Ethylene Oxide (EtO) Commercial Sterilization Questionna

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

EtO_114ICR_Supplement3_v5.5.3_P2_12AUG21.xlsx

OMB: 2060-0733

Document [xlsx]
Download: xlsx | pdf

Overview

Introduction
Worksheet
Certification


Sheet 1: Introduction










Ethylene Oxide (EtO) Commercial Sterilization





OMB Control No. 2060-NEW
CAA Section 114 Information Collection Request (ICR)





Approval Expires mm/dd/yyyy
Supplement 3 - Section I, Table 1

























Paperwork Reduction Act Burden Statement
















This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2060-NEW). Responses to this collection of information mandatory under section 114(a) of Clean Air Act. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The average public reporting and recordkeeping burden for this collection of information is estimated to be proximately 108 hours per response. Send comments on the Agency’s need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.


















Introduction
















The U.S. Environmental Protection Agency (EPA) is requesting facility data and information to inform the Technology Review project for 40 CFR part 63, subpart O, Ethylene Oxide (EtO) Commercial Sterilization source category. The purpose of this ICR is to enable facilities to submit accurate facility information. For more detailed instructions on how to fill out, name and submit the main questionnaire, supplements and additional documents, refer to the Instructions Document for the Ethylene Oxide Commercial Sterilization Section 114 ICR at: https://www.epa.gov/stationary-sources-air-pollution/ethylene-oxide-emissions-standards-sterilization-facilities (click to visit).


















About this Supplement
















This is a supplement to the Section 114 ICR. You may use this supplement if more space is needed to provide the data requested in Section I (EtO Monitoring), Table 1 of the main questionnaire.

Please follow the instructions below if you prefer to use this supplement:
(1) Fill out the Facility Details section in this supplement so that data entered here can be linked to your main questionnaire upon submission;
(2) In the main questionnaire - Leave the original table BLANK in order to avoid duplicates. Be sure to select “Yes” in Cell F10 above the original table, indicating that this supplement is used.

This supplement contains worksheets and data fields shaded in different colors:
Worksheets and data fields shaded in green indicate that facility shall provide inputs according to the corresponding instructions
Worksheets and data fields shaded in gold contain instructions and supporting information that help facility with this questionnaire
Data fields shaded in gray indicate that these either do not need to be filled out or will be automatically filled out based on facility's inputs in relevant fields
Data fields shaded in red by facility indicate that these fields contain confidential business information (CBI), and relevant data needs special handling *
"Certification" worksheet in blue must be completed by facility before submission
If any information entered contains CBI, be sure to select "Yes" in the designated cell (Cell N2) on each worksheet, shade in red all cells with real CBI data in the CBI version, then follow the instructions in Section V of the Instructions Document to create the non-CBI version of your response.

Sheet 2: Worksheet































Ethylene Oxide (EtO) Commercial Sterilization





Does any information entered on this worksheet contain confidential business information (CBI)? Specify in Cell N2 on the right → Be sure to shade in red all cells with real CBI data in the CBI version
After creating the non-CBI version, select and copy the Sample CBI Cell (Cell O2) and paste directly into each cell with real CBI data. Make sure all cells that contained CBI look the same as the Sample CBI Cell (Cell O2) before saving the non-CBI version of your response

CBI
EIS ID
(Auto-populated)














CAA Section 114 Information Collection Request (ICR)





Sample CBI Cell
(above)














Supplement 3 - Section I, Table 1






































































A. Facility Details


























































Table 1. Facility Information




























Field # A-1 A-2 A-3 A-4 A-5 A-6 A-7 A-8


















Data Primary NAICS code EIS ID Facility name Facility address Facility city Facility state Facility zip code Phone number


















Instruction Enter the primary NAICS code for the facility Enter EIS ID for the facility Enter facility name Enter the street address of facility verified by U.S. Postal Service (USPS). Do not include P.O. box in this field Enter facility city Select from the dropdown menu in this column Enter facility zip code verified by U.S. Postal Service (USPS) Provide a contact phone number at the facility


















Response






















































































I. EtO Monitoring


























































Table 1. Personal Monitoring (Badges) for EtO




























List all personal monitoring events during the last 5 years




























Field # I-1 I-2 I-2.1 I-3 I-3.1 I-3.2 I-4 I-5 I-6 I-7 I-8
Data Unique ID Date Room area(s) involved and time spent on this personal (badge) monitoring event Description of Work Conditions Sampling method of personal (badge) monitoring Level of detection (LOD) as required by the sampling method Monitoring result Monitoring result flag Averaging periods Instrument 1 Instrument 2 (if any)
Instruction Enter from test report or documentation, if available. Otherwise, use a unique identifier for each personal monitoring event Enter date of the personal monitoring event
(mm/dd/yyyy)
Specify ID(s) of the room area(s) involved in this personal (badge) monitoring event, and provide an estimate of the percentage of time spent in each room area in parentheses "()". If there are multiple room areas involved, separate your entries by commas (,). Example: "Room Area 1 (40%), Room Area 2 (25%), Room Area 3 (35%)".
Ensure that all entries in this column can be found in the main questionnaire, "Room Area" worksheet, Table 1, Field B-1. Please double check before submission
Provide a brief description of the work conditions of facility during each personal monitoring event Specify the sampling method used for the personal (badge) monitoring Enter the value of LOD in this column Enter the unit of LOD in this column Enter the average concentration monitored
(ppm)
Enter the maximum concentration monitored
(ppm)
Enter the minimum concentration monitored
(ppm)
Specify any action level, error, or flag of monitoring result Specify any averaging periods for each personal monitoring event Specify the instrument used during each personal monitoring event Enter the value of detection level of instrument Specify the unit of detection level of instrument Specify the instrument used during each personal monitoring event Enter the value of detection level of instrument Specify the unit of detection level of instrument
Response


















Sheet 3: Certification

Ethylene Oxide (EtO) Commercial Sterilization









CAA Section 114 Information Collection Request (ICR)




















Click here to go to "Introduction"































Acknowledgment of CBI Handling

Before certifying and submitting this questionnaire, please make sure that you have selected "Yes" in Cell N2 on all the worksheets where CBI data were entered, and shaded in red all cells with real CBI data in the CBI version of your response.

Refer to Section V in the Instructions Document when creating the non-CBI version of your response. Confirm that all cells that contained CBI before look the same as the Sample CBI Cell (Cell O2), and any attached CBI document is deleted from the "Documents" worksheet before saving the non-CBI version.

Please submit both the CBI and non-CBI version of your response to the EPA. The non-CBI version will be made available to the public.

By checking this box, I acknowledge that I have read, understand, and agree to the instructions and procedure of handling CBI data and documents submitted within this response.

(Check this box only if this is the non-CBI version of your response) By checking this box, I confirm that all CBI data and documents have been removed from this response.






















Certification by Reporter




Certification by Facility Personnel














Complete the fields below for the person who completes the questionnaire and who is available for follow-up questions, if any, on the information provided in this questionnaire
Please complete the fields below for the facility personnel who certifies the information provided in this questionnaire (may be the owner or legal operator of the facility)

Name

Name
Title

Title
Organization

Organization
Email

Email
Phone

Phone
Fax

Fax
General comments

General comments















I certify that the statements and information are to the best of my knowledge and belief true, accurate, and complete.

I certify that the statements and information are to the best of my knowledge and belief true, accurate, and complete.














Signature
Signature







Date
Date

































Certification by Professional Engineer




Certification by Certified Industrial Hygienist














Complete the fields below for the professional engineer (PE) who certifies the information provided in this questionnaire
Complete the fields below for the certified industrial hygienist (CIH) who certifies the information provided in this questionnaire

Name

Name
Title

Title
Organization

Organization
Email

Email
Phone

Phone
Fax

Fax
General comments

General comments















I certify that the statements and information are to the best of my knowledge and belief true, accurate, and complete.

I certify that the statements and information are to the best of my knowledge and belief true, accurate, and complete.














Signature
Signature







Date
Date












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