vices as a general acute care hospital (as defined in title 22, CCR, section 70005), or any military hospital.
(2) Aeration is the process during which residual ethylene oxide dissipates, whether under forced air
flow, natural or mechanically assisted convection, or other means, from previously sterilized materials after the
sterilizer cycle is complete.
(3) Aeration-only facility means a facility which performs aeration on materials which have been
sterilized with ethylene oxide at another facility.
(4) 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.
(5) Aerator exhaust stream means all ethylene oxide-contaminated air which is emitted from an aerator.
(6) 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.
(7) Commercial sterilizer means any facility which as its principal business sterilizes products or
equipment manufactured elsewhere, or a facility which sterilizes products or equipment it manufactures. A
commercial sterilizer is also a non-medical facility that sterilizes items used in conducting its business.
(8) 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.
(9) Control efficiency is the ethylene oxide (EtO) mass or concentration reduction efficiency of a control
device, as measured with ARB Test Method 431 (title 17, CCR, section 94143) according to the source testing
requirements herein, and expressed as a percentage calculated across the control device as follows:
EtO in - EtO out x 100 = % Control Efficiency
EtO in
(10) District means the local air pollution control district or air quality management district.
(11) Ethylene oxide (EtO) is the substance identified as a toxic air contaminant by the Air Resources
Board in 17 CCR section 93000.
(12) 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 of land.
(13) 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 a one-year period.
(14) 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. (15) 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.
(16) Non-commercial sterilizer means a facility other than a commercial facility at which ethylene oxide
is used for sterilizing or fumigation, or at which aeration occurs.
(17) Sterilant gas means ethylene oxide or any combination of ethylene oxide and (an)other gas(es) used
in a sterilizer.
(18) 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.
(19) 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, steam or other washes, and ends
after evacuation of the final wash.
(20) 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.
(21) Sterilizer exhaust stream is all ethylene oxide-contaminated air which is intentionally removed from
the sterilizer during the sterilizer cycle.
(22) 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. Effective January 28, 1999, any person who owns or operates any non-commercial
sterilizer or aerator or any person who owns or operates a commercial sterilizer or an aerator that uses less than
2,000 pounds of EtO per consecutive 12-month period after December 6, 1996, must comply with Part I of this
regulation, section 93108.
(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:
(1) the name(s) of the owner and operator of the facility;
(2) the location of the facility;
(3) the number of sterilizers and aerators at the facility; and
(4) 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 current 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. Commercial sterilizers shall maintain copies of these reports on
site for 5 years. This report shall include one of the following, as determined by the district:
(1) 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
(2) 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 unless all of the following requirements are
satisfied:
(1) the exhaust systems and EtO supply system including, but not limited to, any piping, ducting, fittings,
valves, or flanges, through which ethylene oxide-contaminated air is conveyed between the sterilizer, aerator
and the control device shall be leak-free;
(2) all of the control requirements shown in Table I below for the applicable control category are met;
(3) the average concentration of ethylene oxide shall not exceed:
(A) 30 mg/ml in any liquid discharge associated with the sterilization cycle; and
(B) 10 mg/ml in any liquid discharge associated with the aeration cycle for those facilities where Table I
requires aeration control; Table I
Control and Compliance Requirements
Control Category
Requirements
(a)
(b)
(c)
Facility-wide
Exhaust
Exhaust
Pounds of
Streams
Streams
Control
Ethylene Oxide
to be
to be
Efficiency
Used Annually
Controlled
Tested
(%)
Less than or
None
None
None
equal to 25
More than 25
Sterilizer
Sterilizer
99.0
and less than or
equal to 600
More than 600
Sterilizer
Sterilizer
99.9
and less than or
Aerator
Aerator
95.0
equal to 5,000
Sterilizer/Aerator
Sterilizer/Aerator
99.7
Back-draft Valve
N/A*
More than 5,000
Sterilizer
Sterilizer
99.9
Aerator
Aerator
99.0
Sterilizer Door
N/A*
Hood &
Back-draft Valve
N/A*
Aeration-only
Aerator
Aerator
95.0
Facilities
* Not Applicable
(4) 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
(5) 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.
(f) Exemptions:
(1) The requirements set forth in subsection (e) above do not apply to any facility which treats materials in
a sterilizer and