§ 63.360 - Applicability.

§ 63.360 Applicability.

(a) All sterilization sources using 1 ton (see definition) in sterilization or fumigation operations You 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 O^a Applies to sources using 1 to 10 tons in subpart O^a Comment 63.1(a)(1)YesAdditional 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)YesSubpart O clarifies the applicability of each paragraph in subpart A to sources subject to subpart O. 63.1(a)(5)NoReserved. 63.1(a)(6)Yes 63.1(a)(7)Yes 63.1.1(a)(8)Yes 63.1(a)(9)NoReserved. 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)YesSubpart 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)NoReserved. 63.1(c)(4)Yes 63.1(c)(5)No§ 63.360 specifies applicability. 63.1(c)(6)Yes 63.1(d)NoReserved. 63.1(e)Yes 63.2YesAdditional terms defined in § 63.361; when overlap between subparts A and O occurs, subpart O takes precedence. 63.3YesOther units used in subpart O are defined in the text of subpart O. 63.4(a)(1)-(3)Yes 63.4(a)(4)NoReserved. 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)YesNo 63.5(b)(2)NoReserved. 63.5(b)(3)NoSee § 63.366(b)(2). 63.5(b)(4)YesNo 63.5(b)(5)YesNo 63.5(b)(6)YesNo 63.5(c)NoReserved. 63.5(d)(1)-(2)NoSee § 63.366(b)(3). 63.5(d)(3)-(4)YesNo 63.5(e)YesNo 63.5(f)(1)-(2)NoSee § 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)NoReserved. 63.6(e)NoSubpart 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)NoSubpart O does not contain any opacity or visible emission standards. 63.6(i)(1)-(14)Yes 63.6(i)(15)NoReserved 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)YesNo 63.7(d)YesNo 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)NoReserved 63.7(g)(3)Yes 63.7(h)Yes 63.8(a)(1)Yes 63.8(a)(2)Yes 63.8(a)(3)NoReserved 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)NoA 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)NoFrequency of monitoring measurements is provided in § 63.364; opacity monitors are not required for these standards. 63.8(c)(6)NoPerformance specifications for gas chromatographs and temperature monitors are contained in § 63.365. 63.8(c)(7)(i)(A)-(B)NoPerformance specifications for gas chromatographs and temperature monitors are contained in § 63.365. 63.8(c)(7)(i)(C)NoOpacity monitors are not required for these standards. 63.8(c)(7)(ii)NoPerformance specifications for gas chromatographs and temperature monitors are contained in § 63.365. 63.8(c)(8)No 63.8(d)YesNo 63.8(e)(1)Yes 63.8(e)(2)Yes 63.8(e)(3)YesNo 63.8(e)(4)Yes 63.8(e)(5)(i)Yes 63.8(e)(5)(ii)NoOpacity 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)NoOpacity monitors are not required for these standards. 63.9(g)(1)Yes 63.9(g)(2)-(3)NoOpacity monitors and relative accuracy testing are not required for these standards. 63.9(h)(1)-(3)Yes 63.9(h)(4)NoReserved. 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)YesOnly as specified in § 63.9(j). 63.10(a)Yes 63.10(b)(1)Yes 63.10(b)(2)(i)NoNot 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)NoA 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)NoReserved. 63.10(c)(5)Yes 63.10(c)(6)No 63.10(c)(7)NoNot 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)YesNo 63.10(c)(15)NoA 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)NoSubpart O does not contain opacity or visible emissions standards. 63.10(d)(4)Yes 63.10(d)(5)NoA 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)NoOpacity 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)NoOpacity monitors are not required for these standards. 63.10(f)Yes 63.11Yes 63.12-63.15Yes

^a See definition.

(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)

requirements of this subpart if you own or operate a sterilization facility that has an affected source specified in paragraph (b) of this section. Table 6 to this subpart shows which parts of the General Provisions in §§ 63.1 through 63.15 apply to you.

(b) The affected sources subject to this subpart are:

(1) Each SCV at any sterilization facility;

(2) Each ARV at any sterilization facility;

(3) Each CEV at any sterilization facility;

(4) The collection of all Group 1 room air emissions at any sterilization facility; and

(5) The collection of all Group 2 room air emissions at any sterilization facility.

(c) An existing affected source is one the construction or reconstruction of which was commenced on or before April 13, 2023.

(d) A new affected source is one the construction or reconstruction of which is commenced after April 13, 2023.

(e) An SCV, ARV, or CEV is reconstructed if you meet the reconstruction criteria as defined in § 63.2, and if you commence reconstruction after April 13, 2023.

(f) This subpart does not apply to beehive fumigators.

(

d

g) 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

h) This subpart does not apply to

ethylene oxide

EtO sterilization operations at stationary sources such as hospitals,

doctors

doctor's offices, clinics, or other facilities whose primary purpose is to provide medical or dental services to humans or animals.

(

f

i) 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

j) You must comply with the provisions of this subpart

as follows

no later than the dates specified in paragraphs (j)(1) through (17) of this section:

(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]

If you own or operate an existing affected source, you must comply with the applicable provisions of this subpart no later than the dates specified in tables 1 through 5 to this subpart, as applicable.

(2) If you own or operate a new affected source, and the initial startup of your affected source is on or before April 5, 2024, you must comply with the provisions of this subpart no later than April 5, 2024.

(3) If you own or operate a new affected source, and the initial startup is after April 5, 2024, you must comply with the provisions of this subpart upon startup of your affected source.

(4) If existing SCV, ARV, or CEV or parts of an existing collection of Group 1 or Group 2 room air emissions are replaced such that the replacement meets the definition of reconstruction in § 63.2 and the reconstruction commenced after April 13, 2023, then the existing affected source becomes a new affected source. The reconstructed source must comply with the requirements for a new affected source upon initial startup of the reconstructed source or by April 5, 2024, whichever is later.

(5) All existing SCVs at facilities that meet or exceed 1 tpy of EtO use within any consecutive 12-month period after April 7, 2025, that increase their EtO use after April 6, 2026, such that the SCV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(6) All existing SCVs at facilities that do not exceed 1 tpy of EtO use within any consecutive 12-month period after April 6, 2026, that increase their EtO use thereafter, such that the SCV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(7) All new SCVs at facilities that increase their EtO use over a year after startup such that the SCV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(8) All existing ARVs at facilities that meet or exceed 10 tpy of EtO use within any consecutive 12-month period after April 7, 2025, that increase their EtO use after April 6, 2026, such that the ARV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(9) All existing ARVs at facilities that do not exceed 10 tpy of EtO use within any consecutive 12-month period after April 6, 2026, that increase their EtO use after thereafter, such that the ARV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(10) All new ARVs at facilities that increase their EtO use over a year after startup such that the ARV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(11) All existing CEVs at facilities that do not exceed 60 tpy of EtO use within any consecutive 12-month period after April 6, 2026, that increase their EtO use thereafter, such that the CEV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(12) All new CEVs at facilities that increase their EtO use over a year after startup such that the CEV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(13) All existing collections of Group 1 room air emissions at facilities that do not exceed 40 tpy of EtO use within any consecutive 12-month period after April 6, 2026, that increase their EtO use thereafter, such that the collection of Group 1 room air emissions becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(14) All new Group 1 room air emissions at facilities that increase their EtO use over a year after startup such that the Group 1 room air emissions become subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(15) All existing collections of Group 2 room air emissions at facilities that meet or exceed 4 tpy of EtO use within any consecutive 12-month period after April 7, 2025, that increase their EtO use after April 6, 2026, such that the collection of Group 2 room air emissions becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(16) All existing collections of Group 2 room air emissions at facilities that do not exceed 4 tpy of EtO use within any consecutive 12-month period after April 6, 2026, that increase their EtO use thereafter, such that the collection of Group 2 room air emissions becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.

(17) All new Group 2 room air emissions at facilities that increase their EtO use over a year after startup such that the Group 2 room air emissions become subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.