LASAPCD ART.VI ETO EMISSIONS FROM STERILIZERS AND AERATORS
LAST REVISED 11/11/11

                                  ARTICLE VI
               ETHYLENE OXIDE EMISSIONS FROM STERILIZERS AND AERATORS

          A.  Purpose.  To  comply  with the California Code of Regulations
          Section  93108, by controlling  airborne  emissions  of  Ethylene
          Oxide.

          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)   "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 value 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:

          [SUM (Eto in) - SUM (Eto out)] x 100 = %  Control Efficiency
          ------------------------------
                  SUM(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, in less than:

               (A)  30 ppm for sterilant gas composed of 12% ethylene oxide
                    18% 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   of  a
          nondispersive   infrared analyzer, calibrated with methane, or  a
          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
          chlorofluorocarbon12.

          (15)  "Local medical emergency" means an unexpected occurrence in
          the area  served by the acute care facility resulting in a sudden
          increase in  the  amounts  of  medical treatments which require a
          significant increase in the operation of 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 tidal 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 offer 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 use 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 following 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 distrlct, 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,  and  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  system 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 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     Exhaust     Exhaust
          Pounds of         Streams     Streams   Control    Date of
          Ethylene Oxide    to be       to be     Efficiency Compliance
          Used per Year     Controlled  Tested    (%)        (months)
          --------------------------------------------------------------
          less than or      None        None      None       None
          equal to 25
          --------------------------------------------------------------
          more than 25      Sterilizer  Sterilizer 99.0      24
          and less than or
          equal to 600
          --------------------------------------------------------------
          more than 600     Sterilizer  Sterilizer 99.9      18
          and less than or  Aerator     Aerator    95.0
          equal to 5,000    Back-draft             N/A*
                              valve
          --------------------------------------------------------------
          more than 5,000   Sterilizer  Sterilizer 99.9      12
                            Aerator     Aerator    99.0
                            Sterilizer               N/A*
                             Door Hood
                            Back-draft               N/A*
                             Valve
          --------------------------------------------------------------
           Aeration-Only    Aerator     Aerator    95.0      18
           Facilities

          --------------------------------------------------------------
           * Not Applicable

           G. Exemptions.

          (1)  The  requirements  set  forth in subsection (F) above do not
          apply  to any facility which treats  material 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(F),
          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 (F), 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
          (F), if a reduction in the amount of ethylene  oxide  across  the
          control  device  is demonstrated, 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 (F).
          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  (F)(1)  and  (F)(2)  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 measure, submit to the district a plan
          to  discontinue   operation  of  all sterilizers and aerators  or
          comply with the  district subsections (F)(3), (F)(4), and (F)(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
          subsection   (F)(3),  (F)(4),  and (F)(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  to  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 aeretor 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.