SLOAPCD RULE 414 ETHYLENE OXIDE - STERILIZATION AND AERATION

LAST REVISED 11/19/91

RULE 414. ETHYLENE OXIDE - STERILIZATION AND AERATION

(Adopted 11/19/91)

A. APPLICABILITY

The requirements of this Rule shall apply to any person who

operates an ethylene oxide sterilizer and/or an aerator.

B. DEFINITIONS

For the purposes of this Rule, the following definitions

shall apply:

1. "Aeration": The process during which residual ethylene

oxide dissipates by forced air flow, through natural or

mechanically assisted convection, or other means, from

previously sterilized materials after the sterilization

cycle is completed.

2. "Aerator": Any equipment, space, or room in which air is

used to remove residual ethylene oxide from sterilized

materials. An aerator is not any equipment, space, or

room in which materials that have previously undergone

ethylene oxide sterilization and aeration can be handled,

stored, and transported in the same manner that have not

been sterilized with ethylene oxide.

3. "Aerator Exhaust Stream": All ethylene oxide

contaminated effluent gases which are emitted from an

aerator.

4. "Back-Draft Valve Exhaust Stream": The effluent gas

stream which results from the collection of ethylene oxide

contaminated gases during unloading of the sterilizer and

which is removed through a back-draft valve or rear

chamber exhaust system.

5. "Control Efficiency": The ethylene oxide mass or

volume concentration reduction efficiency of control

equipment, as measured by ARB Test Method 431 and

expressed as a percentage as follows:

sum ETOin - sum ETOout

---------------------- x 100 = % Control Efficiency

sum ETOin

6. "Ethylene Oxide (ETO, C2H4O)": A colorless, flammable

gas that has been identified as a suspected human

carcinogen and a toxic air contaminant by the California

Air Resources Board.

7. "Leak": A concentration of sterilant gas measured one

centimeter from the source equal to or greater than:

a. 30 ppm, as methane, for sterilant gas composed

of 12 percent ethylene oxide and 88 percent

chlorofluorocarbon-12 by weight; or

b. 10 ppm, as methane, for all other compositions

of sterilant gas.

If a detector with an audible alarm is used, a leak

shall be defined as a concentration of sterilant gas

measured one centimeter from the source which causes the

alarm to sound.

8. "Source-wide Use of Ethylene Oxide": The total weight of

ethylene oxide used in all sterilizers at a stationary

source during a calendar year, expressed as pounds per

year.

9. "Sterilant Gas": Ethylene oxide or any combination of

ethylene oxide and other gases used in a sterilizer.

10. "Sterilizer": Any equipment that uses ethylene oxide or

an ethylene oxide mixture in any sterilization or

fumigation process.

11. "Sterilizer Cycle": The process which begins when

ethylene oxide is introduced to a sterilizer, includes

the initial purge or evacuation after sterilization and

subsequent air washes, and ends after evacuation of the

final air wash.

12. "Sterilizer Door Hood Exhaust Stream": The effluent gas

stream which results from the collection of fugitive

ethylene oxide emissions by means of a hood over the

sterilizer door, during the period in which the

sterilizer door is open after the sterilizer cycle has

been completed.

13. "Sterilizer Exhaust Stream": The ethylene

oxide-contaminated effluent gases emitted from a

sterilizer.

14. "Sterilizer Exhaust Vacuum Pump": A device (including

any associated heat exchanger) used to evacuate sterilant

gas during the sterilizer cycle but not a device used

solely to evacuate a sterilizer prior to the introduction

of ethylene oxide.

C. EXEMPTIONS

The provisions of Sections D., Requirements, shall not apply

to any sterilizer and/or aerator at a stationary source where the

source-wide use of ethylene oxide is four lb/yr or less, provided

the requirements of Section E, Recordkeeping, are satisfied.

This exemption applies only to stationary sources where a

sterilizer is operated.

D. REQUIREMENTS

1. No person shall operate any sterilizer at a stationary

source where the source-wide use of ethylene oxide is

greater than four pounds per year (lb/yr), but no greater

than 600 lb/yr, unless the sterilizer exhaust stream is

vented to control equipment with a control efficiency of

at least 99.0 percent.

2. No person shall operate any sterilizer and/or aerator at a

stationary source where the source-wide use of ethylene

oxide is greater than 600 lb/yr, but no greater than

5,000 lb/yr, unless all of the following requirements are

satisfied:

a. The sterilizer exhaust stream shall be vented to

control equipment with a control efficiency of at

least 99.9 percent.

b. The aerator exhaust stream and back-draft valve

stream shall be vented to control equipment with a

control efficiency of at least 95.0 percent.

3. No person shall operate any sterilizer and/or aerator at

a stationary source where the source-wide use of ethylene

oxide is greater than 5,000 lb/yr, unless all of the

following requirements are satisfied:

a. The sterilizer exhaust stream shall be vented to

control equipment with a control efficiency of at

least 99.9 percent.

b. The aerator exhaust stream, sterilizer door hood

exhaust stream and back-draft valve exhaust stream

shall be vented to control equipment with a control

efficiency of at least 99.0 percent.

4. No person shall operate an aerator at a stationary source

where products that have been sterilized at another

stationary source are aerated, unless the aerator exhaust

stream is vented to control equipment with a control

efficiency of at least 95.0 percent.

5. Compliance shall be verified by source testing at least

every 24 months, with the first source test being

performed no later than the date specified pursuant to

Subsection H, Compliance Schedule.

6. Any person who operates a sterilizer and/or aerator

shall submit to the APCO a compliance plan no later than

the date specified in Subsection H, Compliance Schedule.

The compliance plan shall contain the following:

a. The name of the manufacturer, model number, and a

description of the equipment which will be used to

comply with the emission control requirements of

this Subsection and with the requirements of

Subsection D.8.a., Requirements.

b. The dates or estimated dates of the purchase,

delivery, and installation of such equipment.

7. Any person who operates a sterilizer and/or aerator

shall submit to the APCO a copy of the purchase order for

the equipment necessary to comply with the emission

control requirements of this Subsection no later than the

date specified pursuant to Subsection H, Compliance

Schedule.

8. No person shall operate any sterilizer or aerator unless

all of the following requirements are satisfied:

a. No working fluid from the sterilizer exhaust vacuum

pump shall be discharged to any wastewater stream.

b. No sterilant gas shall leak from any portion of any

sterilant, aerator, control equipment, or emission

collection system including, but not limited to any

piping, fittings, valves, or flanges through which

ethylene oxide is conveyed.

E. RECORDKEEPING

1. Any person who operates a sterilizer shall maintain

monthly records of the amount of ethylene oxide purchased,

used, and returned. In addition, records showing the

results of all source tests shall be maintained.

2. All records except source test records shall be retained

for at least two years. Source test records shall be

maintained for at least four years. All records shall be

made available to the APCO upon request.

F. REPORTING REQUIREMENTS

Any person who operates a sterilizer and/or an aerator shall

submit to the APCO the following information in writing by

December 19, 1991:

1. The name, address, and phone number of the owner and

operator of any stationary source where a sterilizer

and/or an aerator is operated.

2. The number of sterilizers and aerators at the stationary

source.

3. The total weight of ethylene oxide and sterilant gas used

in all sterilizers at the stationary source during the

year of 1990.

G. TEST METHODS

1. Source tests to determine compliance with the emission

reduction requirements of Subsection D., Requirements,

shall be conducted using ARB Test Method 431. If a

reduction in the amount of ethylene oxide across the

control equipment is demonstrated, but the control

efficiency cannot be determined because the concentration

of ethylene oxide measured at the outlet of the control

equipment is below 0.2 ppm, the control equipment shall

be deemed in compliance with the emission reduction

requirements of Subsection D., Requirements. In addition,

the following requirements shall be met:

a. Tests on control equipment shall be run with a

typical load in the sterilizer or aerator.

b. The inlet and outlet of the control equipment shall

be sampled simultaneously during testing to measure

the control efficiency.

c. The efficiency of control equipment shall be

determined under normal operating conditions. To

measure the control efficiency of control equipment

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 equipment 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 equipment 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.

d. There shall be no dilution of the air stream between

the inlet and outlet test points during the source

test.

2. Leak determinations shall be conducted using 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 APCO. A detector with an

audible alarm using a metal oxide semi-conductor sensor

and with a detection level of five ppm or less for

ethylene oxide shall be considered an acceptable

alternative.

H. COMPLIANCE SCHEDULE

1. Any person subject to the provisions of Section D.1,

Requirements, shall satisfy the following compliance

schedule:

a. Submit to the APCO a compliance plan pursuant to

Subsection D., Requirements, by September 1, 1992.

b. Submit to the APCO a complete application for an

Authority to Construct for any sterilizer, aerator,

and associated control equipment by January 1, 1993.

c. Submit to the APCO a copy of the purchase order

specified pursuant to Subsection D.7, Requirements,

by July 1, 1993.

d. Demonstrate compliance with the requirements for

Subsection D.1. through source testing, by November

19, 1993.

2. Any person subject to the provisions of Subsection D.2.,

Requirements, shall satisfy the following compliance

schedule:

a. Submit to the APCO a compliance plan pursuant to

Subsection D.6., Requirements, by March 1, 1992.

b. Submit to the APCO a complete application for an

Authority to Construct for any sterilizer, aerator,

and associated control equipment by July 1, 1992.

c. Submit to the APCO a copy of the purchase order

specified pursuant to Subsection D.7., Requirements,

by January 1, 1993.

d. Demonstrate compliance with the requirements of

Subsection D.2. through source testing, by May 19,

1993.

3. Any person subject to the provisions of Subsection

D.3., Requirements, shall satisfy the following

compliance schedule:

a. Submit to the APCO a compliance plan pursuant to

Subsection D.6., Requirements, by March 1, 1992.

b. Submit to the APCO a complete application for an

Authority to Construct for any sterilizer, aerator,

and associated control equipment by July 1, 1992.

c. Submit to the APCO a copy of the purchase order

specified pursuant to Subsection D.7., Requirements,

by September 1, 1992.

d. Demonstrate compliance with the requirements of

Subsection D.3., Requirements, through source

testing, by November 19, 1992.

4. Any person subject to the provisions of Subsection

D.4., Requirements, shall satisfy the following

compliance schedule:

a. Submit to the APCO a compliance plan pursuant to

Subsection D.6., Requirements, by March 1, 1992.

b. Submit to the APCO a complete application for an

Authority to Construct for any sterilizer, aerator,

and associated control equipment by July 1, 1992.

c. Submit to the APCO a copy of the purchase order

specified pursuant to Subsection D.7., Requirements,

by January 1, 1993.

d. Demonstrate compliance with the requirements of

Subsection D.3. through source testing, by May 19,

1993.

5. All Subsections of this Rule shall apply to any new

facility or source obtaining a District Permit to Operate

on or after November 19, 1991.

a. Submit to the APCO a complete application for an

Authority to Construct for any sterilizer, aerator,

and associated equipment prior to equipment purchase.

b. Submit to the APCO a copy of the purchase order

pursuant to Subsection D.7., Requirements, at least

thirty (30) calendar days prior to installation.

c. Demonstrate compliance with the requirements of

Subsection D., Requirements, through source testing

within sixty (60) calendar days after installation

or as directed in the Permit to Operate for the

sterilizer or aerator.