(a) All sterilization sources using 1 ton (see definition) in sterilization or fumigation operations are subject to the emissions standards in Sec. 63.362, except as specified in paragraphs (b) through (e) of this section. Owners or operators of sources using 1 ton (see definition) subject to the provisions of this subpart must comply with the requirements of subpart A, of this part according to the applicability of subpart A of this part to such sources in Table 1 of this section.
Table 1 of Section 63.360--General Provisions Applicability to Subpart O----------------------------------------------------------------------------------------------------------------
Applies to sources Applies to sources
Reference using 10 tons in using 1 to 10 tons in Comment
subpart O \a\ subpart O \a\----------------------------------------------------------------------------------------------------------------63.1(a)(1)............................. Yes Additional terms defined
in Sec. 63.361; when
overlap between subparts
A and O occurs, subpart
O takes precedence.63.1(a)(2)............................. Yes63.1(a)(3)............................. Yes63.1(a)(4)............................. Yes Subpart O clarifies the
applicability of each
paragraph in subpart A
to sources subject to
subpart O.63.1(a)(5)............................. No Reserved.63.1(a)(6)............................. Yes63.1(a)(7)............................. Yes63.1.1(a)(8)........................... Yes63.1(a)(9)............................. No Reserved.63.1(a)(10)............................ Yes63.1(a)(11)............................ Yes Sec. 63.366(a) of
subpart O also allows
report submissions via
fax and on electronic
media.63.1(a)(12)-(14)....................... Yes63.1(b)(1)-(2)......................... Yes63.1(b)(3)............................. No Sec. 63.367 clarifies
the applicability of
recordkeeping
requirements for sources
that determine they are
not subject to the
emissions standards.63.1(c)(1)............................. Yes Subpart O clarifies the
applicability of each
paragraph in subpart A
to sources subject to
subpart O in this table.63.1(c)(2)............................. Yes Sec. 63.360(f) exempts
area sources subject to
this subpart from the
obligation to obtain
Title V operating
permits.63.1(c)(3)............................. No Reserved.63.1(c)(4)............................. Yes63.1(c)(5)............................. No Sec. 63.360 specifies
applicability.63.1(d)................................ No Reserved.63.1(e)................................ Yes63.2................................... Yes Additional terms defined
in Sec. 63.361; when
overlap between subparts
A and O occurs, subpart
O takes precedence.63.3................................... Yes Other units used in
subpart O are defined in
the text of subpart O.63.4(a)(1)-(3)......................... Yes63.4(a)(4)............................. No Reserved.63.4(a)(5)............................. Yes63.4(b)................................ Yes63.4(c)................................ Yes63.5(a)................................ No Sec. 63.366(b)(1)
contains applicability
requirements for
constructed or
reconstructed sources.63.5(b)(1)............................. Yes.................. No...................63.5(b)(2)............................. No Reserved.63.5(b)(3)............................. No See Sec. 63.366(b)(2).63.5(b)(4)............................. Yes.................. No...................63.5(b)(5)............................. Yes.................. No...................63.5(b)(6)............................. Yes.................. No...................63.5(c)................................ No Reserved.63.5(d)(1)-(2)......................... No See Sec. 63.366(b)(3).63.5(d)(3)-(4)......................... Yes.................. No...................63.5(e)................................ Yes.................. No...................63.5(f)(1)-(2)......................... No See Sec. 63.366(b)(4).63.6(a)(1)............................. Yes63.6(a)(2)............................. No Sec. 63.360 specifies
applicability.63.6(b)-(c)............................ No Sec. 63.360(g) specifies
compliance dates for
sources.63.6(d)................................ No Reserved.63.6(e)................................ No Subpart O does not
contain any operation
and maintenance plan
requirements.63.6(f)(1)............................. No Sec. 63.362(b) specifies
when the standards
apply.63.6(f)(2)(i).......................... Yes
63.6(f)(2)(ii)......................... No Sec. 63.363 specifies
parameters for
determining compliance.63.6(f)(2)(iii)-(iv)................... Yes63.6(f)(2)(v).......................... No63.6(f)(3)............................. Yes63.6(g)................................ Yes63.6(h)................................ No Subpart O does not
contain any opacity or
visible emission
standards.63.6(i)(1)-(14)........................ Yes63.6(i)(15)............................ No Reserved63.6(i)(16)............................ Yes63.6(j)................................ Yes63.7(a)(1)............................. Yes63.7(a)(2)............................. Yes63.7(a)(3)............................. Yes63.7(b)................................ Yes63.7(c)................................ Yes.................. No...................63.7(d)................................ Yes.................. No...................63.7(e)................................ Yes Sec. 63.365 also
contains test methods
specific to sources
subject to the emissions
standards.63.7(f)................................ Yes63.7(g)(1)............................. Yes63.7(g)(2)............................. No Reserved63.7(g)(3)............................. Yes63.7(h)................................ Yes63.8(a)(1)............................. Yes63.8(a)(2)............................. Yes63.8(a)(3)............................. No Reserved63.8(a)(4)............................. Yes63.8(b)(1)............................. Yes63.8(b)(2)............................. Yes63.8(b)(3)............................. No63.8(c)(1) (i)-(ii).................... No A startup, shutdown, and
malfunction plan is not
required for these
standards.63.8(c)(1)(iii)........................ Yes63.8(c)(2)-(3)......................... Yes63.8(c)(4)-(5)......................... No Frequency of monitoring
measurements is provided
in Sec. 63.364; opacity
monitors are not
required for these
standards.63.8(c)(6)............................. No Performance
specifications for gas
chromatographs and
temperature monitors are
contained in Sec.
63.365.63.8(c)(7)(i)(A)-(B)................... No Performance
specifications for gas
chromatographs and
temperature monitors are
contained in Sec.
63.365.63.8(c)(7)(i)(C)....................... No Opacity monitors are not
required for these
standards.63.8(c)(7)(ii)......................... No Performance
specifications for gas
chromatographs and
temperature monitors are
contained in Sec.
63.365.63.8(c)(8)............................. No63.8(d)................................ Yes.................. No...................63.8(e)(1)............................. Yes63.8(e)(2)............................. Yes63.8(e)(3)............................. Yes.................. No...................63.8(e)(4)............................. Yes63.8(e)(5)(i).......................... Yes63.8(e)(5)(ii)......................... No Opacity monitors are not
required for these
standards.63.8(f)(1)-(5)......................... Yes63.8(f)(6)............................. No63.8(g)(1)............................. Yes63.8(g)(2)............................. No63.8(g)(3)-(5)......................... Yes63.9(a)................................ Yes63.9(b)(1)-(i)......................... Yes
63.9(b)(1)(ii)-(iii)................... No Sec. 63.366(c)(1)(i)
contains language for
sources that increase
usage such that the
source becomes subject
to the emissions
standards.63.9(b)(2)-(3)......................... Yes Sec. 63.366(c)(3)
contains additional
information to be
included in the initial
report for existing and
new sources.63.9(b)(4)-(5)......................... No Sec. 63.366(c)(1)(ii)
and (iii) contains
requirements for new or
reconstructed sources
subject to the emissions
standards.63.9(c)................................ Yes63.9(d)................................ No63.9(e)................................ Yes63.9(f)................................ No Opacity monitors are not
required for these
standards.63.9(g)(1)............................. Yes63.9(g)(2)-(3)......................... No Opacity monitors and
relative accuracy
testing are not required
for these standards.63.9(h)(1)-(3)......................... Yes63.9(h)(4)............................. No Reserved.63.9(h)(5)............................. No Sec. 63.366(c)(2)
instructs sources to
submit actual data.63.9(h)(6)............................. Yes63.9(i)................................ Yes63.9(j)................................ Yes63.10(a)............................... Yes63.10(b)(1)............................ Yes63.10(b)(2)(i)......................... No Not applicable due to
batch nature of the
industry.63.10(b)(2)(ii)........................ Yes63.10(b)(2)(iii)....................... No63.10(b)(2)(iv)-(v).................... No A startup, shutdown, and
malfunction plan is not
required for these
standards.63.10(b)(2)(vi)-(xii).................. Yes63.10(b)(2)(xiii)...................... No63.10(b)(2)(xiv)....................... Yes63.10(b)(3)............................ No Sec. 63.367 (b) and (c)
contains applicability
determination
requirements.63.10(c)(1)............................ Yes63.10(c)(2)-(4)........................ No Reserved.63.10(c)(5)............................ Yes63.10(c)(6)............................ No63.10(c)(7)............................ No Not applicable due to
batch nature of the
industry.63.10(c)(8)............................ Yes63.10(c)(9)............................ No63.10(c)(10)-(13)...................... Yes63.10(c)(14)........................... Yes.................. No...................63.10(c)(15)........................... No A startup, shutdown, and
malfunction plan is not
required for these
standards.63.10(d)(1)............................ Yes63.10(d)(2)............................ Yes63.10(d)(3)............................ No Subpart O does not
contain opacity or
visible emissions
standards.63.10(d)(4)............................ Yes63.10(d)(5)............................ No A startup, shutdown, and
malfunction plan is not
required for these
standards.63.10(e)(1)............................ Yes63.10(e)(2)(i)......................... Yes63.10(e)(2)(ii)........................ No Opacity monitors are not
required for these
standards.63.10(e)(3)(i)-(iv).................... Yes63.10(e)(3)(v)......................... No Sec. 63.366(a)(3)
specifies contents and
submittal dates for
excess emissions and
monitoring system
performance reports.
63.10(e)(3)(vi)-(viii)................. Yes63.10(e)(4)............................ No Opacity monitors are not
required for these
standards.63.10(f)............................... Yes63.11.................................. Yes63.12-63.15............................ Yes----------------------------------------------------------------------------------------------------------------\a\ See definition.
(b) Sterilization sources using less than 1 ton (see definition) are not subject to the emissions standards in Sec. 63.362. The recordkeeping requirements of Sec. 63.367(c) apply.
(c) This subpart does not apply to beehive fumigators.
(d) This subpart does not apply to research or laboratory facilities as defined in section 112(c)(7) of title III of the Clean Air Act Amendment of 1990.
(e) This subpart does not apply to ethylene oxide sterilization operations at stationary sources such as hospitals, doctors offices, clinics, or other facilities whose primary purpose is to provide medical services to humans or animals.
(f) If you are an owner or operator of an area source subject to this subpart, you are exempt from the obligation to obtain a permit under 40 CFR part 70 or 71, provided you are not required to obtain a permit under 40 CFR 70.3(a) or 71.3(a) for a reason other than your status as an area source under this subpart. Notwithstanding the previous sentence, you must continue to comply with the provisions of this subpart applicable to area sources.
(g) The owner or operator shall comply with the provisions of this subpart as follows:
(1) All sterilization chamber vents subject to the emissions standards in Sec. 63.362 with an initial startup date before December 6, 1998, no later than December 6, 1998.
(2) All sterilization chamber vents subject to the emissions standards in Sec. 63.362 with an initial startup date on or after December 6, 1998, immediately upon initial startup of the source.
(3) All sterilization chamber vents at sources using less than 1 ton of ethylene oxide that increase their ethylene oxide usage after December 6, 1998 such that the sterilization chamber vent becomes subject to the emissions standards in Sec. 63.362(c), immediately upon becoming subject to the emission standards.
(4) All aeration room vents subject to the emissions standards in Sec. 63.362 with an initial startup date before December 6, 2000, no later than December 6, 2000.
(5) All aeration room vents subject to the emissions standards in Sec. 63.362 with an initial startup date on or after December 6, 2000, immediately upon initial startup of the source.
(6) All aeration room vents at sources using less than 10 tons that increase their ethylene oxide usage after December 6, 2000, such that the aeration room vents become subject to the emissions standards in Sec. 63.362, immediately upon becoming subject to the emission standards.
(7)-(10) [Reserved] [59 FR 62589, Dec. 6, 1994, as amended at 61 FR 27788, June 3, 1996; 63 FR 66994, Dec. 4, 1998; 64 FR 67793, Dec. 3, 1999; 64 FR 69643, Dec. 14, 1999; 66 FR 55582, Nov. 2, 2001; 70 FR 75345, Dec. 19, 2005]