SACAQMD RULE 482 ETHYLENE OXIDE - STERILIZERS AND AERATORS          
LAST REVISED 05/18/93          

          SACRAMENTO METROPOLITAN AQMD                RULES AND REGULATIONS
                        RULE 482 ETHYLENE OXIDE - STERILIZERS AND AERATORS
                                         Adopted 05-18-93

                                              INDEX

          100 GENERAL
              101  PURPOSE
              110  EXEMPTION - LOW USAGE

          200 DEFINITIONS
              201  ACUTE CARE FACILITY
              202  AERATION
              203  AERATION-ONLY FACILITY
              204  AERATOR
              205  BACK-DRAFT VALVE
              206  CONTROL DEVICE
              207  CONTROL EFFICIENCY
              208  DICHLORODIFLUOROMETHANE
              209  ETHYLENE OXIDE
              210  EXHAUST STREAM
              211  FACILITY
              212  FACILITY-WIDE
              213  LEAK-FREE
              214  LOCAL MEDICAL EMERGENCY
              215  PORTABLE HYDROCARBON DETECTION INSTRUMENT
              216  STERILANT GAS
              217  STERILIZATION/FUMIGATION
              218  STERILIZER
              219  STERILIZER CYCLE
              220  STERILIZER DOOR HOOD EXHAUST STREAM
              221  STERILIZER EXHAUST STREAM
              222  STERILIZER EXHAUST VACUUM PUMP

          300 STANDARDS
              301  OPERATING CONDITIONS
              302  TABLE I - CONTROL AND COMPLIANCE REQUIREMENTS

          400 ADMINISTRATIVE REQUIREMENTS
              401  NOTIFICATION
              402  REPORTING
              403  COMPLIANCE SCHEDULE

          500 MONITORING AND RECORDS
              501  SOURCE TEST
              502  LEAK FREE TEST METHOD
              503  RECORD KEEPING

          100 GENERAL

              101  PURPOSE:   To  limit  ethylene  oxide  emissions  to the
                   atmosphere  from  sterilization,  fumigation or aeration
                   processes.

              110  EXEMPTION - LOW USAGE:  Any facility  with  a  facility-
                   wide  usage  of  sterilant gas less than or equal to  25
                   pounds per year shall be exempt from the requirements of
                   Section 300.

          200 DEFINITIONS

              201  ACUTE CARE FACILITY:  Any facility currently licensed by
                   the California State  Department of Health Services as a
                   general acute care hospital  as  defined  in  Title  22,
                   California  Code  of  Regulations, Section 70005, or any
                   military hospital.

              202  AERATION:  The process  during  which  residual ethylene
                   oxide  dissipates,  by  forced  air  flow,  natural   or
                   mechanically  assisted  convection,  or other means from
                   previously  sterilized  materials after  the  sterilizer
                   cycle is completed. Aeration is completed when materials
                   that   have   previously   undergone    ethylene   oxide
                   sterilization  can  be  handled  in the same  manner  as
                   similar  materials  that have not been  sterilized  with
                   ethylene oxide.

              203  AERATION-ONLY  FACILITY:    A  facility  which  performs
                   aeration on materials which have  been  sterilized  with
                   ethylene oxide at another facility.

              204  AERATOR:   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.

              205  BACK-DRAFT  VALVE:   A  valve  or  rear  chamber exhaust
                   system for removal of ethylene oxide during unloading of
                   sterilized materials.

              206  CONTROL  DEVICE:   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 approved  by  the  Air  Pollution
                   Control Officer,  pursuant to Rule 201 of the District's
                   Rules and Regulations.

              207  CONTROL EFFICIENCY:   The  ethylene  oxide (EtO) mass or
                   concentration reduction efficiency of  a control device,
                   as  measured with the method described in  Section  501,
                   and expressed  as  a  percentage  calculated  across the
                   control device as follows:

                           % Control Efficiency =šEtO in  - šEtO out  X 100
                                                 --------------------------     
                                                           šEtO in

              208  DICHLORODIFLUOROMETHANE   (CFC-12):    A  commonly  used
                   diluent  for ethylene oxide mixtures emitted  from  some
                   sterilizers and aerators as a part of the mixture.

              209  ETHYLENE OXIDE(C2H4O):   A colorless, flammable gas with
                   the chemical formula of(C2H4O)  that has been identified
                   as  a  suspected  human  carcinogen  and   a  toxic  air
                   contaminant by the California Air Resources Board (ARB).

              210  EXHAUST   STREAM:    The   ethylene   oxide-contaminated
                   effluent emitted from a sterilizer or aerator.

              211  FACILITY:    Any   entity  which  owns  or  operates   a
                   sterilizer or aerator,  is owned or operated by the same
                   person or persons, and is  located on the same parcel or
                   contiguous parcels.

              212  FACILITY-WIDE USAGE:  The total  pounds of sterilant gas
                   used in all of the sterilizers at  the facility during a
                   continuous 12 month period.

              213  LEAK-FREE:    The   state   which   exists   when    the
                   concentration  of  sterilant  gas  measured 1 centimeter
                   away  from  any  portion  of  the exhaust  system  of  a
                   sterilizer  or  aerator,  during conditions  of  maximum
                   sterilant gas mass flow, is  less  than  30  ppm  for  a
                   sterilant  gas composition of 12% ethylene oxide and 88%
                   CFC-12 by weight,  or 10 ppm for other gas compositions,
                   as determined by the test method in Section 501.2.

              214  LOCAL MEDICAL EMERGENCY:   An  unexpected  occurrence in
                   the  area  served by the acute 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.

              215  PORTABLE    HYDROCARBON    DETECTION   INSTRUMENT:     A
                   hydrocarbon  analyzer which uses  the  flame  ionization
                   detection or thermal  conductivity  methods specified in
                   the test method in Section 501.2.

              216  STERILANT  GAS:   Ethylene oxide or any  combination  of
                   ethylene oxide and other gases used in a sterilizer.

              217  STERILIZATION/FUMIGATION:     The   process   by   which
                   sterilant  gas  is  used to destroy  bacteria,  viruses,
                   fungi, and other unwanted  organisms  on products. These
                   products  include,  but  are  not  limited  to,  medical
                   products, cosmetics, and foodstuffs.

              218  STERILIZER:   Any chamber or related piece of  equipment
                   that  uses  sterilant   gas   in  any  sterilization  or
                   fumigation process.

              219  STERILIZER  CYCLE:   The  process   which   begins  when
                   sterilant  gas  is  introduced into the sterilizer,  and
                   includes  the  initial   purge   or   evacuation   after
                   sterilization  and subsequent air washes, and ends after
                   evacuation of the final air wash.

              220  STERILIZER DOOR  HOOD  EXHAUST  STREAM:   The air stream
                   which results from collection of fugitive sterilant  gas
                   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.

              221  STERILIZER EXHAUST STREAM:  All  the sterilant gas which
                   is intentionally removed from the  sterilizer during the
                   sterilizer cycle.

              222  STERILIZER  EXHAUST  VACUUM  PUMP:   A  device  used  to
                   evacuate the sterilant gas during the sterilizer  cycle,
                   including  any  associated  heat exchanger. A sterilizer
                   exhaust pump is not a device  used  solely to evacuate a
                   sterilizer prior to the introduction of ethylene oxide.

          300 STANDARDS

              301  OPERATING  CONDITIONS:   A person shall  not  operate  a
                   sterilizer  or  aerator  unless  all  of  the  following
                   requirements are satisfied:
                   301.1   There  is  no discharge  of  sterilizer  exhaust
                           vacuum pump working fluid to wastewater streams;
                   301.2   The exhaust  stream  including,  but not limited
                           to,  any  piping,  ducting,  fittings,   valves,
                           flanges,    through    which    sterilant   gas-
                           contaminated air is conveyed from the sterilizer
                           and aerator to the outlet of the control device,
                           is leak free.
                   301.3   All of the control requirements in  Table  I  of
                           Section   302,   for   the   applicable  control
                           category, are met;
                   301.4   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 or aerator exhaust stream;
                   301.5   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;
                   301.6   If  reduction  in  the amount of ethylene  oxide
                           across the control device  is  demonstrated, but
                           control   efficiency   cannot   be  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 the requirements in Table I of Section 302.

              302  CONTROL AND COMPLIANCE REQUIREMENTS

                                       TABLE I


   LBS ETO          EXHAUST        EXHAUST        CONTROL        MAXIMUM ETO
   EMITTED/YR       STREAM TO BE   STREAM TO BE   EFFICIENCY     EMITTED IN
                    CONTROLLED     TESTED                        LBS/YR

  > 25 - ů 600      Sterilizer     Sterilizer       99.0%            6

 > 600 - ů 5,000    Sterilizer     Sterilizer       99.9%            5
                    Aerator        Aerator          95.0%           25
                    Back-draft
                    Valve

     >5,000         Sterilizer,    Sterilizer        99.9            5
                    Aerator &      Aerator           99.0            5
                    Sterilizer
                    Door Hood
                    Back-draft
                    Valve

  Aeration-Only     Aerator       Aerator            95.0            25
   Facilities


          400 ADMINISTRATIVE REQUIREMENTS

              401  NOTIFICATION:    Any  person  who  owns  or  operates  a
                   sterilizer or aerator  must  submit  by August 18, 1993,
                   the following information:
                   401.1   The name of the facility, and
                   401.2   The  name(s)  of  the owner or operator  of  the
                           facility, and
                   401.3   The location of the facility, and
                   401.4   The number of sterilizers  and  aerators  at the
                           facility, and
                   401.5   An  estimate  of  the  total  pounds of ethylene
                           oxide,  and sterilant gas used by  the  facility
                           during the 1991 calendar year.

              402  REPORTING:  Any person who owns or operates a sterilizer
                   shall furnish a written report to the District by August
                   18,  1994 and annually  thereafter.  This  report  shall
                   include one of the following:
                   402.1   The  number  of sterilizer cycles and the pounds
                           of ethylene oxide  purchased, used, and returned
                           in the previous calendar year, or
                   402.2   The total pounds of  sterilant gas and the total
                           pounds of ethylene oxide  purchased,  used,  and
                           returned in the previous calendar year.

              403  COMPLIANCE   SCHEDULE:   The  owner  or  operator  of  a
                   sterilizer or aerator which is subject to the provisions
                   of this rule shall  comply with the following applicable
                   compliance schedule:
                   403.1   If the facility-wide  usage of ethylene oxide is
                           greater  than  5,000  pounds   per   year,  full
                           compliance  with  Section 300 shall be met,  and
                           the facility shall  submit  to the Air Pollution
                           Control Officer, an application  for  permit  to
                           operate, by May 18, 1994.
                   403.2   If  the facility-wide usage of ethylene oxide is
                           greater than 600 but less than or equal to 5,000
                           pounds  per  year,  full compliance with Section
                           300 shall be met and  the  facility shall submit
                           to  the  Air  Pollution  Control   Officer,   an
                           application for a Permit to Operate, by November
                           18, 1994.
                   403.3   If  the facility-wide usage of ethylene oxide is
                           greater  than  25, but less than or equal to 600
                           pounds per year,  full  compliance  with Section
                           300  shall  be  met  with  Section  300 and  the
                           facility  shall  submit,  to  the  Air Pollution
                           Control Officer, an application for  a Permit to
                           Operate by May 18, 1995.

          500 MONITORING AND RECORDS

              501  TEST METHODS:  In addition to the test methods specified
                   below,   equivalent  test  methods  may  be  used.  Such
                   equivalent   test   methods  must  be  approved  by  the
                   Executive Officer of  the  Air  Resources Board prior to
                   use.  If used to determine compliance,  such  equivalent
                   test methods  must  provide  the same results as the ARB
                   method it is intended to replace.
                   501.1   SOURCE TEST:  Emissions  of ethylene oxide shall
                           be  determined by ARB Test  Method  431,  or  an
                           equivalent test method approved by the Executive
                           Officer  of  the Air Resources Board. The source
                           test shall be conducted in the following manner:
                           a.  The  test   on   a   control  device  for  a
                               sterilizer exhaust stream  shall be run with
                               a  typical load, as determined  by  the  Air
                               Pollution    Control    Officer,    in   the
                               sterilizer.
                           b.  The  test on a control device for an aerator
                               exhaust  stream  shall be run with a typical
                               load, as determined  by  the  Air  Pollution
                               Control Officer, 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.
                               i.  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.
                               ii. 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  a  least  60  minutes,  starting  15
                                   minutes after aeration begins.
                               iii.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.
                   501.2   LEAK FREE TEST  METHOD:   Fugitive  emissions of
                           ethylene oxide shall be determined by  ARB  Test
                           Method  21  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 Air Pollution Control Officer.
                           a.  A CFC-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 CFC-12.

                   502     RECORD KEEPING:  Any person who owns or operates
                           a sterilizer or aerator shall maintain  a log of
                           the  date  and time of each sterilizer operation
                           cycle, and record  all ethylene oxide purchases.
                           These records shall  be  retained  for two years
                           and made available to the Air Pollution  Control
                           Officer upon request.