SISAPCD RULE 8.5 ETO AIRBORNE TOXIC CONTROL MEASURE          
LAST REVISED 11/11/11
          
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          Rule 8.5 Ethylene Oxide Airborne Toxic Control Measure
                   Sterilizers and Aerators
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          A. Purpose
             To  comply  with  the  California Code of Regulations, Section
             93102, by reducing ethylene  oxide  emission  from sterilizers
             and  aerators  and  cancer  incidence  to  the  lowest   level
             achievable  trough  the  application of best available control
             technology at operations subject to this measure.

          B. 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. 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.

            6. 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.

            7. Control Efficiency
                Is the ethylene oxide (EtO) mass or concentration reduction
                efficiency or 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:

             8.EtO in - EtO out

                  EtO in - EtO out
                  *컴컴컴컴컴컴컴*  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 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.

            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% chloro-fluorocarbon-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  the  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.

          C. Applicability
             Any  person who owns or operates a sterilizer  or  an  aerator
             must comply with this regulation.

          D. Notification
             Any  person  subject  to  this  regulation  must  provide  the
             District  with  the fol-lowing information, in writing, within
             30 days of the date of District adoption:
            1.  The name(s) of the owner and operator of the facility, and
            2.  The 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.

          E. 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  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.

          F. 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,

            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
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                              (a)          (b)         (c)         (d)
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          Facility-wide     Exhaust      Exhaust
          Pounds of         Streams      Streams     Control     Date of
          Ethylene Oxide    to be        to be       Efficiency  Compliance
          Used per Year     Controlled   Tested      (%)         (months)
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          less than or      None         None        None        None
          equal to 25
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          more than 25      Sterilizer   Sterilizer  99.0        24
          and less than or
          equal to 600
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          more than 600     Sterilizer   Sterilizer  99.9        18
          and less than or  Aerator      Aerator     95.0
          equal to 5,000    Back-draft Valve         N/A*
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          more than 5,000   Sterilizer   Sterilizer  99.9        12
                            Aerator &    Aerator     99.9
                            Sterilizer Door          N/A*
                            Hood
                            Back-draft Valve         N/A*
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          Aeration-Only     Aerator      Aerator     95.0        18
          Facilities
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          * Not Applicable
          G.Exemptions
            1.  The requirements set  forth  in subsection (E) above do not
                apply to any facility which treats  materials  in a steril-
                izer  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  (E),
                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.

          H. Compliance
             The  facility  shall  be  in compliance  with  all  provisions
             specified in subsection (E),  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 (E), 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
             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 (E).  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  (E)(1)  and  (E)(2)  and
                demonstrate  a  control efficiency of 99.9% for the steril-
                izer 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 subsec-
                tions (E)(3), (E)(4), and (E)(5), and

            3.  Within  18 months of  the  date  of  District  adoption  of
                regulations  enacting  this  control measure, do one of the
                following:

               a.  Demonstrate to the satisfaction  of  the  District  that
                   operation   of  all  sterilizers  and  aerators  at  the
                   facility has been permanently discontinued: or

               b.  Demonstrate  compliance   with   the   requirements   of
                   subsections  (E)(3),  (E)(4),  and (E)(5), in accordance
                   with  the  source  testing  provisions   set   forth  in
                   subsection (I), below.

          J. Source Testing
             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:

            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 effi-
                ciency 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.

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