---
kind: "section"
citation: "40 C.F.R. § 63.10400"
title: "40"
number: "63.10400"
heading: "How do I demonstrate initial compliance?"
url: "https://uscodex.org/cfr/40/63.10400"
---

# §63.10400. How do I demonstrate initial compliance?

- (a) Except as provided in paragraphs [(b)](#b) and [(c)](#c) of this section, you must demonstrate initial compliance with the management practice standard in [§ 63.10390](/cfr/40/63.10390.md) by submitting an Initial Notification of Compliance Status certifying that you are sterilizing full loads of items having a common aeration time except under medically necessary circumstances.
- (b) If you operate your sterilization unit(s) with an air pollution control device pursuant to a State or local regulation, you may demonstrate initial compliance with [§ 63.10390](/cfr/40/63.10390.md) by submitting an Initial Notification of Compliance Status certifying that you are operating the sterilization unit in accordance with your State or local regulation and following control device manufacturer's recommended procedures.
- (c) If you operate your sterilization unit(s) with an air pollution control device but are not subject to any State or local regulation, you may demonstrate initial compliance with [§ 63.10390](/cfr/40/63.10390.md) by submitting an Initial Notification of Compliance Status certifying that you are venting the ethylene oxide emissions from each sterilization unit to an add-on air pollution control device. You must certify that you are operating the control device during all sterilization processes and in accordance with manufacturer's recommended procedures.

## Notes

### Source

Source: 72 FR 73623, Dec. 28, 2007, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 7401 et seq.

### Source

Source: 57 FR 61992, Dec. 29, 1992, unless otherwise noted.