . Does the source use less than 10 tons of ethylene
oxide per year? If "Yes," go to Step 2. If "No," go
to Step 4.
2. Is the source subject to emissions limitations in the
regulation? If "Yes," go to Step 4. If "No," go to
Step 3.
3. Does the source maintain records of EO usage on a
12-month rolling basis? Stop here.
4. Does the source maintain the following malfunction
records:
(a) The occurrence and duration of each malfunction of
the air pollution control equipment; AND
(b) Records of each period during which a continuous
monitoring system is malfunctioning or inoperative
(including out-of-control periods)?
5. Does the source maintain records of all required
measurements needed to demonstrate compliance
with the standard?
6. Does the source maintain records of all results of
performance tests and CMS performance
evaluations, as well as all measurements as may be
necessary to determine the conditions of the
performance tests and evaluations?
Y
N
Inspector notes
7-15
-------
RECORDING AND REPORTING REQUIREMENTS
Step in inspection
7. Does the source maintain the following records
relating to CMS:
(a) All CMS calibration checks;
(b) All adjustments and maintenance performed on
CMS;
(c) All required CMS measurements (including
monitoring data recorded during unavoidable CMS
breakdowns and out-of -control periods);
(d) The date and time identifying each period during
which the CMS was inoperative except for zero
(low-level) and high-level checks;
(e) The specific identification (i.e., the date and time of
commencement and completion) of each time period
of excess emissions and parameter monitoring
exceedances tat occurs during periods other than
startups, shutdowns, and malfunctions of the source;
(0 The nature and cause of any malfunction (if know);
the corrective action taken or preventive measures
adopted;
(g) The nature of the repairs or adjustment to the CMS
that was inoperative or out of control;
(h) The total process operating time during the reporting
period; and
(I) All procedures that are part of a quality control
program developed and implemented for CMS?
Y
N
Inspector notes
7-16
-------
CHAPTER 8
COMMONLY ASKED QUESTIONS AND ANSWERS
Q: Am I a major source?
A: The term "major source" refers to a category of stationary sources that are regulated for
emissions of hazardous air pollutants (HAP's) under Section 112 of the Clean Air Act. Your
facility is a major source if it emits or has the potential to emit, after air pollution controls,
10 tons per year of any one hazardous pollutant or 25 tons per year of any combination of
HAP's. Facilities that emit lesser quantities of HAP's are "area sources." The term "area" is
used rather than "non-major" or "minor" to emphasize that while individual facilities are
smaller, their aggregate emissions are still a concern, especially in urban areas containing
many facilities. Ethylene oxide is designated as a hazardous air pollutant.
Q: In terms of the requirements of this standard, 40 CFR Part 63, Subpart O, does it matter
whether lama major or area source?
A: No. Some of the National Emission Standards for Hazardous Air Pollutants (NESHAP)
do differentiate between major and area sources and some only regulate the major
sources. However, this standard, 40 CFR Part 63, Subpart O (Sterilizer NESHAP),
regulates both major and area sources.
Q: Does my ethylene oxide usage have an impact on the requirements of the Sterilizer
NESHAP?
A: Yes. If your facility uses less than 1 ton of ethylene oxide per year (all consecutive
12-month periods after December 6, 1996), you are subject to only the recordkeeping
requirements of the standard (Section 63.367). If you use 1 or more tons of ethylene oxide
per year, you are also subject to the emission standards of the Sterilizer NESHAP. Which
emission standards apply to you depend on whether or not you use 10 or more tons of
ethylene oxide per year. Please note that how the standards apply to you is based on
ethylene oxide usage, not ethylene oxide emissions. The basis here is different from that
used to determine whether you are a major or area source.
Q: When do I need to comply with the Sterilizer NESHAP?
A: If the startup of your sterilization facility occurred on or before December 8, 1997, your
compliance date is December 8, 1997. If your startup will be after December 8, 1997,
your compliance date is the date of startup. As of your compliance date, you are required
to meet all standards that apply to you, depending on your ethylene oxide usage (see
Question 3).
8-1
-------
COMMON QUESTIONS AND ANSWERS
If the Sterilizer NESHAP emission standards apply to your facility, you will need to
conduct initial performance testing within 180 days of your compliance date or by June 8,
1998, if your compliance date is December 8, 1997. The performance testing is conducted
with the methods and procedures in Sections 63.7 and 63.365. Performance testing will
determine the values to be used for compliance monitoring at your facility. Monitoring
requirements are described in Section 63.364 of the Sterilizer NESHAP and come into
effect on the date of completion of the initial performance test.
Q: What does the Title V permit deferral I've heard about have to do with what I'm required
to do for this standard (Sterilizer NESHAP)?
A: On June 3, 1996, the USEPA published an amendment to the Sterilizer NESHAP in the
Federal Register (61 FR 27785). In its original form, the Sterilizer NESHAP required
that subject sources using 1 ton or more obtain a Title V permit. The amendment revises
Section 63.360(f) to state that subject sources which use 1 ton, but are not major or
located at major sources, may be deferred by the applicable Title V permitting authority
from the Title V permitting requirements for 5 years until December 9, 1999. Most States
have indicated that they will grant these deferrals. This means that if you are an area
source using 1 ton per year, you have until December 9, 2000, to submit your Title V
permit application, unless your State agency specifies an earlier deadline.
The deferral of the Title V application deadline does NOT affect the compliance deadline
of the Sterilizer NESHAP. Therefore, if your company is an area source using 1 ton, you
must be in compliance with the emission standards by December 8, 1997.
Q: How does combining my emissions from two or more emissions points to one control
device affect my initial compliance test and ongoing monitoring?
A: In certain circumstances, it is possible to combine the emissions flows from multiple
emissions points to a single emissions control device (e.g., combine the emissions from
the sterilizer vent and aeration room to a catalytic oxidizer). If such an approach were
attempted, the owner or operator would need to obtain prior approval from the delegated
State agency. In addition, during the initial compliance test, the emissions points would
need to be isolated so that the monitoring parameters may be accurately determined.
After initial compliance is determined, the emissions may be manifolded to a common
control device provided that the monitoring parameter limits determined during the initial
compliance test are not exceeded.
8-2
-------
COMMON QUESTIONS AND ANSWERS
Q: I determined initial compliance with the aeration room vent standards by calculating the
percent reduction in emissions, must I continue to calculate the percent reduction to
satisfy the ongoing monitoring requirements?
A: The aeration room vent standards for sources using 10 or more tons of EO per year
require either a 99 percent emission reduction or a maximum EO concentration of 1
ppmv. The standards do not require a source to commit to either approach. Therefore, it
would be possible for a source to determine initial compliance with the standards by
calculating their percent reduction in aeration room vent emissions, and then comply with
the 1 ppmv concentration limit to show ongoing compliance.
8-3
-------
-------
APPENDIX A
GLOSSARY OF TERMS
Administrator means the Administrator of the United States Environmental Protection
Agency of his or her authorized representative (e.g., a State that has been delegated the authority
to implement the provisions of 40 CFR part 63).
Aeration room means any vessel or room that is used to facilitate off-gassing of ethylene
oxide at a sterilization facility.
Aeration room vent means the point(s) through which the evacuation of ethylene oxide-laden
air from an aeration room occurs.
Area source means any stationary source of hazardous air pollutants that is not a major
source as defined below in this appendix. Another term for area source is "nonmajor source."
Baseline temperature means any temperature at the outlet point of a catalytic oxidation unit
control device or at the exhaust point from the combustion chamber for a thermal oxidation unit
control device established during the performance test when the respective unit achieves at least
99-percent control of ethylene oxide emissions.
Chamber exhaust vent means the point(s) through which ethylene oxide-laden air is removed
from the sterilization chamber during chamber unloading following the completion of
sterilization and associated air washes.
Compliance date means the date by which a source subject to the emissions standards in
' § 63.362 is required to be in compliance with the standard.
Effective date means the date of promulgation in the Federal Register notice
(December 6, 1994).
Initial startup date means the date when a source subject to the emissions standards in
§ 63.362 first begins operation of a sterilization process.
Major source means any stationary source or group of stationary sources located within a
contiguous area and under common control that emits or has the potential to emit considering
controls in the aggregate, 10 tons per year or more of any hazardous air pollutant, or 25 tons per
year or more of any combination of hazardous air pollutants.
Manifolding emissions means combining ethylene oxide emissions from two or more
different vent types for the purpose of controlling these emissions with a single control device.
Maximum ethylene glycol concentration means any concentration of ethylene glycol in the
scrubber liquor of an acid-water scrubber control device established during a performance test
when the scrubber achieves at least 99-percent control of ethylene oxide emissions.
Maximum liquor tank level means any level of scrubber liquor in the acid-water scrubber
liquor recirculation tank established during a performance test when the scrubber achieves at
least 99-percent control of ethylene oxide emissions.
Operating parameter value means a minimum or maximum value established for a control
device or process parameter which, if achieved by itself or in combination with one or more other
operating parameter values, determines that an owner or operator is in continual compliance with
the applicable emission limitation standard.
Oxidation temperature means the temperature at the outlet point of a catalytic oxidation unit
control device or at the exhaust point from the combustion chamber for a thermal oxidation unit
control device.
A-l
-------
GLOSSARY OF TERMS
Parametric monitoring means monitoring of a specific operating parameter of the control
device that demonstrates that the control device is operating under conditions that meet the
standard.
Research or laboratory operation means an operation whose primary purpose is for research
and development of new processes and products, that is conducted under the close supervision of
technically trained personnel, and that is not involved in the manufacture of products for
commercial sale in commerce, except in a de minimis manner.
Source(s) using less than 1 ton means source(s) using less than 907 kg (1 ton) of ethylene
oxide within all consecutive 12-month periods after December 6, 1996.
Source(s) using I ton means source(s) using 907 kg (1 ton) or more of ethylene oxide within
any consecutive 12-month period after December 6, 1996.
Source(s) using I to 10 tons means source(s) using 907 kg (I ton) or more of ethylene oxide
in any consecutive 12-month period but less than 9,070 kg (10 tons) of ethylene oxide in all
consecutive 12-month periods after December 6, 1996.
Source(s) using less than 10 tons means source(s) using less than 9,070 kg (10 tons) of
ethylene oxide in all consecutive 12-month periods after December 6, 1996.
Source(s) using 10 tons means source(s) using 9,070 kg (10 tons) or more of ethylene oxide
in any consecutive 12-month period after December 6, 1996.
Sterilization chamber means any enclosed vessel or room that is filled with ethylene oxide
gas or an ethylene oxide/inert gas mixture, for the purpose of sterilizing and/or fumigating at a
sterilization facility.
Sterilization chamber vent means the point (prior to the vacuum pump) through which the
evacuation of ethylene oxide from the sterilization chamber occurs following sterilization or
fumigation, including any subsequent air washes.
Sterilization facility means any stationary source where ethylene oxide is used in the
sterilization or fumigation of materials.
Sterilization operation means any time when ethylene oxide is removed from the sterilization
chamber through the sterilization chamber vent or the chamber exhaust vent or when ethylene
oxide is removed from the aeration room through the aeration room vent.
A-2
-------
APPENDIX B.
DETAILED TABLE OF CONTENTS OF THE REGULATION
Table B-l. Detailed Table of Contents of the Regulation
Section in regulation
§ 63.360(a)
§ 63.360(b)
§ 63.360(c)
§ 63.360(d)
§ 63.360(e)
§ 63.360(f)
§ 63.360(g)
§63.360(g)(l)
§ 63.360(g)(2)
§ 63.360(g)(3)
§ 63.361
§ 63.362(a)
§ 63.362(b)
§ 63.362(c)
§ 63.362(d)
§ 63.362(e)
§63.362(e)(l)
§ 63.362(e)(2)
§ 63.363(a)
§ 63.363(b)
Contents or Requirement
§63.360 Applicability
Sources using £ 1 ton EO per year subject to rule (including subpart A)
Sources using <1 ton EO per year only subject to recordkeeping in
§ 63.367(c)
Exemption for beehive fumigation sources
Exemption for research and development sources
Exemption for medical facilities
Sources using * 1 ton EO per year must obtain title V permit
Compliance dates (CD):
• Startup before 12/8/97 - CD = 12/6/97
• Startup after 12/8/97 - CD = startup date
• Increase EO usage after 12/8/97 — CD = date of increase
§63.361 Definitions
Definitions of terms used in regulation
§63.362 Standards
Comply with standards as of CD for source
Standards apply only during sterilization operation, not during malfunctions
Sterilization chamber vent (SCV) (sources using 2 1 ton) -» 99 percent
reduction
Aeration room vent (ARV) (sources using 2: 10 tons) -» 99 percent reduction
or 1 ppmv EO
Chamber exhaust vent (CEV) standards:
• Sources using 2 10 tons — manifold to SCV or ARV or 99 percent
reduction
• Sources using 1 to 10 tons — 5,300 ppmv EO; may manifold to SCV or
99 percent reduction (without manifolding)
§63363 Compliance
Initial performance test required within 1 80 days after CD
Determining compliance with SCV standard:
B-l
-------
DETAILED TABLE OF CONTENTS OF THE REGULATION
Table B-l. (continued)
Section in regulation
§63.363(b)(l)
§63.363(b)(l)(I)
§63.363(b)(l)(ii)
§ 63.363(b)(2)
§ 63.363(c)
§63.363(c)(l)
§ 63.363(c)(2)
§ 63.363(c)(3)
§ 63.363(d)
§63.363(d)(l)
§ 63.363(d)(2)
§ 63.363(d)(2)(I)
§ 63.363(d)(2)(ii)
§ 63.363(e)
§63.363(e)(l)
§ 63.363(e)(2)
§ 63.363(e)(2)(I)
§ 63.363(e)(2)(ii)
§ 63.363(e)(3)
§ 63.363(0
Contents or Requirement
• Use test method in § 63.365(b)( 1) to determine efficiency
•• Establish site-specific operating parameters for acid-water scrubbers
— ethylene glycol concentration [EG] or scrubber liquor tank level
•• Establish site-specific operating parameter for catalytic/thermal
oxidizers — baseline temperature
• Parameter violations
Determining compliance with ARV standard:
• Use test method in § 63.365(c)( 1) to determine EO concentration; use §
63.365(d)(l) to determine efficiency
• Establish site-specific operating parameter for catalytic/thermal
oxidizers =* baseline temperature [T]
• Parameter violations
Determining compliance with CEV standard for sources using £ 10 tons:
• If manifolding to SCV or ARV, comply with those parameters
• If using dedicated control device:
•• Use test method in § 63.365(d)(2) to determine efficiency; establish
site-specific operating parameters for acid-water scrubbers =* [EG]
or scrubber liquor tank level; establish operating parameter for
catalytic/thermal oxidizers => [T]
•• Parameter violations
Determining compliance with CEV standard for sources using 1 to 10 tons:
• If manifolding to SCV, comply with those parameters
• If using dedicated control device:
•• Use test method in § 63.365(c)(2) to determine EO concentration
[EO]
•• Use test method in § 63.365(d)(2) to determine efficiency; establish
site-specific operating parameters for acid-water scrubbers — [EG]
or scrubber liquor tank level; establish operating parameter for
catalytic/thermal oxidizers =* [T]
• Parameter violations
Compliance procedures for sources using other control devices
B-2
-------
DETAILED TABLE OF CONTENTS OF THE REGULATION
Table B-l. (continued)
Section in regulation
Contents or Requirement
§ 63.364 Monitoring
§ 63.364(a)
Sources must comply with this section and subpart A
§ 63.364(b) Acid-water scrubber monitoring:
§63.364(b)(l) • [EG]-weekly
§ 63.364(b)(2) • Scrubber liquor tank level - weekly
§ 63.364(c) Catalytic/thermal oxidizer monitoring:
§ 63.364(c)( 1) • SCV — [T] over cycle length; average every third cycle
§ 63.364(c)(2) • ARV =» [T] over 1 hour; average every third hour
§ 63.364(c)(3) • CEV - [T] over cycle length
§ 63.364(c)(4) • Verify accuracy of [T] monitor every 6 months
§ 63.364(d) Other control device monitoring according to § 63.365(g)
§ 63.364(e) Monitoring of [EO]:
§ 63.364(e)(l) • ARV - [EO] hourly; average every third hour; install gas chromatograph
and calibrate daily
§ 63.364(e)(2) • CEV (1 to 10 tons) - [EO] before chamber exhaust activation; install gas
chromatograph and calibrate daily
§ 63.364(0 If manifolding, comply with parameters for that device
§ 63.365 Test Methods and Procedures
§ 63.365(a) Sources subject to this section and subpart A
§ 63.365(b) SCV - efficiency and parameter determination:
§ 63.365(b)( 1) • First evacuation of SCV - efficiency and parameter
§ 63.365(b)(2) • Last evacuation of SCV - efficiency and parameter
§ 63.365(c) Concentration determination for ARV and CEV (1 to 10 tons):
§63.365(c)(l) • ARV-[EO]
§ 63.365(c)(2) • CEV (1 to 10 tons) - [EO]
§ 63.365(d) Efficiency and parameter determination for ARV and CEV:
§63.365(d)(l) • ARV - efficiency
§ 63.365(d)(2) • CEV (not manifolded)
B-3
-------
DETAILED TABLE OF CONTENTS OF THE REGULATION
Table B-l. (continued)
Section in regulation
§ 63.365(e)
§63.365(e)(l)
§ 63.365(e)(2)
§ 63.365(0
§63.365(0(1)
§ 63.365(0(2)
§ 63.365(0(3)
§ 63.365(g)
§ 63.365(h)
Contents or Requirement
Parameter determination for acid-water scrubber:
• [EG] (any vent type)
• Scrubber liquor tank level (any vent type)
Temperature determination for catalytic/thermal oxidizer.
• SCV
• ARV
• CEV
Efficiency and parameter determination for other control devices
Alternative to gas chromatography for ARV or CEV standards
§63366 Reporting
§ 63.366(a)
§ 63.366(b)
§ 63.366(c)
Sources subject to this section and subpart A; content and submittal
for summary, excess emissions, and monitoring system performance
dates
reports
Construction/reconstruction reporting
Notification reports
§63.367 Recordkeeping
§ 63.367(a)
§ 63.367(b)
§ 63.367(c)
Sources subject to this section and subpart A
Sources using 1 to 10 tons maintain records of EO usage on 12-month
rolling basis
Sources using < 1 ton maintain records of EO usage on 12-month rolling
basis
B-4
-------
APPENDIX C.
LIST OF KNOWN FACILITIES
Table C-l. List of Known Facilities
Facility name
Travenol Laboratories, Inc.
Alabama Dept. Of Agriculture
Arkansas History Commission
W.L. Gore & Assoc., Inc.
Procter & Gamble
The Heard Museum
Botanicals International
Cal-Compack Foods
Farmer Bros. Co.
Santa Maria Chili, Inc.
Allergan Pharmaceuticals
Maurry Biological Co., Inc.
Barnes Hind, Inc.
Medlon, Inc.
Ways & Means, Inc.
IVAC Corporation
American Bentley
American Edwards Laboratories
American Pharmaseal
Shiley, Inc.
3M
Abco Laboratories
Micro-Biotrol, Inc.
Sterilization Services of Calif.
Lowie Museum of Anthropology
Telectronics
Cobe Laboratories
Valleylab, Inc.
Parent company
American Hospital Supply
Zuellig Botanicals, Inc.
American Hospital Supply
American Hospital Supply
American Hospital Supply
Pfizer
University of California
Pfizer
City
Mountain Home
Montgomery
Little Rock
Flagstaff
Phoenix
Phoenix
Long Beach
Santa Ana
Torrance
Santa Maria
Irvine
Los Angeles
Sunnyvale
Burbank
San Rafael
San Diego
Irvine
Irvine
Irwindale
Irvine
Goleta
Concord
Vernon
Anaheim
Berkeley
Englewood
Lakewood
Boulder
State
AK
AL
AR
A2
AZ
AZ
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CO
CO
C-l
-------
LIST OF KNOWN FACILITIES
Table C-l. (continued)
Facility name
Acme United Corp.
Becton, Dickinson & Company
Critikon, Inc.
United States Surgical Corporation
Cryomedics, Inc.
Davis & Geek, Inc.
Delaware Dept. Of Agriculture
El DuPont
Cordis Corp.
Critikon, Inc.
Sterile Design, Inc.
Seamless Hospital Products Co.
Steridyne Corp,.
Kendall Company
C.R. Bard, Inc.
Micro-Biotrol, Inc.
Sterilization Services of Georgia
Univ. Of Hawaii Hamilton Library
Clinton Corn Processing Co.
Tone Brothers, Inc.
Parks Library
Abbott Laboratories
Abbott Laboratories
Travenol Laboratories, Inc.
Elgin Medical Corporation
Araclean Services, Inc.
Micro-Biotrol, Inc.
Medsteril, Inc.
Graham Center Archives
Parent company
Johnson & Johnson
American Cyanamid Company
Johnson & Johnson
ADM
American Hospital Supply
Wheaton College
City
Stratford
Canaan
Southington
North Haven
Trumbull
Danbury
Dover
Wilmington
Miami
Tampa
Tampa
Ocala
Riviera Beach
Augusta
Covington
Smyrna
Atlanta
Honolulu
Clinton
Des Moines
Ames
North Chicago
North Chicago
Round Lake
Elgin
LaGrange
Willowbrook
Mundelein
Wheaton
State
CT
CT
CT
CT
CT
CT
DE
DE
FL
FL
FL
FL
FL
GA
GA
GA
GA
HI
IA
IA
IA
IL
IL
IL
IL
IL
IL
IL
IL
C-2
-------
LIST OF KNOWN FACILITIES
Table C-l. (continued)
Facility name
Eli Lilly and Co.
Eli Lilly and Co.
Cook Inc.
Reynier's Germfree Building
Kendall Company
Charles River Laboratories, Inc.
Portex, Inc.
C.R. Bard, Inc.
El DuPont
Findley Research, Inc.
American Antiquarian Society
New Bedford Whaling Museum
Conservation Lab
First Church of Christ Scientist
Maryland Dept. Of Agriculture
Baltimore Spice
McCormick & Co., Inc.
BBL Microbiology Systems
Frederick Cancer Research Facility
The Jackson Laboratory
Charles River Laboratories, Inc.
General Spice, Inc.
Parke-Davis
The UpJohn Company
Sarns, Inc.
Tri-State Hospital Supply Corp.
The UpJohn Company
The UpJohn Company
Medtronic, Inc. Rice Creek Facility
Parent company
-
Old Sturbridge Village
Durkee Foods
Becton Dickinson
NCI
Warner-Lambert Co.
3MCo.
Medtronic, Inc.
City
Indianapolis
Indianapolis
Bloomington
Notre Dame
Franklin
Wilmington
Wilmington
Billerica
Billerica
Fall River
Worcester
New Bedford
Sturbridge
Boston
Annapolis
Garrison
Hunt Valley
Cockeysville
Frederick
Bar Harbor
Portage
Detroit
Rochester
Kalamazoo
Ann Arbor
Howell
Kalamazoo
Kalamazoo
Minneapolis
State
IN
IN
IN
IN
KY
MA
MA
MA
MA
MA
MA
MA
MA
MA
MD
MD
MD
MD
MD
ME
MI
MI
MI
MI
MI
MI
MI
MI
MN
C-3
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LIST OF KNOWN FACILITIES
Table C-l. (continued)
Facility name
Daig Corporation
SciMed Life Systems, Inc.
PRL
American Medical Systems, Inc.
A.D.T. Lab Industries, Inc.
Spicecraft, Inc.
Hollister, Inc.
Diagnostic Division
Monsanto Company
Midwest Sterilization Corp.
Flavorite Laboratories, Inc.
Travenol Laboratories, Inc.
NC Dept. Of Agriculture
Charles River Laboratories, Inc.
Abbott Laboratories
Abbott Laboratories
Arrow International
Edward Week and Company, Inc.
IV AC Corporation
Baltimore Spice
Concord Laboratories, Inc.
Millipore Corporation
Rutgers-Kilmer Facility
Meer Corporation
American Hoechst Corporation
E.R. Squibb & Sons
Leeming/Pacquin
1 Squibb Corporation
C.R. Bard, Inc.
'arent company
vledtronic. Inc.
Pfizer
Mallinckrodt, Inc.
American Hospital Supply
Durkee Foods
NJ Department of Agriculture
Squibb
Pfizer, Inc.
City
tfinnetonka
'lymouth
Coon Rapids
vlinnetonka
-akeville
Gerald
fCirksville
Maryland Hts
St. Louis
Cape Girardeau
Horn Lake
Cleveland
Raleigh
Raleigh
Laurinburg
Rocky Mount
Randleman
RTP
Creedmoor
Grand Forks
Keene
Jaffrey
New Brunswick
North Bergen
Somerville
North Brunswick
Parsippany
Lawrenceville
Murray Hill
State
MN
MN
MN
MN
MN
MO
MO
MO 1
MO I
MO
MS
MS
NC
NC
NC
NC
NC
NC
NC
ND
r.n
NJ
NJ
NJ
NJ
NJ
™
NJ |
C-4
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LIST OF KNOWN FACILITIES
Table C-l. (continued)
Facility name
Vemitron Medical Products
Ethicon, Inc.
Johnson & Johnson Products, Inc.
Johnson & Johnson Products, Inc.
Johnson & Johnson Products, Inc.
Overseas Spice Co.
Micro-Biotrol, Inc.
ETO Sterilization, Inc.
N. Am. Sterilization & Package Co
Paeon Manufacturing Corporation
Archives & History Center
Ethicon, Inc.
Baltimore Spice
Charles River Laboratories, Inc.
direrle Laboratories
Bristol-Myers Company
G.C. Hanford Manufacturing Co.
H.W. Andersen Products
MCC Division
Castle
Deknatel Division
Ethox Corp.
Chesebrough-Pond' s
Morris J. Golombeck, Inc.
Sterilization Tech. Services, Inc.
Medical Sterilization, Inc.
Ben Venue Laboratories, Inc.
Medex, Inc.
Dravon Medical, Inc.
Parent company
Johnson & Johnson
Johnson & Johnson
Johnson & Johnson
Johnson & Johnson
United Methodist Church
Johnson & Johnson
Durkee Foods
American Cyanamid Company
Mallmckrodt. Inc.
Sybron Corp.
Pfizer Hospital Products Group
Sherwood Medical Company
City
Carlstadt
Somerville
New Brunswick
New Brunswick
New Brunswick
Newark
Boundbrook
Linden
Sparta
South Planfield
Madison
Albuquerque
Sparks
Kingston
Pearl River
East Syracuse
Syracuse
Oyster Bay
North Argyle
Rochester
Queens Village
Buffalo
Sherburne
Brooklyn
Rush
Syosset
Bedford
Milliard
Clackamas
State
NJ
NJ
NJ
NJ
NJ
NJ
NJ
NJ
NJ
NJ
NJ
NM
NV
NY
NY
NY
NY
NY
NY
NY
NY
NY
NY
NY
NY
NY
OH
OH
OR
C-5
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LIST OF KNOWN FACILITIES
Table C-l. (continued)
Facility name
Durkee Famous Foods
Merck Sharp & Dohme
Sterling Drug, Inc.
Wyeth Laboratories, Inc.
Wyeth Laboratories, Inc.
The West Co. Jersey Shore Facility
Burron Medical, Inc.
Sharpoint, Inc.
Araclean Services, Inc.
Squibb Manufacturing, Inc.
Lederle Parenteral, Inc.
Abbott Laboratories
Travenol Laboratories, Inc.
Travenol Laboratories, Inc.
Travenol Laboratories, Inc.
Davis & Geek, Inc.
Millipore Cidra, Inc.
MED REL, Inc.
C.R. Bard, Inc.
American V. Mueller
American Edwards Laboratories
U.S. Surgical Corporation
Medtronic Puerto Rico, Inc.
C.R. Bard, Inc.
Ethide Laboratories, Inc.
Travenol Laboratories, Inc.
Smith and Nephew
3M
Tennessee Dept. Of Agriculture
Parent company
Durkee Foods
American Cyanamid Company
American Hospital Supply
American Hospital Supply
American Hospital Supply
American Cyanamid Company
Medtronic, Inc.
American Hospital Supply
American Hospital Supply
Medtronic, Inc.
American Hospital Supply
City
Bethlehem
West Point
Myerstown
West Chester
Marietta
Jersey Shore
Allentown
Sinking Spring
Scranton
Humacao
Carolina
Barceloneta
Aguada
Aibonito
Jayuya
Manati
Cidra
Humacao
Las Piedras
Anasco
Anasco
Ponce
Villalba
Cranston
Coventry
Kingstree
Columbia
Brookings
Nashville
State
PA
PA
PA
PA
PA
PA
PA
PA
PA
PR
PR
PR
PR
PR
PR
PR
PR
PR
PR
PR
PR
PR
PR
RI
RI
SC
SC
SD
TN
C-6
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LIST OF KNOWN FACILITIES
Table C-l. (continued)
Facility name
American Pharmaseal
Sterilization Services of Tennessee
F •„. Pak Chili Company, Inc.
Baltimore Spice
Alcon Laboratories, Inc.
Sherwood Medical Company
Alva Medical
Argon Medical Corporation
U.S. Clinical Products, Inc.
Ethicon, Inc.
Seamless Hospital Products Co.
Fort Belknap Archives, Inc.
Permian Basin Petroleum Museum
Abbott Laboratories
Dept. of Ag & Consumer Services
Old Mansion, Inc.
Sterile Concepts, Inc.
Lukens Corporation
Gambro, Inc.
Crescent Foods
Action Medical Systems, Inc.
Foran Spice Company
West Virginia Dept. Of Agriculture
Parent company
American Hospital Supply
Durkee Foods
Mallinckrodt, Inc.
Squibb
Johnson & Johnson
Comonwealth of Virginia
City
Johnson City
Memphis
Fabens
Anthony
Forth Worth
Commerce
Angleton
Athens
Richardson
San Angelo
El Paso
Graham
Midland
Salt Lake City
Richmond
Richmond
Richmond
Lynchburg
Newport News
Seattle
Kirkland
Oak Creek
Charleston
State
TN
TN
TX
TX
TX
TX
TX
TX
TX
TX
TX
TX
TX
UT
VA
VA
VA
VA
VA
WA
WA
WI
wv
C-7
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TECHNICAL REPORT DATA
(Please read Instructions on reverse before completing)
I REPORT NO
EPA 456/R-97-004
3 RECIPIENTS ACCESSION NO
•» TITLE AND SUBTITLE
Ethylene Oxide Commercial Sterilization and Fumigation Operations
NESHAP Implementation Document
5 REPORT DATE
September 1997
6 PERFORMING ORGANIZATION CODE
7 AL'THOR(S)
David G. Hearne
Susan J. Shrager
8 PERFORMING ORGANIZATION REPORT NO
4203-31-02
9 PERFORMING ORGANIZATION NAME AND ADDRESS
Midwest Research Institute
5520 Dillard Road, Suite 100
Cary, NC 27511
10 PROGRAM ELEMENT NO
11 CONTRACTORANT NO
68-D3-0031.WA31
12 SPONSORING AGENCY NAME AND ADDRESS
Office of Air Quality Planning and Standards
Office of Air and Radiation
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
13 TYPE OF REPORT AND PERIOD COVERED
Final
14 SPONSORING AGENCY CODE
EPA/200/04
15 SUPPLEMENTARY NOTES
Project Officer is Gilbert Wood. Mail Drop 12, (919) 541-5272
16 ABSTRACT
National emissions standards to control emissions of HAP from new and existing ethylene oxide commercial
sterilization and fumigation operations were promulgated in 1994. This document contains information to assist State
and local air pollution control agencies as well as the regulated community in the implementation of these standards.
This document provides a common sense summary of the NESHAP requirements, describes the most frequently
encountered emissions points, and describes the most commonly used emissions control devices. Sample inspection
sheets are also provided as is a bibliography of Federal, State and private sources of additional information related to
these standards.
KEY WORDS AND DOCUMENT ANALYSIS
DESCRIPTORS
b IDENTIFIERS/OPEN ENDED TERMS
c COSAT1 Field/Group
Air pollution
Air pollution control
National emissions standards
Hazardous air pollutants
Ethylene oxide
Commercial sterilization and fumigation industry
Implementation guidance
Air pollution control
Ethylene oxide
Stationary sources
13B
18 DISTRIBUTION STATEMENT
19 SECURITY CLASS IRepon)
Unclassified
21 NO OF PAGES
70
Unlimited
20 SECURITY CLASS lfage>
Unclassified
22 PRICE
EPA Form 1220-1 (R«v. 4-77) PREVIOUS EDITION IS OBSOLETE
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