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

Forms and Documents

Document Name	Status
Copy of 1666_10 burden estimates.xlsx Supplementary Document	2016-06-21
1666ss10.docx Supporting Statement A	2016-06-21

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: 201606-2060-010
Status: Historical Active	Previous ICR Reference No: 201306-2060-016
Agency/Subagency: EPA/OAR	Agency Tracking No: 1666.10
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: 11/16/2016
	Date Received in OIRA: 08/30/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2019	36 Months From Approved	11/30/2016
Responses	248	0	242
Time Burden (Hours)	9,200	0	8,887
Cost Burden (Dollars)	681,000	0	664,500

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Abstract: 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.

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Authorizing Statute(s): US Code: 44 USC 3501 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:
	80 FR 32116	06/05/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 59215	08/29/2016
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	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

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 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.

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Annual Cost to Federal Government: $28,500

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 08/30/2016

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