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e-CFR data is current as of August 6, 2020

Title 40Chapter ISubchapter CPart 63Subpart WWWWW → Subject Group

Title 40: Protection of Environment
Subpart WWWWW—National Emission Standards for Hospital Ethylene Oxide Sterilizers

Notifications, Reports, and Records

§63.10430   What notifications must I submit and by when?

(a) You must submit an Initial Notification of Compliance Status that includes the information required in paragraphs (a)(1) through (5) of this section and the applicable certification in §63.10400.

(1) The name and address of the owner or operator.

(2) The address (i.e., physical location) of the affected source.

(3) An identification of the standard and other applicable requirements in this subpart that serve as the basis of the notification and the source's compliance date.

(4) A brief description of the sterilization facility, including the number of ethylene oxide sterilizers, the size (volume) of each, the number of aeration units, if any, the amount of annual ethylene oxide usage at the facility, the control technique used for each sterilizer, and typical number of sterilization cycles per year.

(5) A statement that the affected source is an area source.

(b) You must submit the Initial Notification of Compliance Status to the appropriate authority(ies) specified in §63.9(a)(4). In addition, you must submit a copy of the Initial Notification of Compliance Status to EPA's Office of Air Quality Planning and Standards. Send your notification via e-mail to [email protected] or via U.S. mail or other mail delivery service to U.S. EPA, Sector Policies and Programs Division, Coatings and Chemicals Group (E143-01), Attn: Hospital Sterilizers Project Leader, Research Triangle Park, NC 27711.

(c) You must submit the Initial Notification of Compliance Status no later than 180 calendar days after your compliance date, consistent with §63.10402.

§63.10432   What records must I keep?

You must keep the records specified in paragraphs (a) and (b) of this section.

(a) A copy of the Initial Notification of Compliance Status that you submitted to comply with this subpart.

(b) Records required by §63.10420 for each sterilization unit not equipped with an air pollution control device.

§63.10434   In what form and for how long must I keep my records?

(a) Your records must be in a form suitable and readily available for expeditious review.

(b) You must keep each record for 5 years following the date of each record.

(c) You must keep each record onsite for at least 2 years after the date of each record. You may keep the records offsite for the remaining 3 years.

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