PLACER COUNTY AIR POLLUTION CONTROL DISTRICT

RULE 903 - ETHYLENE OXIDE CONTROL MEASURE STERILIZER, ETC.
(Adopted 2/5/91)


          A.   GENERAL



               1.   Applicability - Any  person  who  owns  or operates a

                    sterilizer   or an aerator must comply with  this

                    regulation.



               2.   The requirements set forth in Section C 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.



               3.   The  District  Hearing  Board  may grant  an  emergency

                    variance from Items (a) and (c)  in  Table I of Section

                    C, Standards, 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.



          B.   DEFINITIONS



               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.   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:



                    äEtOin  -  äEtOout   x   100   =   % Control Efficiency

                                        äEtOin



               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  Placer  County  Air  Pollution

                    Control District.



               11.  Ethylene Oxide (EtO) - is a 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:



                    a.   30 ppm for sterilant gas composed of 12%  ethylene

                         oxide  and  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 semiconductor 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  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.   STANDARDS



               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             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                 Sterilizer    Sterilizer   99.9          12

5,000                     Aerator &     Aerator      99.0

                          Sterilizer Door            N/A*

                          Hood

                          Back-draft Valve           N/A



Aeration-Only             Aerator       Aerator      95.0          18

Facilities



* Not Applicable



          D.   ADMINISTRATIVE REQUIREMENTS



               The  facility  shall  be  in  compliance with all provisions

               specified in Section C, Standards,  no  later  than the date

               specified in column (d) of Table I.



               1.   Compliance  of  Ethylene  Oxide  Concentrations   Below

                    Detection  -  For the purpose of determining compliance

                    with the control efficiency requirement shown in column

                    (c) of Table I, Section 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 0.2 parts per million ethylene  oxide,

                    the facility  shall  be  considered to be in compliance

                    with this requirement.



               2.   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 Section C.  If this

                    compliance  option is chosen,  the  owner  or  operator

                    shall:

                    a.   Within 3  months  of the date of District adoption

                         of  regulations  enacting  this  control  measure,

                         comply with the requirements  shown in Subsections

                         C.1  and C.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 E.3; and



                    b.   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

                         Subsections C.3, C.4, and C.5, and



                    c.   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  C.3,  C.4,   and   C.5,   in

                              accordance with the source testing provisions

                              set forth in Subsection E.3.



          E.   MONITORING AND RECORDS



               1.   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:



                    a.   The  name(s)  of the owner  and  operator  of  the

                         facility, and



                    b.   The location of the facility, and



                    c.   The  number of sterilizers  and  aerators  at  the

                         facility, and



                    d.   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.



                    The District may exempt a source from  this requirement

                    if    the   District   maintains   current   equivalent

                    information on the source.



               2.   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:



                    a.   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



                    b.   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.

               3.   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:



                    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 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.



                    e.   There shall  be  no  dilution  of  the  air stream

                         between  the  inlet and outlet test points  during

                         testing.