MENAQMD RULE R3-5 ATCM ETHYLENE OXIDE EMIS STERIL & AERATOR                              
LAST REVISED 05/12/92                              
                              
                              REGULATION 3 - SECTION 5



          RULE 5-100 - TITLE


           AIRBORNE TOXIC CONTROL MEASURE FOR ETHYLENE OXIDE EMISSIONS
                           FROM STERILIZERS AND AERATORS


                   This regulation is adopted pursuant to the provisions of
          California Code of Regulations Section 93102, and as required 
          by Health and Safety Code Section 39666(b).

                                                     [Adopted May 12, 1992]

          RULE 5-110 - PURPOSE

          On November 12, 1987, pursuant to Section 39662 of the Health and
          Safety Code, the Air Resources Board (ARB) identified ethylene
          oxide as a toxic air contaminant.  In so identifying ethylene
          oxide, the Air Resources Board determined that there is not
          sufficient available scientific evidence to support identification 
          of a threshold exposure level below which no significant adverse 
          health effects are anticipated (see California Code of Regulations 
          Section 93000).  This airborne toxic control measure will reduce 
          ethylene oxide emission from sterilizers and aerators and cancer 
          incidence to the lowest level achievable through application of 
          best available control technology at operations subject to this 
          measure.

          RULE 5-120 - APPLICABILITY

          This regulation shall apply to any person who owns, operates, or
          who plans to build, own, or operate, a sterilizer or aerator.

          RULE 5-130 - DEFINITIONS

          For the purposes of this regulation, 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 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:

             Control Efficiency (%)   =  šEtO in - šEtO out x 100
                                         __________________
                                                šEtO 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)" means the substance identified as a
          toxic air contaminant by the Air Resources Board in 17 CCR
          Section 93000.

             12.  "Facility" means an 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" means 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/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 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 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.

          RULE 5-200 - PERMITS

          (a)  The owner or operator of any new or existing sterilizer/aerator 
          which emits more than 25 pounds per year shall file an application 
          for an Authority to Construct with the District, as provided in 
          Regulation 1, Rule 200.

          (b)  The owner or operator of an existing sterilizer/aerator which
          emits more than 25 pounds per year shall file an application for
          authority to construct not later than August 10, 1992.

          (c)  The applicant shall pay the fees as specified in Rule 5-300 -
          Fees.

          RULE 5-300 - FEES

          (a)  Every applicant for an Authority to Construct or holder of a
          permit to operate a sterilizer/aerator which emits more than 25
          pounds per year medical waste incinerator shall pay an initial
          fee or permit renewal fee or other fees as provided in Regulation
          1, Rule 300, according to the schedule of fees in Regulation 3,
          Rule 5-310.

          (b)  The applicant for an Authority to Construct shall pay the
          initial fee at the time of filing of the application.

          (c)  Permit renewal fees not payed in a timely fashion as provided
          in Regulation 1, Rule 300 are subject to the penalty provisions
          in Regulation 1, Rule 300(i)

          RULE 5-310 - FEE SCHEDULE

          The owner or operator of any sterilizer or aerator, for which an
          Authority to Construct or Permit to Operate is required, shall be
          assessed a permit fee in accordance with Regulation 1, Rule 300,
          based on the capacity of the sterilizer or aerator according to
          this schedule:
            
                                               INITIAL            ANNUAL
          CATEGORY (See Table I, Rule 5-400)     FEE             RENEWAL

          Category 1 (Emissions <25 lb/yr).....  $   200.00     $  100.00
          Category 2 (25 or= 5,0000 lb/yr)..... $ 1,600.00     $  800.00
          Category 5 (Aeration only facility)    $   400.00     $  200.00

          RULE 5-400 - CONTROL OF ETHYLENE OXIDE EMISSIONS FROM
                       STERILIZERS/AERATORS

          (a)  NOTIFICATION:

          No later than June 11, 1992, every Owner/Operator of an 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.

          (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     Exhaust            Exhaust      Control    Date of
     Pounds of         Streams            Streams      Efficiency Compliance
     Ethylene Oxide    to be              to be        (%)
     Used per year     Controlled         Tested
     _________________________________________________________________________
     Category 1

     Less than 25      None                None         None      None
     -------------------------------------------------------------------------
     Category 2

     25 or more and    Sterilizer         Sterilizer    99.0      May 12, 1994
     less than 600
     __________________________________________________________________________
     Category 3

     600 or more       Sterilizer         Sterilizer    99.9      Nov. 8, 1993
     and less 5,000
                       Aerator            Aerator       95.0
                       Back-draft Valve                 N/A
     _________________________________________________________________________
     Category 4

     5,000 and more    Sterilizer         Sterilizer   99.9       May 12, 1993

                       Aerator            Aerator      99.0
                       Sterilizer
                       Door Hood                       N/A
                       Back-draft Valve                N/A
     __________________________________________________________________________
     Category 5

     Aeration-Only     Aerator            Aerator      95.0       Nov. 8, 1993
     Facilities
     __________________________________________________________________________
     N/A = 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 0.2 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.  No later than August 10, 1992, 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 subsection i; and
                                                      
             2.  No later than November 8, 1992, 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.  No later than November 8, 1993, 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 c3, c4, and c5, in accordance with the source testing
          provisions set forth in Rule 5-500.

          RULE 5-500 - TESTING METHOD

          Source testing shall be conducted in accordance with ARB Test
          Methods and the method evaluations cited therein or an acceptable
          source test method approved by the Executive Officer of the Air
          Resources Board.  Specific testing requirements to apply the
          regulatory limits of this rule are as follows:

          (a)  To determine the "control efficiency" requirements of this
          regulation, ethylene oxide (EtO) mass or concentration reduction
          efficiency of a control device, shall be 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:

             Control Efficiency (%)   =  šEtO in - šEtO out x 100
                                         __________________
                                                šEtO in

          The procedures that will be utilized during the source testing
          are as follows:

             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 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.

             5.  There shall be no dilution of the air stream between the
          inlet and outlet test points during testing.

          (b)  To determine the "leak free" requirements of this regulation
          the 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 shall be 
          used.  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.