NORTH COAST UNIFIED AIR QUALITY MANAGEMENT DISTRICT

SECTION 5

CONTROL OF ETHYLENE OXIDE EMISSIONS FROM STERILIZERS/AERATORS


RULE 5-400 -
Control of Ethylene Oxide Emissions from Sterilizers/Aerators

(a) 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.


(b) 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.


(c) 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


(d.) 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.


(e.) 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 0.3 0.2 parts per million ethylene oxide, the facility shall be considered to be in compliance with this requirement.


(f.) 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 Rule 5-500; 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.