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

Forms and Documents

Document Name	Status
1666t11.xlsx Supplementary Document	2019-09-30
1666ss11.docx Supporting Statement A	2019-09-23

IC Document Collections

IC ID	Document Title	Status
24382	NESHAP for Ethylene Oxide Emissions from Sterilization Facilies (40 CFR Part 63, Subpart 0)(Renewal)	Modified

ICR Details

OMB Control No: 2060-0283	ICR Reference No: 201909-2060-012
Status: Active	Previous ICR Reference No: 201606-2060-010
Agency/Subagency: EPA/OAR	Agency Tracking No: 1666.11
Title: NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR part 63, subpart O) (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/29/2020
	Date Received in OIRA: 09/30/2019
Terms of Clearance: 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
Expiration Date	01/31/2023	36 Months From Approved	01/31/2020
Responses	254	0	248
Time Burden (Hours)	9,480	0	9,200
Cost Burden (Dollars)	698,000	0	681,000

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 7401 et.seq Name of Law: Clean Air Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 19777	05/06/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 50825	09/26/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $698,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 09/30/2019

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