Ethylene Oxide (EtO) Standard (29 CFR 1910.1047)

OMB Control No: 1218-0108	ICR Reference No: 201403-1218-008
Status: Historical Active	Previous ICR Reference No: 201105-1218-008
Agency/Subagency: DOL/OSHA	Agency Tracking No: 1218-0108(2014)
Title: Ethylene Oxide (EtO) Standard (29 CFR 1910.1047)
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: 06/26/2014
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/22/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2017	36 Months From Approved	06/30/2014
Responses	152,984	0	254,038
Time Burden (Hours)	35,051	0	41,484
Cost Burden (Dollars)	5,715,060	0	6,636,464

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Abstract: The standard requires employers to monitor worker exposure to Ethylene Oxide (EtO), to provide medical surveillance, and to establish and maintain accurate records of worker exposure to EtO. These records will be used by employers, workers, physicians, and the Government to ensure that workers are not harmed by exposure to EtO.

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Authorizing Statute(s): US Code: 29 USC 657 Name of Law: Occupational Safety and Health Act    US Code: 29 USC 651 Name of Law: Occupational Safety and Health Act    US Code: 29 USC 655 Name of Law: Occupational Safety and Health 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:
	79 FR 4178	01/24/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 22534	04/22/2014
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 (EtO)

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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	152,984	254,038	0	0	-101,054	0
Annual Time Burden (Hours)	35,051	41,484	0	0	-6,433	0
Annual Cost Burden (Dollars)	5,715,060	6,636,464	0	0	-921,404	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 overall adjustment decrease in burden hours for this ICR. The burden hours have decreased a total of 6,433 hours (from 41,484 to 35,051 hours). The adjustment primarily is due to a decrease in the estimated number of hospital facilities that use Ethylene Oxide (EtO). The total number of hospital facilities decreased since the last ICR from 4,001 to 3,155, a decrease of 846 facilities. There is an overall adjustment decrease in capital costs of $921,404 (from $6,636,464 to $5,715,060) resulting from a decrease in the number of hospitals using Ethylene Oxide; therefore, a reduction in the number of workers potentially exposed to EtO. This decrease off-sets the increase in the cost of a medical exam from $152 to $163; and the increase in the cost to analyze an exposure monitoring sample, from $56 to $61.

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Annual Cost to Federal Government: $132

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

Agency Contact: Robert Washington 202 693-2259 [email protected]

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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: 04/22/2014

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