40 CFR 63.10400 - How do I demonstrate initial compliance?

Beta! The text on the eCFR tab represents the unofficial eCFR text at ecfr.gov.
§ 63.10400 How do I demonstrate initial compliance?

(a) Except as provided in paragraphs (b) and (c) of this section, you must demonstrate initial compliance with the management practice standard in § 63.10390 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 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 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.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 40 published on 2015-07-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 40 CFR Part 63 after this date.

  • 2015-12-07; vol. 80 # 234 - Monday, December 7, 2015
    1. 80 FR 76152 - National Emission Standards for Aerospace Manufacturing and Rework Facilities Risk and Technology Review
      GPO FDSys XML | Text
      ENVIRONMENTAL PROTECTION AGENCY
      Final rule.
      This final action is effective on December 7, 2015.
      40 CFR Part 63