MOJAQMD RULE 1501 CONTROL OF ETHYLENE OXIDE EMISSIONS
LAST REVISED 09/23/91



RULE 1501

CONTROL OF ETHYLENE OXIDE EMISSIONS

(Adopted: September 23, 1991)

The purpose of this rule is to control emissions of ethylene oxide from sterilization operations.

(A) Definitions

  1. "Aeration" - A process during which residual ethylene oxide dissipates, whether under forced air flow, natural or mechanically assisted convection, or any other means, from previously sterilized materials after the sterilizer cycle is complete.

  2. "Aeration - only Facility" - A facility which performs aeration on materials which have been sterilized with ethylene oxide at another facility.

  3. "Aerator" - Any equipment or space in which materials previously sterilized with ethylene oxide are placed or remain for the purpose of aeration.

  4. "Aerator Exhaust Stream" - All ethylene oxide-contaminated air which is emitted from an aerator, including the ethylene oxide-contaminated air which may be removed from a sterilizer through a rear chamber exhaust system.

  5. "Commercial Facilities" - All ethylene oxide-using facilities except hospitals and medical facilities.
  6. "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:

  7. "Ethylene Oxide Sterilization Chamber" - A chamber using ethylene oxide, or a combination of ethylene oxide and CFC-12 or other diluents, to destroy bacteria and viruses on medical products, food products, containers, or other materials.

  8. "Existing Facility" - A facility operating a sterilizer or aerator which was installed and operating before September 23, 1991.

  9. "Facility" - Means any property, real or personal, which incorporate one or more plants, processes, process lines, production units, or pieces of equipment, all being operated or maintained by a person as part of an identifiable business on continuous or adjacent property.

  10. "Hospital Sterilizer" - A sterilizer located at a hospital, medical clinic, dental clinic, veterinary clinic, or any other type of medical facility.

  11. "Leak-free" - Refers to that state which exists when the concentration of sterilant gas measured 1 centimeter 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 ppm, as determined by ARB Test Method 21 (Title 17, CCR, Section 94124) using a portable flame ionization detector calibrated with methane, or an equivalent method approved by the District.

  12. "Sterilization Cycle" - 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.

  13. "Sterilizer Exhaust Stream" - All ethylene oxide-contaminated air which is intentionally removed from the sterilizer during the sterilizer cycle. Ethylene oxide-contaminated air may also be removed from the sterilizer through a back-draft valve or rear chamber exhaust system during unloading of the sterilized materials.

  14. "Sterilant Gas" - Ethylene oxide or any combination of ethylene oxide and other gas(es) used in a sterilizer.

  15. "Vacuum Pump" - A pump used to evacuate the sterilant gas during the sterilizer cycle, including any associated heat exchanger.

(B) Standards

  1. Commercial and Hospital Sterilizers

  2. A person shall not operate an ethylene oxide sterilization chamber after the adoption date of this Rule unless the sterilizer and aerator exhaust stream emissions are reduced to less than the following levels by a District approved control device which is sized, installed, operated, and maintained in accordance with accepted engineering practices:

    (a) If the facility-wide usage of ethylene oxide is at least 25 pounds per year but 600 pounds per year, the sterilizer exhaust emissions shall be reduced by at least 99% (by weight).

    (b) If the facility-wide usage of ethylene oxide is more than 600 pounds per year and less than or equal to 5,000 pounds per year, then the sterilizer exhaust stream emissions must be reduced by at least 99.9% (by weight) from sterilizers and by at least 95% (by weight) from aerators.

    (c) If the facility-wide usage of ethylene oxide is more than 5,000 pounds per year, then the sterilizer exhaust stream emissions shall be reduced by at least 99.9% (by weight) and any sterilizer door hood exhaust stream shall be ducted to the control device used to control the aerator exhaust stream emissions by at least 99% (by weight).

  3. Vacuum Pump

  4. A person shall not operate an ethylene oxide sterilization chamber unless the vacuum pump is of a recirculating design, or the chamber evacuation is otherwise designed such that no ethylene oxide is released in the wastewater stream.

  5. Reporting Limit

  6. For the purpose of determining compliance with the control efficiency requirements of Section (B)(1) and (B)(2) of this Rule, if a reduction in the amount of ethylene oxide across the control device is sampled, and the concentration of ethylene oxide measured in the outlet of the control device is below 0.2 ppm, the facility shall be considered to be in compliance with this requirement.

  7. Continuous Control

  8. Any sterilizer exhaust stream or aerator exhaust stream subject to control efficiency requirements in Sections (B)(1) or (B)(2) shall be continuously vented to, and shall not bypass, the control device.

  9. Leak-free Operation

  10. A person shall not operate an ethylene oxide sterilization chamber or aerator unless the entire exhaust system, including, but not limited to, any piping, ducting, fittings, valves, or flanges, through which ethylene oxide-contaminated air is conveyed, is leak-free.



(C) Recordkeeping

  1. Operations Log

  2. Any person subject to this Rule shall maintain an operations log which notes the date and time of each sterilization operation cycle and the quantity of EtO and/or sterilant gas used. The log will include the District's designated company number, facility number and permit to operate number(s).

  3. Purchases

  4. Any person subject to this Rule shall maintain records of all purchases of ethylene oxide and CFC-12.

  5. Maintenance of Equipment

  6. Any person subject to this Rule shall maintain all records to demonstrate proper operation and maintenance of emission control equipment.

  7. Availability of Records

  8. All records required by Sections (C)(1), (C)(2) and (C)(3) shall be retained at the facility for a minimum of two years and be made available for inspection upon request of the District.

(D) Determination of Emissions

  1. Method

  2. Emissions of ethylene oxide shall be measured as prescribed in ARB Test Method 431 (Title 17, CCR 60, Section 94143) or any method approved by the Executive Officer of the ARB in consultation with the Air Pollution Control Officer of the District.

  3. Source Testing

  4. Source testing shall be conducted in accordance with Section (D)(1) of this Rule. Specific requirements for application are given below:

    (a) 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.

    (b) 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.

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

    (d) 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 25 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.

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

(E) Compliance Schedule

  1. Any person subject to Section (B) shall, no later than 60 days from the date of enactment, perform a source test to determine compliance, as specified in Section (D).

  2. Any person operating an existing facility using between 25 and 600 pounds of ethylene oxide in any consecutive 12 month period shall comply with the requirements of Section (B)(1)(a) no later than six months after September 23, 1991.

  3. Any person operating an existing facility using more than 600 pounds, up to and including 5,000 pounds, of ethylene oxide in any consecutive 12 month period shall comply with the requirements of Section (B)(1)(b) no later than 12 months after September 23, 1991.

  4. Any person operating an existing facility using more than 5,000 pounds of ethylene oxide in any consecutive 12 month period shall comply with Section (B)(1)(c) no later than 18 months after September 23, 1991.

  5. Any person operating an existing aeration-only facility shall comply with the requirements of Section (B) no later than 18 months after September 23, 1991.

  6. Any person installing or intending to install new equipment shall comply with the applicable provisions of Section (B) of this Rule upon installation and startup.

(F) Exemptions

  1. All Sections of this Rule, except Section (C), do not apply to a facility where the facility-wide usage of ethylene oxide is less than 25 pounds per year.

  2. The provisions of this Rule do not apply to sterilizers of the liner-bag design using ampules of ethylene oxide, provided that no more than one ounce is used in any one charge, and no more than 25 pounds is used annually.