Ethylene Oxide Commercial Sterilization and Fumigation Operations Neshap Implementation Document Updated March 2004


        United States
        Environmental Protection
        Agency
Office of Air Quality
Planning and Standards
Research Triangle Park, NC 27711
EPA-456/R-97-004
September 1997
(Updated March 2004)
        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
                   March 2004

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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 in its original form 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.  This modified version is only available as an electronic file.
                                           in

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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	       2-1
     2.1  COMPLIANCE DATES  	       2-1
     2.2  EMISSIONS REDUCTIONS AND LIMITS  	       2-2
     2.3  INITIAL PERFORMANCE TESTING	       2-2
     2.4  ONGOING MONITORING 	       2-2
     2.5  RECORDKEEPING 	       2-3
     2.6  REPORTING	       2-3

CHAPTER 3. APPLICABILITY OF THE REGULATION 	       3-1
     3.1  APPLICABILITY 	       3-1
     3.2  EXEMPTIONS  	       3-1
     3.3  SOURCE DESCRIPTION	       3-1
         3.3.1  Equipment	        3-3
         3.3.2  Sterilant Gases  	       3-3
         3.3.3  Sterilization Cycle  	       3-3
         3.3.4  Emission Sources  	       3-6

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	       4-3

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	       6-2
         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
                                       IV

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                          TABLE OF CONTENTS (continued)
                                                                               Page

     6.2  REPORTING	       6-3
         6.2.1  Initial Notification  	       6-3
         6.2.2  Notification of Construction/Reconstruction 	       6-3
         6.2.3  Notification of Performance Test and CMS Performance Evaluation 	       6-4
         6.2.4  Test Plans  	       6-4
         6.2.5  Notification of Compliance Status 	       6-4
         6.2.6  Deviations and CMS Performance Report/Summary Report	       6-5

CHAPTER 7. INSPECTION PROCEDURES	       7-1

CHAPTER 8. COMMONLY ASKED QUESTIONS AND ANSWERS	       8-1

CHAPTER 9. AVAILABLE IMPLEMENTATION MATERIALS 	       9-1

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                                  LIST OF FIGURES

No.                                                                              Page

3-1.    Applicability flowchart  	      3-2
3-2.    Schematic of an ethylene oxide gas sterilizer 	      3-4
3-3.    Schematic of emission sources at commercial sterilization facilities 	      3-7
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	      3-8
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
                                          VI

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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 100 EO
commercial sterilization and fumigation sources exist in the United States. 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.
Sterilization sources using less than 1 ton are not subject to the emission standards, but are
subject to the recordkeeping requirements of the regulation.
In general, the regulation specifies:
S Compliance dates

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SUMMARY OF THE REGULATION
becomes subject to the emissions standards in Section 63.362(c), immediately upon becoming
subject to the emission standards.
- Aeration room vents subject to the emissions standards in Section 63.362 with an initial
startup date before December 6, 2000, no later than December 6, 2000.
- Aeration room vents subject to the emissions standards in Section 63.362 with an initial
startup date on or after December 6, 2000, immediately upon initial startup of the source.
- Aeration room vents at sources using less than 10 tons that increase their ethylene oxide
usage after December 6, 2000, such that the aeration room vents become subject to the emissions
standards in Section 63.362, immediately upon becoming subject to the emission standards.
- New sources (i.e., initial startup date on or after December 6, 1998) that are subject to
emission standards must be in compliance with the regulation as stated in the previous
paragraphs. Consult your enforcing agency if you have any questions regarding the applicable
compliance date
for your source.
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 tons of EO per year,
99 percent reduction; and
S 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.
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
2-2
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SUMMARY OF THE REGULATION
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 to maintain the minimum temperature based on the manufacturer's design. In
addition, if using a catalytic oxidizer, the source must periodically replace the catalyst or annually
test the control device performance and, if necessary, restore the catalyst. For any type of
emission reduction technique used to control emissions for ARV, the source may monitor the EO
concentration once per hour.
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 deviations data (i.e., deviations
from any emission limitation, work practice, or operating limit). 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 of 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
3.1 APPLICABILITY
The regulation applies to 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 Figure 3-1 flowchart may be
used to determine the applicability of the requirements of the regulation to a particular source.
3.2 EXEMPTIONS
The regulation specifically exempts certain types of sources. These sources are:
S Beehive fumigators;
S Research and laboratory facilities, as defined in section 112(c)(7) of the CAA; and
S 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
sterilization Chamber Vent > 907
kg (> 1 ton) per yr
99% Reduction - See Sec
63.362(C)
Aeration Room Vent >
9.070 kg (> 10 tons) peryr
See Sec. 63 362(d)
99% Reduction
Performance Test
See Sec. 63.365(b)(1)
Performance
Test
See Sec.
63 365(d)(2)
Performance
Test - See Sec.
63.365(c)(1)
and (c)(2)
Compliance
See Sec.
63.363(b)
Complinace
See Sec.
63.363(e)
Compliance
See Sec.
63.363(c)(3)
Compliance
See Sec.
63.363(e)
Compliance
See Sec.
63.363(c)(2)
AwS

Mon.
[EG]

C/TO

Mon.
SLTL

Mon.
T
Other
Device

Ongoing Compliance Status Reports
Summary Report and/or Deviations
Every 6 Months

Key to Control Devices: AwS - Acid Water Scrubber; Key to Parameters: [EG] -Ethylene Glycol Cone.:

C/TO - Catalytic/Thermal Oxidizer; SLTL - Scubber Liquor Tank Level; T - Temp.;

Other Device - Other Device. [EO] - Ethylene Oxide Cone.

Figure 3-1. Applicability Flowchart
3-2
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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 be 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 3-2. 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.
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.
3-3
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APPLICABILITY OF THE REGULATION
GAS LINE LIQUIFIED GAS
FILTER TO VAPORIZER
GAS
SOURCE
CONTROL
PANEL
VAPORIZER
DOOR
Figure 3-2. Schematic of a gas sterilizer.
(Courtesy of Union Carbide Corporation, Linde Division.)
3-4
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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 four to six 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 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
3-5
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APPLICABILITY OF THE REGULATION
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
off gassing.
3.3.4 Emission Sources
The four principal sources of EO emissions from sterilization/fumigation processes are the
following:
S Sterilizer vent(s) (i.e., the vent on the vacuum pump gas/liquid separator);
S Sterilization chamber vacuum pump drain;
S Chamber exhaust vent(s); and
S Aeration room vent(s).
A schematic of these emission sources is shown in Figure 3-3.
3-6
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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 3-3. Schematic of emission sources at commercial sterilization facilities.
3-7
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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 with 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
No controls required; minimal recordkeeping
requirements apply.
99% emission
reduction
99% emission
reduction
No control
1 ppmv maximum
outlet concentration
-OR--
99% emission
reduction
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
H20/H2SOl/ETHVLENE GLYCOL SOLUTION
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
V
STEAM
9 PSIG
TO ATMOSPHERE
Figure 4-2. Schematic of a typical 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. Ethylene 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
FLARE
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:
S Initial performance testing
S Site-specific operating parameters setting
S 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. For sources with an initial startup date of December 6, 1998 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
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
Minimum temperature during initial
performance test
-AND--
For catalytic oxidizer, perform work practice
§ 63.365(e)(l)
§ 63.365(e)(2)
Based on manufacturer's
design
Aeration Room Vent (ARV) Standard
Catalytic or Thermal
oxidizer
1 . Minimum temperature during initial
performance test
--AND-
For catalytic oxidizer, perform work practice
-OR--
2. Outlet total EO concentration
Based on manufacturer's
design
§63.365(c)(l)
5-2
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DEMONSTRATING COMPLIANCE
must submit to the Administrator or appropriate enforcement agency their own recommendations
for operating parameters to be established and monitored to demonstrate continuous compliance.
Based on this information, the Administrator or enforcement agency will determine the operating
parameter(s) to be measured during the performance test. Using the methods approved in section
63.365(g) of the rule, facilities must determine site-specific operating limit(s) for the operating
parameters approved by the Administrator.
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 each emission limitation (including any operating limit) or work
practice required, except during periods of startup, shutdown, and malfunction. 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 and
5-3 summarize the ongoing monitoring requirements associated with the sterilization chamber vent
standard, and aeration room vent standard, respectively. Each of these tables includes the
equipment specifications and the monitoring frequency, as well as indicators of a deviation of the
standard for the various air pollution control systems and strategies that may be used.
If using a catalytic oxidizer, the following work practices apply: (1) Once per year after the
initial compliance test, conduct a performance test during routine operations with product in the
chamber using procedures in section 63.365(b) or (d) as appropriate. If percent efficiency is less
than 99 percent, restore catalyst as soon as practicable but no later than 180 days after the
performance test; or (2) Once per year after the initial compliance test, analyze ethylene oxide
concentration data from section 63.364(e) or a CEMS and restore the catalyst as soon as practicable
but no later than 180 days after data analysis; or (3) Every 5 years, beginning 5 years after the
initial compliance test (or by December 6, 2002, whichever is later), replace the catalyst material.
5-3
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DEMONSTRATING COMPLIANCE