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

ICR 201909-2060-012

OMB: 2060-0283

Federal Form Document

Forms and Documents
Supplementary Document
Supporting Statement A
ICR Details
2060-0283 201909-2060-012
Active 201606-2060-010
EPA/OAR 1666.11
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 01/29/2020
Retrieve Notice of Action (NOA) 09/30/2019
Upon resubmission, the agency must update the burden estimates to accurately reflect the number of respondents in industry and verify that there are no reporting or recordkeeping requirements for States in 40 CFR part 63, subpart O. The agency must also ensure that burden is calculated for all of the requirements and that the requirements and burden tables are consistent throughout the supporting statement. The agency must provide screen shots of the electronic mode of collection that is used for this information collection. In addition, the agency must have a burden statement that aligns with the requirements under 5 CFR 1320.8(b)(3) and placement of the OMB control number for on-line submissions on the initial screen per 5 CFR 1320.3(f)(2).
  Inventory as of this Action Requested Previously Approved
01/31/2023 36 Months From Approved 01/31/2020
254 0 248
9,480 0 9,200
698,000 0 681,000

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Commercial Ethylene Oxide Sterilization and Fumigation Operations apply to both new and existing commercial ethylene oxide (EO) sterilization and fumigation facilities using one ton of EO (as defined in 40 CFR section 63.361) after December 6, 1994. New facilities include those that commenced construction or reconstruction after the date of proposal. Owners and operators of these facilities are required to comply with reporting and record keeping requirements for the General Provisions (40 CFR Part 63, Subpart A), as well as for the applicable standards in 40 CFR Part 63, Subpart O. This includes submitting notifications, performance test reports, and periodic reports, as well as maintaining records of continuous parameter monitoring data, any malfunctions, and equipment inspections. These reports are used by EPA to determine compliance with 40 CFR Part 63, Subpart O.

US Code: 42 USC 7401 et.seq Name of Law: Clean Air Act

Not associated with rulemaking

  84 FR 19777 05/06/2019
84 FR 50825 09/26/2019

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 254 248 0 0 6 0
Annual Time Burden (Hours) 9,480 9,200 0 0 280 0
Annual Cost Burden (Dollars) 698,000 681,000 0 0 17,000 0
There is an adjustment increase in the burden in this ICR compared to the previous ICR. The increase is based on an increase in the number of sources subject to the NESHAP due to continued growth in the industry. The increase in the number of sources is also reflected in an increase in operation and maintenance costs.

Patrick Yellin 202 564-2970


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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