[Code of Federal Regulations]
[Title 40, Volume 9]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR63.361]

[Page 471-473]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 63_NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
 
     Subpart O_Ethylene Oxide Emissions Standards for Sterilization 
                               Facilities
 
Sec.  63.361  Definitions.

    Terms and nomenclature used in this subpart are defined in the Clean 
Air Act (the Act) as amended in 1990, Sec. Sec.  63.2 and 63.3 of 
subpart A of this part, or in this section. For the purposes of subpart 
O, if the same term is defined in subpart A and in this section, it 
shall have the meaning given in this section.
    Aeration room means any vessel or room that is used to facilitate 
off-gassing of ethylene oxide at a sterilization facility.
    Aeration room vent means the point(s) through which the evacuation 
of ethylene oxide-laden air from an aeration room occurs.

[[Page 472]]

    Baseline temperature means a minimum temperature at the outlet from 
the catalyst bed of a catalytic oxidation control device or at the 
exhaust point from the combustion chamber of a thermal oxidation control 
device.
    Chamber exhaust vent means the point(s) through which ethylene 
oxide-laden air is removed from the sterilization chamber during chamber 
unloading following the completion of sterilization and associated air 
washes.
    Compliance date means the date by which a source subject to the 
emissions standards in Sec.  63.362 is required to be in compliance with 
the standard.
    Deviation means any instance in which an affected source, subject to 
this subpart, or an owner or operator of such a source:
    (1) Fails to meet any requirement or obligation established by this 
subpart including, but not limited to, any emission limitation 
(including any operating limit) or work practice standard;
    (2) Fails to meet any term or condition that is adopted to implement 
an applicable requirement in this subpart and that is included in the 
operating permit for any affected source required to obtain such a 
permit; or
    (3) Fails to meet any emission limitation (including any operating 
limit) or work practice standard in this subpart during startup, 
shutdown, or malfunction, regardless of whether or not such failure is 
permitted by this subpart.
    Effective date means the date of promulgation in the Federal 
Register notice.
    Initial startup date means the date when a source subject to the 
emissions standards in Sec.  63.362 first begins operation of a 
sterilization process.
    Manifolding emissions means combining ethylene oxide emissions from 
two or more different vent types for the purpose of controlling these 
emissions with a single control device.
    Maximum ethylene glycol concentration means any concentration of 
ethylene glycol in the scrubber liquor of an acid-water scrubber control 
device established during a performance test when the scrubber achieves 
at least 99-percent control of ethylene oxide emissions.
    Maximum liquor tank level means any level of scrubber liquor in the 
acid-water scrubber liquor recirculation tank established during a 
performance test when the scrubber achieves at least 99-percent control 
of ethylene oxide emissions.
    Oxidation temperature means the temperature at the outlet point of a 
catalytic oxidation unit control device or at the exhaust point from the 
combustion chamber for a thermal oxidation unit control device.
    Source(s) using less than 1 ton means source(s) using less than 907 
kg (1 ton) of ethylene oxide within all consecutive 12-month periods 
after December 6, 1996.
    Source(s) using 1 ton means source(s) using 907 kg (1 ton) or more 
of ethylene oxide within any consecutive 12-month period after December 
6, 1996.
    Source(s) using 1 to 10 tons means source(s) using 907 kg (1 ton) or 
more of ethylene oxide in any consecutive 12-month period but less than 
9,070 kg (10 tons) of ethylene oxide in all consecutive 12-month periods 
after December 6, 1996.
    Source(s) using less than 10 tons means source(s) using less than 
9,070 kg (10 tons) of ethylene oxide in all consecutive 12-month periods 
after December 6, 1996.
    Source(s) using 10 tons means source(s) using 9,070 kg (10 tons) or 
more of ethylene oxide in any consecutive 12-month period after December 
6, 1996.
    Sterilization chamber means any enclosed vessel or room that is 
filled with ethylene oxide gas, or an ethylene oxide/inert gas mixture, 
for the purpose of sterilizing and/or fumigating at a sterilization 
facility.
    Sterilization chamber vent means the point (prior to the vacuum 
pump) through which the evacuation of ethylene oxide from the 
sterilization chamber occurs following sterilization or fumigation, 
including any subsequent air washes.
    Sterilization facility means any stationary source where ethylene 
oxide is used in the sterilization or fumigation of materials.
    Sterilization operation means any time when ethylene oxide is 
removed from the sterilization chamber through the sterilization chamber 
vent or the

[[Page 473]]

chamber exhaust vent or when ethylene oxide is removed from the aeration 
room through the aeration room vent.
    Thermal oxidizer means all combustion devices except flares.

[59 FR 62589, Dec. 6, 1994, as amended at 66 FR 55583, Nov. 2, 2001]