Ethylene Oxide (EtO) Commercial Sterilization Questionna

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Overview

Introduction
Worksheet
Certification

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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.

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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

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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