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 1 - Section B, Table 3
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 B (Room Area), Table 3 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) Validate your entries in Field B-1 of this supplement based on the main questionnaire. This means that every entry in Field B-1 of this supplement should be found in the same field (Field B-1) in "Room Area" worksheet, Table 1, of the main questionnaire; (3) In the main questionnaire - Leave the original table BLANK in order to avoid duplicates. Be sure to select “Yes” in Cell F82 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 the worksheet, shade all cells with CBI in red, then follow the instructions specified on the worksheet or in Section IV of the Instructions Document.

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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 each cell that contains CBI in red Before saving the non-CBI version of your response, select and copy the Sample CBI Cell (Cell O2), and paste directly into each cell that contains CBI. Make sure that all "CBI" cells are shaded in red

CBI

EIS ID (Auto-populated)

CAA Section 114 Information Collection Request (ICR)

Sample CBI Cell (above)

Supplement 1 - Section B, Table 3

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

B. Individual Room Area (All Areas where EtO is Used or Emitted)

Table 3. Leak Checks of Components in EtO Service

If leak checks are performed on multiple types of components in a room area, use another row in this table, repeat your entries in Fields B-1 and B-22, then fill out the other fields as necessary

Field #

B-1

B-22

B-23

B-24

B-25

B-26

B-27

B-28

B-29

B-30

B-31

B-32

B-33

B-34

B-35

B-36

B-37

Data

Room area ID for all rooms and areas where EtO is used or emitted

Are leak checks performed in the room area?

Component type

Total component count

What is the percentage of components that are included in regular leak checks?

Frequency of leak checks

Average length of time to perform leak checks

Instrument and standard method for leak checks

Leak check procedure

Average cost per inspection

Average percentage of leaking components identified

Definition of leak

Applicable state/local regulations

Repair method/procedure for the leaks identified

Average cost per repair for leaks identified

Are there any specialty components that are not readily available on site and that need to be ordered in the event of a component replacement?

Are there any other impediments that would prevent immediate repair of leaks?

Instruction

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

Select from the dropdown menu in this column

Select from the dropdown menu in this column If you select "Other (double click and type here)", be sure to enter your response between the parentheses Example: "Other (your component)"

Specify the total number of component of this type

Specify the percentage of components that are included in regular leak checks (percent)

Specify how often leak checks are performed

Enter average length of time to perform leak checks per component type, per inspection (hours)

Briefly describe the instrument and standard method used for leak checks

Describe the leak check procedure for each room area. Specifically, provide any action levels

Enter the dollar amount in this column

Specify the dollar year in this column

Enter average percentage of leaking components identified during each leak check (percent)

If applicable, specify the definition or criteria of leak in the state/local regulations that require leak checks, or the definition that facility refers to

Specify any state/local regulations applicable to your facility for leak checks

Provide a brief description of the repair method/procedure for the leaks identified

Enter the dollar amount in this column

Specify the dollar year in this column

Select from the dropdown menu in this column

How long does it take, on average, for the facility to receive the components? (days) (if you select "Yes" on the left)

Select from the dropdown menu in this column

List the impediments that would prevent immediate repair of leaks (if you select "Yes" on the left)

Response

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Sheet 3: Certification

Ethylene Oxide (EtO) Commercial Sterilization
CAA Section 114 Information Collection Request (ICR)
Supplement 1 - Section B, Table 3
Acknowledgment of CBI Handling Before certifying and submitting this supplement, please make sure that you have selected "Yes" in Cell N2 on the worksheet if CBI was entered, and shaded all fields that contain CBI in red. This should be the CBI version of your response. When creating a non-CBI version of your response, please save this Excel workbook as a new copy following the naming convention specified in Section V of the Instructions Document. Confirm that all fields that contained CBI before are now showing "CBI" with a red shade, and any embedded CBI document is deleted. Refer to Section IV in the Instructions Document for full details. Please submit both the CBI version and the non-CBI version of your response to 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 questionnaire) By checking this box, I confirm that all CBI data and documents have been deleted 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