40 CFR 63.10400 - How do I demonstrate initial compliance?

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§ 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.

Title 40 published on 2014-07-01

The following are only the Rules published in the Federal Register after the published date of Title 40.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-08-15; vol. 79 # 158 - Friday, August 15, 2014
    1. 79 FR 48072 - NESHAP for Reciprocating Internal Combustion Engines; NSPS for Stationary Internal Combustion Engines
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      ENVIRONMENTAL PROTECTION AGENCY
      Notice of final decision on reconsideration.
      Effective August 15, 2014. Any petitions for review of the letters announcing the EPA's decision not to propose changes to the regulations in response to the public comments received on the three issues under reconsideration described in this Notice must be filed in the U.S. Court of Appeals for the District of Columbia Circuit by October 14, 2014.
      40 CFR Parts 60 and 63

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United States Code

Title 40 published on 2014-07-01

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

  • 2014-08-15; vol. 79 # 158 - Friday, August 15, 2014
    1. 79 FR 48072 - NESHAP for Reciprocating Internal Combustion Engines; NSPS for Stationary Internal Combustion Engines
      GPO FDSys XML | Text
      ENVIRONMENTAL PROTECTION AGENCY
      Notice of final decision on reconsideration.
      Effective August 15, 2014. Any petitions for review of the letters announcing the EPA's decision not to propose changes to the regulations in response to the public comments received on the three issues under reconsideration described in this Notice must be filed in the U.S. Court of Appeals for the District of Columbia Circuit by October 14, 2014.
      40 CFR Parts 60 and 63