Ethylene Oxide Standard (29 CFR 1910.1047)

Forms and Documents

Document Name	Status
30-day FRN (1218-0108) published.pdf Supplementary Document	2020-09-26
SSA (EtO) 1218-0108 9.9.20 smp edits 9.9.2020.docx Supporting Statement A	2020-09-10
respiratory_protection_standard ('20).pdf~RF375008.TMP Supplementary Document	2020-09-10
Rules of agency practice and procedure concerning OSHA access to employee medical records.('20).docx.pdf Supplementary Document	2020-09-10
29 CFR 1910.1047 (EtO) '2.docx Supplementary Document	2020-09-02
OSHA-2009-0035-0011 (15).pdf Supplementary Document	2020-07-27
OSH Sec.657('19).pdf Supplementary Document	2020-07-27
OSH Sec.655 ('19).pdf Supplementary Document	2020-07-27
OSH Act 651 ('17).docx Supplementary Document	2020-07-27

IC Document Collections

IC ID	Document Title	Status
242974	Appendix D (Ethylene Oxide)	New
14035	Ethylene Oxide (EtO)	Modified

ICR Details

OMB Control No: 1218-0108	ICR Reference No: 202007-1218-005
Status: Active	Previous ICR Reference No: 201809-1218-017
Agency/Subagency: DOL/OSHA	Agency Tracking No: 1218-0108(2020)
Title: Ethylene Oxide 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: 12/09/2020
	Date Received in OIRA: 09/28/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2023	36 Months From Approved	12/31/2020
Responses	112,013	0	100,952
Time Burden (Hours)	31,257	0	27,880
Cost Burden (Dollars)	4,970,808	0	4,250,388

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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:
	85 FR 31812	05/27/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 60837	09/28/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Ethylene Oxide (EtO)
Appendix D (Ethylene Oxide)

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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	112,013	100,952	0	0	11,061	0
Annual Time Burden (Hours)	31,257	27,880	0	0	3,377	0
Annual Cost Burden (Dollars)	4,970,808	4,250,388	0	0	720,420	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 increase in burden hours for this ICR. The burden hours have increased a total of 3,377 hours (from 27,880 hours to 31,257 hours). The adjusted increase is primarily due to an increase in the estimated number of establishments covered by the standard. There is an overall adjusted increase in capital costs of $720,220 (from $4,250,388 to $4,970,808). There was an increase number of medical exams administered. Also, the cost of exposure monitoring samples and medical examinations elevated as well.

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Annual Cost to Federal Government: $0

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: 09/28/2020

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