40 CFR § 63.10382
Am I subject to this subpart?
June 9, 2020
(a) You are subject to this subpart if you own or operate an ethylene oxide sterilization facility at a hospital that is an area source of hazardous air pollutant (HAP) emissions.
(b) The affected source subject to this subpart is each new or existing sterilization facility.
(1) An affected source is existing if you commenced construction or reconstruction of the affected source before November 6, 2006.
(2) An affected source is new if you commenced construction or reconstruction of the affected source on or after November 6, 2006.