NORTHERN SONOMA COUNTY AIR POLLUTION CONTROL DISTRICT

REGULATION 3 - SECTION 5

RULE 5-100 - TITLE:

Airborne Toxic Control Measure for Ethylene Oxide Emissions From Sterilizers and Aerators

This regulation is adopted pursuant to the provisions of Section 93102, Titles 17 and 26, California Code of Regulations (CCR).

RULE 5-110 - PURPOSE:
On November 12, 1987, pursuant to Section 39662 of the Health and Safety Code, the Air Resources Board (ARB) identified ethylene oxide as a toxic air contaminant for which there is not sufficient available scientific evidence to support identification of a threshold exposure level below which no significant adverse health effects are anticipated (see Title 17, California Code of Regulations, Section 93000). This airborne toxic control measure will reduce ethylene oxide emission from sterilizers and aerators and cancer incidence to the lowest level achievable through application of best available control technology at operations subject to this measure.

RULE 5-120 - APPLICABILITY:
This regulation shall apply to any person who owns, operates, or who plans to build, own, or operate, a sterilizer or aerator.

RULE 5-130 - DEFINITIONS:
For the purposes of this regulation, the following definitions shall apply:

  1. "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 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. "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.

  8. "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

       
  9. "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.

  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 an 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.

  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:

    1. 30 ppm for sterilant gas composed of 12% ethylene oxide/88% chlorofluorocarbon-12 by weight; and

    2. 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. "Sterilant gas" means ethylene oxide or any combination of ethylene oxide and (an)other gas(es) used in a sterilizer.

  17. "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.

  18. "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.

  19. "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.

  20. "Sterilizer exhaust stream" is all ethylene oxide- contaminated air which is intentionally removed from the sterilizer during the sterilizer cycle.

  21. "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.


RULE 5-200 - PERMITS:

  1. The owner or operator of any new or existing sterilizer/aerator which emits more than 25 pounds per year shall file an application for an Authority to Construct with the District, as provided in Regulation 1, Rule 200.

  2. The owner or operator of an existing sterilizer/aerator which emits more than 25 pounds per year shall file an application for authority to construct not later than January 20, 1992.

(2) The applicant shall pay the fees as specified in Rule 5-300 - Fees.


RULE 5-300 - FEES:

  1. Every applicant for an Authority to Construct or holder of a permit to operate a sterilizer/aerator shall pay an initial fee or permit renewal fee or other fees as provided in Regulation 1, Rule 300, including the annual CPI fee adjustment factor, using as a basis the schedule of fees in Regulation 3, Rule 5-310.

  2. The applicant for an Authority to Construct shall pay the initial fee at the time of filing of the application.

  3. Permit renewal fees not payed in a timely fashion as provided in Regulation 1, Rule 300 are subject to the penalty provisions in Regulation 1, Rule 300(i).


RULE 4-310 - FEE SCHEDULE:
The owner or operator of any sterilizer or aerator, for which an Authority to Construct or Permit to Operate is required, shall be assessed a permit fee in accordance with Regulation 1, Rule 300, based on this schedule:

CATEGORY

INITIAL EE

ANNUAL RENEWAL

Sterilizer/Aerator (less 600 lb/yr)

$ 175.00

$ 85.00

Sterilizer/Aerator (more 599 lb/yr)

$ 250.00

$ 125.00


RULE 5-400 - CONTROL OF ETHYLENE OXIDE EMISSIONS FROM STERILIZERS/AERATORS:
  1. Notification:
    Within 30 days after adoption of this rule by the District, every Owner/Operator of a ethylene oxide sterilizer or aerator shall provide the following information to the District:

    1. Owner/Operator of the facility, and

    2. location of the facility, and

    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.
  2. 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:

    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.

  3. 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:
    1. there is no discharge of sterilizer exhaust vacuum pump working fluid to wastewater streams, and

    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

    3. all of the control requirements shown in Table I below for the applicable control category are met; and

    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.

    TABLE I
    Control and Compliance Requirements

     CONTROL CATEGORY  REQUIREMENTS
       (A)  (B)  (C)  (D)
    Facility-wide Pounds of Ethylene Oxide Used per Year Exhaust Streams to be Controlled Exhaust Streams to be Tested Control Efficiency (%)  Date of Compliance (months)
    Less than or equal to 25  None  None  None  None
    More than 25 and less than or equal to 600   Sterilizer  Sterilizer  99.0  24
    More than 600 and less than or equal to 5,000  Sterilizer
    Aerator
    Back-draft Valve
    Sterilizer
    Aerator
    99.9
    95.0
    N/A
    *
    18 
     More than 5,000 Sterilizer Aerator
    Sterilizer
    Door Hood Back-draft Valve
    Sterilizer Aerator  99.9
    99.0
    N/A
    *
    N/A
    * 
    12 
    Aeration Only Facilities  Aerator  Aerator  95.0  18
    *Not Applicable
  4. Exemptions:

    1. The requirements set forth in subsection c 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.

    2. The District hearing board may grant an emergency variance from items a and c in Table I of subsection c, 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 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 section and any applicable District rule 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.

  5. Compliance Schedule:
    The facility shall be in compliance with all provisions specified in subsection c. Requirements, no later than the date specified in column d of Table I.
    1. For the purpose of determining compliance with the control efficiency requirement shown in column c of Table I, subsection c, 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.

  6. 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 c. If this compliance option is chosen, the owner or operator shall:
    1. within 3 months of the date of District adoption of regulations enacting this control measure, comply with the requirements shown in subsections c1 and c2 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

    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 subsection c3, c4 and c5, and

    3. within 18 months of the date of District adoption of regulations enacting this control measure, do one of the following:
      1. demonstrate to the satisfaction of the District that operation of all sterilizers and aerators at the facility has been permanently discontinued; or

      2. demonstrate compliance with the requirements of subsections c3, c4, and c5, in accordance with the source testing provisions set forth in Rule 5-500.


RULE 5-500 - TESTING METHOD:
Source testing shall be conducted in accordance with ARB Test Methods and the method evaluations cited therein or an acceptable source test method approved by the Executive Officer of the Air Resources Board. Specific testing requirements to apply the regulatory limits of this rule are as follows:

  1. (a) To determine the "control efficiency" requirements of this regulation, ethylene oxide (EtO) mass or concentration reduction efficiency of a control device, shall be 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      
    The procedures that will be utilized during the source testing are as follows:

    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.

    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.

    3. The inlet and outlet of the control device shall be sampled simultaneously during testing to measure the control efficiency.

    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.

    5. There shall be no dilution of the air stream between the inlet and outlet test points during testing.

  2. To determine the "leak free" requirements of this regulation the 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 shall be used. 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.