§ 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.