California Code of Regulations › Title 17 - Public Health › Division 3 - Air Resources › Chapter 1 - Air Resources Board › Subchapter 7.5 - Airborne Toxic Control Measures › Section 93108 - Ethylene Oxide Airborne Toxic Control Measure-Part 1 - Non-Commercial Sterilizers and Aerators and Commercial Sterilizers and Aerators Using Less than 2,000 Pounds of Ethylene Oxide Per 12 Consecutive Months

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Definitions. For the purposes of this
				  section, 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) "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:
(Î£ EtO in - EtO out)/(Î£ EtO in) x
					 100 = % Control Efficiency
(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.