Section 63.360 - Applicability(a) You are subject to the 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.(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.(h) This subpart does not apply to EtO sterilization operations at stationary sources such as hospitals, doctor's offices, clinics, or other facilities whose primary purpose is to provide medical or dental services to humans or animals.(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.(j) You must comply with the provisions of this subpart no later than the dates specified in paragraphs (j)(1) through (17) of this section: (1) 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.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 85 FR 73889 , 1/19/2021; 89 FR 24172 , 4/5/2024