COLUSA COUNTY AIR POLLUTION CONTROL DISTRICT
California Air Resources Board
Ethylene Oxide Airborne Toxic Control Measure for
Sterilizers and Aerators
(a) Definitions. For the purposes of this section, the following definitions shall apply:
- "Acute care facility" means any facility currently licensed by the California Department of
Health Services as a general acute care hospital (as defined in Title 22, CCR, Section 70005), or any military
- "Aeration" is the process during which residual ethylene oxide dissipates which have been
sterilized with ethylene oxide at another facility.
- "Aeration-only facility" means a facility which performs aeration on materials which have
been sterilized with ethylene oxide at another facility.
- "Aerator" means any equipment or space in which materials previously sterilized with ethylene
oxide are placed or remain for the purpose of aeration. An aerator is not any equipment or space in which
materials that have previously undergone ethylene oxide sterilization and aeration can be handled, stored, and
transported in the same manner as similar materials that have not been sterilized with ethylene oxide.
- "Aerator exhaust stream" means all ethylene oxide-contaminated air which is emitted from an
- "Back-draft valve exhaust stream" is the air stream which results from collection of ethylene
oxide-contaminated air which may be removed from the sterilizer through a back-draft valve or rear chamber exhaust
system during unloading of the sterilized materials.
- "Control Device". means an article, machine, equipment, or contrivance which reduces the amount
of ethylene oxide between its inlet and outlet and which is sized, installed, operated, and maintained according
to good engineering practices, as determined by the district.
- "Control efficiency" is the ethylene oxide (EtO) mass or concentration reduction efficiency
of a control device, as measured with ARB Test Method 431 (Title, CCR, Section 94143) according to the source testing
requirements herein, and expressed as a percentage calculated across the control device as follows:
- "Date of compliance" means the time from district adoption of regulations enacting this control
measure until a facility must be in compliance with specific requirements of this rule.
- "District" means the local air pollution control district or air quality management district.
- "Ethylene oxide (Et0)" is the substance identified as a toxic air contaminant by the Air Resources
Board in 17 CCR< Section 93000.
- "Facility" means any entity or entities which: own or operate a sterilizer or aerator, are
owned or operated by the same person or persons, and are located on the same parcel or contiguous parcels.
- "Facility-wide pounds of ethylene oxide used per year" is the total pounds of ethylene oxide
used in all of the sterilizers at the facility during one-year period.
- "Leak-free" refers to that state which exists when the concentration of sterilant gas measured
1 cm. away from any portion of the exhaust system of a sterilizer or aerator, during conditions of maximum sterilant
gas mass flow, is less than:
(A) 30 ppm for sterilant gas composed of 12% ethylene oxide/
88% chlorofluorocarbon-12 by weight; and
(B) 10 ppm for other compositions of sterilant gas, as determined by ARB Test Method 21 (Title 17, CCR, Section
94124) using a portable flame ionization detector or a non-dispersive infrared analyzer, calibrated with methane,
or an acceptable alternative method or analytical instrument approved by the district. A chlorofluorocarbon-12
specific audible detector using a metal oxide semi-conductor sensor shall be considered an acceptable alternative
for exhaust systems carrying a sterilant gas mixture of ethylene oxide and chlorofluorocarbon-12.
- "Local medical emergency" means an unexpected occurrence in the area served by the acute care
facility resulting in a sudden increase in the amount of medical treatments which require a significant increase
in the operation of a sterilizer or aerator.
- "Sterilant gas" means ethylene oxide or any combination of ethylene oxide and (an) other gas(es)
used in a sterilizer.
- "Sterilizer" means any equipment in which ethylene oxide is used as a biocide to destroy bacteria,
viruses, fungi, and other unwanted organisms on materials. Equipment in which ethylene oxide is used to fumigate
foodstuffs is considered a sterilizer.
- "Sterilizer cycle" means the process which begins when ethylene oxide is introduced into the
sterilizer, includes the initial purge or evacuation after sterilization and subsequent air washes, and ends after
evacuation of the final air wash.
- "Sterilizer door hood exhaust stream" is the air stream which results from collection of fugitive
ethylene oxide emissions, by means of an existing hood over the sterilizer door, during the time that the sterilizer
door is open after the sterilizer cycle has been completed.
- "Sterilizer exhaust stream" is all ethylene oxide-contaminated air which is intentionally
removed from the sterilizer during the sterilizer cycle.
- "Sterilizer exhaust vacuum pump" means a device used to evacuate the sterilant gas during
the sterilizer cycle, including any associated heat exchanger. A sterilizer exhaust vacuum pump is not a
device used solely to evacuate a sterilizer prior to the introduction of ethylene oxide.
(b) Applicability. Any person who owns or operates a sterilizer or an aerator must comply with this regulation.
(c) Notification. Any person subject to this regulation must provide the district with the following
information, in writing, within 30 days of the date of district adoption:
- the name(s) of the owner and operator of the facility, and
- the location of the facility, and
- the number of sterilizers and aerators at the facility, and
- an estimate of the total pounds of ethylene oxide and sterilant gas used by the facility, in all sterilizers,
during the previous calendar year, as determined by a method approved by the district. A district may exempt a
source from this requirement if the district maintains currant equivalent information on the source.
(d) Reporting. Any person who owns or operates a sterilizer shall furnish a written report to the district
annually on the date specified by the district, or, at the district's discretion, shall maintain such a report
and make it available to the district upon request. This report shall include one of the following, as determined
by the district:
- the number of sterilizer cycles and the pounds of ethylene oxide used per cycle for each sterilizer during
the reporting period, as determined by a method approved by the district; or
- the total pounds of sterilant gas and the total pounds of ethylene oxide purchased, used, and returned in the
previous calendar year, as determined by a method approved by the district.
(e) Requirements. No person shall operate a sterilizer or aerator after the applicable date shown in
column (d), Table I, unless all of the following requirements are satisfied:
- there is no discharge of sterilizer exhaust vacuum pump working fluid to waste water streams, and
- the exhaust systems including, but not limited to, any piping, ducting, fittings, valves, or flanges, through
which ethylene oxide- contaminated air is conveyed from the sterilizer and aerator to the outlet of the control
device are leak-free, and
- all of the control requirements shown in Table I below for the applicable control category are met; and
- for facilities using more than 600 pounds of ethylene oxide per year, the back-draft valve is ducted to the
control device used to control the sterilizer exhaust stream or the aerator exhaust stream; and
- for facilities using more than 5,000 pounds of ethylene oxide per year, the sterilizer door hood exhaust stream
is ducted to the control device used to control the aerator exhaust stream.
CONTROL AND COMPLIANCE REQUIREMENTS
CONTROL CATEGORY REQUIREMENTS
Pounds of Ethylene Oxide
Used per year
to be Controlled
to be Tested
Control Efficiency (%)
Date of Compliance (months)
|less than or equal to 25
|more than 25 and less than or equal to 600
|more than 600 and less than or equal to 5,000
|more than 5,000
Sterilizer Door Hood
|* Not Applicable
- The requirements set forth in subsection (e) above do not apply to any facility which treats materials in a
sterilizer and which uses a total of 25 pounds or less of ethylene oxide per calendar year.
- The district hearing board may grant an emergency variance from items (a) and (c) in Table I of subsection
(e), Requirements, to a person who owns or operates an acute care facility if response to a local medical emergency
requires increased operation of a sterilizer aerator such that the requirements cannot be met.
The demonstrated need for such increased operation shall constitute "good cause" pursuant to Health and
Safety Code Section 42359.5. The emergency variance variance shall be granted in accordance with this section and
any applicable district rule regarding the issuance of of emergency variances for such occurrences, including the
requirement that the emergency variance shall not remain in effect longer than 30 days; however, the emergency
variance shall be granted only for the period of time during which increased operation of a sterilizer or aerator
is necessary to respond to the local emergency.
(g) Compliance. The facility shall be in compliance with all provisions specified in subsection (e),
Requirements, no later than the date specified in column (d) of Table I.
- For the purpose of determining compliance with the control efficiency requirement shown in column (c) of Table
I, subsection (e), if a reduction in the amount of ethylene oxide across the control device is demonstrated, but
the control efficiency cannot be affirmatively demonstrated because the concentration of ethylene oxide measured
in the outlet of the control device is below 0.2. parts per million ethylene oxide, the facility shall be considered
to be in compliance with this requirement.
(h) Alternate Compliance Date. The owner or operator of any facility which uses more than 600 pounds
of ethylene oxide per year may choose this alternate compliance option which addresses the date for compliance
with the requirements of subsection (e). If this compliance option is chosen, the owner or operator shall:
- within 3 months of the date of district adoption of regulations enacting this control measure, comply with
the requirements shown in sub sections (e) (1) and (e)(2) and demonstrate a control efficiency of 99.9% for the
sterilizer exhaust stream, in accordance with the source testing requirements set forth in subsection (i); and
- within 6 months of the date of district adoption of regulations enacting this control measure, submit to the
district a plan to discontinue operation of all sterilizers and aerators or comply with the district requirements
to submit a plan to comply with the requirements of subsections (e)(3), (e)(4), and (e)(5), and
- within 18 months of the date of district adoption of regulations enacting this control this control measure,
do one of the following:
(A) demonstrate to the satisfaction of the district that operation of all sterilizers and aerators at the facility
has been permanently discontinued; or
(B) demonstrate compliance with the requirements of subsections (e)(3), (e)(4), and (e)(5), in accordance with
the source testing provisions set forth in subsection (i), below.
(i) Source Testing. Source testing shall be conducted according to ARB Test Method 431 (Title 17, CCR,
Section 94123) and the method evaluations cited therein or an acceptable source test method approved by the Executive
Office of the Air Resources Board. Specific requirements for application are given below:
- The test on a control device for a sterilizer exhaust stream shall be run with a typical load, as approved
by the district, in the sterilizer.
- The test on a control device for an aerator exhaust stream shall be run with a typical load, as approved by
the district, in the aerator.
- The inlet and outlet of the control device shall be sampled simultaneously during testing to measure the control
- The efficiency of each control device shall be determined under conditions of maximum ethylene oxide mass flow
to the device, under normal operating conditions. The measure the control efficiency of the control device on the
sterilizer exhaust stream, sampling shall be done during the entire duration of the first sterilizer evacuation
after ethylene oxide has been introduced. To measure the control efficiency of the control device on an aerator
exhaust stream with a constant air flow, sampling shall be done during a period of at least 60 minutes, starting
15 minutes after aeration begins. To measure the control efficiency of the control device on an aerator exhaust
stream with a non-constant air flow, sampling shall be done during the entire duration of the first aerator evacuation
after aeration begins.
- There shall be no dilution of the air stream between the inlet and outlet test points during testing.