View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
2060-0283
ICR Reference No:
202211-2060-002
Status:
Active
Previous ICR Reference No:
201909-2060-012
Agency/Subagency:
EPA/OAR
Agency Tracking No:
1666.12
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 with change
Conclusion Date:
06/17/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/23/2022
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is approved for three years.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2027
36 Months From Approved
06/30/2024
Responses
175
0
254
Time Burden (Hours)
6,640
0
9,480
Cost Burden (Dollars)
534,000
0
698,000
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.
Authorizing Statute(s):
US Code:
42 USC 7401 et.seq
Name of Law: Clean Air Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
87 FR 20487
04/08/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 71633
11/23/2022
Did the Agency receive public comments on this ICR?
No
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)
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
175
254
0
0
-79
0
Annual Time Burden (Hours)
6,640
9,480
0
0
-2,840
0
Annual Cost Burden (Dollars)
534,000
698,000
0
0
-164,000
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 a decrease in the total estimated respondent burden compared with the ICR currently approved by OMB. The adjustment decrease in burden from the most-recently approved ICR is due to a decrease in the number of sources. The previous ICR indicated 128 respondents. The EPA has recently identified 97 respondents over the next three years based on a Section 114 request for the Ethylene Oxide Commercial Sterilization and Fumigation Operations from May 2021. Conclusively, there has been a 25% decrease in sources. This ICR also reflects that there is overall zero growth anticipated in the industry over the next three years, and removes the burden associated with new source activities. The overall result is a decrease in burden hours and operation and maintenance costs.
Annual Cost to Federal Government:
$16,400
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
Agency Contact:
Muntasir Ali 919 541-0833
Common Form ICR:
No
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:
11/23/2022
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