Ethylene Oxide Commercial Sterilization Facilities National Emission Standards for Hazardous Air Pollutants (NESHAP) Technology Review (New)

Forms and Documents

Document Name	Status
Ethylene Oxide Commercial Sterilization Facilities Form and Instruction	New
2623t01.xlsx Supplementary Document	2021-05-10
2623ss01.docx Supporting Statement A	2021-05-10

IC Document Collections

IC ID	Document Title	Status
247273	Ethylene Oxide Commercial Sterilization Facilities Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202105-2060-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: EPA/OAR	Agency Tracking No: 2623.01
Title: Ethylene Oxide Commercial Sterilization Facilities National Emission Standards for Hazardous Air Pollutants (NESHAP) Technology Review (New)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/10/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	61	0
Time Burden (Hours)	6,573	0
Cost Burden (Dollars)	920	0

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Abstract: This information collection is being conducted by EPA's Office of Air and Radiation (OAR) pursuant to section 114 of the Clean Air Act, as amended (CAA or the Act), to inform an upcoming rule reviewing the national emissions standards for hazardous air pollutants (NESHAP) for ethylene oxide (EtO) commercial sterilization aimed at reducing emissions and updating the standards to reflect developments in practices, processes, and control technologies as required by CAA section 112(d)(6). This is a one-time information collection. The NESHAP for EtO Commercial Sterilization and Fumigation Operations were finalized in December 1994 (59 FR 62585) at 40 CFR part 63, subpart O. The EPA completed a residual risk and technology review for the NESHAP in 2006 and concluded, at that time, that no revisions to the standards were necessary (71 FR 17712, April 7, 2006).

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Authorizing Statute(s): None

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:
	85 FR 35931	06/12/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 24862	05/10/2021
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
Ethylene Oxide Commercial Sterilization Facilities	NA, NA, NA, NA	Ethylene Oxide (EtO) Commercial Sterilization Main ,   Ethylene Oxide (EtO) Commercial Sterilization Questionnaire - Supplement 1 ,   Ethylene Oxide (EtO) Commercial Sterilization Questionnaire - Supplement 2 ,   Ethylene Oxide (EtO) Commercial Sterilization Questionnaire - Supplement 3

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ICR Summary of Burden

	Total Request	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	61	0	0	61	0	0
Annual Time Burden (Hours)	6,573	0	0	6,573	0	0
Annual Cost Burden (Dollars)	920	0	0	920	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new collection.

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Annual Cost to Federal Government: $92,579

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? No

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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: 05/10/2021

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