NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR part 63, subpart O) (Renewal)

ICR 201606-2060-010

OMB: 2060-0283

Federal Form Document

Forms and Documents
Supplementary Document
Supporting Statement A
ICR Details
2060-0283 201606-2060-010
Historical Active 201306-2060-016
EPA/OAR 1666.10
NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR part 63, subpart O) (Renewal)
Extension without change of a currently approved collection   No
Approved without change 11/16/2016
Retrieve Notice of Action (NOA) 08/30/2016
  Inventory as of this Action Requested Previously Approved
11/30/2019 36 Months From Approved 11/30/2016
248 0 242
9,200 0 8,887
681,000 0 664,500

The affected entities are subject to the General Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes, or additions to the Provisions specified at 40 CFR part 63, subpart O. Owners or operators of the affected facilities must submit initial notification, performance tests, and periodic reports and results. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. Reports, at a minimum, are required semiannually.

US Code: 44 USC 3501 et.seq Name of Law: Clean Air Act

Not associated with rulemaking

  80 FR 32116 06/05/2015
81 FR 59215 08/29/2016

IC Title Form No. Form Name
NESHAP for Ethylene Oxide Emissions from Sterilization Facilies (40 CFR Part 63, Subpart 0)(Renewal)

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 248 242 0 0 6 0
Annual Time Burden (Hours) 9,200 8,887 0 0 313 0
Annual Cost Burden (Dollars) 681,000 664,500 0 0 16,500 0
There is an adjustment increase in respondent burden in this ICR from the most recently approved ICR. This is due to several reasons: 1) this ICR assumes all existing sources will have to re-familiarize with the regulatory requirements each year; 2) there is an estimated increase in the respondent universe since the last ICR, with an addition of two new sources per year; and 3) the number of responses associated with waiver request and alternative method/monitoring was corrected for consistency. This results in an increase in the labor hours, costs, and total number of responses.

Patrick Yellin 202 564-2970 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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