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Electronic Code of Federal Regulations

e-CFR data is current as of December 4, 2019

Title 40Chapter ISubchapter CPart 63Subpart WWWWW → Subject Group


Title 40: Protection of Environment
PART 63—NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED)
Subpart WWWWW—National Emission Standards for Hospital Ethylene Oxide Sterilizers


Other Requirements and Information

§63.10440   What parts of the General Provisions apply to me?

Table 1 to this subpart shows which parts of the General Provisions in 40 CFR 63.1 through 63.16 apply to you.

§63.10442   Who implements and enforces this subpart?

(a) This subpart can be implemented and enforced by us, the U.S. EPA, or a delegated authority such as your State, local, or tribal agency. If the U.S. EPA Administrator has delegated authority to your State, local, or tribal agency, then that agency has the authority to implement and enforce this subpart. You should contact your U.S. EPA Regional Office to find out if this subpart is delegated to your State, local, or tribal agency.

(b) In delegating implementation and enforcement authority of this subpart to a State, local, or tribal agency under 40 CFR part 63, subpart E, the authorities contained in paragraph (c) of this section are retained by the Administrator of the U.S. EPA and are not transferred to the State, local, or tribal agency.

(c) The authorities that will not be delegated to State, local, or tribal agencies include approval of alternatives to the applicability requirements under 40 CFR 63.10382, the compliance date requirements in 40 CFR 63.10384, and the management practice standards as defined in 40 CFR 63.10390.

§63.10446   Do title V permitting requirements apply to area sources subject to this subpart?

You are exempt from the obligation to obtain a permit under 40 CFR part 70 or 40 CFR part 71, provided you are not otherwise required by law to obtain a permit under 40 CFR 70.3(a) or 40 CFR 71.3(a). Notwithstanding the previous sentence, you must continue to comply with the provisions of this subpart.

§63.10448   What definitions apply to this subpart?

Terms used in this subpart are defined in the Clean Air Act (CAA), in 40 CFR 63.2, and in this section as follows:

Aeration process means any time when ethylene oxide is removed from the aeration unit through the aeration unit vent or from the combination sterilization unit through the sterilization unit vent, while aeration or off-gassing is occurring.

Aeration unit means any vessel that is used to facilitate off-gassing of ethylene oxide.

Air pollution control device means a catalytic oxidizer, acid-water scrubber, or any other air pollution control equipment that reduces the quantity of ethylene oxide in the effluent gas stream from sterilization and aeration processes.

Combination sterilization unit means any enclosed vessel in which both the sterilization process and the aeration process occur within the same vessel, i.e., the vessel is filled with ethylene oxide gas or an ethylene oxide/inert gas mixture for the purpose of sterilizing and is followed by off-gassing of ethylene oxide.

Common aeration time means that items require the same length of time to off-gas ethylene oxide.

Full load means the maximum number of items that does not impede proper air removal, humidification of the load, or sterilant penetration and evacuation in the sterilization unit.

Hospital means a facility that provides medical care and treatment for patients who are acutely ill or chronically ill on an inpatient basis under supervision of licensed physicians and under nursing care offered 24 hours per day. Hospitals include diagnostic and major surgery facilities but exclude doctor's offices, clinics, or other facilities whose primary purpose is to provide medical services to humans or animals on an outpatient basis.

Hospital central services staff means a healthcare professional, including manager and technician, who is either directly involved in or responsible for sterile processing at a hospital.

Medically necessary means circumstances that a hospital central services staff, a hospital administrator, or a physician concludes, based on generally accepted medical practices, necessitate sterilizing without a full load in order to protect human health.

State or local regulation means a regulation at the State or local level that requires a hospital to reduce the quantity of ethylene oxide emissions from ethylene oxide sterilization units.

Sterilization facility means the group of ethylene oxide sterilization units at a hospital using ethylene oxide gas or an ethylene oxide/inert gas mixture for the purpose of sterilizing.

Sterilization process means any time when ethylene oxide is removed from the sterilization unit or combination sterilization unit through the sterilization unit vent.

Sterilization unit means any enclosed vessel that is filled with ethylene oxide gas or an ethylene oxide/inert gas mixture for the purpose of sterilizing. As used in this subpart, the term includes combination sterilization units.

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