FEATHER RIVER AIR QUALITY MANAGEMENT DISTRICT
RULE 11.4 - AIR TOXIC CONTROL MEASURE FOR STERILIZERS AND AERATORS
A. PURPOSE
(Adopted 3/2/92)
To limit the emissions of ethylene oxide to the atmosphere from sterilizer and aerator operations.
B. DEFINITIONS
(Adopted 3/2/92)
For the purposes of this Rule, the following definitions shall apply:
Acute Care Facility: 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 hospital.
Aeration: 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.
Aeration-only Facility: a facility which performs aeration on materials which have been sterilized with
ethylene oxide at another facility.
Aerator: any equipment or space in which material previously sterilized with ethylene oxide is 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: all ethylene oxide-contaminated air which is emitted from an aerator.
Back-draft Valve Exhaust Stream: 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: 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: 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:
Date of Compliance: the time from District adoption of regulations enacting this control measure (3-2-92)
until a facility must be in compliance with specific requirements of this Rule.
Ethylene Oxide (EtO): the substance identified as a toxic air contaminant by the Air Resources Board in
17 CCR, Section 93000.
Facility: 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: the total pounds of ethylene oxide used in all of
the sterilizers at a facility during a one-year period.
Leak-Free: 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:
Local Medical Emergency: 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: ethylene oxide or any combination of ethylene oxide and other gases used in a sterilizer.
Sterilizer: 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: the process which begins when ethylene oxide is introduced into the sterilizer, including
the initial purge or evacuation after sterilization and subsequent air washes, and ending after evacuation of the
final air wash.
Sterilizer Door Hood Exhaust Stream: 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: all ethylene oxide-contaminated air which is intentionally removed from the sterilizer
during the sterilizer cycle.
Sterilizer Exhaust Vacuum Pump: 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.
C. APPLICABILITY
(Adopted 3/2/92)
Any person who owns or operates a sterilizer or an aerator must comply with this regulation.
D. NOTIFICATION
(Adopted 3/2/92)
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:
D.1 the name of the owner and operator of the facility; and
D.2 the location of the facility; and
D.3 the number of sterilizers and aerators at the facility; and
D.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.
The District may exempt a source from this requirement if the District maintains current equivalent information
on the source.
E. REPORTING
(Adopted 3/2/92)
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:
E.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
E.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.
F. REQUIREMENTS
(Adopted 3/2/92)
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:
F.1 there is no discharge of sterilizer exhaust vacuum pump working fluid to waste water streams; and
F.2 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
F.3 all of the control requirements shown in Table I below for the applicable control category are met; and
F.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
F.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.
G. EXEMPTIONS
(Adopted 3/2/92)
G.1 The requirements set forth in Section F. 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.
G.2 The District Hearing Board may grant an emergency variance from items (a) and (c) in Table I of Section F. to a person who owns or operates an acute care facility, if response to a local medical emergency requires increased operation of a sterilizer or 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 shall be granted in accordance with this rule and any applicable
District rules regarding the issuance 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 medical emergency.
H. COMPLIANCE
(Adopted 3/2/92)
The facility shall be in compliance with all provisions specified in Section F. 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, Section F., 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.
I. ALTERNATE COMPLIANCE DATE
(Adopted 3/2/92)
The owner or operator of any facility which uses more than 600 pounds of ethylene oxide per year may choose an
alternate compliance option which addresses the date for compliance with the requirements of Section F. If an alternate
compliance option is chosen, the owner or operator shall:
I.1 within 3 months of the date of District adoption of regulations enacting this control measure, comply with the requirements shown in Subsection F.l and F.2 and demonstrate a control efficiency of 99.9% for the sterilizer exhaust stream, in accordance with the
source testing requirements set forth in Section J.; and
I.2 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 F.3, F.4, and F.5; and
I3. within 18 months of the date of District adoption of regulations enacting this control measure, do one of the following:
- demonstrate to the satisfaction of the District that operation of all sterilizers and aerators at the facility has been permanently discontinued; or
- demonstrate compliance with the requirements of Subsections F.3, F.4, and F.5, in accordance with the source testing provisions set forth in Section J below.
J. SOURCE TESTING
(Adopted 3/2/92)
Source testing shall be conducted according to ARB Test Method 431 (Title 17, CCR, Section 94143) and the method
evaluations cited therein or an acceptable source test method approved by the Executive Officer of the Air Resources
Board. Specific requirements for application are given below:
J.1 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.
J.2 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.
J.3 The inlet and outlet of the control device shall be sampled simultaneously during testing to measure the control efficiency.
J.4 The efficiency of each control device shall be determined under conditions of maximum ethylene oxide mass flow to the device, under normal operating conditions. To 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.
J.5 There shall be no dilution of the air stream between the inlet and outlet test points during testing.
