(a) All sterilization sources using 1 ton (see definition) in sterilization or fumigation operations are subject to the emissions standards in § 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
| Reference | Applies to sources using 10 tons in subpart Oa | Applies to sources using 1 to 10 tons in subpart Oa | Comment |
|---|---|---|---|
| 63.1(a)(1) | Yes | Additional terms defined in § 63.361; when overlap between subparts A and O occurs, subpart O takes precedence. | |
| 63.1(a)(2) | Yes | ||
| 63.1(a)(3) | Yes | ||
| 63.1(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) | Yes | ||
| 63.1(a)(7) | Yes | ||
| 63.1.1(a)(8) | Yes | ||
| 63.1(a)(9) | No | Reserved. | |
| 63.1(a)(10) | Yes | ||
| 63.1(a)(11) | Yes | § 63.366(a) of subpart O also allows report submissions via fax and on electronic media. | |
| 63.1(a)(12)-(14) | Yes | ||
| 63.1(b)(1)-(2) | Yes | ||
| 63.1(b)(3) | No | § 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 | § 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) | Yes | ||
| 63.1(c)(5) | No | § 63.360 specifies applicability. | |
| 63.1(c)(6) | Yes | ||
| 63.1(d) | No | Reserved. | |
| 63.1(e) | Yes | ||
| 63.2 | Yes | Additional terms defined in § 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) | Yes | ||
| 63.4(a)(4) | No | Reserved. | |
| 63.4(a)(5) | Yes | ||
| 63.4(b) | Yes | ||
| 63.4(c) | Yes | ||
| 63.5(a) | No | § 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 § 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 § 63.366(b)(3). | |
| 63.5(d)(3)-(4) | Yes | No | |
| 63.5(e) | Yes | No | |
| 63.5(f)(1)-(2) | No | See § 63.366(b)(4). | |
| 63.6(a)(1) | Yes | ||
| 63.6(a)(2) | No | § 63.360 specifies applicability. | |
| 63.6(b)-(c) | No | § 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 | § 63.362(b) specifies when the standards apply. | |
| 63.6(f)(2)(i) | Yes | ||
| 63.6(f)(2)(ii) | No | § 63.363 specifies parameters for determining compliance. | |
| 63.6(f)(2)(iii)-(iv) | Yes | ||
| 63.6(f)(2)(v) | No | ||
| 63.6(f)(3) | Yes | ||
| 63.6(g) | Yes | ||
| 63.6(h) | No | Subpart O does not contain any opacity or visible emission standards. | |
| 63.6(i)(1)-(14) | Yes | ||
| 63.6(i)(15) | No | Reserved | |
| 63.6(i)(16) | Yes | ||
| 63.6(j) | Yes | ||
| 63.7(a)(1) | Yes | ||
| 63.7(a)(2) | Yes | ||
| 63.7(a)(3) | Yes | ||
| 63.7(b) | Yes | ||
| 63.7(c) | Yes | No | |
| 63.7(d) | Yes | No | |
| 63.7(e) | Yes | § 63.365 also contains test methods specific to sources subject to the emissions standards. | |
| 63.7(f) | Yes | ||
| 63.7(g)(1) | Yes | ||
| 63.7(g)(2) | No | Reserved | |
| 63.7(g)(3) | Yes | ||
| 63.7(h) | Yes | ||
| 63.8(a)(1) | Yes | ||
| 63.8(a)(2) | Yes | ||
| 63.8(a)(3) | No | Reserved | |
| 63.8(a)(4) | Yes | ||
| 63.8(b)(1) | Yes | ||
| 63.8(b)(2) | Yes | ||
| 63.8(b)(3) | No | ||
| 63.8(c)(1) (i)-(ii) | No | A startup, shutdown, and malfunction plan is not required for these standards. | |
| 63.8(c)(1)(iii) | Yes | ||
| 63.8(c)(2)-(3) | Yes | ||
| 63.8(c)(4)-(5) | No | Frequency of monitoring measurements is provided in § 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 § 63.365. | |
| 63.8(c)(7)(i)(A)-(B) | No | Performance specifications for gas chromatographs and temperature monitors are contained in § 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 § 63.365. | |
| 63.8(c)(8) | No | ||
| 63.8(d) | Yes | No | |
| 63.8(e)(1) | Yes | ||
| 63.8(e)(2) | Yes | ||
| 63.8(e)(3) | Yes | No | |
| 63.8(e)(4) | Yes | ||
| 63.8(e)(5)(i) | Yes | ||
| 63.8(e)(5)(ii) | No | Opacity monitors are not required for these standards. | |
| 63.8(f)(1)-(5) | Yes | ||
| 63.8(f)(6) | No | ||
| 63.8(g)(1) | Yes | ||
| 63.8(g)(2) | No | ||
| 63.8(g)(3)-(5) | Yes | ||
| 63.9(a) | Yes | ||
| 63.9(b)(1)-(i) | Yes | ||
| 63.9(b)(1)(ii)-(iii) | No | § 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 | § 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 | § 63.366(c)(1)(ii) and (iii) contains requirements for new or reconstructed sources subject to the emissions standards. | |
| 63.9(c) | Yes | ||
| 63.9(d) | No | ||
| 63.9(e) | Yes | ||
| 63.9(f) | No | Opacity monitors are not required for these standards. | |
| 63.9(g)(1) | Yes | ||
| 63.9(g)(2)-(3) | No | Opacity monitors and relative accuracy testing are not required for these standards. | |
| 63.9(h)(1)-(3) | Yes | ||
| 63.9(h)(4) | No | Reserved. | |
| 63.9(h)(5) | No | § 63.366(c)(2) instructs sources to submit actual data. | |
| 63.9(h)(6) | Yes | ||
| 63.9(i) | Yes | ||
| 63.9(j) | Yes | ||
| 63.9(k) | Yes | Only as specified in § 63.9(j). | |
| 63.10(a) | Yes | ||
| 63.10(b)(1) | Yes | ||
| 63.10(b)(2)(i) | No | Not applicable due to batch nature of the industry. | |
| 63.10(b)(2)(ii) | Yes | ||
| 63.10(b)(2)(iii) | No | ||
| 63.10(b)(2)(iv)-(v) | No | A startup, shutdown, and malfunction plan is not required for these standards. | |
| 63.10(b)(2)(vi)-(xii) | Yes | ||
| 63.10(b)(2)(xiii) | No | ||
| 63.10(b)(2)(xiv) | Yes | ||
| 63.10(b)(3) | No | § 63.367 (b) and (c) contains applicability determination requirements. | |
| 63.10(c)(1) | Yes | ||
| 63.10(c)(2)-(4) | No | Reserved. | |
| 63.10(c)(5) | Yes | ||
| 63.10(c)(6) | No | ||
| 63.10(c)(7) | No | Not applicable due to batch nature of the industry. | |
| 63.10(c)(8) | Yes | ||
| 63.10(c)(9) | No | ||
| 63.10(c)(10)-(13) | Yes | ||
| 63.10(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) | Yes | ||
| 63.10(d)(2) | Yes | ||
| 63.10(d)(3) | No | Subpart O does not contain opacity or visible emissions standards. | |
| 63.10(d)(4) | Yes | ||
| 63.10(d)(5) | No | A startup, shutdown, and malfunction plan is not required for these standards. | |
| 63.10(e)(1) | Yes | ||
| 63.10(e)(2)(i) | Yes | ||
| 63.10(e)(2)(ii) | No | Opacity monitors are not required for these standards. | |
| 63.10(e)(3)(i)-(iv) | Yes | ||
| 63.10(e)(3)(v) | No | § 63.366(a)(3) specifies contents and submittal dates for excess emissions and monitoring system performance reports. | |
| 63.10(e)(3)(vi)-(viii) | Yes | ||
| 63.10(e)(4) | No | Opacity monitors are not required for these standards. | |
| 63.10(f) | Yes | ||
| 63.11 | Yes | ||
| 63.12-63.15 | Yes | ||
(b) Sterilization sources using less than 1 ton (see definition) are not subject to the emissions standards in § 63.362. The recordkeeping requirements of § 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 § 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 § 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 § 63.362(c), immediately upon becoming subject to the emission standards.
(4) All aeration room vents subject to the emissions standards in § 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 § 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 § 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; 85 FR 73889, Nov. 19, 2020]